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Foundation in Pharmacy PracticeBen J Whalley, Kate E Fletcher, Sam E Weston, Rachel L Howard and Clare F Rawlinson
Foundation in Pharmacy Practice
Foundation inPharmacy Practice
Ben J Whalley BPharm (Hons), MRPharmS, PhD
Lecturer in Clinical Pharmacy, Reading School of Pharmacy, University of Reading,UK
Kate E Fletcher MRPharmS, Dip Clin Pharm, PhD
Teacher Practitioner, Reading School of Pharmacy, University of Reading, UK Lead Pharmacist for Specialist Surgery, Royal Berkshire NHS Foundation Trust,Reading, UK
Sam E Weston MRPharmS, MBA
Teacher Practitioner, Reading School of Pharmacy, University of Reading,UK
Rachel L Howard MRPharmS, Dip Clin Pharm, PhD
Lecturer in Pharmacy Practice, Reading School of Pharmacy, University of Reading,UK
Clare F Rawlinson MPharm, MRPharmS, PhD
Lecturer in Pharmacy Practice, Reading School of Pharmacy, University of Reading,UK
London • Chicago
Published by the Pharmaceutical PressAn imprint of RPS Publishing
1 Lambeth High Street, London SE1 7JN, UK100 South Atkinson Road, Suite 200, Greyslake, IL 60030-7820, USA
© Pharmaceutical Press 2008
is a trade mark of RPS Publishing
RPS Publishing is the publishing organisation of the RoyalPharmaceutical Society of Great Britain
First published 2008
Typeset by J&L Composition Ltd, Filey, North YorkshirePrinted in Great Britain by Cambridge University Press, Cambridge
ISBN 978 0 85369 747 3
All rights reserved. No part of this publication may bereproduced, stored in a retrieval system, or transmitted in anyform or by any means, without the prior written permission ofthe copyright holder.
The publisher makes no representation, express or implied,with regard to the accuracy of the information contained in thisbook and cannot accept any legal responsibility or liability forany errors or omissions that may be made.
The rights of Ben J Whalley, Kate E Fletcher, Sam E Weston,Rachel L Howard and Clare F Rawlinson to be identified as theauthors of this work has been asserted by them in accordancewith the Copyright, Designs and Patents Act, 1988.
A catalogue record for this book is available from the British Library.
The authors dedicate this book to Dr R T Gladwell, Director of Teaching and Learning, Reading School of Pharmacy (2005–2007)
v i i
Contents
Foreword ixAbout the authors xAcknowledgements xii
1 What is Pharmacy Practice? 1Ben J Whalley
2 Structure and function of the NHS in England 9Rachel L Howard
3 An overview of community pharmacy – the role of the communitypharmacist: past, present and future 23Sam E Weston
4 An overview of hospital pharmacy 33Kate E Fletcher
5 An overview of industrial sector pharmacy 43Clare F Rawlinson
6 Introduction to medicines management 55Rachel L Howard
7 Structure and function of the Royal Pharmaceutical Society ofGreat Britain 71Kate E Fletcher
8 Essential communication skills for pharmacists 77Kate E Fletcher
9 Prescriptions – types and legal requirements 85Sam E Weston
10 Understanding and interpreting prescriptions 97Sam E Weston
v i i i Contents
11 Packaging of medicines 109Sam E Weston
12 Labelling of medicines 117Sam E Weston
13 Extemporaneous dispensing: a beginner’s guide 125Sam E Weston and Kate E Fletcher
14 Compliance, adherence and concordance 135Rachel L Howard
15 Sale and supply of medicines: risk and advice provision 151Rachel L Howard
16 Major routes of drug administration 169Kate E Fletcher
Glossary of terms commonly used in Pharmacy Practice 181Index 201
Many Schools of Pharmacy now introduce Phar-macy Practice at the start of the course to showstudents how Practice draws on clinical andscientific knowledge and to instil a professionalattitude from the very beginning. More practi-cally, students often take vacation and Saturdayjobs in a pharmacy to supplement their incomeas well as to gain experience and they need thebasics behind them to do so. Introducing Prac-tice at such an early stage means it is necessaryto start at a fundamental level. Until now therehas not been a suitable textbook to help thestudents or their teachers.
The authors, all members of the PharmacyPractice team at Reading, have experience of thePractice of pharmacy in all its guises: frommanaging – and owning – a community phar-macy and a locum agency, ethics committeemembership, PCT experience, and specialistclinical pharmacy, right through to pre-registration tutelage in both the hospital andcommunity sectors. They have already broughttheir experience to bear in devising a freshapproach to a new course, in a new School ofPharmacy. The introductory module proved sopopular with students that this textbook,including all the new material the team hadwritten, was suggested.
The scope of the book covers the structure ofthe NHS and RPSGB; the varied and changing
roles of the pharmacist in different sectors(including industry); an introduction to medi-cines management, law, ethics, confidentialityand duty of care; essential communicationskills; major routes of drug administration; avery useful section on dispensing: practicalities,labelling, legal issues relating to different typesof prescriptions and a beginners guide (withhandy tips) to extemporaneous dispensing androutes of administration; and a glossary ofcommonly used Pharmacy Practice terms.
Foundation in Pharmacy Practice is not only atextbook but it is also a teaching and learningresource, providing checklists, hints and tips.Teachers of Pharmacy Practice will find it usefulfor developing undergraduate courses, and pre-registration pharmacists will find it a valuableresource and revision guide, as will pharmacistsreturning to practice after a break, or thosemoving sector, from hospital to communitypharmacy for example. Most importantly, it willhelp the new undergraduate pharmacy studentto discover and find their way around theprofession they have chosen.
Elizabeth M Williamson, MRPharmSProfessor of Pharmacy and Director of Practice
April 2008
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Foreword
x
Ben J Whalley
Dr Whalley is a lecturer at the Reading Schoolof Pharmacy. In May 2006 he received an awardfor outstanding contributions to teaching andlearning support from the University of Readingfor his part in formulating and delivering thenew Pharmacy Practice course, and in particularthe development of novel teaching methods,including lecture podcasting and extensive useof the virtual learning environment. He is aqualified and registered pharmacist (1992), andobtained his PhD (Neuroscience) from theSchool of Pharmacy, University of London in2003. He continues to practise in the commu-nity sector as a registered pharmacist, hasworked as a practice-based pharmacist forBromley Primary Care Trust and has appeared asa scientific adviser in a number of televisionprogrammes. He also acts as Receiving Editor forthe European Journal of Neuroscience and is anExpert Pharmacist Member of the Thames ValleyMulti-Centre NHS Research Ethics Committeeand an Associate of the Institute of HealthSciences.
Kate E Fletcher
Since qualifying as a pharmacist in 1995, KateFletcher has worked in hospital pharmacy,specialising in general surgery, neurosurgery,neuro-intensive care and geratology. She hasworked at the Royal Berkshire NHS FoundationTrust in Reading for 4 years, and is currentlyLead Pharmacist for Specialist Surgery. She hasbeen involved with teaching nurses, doctors and
pharmacists for the past 7 years and has beena pre-registration pharmacist tutor for the past3 years, tutoring individual trainees and takingpart in delivery of the Thames Valley RegionalProgramme for Pre-Registration Pharmacists.She joined the Department of Pharmacy Practiceat the Reading School of Pharmacy in November2005, where she is involved in developingMPharm course content, lectures on a variety ofclinical and non-clinical subjects and supervisespractical sessions.
Sam E Weston
Sam Weston currently convenes Year 2 of thePharmacy Practice course of the School ofPharmacy at the University of Reading, and hasplayed a part in creating and delivering the newundergraduate MPharm course since January2006. She is a qualified and registered pharma-cist (1998), and is currently reading for her PhDat Reading School of Pharmacy, investigatingthe potential use of cannabis in the treatment ofepilepsy. She has an MBA (Open University) andalso runs a locum pharmacy agency, whilstcontinuing to work as a locum pharmacist in thecommunity, hospital and prison sectors.
Rachel L Howard
Rachel Howard has worked as a clinical pharma-cist for 10 years in both hospital and generalpractice, with particular experience in cardi-ology, care of the elderly and medical admissions.
About the authors
About the authors xi
Since 2000 she has conducted research into theunderlying causes of medication-related admis-sions to hospital and how these events can beavoided. This formed the basis for her PhD,awarded by the University of Nottingham in2006. Dr Howard has contributed chapters totwo books on patient safety, focusing on medi-cines management in primary care and theexploration of medication-related morbidity.She has worked with leading academics in thefield of patient safety, helping to develop a draftdesign specification for electronic prescribing forNHS prescribing systems and to test an IT-basedpharmacist-led intervention to reduce poten-tially hazardous prescribing in primary care. In2006 she took up the position of Lecturer inPharmacy Practice at the University of ReadingSchool of Pharmacy.
Clare F Rawlinson
Dr Rawlinson is a qualified and registered phar-macist (2002) who obtained her PhD in DrugDelivery at the Institute of PharmaceuticalInnovation, University of Bradford (2006). Herexperience spans industrial, hospital andcommunity sectors of pharmacy and she previ-ously held a Developmental Lectureship inPharmaceutics at the University of Bradford. Shehas recently developed the Law and Ethicsmodule of the Pharmacy Practice course atReading School of Pharmacy, where her otherroles include pre-registration placement tutorand Industrial Pharmacists Group representa-tive. She is a committee member of the Analyt-ical Science Network, which provides supportfor early career analytical scientists working inall sectors of industry, and which is affiliatedwith the Analytical Division of the Royal Societyof Chemistry. Dr Rawlinson is also a reviewer forthe International Journal of Pharmaceutics.
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The writing of any textbook is not conceived orconducted by the authors in glorious isolation.We would therefore like to thank all of the peoplewho have freely given advice, support and timeto this endeavour. Moreover, we would also liketo thank some particular individuals, withoutwhose efforts this process would have been muchharder, if not impossible: Professor E Williamsonfor her support and advice throughout the writingof this book, and Kevin Flint, David Allen andDaniel Grant for their help with photographs,figures and information sources. Also, manythanks to staff and patients at the Royal BerkshireNHS Foundation Trust for agreeing to have theirphotographs taken, in particular Mr W G V
Woodley, Claire-Louise Cartwright, JenniferCockerell, Dr Chloe Dallimore, Tania Jones,Adella Mutero, Sawsan Turkie, Amanda Wheelerand Jonathan Yazbek. We would also like tothank Dr Claudia Vincenzi and Dr Riddhi Shuklafor their contributions about careers in industrialpharmacy.
Finally, we should not forget that large partsof the Pharmacy Practice courses that we teachare influenced significantly by the studentswe are privileged to teach. Their enthusiasmfor, commitment to and engagement with ourcourses provide constant inspiration and moti-vation in our work, which we hope is reflectedin this book.
Acknowledgements
Introduction
The principal aim of this book is to provide anessential reference on Pharmacy Practice forPharmacy Masters (MPharm) students, particu-larly those just embarking on their study ofPharmacy at undergraduate level. As such, itprovides an overview of the major topics inPharmacy Practice encountered by such students,in a practical, clear and succinct manner.
As a text aimed at new Pharmacy students, it isnot intended as an exhaustive reference text foreach topic covered; rather, it should be consid-ered as a starting point for further study, facili-tated by regular signposting and referencing tothe many excellent advanced texts available.Students are strongly encouraged to pursue suchdirections as required, and as their overall level ofunderstanding and ability develops.
The rapidly changing nature of the professionand the unfamiliar terminology and acronymsthat are widely used often present barriers tostudents beginning their study of PharmacyPractice. This book provides a glossary ofcommon terms used in the discipline, which canbe used either as the book is read as a whole, oras a companion text during the study of othertexts on Pharmacy Practice.
This book also provides a practical guide toextemporaneous dispensing, including hints andtips for successful dispensing. This guide is to beused in conjunction with formal pharmaceuticaltexts such as:
• British Pharmacopoeia (BP)• British National Formulary (BNF; published
every 6 months)• Martindale: The Complete Drug Reference• Pharmaceutical Codex• Medicines, Ethics and Practice Guide for
Pharmacists and Pharmacy Technicians (MEP;published annually).
Pharmacy Practice: definitions
As a first step in undertaking the study ofPharmacy Practice, it is vital to understandwhat the term means. What is Pharmacy Practice?Which specific subject areas does it encompass?How does it relate and link to other relevantdisciplines that comprise the undergraduatePharmacy degree? Considering and answeringthese important questions will provide anoverview of the subject, a prerequisite for itssuccessful study and practice.
Introduction . . . . . . . . . . . . . . . . . . . . . . . 1
Pharmacy Practice: definitions . . . . . . . . . . 1
More than a definition . . . . . . . . . . . . . . . 2
Summary . . . . . . . . . . . . . . . . . . . . . . . . 7
References. . . . . . . . . . . . . . . . . . . . . . . . 7
1What is Pharmacy Practice?
Ben J Whalley
1
In simple terms, Pharmacy Practice is thediscipline within Pharmacy that involves devel-oping the professional roles of the pharmacist.Consequently, and within the scope of theMPharm degree, it can also be described asapplication of the knowledge and skills acquiredas part of the other related disciplines within theMPharm programme to actual patient care.
By giving careful consideration to the defini-tion above, it should be clear that a solid grasp ofPharmacy Practice is vital, since it facilitatesand enables pharmacists to fully exploit theirsubstantial knowledge and expertise in areassuch as pharmacology, pharmaceutics, chemistryand therapeutics within a clinical context.
More than a definition
Whilst the definition used above provides uswith the scope of the discipline, it is also impor-tant to consider the individual components thatcomprise the whole. The following areas can beconsidered as critical parts of the discipline.
Healthcare systems
To operate effectively and deliver the best careto patients, a pharmacist needs to understandthe way in which healthcare provision to thegeneral population is organised in the UK. Apharmacist should be able to comprehensivelyanswer questions such as:
• Which public and private organisationsdeliver healthcare to the population?
• Which professionals work in which areas toprovide such health care?
• What role does the UK Government play insuch provision?
• How do individual patients enter suchsystems for treatment?
As one of the largest employers in Europe, theUK’s National Health Service (NHS) has enor-mous scope and size, making the answers tothe above questions important. An overview ofpast and current NHS structure and healthcareprovision is provided in Chapter 2.
Public health (Chapter 2 )
As health professionals, pharmacists areconcerned not just with the treatment ofexisting disease states, but also with theirprevention and the promotion of healthierlifestyles. Consequently, the area of publichealth concerns the prevention rather than thetreatment of disease, often via the surveillanceof specific disease states and the promotion ofhealthy behaviours shown to reduce the inci-dence and/or severity of such states. This hasgiven rise to a definition of public health as thescience and art of promoting health, preventingdisease and prolonging healthy life through theorganised efforts of society.
The role of the pharmacist(see Chapters 3–5)
Many students entering the study of Pharmacyare already aware of the traditional role ofthe pharmacist as a dispenser of medicinesprescribed by doctors and other health profes-sionals; however, it is critical to appreciate thatthe pharmacist’s role has developed rapidly inrecent years to include many other roles beyondthe dispensing of drugs. In fact, with the adventand development of suitably qualified technicalstaff within the conventional dispensingprocess, the pharmacist’s role in this area is nowsteadily reducing and so gives rise to opportuni-ties that make better use of the pharmacist’sunique range of skills and expertise alongsidethose of other members of the healthcare team.Furthermore, the variety and specialisation of theroles performed by pharmacists within differentareas of the profession (community, hospital,industry, veterinary, etc.), have also producedconsiderable variety in what pharmacists actuallydo in their day-to-day work.
Communication skills (see Chapter 8)
The ability to communicate effectively andappropriately is a vital requirement for today’spharmacists. Given the number of people thata pharmacist communicates with on a regular
2 Chapter 1 • What is Pharmacy Practice?
basis – patients and other members of a health-care team (e.g. doctors, dentists, nurses etc.) – itis important that communication is conductedat an appropriate level. For example, considerthese two statements:
If the patient’s arterial hypertension is notadequately controlled, there may be a height-ened risk of heart attack, stroke, arterialaneurysm or chronic renal failure.
The medicines you have received are intendedto help reduce your high blood pressure. It isvery important that you take these medicines inthe way the doctor has advised, to keep yourblood pressure down. Not taking your medi-cines is likely to cause your blood pressure torise, which could eventually lead to increasedchances of problems with your heart or kidneys,or of you having a stroke.
It should be obvious that the first statementcontains specialised clinical terminology andwould be appropriate for a conversation with adoctor, specialist cardiovascular nurse or similarprofessional clinician; the second statement ismore suitable for a conversation with a patientreceiving treatment for hypertension. From theexamples given above, it should be clear thatthe way in which pharmacists communicatewith the different individuals they encounterin the course of their professional role is crit-ical in getting the right information across inthe right way, according to the individual’slevel of knowledge, need for specific informa-tion and relationship to the information beingdiscussed.
Clinical governance (see Chapters 3 & 6)
The term clinical governance describes a system-atic approach to maintaining and improvingquality of patient care. It has been previouslydefined as ‘A framework through which NHSorganisations are accountable for continuallyimproving the quality of their services andsafeguarding high standards of care, by creat-ing an environment in which excellence inclinical care will flourish’ (Scally & Donaldson,1998). This definition is based on three keyprinciples:
• recognisably high standards of care• transparent responsibility and accountability
for such standards• constant improvement.
Standard operating procedures(see Chapters 3 & 12)
Standard operating procedures (SOPs) are anintegral part of the pharmacist’s role. Theycomprise detailed written instructions forspecific tasks (e.g. dispensing, labelling andchecking of medication, disposal of unwantedmedicines, etc.) in order to achieve uniformity,safety and efficiency in the performance of thegiven task. It is critical that SOPs are reviewedregularly (the frequency of review requireddepends on the nature of the task beingdescribed), and also in the event of a near missor serious incident, all of which require recordkeeping and review in their own right. Theroutine use of SOPs and a formalised meansof recording, reviewing and reflecting upon(potentially) hazardous incidents enables phar-macists to improve the safety and efficiency ofthe services they provide to patients.
Adherence, compliance and concordance(Chapter 14)
How patients take their medicine – andwhether it is as the prescriber intended – aremajor issues in ensuring that disease states aretreated appropriately. Historically, clinicianstook a strongly paternalistic approach topatient care; patients were expected to ‘do asthey were told’ and so to comply and adhere tothe prescriber’s directions. More recently, thisviewpoint has largely fallen into disregard aspatients have become much better informedabout their own health and the available treat-ments for the disorders they have. However,one might also argue that, with the advent ofthe internet and the availability of largeamounts of unverified and frequentlyconflicting information, patients often ulti-mately end up being less reliably informed!These changes, coupled with broader ranges of
More than a definition 3
information for patients, have resulted in a seachange in patients’ and health professionals’perceptions of an effective patient relationshipbetween the patient and health professional.
To this end, a more concordant (concord-ance: ‘a harmony of opinions’) approach is nowadvocated where open discussion between thepatient and the health professional(s) involvedin his or her care is ongoing, with the aim ofagreeing a care plan with the patient thataccounts for more than just the prescriber’schoice of the best drug. In this regard, factorsthat might affect a patient’s ability or desire toadhere to a treatment plan are considered; thesemay be issues such as anticipated side-effects,suitable packaging and presentation (what useare child-resistant containers to a patient withchronic arthritis in the hands?), availability (apatient is unlikely to take a medicine that ishard to obtain or unreliable in its supply) andethical/belief factors (some medicines containingredients that may present a dilemma to apatient). Some of these factors, and theinfluences that they have had on our currentconcordance-based view and the pharmacist’srole in this area are discussed in Chapter 14.
Law and ethics
As with the majority of recognised healthprofessionals, a pharmacist’s role is determinedby law (e.g. The Medicines Act (1968), TheMisuse of Drugs Act (1971)), Royal Pharmaceu-tical Society of Great Britain (RPSGB) rules andgeneral biomedical ethics. As a result of this, acomprehensive knowledge of the legalities, rulesand ethical considerations is a critical require-ment for pharmacists; a requirement exem-plified by the fact that MPharm studentsundertake a specific ‘Law & Ethics’ examinationas part of the degree course.
From a pharmacist’s point of view, the reasonsfor this knowledge are twofold.
• Firstly, when acting as gatekeepers in theprovision of medicines, they must ensurethat they are acting within the constraintslaid down in law so as to protect themselves,the patient and the prescriber. A pertinent
example of this is the fact that, at the time ofwriting, a dispensing error is still considered acriminal offence with which you can beformally charged.
• Secondly, inevitable ethical and legaldilemmas arise frequently during the course ofpatient care; pharmacists must have a detailedunderstanding of, and working skills in, theapplication of ethical principles to guide themthrough the often difficult choices that theyare presented with.
Note that, with the frequent changes to the legaland ethical considerations for pharmacists, anyspecific and current discussion of law and ethicsrapidly becomes out of date. The MEP providesup-to-date guidance in this area.
Pharmaceutical care and diseasemanagement
The recent and rapidly accelerating change in thepharmacist’s role towards more clinical aspectshas significantly raised the profile of conceptssuch as pharmaceutical care, which can bedefined as ‘the design, implementation, andmonitoring of a therapeutic drug plan to producea specific therapeutic outcome’, and diseasemanagement – ‘the development of integratedtreatment plans for patients with long-termconditions’. As can be clearly seen from thesedefinitions, such approaches require consider-ably more from today’s pharmacists than simplydispensing medication in response to a validprescription, and fully justify an early introduc-tion of Pharmacy Practice within the MPharmdegree programme and the more clinical focus ofthe pharmacist’s role.
Clinical interventions (Chapter 15)
A clinical intervention can be defined as ‘anaction that is intended to alter the course of adisease process or its treatment’. Historically,pharmacists intervened when an error (over-dose, inappropriate medication, etc.) was identi-fied on a prescription presented by a patientto a community pharmacy or delivered to the
4 Chapter 1 • What is Pharmacy Practice?
dispensary from a hospital ward. More recently,the increasing clinical focus of the pharmacist’srole has broadened the range of situationswithin which a pharmacist may make an inter-vention. An understanding of these situationsand the ability to deal with them effectively andas part of the larger healthcare team is a criticalpart of a pharmacist’s training.
Continuing professional development (CPD)
The rapid pace of change within the healthcaresector, the introduction of new medications,therapeutic strategies and diagnostic approa-ches, and the widening role of the pharmacistall mean that every pharmacist must have anongoing commitment to continuing their owneducation and training vital for effective perfor-mance in their clinical and management roles.To this end, the RPSGB (the representative andregulatory body for pharmacists in the UK(excluding Northern Ireland)) recently intro-duced a mandatory requirement for annualevidence of accredited demonstration of CPD inorder to remain registered as a pharmaceuticalchemist. Pharmacists can engage with CPDthrough a wide variety of routes, includingaccredited ‘on the job’ training, distancelearning modules (via publications such asthe Pharmaceutical Journal or Chemist andDruggist and online via the Centre forPharmacy Postgraduate Education (CPPE;www.cppe.manchester.ac.uk)) and events runby the Local Pharmaceutical Committee, toname but a few. The concept of CPD for phar-macy students is frequently introduced early inthe MPharm degree programme, often in theform of academic portfolios that encouragereflection on critical events, learning objectivesand milestones. Consequently, the majority oftoday’s postgraduate pharmacy students arealready familiar with the principles of CPDbefore registration.
Extemporaneous dispensing (Chapter 13)
Extemporaneousdispensingrefers to theprocessof‘freshly’ preparing medicines to be provided to a
patient,etc.Thisprocess,whilstonthewanewithinthe community pharmacy sector, is still a relevantpart of the hospital pharmacist’s role. As such, asoundabilitytoextemporaneouslypreparemedica-tions suchascreams, lotions, syrups, suppositories,etc., is still a fundamental requirement for pharma-cists. Training and assessment in extemporaneousdispensingskills isan integralpartofapharmacist’s(and pharmacy student’s) development. As a newarea for the majority of students, it can often posedifficulties when adjusting to the conventions,considerations and concerns involved. To addressthese, this text includes a chapter devoted tospecific practical ‘tips’ for successful extempora-neous dispensing. Extemporaneous dispensingalso makes considerable use of a pharmacist’smathematical skills (principally associated withdilutions, concentrations and appropriate masscalculations); thus, competence in this area isan absolute necessity. The reader’s attention isdrawn to a case in which a pharmacist andpre-registration pharmacy graduate incorrectlyprepared Peppermint Water BP for treatment ofcolic in a baby (Pharmaceutical Journal, 2000)because they misunderstood the differencebetween concentrated chloroform and double-strength chloroform (used in Peppermint WaterBP). As a result, too much of this ingredient wasused, and the baby died. (See Box 15.10 (page 166)for more details.)
Health psychology and social pharmacy
People experience health and disease indifferent ways. Each individual’s experience isinfluenced by multiple factors, including theirculture, past events, attitudes of family andfriends, the society they live in, age, sex, socialclass, and their understanding of what ishappening to them. All these factors will influ-ence how and when patients seek medical helpand how they respond to medical (or otherhealth professionals’) advice and recommendedtreatments. In order to help patients gain themost benefit from their treatment, it is essentialthat pharmacists have an understanding of howthese factors may influence a patient’s behav-iour. This helps pharmacists to adapt theirapproach to individual patients. In addition, the
More than a definition 5
way in which individual pharmacists (and phar-macy as a profession) are perceived by patientsand other health professionals is influenced bysocial factors. An understanding of these factorscan help improve the way pharmacists commu-nicate with these groups and therefore howeffectively they practise.
Many of these issues are dealt with throughoutthis book, particularly patients’ experience ofhealth and illness and how this affects medicinetaking (Chapter 14).
Drug misuse and its treatment
Drug misuse, whether it presents as a patient’smisuse of prescribed/purchased medication orthe misuse of illicit drugs such as heroin,cocaine, cannabis, etc., falls within a pharmacist’sremit. In the former case, pharmacists are wellplaced to spot warning signs or indications thata patient may be misusing a medication, such asinappropriate use of a medication that may ulti-mately lead to the worsening of a condition (e.g.excessive use of ‘reliever inhalers’ in asthma) orabuse (e.g. of prescribed opioid-based anal-gesics). In the latter case, pharmacists mayencounter illicit drug users when attempts aremade to purchase items (e.g. syringes) or chem-icals (e.g. citric acid) used in the administrationof ‘street’ drugs. Moreover, if illicit drug usersenter sanctioned treatment programmes (e.g.methadone treatment for opioid dependency),their treatments are often dispensed by a singlepharmacy and on a daily basis; this treatmentand the consumption of the drug can, at theprescriber’s discretion, be conducted under thepharmacist’s personal supervision.
In both situations, a pharmacist must have asound appreciation of the associated psycho-logical considerations for the patient, excellentcommunication skills and a working knowledgeof the support systems in place for individuals insuch circumstances.
Identification, management and preventionof interactions
In highly simplistic terms, unwanted drug effectscan be divided into drug–body interactions (side-effects), drug–drug interactions and drug–foodinteractions. It should also be borne in mind,however, that the term ‘interaction’ can be usedto describe any effect a drug may have on apatient – including the desired therapeutic effect!Given a pharmacist’s expert knowledge of drugs,this is an area where they are very well placed toinfluence change in a patient’s treatment, use ofa medication(s), or alterations to diet and lifestylechoices in order to minimise or remove suchproblems. Other health professionals such asdoctors and nurses are often highly reliant onthe pharmacist’s knowledge in this area in opti-mising a patient’s treatment. The input of thepharmacist is also an invaluable contribution tothe concordance-based approach to treatment inwhich the health professional and patient agreeon a treatment plan (described in Chapter 14).
Adverse drug reactions
Adverse drug reactions are dangerous responsesin a patient to a particular treatment. We aretypically most aware of the risk of adverse reac-tions with newer drugs, because knowledgeabout the adverse-effect profile and likely inter-actions are more limited than with establisheddrugs, and exposure to large patient populationsis more limited. However, more established ther-apies can also produce adverse drug reactions viaidiosyncratic effects in some patients.
Moreover, research that uncovers issues associ-ated with new drugs may also raise doubts aboutestablished related treatments. For example, thecyclo-oxygenase 2 inhibitors were shown toincrease the risk of cardiovascular disease. As aresult, further investigation of more establisheddrugs (with a similar mechanism of action) was
6 Chapter 1 • What is Pharmacy Practice?
required to determine whether they pose similarrisks. By means of national adverse eventreporting systems (e.g. the Yellow Card Scheme forreporting to the Medicines and Healthcare prod-ucts Regulatory Agency/Committee on Safety ofMedicines; see page 27) or local policies, phar-macists are well placed to intervene and tohighlight suspected adverse drug reactions byvirtue of their expert knowledge.
Summary
From this brief overview of some of the maincomponents of Pharmacy Practice it should beclear that, in addition to the extensive scientific
training received by Pharmacy students andpharmacists, a diverse range of other skills anda competent means of exercising them arevital. Pharmacy Practice lies at the interface ofscientific knowledge and these other skills,enabling today’s pharmacists to operate effec-tively, safely and to the benefit of the patientand the healthcare team.
References
Pharm J (2000). 264 (7087): 390–392.Scally G, Donaldson L J (1998). Clinical governance
and the drive for quality improvement in the newNHS in England. BMJ 317: 61–65.
References 7
Introduction
This chapter describes the structure and func-tion of the National Health Service (NHS) inEngland. Following devolution of power in theUK, there are significant differences in thestructure of the NHS in England, Scotland,Wales and Northern Ireland. Only the NHSin England is described in detail. Differentprescription types for each country are, however,described in Chapter 9. This chapter begins bydescribing the history of the NHS and its struc-ture, followed by recent developments in theNHS. The chapter closes with a description ofthe roles of pharmacists within the NHS. Moredetailed information on the roles of pharma-cists working within community, hospital andindustrial pharmacy is given in Chapters 3, 4and 5. More detailed information on thehistory of the NHS and recent changes can befound at www.nhshistory.com.
History of the NHS
In 1942 Sir William Beveridge published SocialInsurance and Allied Services, a report to the UKgovernment in which he recommended thecreation of an NHS to provide care for all citizensthrough a system of central taxation and othercompulsory financial contributions (Beveridge,1942). In 1946, the National Health Service Actestablished the structure of the NHS for Englandand Wales. The NHS was born on 5 July 1948,providing services, free of charge, for the preven-tion, diagnosis and treatment of disease. Thiswas the first time in the world that completelyfree health care was made available on the basisof citizenship rather than the payment of fees orinsurance premiums (BBC, 1998a).
Before the creation of the NHS in England andWales, health care was a luxury that usually onlythe rich could afford. Most hospitals and doctorscharged for their care, and many poor people
Introduction . . . . . . . . . . . . . . . . . . . . . . . 9
History of the NHS . . . . . . . . . . . . . . . . . . 9
Structure of the NHS. . . . . . . . . . . . . . . . 10
Recent changes in the NHS . . . . . . . . . . . 16
Pharmacist roles within the NHS . . . . . . . 19
Summary . . . . . . . . . . . . . . . . . . . . . . . 22
References. . . . . . . . . . . . . . . . . . . . . . . 22
2Structure and function of the NHS in England
Rachel L Howard
9
relied on home remedies that could sometimesbe dangerous. The creation of an NHS, freeat the point of delivery, revolutionised accessto health care in England and Wales andcontributed to an increase in life expectancy ofmore than 10 years since 1948. Although nolonger truly free (the NHS charges for someservices, including prescriptions, spectacles anddental care to some individuals), care providedby general practitioners (GPs) and hospitalsremains free at the point of delivery. The NHSlargely remains true to its fundamental prin-ciples that health care should be free, availableto all, and of uniform quality no matter wherepeople live or their background (BBC, 1998b).
Since its creation, the NHS has struggledfinancially (BBC, 1998a). Demand has alwaysexceeded the resources available, and this has ledto repeated changes to the structure of the NHS inan effort to increase efficiency. These changescycle between centralised management (nationalpolicies driving the delivery of health care at alocal level) and localised management (localhealth needs driving the delivery of health careat a local level). The NHS is currently changingfrom centralised management to localisedmanagement (Department of Health, 1997).
Structure of the NHS
The structure of the NHS in England issummarised in Figure 2.1 and is described inmore detail below. From a patient’s perspective,the NHS is divided into two sectors: primary careand secondary care.
• Primary care is the first point of contact mostpeople have with the NHS. It is delivered by awide range of health professionals, includingGPs, dentists, pharmacists, nurses and opti-cians. Treatment in primary care focuses onroutine injuries and illnesses as well aspreventive care (public health), such ashelping people to stop smoking. Althoughprimary care is largely responsible forpeople’s general health needs, specialistservices are increasingly being provided inprimary care to improve access for patients.
• Secondary or acute care is usually provided byan NHS hospital. Services can be provided topatients as outpatients (patients attendhospital services during the day and do notstay overnight) or as inpatients (wherepatients are admitted to hospital and remainfor one or more nights). Admissions tohospital can be planned (elective admis-sions), for example if a patient needs a non-urgent operation; or unplanned (emergencyadmissions). More information on servicesprovided by secondary care can be found viathe NHS website (ww.nhs.uk).
The Department of Health
The NHS in England is led and supported by theDepartment of Health (DH) (see Box 2.1), whoseremit is ‘to improve the health and wellbeing ofthe people of England’ (Department of Health,2007). The DH is run by six government minis-ters and over 2000 staff members. The Secretaryof State for Health is the senior governmentminister and overall head of the DH and as suchtakes overall responsibility for NHS and socialcare delivery and system reforms, finance andresources, and strategic communications. TheSecretary of State for Health, the Prime Ministerand other health ministers are advised by theChief Medical Officer (CMO) (see Box 2.2) onthe delivery of health care.
Five further Chief Professional Officers advisethe Government and DH on issues relating tonursing, dentistry, health professions, scienceand pharmacy. The Chief PharmaceuticalOfficer (CPO) is the professional lead at the DHresponsible for implementing the Pharmacy inthe Future programme (see Box 2.3). Furtherinformation about the CPO can be found on theDepartment of Health website (www.dh.gov.uk).
The DH directs national policy on thedelivery of health care in England. This policyis given local strategic direction by the strategichealth authorities (SHAs) (see Box 2.4). Insteadof managing health care directly, the SHAssupport the work of local trusts and ensure thequality of that work. Within each SHA theprovision of NHS care is divided betweendifferent trusts.
10 Chapter 2 • Structure and function of the NHS
Structure of the NHS 11
Houses of Parliament
Secretary of State for Health Special Health Authorities
Provide health and social careservices to England
Strategic Health Authorities (SHAs)Strategic planning locally
Monitors provision of health care in EnglandHealthcare Commission
Provision of all local health and social care services
Department of Health (DH)Strategic planning nationally
Plan and commission local services
Care trusts Acute trustsMental health
trustsAmbulance
trusts
Primary care trusts (PCTs)
General practitionersPharmacists
DentistsOpticians
Walk-in centres
Accountable to
Accountable to
Accountable to
Accountable to
Funding
Funding
Funding
Figure 2.1 Structure of the NHS in England.
• Primary care trusts (PCTs) (see Box 2.5)manage and buy (commission) the healthservices necessary to treat their local popula-tion; they are better positioned than SHAs toassess local population health needs.
• NHS acute trusts (see Box 2.6) are commis-sioned by PCTs to manage the provision ofhospital services within the NHS, ensuringhigh-quality health care and efficient use ofmoney.
• Ambulance trusts (see Box 2.7) are commis-sioned by PCTs to respond to emergency (999)calls, transport patients, and, increasingly, toprovide out-of-hours care.
• Mental health trusts (see Box 2.8) arecommissioned by PCTs to provide specialisthealth and social care for patients withmental health problems.
A small number of care trusts exist in England tohelp local authorities (social service providers)and PCTs (health service providers) to developcloser working relationships between health andsocial care. This facilitates a coordinated carepackage for patients which covers their health
12 Chapter 2 • Structure and function of the NHS
Box 2.1 The Department of Health (DH)
The DH sets and communicates the strategic directionfor the National Health Service (NHS). The DH hasundergone many changes since its creation, as outlinedhere.
1919 Ministry of Health created to combine themedical and public health functions ofcentral government, and tocoordinate/supervise the local healthservices of England and Wales
1966 Ministry of Health and Ministry of SocialSecurity merged to form the Department ofHealth and Social Security
1998 Split into the Department of Health and theDepartment of Social Security
1989 Chief Executive and Leeds-based NHSExecutive created in response to theWorking for Patients White paper.
2003–4 DH reduced in size to six ministers, 2245staff and three executive agencies
The DH has six key objectives.
1. Improve and protect the health of the population,with special attention to the needs of the poorest,and those with long-term conditions
2. Enhance the quality and safety of services forpatients and users
3. Deliver a better experience for patients and users 4. Improve the capacity, capability and efficiency of
the health and social care systems5. Improve the service provided as a department of
state to, and on behalf of, ministers and thepublic, nationally and internationally
6. Become more capable and efficient as adepartment, and cement reputation as anorganisation that is both a good place to dobusiness with, and a good place to work
More information can be found atwww.dh.gov.uk/AboutUs/fs/en
Box 2.2 The Chief Medical Officer (CMO)
The first CMO was appointed in 1855 as the prin-cipal medical adviser to the government. The CMOis independent of the government, but based at theDepartment of Health. The CMO’s responsibilitiesinclude:
1. Preparation of policies and plans, andimplementation of programmes to protect thehealth of the public
2. Promotion and taking action to improve thehealth of the population and reduce healthinequalities
3. Leading initiatives in the National HealthService to enhance quality, safety andstandards in clinical services
4. Preparing and reviewing health policy.
More information can be found atwww.dh.gov.uk/AboutUs/MinistersAndDepartmentLeaders/ChiefMedicalOfficer/fs/en
Structure of the NHS 13
Box 2.3 Pharmacy in the Future
Pharmacy in the Future, published by the Department ofHealth in 2000, set out the role that pharmacists wouldplay in achieving the new NHS plan. It announced aprogramme of changes to provision of pharmacyservices, overseen by the Chief Pharmaceutical Officer.It included three challenges.
1. Meeting the changing needs of patients – pharmacistsshould provide easy access to medicines and adviceabout medicines, increase support to patients usingmedicines, and give patients confidence in theadvice they receive from pharmacists.
2. Responding to the changing environment –community pharmacy is becoming increasinglycompetitive and patients are demanding novel
services such as electronic ordering and homedelivery. Improvements in technology will requirefurther changes to ways of working.
3. Enhancing public confidence in the profession – inorder to perform expanded services, pharmacistsmust ensure they are up to date with theirknowledge and skills. Continuing professionaldevelopment must become the norm. Also,arrangements for dealing with things that gowrong must be modernised, for example reportingand learning from errors and near misses.
More information on Pharmacy in the Future can befound at the Department of Health website:www.dh.gov.uk
Box 2.4 Strategic health authorities (SHAs)
SHAs manage the National Health Service (NHS)locally on behalf of the Secretary of State, and are akey link between the Department of Health and theNHS. SHAs were created in 2000 by merging 100health authorities. Initially there were 28 SHAs, butthese were merged to just 10 in July 2006 to increaseefficiency.
SHAs are responsible for:
1. Developing plans to improve health services intheir local area
2. Ensuring local health services are high quality andperform well
3. Increasing the capacity of local health services sothey can provide more services
4. Making sure national priorities are integrated intolocal health service plans (e.g. programmes forimproving cancer services).
SHAs currently support and monitor the performance ofthe primary care trusts and hospitals in theirgeographic area; however, with the creation of theHealthcare Commission (see Box 2.11), the SHAs willbecome less involved in monitoring performance.
More information on SHAs can be found atwww.nhs.uk/England/Aboutnhs
Box 2.5 Primary care trusts (PCTs)
PCTs were formed in April 2002 from the primary caregroups. Originally, there were 303 PCTs acrossEngland, but from October 2006 this number wasreduced to 152, to increase efficiency. Most PCTs nowshare their boundaries with local authorities, in order tobetter coordinate health and social services.
PCTs report directly to their strategic healthauthority, and control approximately 80% of the moneyprovided by the Government to spend on health care inEngland. PCTs manage and pay for local servicesprovided by general practitioners, hospitals, pharma-cists, dentists, opticians, mental health services, NHSwalk-in centres, NHS Direct, and patient transport.
needs and the social support necessary for asmooth recovery.
In addition to the local trusts, the Govern-ment set up special health authorities to providecentralised services to the whole of England (seeBox 2.9). NHS Direct was set up under this
scheme and, with NHS walk-in centres (see Box2.10), is commissioned to provide rapid-accesshealth care to the general public.
The provision of health care in England isoverseen by the Healthcare Commission, anindependent health watchdog (see Box 2.11).
14 Chapter 2 • Structure and function of the NHS
Box 2.5 Primary care trusts (PCTs) (continued)
PCTs are responsible for:
• assessing the health needs of the local populationand local community
• commissioning (buying) the right services to meetthese needs
• improving the overall health of the local community• ensuring services can be accessed by everyone
who needs them• listening to, and acting on, patients’ views on
services• ensuring that organisations providing services,
including social care organisations, work togethereffectively
• conducting annual assessments of general practicesin their area.
Increasingly, PCTs are working with general practices tocommission health services (see Box 2.13). Some of theservices that PCTs currently provide (e.g. primary carepharmacists, school nurses, etc.) are being removed fromdirect PCT control as part of a ‘commissioner–providersplit’. In the future, these services will be commissionedby PCTs and general practice surgeries, and individualsperforming these roles will no longer be employed bythe PCTs.
Box 2.6 Acute trusts and foundation hospital trusts
Most hospitals within the National Health Service(NHS) are managed by acute trusts. Servicesprovided include: hospital admissions, day surgery(where an overnight stay is not needed) and out-patient services (where patients attend consultationsand clinics). Most patients are referred to hospital bytheir general practitioner (GP) (elective visits), butpatients can also attend without a GP referral inemergencies (non-elective or emergency visits).
Acute trusts employ most of the NHS workforce:doctors, nurses, hospital dentists, pharmacists,midwives, health visitors, managers, information tech-nology specialists, physiotherapists, radiographers,podiatrists, speech and language therapists, dieti-tians, counsellors, occupational therapists, psycholo-gists, and support staff, including receptionists,porters, cleaners, engineers, caterers and domesticand security staff.
Not all hospitals are the same. Some providespecialist centres for disease management. Teachinghospitals are linked to universities and help to trainhealth professionals. Hospitals not linked to universi-ties are usually known as district general hospitals.Hospitals that provide exceptionally efficient and high-quality services can apply to become foundationhospital trusts. These are run by local managers, staffand members of the public. Foundation trust status hasmany benefits, including greater control over theservices provided and less frequent monitoring by theHealthcare Commission (see Box 2.11). Increasingly,some healthcare services traditionally provided byhospitals, such as minor surgery and diagnostic proce-dures, are being commissioned from independentsector treatment centres – privately run treatmentcentres which target their services at areas that havetraditionally had long waiting times.
Structure of the NHS 15
Box 2.7 Ambulance trusts
Thirteen ambulance trusts in England provide emer-gency services on behalf of primary care trusts (PCTs).Ambulance services are coordinated by a control room,which decides how urgently an ambulance is needed.Levels of urgency are divided into three categories:
A: immediately life-threatening emergenciesB: serious conditions that are not immediately life
threateningC: non-urgent conditions.
The control room decides which service is needed,when to send out a vehicle and which type of vehicleto send – an ambulance or a rapid response vehicle(usually a car) staffed by a paramedic. In non-urgentconditions the control room may recommend contactingthe general practitioner or attending a walk-in centre.
In addition to providing emergency transport, manyambulance trusts also provide routine transport forpatients to attend hospital clinics.
Box 2.8 Mental health trusts
Although many mental health problems can betreated by general practitioners in primary care,approximately two in every 1000 people willrequire more specialist care. This care is providedby the mental health trusts. Services include:
• inpatient beds in specialist mental health units• counselling• electroconvulsive therapy• specialist services for children and adolescents• specialist substance abuse services• prison mental health services• mental health crisis resolution• community-based accommodation• assessment of offenders for mental health
problems• day care for patients with mental health problems• assessment, rehabilitation and training in the
field of work and employment.
Box 2.9 Special health authorities
Special healthauthoritiesprovidecentralised servicesto the whole of England. Some of these are describedbriefly below. Further information on the functions oftheseauthorities canbe foundon theirwebsites.
• National Institute for Health and ClinicalExcellence (NICE) makes recommendations ontreatments and care using the best availableevidence (www.nice.org.uk).
• National Patient Safety Agency (NPSA),created in July 2001, coordinates significantevent reporting across England, and helps theNational Health Service (NHS) to learn frommistakes and problems affecting patient safety(www.npsa.nhs.uk).
• Health Protection Agency (HPA) is dedicated toprotecting people’s health and reducing theimpact of infectious diseases, chemicalhazards, poisons and radiation hazards(www.hpa.org.uk).
• National Treatment Agency for SubstanceMisuse (NTA) aims to increase the availability,capacity and effectiveness of treatment for drugmisuse in England (www.nta.nhs.uk).
• NHS Blood and Transplant (NHSBT), created inOctober 2005, provides a reliable and efficientsupply of blood, organs and associated servicesto the NHS (www.nhsbt.nhs.uk).
• Information Centre for Health and Social Care(IC), created in August 2005, collects, analysesand distributes national statistics on health andsocial care (www.ic.nhs.uk).
Recent changes in the NHS
In the 1980s and early 1990s the Conservativegovernment increased the power of GPs inthe NHS and introduced performance-relatedpay by offering financial incentives toencourage improvements in quality of care(Moore et al., 1987). In addition, they createdan internal NHS market, arguing that compe-tition between healthcare providers would
also improve the quality of health care.Increasingly, spending power was transferredto primary care (Parliament, 1996a, b). Powerin the NHS was centralised, graduallychanging 14 regional health authorities intoeight regional offices of the DH. Responsi-bility for planning, funding and deliveringhealth care, however, was split between 100health authorities, around 3500 GP fund-holders (representing half of GP practices) and
16 Chapter 2 • Structure and function of the NHS
Box 2.10 NHS Direct and NHS walk-in centres
NHS Direct was created in March 1998 to provideconfidential nurse-led health advice over the telephone24 hours a day, every day, for example:
• what to do if you or a family member feels ill• self-care for health conditions such as coughs and
colds• local health services, such as doctors, dentists and
out-of-hours pharmacies• self-help or support organisations.
Additional information for patients is available throughthe internet (www.nhsdirect.nhs.uk) and the digital televi-sion service, including a health encyclopedia and adviceon self-management of minor ailments. If patients requirenon-urgent information, which is not on the website, theycan send an enquiry to the information team.
Eighty-four NHS walk-in centres in England providefast no-appointment advice and treatment for minorconditions. The centres are run by nurses and usuallyopen every day from early morning to late evening.They offer a range of services, including:
• assessment by an experienced National HealthService nurse
• treatment for minor illnesses and injuries• advice on staying healthy• information on other health services such as out-of-
hours care and dental services.
Further information on NHS Direct and NHS walk-incentres can be found via the NHS website(www.nhs.uk).
Box 2.11 The Healthcare Commission
TheHealthcareCommissionwas createdunder theHealthand Social Care (Community Health and Standards) Act2003 as an independent health watchdog for England.The Healthcare Commission is accountable to theSecretary of State for Health, and advises and informs theSecretary of State for Health about healthcare provisionby, or for, National Health Service (NHS) bodies.
The Healthcare Commission’s objectives are:
1. to inspect the quality and value for money ofhealth care and public health
2. to equip patients and the public with the bestpossible information about healthcare provision
3. to promote improvements in health care andpublic health.
The Healthcare Commission performs annual checks ofeach local NHS organisation. Organisations arescored: excellent, good, fair or weak on the basis ofthe quality of services provided and resource use.
More information can be found atwww.healthcarecommission.org.uk.
over 400 NHS acute trusts (Department ofHealth, 1997).
The New NHS
When the Labour government came to power in1997, the NHS was once again in financial crisis.This government argued that there was littlestrategic coordination of NHS services, and thatthe internal market had increased expenditureon administration, created divisions betweenhealth professionals, and led to inequalities inpatient care. Labour published The New NHS.Modern. Dependable and developed their first10-year plan to modernise the NHS, replacingthe competitive internal market with patientcare that would be driven by integration andhigh standards of performance (Department ofHealth, 1997). Despite its criticism of theConservative goverment’s changes to the NHS,the majority of Labour’s proposed reforms builton these changes, focusing on quality, efficiencyand performance, and resulted in the introduc-tion of the National Institute for Clinical Excel-lence (NICE; now called the National Institutefor Health and Clinical Excellence), NationalService Frameworks (NSFs), Primary Care Groups(PCGs), the Healthcare Commission and theconcept of ‘clinical governance’ (Rivett, 2007).NICE develops evidence-based guidelines forpublic health, health technologies and clinicalpractice (see www.nice.org.uk for more informa-tion). The NSFs introduced national standards ofcare for a range of clinical conditions andpatient groups, including older patients andchildren. Primary care groups (later changed toPCTs) encouraged local GPs and nurses to worktogether, focusing on prompt, accessible, seam-less care delivered to a high standard. TheHealthcare Commission was established toensure high standards of health care throughoutthe NHS (see Box 2.11).
In addition, proposals to improve NHS perfor-mance centred on better use of informationtechnology (Department of Health, 1997). NHSDirect (see Box 2.10) provides 24-hour care viatelephone, and the NHSnet and internet allowrapid access to information. Linking laboratoriesto GPs’ computer systems allows results of blood
tests to be communicated electronically to GPsurgeries, and the National Library for Health(www.library.nhs.uk) provides a wealth of infor-mation for health professionals. Patients canalso get rapid access to information throughNHS Direct online (www.nhsdirect.nhs.uk) andvia digital television. Plans still to be imple-mented include the single electronic patientrecord. This will be an online record that willprovide up-to-date and timely information tohealth professionals about patients’ medical andmedication histories, and care they havereceived.
The NHS Plan
The changes in healthcare provision set out inThe New NHS. Modern. Dependable (Departmentof Health, 1997) did not achieve what theLabour government hoped for. Therefore, intheir second term in government, Labourannounced further changes, with the publica-tion of their second 10-year plan ‘The NHSPlan’ (Department of Health, 2000a). Thesechanges encompassed government spending onthe NHS (to increase by 50% over 5 years),staffing, infrastructure and patient involvementin the NHS. As a result of these changes,patients:
• can influence how NHS services are organisedthrough patient consultations and patientadvisory and liaison services (PALS) (wherepatients can comment on the health carethey have received and suggest changes)
• receive more information about the type ofcare they receive and the performance ofhospitals where they receive care
• choose which local provider they want toreceive their care from.
Staffing changes included:
• increased numbers of, and better paid,healthcare staff – numbers of health profes-sionals were initially increased under theLabour reforms; however, financial difficul-ties, caused by underestimating the cost ofnew contracts for doctors (under the new GPand consultant contracts) and other staff
Recent changes in the NHS 17
(under Agenda for Change) have meant thatstaffing levels are falling again
• new contracts of employment for hospitalconsultants (October 2003) and GPs (April2004) – the new GP contract included pay-ments through the Quality and OutcomesFramework (QOF) (see Box 2.12), which hasacted as an incentive for GPs to improveservices to patients
• better use of healthcare staff skills – the roles ofmany non-medical health professionals havebeen extended. For example, appropriatelyqualified pharmacists and nurses can nowprescribe medicines within the confines of aclinical management plan which is agreedwith the patient and doctor (supplementaryprescribing) or independently (independentprescribers).
Changes to NHS infrastructure included:
• building new hospitals and GP surgeries• increased training places for medical students• creation of foundation trusts for hospitals
that perform exceptionally well• creation of care trusts to facilitate closer
working between healthcare and social careproviders
• closer working with private providers ofhealth care – local commissioning of health-
care services now allows private providers toperform minor surgery for example. Theprivate sector is increasingly becoming anintegral part of NHS care.
Shifting the balance of power
In 2001, the Secretary of State for Healthannounced further changes to the NHS in a seriesof speeches and white papers called ‘Shifting thebalance of power’, in order to achieve the objec-tives set out in the NHS Plan (Department ofHealth, 2001a, b; 2002). These changes included:
• shifting commissioning of healthcare servicesto PCTs
• devolving responsibility for the strategicdirection of local healthcare services to SHAs(Box 2.4).
Creating a patient-led NHS
In 2005, further guidance on implementing theNHS Plan was announced through the ‘Creatinga Patient-led NHS’ programme (Department ofHealth, 2005). This consisted of a series ofwhite papers detailing how patients shouldbecome more involved in decisions about the
18 Chapter 2 • Structure and function of the NHS
Box 2.12 Quality and Outcomes Framework (QOF)
The QOF forms part of the General Medical Servicescontract introduced in April 2004. It provides financialincentives togeneralpractitioners toencourageprovisionof high-quality care. The QOF measures the achievementof general practices against a range of evidence-basedclinical, practice organisation, and management indica-tors. Practices score points according to their levels ofachievement against these indicators, and payments topractices are calculated from the points achieved. Thesepayments can then be used to further improve patientcare. The QOF is divided into four domains:
• clinical – 76 indicators in 11 disease areas,including heart disease, lung disease, diabetesand epilepsy. The majority of points are awardedin this domain
• organisational – 56 indicators in five areasincluding record keeping, communication withpatients, and medicines management
• patient experience – four indicators coveringpatient survey and consultation length
• additional services – ten indicators in four areas,including cervical screening, child healthsurveillance, maternity services and contraceptiveservices.
The indicators are reviewed each year to encouragefurther improvements in quality of care.
Further information on the QOF can be found atwww.ic.nhs.uk/services/qof andwww.primarycarecontracting.nhs.uk.
provision of healthcare services, and healthprofessionals in the commissioning of localhealthcare services through practice-basedcommissioning (see Box 2.13). It was hopedthat increased patient control over the provi-sion of health services would improve costeffectiveness and efficiency in the NHS(Wanless, 2002). In addition, the introductionof ‘payment by results’ (see Box 2.14) was alsointended to increase efficiency. These reportsalso paved the way for reducing the number ofSHAs from 28 to 10 and PCTs from 303 to152, in order to create more money to spenddirectly on patient care by reducing the moneyspent on management. In addition, thesechanges meant that many PCTs have the sameboundaries as local authorities, making iteasier to link the provision of health care andsocial care.
Pharmacist roles within the NHS
Of all the health professionals, pharmacistshave the most detailed education in the use ofmedicines. They are ideally placed to supportother health professionals in medicinesmanagement and, increasingly, to take the leadin managing patients. This potential wasrecognised in ‘Pharmacy in the Future: Imple-menting the NHS Plan’ (see Box 2.3) (Depart-ment of Health, 2000b). Pharmacists mostlywork within three areas of the NHS: commu-nity pharmacies, hospitals and primary care.Further information on the roles of pharma-cists working in different areas is available ina series of articles published in the Pharma-ceutical Journal (available via www.pharmj.com)and in Chapters 3 and 4.
Pharmacist roles within the NHS 19
Box 2.13 Practice-based commissioning (PBC)
PBC is an opportunity for all primary health profes-sionals (not just GPs) to improve services for their localpopulations. Practices can work with their local primarycare trusts (PCTs) to commission these services. Prac-tices decide which services are needed, whilst PCTsmanage the bureaucracy of commissioning servicesand provide incentives to engage practices in thecommissioning process. Many PCTs are recommendingthat practices form clusters (groups of practices withsimilar patient groups) for commissioning because
larger groups will have more power to buy the servicesthey need. Practices are encouraged to think creativelyabout new ways to provide services. It is hoped that PBCwill transfer some services from secondary care toprimary care, making such services more accessible topatients and more cost efficient. Practices will beallowed to keep up to 70% of the cost savings generatedby PBC to further improve patient care locally.
More information about PBC can be found on theDepartment of Health website (www.dh.gov.uk).
Box 2.14 Payment by results (PbR)
PbR aims to provide a transparent, rules-based systemfor paying hospitals for the services they provide. Inthe past, hospitals were paid in advance for theirservices through ‘block contracts’. Contracts werenegotiated locally and the amount paid was based onthe expected workloads. If less work than expectedwas done, hospitals kept the extra money; if morewas done than expected, hospitals were paid for theextra work. PbR moves away from this system by
paying a fixed rate (tariff) for a service each time it isprovided. The tariff is calculated from the average costof providing a service. If a service is provided for lessthan the tariff cost, then the provider will make aprofit. Conversely, if the service costs more than thetariff, the provider will make a loss. This willencourage efficiency.
More information on PbR can be found on theDepartment of Health website (www.dh.gov.uk).
Community pharmacists
The majority of pharmacists (70%) work incommunity pharmacy (Hassell et al., 2006) and80% of their work is for the NHS (Department ofHealth, 2003b). The major work of communitypharmacists involves supplying medicines tothe public, either by dispensing prescriptions orby selling medicines to treat minor ailments. Acommunity pharmacist must be present at apharmacy for medicines to be supplied. Thesupply of medicines requires pharmacists toperform a number of tasks, including:
• assessing the safety of prescriptions for patients• ensuring that prescriptions and medication
labels are legal and accurate• advising patients on how and when to take
their medicines, which medicines to avoid,and possible side-effects of medicines andwhat to do if they occur
• advising patients which over-the-countermedicine they should take to treat a minorailment.
Increasingly, the community pharmacist’s role isexpanding into new and exciting areas, helpedby the introduction of the new PharmacyContract, extension of prescribing rights to non-medical health professionals, and support by thegeneral public (Department of Health and HMGovernment, 2006). The changes to the NHSdescribed earlier have opened up new opportu-nities for community pharmacists (Departmentof Health, 2003b). PCTs and general practices arenow commissioning community pharmacists toprovide services that would only previouslyhave been supplied by hospitals or GPs (PrimaryCare Contracting, 2006).
• Medicines use reviews – community pharma-cists are paid to liaise with patients about theirmedicines. Community pharmacists have theopportunity to assess patient understanding,identify problems and provide solutions.Another medicines management role isvisiting patients at home after discharge fromhospital, helping them to avoid problemswith their medication such as confusion overwhich medicines to take, difficulties openingpackaging or side-effects from medication.
• Minor ailments schemes – community phar-macists can supply medicines free of chargeto patients (who would not normally pay fortheir medicines) to help treat minor ailmentssuch as fever, cough, etc. Such schemesreduce the need for patients to attendhospital emergency departments.
• Public health schemes – some communitypharmaciesoffer smokingcessationclinics andhelp with obesity management (Departmentof Health, 2003a).
• Substance misuse support – communitypharmacists can provide needle exchangeschemes, observed methadone administra-tion and other support services to help drugaddicts or misusers of other substances tostop.
• Point of care testing – community pharma-cies can offer testing for disease management(e.g. for diabetes, heart disease or anticoagu-lation monitoring). These services can alsoinvolve diagnostic testing for heart disease ordiabetes. These services help the NHS to meetthe standards set out in the NSFs.
• Repeat dispensing – patients receive repeatsupplies of their medication without needingto contact their GP surgery. This differs fromrepeat prescribing, where a patient requests asigned prescription from the GP surgery andthen takes it to the pharmacy.
• Patient education – in addition to coun-selling patients about their medication,community pharmacists can also run educa-tion sessions about general disease manage-ment, and provide written information on arange of conditions, medicines and services.
In addition, community pharmacists are oftenresponsible for managing their businesses, andmust therefore run the pharmacy efficiently andprofitably. This can include financial manage-ment (ensuring that the pharmacy makes aprofit), merchandising (advertising the productssold in the pharmacy), responsibility for staff andpremises (people management), stock control(ensuring that sufficient stock is available to meetcustomer demands), stock rotation (ensuringthat old stock is used before new stock) andordering. To keep their pharmacies profitable,pharmacists often sell non-pharmaceutical
20 Chapter 2 • Structure and function of the NHS
products such as cosmetics, toiletries and photo-graphic products (including developing andprinting photos).
During their working day, community phar-macists work closely with patients (advisingthemontheirmedicines) andprescribers (helpingthem select the most appropriate medicationfor a patient or resolving problems with prescrip-tions). They also work closely with pharmacysupport staff such as technicians and counterassistants. Further information on the role ofcommunity pharmacists is given in Chapter 3.
Hospital pharmacists
Around 20–25% of pharmacists work in hospitalpharmacies (Hassell et al., 2006), performingessential roles in medicines’ supply and ensuringthat medicines are used safely, effectively andeconomically (Audit Commission, 2001; Depart-ment of Health, 2003b). This complex roleinvolves working closely with patients, doctors,nurses, other health professionals, and phar-macy support staff (technicians and assistanttechnical officers). Pharmacists performnumerous roles in the hospital setting:
• checking hospital prescription charts forlegibility, accuracy, legality and clinicalappropriateness, in the dispensary and onthe ward
• overseeing the dispensing of medicines tohospital wards and patients
• clarifying patients’ medication histories onadmission to hospital
• organising patients’ medication for dischargefrom hospital
• discussing patients’ medication regimenswith them, ensuring they understand whenand how to take the medications, what totake them for and important side-effects tolook for and what to do if they occur
• liaisingwithdoctorstoensurethatprescriptionsare clinically appropriate and cost-effective
• liaising with nursing staff to ensure thatmedicines are stored and administeredappropriately
• answering enquiries from health profes-sionals and the public about medicines
• organising supplies of medicines for use inclinical trials.
As the focus of the NHS has turned to efficiencyand quality, hospital pharmacists must respondby providing efficient and safe supply of medi-cines as part of the drive to increase the effi-ciency and quality of care in the hospitalsthey work for. In common with communitypharmacists, the role of hospital pharmacistshas expanded with the changes in the NHS.Pharmacists are increasingly taking part in wardrounds, prescribing medicines as supplemen-tary or independent prescribers (or under thedirection of hospital consultants as part of apatient group direction), promoting the appro-priate and rational use of antibiotics, over-seeing the production of specialised productsnot available from pharmaceutical companies,and helping to ensure that patients are safelydischarged by liaising with community andprimary care pharmacists.
Further information on the roles of hospitalpharmacists in the NHS can be found in a seriesof careers articles published in Hospital Pharmacist(available from www.pharmj.com/hp) and inChapter 4.
Primary care pharmacists
Only 8% of pharmacists work in primary care,the newest role for pharmacists (Hassell et al.,2006). Primary care pharmacists are taking onnew roles and working in new areas where phar-macists have not traditionally been present,such as general practices. Pharmaceuticaladvisers have strategic roles, directing the provi-sion of services and overseeing the use of medi-cines in their local area. Practice pharmacistshave clinical roles similar to that of hospitalpharmacists. They work closely with patientsand GPs to ensure safe and cost-effective useof medicines. Primary care pharmacists canhelp general practices to reduce the amountof money spent on medicines by switching tocheaper equally effective products, whereappropriate, and to develop formularies. Theyhelp general practices to adhere to guidelinesfor medicines’ usage developed by NICE and
Pharmacist roles within the NHS 21
to meet targets for medicines’ managementdetailed in the NSFs and QOF. Primary care phar-macists support GPs in reducing inappropriateprescribing that might otherwise contribute tohospital admissions. They reduce GP workloadsby conducting medicine review clinics andreviewing hospital discharge prescriptions (themedicines that patients are prescribed whenthey leave hospital), helping to ensure thatpatients are treated optimally when they returnhome.
Summary
This chapter should have given you a betterunderstanding of the structure of the NHS andhow recent changes have affected healthcareprovision in England. In addition, you shouldhave an appreciation of the rapidly expandingroles of pharmacists in healthcare provision.
References
Audit Commission (2001). A Spoonful of Sugar –Medicines Management in NHS Hospitals, London:Audit Commission. (Accessible via www.audit-commission.gov.uk.)
BBC (1998a). The NHS: ‘One of the greatest achieve-ments in history’. Available from http://news.bbc.co.uk/1/hi/events/nhs_at_50/special_report/ 123511.stm(accessed 23 January 2007).
BBC (1998b). True to its principles? Available from http://news.bbc.co.uk/1/hi/events/nhs_at_50/special_report/125891.stm (23 January 2007).
Beveridge W (1942). Social Insurance and Allied Services(The Beveridge Report). CMND 6404, London:Stationery Office.
Department of Health (1997) The New NHS. Modern.Dependable. Cm 3807.
Department of Health (2000a). The NHS Plan: a Planfor Investment, a Plan for Reform. London: StationeryOffice.
Department of Health (2000b). Pharmacy in the Future:Implementing the NHS Plan. London: Department ofHealth.
Department of Health (2001a). Shifting the Balance ofPower Within the NHS: Securing Delivery. London:Department of Health.
Department of Health (2001b). Shifting the Balance ofPower: Securing Delivery – Human Resources Frame-work. London: Department of Health.
Department of Health (2002). Shifting the Balanceof Power: the Next Steps. London: Department ofHealth.
Department of Health (2003a).Tackling Health Inequal-ities: A Programme for Action. London: Departmentof Health.
Department of Health (2003b). A Vision for Pharmacyin the New NHS. London: Department of Health.
Department of Health (2005). Creating a Patient-ledNHS: Delivering the NHS Improvement Plan. London:Department of Health.
Department of Health (2007). Department of Health:About Us. Available from http://www.dh.gov.uk/AboutUs/fs/en (accessed 25 January 2007).
Department of Health & HM Government (2006). OurHealth, Our Care, Our Say: a New Direction forCommunity Services. Cm 6737, London: StationeryOffice.
Hassell K, Seston L, Eden M (2006). Pharmacy WorkforceCensus 2005: Main Findings. University ofManchester.
Moore J, Walker P, King T, Rifkind M (1987) PromotingBetter health: the Government’s Programme forImproving Primary Health Care. Cm 249, London:Stationery Office.
Parliament (1996a). Choice and Opportunity. PrimaryCare: the Future. Cm 3390, London: StationeryOffice.
Parliament (1996b) Primary Care: Delivering the Future.Cm 3512, London: Stationery Office.
Primary Care Contracting (2006). Practice BasedCommissioning (PBC) Bulletin 5 – Pharmacy andPBC. Available from www.primarycarecontracting.nhs.uk (accessed 30 January 2007).
Rivett G (2007). Introduction to the Decade from 1998.Available from www.nhshistory.net (accessed 30January 2007).
Wanless D (2002). Securing Our Future Health: Taking ALong-Term View. Final Report. London: HM Treasury.
22 Chapter 2 • Structure and function of the NHS
Introduction
More pharmacists currently work in the commu-nity sector than in any other part of the pharma-ceutical industry – nearly 75% work in thissetting, either employed by multiple pharmacychains as pharmacists, pharmacy or storemanagers or relief pharmacists, or self-employed as pharmacy owners or locums. Thisrole has changed significantly over the years,and continues to develop at a rapid pace aspharmacists rise to the challenges and changespresented to them by the ever-changingNational Health Service (NHS).
In the UK, a community pharmacist canexpect to consult with up to 15 patients a dayon an over-the-counter (OTC) basis (Figure 3.1),as well as interacting with patients who arepresenting prescription forms or collectingdispensed medications. At the time of writing,a community pharmacist rarely has access toa patient’s full confidential medical record,
Introduction . . . . . . . . . . . . . . . . . . . . . . 23
The past role of the communitypharmacist . . . . . . . . . . . . . . . . . . . . . . 24
Today’s community pharmacist. . . . . . . . . 26
Essential services . . . . . . . . . . . . . . . . . . 27
Other services . . . . . . . . . . . . . . . . . . . . 29
The future of the communitypharmacist . . . . . . . . . . . . . . . . . . . . . . 31
References. . . . . . . . . . . . . . . . . . . . . . . 31
3An overview of community pharmacy – the roleof the community pharmacist: past, present andfuture
Sam E Weston
23
Figure 3.1 Over-the-counter prescribing.
although many strategic health authorities areseeking to improve this and are looking at waysto introduce electronic access for pharmacists.The current lack of access means that pharma-cists must rely heavily on their communicationskills to obtain relevant information from apatient to allow for correct diagnosis and supplyof treatment – or referral to a general practitioner(GP) if appropriate.
This chapter provides an overview of thechanges in the role of the community pharma-cist, the current situation and possible futuredevelopments of services provided by commu-nity pharmacists.
The past role of the communitypharmacist
Wherever there are civilised societies we findpharmacy, because it fulfils one of man’s basicneeds – the maintenance of health. The develop-ment of medicines from plants, animals andinsects became routine thousands of years ago,long before it became a part of the profession wenow recognise. However, we must not forgetthat the same skills and knowledge that bringhealing and health can also be used to destroy –inappropriate dosing of medication, potentialinteractions or medicines that are simply unsuit-able for a certain patient should be identified bythe pharmacist. In addition to this, the qualityof advice and information provided to thepatient by the pharmacist, or by supportinghealthcare staff, should be monitored in order toensure that patients receive the best possiblecare. In the event that such procedures are notcarried out, it is possible that medicationsprescribed or advice given to patients may causethem harm rather than benefit their health.Pharmacists today are ideally placed in the frontline of health care. Within the domain of thegeneral public and armed with a huge knowl-edge of medicines and poisons, they are able toidentify existing disease states and offer suitabletreatment. In addition, they can supply adviceand information for the prophylactic use ofmedicines, thus preventing diseases from arisingin the first place.
Pharmacy has a long history. Fossils fromplants with medicinal properties have beenfound with the remains of Neanderthals, indi-cating that early man used these plants asdrugs around 50 000 BC. The first prescription ofwhich we have authentic records is now in theBritish Museum and dates back to 3700 BC,although it is not confirmed whether this scriptwas found in the tomb of a patient or whether itwas recovered from the effects of a pharmacist.The earliest historical record for the preparationof drugs comes from Babylonia, circa 2600 BC,where clay tablets were inscribed with thedescription of an illness, a formula for the prepa-ration of the remedy and an incantation toimpart or enhance the healing quality of themedication.
A more detailed history of pharmacy datesback to medieval times. when priests, both menand women, ministered to the sick with reli-gious rites as well as medicines. Specialisationfirst occurred early in the 9th century in thecivilised world around Baghdad, where the firstprivately owned drug stores were established. Itgradually spread to Europe as alchemy, eventu-ally evolving into chemistry as physicians beganto abandon beliefs that were not demonstrablein the physical world. Physicians often bothprepared and prescribed medicines (comparablewith today’s dispensing doctors), whilst pharma-cists not only compounded prescriptions butalso manufactured medicaments in bulk forgeneral sale (see Figures 3.2–3.5). Not until wellinto the 19th century was the distinctionbetween the pharmacist as a specialist in thepreparation of medicines and the physician as atherapist generally accepted.
Combining different agents, or compounding,was considered an art form practised by priestsand doctors and the first known chemicalprocesses were carried out by the artisans ofMesopotamia, Egypt and China. Most of thesecraftspeople were employed in temples andpalaces, making luxury goods for priests andnobles. In the temples, the priests in particularhad time to speculate on the origin of thechanges they saw in the world about them.Their theories often involved what wasperceived as magic, but they also developedastronomical, mathematical and cosmological
24 Chapter 3 • Community pharmacy
ideas, which they then used in attempts toexplain some of the changes that are nowconsidered chemical (British Society for theHistory of Pharmacy, 2007). More informationcan be found on the British Society for theHistory of Pharmacy website (www.bshp.org).
Pharmacy first became legally separated frommedicine in 1231 AD in Sicily and southern Italy.King Frederick of Sicily, Emperor of Germany,presented the first European edict differentiatingbetween the responsibilities of physicians andapothecaries at his palace in Palermo. Thispaved the way for further legislation defining
the role of apothecary, the development ofthe first official pharmacopoeia (the RicettarioFlorentino published in Florence in 1498), theestablishment of the College de Pharmacie inFrance in 1777 and the eventual formation of
The past role of the community pharmacist 25
Figure 3.2 A leech jar, used to store leeches. Bloodletting was a universal practice in ancient Greek andRoman times. By the 1700s, apothecaries and physiciansused leeches instead of opening a vein. They were alsoused to treat infected wounds and to promote healing oftissues.
Figure 3.3 A press used for making suppositories (forrectal administration of medicines) or pessaries (forvaginal administration).
Figure 3.4 Storage jars for dried herbs used in thepreparation of ‘pills’.
Figure 3.5 A syrup jar used to store Syrupus Papaveris– an analgesic and anti-inflammatory medicine preparedby infusing dried poppy heads and seeds in boiling waterand sugar.
the Pharmaceutical Society of Great Britain in1841 (Taylor & Harding, 2001).
During the 19th century, the art of com-pounding began to give way to new technolo-gies. However, it has been estimated that a‘broad knowledge of compounding’ was stillessential for 80% of the prescriptions dispensedin the 1920s. Although pharmacists increasinglyrelied on chemicals purchased from the manu-facturer to make up prescriptions, there stillremained much to be done secundum artem(‘to make favourably with skill’) at the time ofpreparation and dispensing. Pharmacists spreadtheir own plasters, prepared pills (of aloes andmyrrh or quinine and opium, for example),prepared powders of all kinds, and made upconfections, conserves, medicated waters andperfumes. They also prepared tinctures (of, forexample, laudanum, paregoric and colchicum)in five-gallon demijohns. Frequently, pharma-cists combined into a single dosage form (a‘pill’), two or more medicines, which wouldtoday be written and dispensed as separate itemson a prescription. This allowed them to takeadvantage of what were considered to befavourable interactions between medicines, orsimply to reduce the number of pills taken by apatient, thus improving the chance of thepatient taking medications correctly. Pharma-cists were often called upon to provide first aidand medicines for such common ailments asburns, frostbite, colic, flesh wounds, poisoning,constipation and diarrhoea, as a consultationwith a physician for such minor ailments wascostly. Pharmacists then, as today, were a first-line of defence in these situations, as they couldprovide advice and supply a treatment at thesame time and for a much reduced price.
In addition to maintaining a prescriptionlaboratory, pharmacists usually carried patentedand proprietary remedies along with herbsand locally popular nostrums (‘a favourite butuntested remedy for problems or evils’) of theirown design.
Today, the modern pharmacist deals withcomplex pharmaceutical remedies far differentfrom the elixirs, spirits and powders described inthe Pharmacopoeia of London (1618) and the
Pharmacopoeia of Paris (1639). In the UK today,major medicines are selected for inclusion in theBritish Pharmacopoeia (BP), first published inEnglish (previously in Latin) in 1864. Thesemedicinal substances are required to reach rigor-ously tested standards before being consideredfor inclusion. Once produced as medicinal prod-ucts, medicines are listed in the bi-annuallyupdated British National Formulary (BNF), acompendium of all medicines and appliances(such as catheters, wound-management productsand elastic hosiery) that can be prescribed on anNHS prescription form. The BNF also providesguidance about medications that cannot beprescribed on an NHS prescription – known as‘blacklisted’ medicines – and medicines that areconsidered less suitable for prescribing.
Today’s community pharmacist
Pharmacists are experts in the use of medicines.They complete a 3 year masters degree and a yearof practical training, and must pass an examina-tion before qualifying to register with the RoyalPharmaceutical Society of Great Britain (RPSGB)as a Pharmaceutical Chemist (ParliamentaryOffice of Science and Technology, 2005).
The traditional role of the community pharma-cist, and one that still provides the main source ofincome for the majority of pharmacies, is that ofdispensing. In 2005, 720 million prescriptionitems were dispensed (Figure 3.6), an increase of5% from 2004 (IC, 2006). The largest growth areain terms of volume is cardiovascular disease, interms of both prescription items dispensed andnet ingredient cost. Other disease states thatplace a high cost burden on the NHS includediabetes, gastrointestinal disorders and respira-tory diseases (IC, 2007).
Other roles of the community pharmacist arelargely divided into two categories:
• essential services – provided by virtuallyevery pharmacy in the UK
• enhanced services – developed in line withthe new NHS contract discussed in Chapter 2.
26 Chapter 3 • Community pharmacy
Essential services
Repeat dispensing
A community pharmacist can supply medica-tion to the patient in the event that the patientreceives a regular prescription from their GP fora particular condition, has been maintainedsuccessfully without need for any change to themedication regimen for a period of time, and isnot due for a GP review of their medications.GPs supply prescriptions in advance to the phar-macy, allowing a reduction in their workload, aswell as reduced drug wastage and greater use ofthe pharmacist’s skills.
Adverse drug reaction reporting
The Yellow Card Scheme was launched in 1964,and is used to report suspected adverse drugreactions (ADRs) to the Medicines and Health-care products Regulatory Authority (MHRA) andCommittee on Safety of Medicines (CSM). Both
hard copies (the yellow pages in the back of theBNF) and electronic versions (implemented in2002 and available at www.mhra.gov.uk) of theyellow card are currently in use. Reports aredivided into two categories:
• ‘black triangle drugs’ (noted as such in theBNF; these are drugs that have receivedmarket authorisation in the last 2 years) forwhich any suspected ADRs should bereported
• all other drugs, for which only serioussuspected ADRs should be reported.
Currently the Yellow Card Scheme can be used bydoctors, nurses, pharmacists, dentists, coro-ners, optometristsandradiographers(www.mhra.gov.uk). Members of the public are now able touse this scheme, both online and by directlycontacting the manufacturer of a medicationthat may have caused an adverse event. This hasallowed for more comprehensive profiles to bedeveloped for any medicine that may havecaused a suspected adverse reaction. More infor-mation about the Yellow Card Scheme can befound on the MHRA website (www.mhra.gov.uk).
Patient counselling
This involves giving advice to patients on howto use their prescribed medications, often usedas an informal method of checking on howpatients are coping with their medications.Early identification of problems, such as timingof medications, side-effects or problems withphysical manipulation of the packaging can beaddressed promptly, with minimum disruptionto the patient’s lifestyle.
Identification of interactions of prescribedmedications with other medicines, herbalremedies and foodstuffs
The ageing population, both in the UK andworldwide (United Nations, 2001) means thatmany more patients are taking more thanone clinically justified medication – so-called
Essential services 27
Figure 3.6 A working dispensary.
polypharmacy – thus increasing the potentialfor drug–drug interactions.
The re-emergence of herbal supplements asbeneficial to health, as well as their increasingpopularity as complementary medicines, leadsto another host of possible interactions. Manypeople hold firmly to the misconception that‘natural is good’, which suggests, incorrectly,that herbal medicines have none of the side-effects or toxicity problems that arise with‘unnatural’ medicines.
New research has shown that some foods haveenzyme inhibiting or enhancing effects (such asgrapefruit juice). The community pharmacist isideally placed to question patients about poten-tial interactions and to counsel patients beforesuch interactions occur.
Responding to symptoms
Community pharmacists can provide advice onappropriate purchase of OTC and pharmacy (P)medicines (which can only be sold under thesupervision of a pharmacist) for symptomaticrelief in the case of self-limiting minor illnessesand common complaints. In this situation thecommunity pharmacist needs to draw on anextensive group of skills:
• communication skills in order to draw outrelevant information from the patient, as wellas to impart health advice
• clinical skills in order to interpret symptomsand determine a therapeutic objective
• knowledge of current OTC medication inorder to recommend a suitable product
• directing the patient to their GP in the eventthat symptoms may suggest a more seriouscomplaint.
Public health
This involves participation in local and nationalcampaigns to raise awareness of specific healthissues. Promotions (organised both centrallyand locally) include smoking cessation clinics,raising awareness of the risk factors thatcontribute to major disease states such as heart
disease (e.g. improving diet and exercise regi-mens), diabetes (e.g. monitoring blood glucoselevels), promoting influenza vaccination for at-risk patients (the elderly and those with chronicrespiratory diseases) and advice on appropriateuse of antibiotics. The prescribing of antibioticsfor the treatment of viral infections is inappro-priate and is one factor that is contributing tothe growing problem of antibiotic-resistancein bacteria. Antibiotic resistance can also occurif patients do not take a course of antibioticscorrectly – the bacteria that the medicine issupposed to kill can develop resistance to it andthen, in the event that the patient requires theantibiotic to treat another bacterial infection, ahigher dose may be required, or the antibioticmay not prove effective, because the bacteriahave become resistant to it. Pharmacists occupya valuable position in this regard by being ableto intervene at the point of dispensing if theyfeel that a prescribed antibiotic is inappropriate.
Signposting
Referral of patients to the most appropriatehealthcare providers in order to reduce inappro-priate use of health and social care services (e.g.frequent visits from GPs, practice nurses, physio-therapists). Lists are provided by primary caretrusts (PCTs), and include voluntary patientsupport groups. Often patients can get advicefrom telephone help lines such as NHS Direct orfrom the internet (e.g. www.nhsdirect.nhs.uk).
Disposal of unwanted medications
The aims of this service are:
• to reduce the incidence of accidental poison-ing in the home, and the risk of medicationsbeing diverted to individuals they were notintended for
• to reduce the risk to the public caused bymedicines disposed of unsafely
• to reduce the environmental impact of unsafedisposal.
Patients are requested to return unused medi-cines to the community pharmacy for safe
28 Chapter 3 • Community pharmacy
disposal in destruction of old pharmaceuticals(DOOP) bins, which are then collected by a phar-maceutical waste disposal company (contractedby the PCT).
Clinical governance
Clinical governance refers to ‘a frameworkthrough which NHS organisations are account-able for continuously improving the quality oftheir services and safeguarding high standards ofcare, by creating an environment in which excel-lence in clinical care will flourish’ (NationalPrescribing Centre, 2007). This is a large areathat affects every aspect of the pharmacist’s roleand is characterised by:
• audit – defined as an important review ofcurrent practice, revision of any part of prac-tice which does not give the best standardsof care for patients, and integration of newprocedures for improving these standards
• continuing professional development• accreditation training• staff development programmes• development and implications of standard
operating procedures (SOPs)
within the community pharmacy setting (seeChapters 6 and 15).
Medicines use review (MUR)
This is an advanced service that requires bothpharmacist and premises to be accredited froma higher education institution (e.g. The Centrefor Inter-Professional Postgraduate Educationand Training (CIPPET; www.pharmacy.rdg.ac.uk/cippet) or the Centre for Pharmacy PostgraduateEducation (CPPE; www.cppe.manchester.ac.uk).MURs can be routine (when a pharmacistand patient make an appointment to meet anddiscuss the patient’s treatment regimen, andaddress any issues, such as side-effects or unusedmedications being stopped on a regular prescrip-tion), or may be triggered by prescription inter-vention (such as when a pharmacist notices apotential interaction or that a patient may bereceiving a new drug in order to counter side-
effects produced by a regular medication). AnMUR involves a face-to-face consultation withthe patient in order to examine current medi-cine usage, check for potential side-effects andproduce a report, which is copied to thepatient’s GP, suggesting changes in the medica-tion schedule if necessary. Specific patientgroups to be routinely included in the MURprotocol for a pharmacy may be suggested byPCTs depending on the needs of a particular area(e.g. patients over 70 years of age; patients withhypertension; patients with diabetes).
Other services
Retailing
Most community pharmacists are also businesspeople. Those employed as managers and thosewho are pharmacy owners have an obviousrequirement to run the pharmacy as a profit-making organisation. In addition, the pharma-cist must have managerial skills in order to directand develop their support staff, as well beinginvolved in reviewing the needs and require-ments of the patients who use their premises.Managers need to develop skills in many areas:
• strategic planning – both for the business as awhole, and for individual members of staff
• financial strategy and planning – an essentialcomponent for running any business success-fully, both for review of past performance andalso for future budget plans
• problem solving – often managers are requiredto think ‘outside the box’ and come up witha highly creative solution to a problem thatcan be enthusiastically taken on board bystaff members
• marketing – the right advertising is needed inorder to attract the right support staff andalso to bring in customers.
Locally enhanced services
These are commissioned by PCTs, in response tolocal healthcare needs and so will vary from one
Other services 29
PCT area to another. Community pharmaciesdo not have to provide all of these services, butthe PCT area will ensure that all the requiredservices are catered for between the communitypharmacies in one healthcare authority. Theyinclude the following services.
Smoking cessation clinics
These clinics have been developed in order toreduce the number of minor consultations withGPs, helping to reduce their workloads. Aninitial screening is often done by a practicenurse before the patient is referred to a commu-nity pharmacist. The pharmacist can then assessthe needs of the patient and carry out peak flowmeasurements, which are a useful measure forthe patient to see how their lung functionimproves the longer they do not smoke.
Minor ailments schemes
These were also created in order to reduce minorconsultations for GPs in order to free up theirtime to treat more seriously ill patients, as wellas to utilise more effectively the medicinesknowledge of qualified and registered pharma-cists. Patients can be prescribed antihistaminesand steroid nasal sprays for hay fever, deconges-tants and analgesics for cold and flu symptoms,and pain relief, cough mixtures, etc. In this waypatients are provided with symptomatic relieffrom a minor ailment, without a perhaps unnec-essary visit to the GP, which can also be time-consuming for the patient; indeed they mayhave recovered from the illness by the time theyget to see the doctor.
Substance misuse
Patients with a drug dependency (e.g. heroin,amphetamines or painkillers) can be started ona programme of withdrawal. Specialist GPs orsubstance misuse clinics can supply prescrip-tions for methadone (a drug that prevents theonset of withdrawal symptoms experienced byusers of opioids such as heroin), which can besupplied as a single dose on a daily basis (eitheras supervised consumption on the pharmacypremises, or to take away) or as a week’s supply
of daily doses. The community pharmacist isideally situated to monitor these patients’progress and to provide continuing support.
Emergency hormonal contraception
The ‘morning-after pill’ to prevent unwantedpregnancy has been available from GPs andfamily planning clinics for many years. Commu-nity pharmacies are now allowed to sell thisproduct as a ‘P’ licensed product, or to supplyit free of charge if a patient group directive(PGD) is in existence in their PCT (Departmentof Health, 2007). Pharmacists must undergotraining to be able to prescribe on a PGD form.This is a document that makes it legal formedicines to be given to a defined group ofpatients by suitably trained health professionalsother than a doctor, without an individualprescription having to be written for each patient.
Advice to residential and care homes
Community pharmacies can supply residentialhomes with medication in weekly dispensingtrays and monitored dosage systems. This helpsto ensure that patients receive their medicationat the correct time, and improves the ease ofadministration for home staff. Communitypharmacists are often closely involved withreviewing these medications and provide adviceto home staff and carers in order to provide thehighest standard of care for the patient group.Further details of training requirements forpharmacists and technicians for the ‘Homeaway from home’ programme can be found onthe CPPE website (www.cppe.manchester.ac.uk).
Health screening
Services for monitoring blood cholesterol, bloodsugar and blood pressure are now routinelyprovided in the majority of community pharma-cies, as many patients are beginning to take amore active role in understanding and treatingtheir illness (RPSGB, 2006). Routine screening iscarried out at a GP surgery; however, the avail-ability of more flexible appointment times ina community pharmacy setting means that
30 Chapter 3 • Community pharmacy
patients can keep to appointment times morereadily, which reduces the workload at the GPpractice allowing nursing staff to treat moreseriously ill patients.
The future of the community pharmacist
The development of additional professionalroles has enhanced pharmacists’ roles within theteam of health professionals. ‘Medicines manage-ment’ involves a range of activities intended toimprove the way that medicines are used, bypatients and by the NHS (see Chapter 6 for moreinformation). Medicines management servicesare processes based on patient need that are usedto design, implement, deliver and monitorpatient-focused care. ‘Priorities for Action’ devel-oped in 2004 by the Department of Health,Social Services and Public Safety (DHSSPS) forthe UK and Northern Ireland, made a priority of‘Working for Healthier People’, giving a budgetcommitment to developing the role of thecommunity pharmacist further, modernisingand improving services, promoting integratedworking across primary, secondary and commu-nity sectors and improving efficiency andperformance. Priorities for Action has endorsedthe development of a medicines managementservice in order to start making full use ofcommunity pharmacists’ skills (DHSSPS, 2006).Areas where community pharmacy cancontribute to the medicines managementagenda include:
• ongoing medication review• improving patient understanding and use of
prescribed medication• developing care programmes and services for
‘at risk’ patient groups• protocols for patient counselling and self-
medication• health promotion and multidisciplinary
research• audit and drug utilisation review.
It is also important to note the substantial rolepharmacists play in providing prescribingsupport. In this context, pharmacists work atdifferent levels: individual practice, local health
and social care group, and health and socialservices board. These pharmacists also contributeto the medicines management agenda. Examplesof the key areas of involvement include:
• prescribing analysis and feedback• formulary development and maintenance• review and management of repeat prescribing
processes• medication review.
Work is also under way to develop prescribingpolicies across the primary–secondary care inter-face, and across the whole of the pharmaceuticalsector, developing opportunities for pharmacistprescribing allied to the Crown Report (1999).
Pharmacy practice has been evolving to meetthe needs of a contemporary healthcare system.The modern role of the community pharma-cist is well articulated in the Report of theJoint Working Party on the Future Role of theCommunity Pharmaceutical Service, published in1992 (Hawksworth & Chrystyn, 1992). In addi-tion, a major and ongoing initiative by theRPSGB – ‘Pharmacy in a New Age’, started in1995 – seeks to set out what pharmacy does andcan offer, supported by information technology,education and training, audit and research.
References
British Society for the History of Pharmacy (2007).www.bshp.org (accessed 5 March 2007).
CIPPET – Centre for Inter-Professional PostgraduateEducation and Training; www.pharmacy.rdg.ac.uk/cippet (accessed 5 March 2007).
CPPE – Centre for Pharmacy Postgraduate Education –www.cppe.manchester.ac.uk
Crown Report (1999). Review of Prescribing, Supply andAdministration of Medicines. Final report.www.jcn.co.uk/pdf/crownreport2.pdf (accessed 5March 2007).
DepartmentofHealth (2007).Patient Group Directionshttp://www.dh.gov.uk/en/Policyandguidance/Emergencyplanning/DH_4069610 (accessed5 March 2007).
DHSSPS (2006). Priorities for Action. Department ofHealth and Social Services and the PharmaceuticalService for Northern Ireland. www.dhsspsni.gov.uk/pfa_2007–08.pdf (accessed 5 March 2007).
References 31
Hawksworth GM, Chrystyn H. (1992). Clinical phar-macy in primary care. Br J Clin Pharmacol 46:415–420.
IC (2006). Prescriptions Dispensed, 2005. http://www.ic.nhs.uk/statistics-and-data-collections/primary-care/prescribing/prescriptions-dispensed-2005. Information Centre for Health and SocialCare (accessed 5 March 2007).
IC (2007). National Prescribing Costs and Items.www.ic.nhs.uk/statistics-and-data-collections/primary-care/prescriptions (accessed 5 March2007).
National Prescribing Centre (2007). Clinical Govern-ance. www.npc.co.uk/publications/auditHandbook/clinical_gov.htm (accessed 26 February 2007).
Taylor K M G, Harding G, eds (2001). PharmacyPractice. Taylor & Francis.
Parliamentary Office of Science and Technology(2005). Changing Role of Pharmacies. www.parliament.uk/documents/upload/postpn246.pdfParliamentary Office of Science and Technology(accessed 26 February 2007).
Royal Pharmaceutical Society of Great Britain (2006).Diagnostic Testing in Community Pharmacy. www.rpsgb.org.uk/pdfs/rpsepicdiagtest.pdf (accessed 5March 2007).
United Nations (2001). World Population Ageing: 1950–2050 www.un.org/esa/population/publications/worldageing19502050/pdf/preface_web.pdf (accessed26 February 2007).
32 Chapter 3 • Community pharmacy
Introduction
This chapter introduces hospital pharmacy anddescribes the roles of the pharmacist and otherpharmacy staff within the hospital setting, clin-ical pharmacy (the role of the pharmacist andother pharmacy staff on hospital wards), thespecialities that pharmacists can work in withinhospital pharmacy and future developments forhospital pharmacy.
Traditional roles of the hospitalpharmacist
Until about 30 years ago, pharmacists in UKhospitals were to be found in the dispensary,processing stock orders and prescriptions, andrarely setting foot outside of the pharmacydepartment, except to perform ‘ward pharmacy’,which at this stage was little more than collectingdispensing work from wards. Consequently, the
traditional roles of the hospital pharmacist weredispensing and supplying stock drugs to wardsand departments. Many products were madeextemporaneously (Box 4.1), and therefore mostdepartments had an in-house quality control(QC) section. QC, or quality assurance (QA) as itis now more often called, involves testing phar-maceutical products to ensure they are safe andsuitable for use. These tests may therefore inves-tigate aspects such as sterility or composition.QA also ensures that unlicensed medicines (Box4.1) ordered by the pharmacy department aremanufactured to the appropriate standardsbefore being supplied for use in patients (seebelow).
In the early 1970s, with the development ofclinical pharmacy and the increasing role ofthe pharmacy technician, pharmacists startedmoving out of the dispensary to work side byside with nurses and doctors on wards. As aresult, the role of the hospital pharmacist in the21st century would be barely recognisable to thepharmacist of 50 years ago because rather thanthe pharmacist being confined to the pharmacy
Introduction . . . . . . . . . . . . . . . . . . . . . . 33
Traditional roles of the hospitalpharmacist . . . . . . . . . . . . . . . . . . . . . . 33
The structure of a typical hospitalpharmacy department . . . . . . . . . . . . . . 34
Clinical pharmacy . . . . . . . . . . . . . . . . . 36
Teaching . . . . . . . . . . . . . . . . . . . . . . . . 37
Specialisation in hospital pharmacy . . . . . 38
The future of hospital pharmacy . . . . . . . 41
Summary . . . . . . . . . . . . . . . . . . . . . . . 41
References. . . . . . . . . . . . . . . . . . . . . . . 41
Useful resources. . . . . . . . . . . . . . . . . . . 41
4An overview of hospital pharmacy
Kate E Fletcher
33
department, they are now to be found in allparts of the hospital; on ward rounds withdoctors, in the Accident and Emergency Depart-ment, in operating theatres and outpatientclinics.
The structure of a typical hospitalpharmacy department
There are many roles within a hospital phar-macy department, only some of which areperformed by pharmacists. While pharmacistsare responsible for all professional aspects of thework of a pharmacy (i.e. ensuring the output ofthe department is safe and legal), technicians areresponsible for a large proportion of that output:dispensing prescriptions, managing pharmacystores and preparing sterile products. The role oftechnicians has also developed in recent years toinclude medicines management (see Chapter 6),medicines information (MI; see page 39), infor-mation technology support (maintaining phar-macy computer systems) and final checking of
prescriptions (accredited checking technicians)(Box 4.1). Some technicians are also movinginto roles such as dispensary management (seepage 38). Thus, the roles of the hospital phar-macist and hospital pharmacy technician arebecoming increasingly interdependent.
34 Chapter 4 • Hospital pharmacy
Box 4.1 Definitions of terms used in Chapter 4
Accredited checking technician
Technicians may be accredited by a nationally recog-nised training scheme to carry out the final accuracycheck of dispensed items clinically approved by aregistered pharmacist.
Extemporaneous product
In the context of medicinal products, an extempora-neous product or preparation is not pre-prepared; it ismade on site, at the time of need, for an individualpatient, based on a prescription (see Chapter 14).
Final accuracy check of a dispensed prescription
This process ensures that the item selected and labelledmatches the prescription in every detail: drug, strength,dose, frequency and name of patient; this checkmay be carried out by a registered pharmacist, or anaccredited checking technician.
Therapeutics
This is the branch of medicine concerned with the treat-ment of disease, using medicines rather than surgery.
Unlicensed medicine
An unlicensed medicine does not have a marketingauthorisation (MA). In the UK, all medicines go throughstrict checks to make sure that they are safe andeffective. When the medicine passes all the requiredchecks, an MA (formerly known as a product licence)is granted, which means that the medicine can be usedin the treatment of specific medical conditions. Phar-maceutical manufacturers must apply to the Medicinesand Healthcare products Regulatory Agency (MHRA)for an MA if they want to sell their medicines in the UK.The MHRA approves the product licence for a medicineif it has been proven to work for the illnesses it wasdeveloped for, does not have too many side-effects orrisks and has been made to a high standard.
Figure 4.1 A clinical pharmacist screens a prescriptionchart.
Assistant technical officers (ATOs) play animportant supportive role to pharmacists andtechnicians. They may be dispensary reception-ists, for example, receiving work into the dispen-sary and answering the telephone; some ATOsare trained to dispense prescriptions and preparesterile products; others may work in pharmacy
stores, preparing stock orders for wards anddepartments. All wards and clinical departmentswithin a hospital (i.e. areas that treat patients)have a stock of the drugs and equipment thatare used regularly in that area. The stock drugsare listed on a pharmacy stock list, and staff inthat area can order any item on the stock listfrom the pharmacy; these orders are processedin the pharmacy stores, and then delivered tothe department that made the order.
Pharmacists, technicians and ATOs work sideby side in the pharmacy, and tend to haveparallel management structures. Pharmacists areusually managed by a more senior pharmacist,and technicians and ATOs are usually managedby a more senior technician. Most departmentshave a senior management team which iscomposed of the chief pharmacist, deputy chiefpharmacist, clinical services manager and opera-tional manager, and which oversees all parts ofthe department. The role of the chief pharmacistis described below. The deputy chief pharmacistmay also be the clinical services manager oroperational manager, or share some of the rolesand responsibilities of the chief pharmacist. The
The structure of a typical hospital pharmacy department 35
Figure 4.2 A pharmacy technician produces labels for aprescription.
Figure 4.3 A pharmacy technician dispenses a dischargeprescription.
Figure 4.4 A pharmacist performs the final technicalcheck of a discharge prescription.
clinical services manager is a senior pharmacistresponsible for the services provided by thepharmacy to wards and other clinical areas, andwill usually manage all the other pharmacists.The operational manager is either a senior phar-macist or technician, and is responsible for the
efficient operation of the pharmacy department.The operational manager will usually managethe technicians and ATOs.
Clinical pharmacy
Clinical pharmacy, that is, the practice of phar-macy ‘at the bedside’, or at least, on wards andin clinical departments, started to develop in theUSA in the late 1960s and in the UK during the1970s. Initially, pharmacists performing wardpharmacy did little more than collect stockorders and transcribe patient-specific drugorders from drug charts, engaging in littlecontact with doctors, nurses or patients. Gradu-ally, pharmacists started to use their expert phar-maceutical knowledge to monitor prescribing,intervening when appropriate to optimise drugtreatment for individual patients. Now, manyhospital pharmacists are fully integrated intothe clinical team, working alongside doctors,nurses, physiotherapists and other members ofthe multidisciplinary team, to deliver optimalcare to patients. With the pharmacist presentat the time of prescribing, errors in selectionof appropriate drug and dosing regimen areminimised, ensuring that the patient receivesmaximum benefit from their treatment withminimal side-effects.
Pharmaceutical care
Pharmaceutical care is the term most oftenused to describe what a clinical pharmacistdoes. It entails regular monitoring of drugtreatment for each patient under their care,including screening prescription charts forsafety, appropriateness, efficacy and side-effects.
Concepts and definitions in clinical phar-macy are changing frequently. Over the years,different jargon has been used to describe thework of the clinical pharmacist. In 1990, Heplerand Strand defined the concept of pharmaceu-tical care for the first time as ‘the responsibleprovision of drug therapy for the purpose ofachieving definite outcomes that improve apatient’s quality of life’.
36 Chapter 4 • Hospital pharmacy
Figure 4.6 A senior assistant technical officer puts stockaway in the dispensary.
Figure 4.5 Shelving in a typical hospital pharmacy stores.
The process of pharmaceutical care can becarried out in a variety of ways. Most clinicalpharmacists have responsibility for particularwards; they will make regular visits (usuallydaily, Monday to Friday) to these wards to carryout a pharmacist ward round, which involvesinspecting each patient’s prescription chart, asdescribed above, and, when necessary, observa-tion charts and medical notes. During theserounds, the pharmacist will talk with the patientto confirm details such as medication history,when and how a patient takes their medication,and also to enquire whether certain medication,such as antiemetics (drugs to prevent and treatnausea and vomiting) or analgesics (painkillers)are working and being tolerated. In order toperform effectively, the pharmacist must havegood communication skills to gather all theinformation they need from both patients andother health professionals (see Chapter 8).
Most pharmacy departments have an out-of-hours on-call system. These systems vary from aresidency service, where a small team of residentpharmacists (often junior grades) take turns (ona rota) to stay on site over night in order toprovide a complete pharmaceutical supply andadvice service, to an ‘at home’ on-call service,where all the pharmacists in a department taketurns (on a rota) to provide an ‘emergency only’service. In this system, pharmacists go home atthe end of the working day, but hospital staffcan contact the pharmacist for advice via apager. There is usually an ‘emergency drugcupboard’ at the hospital that contains drugsthat are not available elsewhere in the hospitaland that nurses and doctors can access out ofhours. A residency service offers a similar levelof service to that available during the workingday; an ‘emergency only’ service offers helpand supply of drugs only when it is vital thatthere is no delay in treatment. The on-callservice offered by a pharmacy department isusually determined by the amount of fundingavailable for the service; clearly it is moreexpensive to run a residency service, as morepharmacists are needed to support it, and notall trusts have sufficient funds to support this.
Many clinical pharmacists participate indoctors’ ward rounds. This enables the phar-macist to obtain greater in-depth knowledge of
a patient’s condition, and to have a directinfluence on prescribing – being present whena therapeutic decision is made enables thepharmacist to ensure that the choice of drug isappropriate for the patient before the prescrip-tion is written. The pharmacist can also ensurethe drug is available, so the patient’s treatmentis not delayed. This combination of prescribingadvice and supply of medication ensurestimely and safe treatment and improvespatient care.
Pharmacists also help and advise nurses onthe safe administration and monitoring of drugtreatment, discuss possible food–drug interac-tions with dietitians, and ascertain from speechand language therapists whether a patient canswallow medications safely.
Pharmacists may also participate in outpatientclinics. Pharmacists are frequently involved inanticoagulant clinics, where they are responsiblefor checking patients’ blood results, advising onwarfarin dose adjustment, and counselling newpatients on their warfarin treatment. (Warfarin isan anticoagulant drug – it reduces the ability ofthe blood to form clots. Warfarin is used inconditions that increase the risk of the bloodclotting such as atrial fibrillation.)
Teaching
Hospital pharmacists begin teaching one anotheras soon as they enter their pre-registrationtraining – through case and project presenta-tions they teach their peers and other membersof the pharmacy department about specificdrugs, conditions, or project design and execu-tion, such as audit technique. Carrying outthese presentations is a requirement of the pre-registration training programme; they are alsoessential skills for the hospital pharmacist, andare an integral part of improving the communi-cation skills essential for a pharmacist’s everydaywork.
As hospital pharmacists become more experi-enced and specialised (see below), part oftheir responsibility is likely to be the teach-ing and training of other pharmacists, nursesand doctors. Senior pharmacists tutor junior
Teaching 37
pharmacists studying for postgraduate qualifica-tions such as a diploma in clinical pharmacy –the senior pharmacist acts as mentor and tutor,helping the ‘diploma pharmacist’ achieve theirgoals. Diplomas in clinical pharmacy are offeredby several universities in the UK, including – butnot limited to – Cardiff University, Universityof Derby, Keele University, the University ofLondon and Queen’s University Belfast. Thereare also opportunities for hospital pharmaciststo specialise in departmental or regionalteaching and training, by presenting to localarea (branch) (see Chapter 7) meetings, or atlocal specialist training days.
Most schools of pharmacy in the UK employteacher practitioners (TPs) – practising pharma-cists who are also members of academic staff.They may come from any sector of pharmacy (i.e.community, hospital, primary care, industry)and contribute up-to-date knowledge and experi-ence of practice to the course content, givingundergraduates an invaluable insight to currentpractice. TPs may also advise full-time academicstaff on various aspects of teaching and coursecontent, to ensure it is relevant to practice, andact as a liaison between academia and their ownparticular sector of practice, to facilitate under-graduate visits and training placements. Forinstance, a visit to a pharmaceutical companymanufacturing plant might be arranged, orstudents might undertake a placement in acommunity pharmacy or hospital pharmacydepartment, to gain experience and knowledgeof working in those environments. TPs alsoestablish links between institutions for researchand educational purposes.
Specialisation in hospital pharmacy
Clinical specialisation
Pharmacists can specialise in many clinicalareas. Most large National Health Service trustswill have specialist pharmacist posts in areassuch as cardiology, critical care, elderly care,gastroenterology, general medicine, haema-tology, oncology, paediatrics, renal medicine,surgery, trauma and orthopaedics.
As well as being experts in the therapeutics(Box 4.1) relating to their speciality, thesepharmacists are often responsible for produc-ing reports that analyse prescribing patternsand spending on medicines and developingprescribing guidelines in partnership with clini-cians. They may also manage junior pharmacistsor pharmacy technicians working within theirspeciality.
Pharmacy specialisation
Some pharmacists choose a non-clinicalspeciality. These include dispensary manager,education and training, MI, QA, and sterile andnon-sterile production.
Dispensary management
The dispensary is the heart of the hospital phar-macy, and as such needs to be run efficiently toensure that the right drug gets to the rightpatient at the right time. Dispensaries havetraditionally been managed by pharmacists, butwith the development of the role of the phar-macy technician in recent years, many dispen-saries are now ‘technician led’. Accreditedchecking technicians (see Box 4.1) are able totake on more of the pharmacist’s role,performing the technical check of a dispensedprescription. This has reduced the number ofpharmacists needed to run a dispensary,allowing them to devote more time to clinicalactivity, and therefore makes better use of theirtraining and expertise.
Education and training
All staff within a pharmacy department, espe-cially pharmacists and technicians, must keepup-to-date with recent developments in theirprofession. Indeed, during the next few yearscontinuing professional development (CPD)will become mandatory for pharmacists andtechnicians to retain their registration.
To facilitate CPD, many pharmacy departmentshave designated pharmacists and technicianswho are responsible for assessing the educationand training needs of the staff. They are often
38 Chapter 4 • Hospital pharmacy
also responsible for managing the training andassessment programmes for pre-registrationpharmacists and student technicians.
When newly registered pharmacists (juniorpharmacists) start work in a hospital pharmacy,they will often enter a clinical training rotation.This involves working in different areas withinthe pharmacy department (such as MI (seebelow), dispensary, or sterile production) and ondifferent wards, for periods (or rotations) of3–4 months; this enables the junior pharmacistto gain experience and skills in different areas ofpharmacy and different clinical specialities.
To progress in a career as a hospital pharma-cist, it is now more or less mandatory to have apostgraduate qualification in clinical pharmacy.This is usually undertaken by junior pharmacistswhen they start on a clinical training rotation,and takes 2–3 years part time. Several universi-ties offer such courses (see above), and indi-vidual pharmacy departments tend to send alltheir junior pharmacists on the same course, sothat it is easier to provide support to thestudents and to plan work rotas when the groupis away on study days, etc., at the same time.The course content is delivered in a varietyof ways, such as fortnightly regional studydays, weekly 2 hour training sessions or week-long residential courses. This is supplementedby course work, which usually includes casestudies and presentations, patient profiles andaudit projects. Most courses also include exams.
Most pharmacists will study to diploma level;however, it is becoming more common forpharmacists to obtain a masters degree inclinical pharmacy. These are offered alongsidethe postgraduate diploma.
As well as formal courses, hospital pharmacydepartments take advantage of study daysprovided both within their trust and by othertrusts. These might involve learning genericskills such as time management, dealing withdifficult situations and people management, ormight be run by pharmacy staff for pharmacystaff, covering subjects and skills unique topharmacy, such as clinical pharmacy skills ormedicines management topics.
Another way pharmacists and technicians canmaintain their knowledge is to attend symposiaand conferences relevant to their area of
practice. Many such conferences take placearound the world each year, providing a usefulforum for pharmacy staff to hear up-to-the-minute presentations from internationalexperts, and to meet other practitioners andexchange ideas and information. Within theUK, popular conferences for clinical pharmacistsare the British Pharmaceutical Conference(BPC), run by the Royal Pharmaceutical Societyof Great Britain (RPSGB), and conferences andsymposia run by the UK Clinical Pharmacy Asso-ciation (UKCPA) and the Guild of HealthcarePharmacists (GHP). Specialist conferencesinclude the annual symposium of the BritishOncology Pharmacy Association (BOPA).
Medicines information
MI is a service provided by pharmacists and tech-nicians in many pharmacy departments for otherpharmacists, other health professionals such asdoctors and nurses, and, in some departments,members of the public.
The MI service has developed alongside clin-ical pharmacy to support clinical pharmacists.MI provides in-depth information on all aspectsof drug use. The staff within MI use medicaland pharmaceutical texts (e.g. Martindale: TheComplete Drug Reference, Trissel’s Handbook onInjectable Drugs, Stockley’s Drug Interactions),pharmaceutical companies and online databases(such as PubMed and Pharmline) to researchqueries made by the service users. Examples ofenquiries include:
• Is drug X safe for use during pregnancy? • Does drug Y interact with drug Z? • Can drug A be given intravenously, and if so,
how should it be given?
Details of these reference books and onlinedatabases are provided on page 41.
Quality assurance
Pharmaceutical products must be of high qualityto ensure patient safety and efficacy of treatment.The production of pharmaceutical products inthe UK is governed by the Rules and Guidancefor Pharmaceutical Manufacturers and Distributorspublished by the Medicines and Healthcare
Specialisation in hospital pharmacy 39
products Regulatory Agency (MHRA) (alsoknown as the ‘Orange Guide’ because of theorange cover). All pharmaceutical productslicensed for use in the UK are manufactured andtested according to the Orange Guide by themanufacturers, and therefore can be assumed tobe of suitable quality when received by a phar-macy. Unlicensed products may not be subjectto the Orange Guide however, and there musttherefore be a mechanism in place to ascertainthe quality of these products. For hospital phar-macies, this is carried out by a QA department.Hospitals can have their own QA department,but in some regions QA services have beencentralised to reduce costs, one departmentserving several hospitals. The staff within thisdepartment are often pharmacists and phar-macy technicians, but may also be other scien-tists and laboratory technicians. All must havethe appropriate skills and knowledge to carryout quantitative and qualitative testing on arange of pharmaceutical products, includingmedicines in various formulations, and medicalgases. QA staff are also involved in risk manage-ment and clinical governance.
Sterile and non-sterile production
Historically, many hospital pharmacy depart-ments had a production unit that made manydifferent sterile (such as bladder irrigation fluidsand eye drops) and non-sterile (such as creams,ointments and liquid medicines) pharmaceutical
products. With the emergence of a far greaterrange of commercially manufactured productsavailable since the 1980s, many of these unitshave greatly reduced output or have been closeddown.
Some production units do remain in hospitals,however, and most commonly they will prepareproducts with a short shelf life, on an individualpatient basis, for instance chemotherapy used inthe treatment of cancer.
Such units are staffed by pharmacists, phar-macy technicians and ATOs who havespecialised in this area of practice. It is increas-ingly common for technicians to manage theseunits, rather than pharmacists. Junior staff fromthe pharmacy department often work in theproduction unit for a few months as part of atraining rotation, to gain some knowledge andskills in this area.
Management
Each area within the hospital pharmacy requiresa manager. As discussed above, this may be apharmacist or technician, depending on theskills that are required for the post. Managementroles often filled by technicians include dispen-sary manager and sterile production manager.Roles such as clinical services manager andmedicines information manager are usuallyfilled by pharmacists.
The department as a whole is usually led bya chief pharmacist, who will typically haveworked in various areas within hospital phar-macy and so have a broad understanding of howit works. They also need to have good commu-nication and time- and people-managementskills. They are likely to have been registered fora minimum of 10 years. The chief pharmacisttakes overall responsibility for the work of allthe staff within the department; he or she isresponsible for ensuring that the work carriedout by the department meets the legal andethical standards laid out in the legislature (e.g.the Medicines Act 1968), and in Medicines, Ethicsand Practice Guide for Pharmacists and PharmacyTechnicians. The Chief Pharmacist is also answer-able to the trust’s management with regard to theservices provided by the pharmacy department.
40 Chapter 4 • Hospital pharmacy
Figure 4.7 Pharmacy technicians producing steriledispensed items in an aseptic unit.
The future of hospital pharmacy
With the introduction of supplementary andindependent prescribing, pharmacists have theopportunity to enhance their existing skills andto expand the ways in which they use them, tothe benefit of patients. As pharmacists moveinto these extended roles, pharmacy techniciansand ATOs are developing their skills and knowl-edge to take on roles previously fulfilled bypharmacists.
The future of hospital pharmacy will see thecontinuation of the development of patient-centred care. The introduction of new technolo-gies, such as electronic prescribing and roboticdispensing, will enable pharmacy staff to spendmore time on patient-focused activities toimprove the outcome of treatment.
Summary
Hospital pharmacy offers a wide-ranging andchallenging career for the newly qualified phar-macist, using many of the skills and much of theknowledge acquired at university.
This chapter provides the student with anunderstanding of what this career offers and theroles available in the hospital pharmacy: prac-tising in a multidisciplinary team as a specialistclinical pharmacist, managing a sterile produc-tion unit, running the MI centre, or moving intoa management role, such as dispensary manager,clinical services manager or even becoming achief pharmacist. Underpinning all of these
roles is the fundamental role of the pharmacist,which is to ensure that the patient receives thebest pharmaceutical care possible, maximisingbenefit from the medicines they receive.
References
Hepler C D, Strand L M (1990). Opportunities andresponsibilities in pharmaceutical care. Am J HospPharm 47: 533–543.
Useful resources
Baxter K, ed (2007). Stockley’s Drug Interactions, 8thedn. London: Pharmaceutical Press.
Medicines and Healthcare products Regulatory Agency(2007). Rules and Guidance for Pharmaceutical Manu-facturers and Distributors. London: PharmaceuticalPress (the so-called Orange Guide).
Pharmline (Database for medicines management,prescribing and pharmacy): www.pharm-line.nhs.uk
PubMed (reference database provided by the USNational Library of Medicine): http://www.ncbi.nlm.nih.gov/sites/entrez?db�PubMed
Royal Pharmaceutical Society of Great Britain (2007).Medicines, Ethics and Practice: A Guide For Pharma-cists and Pharmacy Technicians, 31st edn. London:Pharmaceutical Press.
Sweetman S C, ed (2006). Martindale: The CompleteDrug Reference, 35th edn. London: PharmaceuticalPress.
Trissel L A (2007). Handbook on Injectable Drugs, 14thedn. Transatlantic Publishing.
Useful resources 41
Introduction
The role of the pharmacist as a distinct entityseparate from the physician has emerged over thecourse of history. At its inception, this roleinvolved the compounding of medicinal prod-ucts, including chemist’s nostrums and extempor-aneously prepared items (see Chapter 14). Overtime, this local preparation of medicines withinindividual pharmacies, whether to a formulaprescribed by the doctor or by the pharmacist,has diminished. These formulations have beenreplaced by products developed, licensed andmanufactured by companies with specific exper-tise in these areas. The majority of medicinalproducts dispensed to patients nowadays areprepared by central manufacturing processesperformed by pharmaceutical companies.
This centralised development ‘pipeline’ formedicinal products has allowed a large range ofnew chemical entities (NCEs) to be discoveredand more complicated dosage forms and devicesto be developed. Potential NCEs must pass
through a complex series of regulated clinicaltrials in order to become licensed and proceed tomarket. This strict framework aims to assess thesafety and efficacy of these products and toprevent severe or unacceptable side-effects forpotential patients. Pharmaceutical companieshave various departments, employing peoplewith particular skill sets, which deal with thesedifferent stages of getting a new drug success-fully to the market. This development pipelineprovides the benefit of effective, quality-assuredand ‘safe’ medicines to the population. (Note:safety is subjective – no drug is truly safe. Alldrugs show some adverse effects or side-effectsin some patient populations.) The drug develop-ment process aims to address previously untreat-able conditions and improve on the treatmentscurrently provided for other disease states.
Within their undergraduate training, phar-macists study a wide range of subjects. Theseinclude:
• medicinal chemistry – the design, synthesisand development of pharmaceutical drugs
Introduction . . . . . . . . . . . . . . . . . . . . . . 43
Research and development . . . . . . . . . . . 44
Manufacturing . . . . . . . . . . . . . . . . . . . . 45
Quality assurance . . . . . . . . . . . . . . . . . 46
Clinical trials . . . . . . . . . . . . . . . . . . . . . 47
Medicines information . . . . . . . . . . . . . . 49
Sales and marketing. . . . . . . . . . . . . . . . 49
Regulatory affairs . . . . . . . . . . . . . . . . . 50
General management and business . . . . . 51
So you want to be an industrialpharmacist . . . what next? . . . . . . . . . . . 52
References. . . . . . . . . . . . . . . . . . . . . . . 53
Useful resources. . . . . . . . . . . . . . . . . . . 53
5An overview of industrial sector pharmacy
Clare F Rawlinson
43
• pharmacology – how substances interact withliving organisms to change their function
• pharmaceutics – the science of dosage formdesign, i.e. the processes of turning an NCE(drug) into a safe and efficacious medicine.
This gives qualified pharmacists a uniquebreadth of knowledge and skill profile that isparticularly useful within the pharmaceuticalindustry. The pharmacist is therefore well quali-fied to play a key role within a network of multi-disciplinary professionals at each stage of thedrug development process (Wicks, 2000). Thischapter describes some of the major areas wherethese opportunities arise.
Research and development
Research and development (R&D) covers thewhole process of making a drug compound intoa viable dosage form to be taken by or adminis-tered to a patient. At the beginning of thisprocess of discovery, the basic structure of a lead(or parent) compound that has promising thera-peutic effects can be modified by using differentmethods of synthesis. These changes (e.g. tochemical side group) can make the drug target aspecific receptor or site more accurately. ManyNCEs with slight modifications in structure aresynthesised. These are then rapidly analysed fortherapeutic potential and favourable physicalproperties using specialised high-throughputscreening techniques. This process is managedby a scientist with a speciality in medicinalchemistry.
Once a promising NCE is identified, it will bepassed to the formulation department. This isthe stage of R&D where the majority of pharma-cists are employed. The NCE is transformedfrom a pure, usually powdered, drug compoundto a formulation that can be administered to apatient, for example by intravenous injection oras a tablet. The preferred route of administrationis usually oral (i.e. tablet or capsule). This routedoes not involve the risk of infection associatedwith subcutaneous or intravenous injection andis easy for the patient to administer themselves.However, an intravenous formulation will often
be developed first for early clinical trials (seepage 47).
In order to obtain a therapeutic response to adrug, an adequate concentration of the drugneeds to be delivered to and maintained at thesite(s) of action (Proudfoot, 1988). The amountof drug at the site of action relative to thedose administered is termed the bioavailability.This is affected by many factors once thedrug is in the body (e.g. degradation, elimina-tion and absorption) which in turn are influ-enced by the physicochemical characteristics ofthe compound. These characteristics may hinderdelivery by a particular route (e.g. a product thatdoesn’t dissolve in aqueous solutions is difficultto deliver in an oral formulation). The formula-tion scientist may modify the NCE to improvethese physicochemical characteristics, whichmay be through selection of a different drug saltor a polymorphic form with different solubility,physical state or stability. Alternatively, theymay add carefully selected excipients thatimprove the delivery of the drug compound(e.g. by improving its dissolution profile).
This area of development may involve manydosage forms: tablets, capsules, solutions andsuspensions for oral administration; creams,ointments and transdermal patches; inhalers;suppositories and enemas; injectable solutions;eye and ear drops. During development of theseproducts a formulation will be established and amanufacturing technique developed. The scien-tists involved will be interested in achievingeffective delivery and good bioavailability fromproducts, as well as ensuring adequate stabilityfor the lifetime of the product.
Formulation scientists also work on estab-lished drug compounds to improve or modifytheir delivery. Examples include modified-release preparations such as sustained-releasepainkillers or antidiabetic drugs that allow lessfrequent dosing of the medicine. This canproduce a more convenient product, improvingpatient adherence and therefore efficacy ofthe treatment. Delivery of established drugcompounds through novel routes of administra-tion, with associated benefits of this new route,is another area of development. A recentexample of this is the delivery of insulin via aninhaler device. This avoids the pain of injection,
44 Chapter 5 • Industrial sector pharmacy
the traditional route of administration. Thesenew products also result in new patents forthe pharmaceutical company, with associatedrevenue.
A sub-speciality within this field of formula-tion has emerged with the development ofbiotechnology. This involves the delivery ofvaccines, proteins, DNA and drug moleculesto the body through a variety of ‘smart’devices or targeted delivery. This includesproducts often described under the umbrella of‘nanotechnology’.
The pharmacist has a unique integratedunderstanding of physiology, pharmacologyand chemistry, making them ideally placedto understand the relationship between drugstructure, formulation and bioavailability and,in addition, to integrate concepts of patientacceptability into this development process.They therefore work successfully alongside
chemists and pharmacologists, throughout theR&D process.
A relevant PhD is desirable for a career in thisarea of industrial pharmacy. Depending on thesubject studied, this develops a knowledge basespecific to medicinal chemistry and/or formula-tion and, in addition, project management andstrategic problem-solving skills. Pharmaceuticalcompanies will often support employees topursue a part-time postgraduate degree byresearch alongside employment.
Manufacturing
Small-scale manufacturing is performed duringformulation development within the R&Ddepartment. However, when a product moveson to full-scale manufacture problems may arise
Manufacturing 45
Box 5.1 Case study: Research and development formulation
I studied Pharmacy at Trinity College Dublin, gradu-ating in 1993. After registering, I was keen to startworking so I got a job in community pharmacy. Then(as now), this branch of pharmacy had the higheststarting salaries. After 3 years, 2 of which involvedmanaging a pharmacy, I decided that I needed moreof a challenge.
I was fortunate to get my start in industry as a formu-lation scientist in their new technologies department atElan Pharmaceutical Technologies. Elan specialised indelivering ‘old’ drugs in new ways (e.g. formulating athree-times-a-day drug as once daily) and in developingnew routes of delivery (e.g. trying to make oral formu-lations of injectable drugs). From this job I gainedextensive practical experience both in a laboratorysetting and in good manufacturing practice, and avaluable introduction to how challenging busy projectscan be.
After 2 years with Elan, I decided that gaining aPhD would be a logical step if I wished to progress mycareer in research and development. I was fortunate tobe offered an industry-sponsored PhD with the Univer-sity of Nottingham, looking at the use of a novelabsorption enhancer, chitosan, for the oral delivery of
poorly bioavailable drugs such as insulin. Studying forthe PhD gave me an excellent hands-on way of buildingmy scientific confidence and improving my problem-solving skills. After getting my PhD, I worked for astart-up drug delivery company investigating novelgastroretentive technologies.
In 2005, I began my current job as a senior scien-tist in the formulation department at Bristol-MyersSquibb. I work with people of different disciplines indifferent geographical locations, and the work rangesfrom practical work to report writing to formal presen-tations, with ample opportunity for travel. The companyplaces a strong emphasis on career development.
For me personally, I have found pharmacist roles inindustry to offer far greater challenges and variety thanworking in community pharmacy, and opportunities forcareer progression offer a huge choice. My advice fora young graduate starting out would be to try outdifferent jobs, and to look beyond tempting startingsalaries to find something you really enjoy doing.
Dr Michael Leane
Senior Scientist, Pharmaceutics Research andDevelopment, Bristol-Myers Squibb
at any stage of production; poor flow of powdersfrom hoppers, segregation of mixed powdersduring movement of materials between stages ofmanufacture, and incorrect granulation mixtureconsistency are just some examples of the prob-lems that may be encountered during tabletting.
Pharmacists are often involved in the producttransfer process (i.e. from the formulation labor-atory to the manufacturing plant). They canapply knowledge of pharmaceutics to deduce thecause of a problem. This information can be usedto make slight alterations to the formulationwhilst liaising with the R&D department tosolve the particular problem without adverselyaffecting the final performance of the product.
Quality assurance
Quality assurance is an important part of themanufacturing process, and pharmacists oftenbecome involved in this area. Quality is aconcept that means different things to differentpeople. In relation to pharmaceutical products itmeans that the product is fit for purpose – it isfit to be given to a patient in the confidence thatit will have the desired effects and will not harmor damage him of her in any way, through faultsof manufacture (Sharp, 1994). Quality assuranceinvolves testing the raw material and manu-factured product at different stages to ensure
46 Chapter 5 • Industrial sector pharmacy
Box 5.2 Case study: Manufacturing
I studied Pharmacy at John Moore’s University Liverpooland graduated in July 2004. I enjoyed all aspects ofthe degree course but particularly the Industrial Phar-macy module and my final year project, which was astudy of dosage form design, in which I looked at thetabletting properties of various grades of hydroxy-propylmethylcellulose (HPMC) and lactose.
I completed my pre-registration year in the commu-nity sector and, following registration, I spent a further6 months as a relief manager, and then a permanentmanager, for the same firm. Whilst enjoying my timein community pharmacy, I realised that I wanted touse more of the knowledge gained at university, soI decided to move into the industrial sector. I became ascientist in the pharmaceutical development group atBristol-Myers Squibb (BMS).
Since beginning at BMS I have been involved in anumber of different projects, each at a different stagein the drug development programme. Working onvarious projects has provided variety, as well as very
useful experience. No two days are ever exactly alike.Typical activities range from small- to medium-scalemanufacturing (using a wide range of equipment),dissolution testing and recording, reporting andsummarising the resultant data.
Non-project related activities include the calibrationand validation of equipment, audit, setting up andchairing a Pharmacist forum within the company, andbeing a representative on a number of sub-teamsrelated to electronic laboratory notebooks.
Working in industry has allowed me to use much ofthe knowledge gained on my degree course, whilstpresenting a constant and interesting challenge. BMSplaces strong emphasis on high-quality training, teamwork and cooperation whilst enabling individuals toplan and take responsibility for their own work.
Michael Thompson
Scientist, Pharmaceutics Research and Development,Bristol-Myers Squibb
that the desired quality is achieved. Examplesinclude testing the mix quality of a physical mixor granulation, the strength of a granule or thefriability of a final tablet product.
As part of this assurance process, good manu-facturing practice (GMP) guidelines must beadhered to. These involve a strict method ofworking, with standard operating procedures(SOPs) for manufacture and clean down, accom-panied by supporting documentation at eachstage of the process. Within these guidelines amedicinal product is fit for purpose when it:
• is the right product• is the right strength• is free from contamination• has in no way deteriorated or broken down• is in the right container• is correctly labelled• is properly sealed in its container and pro-
tected against damage and contamination.
The aim of these processes is to build ‘quality bydesign’ into the manufacturing processes. It isnot possible to test each item manufactured,but there are dangers to patients even if only asmall number of defective items are released forconsumption. Put simply, this means that prod-ucts (and processes) are designed to be ‘good’and to meet specifications, rather than testing atthe point of manufacture to ensure that it is not‘bad’ or out of specifications.
Stability testing of the product also fallswithin the remit of this discipline. This involvestesting drug formulations under acceleratedconditions (i.e. at higher than ambient tempera-tures and pressures). Extrapolation of this datato room temperature allows the prediction ofhow long the product will remain stable (andviable for administration to a patient). Theexpiry date of a marketed product is thendecided on the basis of this data.
Many pharmacists working in this sector arenow choosing to take the ‘qualified person’ (QP)qualification. The primary role of the QP is toensure that each batch of a medicinal producthas been manufactured or assembled andchecked in compliance with the provisions of the
law. The QP authorises the release of each manu-factured batch, and is also involved in ensuringthe standards and completion of appropriatepaperwork for imported and exported rawmaterials and final drug formulations. Thisprofessional qualification involves specific post-graduate training; it is much sought after bypharmaceutical companies, as it is a legalrequirement for the manufacture and supply ofdrugs for clinical trials (Wicks, 2000).
Clinical trials
Clinical trials are a controlled investigation of aclinical treatment. This may include pharmaceu-tical medications, vaccines, medical devices,surgical techniques, clinical practice or ‘nutra-ceuticals’. Here we will focus on the testing ofpharmaceuticals. Within a clinical trial, drugs aretested in human volunteers to establish optimaldosing, efficacy and safety. Before this, anyNCE will have undergone preclinical testing: cellculture tests, animal studies, toxicology, poten-tial effectiveness, gross (severe) side-effects, andpharmacological and toxicity testing in animalsubjects. These results are reviewed by regula-tory authorities. Many compounds are rejectedat this stage (by either the pharmaceuticalcompany or a regulatory authority) because ofan unfavourable toxicity profile; only the mostpromising compounds are tested in humans.
Before starting a trial, approval must besought from the Medicines and Healthcareproducts Regulatory Agency (MHRA) in the UKor other relevant licensing authority (see sectionon Regulatory affairs, page 50). Approval isalso required from the National ResearchEthics (NRE) service. Trials are reviewed by anappointed NRE committee, at least one memberof which must be a pharmacist. Issues discussedmay include whether the benefit of the treat-ment outweighs the risk to the patient, whichwill vary depending on the disease state, patientage and whether treatment is for a chroniccondition (e.g. asthma), or is likely to be short
Clinical trials 47
term (e.g. chemotherapy for life-threateningcancer). Other issues include the use of placeboas a comparator for serious or potentially seriousdiseases. In these cases it may be consideredunethical to give patients a placebo (which isessentially withholding treatment) and the newtreatment will be compared with the best alter-native available on the market. The pharmacistuses his or her clinical, ethical and socialknowledge to inform these decisions.
In Phase I trials, a single dose of the test drugis administered to a small number of healthymale volunteers, usually aged 18–60 years. Thedrug is often in an intravenous formulation atthis stage in order to provide high bioavail-ability and so make efficacy evaluation morestraightforward. Criteria assessed may include:
• tolerability – highest tolerated dose• lowest effective dose• dose–effect relationship• duration of effect• side-effects• pharmacokinetics – time course of absorption,
distribution and elimination).
A pharmacological effect is not necessarilyobserved however, depending on the drug underinvestigation, e.g. the effect of an antibiotic willnot be seen in healthy volunteers.
Phase II trials are only performed if Phase Ishowed promising results. In a Phase II trial, thedrug is tested in 100–300 volunteer patients witha specific indication. This is often performed inthe patients’ normal clinical environment (e.g.hospital or GP surgery). A therapeutic effect isexpected in these patients and the followingcriteria are assessed:
• bioavailability• efficacy• side-effects• pharmacokinetic data, which may differ from
values in healthy volunteers because of theeffect of the disease state
• interactions with current medication• inter-patient variability (between different
patients)• intra-patient variability (in same patient at
different times, e.g. affect of fasted state)• risk–benefit ratio.
If adequate efficacy and advantages over stan-dard therapy are shown in Phase II trials, andany risks from the treatment are acceptable,Phase III trials are performed. The drug is usuallyin its final or near-final formulation at thisstage. The effects of the drug are evaluated in1000–3000 volunteer patients who will beassessed and further information on safety andefficacy will be collected. The following will beestablished/assessed:
• set dosage• type of administration• some contraindications• precautionary measures• safety and efficacy on long-term use• therapeutic advantage over established treat-
ment• clarification of interactions with other drugs.
If Phase III trials are successful, an applicationfor marketing authorsation will be submitted.
Phase IV clinical trials (also called post-marketing surveillance) continue once the drughas received marketing authorisation and isavailable on prescription. These trials allowassessment of clinical data for:
• dosage optimisation• drug–drug interactions• identification of additional indications• adverse effects associated with long-term use• potential for overdose/misuse • detailed evaluation of why some patients do
not respond to the treatment• long-term comparative data.
New dosage forms that allow patent exten-sion may also be evaluated at this stage,including combination products of more thanone NCE/drug.
Pharmacists are involved in all stages of clin-ical trials, starting with designing trial protocolsand organising clinical trials supplies. They areinvolved in screening patients for suitabilityfor inclusion in trials; they are ideally placedto assess criteria such a current drug usageand potential for drug interactions with con-comitant medication. Pharmacists have goodcommunication skills (see Chapter 9), which arevital in ensuring that patients give informedconsent – each potential subject (patient) must
48 Chapter 5 • Industrial sector pharmacy
be adequately informed of the aims, methods,anticipated benefits and potential hazards ofthe study, and the discomfort it may entail.Problems may occur in ensuring that subjects(patients/volunteers under study) understand,especially if the subject is a child or is incapaci-tated. Pharmacists may be employed by a phar-maceutical company or by the clinic runningthe trial (e.g. within a hospital setting).
Pharmacists may also participate in recruit-ment of patients (in contrast to the recruitmentof healthy volunteers) whilst dealing with theirroutine treatment in the clinic. Pharmacistsfrom all sectors of pharmacy also have a role toplay in the Phase IV evaluation of medicines.They are an important partner in the reportingof suspected adverse reactions (side-effects) orunexpected events to the MHRA or other rele-vant body. In the UK, this is through the YellowCard Scheme (see Chapter 4).
Medicines information
Medicines information (MI) is an importantarea of industrial pharmacy. Most pharmaceu-tical companies will have an MI departmentthat holds information pertaining to theirmarketed drugs and sometimes for competitors’drugs as well. This is where data from all clinicaltrials and clinical reporting is collated anddisseminated back to health professionals andthe public. The MI department may also beasked to write technical literature for use bythe company and to be involved in trainingmedical representatives. The legal departmentwithin the company may also be involved inpreparing and regulating the content of thisinformation.
The MI department may act as a point ofcontact (further to the MHRA) for the reportingof adverse drug reactions by clinicians. Thisinformation is collated on to easily accessibledatabases and supplemented with onlineaccess to medical and scientific literature. TheMI department will also field enquiries bydoctors, pharmacists, nurses and patients. Theinformation provided may include:
• alternative administration of the medicine,e.g. can a tablet be crushed for administrationdown a feeding tube without losing its effi-cacy? Can the drug be placed in a parenteralfeed without binding to the ingredients andlosing efficacy? Does this take its use outsideof the product licence? (see Chapter 16)
• technical information about how toadminister/use a medical device
• further details about contraindications,cautions and adverse drug reactions
• dosing in children or the elderly if thisinformation is not currently available
• risk–benefit ratio of a particular drugtreatment/adverse effect
• information about manufacturing and supplyproblems.
A pharmacist is ideally placed to perform theseroles: they have clinical skills to understand thedata available, and the communication skills totranslate this to understandable language foreither another health professional or a patient.They also have the interpersonal skills to trainother members of staff.
Sales and marketing
Once a drug product is brought to market, thepharmaceutical company will invest a largeamount of money on promoting awareness ofthe product. In the UK, companies are notallowed to market prescription-only medicinesdirectly to the public, although they can marketgeneral sales list (GSL) and pharmacy (P) prod-ucts (under strict guidelines). Adverts for GSLproducts and ‘P’ medicines are placed across arange of media outlets, including television, billboards and magazines.
In addition to this promotion to the generalpublic, companies spend a huge amount oftime, money and effort promoting their prod-ucts to prescribers, who may be doctors, nurses,dentists, pharmacists (more recently) and otherhealth professionals. They also promote theirproducts to the wider pharmacy team that willadvise on the prescribing of medicines and makedecisions about formularies, both in hospital
Sales and marketing 49
and community (e.g. primary care trust (PCT)advisory pharmacists). Medical representativeswill visit these individuals in their place ofwork and present the clinical data available onthe efficacy and safety of the new productand promote any advantages over the existingproducts available.
Pharmacists may be involved in developingthe marketing of products, and are ofteninvolved in focus groups when branding isbeing developed for a given product. They arealso employed as medical representatives wheretheir clinical skills enable them to understandthe clinical data involved and to answercomplex questions posed by clinicians in rela-tion to the product being marketed. This fieldrepresents a relatively small number of phar-macists employed within the pharmaceuticalindustry.
Regulatory affairs
In the UK the MHRA is the organisation thatdeals with the licensing and regulation of medi-cines and medical devices. The MHRA does nothave a didactic approach to the enforcementof the regulations surrounding pharmaceuticalproducts. In contrast, the aim of the MHRA is toenable greater access to products, and the timelyintroduction of innovative treatments and tech-nologies that benefit patients and the public(MHRA, 2007). No product is risk free, and theMHRA makes judgements to ensure that thebenefits to patients and the public from theseproducts justify the risks.
As part of this process, the MHRA plays akey role in the regulation of clinical trials(Chamberlain, 2007). Its function is to ensurethe safety of trial participants and the collec-tion of valid data. Information must beprovided to the MHRA by the pharmaceuticalcompany: the trial protocol, investigators’brochure, inclusion and exclusion criteria, safetymonitoring and reporting, non-clinical data andinformation about the quality of the productand manufacturing conditions (credible datacannot be collected if the quality of a product is
inconsistent). The agency does not act in aconsultancy role to the sponsoring company.However, it will discuss particular problems thatarise during a trial with the company involved.
The MHRA also inspects manufacturing sitesof companies and ensures they adhere to GMPguidelines and that the companies facilities arefit for purpose.
When a pharmaceutical company wishes tolicense a new product for the UK market, oncethey have completed the appropriate clinicaltrials, they must submit documentation ofvarious testing performed on the product to theMHRA. This includes a wide range of datacollected from in vitro, animal and humanstudies, data on dosing, indication, pharma-cology, pharmacokinetics, routes of elimination,known adverse drug reactions, toxicity, cautionsand drug interactions, to name but a few. Thismust also include specification of purity andacceptable limits for manufacturing of theproduct (i.e. how must the product perform forit to be deemed ‘correct’, such as disintegrationand dissolution time for a tablet under a givenset of experimental conditions). The pharma-ceutical company will liaise with the MHRAthroughout the process of collecting the clinicaldata for a product submission, and cooperatetowards a (hopefully) successful submission.
The British Pharmacopoeia Commission pre-pares and publishes the British Pharmacopoeia(BP). This book contains monographs for drugsused in the UK in the practice of medicine,surgery, dentistry and midwifery (British Pharma-copoeia Commission, 2007). These monographscontain relevant information (i.e. descriptionsof, standards for or notes on other mattersrelating to these substances). Any medicinalproduct manufactured or sold in the UK (e.g. bya generics manufacturer) must comply withthese standards. The BP also provides guidanceon many of the methods that are used to testnew drug products for licence submission.Other pharmacopoeias also exist, including theEuropean Pharmacopoeia.
Pharmaceutical companies will have a specificdepartment that is responsible for regulatoryaffairs. This department will collate the largeamount of data required for a drug licence
50 Chapter 5 • Industrial sector pharmacy
submission and transform it into the appropriateformat for the particular regulatory agency(depending on the country that registration isbeing submitted for). This department will alsoliaise with the different agencies to try to ensurea successful outcome.
Pharmacists are ideally placed to work withinthese pharmaceutical regulatory bodies anddepartments. They have the knowledge to beable to interpret both the scientific and clinicaldata for drugs and to be able to understand therisk–benefit analysis that must be made for allmedicines before they can be approved foradministration to the public. Equivalent organ-isations to these UK agencies exist in differentcountries around the world, for example theFood and Drug Administration (FDA) in theUSA. The European Agency for the Evaluation ofMedical Products (EMEA) deals with centralised
procedures for market authorisations. Opportu-nities for employment for UK pharmacists alsoexist in these groups.
General management and business
As with all areas of pharmacy, the differentdisciplines of industrial pharmacy offer oppor-tunities to move into management. This mayinvolve dealing with staff, economic evaluationof a business situation, budgeting, strategicplanning for use of equipment or resources,and critical decision making. Pharmacists arealso becoming employed in strategic businessroles, facilitating interactions between acad-emia, start-up companies and small and largepharmaceutical companies (Dawson, 1999). The
General management and business 51
Box 5.3 Case study: Regulatory affairs
As an undergraduate, I did a 6 year course inPharmaceutical Chemistry and Technology at the Univer-sity of Trieste, Italy. This course included all the modulesof the Pharmacy degree and additional courses relatingto the production of pharmaceutical products. My finalundergraduate thesis focused on scale-up procedures ingranulate production and was carried out in collabor-ation with a small Italian pharmaceutical companyand the University of Bradford in the UK. Whilst atBradford, I was offered a PhD scholarship sponsored byAstraZeneca to study the stabilising effect of novel excip-ients on freeze-dried proteins. I conducted my researchat the University of Bradford and in AstraZeneca’slaboratories in Loughborough in the UK and Södertäljein Sweden. Through my industrial experience, I realisedthat I enjoyed planning, validating and analysing theexperiments and the data collected, rather than theactual running of the experiments.
Whilst writing my PhD thesis, I worked part-time asa locum pharmacist and I started developing an interestin the roles that public bodies such as the National
Institute for Health and Clinical Excellence (NICE) andthe Medicines and Healthcare products RegulatoryAgency (MHRA) have in public health.
Having gained a better understanding of my inter-ests, I came to my current job as a pharmaceuticalassessor at the MHRA. As a pharmaceutical assessor, Ilook at the dossiers of medicines to assess their safetybefore they get marketing authorisation for the UK andEuropean markets. I work in collaboration with medicaldoctors and toxicologists and liaise with pharmaceu-tical companies and other European agencies. In thisjob, I evaluate all the data collected by pharmaceuticalcompanies in relation to the manufacturing of theproduct. It is an exciting, stimulating and challengingjob that allows me to put into practice what I havelearned in my degree and specialised in during myPhD, with the benefit of the perspective I gained duringmy community experience.
Dr Claudia Vincenzi
Pharmaceutical Assessor, MHRA
multidisciplinary skills of pharmacists makethem particularly adept at moving betweenthese different environments.
So you want to be an industrialpharmacist . . . what next?
Undergraduates who are interested in a career inany of the areas of industrial pharmacy shouldgain relevant work experience. Some companiesoffer training opportunities to pharmacy stu-dents, for example through summer vacationprogrammes. These can offer an extremely variedexperience, depending on the work performed ata particular location, which could range fromformulation and analytical testing to clinicaltrials management and provision of medicinesinformation. Students should enquire about such
placements well in advance. Competition forplacements is high as only a limited number ofcompanies offer these opportunities; excellentacademic performance is vital to getting aplacement.
Pre-registration training places within indus-try are scarce compared with hospital andcommunity pharmacy and thus there is intensecompetition for placements. However, pre-registration training within this sector is not aprerequisite for a career in industrial pharmacy.Gaining a quality pre-registration placement inanother sector, being informed of the differentopportunities available in industrial pharmacyand having enthusiasm for work within thissector can be a highly effective route into theindustry.
In 2004, 33% of pharmacists working withinindustrial pharmacy held a PhD (Kerridge,2004). A further 34% held an additional
52 Chapter 5 • Industrial sector pharmacy
Box 5.4 Case study: Management and business in pharmaceutical innovation
Although I completed a PhD in Neuropharmacologyafter getting my degree in Pharmacy, my purpose wasnot to move into a specific career direction. Embarkingon the PhD made me realise that I did not want tobecome a lecturer or academic researcher. However,during the course of the PhD I came across a programmecalled Bioscience Young Enterprise Scheme which wasopen for postgraduate students and which introducedthe concept of commercialising science/academic‘know-how’. I participated in this scheme, found it to bevery interesting and decided that I wanted to work in thisarea.
I started out by volunteering my services for 1 monthat the newly opened Institute of Pharmaceutical Innova-tion (IPI) in March 2004. This is a research facility dedi-cated to supporting innovation in drug developmentand drug delivery. It performs collaborative researchbetween industry and academia and provides contractservices. The IPI had just been opened, so I was seeinga young business operating first hand and found thecommercial aspects to be very interesting. I wasparticularly fortunate as the IPI also enjoyed havingme and felt that I was of benefit to the organisation;
I subsequently gained a salaried position and I am stillhere 3 years later!
My current role is very varied. I have responsibilityfor developing and maintaining the IPI’s marketingmaterials and website and underpinning the commer-cialisation and research promotion activity. Thisinvolves performing commercial analysis, coordinatingagendas for business development and researching newstrategic opportunities (e.g. potential new customers,funding initiatives, etc.). I also attend networkingevents to raise the profile of our capabilities, andorganise our conference programme. Other responsi-bilities include programme management for keycommercial projects and start-up companies basedwithin the IPI.
Overall, I enjoy the variety of my role and the factthat my skills and ability can make a real and positivecontribution to developing the business and generatingrevenue for the IPI.
Dr Riddhi Shukla
Commercial Projects Manager, Institute ofPharmaceutical Innovation
qualification relevant to their position (e.g.Qualified Person (QP), Master of BusinessAdministration or a clinical diploma). However,many opportunities exist for training for thesequalifications in parallel to employment,supported by an employer. Indeed, industrialpharmacy continues to deliver unparallelededucation and career growth opportunities(Wicks, 2000). Certainly qualification andregistration with the Royal PharmaceuticalSociety of Great Britain, followed by studyingfor a PhD, is not the only route into this sectorof pharmacy. Experience gained after severalyears of practice in hospital or communitypharmacy can be advantageous for some roleswithin industry (e.g. medicines information,clinical trial supply logistics). There are there-fore also opportunities to move into this field afew years after qualification.
Working within the pharmaceutical industryallows you to contribute to the development ofnew effective and safe medicines benefiting aworldwide population. It presents interestingalternatives that use our professional skills andtraining, and opportunities to move betweendifferent fields and tackle different disciplines ofscience, information, marketing and manage-ment. Most importantly, it presents the chanceof an exciting, varied and challenging career.
References
British Pharmacopoeia Commission (2007). BritishPharmacopoeia. London: Stationery Office.
Chamberlain, J (2007). Legal and regulatory aspects:good control of manufacturing process. Pharm J278: 563–564.
Dawson B. (1999). New challenges: a role forpharmacists in industry. Pharm J 263: 534–535.
Kerridge J. (2004). Survey of industrial pharmacists inemployment. Pharm J 272: 396–397.
Medicines and Healthcare products Regulatory Agency(2007). How we Regulate. www.mhra.gov.uk(accessed August 2007).
Proudfoot S (1988). Factors influencing bioavailability:factors influencing drug absorption from thegastrointestinal tract. Pharmaceutics. In: Aulton M,ed. Pharmaceutics. The Science of Dosage Form Design.New York: Churchill Livingstone, pp 135–173.
Sharp J (1994). Quality Rules: Short Guide to GoodManufacturing Practice, 2nd edn. Reading: AnchorPress.
Wicks S (2000). Careers and development in a growingindustrial sector. Pharm J 264: 150–151.
Useful resources
RPSBG careers: www.pharmacycareers.org.ukAssociation of the British Pharmaceutical Industry
(ABPI): www.abpi-careers.org.uk
Useful resources 53
Introduction
This chapter introduces the concept of medi-cines management and the role of the com-munity pharmacist. The chapter begins bydescribing what medicines management is, whyit is needed, the different types of medicinesmanagement, and how these are achieved. Thechapter closes with a description of the medi-cines management services that communitypharmacists in the UK can provide.
Many of the principles of medicines manage-ment described in this chapter also apply tohospital pharmacists. However, the specificroles can differ markedly between hospital andcommunity pharmacists; a description of theseindividual roles is beyond the scope of thischapter.
What is medicines management?
The objective of medicines management is toprovide the best possible outcome for patients atthe lowest possible cost. Medicines managementis not aimed solely at cost reduction, but atproviding the most cost-effective care for thebest possible patient outcomes. The term medi-cines management incorporates all aspects ofmedicines usage by patients and health profes-sionals, including the ways in which medicinesare selected, procured, delivered, prescribed,administered, monitored and reviewed. Medi-cines management has been given a variety ofdefinitions (see Box 6.1), the most succinct ofwhich is, ‘the systematic provision of medicinestherapy through a partnership effort betweenpatients and professionals to deliver best
Introduction . . . . . . . . . . . . . . . . . . . . . . 55
What is medicines management? . . . . . . . 55
Development of medicinesmanagement . . . . . . . . . . . . . . . . . . . . . 56
Consequences of poor medicinesmanagement . . . . . . . . . . . . . . . . . . . . . 58
Types of medicines management . . . . . . . 59
Ways in which medicines managementis achieved . . . . . . . . . . . . . . . . . . . . . . 62
Community pharmacists and medicinesmanagement under the new PharmacyContract . . . . . . . . . . . . . . . . . . . . . . . . 65
Summary . . . . . . . . . . . . . . . . . . . . . . . 68
References. . . . . . . . . . . . . . . . . . . . . . . 68
6Introduction to medicines management
Rachel L Howard
55
patient outcome at minimised cost’ (Tweedieand Jones, 2001). (Chapter 14 discusses patientsand professionals working in partnership.)
Development of medicines management
For many years doctors have been prescribingmedicines with the intention of providingpatient benefit. Medicines management has notbeen a focus in the past, so why has there beenan increasing emphasis on this area in recentyears?
The majority of health professionals andpatients recognise that all medicines can causeadverse drug reactions (ADRs). In many cases,these reactions are a minor inconvenience topatients. However, ADRs can result in seriouspatient injury, leading to hospital admission,disability or even death. These serious ADRshave been studied for many years but, untilrecently, there has been less interest in whetherADRs could be avoided or the effects on patientslessened. A focus on the preventability ofADRs became apparent in the 1980s with thepublication of a number of studies describing
preventable drug-related admissions to hospital(Trunet et al., 1980; Bigby et al., 1987; ItalianGroup on Intensive Care Evaluation, 1987). Inthe 1990s the patient safety movement began togain momentum, with an in-depth analysis ofpatients’ injuries caused by general medical carein US hospitals (Leape et al., 1995). Enthusiasmfor maximising the safety, efficacy and qualityof patient care reached government level in theUK in 2000 with the publication of the reportAn organisation with a memory (Department ofHealth, 2000a), which reviewed the literature onmedical error and was instrumental in begin-ning to develop a safety culture in the NationalHealth Service (NHS) (see Box 6.2). In addition,An organisation with a memory led to a number ofreports highlighting the importance of medi-cines management and the roles that pharma-cists and other health professionals could play(see Boxes 6.3 and 6.4) (Audit Commission,2001; Smith, 2004). Pharmacy in the Future seta deadline of 2004 for the implementation ofmedicines management schemes in primarycare to help ‘reduce the amount of illness causedby medicines not being used correctly, and cutwaste’ (see Box 2.3, page 13) (Department ofHealth, 2000b).
56 Chapter 6 • Medicines management
Box 6.1 Definitions of medicines management
‘Medicines management . . . encompasses the entireway that medicines are selected, procured, delivered,prescribed, administered and reviewed to optimise thecontribution that medicines make to producinginformed and desired outcomes of patient care.’ (AuditCommission, 2001)
‘Medicines management encompasses a range ofactivities intended to improve the way that medicinesare used, both by patients and by the NHS. Medicinesmanagement services are processes based on patientneed that are used to design, implement, deliver andmonitor patient-focused care. They can include allaspects of the supply and use of medicines, from anindividual medication review to a health promotionprogramme.’ (NPC, 2002)
‘[Medicines management is a practice that] seeks tomaximise health through the optimal use of medicines.It encompasses all aspects of medicines use, fromthe prescribing of medicines through the ways inwhich medicines are taken or not taken by patients.’(Lowe, 2001)
‘[Medicines management is] the systematic provisionof medicines therapy through a partnership ofeffort between patients and professionals to deliverbest patient outcome at minimised cost.’ (Tweedie &Jones, 2001)
‘[Medicines management is] a pooling of medical,pharmaceutical, and patient knowledge for the benefitof the patient, accessing other professionals’ expertisewhere appropriate.’ (Tweedie & Jones, 2001)
Development of medicines management 57
Box 6.2 An organisation with a memory
An organisation with a memory was a report publishedby the Department of Health in 2000, in response to agrowing recognition of the cost of adverse eventswithin the NHS. It set out:
• what was known about the number and types ofadverse events experienced by patients
• where there were holes in our knowledge aboutthe frequency and causes of adverse events
• how other industries, such as aviation and nuclear,have systems in place to learn from mistakes (andtherefore help avoid them happening again)
• the role of organisational structures in eventsleading up to errors, in addition to the role ofhuman errors and the factors which can contributeto these
• the tradition of a ‘blame-orientated approach’ toindividuals when errors occur, whilst advocating
an open and fair approach to individuals whichshould encourage staff to report adverse eventsand errors that occur, without fear of retribution
• how existing systems for reporting events arefragmented and incomplete
• a proposal for:
– a unified national adverse event reportingsystem allowing analysis of events to helpavoid problems in the future
– a more open culture where errors can bediscussed without fear of retribution
– ensuring that, where lessons are identified,changes are put into place nationally.
The full report can be accessed via www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4065083
Box 6.3 A spoonful of sugar
In 2001, the Audit Commission published the report Aspoonful of sugar – medicines management in NHShospitals to emphasise the importance of medicinesmanagement to managers within National HealthService (NHS) hospitals. The report:
• introduces the concept of medicines managementand highlights the obstacles to improving theprovision of medicines management
• describes the cost pressures associated withproviding medicines for patients and the reasonswhy medicines management systems should bereviewed
• sets out the medicines management roles ofdifferent groups within hospitals, such ashospital managers, drugs and therapeutics
committees, risk managers, clinicians andpharmacists
• highlights ways in which risks can be reducedusing computer technology and clinicalpharmacists, as well as different ways of providingmedicines management
• outlines some of the barriers to an increased rolefor hospital clinical pharmacists in medicinesmanagement, and how these can be overcome
• sets out action plans for managers within NHShospitals and professional associations in order toimprove the provision of medicines managementservices.
The full report can be accessed via the AuditCommission website (www.audit-commission.gov.uk).
Consequences of poor medicinesmanagement
The consequences of poor medicines manage-ment include medication errors, patient injuryand wastage of NHS money. Medication errorscan occur at all stages of the medicines manage-ment process (prescribing, dispensing, adminis-tering and monitoring). The majority of errorswill be identified before the medicines reach
patients (near misses) or will result in no harmto patients. However, a significant minority ofmedication errors (usually those described asserious errors) can result in patient harm(preventable drug-related morbidity; PDRM).The stages of the medicines managementprocess at which errors can occur are describedin detail below. The frequency of errors at eachstage of the medicines management process isgiven in Table 6.1.
58 Chapter 6 • Medicines management
Box 6.4 Building a safer NHS for patients: improving medication safety
Following the report An organisation with a memory(see Box 6.2), the Department of Health published aseries of reports entitled Building a safer NHS forpatients. One of these – Improving medication safety(Smith, 2004) – focused specifically on medicationsafety. This report described the:
• frequency and causes of medication errors• role of the National Patient Safety Agency in
preventing medication errors• risks of errors at various stages in the medication
use process• particular risks to patients at high risk of
medication errors, such as patients with allergiesto medications, seriously ill patients, and children
• risks associated with specific groups ofmedications
• ways in which medication errors can be avoidedthrough better use of information technology,medication packaging and different ways ofworking.
The full report can be accessed via www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4071443
National Patient Safety Agency website:www.npsa.nhs.uk
Table 6.1 Frequency of medication management errors
Error type Patient group Frequency of error Reference
Prescribing error Children in hospital 0.45–30 errors per 100 prescriptions Ghaleb et al., 2006Adults in hospital 1.5 errors per 100 prescriptions Dean et al., 2002All patients in primary 0.2–1.9% of prescriptions dispensed Chen et al., 2005
care in community pharmacyDispensing error Patients presenting 22 per 10 000 items dispensed Ashcroft et al.,
prescriptions to a (near misses) 2005community pharmacy 4 per 10 000 items dispensed (errors)
Administration error Patients administering 50% of patients with chronic WHO, 2003their own medication in conditions are poorly adherentthe community
All patients in hospital 15% of patients administered oral Tissot et al., 2003medications by nurses
49% of intravenous medication doses Taxis and Barber, administered; one-third of errors at 2003least moderately serious
Prescribing errors
Prescribing errors can occur when selectingwhich drug to prescribe, or during the act ofwriting or computer-generating a prescription.These errors are more frequent in hospitals thanin primary care, but still represent a significantrisk to patients in the community.
Dispensing errors
Dispensing errors can occur when a medicationis physically selected, labelled or handed to thepatient. Near misses and dispensing errors arerelatively infrequent, but can have importantconsequences for patients and pharmacists (seeChapter 15). Dispensing errors can cause perma-nent physical injury or death to patients, andare still considered a criminal offence under theMedicines Act.
Administration errors
Administration errors can occur when a medica-tion is taken by a patient or given to a patientby a carer or health professional. An administra-tion error that results from a patient not takingtheir medication as prescribed is described asan adherence problem (see Chapter 14). Admin-istration errors can occur when medicines areselected or prepared incorrectly, or administeredvia the wrong route (see Chapter 16).
Monitoring errors
Both patients and health professionals can makemonitoring errors. Monitoring errors can occurwhen a patient does not recognise that thecondition being treated is worsening, or doesnot act in an appropriate way, such as seekinghelp from a health professional or adjusting theirmedication according to a pre-agreed plan. Forexample, patients with diabetes will find theirblood glucose goes up if they have an infectionand should therefore be aware of the ‘sick dayrules’, which recommend increasing their insulindose in response to this. Monitoring errors can
also occur when a health professional does notidentify a deterioration in a patient’s condition,or when they do not perform necessary testswhen starting or continuing medication. Teststhat health professionals might be expected toperform include blood tests, urine tests andmeasurement of blood pressure and pulse rate.These can all be used to monitor the effective-ness of medication and to identify potentialadverse effects.
Preventable drug-related injuries
Serious medication errors can result in PDRM,which is believed to account for about 4% ofadmissions to hospital (Howard et al., 2007).Older patients (over 65 years of age) are twice aslikely to experience a preventable drug-relatedadmission (Winterstein et al., 2002). Nearly 2% ofpatients will experience a PDRM during hospitaladmission (Kanjanarat et al., 2003); in primarycare in the USA, 1.5–3% of patients in their ownhomes, and around 10% of patients in nursinghomes, will experience a PDRM (Gurwitz et al.,2000, 2003; Gandhi et al., 2003).
These PDRMs represent a significant burdento patients, health professionals and the NHS.Medication errors are thought to cost the NHSabout £500 million per year in extra days spentin hospital. In addition, unused medicines areestimated to waste more than £100 millionper year of NHS money (Department of Health,2000b; Audit Commission, 2001). Improve-ments to medicines management services inboth primary and secondary care settings are animportant strategy to help prevent PDRM.
Types of medicines management
Medicines management encompasses a broadrange of services that range in focus from indi-vidual patients to the provision of care to thepopulation as a whole. Five categories of medi-cines management services have been identifiedby the National Prescribing Centre (NPC) andNational Primary Care Research & DevelopmentCentre (NPCRDC; 2002b):
Types of medicines management 59
• clinical medicines management• systems and processes• public health• patients and their medicines• interface medicines management.
The first four categories are of particular rele-vance to community pharmacy and are describedin more detail below.
Clinical medicines management
Clinical medicines management services focuson the patient and ‘the assessment, monitoringand review of prescribing for individual patients’(NPC and NPCRDC, 2002a). All health profes-sionals involved in providing medicines topatients, including pharmacists, have a respon-sibility to use their clinical and professionalskills to provide clinical medicines managementservices.
In primary care many patients receive medica-tion via repeat prescriptions, which are autho-rised by the prescriber for a fixed number ofprescriptions or a fixed time period (often6 or 12 months). During this time, the patientrequests further prescriptions from the recep-tionist, rather than making an appointmentwith their general practitioner (GP). Repeatprescriptions are not checked for their appropri-ateness each time they are issued. Instead, theprescriptions should be carefully assessed at theend of the repeat prescribing period, a processknown as medication review (see Box 6.5).Medication reviews can also be undertaken withpatients who are considered to be at a high riskof medication problems, including those takingspecific high-risk medications, patients takingmore than four regular repeat medications, andpatients where poor adherence is suspected(Department of Health, 2001).
Historically, medication reviews have nothappened for a variety of reasons, includingGPs’ time constraints. Zermansky et al. (2002)found that GPs performed medication reviewswith 56–71% of patients aged 65 years or olderon at least one repeat prescription. Guidelinesfor medication reviews recommend that allpatients aged 65 years or older should have an
annual medication review, whilst those takingfour or more medications should have a medica-tion review every 6 months (Department ofHealth, 2001). GP practices are now paid forproviding medication reviews to patientsthrough the quality and outcomes framework(see Box 2.12) and community pharmacies canbe paid for performing medication reviews asan enhanced service in the new communityPharmacy Contract. Medication reviews forpatients on repeat prescriptions are an idealopportunity for pharmacists to contribute tomedicines management in primary care. Studieshave confirmed that pharmacist-led medicationreviews reduce the cost of prescribing, andimprove patient adherence to medication(Beney et al., 2000; Holland et al., 2006).
Other clinical medicines management servicescould include specialist disease managementclinics and clinical pharmacy interventionsin nursing homes, community hospitals andpatients’ own homes. Pharmacist-led specialistdisease management clinics can improvepatients’ clinical outcomes, but do not seem toimprove the quality of patients’ lives (Beneyet al., 2000). In addition, the CommunityPharmacy Medicines Management ProjectEvaluation Team (2007) found that althoughpatient satisfaction was increased, communitypharmacists had no impact on the appropriate-ness of drugs prescribed for patients with cardio-vascular disease, and the pharmacist-led servicecost more than a GP-led service. Thus, the valueof any service provided requires serious consid-eration in terms of patient benefit and cost tothe NHS.
Systems and processes
In addition to direct clinical management ofpatients, some medicines management servicesfocus on the systems and processes of workinvolved in supplying medicines to patients. Thesafety and efficiency of medicines managementcan be improved by changing systems. Thesemedicines management services can includedeveloping protocols for repeat prescribingsystems or developing integrated care pathways(flow diagrams that give guidance on how to
60 Chapter 6 • Medicines management
manage patients with specific conditions). Inaddition, comparing current practice at workwith these guidelines or standards (a processknown as audit) can help to identify medicinesmanagement systems or processes that could beimproved (see Chapter 15).
Public health
In addition to focusing medicines managementservices at individual patients, it is importantto target services to meet the needs of the local
population – described as public health. Publichealth services can be targeted at individualmembers of the public at the point of care, or aspart of an educational role within NHS organ-isations (PSNC, 2004). Medicines managementservices with a public health focus are shown inBox 6.6. Two of these services are described inmore detail below.
Smoking cessation
Community pharmacists can train to provide asuccessful and cost-effective smoking cessation
Types of medicines management 61
Box 6.5 Medication review
Medication review has been defined as, ‘a structuredcritical examination of a patient’s medicines, with theobjective of reaching an agreement with the patientabout treatment, optimising the impact of medicines,minimising the number of medication-related problemsand reducing waste’ (Shaw et al., 2002). Four differentlevels of medication review have been identified.
• Level 0 – ad hoc: An unstructured opportunisticreview of a patient’s medication in response to aquestion or problem. Ad hoc reviews are notconsidered to be true medication reviews becausethey are unlikely to address all of a patient’smedication problems.
• Level 1 – prescription review: A review of apatient’s medication without access to the clinicalmedical records (see Box 6.7). The patient maynot necessarily be present. Prescription reviewscan be useful for brand-to-generic switches,deciding whether to continue or discontinue amedicine, and optimising pack sizes. Prescriptionreviews can also be useful for assessing a patient’smedication between face-to-face clinicalmedication reviews.
• Level 2 – treatment review: A review of a patient’smedication, often without the patient present,where the reviewer has access to the clinicalrecords. Reviews can cover a patient’s wholemedication list, or focus on single agents (e.g.lithium, a mood stabiliser used in severedepression, mania and related disorders), ortherapeutic groups of agents (e.g.
antihypertensives). Treatment reviews can be usedto modify medication doses or to identify patientswho need monitoring. Treatment reviews can beproblematic because they rely on the treatmentrecord, not the patient’s account of what they take,and changes to medication can be made withoutthe patient’s agreement. This is not congruent withthe concordance model of care (see Chapter 15)and can cause patients to become confused abouttheir medication. This increases the risk ofpreventable drug-related morbidity throughpatients mistakenly taking medications incorrectly.
• Level 3 – clinical medication review (CMR): A face-to-face review of a patient’s medication andclinical condition. A CMR includes a patient’sentire medication history (including non-prescription medicines) and takes account of whatthe patient actually takes and informationcontained in the medical record. During a CMR, apatient’s views and beliefs about their medicinesare accounted for and any changes to treatmentare agreed with the patient. A CMR facilitatesevaluation of the therapeutic value of each drug,identification of untreated conditions, and aconcordant discussion about a patient’s treatment(see Chapter 15). However, CMRs use a lot ofhealth professional resources (and are thereforemore expensive than other reviews). CMRs areconsidered to be the gold standard, but lowerlevel reviews remain useful for the reasons detailedabove.
service. Studies in theUKhave foundthat smokersare 2–5-times more likely to quit smoking whenthey participate in a smoking cessation service ledby a community pharmacist (Anderson et al.,2003a).
Influenza vaccination
Community pharmacy patient medicationrecords (PMRs) (see also ‘Identifying patientsat risk of adverse effects’, page 64) can be used toidentify patients who might benefit frominfluenza vaccination (Anderson et al., 2003b).Pharmacists based in supermarket pharmaciesin the USA have successfully provided immun-isations to adults without adverse effects(Anderson et al., 2003a). A similar service isprovided in Scotland where community phar-macists are able to administer influenza vaccina-tion to adults aged 65 years or over as part of apatient group direction: 888 patients were vacci-nated through this scheme in 2004 (Hind &Downie, 2006).
Patients and their medicines
As part of the integration of health and socialcare in the current NHS system (see Chapter 2),some medicines management services also focuson the health and social care aspects of patientsand their medicines. Community pharmaciescan provide a number of services in thiscategory, including:
• patient education• medication reviews• repeat dispensing• home delivery of medication.
Patient education about medicines should be anintegral part of the dispensing process. Increasingpatient awareness of how to take their medicines,how to manage potential adverse effects, andhow to incorporate their medicine regimens intotheir daily lives can all be included in patientcounselling. In addition, accredited pharmacistsworking in accredited premises can performmedicines use reviews (see Box 6.7). Domiciliarymedication reviews (visiting patients at home orin care homes) can further integrate medicinesmanagement with social care. Domiciliary visitsprovide an ideal opportunity to discuss withpatients how they manage their medicines andany problems they may have experienced. Astudy of older patients in Leeds found that thosewho had received a domiciliary medicationreview were more likely to know why they tooktheir medication (Lowe et al., 2000). In addition,patients’ medication regimens were simplifiedand reasons for poor adherence were identified asa result of the medication review.
Ways in which medicines managementis achieved
Good medicines management requires all healthprofessionals to develop new skills. In particular,community pharmacists need to develop goodworking relationships with doctors and patientsin order to improve communication with thesegroups. Good communication is important for anumber of reasons.
62 Chapter 6 • Medicines management
Box 6.6 Public health medicines managementservices
• Smoking cessation• Coronary heart disease• Obesity and weight reduction• Drug misuse (e.g. supervised methadone
administration, and needle exchangeprogrammes)
• Sexual health (e.g. provision of emergencyhormonal contraception)
• Folic acid and pregnancy• Asthma (e.g. providing an asthma clinic in
conjunction with local GP practices)• Diabetes (e.g. patient education and monitoring
programmes)• Immunisation (e.g. administering influenza
vaccination)• Head lice (e.g. recommending appropriate
treatments such as wet combing)• Oral health (e.g. encouraging the use of
sugar-free medicines in children)
• If community pharmacists are to advisedoctors and other prescribers on medicinesissues for individual patients, or on systemsof medicines management, they must learnhow to communicate confidently butdiplomatically.
• If community pharmacists are to help patientsmanage their medicines effectively, then theymust develop good listening skills and learn tomove away from a compliance model of prac-tice (where patients are expected to do as theyare told) to a concordance model (wherepatients are supported by health professionalsto choose the treatment options most appro-priate for them). More information oncompliance and concordance is provided inChapter 14.
• In addition, community pharmacists needto develop a good understanding of therisks associated with the medications theysupply, to help them identify inappropriateprescriptions and over-the-counter sales.
Communication with patients
Lack of communication skills has been identi-fied as a barrier to community pharmacistsproviding medicines management services inthe UK (Van Mil et al., 2001). Studies conductedin the UK found that older patients only hadcontact with a community pharmacist on12.5–15% of the times they collected a prescrip-tion from a pharmacy (Livingstone, 1996; Joneset al., 1997). In addition, community pharma-cists have historically spent a limited amount oftime talking to patients about their medicines,the mean contact time for patient counsellingranging from 20 seconds to just over a minute(Savage, 1995; Livingstone, 1996). If pharma-cists are to provide effective medicines manage-ment services, they need to spend more timetalking to patients about their medicines. Thenew Pharmacy Contract encourages increasedcontact time with patients by paying commu-nity pharmacists for providing medicines use
Ways in which medicines management is achieved 63
Box 6.7 Medicines use reviews
Under the new Pharmacy Contract, medicines usereviews (MURs) are an advanced service that can beperformed by accredited pharmacists working inaccredited community pharmacies. To achieve accredi-tation, pharmacists must undertake a competencyassessment which ensures that they achieve the stan-dards of practice stated in the national competencyframework. Training and assessment is provided byvarious universities (see www.psnc.org.uk for furtherinformation). Pharmacy premises require a clearly sign-posted private consultation area where the pharmacistand patient can sit down and talk at normal speakingvolumes without fear of being overheard. Owners ofpremises complete a self-certification form stating thattheir premises meet these criteria. This statement isvalidated by the primary care trust that contracts theservice.
MURs provide an opportunity for patients to talkto their community pharmacist about the medicinesthey are taking, what the medicines do, how well
they work, and how to get the most out of them(Department of Health, 2005). In addition, MURsprovide the community pharmacist with an opportunityto intervene on prescriptions where they identify prob-lems (Bellingham, 2004). MURs are not a clinicalprescription review, and pharmacists do not agreechanges to medication with patients – this can only bedone by the prescriber. Nor do they discuss patients’medical conditions or the effectiveness of their treat-ment on the basis of test results (PSNC, 2007a).Community pharmacists should agree an action planwith patients which is then communicated to theappropriate health professional(s), who might includethe general practitioner, practice nurse, communitymatron, prescribing pharmacist or district nurse.
By February 2007, 13 611 pharmacists had beenaccredited and in November 2006, 63 455 MURs wereconducted in 4167 accredited community pharmaciesin England (PSNC, 2007b). In 2007/8, pharmacieswere paid £25 for each MUR.
reviews (see Box 6.7). This service helps pharma-cists to provide a structured discussion withpatients about their medicines and will hope-fully help to overcome some of the barriers tocommunicating with patients, such as time andworkload pressures (Savage, 1995; Smith et al.,2004), lack of remuneration (Anderson et al.,2003c), lack of training (Anderson et al., 2003c),and lack of privacy (Sleath, 1996). Under thenew Pharmacy Contract, pharmacists providingmedicines use reviews are required to have aprivate consultation room, which should helpto ensure patient privacy. Communication withpatients is described in more detail in Chapter 8.
Communication with health professionals
In addition to developing good relationshipswith patients, it is important that communitypharmacists develop good relationships withother health professionals, particularly GPs andother prescribers. This is essential to ensurethat they can effectively intervene on high-riskprescriptions, and act as a source of informationto prescribers about medicines and their use. It isimportant to remember that many communitypharmacists play a vital role in preventingprescribing errors from reaching patients. Thebetter a community pharmacist’s communica-tion skills, the more effective they are likely tobe in this role.
Pharmacists may be reluctant to contact GPsabout prescriptions that may cause a patientharm because: they lack confidence in theirknowledge about the medication; they do nothave access to the patient’s medical records (andtherefore do not understand the bigger pictureof the patient’s treatment); they have previouslyhad their advice ignored when they havecontacted a GP (Moody et al., 2004); they havefound GPs to be aggressive, rude or unap-proachable (Landers et al., 2002; Howard et al.,2008). In addition, some pharmacists believethat GPs view them as subordinate, which maylead some community pharmacists to commu-nicate with GPs in a deferential manner (Hughesand McCann, 2003), an approach that isunlikely to prove effective when wanting to geta prescription changed (Chen et al., 1999).
Hawksworth et al. (1999) found that nearlyone-fifth of recommendations made by commu-nity pharmacists to GPs were rejected. In onecase, had the intervention been accepted, itwould almost certainly have helped avoid ahospital admission. Considering how infre-quently community pharmacists contact GPs tomake interventions (only 75 interventions per10 000 prescriptions dispensed), pharmacistsshould develop the skills necessary to maximisethe impact of the interventions they do make.In addition, community pharmacists need clin-ical knowledge about medicines, which willhelp them to intervene on prescriptions morefrequently. (See Chapter 15 for examples of theconsequences for pharmacists when they do notintervene on prescriptions that cause a patientharm.)
In essence, community pharmacists need tobuild relationships with GPs and other pre-scribers wherever possible, in order to increasetheir effectiveness when making interventionson prescriptions. Face-to-face meetings (perhapsto discuss ways in which pharmacists and GPscan work more closely together and to increaseGPs’ understanding of the role of the commu-nity pharmacist) have been found to improvetrust and communication between communitypharmacists and GPs (Chen et al., 2001; Zillichet al., 2005). In particular, face-to-face meetingscan improve pharmacists’ confidence when theytalk to GPs. This should help to avoid situationsin which pharmacists use a deferential approachor GPs are dismissive of their recommendations.
Identifying patients at risk of adverseeffects
As a profession, pharmacists promote themselveson the basis of their specialist knowledge aboutmedicines; however, there is some evidencethat they do not always apply this knowledge(Harding & Taylor, 1997). In order to perform aneffective medicines management service, it isessential that community pharmacists have arobust understanding of the risks associated withthe medications that they supply, and developthe skills necessary to identify when patientsare at risk of PDRM. Community pharmacists’
64 Chapter 6 • Medicines management
knowledge about medication may be insufficientfor a number of reasons.
Some community pharmacists may havedifficulty accessing training (Howard, 2006) andthis may contribute to their varying levels ofcommitment to continuing professional devel-opment (CPD) (Attewell et al., 2005). In addition,some pharmacies may not provide access toappropriate information resources such as theelectronic British National Formulary, onlinedatasheets or Stockley’s Drug Interactions (Howard,2006). Most pharmacists have limited access topatients’ medical records and rely on the PMR fora medication history. PMRs are often incompletebecause they rarely include over-the-countermedications and rely on patients attending thesame pharmacy each time a prescription isdispensed (whereas patients will often attend themost convenient pharmacy). This lack of access topatient-specific information can make it particu-larly difficult for a community pharmacist toassess the appropriateness of new and ongoingmedications.
Pharmacists do, however, have access to quitea lot of patient-specific information including:
• patient age: prescriptions for children andolder patients should be scrutinised care-fully because they are at a higher risk ofexperiencing adverse effects
• prescription exemptions: patients withdiabetes, renal dialysis, Addison’s disease,myasthenia gravis, epilepsy, hypothyroidismwill have an exemption form stating thatthey have a medical exemption; individualpatients will have to be asked what theexemption is for
• pregnancy and breastfeeding patients willhave a maternity exemption certificate whichis valid from the date of issue to 12 monthsafter the date of birth
• PMR: although the PMR may be incomplete,it can still provide a useful guide to concurrentmedication for patients who regularly attendthe same pharmacy. It can help pharmacists toidentify inappropriate changes in medicationdose, drug interactions and contraindicateddrugs (based on drug treatments for specificdiseases, e.g. patients prescribed inhalers couldhave asthma)
• Patient or relative: patients will often be ableto tell you if they take medicines that have ahigh risk of interaction with other medicines,such as warfarin (an anticoagulant).
This information should be taken into accountwhen assessing the appropriateness of a prescrip-tion. If a pharmacist identifies a prescription thatmay cause harm to the patient, they shouldcontact the prescriber to clarify whether thepatient is at risk, and, if this risk is unacceptable,request that the prescription is changed.
Pharmacists should keep a record of anyrecommendations they make. This record canbe used to audit the provision of medicinesmanagement services (with a view to improvingthe services), to assess the appropriateness ofrecommendations, and to help pharmacistsreflect on their recommendations and identifyany areas where their knowledge base is weak.This can form part of their CPD cycle (seeChapter 15).
Community pharmacists and medicinesmanagement under the new PharmacyContract
The new Pharmacy Contract for the supply ofservices to the NHS by community pharmacistswas introduced in England and Wales in 2005.This contract introduced three tiers of serviceprovision:
• essential (Box 6.8)• advanced (medicines use reviews and
prescription interventions; Box 6.7)• enhanced (Box 6.9).
Essential services have to be provided by allNHS pharmacy contractors in England andWales, whilst advanced services can only beprovided by accredited contractors. In addition,the enhanced services are provided on thebasis of local need. This means that only theservices that local primary care trusts (PCTs)buy (commonly known as commissioning)are provided. It is not enough, however, forpharmacists to wait for PCTs to commissionthese services. In the new competitive market
Community pharmacists and medicines management 65
of the NHS, community pharmacists need toactively identify local service needs andcampaign the PCTs to ensure that these servicesare commissioned from community pharmacies.Community pharmacists can identify theservice needs of their local population innumerous ways.
• Discussion with PCTs: Each PCT will have a‘commissioner’, the person who is responsiblefor buying in services. In addition, medicinesmanagement teams (including the prescribingadviser and practice pharmacists) will haveidentified local medicines managementneeds. Community pharmacists can offer toprovide some of these services.
• National Service Frameworks (NSFs): TheGovernment has published a series of guide-lines for managing specific patient groupssuch as older people and children. The NSFsinclude a number of enhanced services thatcould be provided by community pharma-
cists, for example clinical medication reviews.• Local patient prospectus: This describes
where NHS funds have been spent and whichservices are offered locally, and can be usefulto help identify gaps in local service provision.
• Local knowledge: Community pharmacistshave regular contact with the general publicin their local area. This allows them to builda picture of their patient group, and the typesof services they most need.
• Patient feedback on services: This can begained formally (through questionnaires) orinformally through comments made bypatients when you talk to them. Patient feed-back can be used to evaluate existing services,and to identify which services the generalpublic would like to be provided.
Armed with the above information about existingservices and service needs in the local population,community pharmacists can approach thecommissioners within the local PCT to propose
66 Chapter 6 • Medicines management
Box 6.8 Essential services
• Dispensing: ‘medicines and appliances ordered onNHS prescriptions together with information andadvice to enable safe and effective use by patientsand carers and maintenance of appropriaterecords.’ (PSNC 2004b)
• Repeat dispensing: ‘management and dispensingof repeatable NHS prescriptions for medicines andappliances in partnership with the patient and theprescriber. . . Ascertain[ing] the patient’s need fora repeat supply and communicat[ing] anyclinically significant issues to the prescriber.’(PSNC 2004e)
• Disposing of unwanted medicines: ‘Acceptance bycommunity pharmacies of unwanted medicinesfrom households and individuals which requiresafe disposal.’ (PSNC 2004c)
• Promoting healthy lifestyles (Public Health):Providing ‘opportunistic advice on lifestyle andpublic health issues to patients receivingprescriptions. . . [pro-actively participating] innational/local campaigns to promote public healthmessages to general pharmacy visitors during
specific targeted campaign periods.’ (PSNC2004d)
• Signposting: Providing ‘information to peoplevisiting the pharmacy who require further support,advice or treatment which cannot be provided bythe pharmacy on other health and social careproviders or support organisations who may beable to assist the person’ including referrals toother health or social care providers, ifappropriate. (PSNC 2004f)
• Support for self-care: Providing advice andsupport ‘to enable people to derive maximumbenefit from caring for themselves or theirfamilies.’ (PSNC 2004g)
• Clinical governance: ‘Identify a clinical governancelead and apply the principles of clinical governance(see Chapter 16) to the delivery of services in thepharmacy including standard operating procedures;recording, reporting and learning from adverseincidents; participation in continuing professionaldevelopment and clinical audit; and assessingpatient satisfaction.’ (PSNC 2004a)
new services that could be provided (which thePCT can then pay for). For example, LloydsPharmacy in London now offers a ‘stop now’service and a ‘cut down and quit’ service forsmokers, which include free weekly consulta-tions where carbon monoxide readings are takenand advice is given on managing withdrawalsymptoms (Pharmaceutical Journal, 2007).
The new Pharmacy Contract has begun a shiftin the source of funding for community phar-macy services away from dispensing largevolumes of prescriptions. By providing fundingto pharmacies for wider medicines managementservices, the aim is to expand the role of commu-nity pharmacists in providing health and socialcare services to the general public.
Community pharmacists and medicines management 67
Box 6.9 Enhanced services
• Supervised administration: Supervise ‘theconsumption of prescribed medicines at the pointof dispensing in the pharmacy, ensuring that thedose has been administered to the patient, [aspart of a] user-friendly, non-judgmental, client-centred and confidential service’ , for example formethadone, and medicines used for themanagement of mental health conditions ortuberculosis (PSNC, 2005h).
• Needle and syringe exchange: ‘provide access tosterile needles and syringes, and sharps containersfor return of used equipment. Where agreedlocally, associated materials, for examplecondoms, citric acid and swabs, to promote safeinjecting practice and reduce transmission ofinfections by substance misusers will be provided.’Appropriate public health education will also beprovided to service users. (PSNC, 2005g)
• Smoking cessation: ‘provide one-to-one supportand advice to smokers, refer to specialist servicesif necessary, and facilitate access to, and whereappropriate supply, appropriate stop smokingdrugs and aids.’ (PSNC, 2005g)
• Care home (support and advice on storage, supplyand administration of drugs and appliances):‘ensure the proper and effective ordering of drugsand appliances and their clinical and cost effectiveuse, their safe storage, supply and administrationand proper record keeping in care homes such asnursing and residential homes.’ (PSNC, 2005a)
• Medicines Assessment & Compliance Support:‘Medicines support over and above that providedas part of the essential and enhanced services,including assessment of patients’ ability to taketheir medicines and the supply of compliance aidsas appropriate, including compliance charts,screw top closures, medication administration
record (MAR) charts, labelling medicines in largefonts and multi-compartment compliance aids.’(PSNC, 2005d)
• Full (level 3) clinical medication review (see Box6.5) (PSNC, 2005c)
• Minor ailment service: Providing ‘advice andsupport to people on the management of minorailments, including where necessary, the supply ofmedicines for the treatment of the minor ailment,for those people who would have otherwise goneto their GP for a prescription.’ (PSNC, 2005e)
• Out-of-hours service: ‘Providing access topharmacy services during an extended period ofopening to ensure that people have prompt accessto medicines during the out of hours period.’(PSNC, 2005f)
• Supplementary prescribing: ‘Implementing patientspecific clinical management plans (CMP) with thepatient’s and doctor’s agreement, includingprescribing medicines, ordering diagnostic tests,monitoring test results and response to treatment,adjusting treatment accordingly, and referring toother primary healthcare professionals asappropriate.’ (PSNC, 2005i)
• Emergency Hormonal Contraception Service:‘Providing, free of charge, levonorgestrelemergency hormonal contraception (EHC) tocustomers within the constraints of a patient groupdirection (PGD). If customers requesting EHC falloutside the PGD, they should be referred to anappropriate healthcare professional or sold theproduct OTC (if appropriate). All customersrequesting EHC should be given appropriatecounselling about contraception and sexuallytransmitted infections.’ (PSNC, 2005b)
Summary
Medicines management has arisen from therecognition that drugs can cause injury topatients, but that many of these injuries arepotentially preventable if services for managingmedicines are improved. In the UK, medicinesmanagement aims to deliver the best possibleoutcomes for patients whilst minimising cost tothe NHS. It is not simply about cost cutting, butabout cost-effectiveness.
Medicines management is a complex process,involving various stages in medication use(prescribing, dispensing, administering andmonitoring) and multiple people, including arange of health professionals, patients andtheir carers. Medicines management serviceshave been divided into five categories: clinical,systems and processes, public health, patientsand their medicines, and interface management.
Provision of good medicines managementservices requires community pharmacists tobuild relationships with both patients andprescribers. To do this, they need to developexcellent communication skills and ensure theyhave a good understanding of the risks associ-ated with the medicines they supply. In addi-tion, they must develop the necessary skills toidentify patients at risk from medicines manage-ment problems, such as problems adhering tomedicines, and potential drug interactions orcontraindicated medicines.
The new Pharmacy Contract has providedcommunity pharmacists with a different way offunding their work, which should encouragethem to provide a broader range of medicinesmanagement services.
References
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Anderson C, Blenkinsopp A, Armstrong M (2003b). Thecontribution of community pharmacy to improving thepublic’s health. Report 2: Evidence from the UK non peer-
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Bellingham C (2004). How to offer a medicines usereview. Pharm J 273: 602.
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Bigby J, Dunn J, Goldman L, et al. (1987). Assessingthe preventability of emergency hospital admis-sions. A method for evaluating the quality ofmedical care in a primary care facility. Am J Med 83:1031–1036.
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Dean B, Schachter M, Vincent C, et al. (2002).Prescribing errors in hospital inpatients: their inci-dence and clinical significance. Qual Saf HealthCare 11: 340–344.
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70 Chapter 6 • Medicines management
Introduction
This chapter describes the structure and functionof the Royal Pharmaceutical Society of GreatBritain (RPSGB) at the time of writing (late 2007).However, The Health Act 1999 may result infundamental changes to the regulation of healthprofessions and health professionals. This is likelyto include pharmacists and the role of the RPSGB.Such changes have not yet been announced orformalised. A detailed description of the historyand structure of the RPSGB can be found ontheir website www.rpsgb.org/societyfunctions/aboutthesociety, from which information in thischapter is taken.
The Royal Pharmaceutical Society ofGreat Britain
The RPSGB is the professional and regulatorybody for pharmacists in England, Scotland andWales. In order to practise as a pharmacist in
these countries, an individual must be registeredon the Register of Pharmaceutical Chemists.Entry on to the Register is controlled by theRPSGB.
To qualify for registration, an individual musthave completed a 4 year masters degree in phar-macy from one of the 23 Schools of Pharmacy,completed 12 months’ pre-registration work-based training, and passed the registrationexamination. A fee is payable to be added to theregister, and an annual retention fee to remainon the register. Pharmacists who gained theirqualifications in other countries may be eligiblefor registration with the RPSGB, although manyof these individuals will have to undertakefurther study, examination and training to meetthe standards for registration.
The primary objectives of the RPSGB are tolead, regulate, develop and represent the profes-sion of pharmacy. The Society also works toadvance science, practice, education and knowl-edge in pharmacy, and to promote the pro-fession to external stakeholders, such as theDepartment of Health.
Introduction . . . . . . . . . . . . . . . . . . . . . . 71
The Royal Pharmaceutical Society ofGreat Britain . . . . . . . . . . . . . . . . . . . . . 71
The Pharmaceutical Journal . . . . . . . . . . . 72
A brief history of the Society . . . . . . . . . . 72
The structure of the RPSGB . . . . . . . . . . . 73
The future of the RPSGB . . . . . . . . . . . . . 74
Summary . . . . . . . . . . . . . . . . . . . . . . . 75
References. . . . . . . . . . . . . . . . . . . . . . . 75
7Structure and function of the Royal PharmaceuticalSociety of Great Britain
Kate E Fletcher
71
The Society is also responsible for assuring thecompetence and fitness to practise of those onthe register. It uses various means to achievethis, including:
• controlling entry on to the register• regulating and accrediting undergraduate
pharmacy degrees• setting and enforcing professional standards• promoting good practice• dealing with poor performance and providing
support for improvement• dealing with misconduct and removal from
the register.
Indeed, the combined role of representation andregulation of pharmacists makes the RPSGBunique amongst similar bodies in the UK. Otherhealth professions are represented and regulatedby separate organisations (see The Future of theRPSGB on page 74).
The Pharmaceutical Journal
The Society has published the PharmaceuticalJournal since 1841. ‘The PJ’, as it is often known, isthe official journal of the Society. It has beenpublished weekly since 1870, and aims to providecomprehensive news coverage on all aspects ofpharmacy and to publish original research andarticles on pharmaceutical and related subjects.It is also the main publication in which jobsfor pharmacists and pharmacy technicians areadvertised. More about the PharmaceuticalJournal can be found at www.pjonline.com.
A brief history of the Society
For thousands of years, humans have harnessedthe properties of plants and naturally occurringcompounds in an attempt to treat illness (seeChapter 3). Over time, the people involved inthis process became more specialised, and recog-nised as skilled individuals. By the 18th century,the terms chemist and druggist were being usedin the UK to describe the (mainly) men who
compounded medicines. The term used todayfor this profession is pharmacist.
Pharmacy as a profession was unregulated andunprotected for many years, until the early 19thcentury, when some chemists and druggistsbegan working together to protect the profes-sion’s interests. They argued for an exemptionfrom the Apothecaries Act of 1815, which threat-ened to restrict the work of chemists and drug-gists. The act recognised apothecaries as medicalpractitioners, and gave them certain power overothers. Unqualified persons were forbidden to actor practise as apothecaries, and faced a penalty of£20 if they did so. This act therefore threatenedthe livelihood of chemists and druggists. Thegroup also formed a committee to monitorprogress of a proposed Sale of Poisons Bill in 1819,and created a short-lived General Association ofChemists and Druggists to protect them againstthe Medicine Stamp Act. This act required a dutystamp to be fixed to the packaging of manufac-tured medicines that were not deemed to be of astandard well-known recipe. The tax paid was inproportion to the cost of the medicine. On ashilling (12 penny) remedy it would be one and ahalf pence (Homan, 2002).
In 1841, the profession felt vulnerable; it wasunregulated and unrestricted, so anyone coulduse the title of chemist and/or druggist. On 15April of that year, a group of eminent chemistsand druggists met at the Crown and Anchor Tavernin the Strand, London. Their aim was to unite theprofession into one body, to protect its members’interests and advance scientific knowledge. Thegroup agreed the best foundation for a permanentindependent association was membership basedon a recognised qualification. William Allenproposed the formation of the PharmaceuticalSociety. He went on to become the Society’s firstpresident. A committee of 40 was appointed asthe first council to frame laws and regulations.This was superseded in May 1842 by an electedcouncil of 21 members. The Society took up resi-dence in 17 Bloomsbury Square in September1841, where it remained until the new headquar-ters in Lambeth, South London, were opened inSeptember 1976.
The Society gained its Royal Charter of Incor-poration from Queen Victoria in 1843. A charteris an authority directly from the monarch for
72 Chapter 7 • Structure and function of the RPSGB
a body to take certain powers (Appelbe & Wingfield, 2005). A Charter of Incorporationenables a body to function as a corporation (i.e.a large company or group of companies author-ised to act as a single entity and recognised assuch in law). The Charter gave precedence to‘advancing chemistry and pharmacy andpromoting a uniform system of education’ over‘the protection of those who carry on the busi-ness of chemists and druggists’ (The RoyalCharter of Incorporation, 1843). The charteralso gave the Society a corporate framework thathas been refined by supplemental charters in1901, 1948, 1953 and 2004.
King George VI became the Society’s patron inMarch 1937, and the monarch has been thepatron of the Society ever since. Queen ElizabethII granted the title ‘Royal’ to the Society in May1988.
The structure of the RPSGB
The Royal Pharmaceutical Council
The Royal Pharmaceutical Council governs theRPSGB and is responsible for deciding policyand practice relating to the RPSGB. It iscomposed of:
• 17 pharmacists, elected by the membershipof the Society by postal single transferablevote
• 1 pharmacist appointed by universitiesawarding pharmacy degrees accredited by theSociety
• 2 elected pharmacy technicians (elected bytechnicians on the voluntary register of phar-macy technicians)
• 10 lay members appointed by the PrivyCouncil.
The Council elects its own President.The purpose of the supplemental charter of
2004 was essentially to modernise the charter of1953 and make it fit for the purpose of enablingthe Society to function in the 21st century. Oneresult of the charter was to alter the tenure ofcouncil members: members elected after thesupplemental charter of 2004 came into force
serve for terms of 1, 2 or 3 years, allocatedaccording to the number of votes received.Before this elected members were appointed fora 3 year period.
The Council meets six times a year. It isadvised on specialist areas of pharmacy bycommittees and subcommittees, membershipand special interest groups. Examples includethe Education Committee, Practice Committee,Science Committee, Community PharmacistsGroup, Hospital Pharmacists Group and theIndustrial Pharmacists Group.
The Committees of the RPSGB
The RPSGB exercises is powers through ninecommittees.
• The Education Committee is responsible forsetting educational standards and accreditingproviders. It covers undergraduate education,pre-registration training, continuing profes-sional development (CPD) and pharmacytechnician education.
• The Law and Ethics Committee implementspolicy relating to professional conduct andthe legal aspects of pharmacy practice.
• The Science Committee is responsible forimplementing science policy; considers scien-tific content of the British PharmaceuticalConference (BPC); keeps the Council awareof scientific developments and UK sciencepolicy, and possible effects on pharmacypractice.
• The Investigating Committee is a keycomponent of the fitness to practisecommittee structure. One of the functions ofthe Investigating Committee is to makeinitial decisions in relation to allegations ofimpairment of fitness to practise, by decidingwhether to refer such allegations to otherrelevant parts of the committee structure.
• The Adjudicating Committee assesses phar-macists from outside the European Union(EU) who want to practise in the UK, andEU pharmacists who do not automaticallyqualify to register in the UK.
• The Audit Committee selects the Society’sexternal and internal auditors, and reviews
The structure of the RPSGB 73
the Society’s financial control and risk-management systems, to ensure the relia-bility of its financial reporting.
• The Conference Committee is responsiblefor strategy, planning and development ofthe BPC. It is supported by the ProgrammeGroup, which develops the practice andscience sessions of the BPC.
• The Governance Committee is responsiblefor ensuring that the Society operates in alegal and professional way, and meetscommercial and financial requirements. Italso advises the Council on how changes inlegislation will affect the profession.
• The Remuneration Committee assessesremuneration for Society staff and agreesannual changes in remuneration for seniorstaff.
The National Pharmacy Boards
Until January 2007, the Society in Scotland andWales was represented by the Scottish and WelshExecutives. The responsibilities of the Executiveswere to implement the policies of the Society,organisation and supervision of the localbranches of the Society, and to make recommen-dations to the Council of matters affecting theSociety and its members in Scotland and Wales(RPSGB, 2005).
Following political devolution in GreatBritain, the Society formed the DevolutionReview Group to conduct a review of its struc-ture and function in England, Scotland andWales. As a result of this review, it was proposedthat the Scottish and Welsh Executives werereplaced with national boards, and that anEnglish board was created. The members ofthese boards were elected during 2006 and theboards were duly created on 21 January 2007.The boards are structured and function differ-ently from each other, but the overall aim andpurpose of them is the same; the remit of theboards is to:
1. provide strategic leadership and support forpharmacy practice development
2. assist development of Council policy and
its implementation, and develop and implement policy specific to each country
3. promote the science and practice of phar-macy and its contribution to health
4. provide professional advice to governmentand its agencies, National Health Servicesbodies, and other health and social careorganisations
5. support the Society’s branches in eachcountry
6. support pharmacists in their professionalroles.
Branches and regions of the RPSGB
The Council set up branches of the Societythroughout Great Britain in 1922. Currentlythere are 136 local branches, with a membershipcomprising pharmacists resident in that area.Each branch elects a committee, which runs thebranch and organises regular meetings, usually ofan educational nature. Meetings often involvepresentations by external speakers such as localhospital doctors and academic experts, whoprovide useful insights or updates on currenttherapeutic or research areas. Branch meetingsare a good opportunity for networking with localpharmacists and a valuable source of CPD.
A regional organisation in England and Waleswas set up in 1968. The regions supplement thebranch structure and help smaller branches(Appelbe & Wingfield, 2005). They act as a linkbetween the local branches and the Council,and are also involved in the coordination ofpublic relations activities. The membership ofregions is made up of the members of brancheswithin each region.
The future of the RPSGB
The White Paper Trust, assurance and safety – theregulation of health professionals in the 21st centurywas published in February 2007 following aseries of incidents involving harm to patientscaused by doctors, most notably the Shipman
74 Chapter 7 • Structure and function of the RPSGB
case, and the findings of the inquiries into theseincidents (Department of Health, 2007). Thisdocument sets out the Government’s policy onregulation of all health professions, includingpharmacy, and is likely to result in changes tothe law pertaining to this.
The main recommendation relating to phar-macy will result in fundamental changes to theway the profession is regulated and represented.The White Paper recommends the formation ofa General Pharmaceutical Council (GPhC) totake over the regulatory role of the RPSGB. It islikely that professional leadership will be takenover by a ‘Royal College’-type organisation.These changes will bring the profession in linewith other professions that are regulated andrepresented by different bodies. Examplesinclude medicine: doctors must register with theGeneral Medical Council in order to practise,and professional leadership is provided by anumber of Royal Colleges, such as the RoyalCollege of Physicians, the Royal College ofSurgeons, the Royal College of Psychiatrists, etc.Similarly, nurses and midwives are regulated bythe Nursing and Midwifery Council, and repre-sented by the Royal College of Nursing (Depart-ment of Health, 2007).
This is an exciting time for the membership ofthe Society. It is an opportunity to look to thefuture of the profession and develop representa-tive bodies that will be better suited to the roleof regulation and representation of pharmacistsand pharmacy technicians well into the 21stcentury.
Summary
The RPSGB has a long history stretching backwell over 100 years. At the time of writing,however, the future of the Society is uncertain –it will survive, but it is not yet known in whatform, and what the function will be. For themembership, it is an exciting time, as it is to behoped that modernisation will produce a bodyfit to lead the profession for the next 100 years.
References
Appelbe G E, Wingfield J (2005) Dale and Appelbe’sPharmacy Law and Ethics. 8th edn. London:Pharmaceutical Press.
Department of Health (2007) Trust, assurance andsafety – the regulation of health professionals in the 21stcentury. www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_065946
Homan P G (2002) Patent and brandname medicines.London: Museum of the Royal PharmaceuticalSociety of Great Britain. www.rpsgb.org.uk/pdfs/mussheet10.pdf (accessed 10 September 2007)
RPSGB (2005) Devolution – A Framework for the Future.The Fraser Report. Report of the RPSGB DevolutionReview Group. London: Royal PharmaceuticalSociety of Great Britain.
RPSGB (2006). Annual Review. London: Royal Pharma-ceutical Society of Great Britain.
Royal Charter of Incorporation (1843). London: RoyalPharmaceutical Society of Great Britain.
References 75
Introduction
Pharmacists must be able to communicate effec-tively with many different groups of people inorder to carry out their job:
• patients and their carers• other staff within the pharmacy• nurses and doctors• other health professionals such as physio-
therapists and dietitians.
Pharmacists need to be able to communicate invarious situations, and using different methods,whether it is face to face in the communitypharmacy or hospital ward, over the telephone,making presentations at conferences, or writingletters and emails. The ability to tailor one’sapproach to communication in all its forms forall of these groups is therefore a critical skill thattoday’s pharmacist has to develop. This chapterintroduces some of the verbal and non-verbalskills required to communicate effectively inthese settings.
Having good communication skills will alsocontribute to one of the most importantattributes for a pharmacist, that is, profession-
alism (see Box 8.1). This is a difficult conceptto define, but good communication skillscontribute towards it.
Interacting with patients
The main skills required to interact successfullywith patients are active listening, questioning,responding and explaining. Each of these skillsis explained below.
Active listening
Listening is more than simply hearing a personspeak to you. It should be an active process,ensuring not only that all messages are receivedbut also that the speaker knows that the listenerhas understood the message. For pharmacists,this is particularly important when talking withpatients. It is essential that the patient knowsthat the pharmacist is listening to them andtaking their situation and opinions seriously.Patients – who may not be feeling well or maybe shocked and/or concerned by a diagnosis, for
Introduction . . . . . . . . . . . . . . . . . . . . . . 77
Interacting with patients . . . . . . . . . . . . . 77
Interacting with other healthprofessionals . . . . . . . . . . . . . . . . . . . . . 79
Presentations . . . . . . . . . . . . . . . . . . . . . 80
Summary . . . . . . . . . . . . . . . . . . . . . . . 84
References. . . . . . . . . . . . . . . . . . . . . . . 84
Useful resources. . . . . . . . . . . . . . . . . . . 84
8Essential communication skills for pharmacists
Kate E Fletcher
77
example – are easily intimidated by someone ina ‘white coat’; by demonstrating good listeningskills, the pharmacist can help the patient to feelmuch more comfortable and relaxed about theirsituation and the means by which it can beresolved. This in turn will help the pharmacistto obtain more useful information from thepatient, as the patient will find it easier toshare such information relating to themselves,enabling the pharmacist to fulfil their role moreeffectively. It is not unusual for a patient to givethe pharmacist information that they may feelunable to share with their doctor or nurse, asmany patients perceive pharmacists to be moreunderstanding and approachable.
The three main techniques involved in activelistening are:
• maintaining eye contact – so that the speakercan see you are paying attention
• acknowledging what the speaker says – bysuitable body language such as nodding andverbal agreement
• summarising or paraphrasing what has justbeen said (e.g. using a phrase such ‘So, whatyou’re saying is. . .’).
Questioning
Pharmacists need to use effective questioningin order to obtain information from patients,usually relating to their medication. It is impor-tant not to ask leading questions, as patientswill sometimes just agree or go along with thelead, because they are afraid to get the question‘wrong’. For instance, when trying to identifywhich inhaler a patient uses when the patientdoesn’t know the name of the inhaler, the phar-macist might want to find out what colour itis, as different types have a specific colour. Aleading question would be, ‘Is your inhalerblue?’ However, the patient may be tempted toreply ‘yes’ to this as it might appear to be the‘right’ answer. A better way to ask is, ‘Whatcolour is your inhaler?’ Without giving thepatient a colour, they are not prompted, and willhopefully remember what colour the inhaleractually is. This type of questioning also makesit is easier and more likely for a patient to admitthat they don’t know the answer.
Getting accurate information with regard to amedication history is essential, as this will resultin the patient receiving the correct medication
78 Chapter 8 • Essential communication skills
Box 8.1 Definitions of professionalism in pharmacy
Bumgarner et al. (2007) described professionalism as,‘the enactment of the values and ideals of individualswho are called, as pharmacists, to serve individualsand populations, whose care is entrusted to them,prioritising the interests of those they serve above theirown . . .’
In an extensive review of professionalism in phar-macy, Hammer et al. (2003) conceptualised profes-sionalism in pharmacy as a bicycle wheel. The centreconsists of values associated with professionalism, suchas altruism, caring, honour, integrity and duty. From thiscentre arise spokes, which represent behaviours associ-ated with professionalism, such as respect, account-ability, empathy and compassion. The outer tyre of thewheel represents the surface of professionalism, encom-passing such things as professional attire, courtesy andpunctuality.
Chisholm et al. (2006) listed the following tenbroad traits that enable pharmacists and pharmacystudents to act professionally:
• accountability for his/her actions• commitment to self-improvement of skills and
knowledge• conscience and trustworthiness• covenantal relationship with client (patient)• creativity and innovation• ethically sound decision making• knowledge and skills of the profession• leadership• pride in the profession• service oriented.
while they are in hospital. In this example, if theinformation regarding the patient’s inhalers isnot correct, the wrong medications might beprescribed, resulting in a loss of control of thepatient’s asthma, and therefore the potential fora life-threatening asthma attack to occur.
There are three main types of questioning.
• Open questions have no right or wronganswer and there is usually more than onepossible answer, for example, ‘Please describe. . .?’ or ‘Tell me about. . .?’ Open questionsare used to obtain general information. Anopen question may be followed by a closedor probing question based on part of theanswer, to obtain more precise or detailedinformation.
• Closed or convergent questions home in orconverge on specific information. Examplesare questions that have a right or wronganswer such as, ‘What is your name?’ orquestions that are answered with yes or no:‘Are you John Smith?’
• Probing questions are used to obtain specificinformation. They may be used to clarifyprevious answers, or to elaborate on infor-mation obtained by open questioning. Forexample: ‘Please tell me about the medicationyou take’ might be followed by, ‘What is thename of the tablet you take for your highblood pressure?’
Responding and explaining
Using active listening techniques (see above)will help demonstrate respect, understandingand empathy with the patient. This in turn willhelp you earn the trust and respect of thepatient, and build an effective professional rela-tionship with them, enabling you to do your jobas a pharmacist more effectively. It also is impor-tant to be confident when talking with patients,so they have confidence in what you tell them.It is unlikely that a patient will trust a healthprofessional who is hesitant or doesn’t appearconfident about what they are talking about.
When explaining something to a patient, suchas how to use an inhaler, it is essential to uselanguage and concepts that the patient will
understand. Technical words and jargon shouldnever be used, as many patients will not under-stand such terms, and they might not have theconfidence to ask for a further explanation. Thelevel at which information can be pitched variesbetween individuals, and with experience it ispossible to assess how well a patient understandsthe information you have given them.
It is often necessary to check that a patientunderstands information you have given them,but in doing so it is important not to patronisethem. A good method of checking under-standing is to ask the patient to explain some-thing back to you, for instance, after explaininghow to use an inhaler, ask the patient to explainit back to you.
Interacting with other healthprofessionals
Talking with other health professionals is verydifferent from talking with patients. This canbe quite intimidating for the pre-registrationor newly qualified pharmacist, especially whentalking to doctors, as they might ask questionsor require explanations that the pharmacist maynot be prepared for. This may be because of lackof experience or specialist knowledge of theclinical speciality in question, and becomes less
Interacting with other health professionals 79
Figure 8.1 A hospital pharmacist discusses drug treat-ment with a patient. Her position enables her to speakeasily with the patient.
common as a pharmacist becomes more experi-enced. The principal key, therefore, to successfulinteractions with doctors and other healthprofessionals is preparation.
If you need to get information from otherpeople, think about what you want to know, andthen the questions you need to ask to get thatinformation. If necessary, write the questionsdown, so you don’t forget any of them, and thenarrange your questions in a logical order. Havingto go back to a person repeatedly because you’veforgotten something is embarrassing and is likelyto annoy them!
If you are talking to a prescriber about achange in treatment, make sure you can justifyyour suggestion with evidence, and can alsosupply prescribing information for the alterna-tive choice of treatment, thereby proffering asolution to the issue rather than barriers tosuccessful treatment of the patient.
Presentations
Presentationsarean importantpartofmanyphar-macy undergraduate programmes, and continueto be part of the role of the qualified pharmacist,particularly in primary care and hospital settings.This section discusses how to plan a presentation,decide on content, design slides and use appro-priate body language and voice skills to make agood presentation (Box 8.2).
Planning the presentation
The first steps in planning a presentation areto know how long the presentation should be,and to establish the aim of the presentation. Isit to inform the audience, to educate them,or to persuade and change opinions or atti-tudes? Once you have determined the purpose,it is easier to decide on the appropriate content,structure and style of the presentation.
Next think about the topic(s) you want tocover, and then arrange them in a logical orderso that each slide leads on to the next. This willhelp your audience to follow you more easily. Itis a good idea to start with an outline oroverview of the presentation, so the audienceimmediately knows what you are going to talkabout. Let them know how long you will betalking for and when they can ask questions (i.e.during or after the presentation).
End your presentation with a summary andconclusion. This allows you to reiterate andreinforce the main points of the presentation.It also enables you to create a lasting positiveimpression, as the last things you say will bethose most easily remembered by the audience.
Make sure you prepare for possible questionsyou might be asked. One way to do this is to aska colleague to listen to your presentation and totell you what questions they would ask; prepareanswers for these.
In order to pitch the content at the right level,think about who your audience is. Pharmacistsmay be required to present to nurses, doctorsand other pharmacists. These different groupswill be interested in different parts of the samesubject. For instance, if a hospital pharmacist is
80 Chapter 8 • Essential communication skills
Figure 8.2 A hospital pharmacist discusses a patient’sdrug treatment with a junior doctor.
giving a presentation on a new drug, doctorswill be most interested in indications for use,how to prescribe it and monitoring parameters.Nurses will want to know how to give it safelyand how to monitor the patient immediatelyafter it is given. Pharmacists will want to knowall of these things, and more!
Preparing slides
Most people now use computers to design andproject their slides. However, it is worth consid-ering making a ‘hard’ copy on overhead projector(OHP) slides, in case your disk or memory stickcorrupts, or the projection equipment fails or isnot available.
Slides should:
• be simple and uncluttered• have a balanced even layout• show content in a way that is easily assimi-
lated – it is often better to use several shortslides than one complex one
• be easy to present.
Some examples of bad and good slides are shownin Figures 8.3 and 8.4.
Abbreviations, acronyms and technical termsshould be defined on the first use, to ensure allmembers of the audience understand them.Animation should only be used if it enhancesyour presentation. Excessive animation can bedistracting and detract from the content of thepresentation.
If you use OHP slides, if possible they shouldbe printed or photocopied. In use, make surethey are correctly orientated on the OHP, andthat the OHP is in focus. Try not to fiddle withthem, as this is distracting for the audience andmakes them more difficult to read. You maywant to cover part of the slide and reveal it later,so that the audience doesn’t get ahead of you.
Using notes or cue cards
Some people like to use some form of notes tohelp them remember the content of their presen-tation. These can take the form of cue cards withbullet points, or a longhand version on paper. It
Presentations 81
Figure 8.3 A poorly prepared slide: the font is small and difficult to read, the information is cramped, and there is toomuch information on the slide.
is important not to use these too much, as thiswill affect your presentation style; you will not beable to make eye contact and are less likely tocome across as being confident and knowledge-able if you are reading from notes. It is a goodidea to practise your talk several times, especiallyif you are not used to giving presentations, inorder to reduce reliance on prompts. Use thewords on the slides as prompts to help youremember what to say.
Using your voice
The voice is the main instrument of communi-cation, so it is important you use it effectivelywhen giving a presentation. The voice is vulner-able to stress, so before and during the presenta-tion, try to stay relaxed; breathe deeply and keepyour shoulders and arms relaxed. Have a glass ofwater handy in case your throat gets dry.
The voice can be adversely affected by laryn-geal irritants, so it is best to avoid certainthings before giving a presentation. Theseinclude smoking, spirits (they may feel soothingbut in fact they anaesthetise the throat whilecausing further irritation), smoky, dusty and dryatmospheres, coffee and tea, hot spicy food,gargling, indigestion and heartburn (Mathieson,2007).
Speak clearly and distinctly so that your audi-ence can hear you. Open your mouth well whenspeaking, to avoid mumbling. If possible, go tothe room you are presenting in before the day,so you know how big it is. Practise speaking in itwith a friend listening in different parts of theroom to check your volume is right.
It might be useful to try some voice exercises towarm up your voice and help you speak clearly.For example, try these phrases, which need to beenunciated carefully to be easy to hear andunderstand (Van Emden & Becker, 2004):
82 Chapter 8 • Essential communication skills
Figure 8.4 Some examples of well prepared slides. The font is large and clear; the information is laid out clearly withbullet points; there is not too much information on each slide.
• electromagnetic compatibility (is every ‘t’clear?)
• romantics, realists and impressionists (avoidsaying ‘dimpressionists’)
• peas, beans, broccoli and cauliflowers (makesyour mouth work hard).
When nervous it is common to speak morequickly than usual, which can make it difficultfor people to hear everything you say, so try toslow down. Nervousness can also make youspeak in a higher pitch than usual, so be awareof this and use a pitch that is comfortablefor you to avoid straining your voice. Ensurethat you complete each sentence clearly. It iscommon for the voice to tail off towards the endof a sentence.
Make sure you address everyone. Appropriatebody language will help your voice skills (seebelow).
Practising your presentation a few timesbefore giving it will help you improve yourpresentation style, and, if you are nervous, willgive you more confidence, as you will be morefamiliar with the content.
Most importantly, be yourself! If you have astrong accent, don’t try to change it, but it maybe particularly important to speak slowly andclearly, so the audience can hear and understandyou.
Body language
Using the right body language will help youmake a more effective presentation. Think aboutthe people who have given presentations to you.The good ones usually use friendly open bodylanguage, and engage with their audience; badspeakers may not make eye contact, and turntowards the screen rather than face the audienceand engage with them.
When giving a presentation, try to have goodeye contact with the audience as a whole; don’tjust stare at one person, you’ll make them feeluncomfortable! Adopt a relaxed posture, withyour head up and level; this will enhance yourvoice and make you easier to hear. Face the audi-ence and make open arm gestures. Don’t fold
Presentations 83
Box 8.2 Giving a presentation
1. Plan the contentConsider: • aim• length• audienceInclude:• overview• summary.
2. Designing slidesSlides should be:• simple• clear• easy to understand• easy to present
3. Using notes or cue cards• do not use as script
4. Using your voice• practice• speak slowly and clearly• stay relaxed• breathe deeply• have drinking water handy
5. Body language• relax• open posture• eye contact• smile!
6. Room layout and equipment• Arrive early• rearrange if necessary• check equipment works• check your presentation works on the computer
set-up provided
your arms, this will come across as unfriendly,and the audience will be less likely to engagewith you. And don’t forget to smile!
Room layout and equipment
If possible, go to the room in which you will bepresenting before the day, so you can see howthe room is laid out. You might want to changethe layout for your presentation, so on the dayget there early so you have time to move thingsaround. Familiarise yourself with the computerand projection equipment, and make sure it allworks. Doing this early can prevent any embar-rassing mishaps after your audience has arrived.
Summary
This chapter demonstrates how effectivecommunication involves much more thanmerely talking to people. The pharmacy studentmust master various forms of communicationsuch as presentation skills, active listening,open, closed and probing questioning, and beaware of how body language can be used to aidcommunication. By learning about and using
these techniques, you will become a moreconfident and effective pharmacist.
References
Bumgarner G W, Spies A R, Asbill C S, Prince V T(2007). Using the humanities to strengthen theconcept of professionalism among first-professionalyear pharmacy students. Am J Pharm Educ 71: 28.
Chisholm M A, Cobb H, Duke L, et al. (2006). Develop-ment of an instrument to measure professionalism.Am J Pharm Educ 70: 85.
Hammer D P, Berger B A, Beardsley R S, Easton M R(2003). Student professionalism. Am J Pharm Educ67: 96.
Mathieson L (2007). Personal communication. London:University College London.
Useful resources
Goodlad S (1996). Speaking technically. a handbook forscientists, engineers, and physicians on how to improvetechnical presentations. London: Imperial CollegePress.
Van Emden J, Becker L (2004). Presentation skills forstudents. Basingstoke: Palgrave Macmillan.
84 Chapter 8 • Essential communication skills
Introduction
This chapter describes current prescriptionforms seen in primary care. These forms areoften updated, but they provide examples of thetypes of prescription form you might see duringyour career.
Types of medicine
At the time of writing, the Medicines Act (1968)classifies medicines into three categories:
• general sales list (GSL) • pharmacy medicine (P)• prescription only medicine (POM).
GSL medicines are available to the publicthrough many outlets, from supermarkets to thelocal garage. These are medicines which have ahistory of being safe and effective, meaningthey can be sold by a person with no medical orpharmacy training.
‘P’ medicines are available only from pharma-cies and can only be sold under the supervision
of a pharmacist. Some ‘P’ medicines are productsthat have been deregulated from POM status,whereas others may have potential for misuse orrequire the supervision of a pharmacist duringthe sale. Other ‘P’ medicines need a pharmacist’sexpert knowledge of drug actions and possibleinteractions in order to be supplied to patientsin certain situations. For example, a patient whois taking certain antihypertensives should nottake the decongestants that are included inmany cold and flu remedies, as the two drugscan interact and cause an increase in thepatient’s blood pressure. Another example is theuse of antihistamines for hay fever symptoms:people who use machinery or drive as part oftheir daily life should be counter-prescribed anon-drowsy once-a-day antihistamine.
POMs are only available on a prescription froman authorised prescriber (as currently defined bythe Medicines Act 1968). The prescription maybe either on a National Health Service (NHS)prescription form (subsidised) by the govern-ment, or a private prescription, the full cost ofwhich is to be paid for by the patient. Autho-rised prescribers include a variety of health
Introduction . . . . . . . . . . . . . . . . . . . . . . 85
Types of medicine. . . . . . . . . . . . . . . . . . 85
Prescribers . . . . . . . . . . . . . . . . . . . . . . 86
Prescription forms . . . . . . . . . . . . . . . . . 86
Information required on a prescription . . . 87
Types of prescription form . . . . . . . . . . . . 87
Restriction to medicines andappliances prescribed on NHS FP10(and variations) forms. . . . . . . . . . . . . . . 93
References. . . . . . . . . . . . . . . . . . . . . . . 94
Useful resources. . . . . . . . . . . . . . . . . . . 95
9Prescriptions – types and legal requirements
Sam E Weston
85
professionals such as general practitioners (GPs),dentists, podiatrists, pharmacists, health visitors,physiotherapists, chiropodists, practice nurses,optometrists, hospital doctors and radiogra-phers, and also veterinary surgeons. Althoughthese health professionals can all prescribemedications, all have some form of restrictionplaced on them as to the range of medicationthey can prescribe. GPs can prescribe any medica-tion at NHS expense except those listed in PartXVIIIA of the Drug Tariff (published monthlyand available online at www.drugtariff.com toregistered users). This section of the Drug Tariffcontains information on medicines and othersubstances that cannot be prescribed under theNHS Pharmaceutical Services, sometimes knownas the ‘black list’ (a list of drugs that have beendeemed as unsuitable for prescription on theNHS on the grounds of efficacy, cost or otherissues). In addition, prescribers are advised toadhere to local formulary guidelines, agreedbetween the Department of Health, local primarycare trusts and hospital trusts in that region.Dentists can prescribe items listed in theDental Practitioner Formulary (DPF) and nursesfrom the Nurse Practitioner Formulary. (Both canbe found in the back of the British NationalFormulary (BNF).) However, it is important tonote that doctors and dentists can prescribeany POM on a private prescription, and are notconfined to formulary guidelines that apply whenprescribing on an NHS prescription form. Thisis discussed in more detail below, in the section onprivate prescriptions (page 91). Note also thatunlicensed medications can be prescribed byqualified doctors under certain circumstances –such as when no other suitable medication isavailable to treat a patient with a certain illness.These unlicensed medications are not listed inthe Drug Tariff, so pharmacists need to be awareof information sources that are available forsuch products (e.g. BNF), in the event that aprescription is presented to them for dispensing.
Prescribers
Historically, only doctors were allowed toprescribe. However, the first Crown Report
published in 1998 recommended changes to theprescribing system and, as a result, nurseprescribing was piloted and then introducedthroughout England from 1998, with asuccessful outcome. Since publication of thesecond Crown Report in 1999, pharmacists havealso joined the ranks of prescribers – both asindependent prescribers and supplementaryprescribers (originally known as dependentprescribers).
• Independent prescribers assess patients, makediagnoses and prescribe suitable medication –this is linked to the role of communitypharmacists within their extended role asprescribers in minor ailment schemes (seeChapter 3).
• Supplementary prescribers are responsible formaintaining the continuation of care of apatient previously diagnosed by a physician;this encompasses the role of pharmacists inthe maintenance of patient care in hospitalsettings (see Chapter 4).
Prescription forms
Prescription forms are currently paper docu-ments, which may be handwritten, typed orcomputer generated. The prescription givesdetails of the medicine(s) to be dispensed for anamed patient and is issued by an authorisedprescriber, as detailed above. The medicationcan be from any of the categories listed at thestart of the chapter.
A prescription item is a single named medica-tion on a prescription (e.g. aspirin 75 mgdispersible tablets). However, a prescription maycontain more than one prescription item (e.g.aspirin 75 mg dispersible tablets and para-cetamol 500 mg tablets), making the prescriptionform a multiple-item prescription. Prescriptionsdo not necessarily include only medications;items such as wound dressings, gluten-free foodproducts, stoma appliances and elastic hosierymay be included on a prescription form.
Electronic prescriptions are the latest devel-opment in NHS prescription forms. Sincethe publication of the NHS Plan in 2000
86 Chapter 9 • Prescriptions – types and legal requirements
(Department of Health, 2000), there has been asteady move towards the routine use of elec-tronic prescriptions in both community andhospital environments. Electronic prescriptionswill have the same legal force as a paperprescription and will eventually replace thelatter completely. The benefits of electronicprescriptions include
• patient convenience• easier ordering of repeat prescriptions• availability of more complete information
about prescribing to all members of a health-care team.
By transferring information about the prescrib-er’s choice of medication for a patient elec-tronically, a more holistic picture about thetreatment regimen can be seen by any memberof the healthcare team, which will, in turn,improve the continuity of the patient’s care.The only exception to the transformation frompaper to electronic format will be privateprescriptions, which will remain paper based forthe immediate future.
Information required on a prescription
A prescription is a means of communicationbetween the prescriber and the pharmacist. Theminimum information and instructions that arerequired are shown in Box 9.1.
Types of prescription form
NHS prescriptions
Prescription forms currently exist in manyguises. Prescription forms must be used forprescribing POMs and appliances. In addition,each prescribing group (doctors, dentists,nurses, etc.) is restricted in the prescription formthat they can use. The information belowwas correct at the time of writing (December2007). Up-to-date information can be obtainedvia the Prescription Pricing Division website:www.ppa.org.uk.
Types of prescription form 87
Box 9.1 Essential information to be included on a National Health Service prescription form
• Name, address and telephone number of theprescriber – this allows the prescriber to becontacted in the event of any problems withinterpreting the prescription.
• Date of the prescription – some legislationgoverning dispensing requires certain medicines tobe dispensed within a certain time from the dateon the prescription (e.g. controlled drugs).
• Name of the medicine, strength and dosage form– in the UK it is advised that medicines are writtenusing their generic (or approved) name (i.e. thename of the drug) rather than their proprietary orbrand name. This is also sometimes referred to asthe recommended international non-proprietaryname (rINN). However, the brand name can bewritten for exceptions where it important that apatient receives the same dosage form; this isparticularly the case with many drugs used to treatepilepsy.
• Dose and dosing regimen – this allows thepharmacist to ensure that the correct dose hasbeen prescribed for the patient; note, however,that some products (e.g. creams and ointments),may not have a specific dose.
• Total amount to be dispensed – this can be writtenas a quantity or as the length of treatment course,for example 21 capsules can be written as ‘21’ oras ‘one capsule, three times a day for 7 days’.
• Directions for use – this includes instruction on howa medicinal product should be used (e.g. ‘spreadthinly’ in the case of steroid creams).
• Name and address of the patient (and age ifunder 12 years old).
• Prescriber’s signature – this must be in indelibleink.
Prescription forms used in England
Prescription forms currently used in England arecarefully divided to ensure that each prescriberuses the correct type of form. Table 9.1 lists themajority of prescription forms used in Englandat the time of writing, their unique identifyingcodes, colours describing differences betweenthem, who uses each form type and for whatpurpose. The potential for fraudulent reproduc-tion and abuse of the prescribing system is ofobvious concern to health professionals and theauthorities; because of this, all NHS prescriptionforms are now made of special paper that makesthem virtually impossible to scan, photocopy orreproduce in any way, in order to minimise thisrisk. For this reason we cannot show images ofthe range of prescription forms, although animage of a blank English FP10 has been usedin Chapter 10 to identify different sections ofthe prescription form for interpretation by thepharmacist.
Prescription forms used in Wales
From March 2004, Welsh prescribers beganusing new bilingual prescription forms with theidentifier code ‘WP10’. Both English and Welshlanguage text appear on the forms. These formscan be presented for dispensing at pharmacies inEngland, and should be dispensed from in theusual manner. All WP10 forms are green but areeasily identifiable by the presence of The WelshAssembly Government (dragon) logo in thebottom-left corner and the NHS Wales logo inthe bottom-right corner.
Each individual prescriber group or type ofprescription is further identifiable by the codeprinted at the bottom of the prescription (e.g.dentists prescribe on WP10D followed by theindividual form serial number). In addition, theprescriber type is printed alongside the ‘Date ofBirth’ and under the ‘Name’ box. The paper andsecurity measures incorporated in the prescrip-tion form are the same as the current English
88 Chapter 9 • Prescriptions – types and legal requirements
Table 9.1 Prescription forms used in England
Paper type Colour Type of form For use by Patients
FP10NC Green Preprinted green form for GPs Practice patientscomputer-generated prescriptions Hospital-based prescribers Outpatient clinics
FP10SS Green Blank green form for computer- GPs (and hospitals or Practice patientsgenerated or handwritten supplementary prescribers Outpatient clinicsprescriptions using accredited systems)
FP10MDA Blue Drug misuse instalment prescriptions, GPs Registered addictscan be preprinted or blank forms Hospital-based prescribers
Supplementary prescribersFP10P Lilac Handwritten prescriptions For use by nurses, Home visit patients
supplementary or additional Patients visiting a prescribers and out-of-hours nurse-led cliniccentres Emergency patients
FP10D Yellow Blank yellow form for Community dentist Practice patientscomputer-generated or handwritten Emergency patientsprescriptions
FP10PCDSS Pink Computer-generated or handwritten GPs Practice patientssingle-sheet prescription for Home visit patientscontrolled drugs Emergency patients
Adapted from information presented on the Prescriptions Pricing Authority website (www.ppa.org.uk)
FP10 series. Table 9.2 outlines the majorprescription forms used in Wales.
Prescription forms used in Scotland
Scottish prescriptions also differ slightly fromthe prescription forms seen in England, and aspecific category of prescription exists solely foruse by pharmacists. The categories of prescriberallowed to prescribe on each form type are alsodifferent. Table 9.3 outlines the major prescrip-tion forms used in Scotland.
Prescription forms used in NorthernIreland
In Northern Ireland, prescription forms arecurrently divided into four categories. There are
currently no specific forms for use by pharma-cists, but local health authority schemes are inplace to allow prescribing by accredited pharma-cists for minor ailment scheme. Table 9.4outlines the major prescription forms used inNorthern Ireland.
Other prescription forms in use
The Isle of Man, Jersey and Guernsey haveseparate prescriptions. The prescription formsspecific for Jersey and Guernsey can only befilled in on the island on which they are issued.Recently, prescription forms specifically used forthe supply of Schedules 2 and 3 controlled drugs(FP10PCD) by a prescriber have been introducedfor patients collecting medications from acommunity pharmacy. These are still relativelyuncommon, as their introduction is being
Types of prescription form 89
Table 9.2 Prescription forms used in Wales
Paper type Colour Purpose For use by Patients
WP10NC Green Preprinted green form for GPs Practice patientscomputer-generated prescriptions Hospital-based prescribers Outpatient clinics
WP10SS Green Blank green form for computer-generated or handwritten GPs (and hospitals or Practice patientsprescriptions supplementary prescribers Outpatient clinics
using accredited systems)WP10MDA Green Drug misuse instalment prescriptions, GPs Registered addicts
Blue can be preprinted or blank forms Hospital-based prescribersSupplementary prescribers
WP10HP Green Hospital based prescribers Outpatient clinicsOrange
WP10CN Green Handwritten or Community nurses Home visit patientsPurple computer-generated prescriptions Patients visiting a
nurse-led clinicEmergency patients
WP10PN Green Handwritten or Practice nurses Home visit patientsPurple computer-generated prescriptions Patients visiting a
nurse-led clinicEmergency patients
WP10D Green Community dentist Practice patientsYellow Emergency patients
WP10SP Green Supplementary prescribers Patients who do not need referral to a GP
Adapted from National Pharmacy Association Drug Tariff Handbook
phased in as old-style prescription forms areused up. Both the old- and the new-styleprescription forms have a space on the backfor the signature of the person collecting the
medication. In the longer term, further changeswill be made to allocate each prescriber with aunique code to allow more accurate monitoringof the prescribing of controlled drugs.
90 Chapter 9 • Prescriptions – types and legal requirements
Table 9.4 Prescription forms used in Northern Ireland
Paper type Colour Purpose For use by Patients
HS21 Green Preprinted green form for GPs Practice patientscomputer-generated prescriptions Hospital-based prescribers Outpatient clinics
HS21S White Ordering stock items for practice GPsor medical bags
No equivalent in England or WalesHS21D Yellow Community dentist Practice patients
Emergency patientsHS21N Purple Nurse prescribers, including General practice
independent and patientssupplementary prescribers
Adapted from National Pharmacy Association Drug Tariff Handbook
Table 9.3 Prescription forms used in Scotland
Paper type Colour Purpose For use by Patients
GP10/GP10SS Orange Preprinted green form for GPs Practice patientscomputer-generated Hospital-based prescribers Outpatient clinicsprescriptions
GP10A Pink Ordering stock items for GPspractice or medical bags
No equivalent in England or Wales
GP10DTS Pink Drug testing scheme officers Registered addictsGP10(N) Purple Nurse prescribers, including General practice
independent and patientssupplementary prescribers
GP14 Yellow Community dentist Practice patientsEmergency patients
CP2 Yellow Pharmacists Patients with minor ailments
CPUS Yellow Urgent supply of Pharmacistsmedication to a patient
HBP Blue Hospital-based prescribers Outpatient supplyHBP(A) Pink Hospital clinics – for supply of
medication to registered drug addicts
Adapted from National Pharmacy Association Drug Tariff Handbook
Private prescriptions
Currently POM, ‘P’ and GSL category medicinescan be supplied from a pharmacy when thepharmacist is presented with a private prescrip-tion. Although prescribers are governed by theDrug Tariff and various national formularieswhen prescribing on an FP10, WP10, GP10 orHS21 form, prescribers are allowed to order anyPOM, ‘P’ or GSL medicine on a private prescrip-tion form (RPSGB, 2007).
Details that must be included on a privateprescription in order for it to be valid include:
• a signature and the prescriber’s name inindelible ink
• the address of practitioner supplying theprescription
• an appropriate date• the qualification details of prescriber• name and address of the patient (and age if
less than 12 years old).
In order to confirm the registration details of aprescribing doctor or dentist, pharmacists haveaccess to the General Medical Council list ofregistered medical practitioners and the GeneralDental Council register online to check that thepresciber is legally registered and thereforeallowed to prescribe medications.
Hospital prescription forms
There is no standard prescription form used forhospital prescribing for inpatients, and theformat varies from one hospital trust to another.(In reality, the chart used to record inpatientmedication is known as ‘an authority to admin-ister’.) However, all forms have space for prescrip-tion details, as well as space for confirming thatthe medicine has been administered to thepatient by a member of nursing or medical staff.Generally, hospital prescriptions are dividedinto four or five sections: regularly administeredmedicines; once-only medication; intermittentinjections; continuous infusions; there may alsobe separate sections for the administration ofblood products or drugs with variable doses,such as warfarin. Finally, the majority ofhospital prescription forms include a section for
‘as required’ medication, which includes medi-cines such as analgesics (painkillers), laxatives,etc., that can be given to the patient by nursingstaff at their discretion, without the need for adoctor to add the medication to the regularmedications section of the prescription form.These items can be written up before they areneeded, together with directions for maximumdaily dose and dosing interval for the nursingstaff to use in the event the patient requiresthe medication. Figure 9.1 is an example of ahospital prescription form used for teachingundergraduate students.
Veterinary prescriptions
In 2002 the Competition Commission publisheda report on veterinary medicines which outlineda monopoly situation in which veterinarianswere prescribing and supplying medicines to petowners. Recommendations have therefore beenmade to encourage the supply of veterinarymedications from pharmacies, and pharmacistsare increasingly being presented with veterinaryprescriptions.
A ‘veterinary medicinal product’ can besupplied in accordance with a prescription.There are no standard forms, so most veterinaryprescriptions take the form of a private prescrip-tion. In addition to the details included on aprivate prescription, a veterinary prescriptionmust also contain:
• the name and address of the owner or keeperof the animal(s)
• the species of animal, identification andnumber of animal(s)
• the premises at which the animal(s) is/arekept if different from that of the owner orkeeper.
The pharmacist should ensure that the prescriberis legally registered and entitled to prescribe themedication on the prescription.
Signed orders
A signed order can be accepted by a pharmacistfor the supply of a Schedule 1 poison to a person
Types of prescription form 91
92 Chapter 9 • Prescriptions – types and legal requirements
Figure 9.1 A hospital prescription chart currently used as an undergraduate teaching resource at the University ofReading, School of Pharmacy (modified from a prescription chart used at Oxford Radcliffe Hospitals NHS Trust). Itconsists of four pages: the first page gives the patient details, premedication, once-only drugs and prophylactic antibi-otics, and infusion therapy; the second and third pages list regular medications; page 4 lists medications that can beadministered as required.
who requires it for the purpose of their trade; forexample, a pest control officer may requirestrychnine or fluoroacetic acid to be used as apoison for moles or rodents. In this situation,the ‘prescription’ or signed order must include:
• a signature in indelible ink• the name and address of the purchaser• details of their trade or profession• the total quantity to be purchased• the purpose for which the poison is required.
In addition to poisons, the community pharma-cist may see signed orders for medicines anddressings for an on-call doctor’s bag or forsupplies for clinics held within a GP surgery. Ina hospital environment, pharmacists will oftenreceive signed orders from ward staff, and partic-ularly from operating theatre staff, for thesupply of controlled drugs for stock purposes.This ensures that a supply of medication is avail-able in an emergency situation or when thepharmacy is closed.
Exemptions
Some exemptions apply to GSL, ‘P’ medicinesand POMs. Certain groups of people are allowedto have these medicines supplied without theuse of a prescription. These groups include:
• hospitals and health centres• practitioners – doctors and dentists• appropriate nurse prescribers• midwives• chiropodists• optometrists• drug treatment services• owners and masters of ships• operator or commander of an aircraft• Royal National Lifeboat Institution• British Red Cross Society• occupational health schemes• first aid personnel on offshore installations
(such as oil rigs)• ambulance paramedics• universities.
Up-to-date details of the restrictions and regula-tions surrounding these and other groups aregiven in the Medicines, Ethics and Practice Guide
for Pharmacists and Pharmacy Technicians. Anorder can be provided by the purchaser in addi-tion to details of their exemption status. It isgood practice to record details of any sale orsupply of POMs to any of the exempted groupsof people described above in the prescription-only register. Details to be recorded include:
• the date on which the POM was sold orsupplied
• the name, quantity, pharmaceutical form andstrength of the medicine
• the name, address, trade, business or profes-sion of the person to whom the medicine hasbeen sold or supplied
• the purpose for which it was sold or supplied.
Restriction to medicines and appliancesprescribed on NHS FP10 (andvariations) forms
Schedule 1 products and appliances
Schedule 1 to the NHS (General Medical ServicesContract) (Prescription of Drugs) Regulations 2004lists medicinal product and appliances thatcannot be prescribed under NHS pharmaceuticalservices. This list is in Part XVIIIA of the DrugTariff and is commonly known as the ‘black list’.The Prescription Pricing Division (PPD) will notreimburse the dispensing contractor for itemsdispensed from this list.
Schedule 2 products and appliances
Schedule 2 to the NHS (General Medical ServicesContract) (Prescription of Drugs) Regulations 2004lists drugs that may be prescribed in certaincircumstances. The groups of patients who mayreceive these drugs for specific purposes arelisted, but these drugs may not be prescribed toother types of patient or for different purposes.This list of drugs is called the ‘selected list’ andis found in Part XVIIIB of the Drug Tariff. Theprescriber must endorse the FP10 with theterm ‘SLS’ (selected list scheme) for the prescrip-tion to be accepted for processing by the PPD.
Restriction to medicines and appliances prescribed on NHS FP10 forms 93
For example, cyanocobalamin tablets may beprescribed for the treatment or prevention ofvitamin B12 deficiency in patients who are veganor have a proven vitamin B12 deficiency ofdietary origin. Appliances listed in Part IX of theDrug Tariff may be supplied on FP10.
Borderline substances
‘Borderline substances include certain foods andtoilet preparations. These products are dividedinto List A and List B and can be found inPart XV of the Drug Tariff. The prescriber mustendorse the prescription specifically with theterm ‘ACBS’. The Advisory Committee onBorderline Substances (ACBS) advises whenpreparations may be regarded as drugs. Anexample is HCU gel, a methionine-free proteinsubstitute for use in the dietary management ofhomocystinuria in children between the ages of12 months and 10 years.
Non-GP prescribers
Dentists
Dentists are restricted to a specific list of prod-ucts that can be prescribed on FP10D and shoulduse the DPF. The PPD will only reimburse thedispensing contractor if the products are in theDPF. The most up-to-date list of preparationssuitable for prescribing on FP10D are listed inPart XVIIA of the Drug Tariff. Note that privatedental prescriptions are not restricted to theDPF.
Nurse prescribers
Two formularies exist for independent nurseprescribers:
• District nurse and health visitor prescriberscan only prescribe preparations in PartXVIIB(i) of the Drug Tariff.
• Independent nurse prescribers (previouslyknown as extended formulary nurseprescribers) can prescribe the above, plus
the list of products in Part XVIIB(ii) of theDrug Tariff. This specific section of the DrugTariff is the most up-to-date record of prod-ucts available in the nurse prescribers’formularies.
Supplementary prescribers
Supplementary prescribers can prescribe (providedthey are included within the patient-specificclinical management plan):
• all GSL medicines, ‘P’ medicines, appliancesand devices, foods and other borderlinesubstances
• all POMs• controlled drugs (Schedule 1 drugs not
intended for medicinal use, e.g. poisons)• medicines for use outside their licensed
indications• unlicensed drugs.
References
Competition Commission (2002). Veterinary Medicines:A report on the supply within the United Kingdom ofprescription-only veterinary medicines Volumes 1 & 2. –www.competition-commission.org.uk/rep_pub/reports/2003/478vetmeds.htm (accessed 11 May2007)
Department of Health (2000). The NHS Plan: a plan forinvestment, a plan for reform. www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4002960
Crown Report (1998). Review of prescribing, supply andadministration of medicines. A report on the supply andadministration of medicines under group prescribing.(The first Crown report.) www.jcn. co.uk/pdf/crownreport1.pdf (accessed 12 April 2007)
Crown Report (1999). Review of prescribing, supply andadministration of medicines. Final report (the secondCrown report). www.jcn.co.uk/pdf/ crownreport2.pdf(accessed 12th April 2007)
Royal Pharmaceutical Society of Great Britain (2007).Medicines, Ethics and Practice Guide for Pharmacistsand Pharmacy Technicians. London: PharmaceuticalPress.
94 Chapter 9 • Prescriptions – types and legal requirements
Useful resources
Drug Tariff: www.ppa.org.ukGeneral Dental Council register: www.gdc-uk.org/
Search�our�registers/Home.htm (accessed 24April 2007)
General Medical Council List of registered medicalpractitioners: www.gmc-uk.org/register/index.asp
Office of Public Sector Information: www.opsi.gov.ukPrescriptions Pricing Division: www.ppa.org.uk
Useful resources 95
Introduction
This chapter describes in detail the FP10 – theprescription form use most frequently inEngland. It provides a thorough ‘road map’ tothe details seen on such a form and also acomprehensive guide to interpreting the infor-mation presented on it. Before considering theprescription form and learning how to interpretit, some thought should be given to the wholeprescribing process. Writing a prescription isonly a small part of this process and there areseveral stages to go through – from diagnosis(defining the patient’s problem), to choosing asuitable therapeutic objective (considering whatneeds to be treated), deciding on a suitable treat-ment regimen, prescribing the chosen regimenand, finally, monitoring the patient’s progress.
The National Prescribing Centre (NPC) hasdeveloped seven principles of good prescribingfor use in training supplementary prescribers(NPC, 1999), which have been adapted for thepurposes of this chapter and are outlined indetail below.
Good prescribing principles – astepwise approach
Figure 10.1 summarises the approach thatshould be adopted for good prescribing, theso-called pyramid. Each stage outlined in thediagram is explained below. Each step shouldbe considered carefully before moving on to thenext step.
Introduction . . . . . . . . . . . . . . . . . . . . . . 97
Good prescribing principles – a stepwiseapproach . . . . . . . . . . . . . . . . . . . . . . . 97
Interpretation of prescriptions . . . . . . . . . 99
References. . . . . . . . . . . . . . . . . . . . . . 107
Useful resources. . . . . . . . . . . . . . . . . . 107
10Understanding and interpreting prescriptions
Sam E Weston
97
Reflect
Record keeping
Review
Negotiate a ‘contract’
Consider the choice of product
Which strategy?
Consider the patient
7
6
5
4
3
2
1
Figure 10.1 The prescribing pyramid. Each step shouldbe considered carefully before continuing to the next step(NPC, 1999).
1 Examine the holistic needs of the patient
Is a prescription necessary? By first consideringthe holistic needs of the patient (such as theirsocial and medical needs), early identification ofnon-drug therapy may become apparent, orperhaps the use of a complementary therapyin conjunction with mainstream medicinaltherapy. Information such as the use of OTCmedication or herbal or homoeopathic prepara-tions should also be taken into account. Somepatients will not divulge this information freelyto their prescriber, or may not consider it rele-vant. Any details of previous drug allergiesshould also be confirmed.
Some pharmacists find mnemonics useful tohelp them remember the critical questions to askpatients during a consultation. (One example isthe WWHAM approach, devised by the NPC, toremind pharmacists of five key points to coverwhen dispensing an OTC medication.). Bear inmind, however, that such mnemonics cannot berelied on to examine all pertinent areas requiredin each consultation.
2 Consider the therapeutic target
When a prescriber meets with a patient, it isimportant to bear in mind that other treatmentoptions should be considered before writing aprescription. Some questions a prescriber mustconsider include:
• Has a diagnosis been made? • Does the patient need a prescription at all? • Are the patient’s expectations a factor?
A prescription should only be given where thereis a genuine need. It should also be rememberedthat patients may wish to receive a prescriptionfor reasons other than to gain treatment for theircondition (e.g. to legitimise the sick role, to gainattention, a friend has recommended it, or to geta prescription for a family member or friend).
3 Choosing a treatment and safety issues
The following issues should be explored whenconsidering which product to prescribe.
• How effective is the product? To ensure thatthe most appropriate prescription item isselected, the prescriber needs to be familiarwith the full range of items in the BritishNational Formulary (BNF), or the formulary towhich they are restricted. To assess how effec-tive the product is, the available clinicalevidence should be critically appraised.Websites such as the Department of Health’sResearch Findings Electronic Register (ReFeR;www.info.doh.gov.uk/doh/refr_web.nsf/home)give up-to-date information on recently devel-oped, clinically trialled and newly releasedmedicines. The National Library for Health(www.library.nhs.uk) provides informationabout treatment options for various illnesses.
• How appropriate is the treatment? Somedrugs are contraindicated (unsuitable for use)in certain patients. For example, aspirin (ormedicines containing it) should not be takenby patients with current or previous historyof stomach ulcers, as it can irritate thestomach lining causing bleeding. Thepatient’s medication history may also revealpotential drug interactions that may haveserious consequences (e.g. warfarin andaspirin must not be taken together, becausethe combined anticoagulant effects of thesetwo drugs may lead to an increased risk ofbleeding).
In addition to choosing a product that is appro-priate for the patient, the dose, formulation andduration of treatment should be tailored to theindividual. Generally, an initial prescriptionshould provide treatment for no more than 1month, in order to ensure an early follow-upconsultation to check on the patient’s progress.
All drugs are associated with a certain risk ofcausing side-effects or adverse drug reac-tions (ADRs). ADRs account for 5% of allhospital admissions, and may be associatedwith a risk of significant morbidity andmortality (Pirmohamed et al., 2004). The WestMidlands Centre for Adverse Drug ReactionsStudies website (www.adr.org.uk) provides up-to-date information on the incidence of ADRs.ADRs are also discussed in more detail inChapter 6. For any given therapeutic interven-tion, the potential benefits of the treatmentmust always be balanced against safety
98 Chapter 10 • Understanding and interpreting prescriptions
concerns. The prescriber should be familiarwith the common ADRs associated with thetreatments they are prescribing.
4 Negotiate a ‘contract’ and achieveconcordance with the patient
The prescriber and the patient should come toan understanding about the patient’s illness anddiscuss potential treatments that will help thepatient to reduce the effect it has on his/her life.Further information on concordance can befound in Chapter 14. Effective communicationis an essential part of good practice (see Chapter8) and includes the need to make sure that thepatient understands the information given. Inthe case of prescribing a medicine, the patientneeds to understand:
• what the medicine is for• how to take the medicine• at what dose and frequency to take it• how long it takes to work• how long to take the medicine for• the possible side-effects and what to do if
they occur.
5 Review the patient on a regular basis
Reviewing the patient enables the prescriber toestablish whether the treatment prescribed iseffective, safe and acceptable. In an ideal world,patients should be reassessed at least every6 months, with no more than six repeat pre-scriptions given without review, as outlined ina comprehensive document produced by theNPC (2004). Repeat prescribing without properreview may be wasteful and inefficient, andmay even be potentially dangerous in somecases.
6 Record keeping
Record keeping must be both accurate and up-to-date – comprehensive notes on the patient’s
consultation, chosen drug regimen, test resultsand future appointments should be kept by theprescriber. In addition to this, the informationrecorded by the pharmacist (discussed in thefollowing section) means a comprehensiverecord of the patient and their treatment isbeing maintained.
7 Reflection
This stage is often not considered until thepatient returns for review with the prescriber. Atthis point the prescriber can decide whether thecorrect medicine regimen has been selected forthe patient.
Interpretation of prescriptions
Once the prescription reaches you, the phar-macist, the next stage of the patient’s carebegins. To dispense a prescription, a methodicalapproach should be adopted in order to allowthe prescriber’s diagnosis and treatment choiceto be conveyed accurately, with the correctmedication, to the patient.
1 Check the patient’s details
Firstly, the patient’s details must be checked(see Figure 10.2). This allows the appropriate-ness of the treatment regimen for the particularpatient to be assessed. Also, accurate recordscan be made of the product(s) dispensed, theproduct labelled for the patient, and the patientcontacted, if necessary, after the medication hasbeen dispensed and supplied to them. The fullname of the patient is usually enough to indi-cate the sex of the patient, and therefore assessthe appropriateness of a particular medication(e.g. finasteride should not be prescribed towomen, except under certain circumstanceswhen adequate contraceptive cover is in place,because it is highly toxic to developing maleembryos).
The patient’s address is also required (seeFigure 10.2). This allows the pharmacist to
Interpretation of prescriptions 99
distinguish between patients who may have thesame name.
In the event that two patients have thesame name and address, the date of birth (seeFigure 10.3) should distinguish between them.This is also useful when calculation of appro-priate dosages for children is required. It is a legalrequirement for the date of birth to appear onan NHS prescription for children under the ageof 12 years, but not on a private prescription.
2 Check the legal requirements of theprescription
The legal requirements are described in detail inChapter 9; a summary is provided in Figures 10.4and 10.5.
3 Check the product details
By checking the name of the drug prescribed,the required pharmaceutical form, the strengthand the total amount to be dispensed, the phar-macist can check that they have sufficientquantity of the medicine in stock in theirdispensary. Many medications are now avail-able in ‘patient packs’ – a 28-day supply ofmedication in a box, complete with patientinformation leaflet – and it is not unusual forthe prescriber to request ‘1 oP’, meaning ‘oneoriginal pack’ is to be supplied. The quantity ofmedication to be supplied should be checked toensure that the prescribed quantity is appro-priate for the patient, as well as whether themedication is available in such a quantity.Some prescriptions are written to indicate that
100 Chapter 10 • Understanding and interpreting prescriptions
Patient’s name
Patient’s address
Figure 10.2 Check the patient’s name (title, forename and surname) and address. The address is useful to distinguishbetween patients with the same name.
Age
Date ofbirth
Figure 10.3 Check the patient’s age and date of birth. The latter is useful to distinguish between patients with the samename and address. This information is also important to identify when the prescription is for a child.
Interpretation of prescriptions 101
Patient’s name
Patient’s address
Drug name
Quantity
Instructions for use
Age
1
2
Date ofbirth
Figure 10.4 Legal requirements of the prescription, Part 1: (1) patient identification details; (2) details of prescribedmedication.
Signature of prescriber Date of prescription
Name and registrationnumber of prescriberAddressTelephone number
1 2
3
Figure 10.5 Legal requirements of the prescription, Part 2: (1) signature of the prescriber; (2) date before which theprescription cannot be dispensed; (3) prescriber’s registration details.
a number of days’ supply is to be provided (seeFigure 10.6).
At this stage, the pharmacist should checkthat the medicine is available on the NHS (usingthe Drug Tariff as discussed in Chapter 9 ortheir computer labelling system), and also if themedication is available as a generic product or asa branded product.
Names of medicines can be very similar, forexample dipyridamole (an antiplatelet drug)and disopyramide (used to treat arrhythmias),so it is of the utmost importance to check thatthe correct product has been selected fromstock by the pharmacist. In addition to similarnames, manufacturers of generic medicationsoften package their drugs in similar livery (seeFigure 10.7), so, again, careful selection fromstock is required.
It is also important to ensure that the correctformulation of the medicine is supplied. Forexample, ibuprofen is available as tablets ofdifferent strengths, oral solutions (two strengths),
oro-dispersible tablets, and gel for topical appli-cation to the skin (see Figure 10.8). In additionto this, if the medicine is available in differentstrengths, the pharmacist should ensure thecorrect strength has been selected from stockaccording to the information provided on theprescription.
In the event that information is missing froma prescription, the pharmacist should usetheir professional skills to decide whether theprescriber needs to be contacted. If the prescribercan be contacted by telephone for instructionsregarding changes to the quantity, strength ordose indicated on the prescription, the pharma-cist is allowed to amend the prescription by handand endorse the prescription with the letters ‘PC’(prescriber contacted) in the section indicated inFigure 10.9, and initial and date the amend-ment. If the total quantity is missing and theprescriber cannot be contacted, the pharmacistis allowed to dispense up to 5 days’ supply ofmedication. In this instance the prescription
102 Chapter 10 • Understanding and interpreting prescriptions
Drug name
Quantity
Instructions for use
2
1
Figure 10.6 Check the details of the prescribed medication: name of drug, dosage form, strength (where appropriate)and either (1) quantity or (2) number of days’ supply.
Interpretation of prescriptions 103
Figure 10.7 Check the name of the medication carefully. Generics manufacturers, in particular, provide a variety ofmedications in similar packaging.
Figure 10.8 Ibuprofen is available over the counter in a variety of formulations.
should be endorsed ‘PNC’ (prescriber notcontacted) and initialled and dated. Figure 10.9(section 2) shows the area where the pharmacistis allowed to endorse the prescription.
4 Check the dosage and directions
The pharmacist should then check the dosageand directions for use of the prescribed
104 Chapter 10 • Understanding and interpreting prescriptions
Prescription registration number
Pres
crip
tion
iden
tific
atio
n co
de
2
3
6
4
5
1
Figure 10.9 Endorsing guidelines: (1) details of the registered pharmacy premises; (2) details of medication(s)dispensed and any additional fees; (3) number of items dispensed. In addition, the prescription identifying code (4), andthe unique prescription registration number (5) should be printed clearly. Section 6 is used by the Prescription PricingDivision to calculate payments for individual prescription forms.
medication. The dosage prescribed shouldalways be checked with reference to the patient’sage, as lower doses are often required in the caseof children or elderly patients. Maximum dosesand dosage regimens can be found in the BNFand BNF for Children. In the case of veterinaryprescriptions, the dose and dosage regimen canbe checked using the Veterinary Pharmacopoeia orin the Summary of product characteristics forveterinary medicines.
5 Check for interactions
The next important check to be made by thepharmacist is for potential interactions betweenmedications. Many drugs are known to inter-act with each other; the most up-to-date sourceof information available to a pharmacist isAppendix 1 of the BNF. The PharmaceuticalJournal, which is the official weekly commu-nication between the Royal PharmaceuticalSociety of Great Britain (RPSGB) and all regis-tered pharmacists, also provides regular updateson drug–drug interactions. All multiple-itemprescriptions should be checked for potentialinteractions. If the patient’s current medicationrecord is available, this should also be checkedfor potential interactions between medicationsbeing supplied concurrently to the patient. If aparticular prescribed medication is known tointeract with many medications, OTC prepara-tions or herbal medicines, the pharmacist shouldcheck with the patient which other medicationsthey might be taking. All significant potentialdrug interactions should be referred to theprescriber. However, it is important to bear inmind that some interactions can be used thera-peutically to enhance the effect of a prescribedmedication. For example, diuretics increase theactivity of some beta-blockers, so initially alower dose of the latter is needed when the twodrugs are used together in the treatment ofhypertension (high blood pressure). Themajority of prescription labelling systems (e.g.NexPhase, Enigma Healthcare) used in pharma-cies have an inbuilt interaction alert system.However, pharmacists should be aware that theycan vary in the accuracy and frequency with
which they are updated; they are none the less auseful prompt to remind a pharmacist to lookinto some unusual interactions in more depth.
6 Produce a label
The labels for the medication give details of itsname, strength, form and instructions for use.Labelling requirements are discussed in detail inChapter 11. By producing these labels via thepharmacy’s electronic patient medication record(PMR) system – used in conjunction with theelectronic labelling system that generates labelsfor dispensed medications – the pharmacist isalso automatically creating a record of themedication supplied to the patient.
7 Recording the prescription
Both legal and professional records of supply areneeded. Professional records include PMRs; thetypes of data to record on such a system weredefined by the RPSGB in 1996. An auditingprocedure to ensure pharmacists adhere to theseguidelines is available on the RPSGB website(www.rpsgb.org/pdfs/accuracy.pdf). Informationshould include:
• patient name, address (including postcode),and telephone number, age, date of birth,sex, NHS number
• prescriber information – name and identifica-tion number, practice details
• medicine supplied – name, strength, form andquantity, dosage regimen, date of dispensing
• patient exemption status, use of child-resistant closures, drug sensitivities, allergies,chronic illnesses.
Legal records required in the UK currently onlyextend to the maintenance of a private prescrip-tion register and controlled drug register. Forprivate prescriptions, records are kept by handin a bound book. Details recorded include:
• date of dispensing• patient’s name and address • prescriber’s details – address of practice,
registration number
Interpretation of prescriptions 105
• prescribed medication – name, strength,form, quantity, directions for use
• price charged.
Note that information on price charged is notlegally required but provides a useful referencefor pharmacists in the event that the prescrip-tion is repeated. The private prescription chargemay vary between pharmacies and depends onthe cost of medication for the individual phar-macy and any ‘mark up’ on that cost, as well asprofessional charges for the pharmacist.
Controlled drugs
Controlled drug registers have been developedand enhanced over recent years, since theShipman Inquiry (2004) called for closer moni-toring of the supply of controlled drugs toprescribers and patients. Figure 10.10 showsan example of a partly completed recordingsheet currently used in a community pharmacyenvironment, as supplied by the NPA.
Information recorded in the controlled drugregister includes:
• name, brand (if applicable), strength andform of medication – currently one page isused per medication in order to keep records
separate from one another and enhanceeasier maintenance of stock levels
• date of transaction• quantity of medication received into pharmacy
stock• address of supplier• name and address of patient• name and registration number of prescriber• name and registration number of supplying
pharmacist• quantity of medication supplied• identity of person collecting medication
(type of identification seen, but this is notcurrently compulsory)
• running total of medication held in thecontrolled drugs cabinet.
8 The final check
Once the medication has been dispensed, thepharmacist (or an accredited checking techni-cian) must carry out a final check which confirmsall of the points discussed above for a secondtime. Where possible, the dispensing procedureand checking procedure should be carried outby a minimum of two people. This will help toreduce errors during the dispensing, labelling
106 Chapter 10 • Understanding and interpreting prescriptions
Figure 10.10 An example of a controlled drugs record sheet.
and checking of the prescribed medication, andensure that the patient receives the correctmedication, at the correct dose, in the correctform and with the correct directions for use.
9 Reimbursement
Once the final check has been performed, theprescription can be endorsed with exactly whatwas supplied to the patient so that the Prescrip-tion Pricing Division (PPD) can reimburse thepharmacy financially for the cost of the suppliedmedication. In addition, the pharmacist iscurrently paid a professional fee per itemdispensed (applied to all items, including appli-ances).The current Drug Tariff gives the value forprofessional fees.
Additional fees are paid:
• when an item is dispensed extemporaneously– made up by the pharmacist on the phar-macy premises (e.g. aqueous cream with 1%menthol)
• for bulk prescriptions (e.g. medicationssupplied in large quantities for schools andinstitutions)
• for extra containers for extemporaneouslydispensed liquids
• for controlled drugs• for expensive items (PPD, 2007a).
The labelling programme may include anendorsement feature allowing the prescriptionto be endorsed electronically. NHS prescriptionforms are kept in the pharmacy for a month,before being sorted into categories defined bythe PPD. The prescriptions are then packed andsent for processing (by no later than the fifthday of the month following that in which themedicine is dispensed) to one of ten PPDs – theprocessing arm of the NHS Business ServicesAuthority (PPD, 2007b).
References
NPC (National Prescribing Centre) (1999). Signposts forprescribing nurses – general principles of goodprescribing. Prescribing Nurse Bulletin 1: 1–4. www.npc.co.uk/nurse_prescribing/pdfs/signpostsvol1no1.pdf (accessed 12 April 2007).
NPC (National Prescribing Centre) (2004). Savingtime, helping patients: a good practice guide toquality repeat prescribing. www.npc.co.uk/repeat_prescribing/pdf/repeat_prescribing_document1.pdf(accessed 20 December 2007).
Pirmohamed M, James S, Meakin S, et al. (2004).Adverse drug reactions as cause of admission tohospital: prospective analysis of 18 820 patients.BMJ 329:15–19.
PPD (Prescription Pricing Division) (2007a). NewContractual Framework for Community Pharmacy;professional fees. www.ppa.org.uk/ppa/contract_framework_for_community_pharmacy.htm#profees
PPD (Prescription Pricing Division) (2007b). Processing and pricing. www.ppa.org.uk/ppa/pro_price.htm
The Shipman Inquiry (2004). Chapter 7, Pharmacistsand pharmacies; the controlled drugs register. In:The fourth report – the regulation of controlled drugsin the community. CM 6249. pp. 96–101. http://www.the-shipman-inquiry.org.uk/fourthreport.asp(accessed 20 December 2007).
Useful resources
Department of Health Research Findings ElectronicRegister (ReFeR): www.info.doh.gov.uk/doh/refr_web.nsf/Home
National Library of Health: www.library.nhs.ukNational Prescribing Centre: www.npc.co.ukPharmaceutical JournalPrescription Pricing Division: www.ppa.org.ukWest Midland Centre for Adverse Drug Reactions:
www.adr.org.uk
Useful resources 107
Introduction
Medicines must be contained, protected andlabelled appropriately, from the time of manu-facture until the time they are used by a patient,in order to maintain their effectiveness as amedication, as well as allowing for accuratedispensing of the required dosage form, strengthand quantity. After manufacture, the packagingof the medication must maintain the quality,safety and stability of the product and protect itfrom physical, climatic, chemical and biologicalhazards. Once the medication reaches thepharmacy, and is to be supplied to patients, therepackaged medicines should be easy to use andof a suitable size, in order to encourage patientadherence to their prescribed medicationregimen. This chapter addresses the next stageof the dispensing procedure – that of choosingthe correct packaging for the patient’s medica-tion once the dispensing procedure has begun.
Choice of packaging during dispensing
Several points need to be considered when select-ing the correct packaging for your dispensedproduct.
The chemical nature of the product
Sensitivity to light, moisture and oxygen needto be considered, as well as compatibility withpackaging materials. For example, glyceryl trini-trate tablets (used to treat angina) should alwaysbe supplied in a glass bottle because of the possi-bility of loss of the volatile drug and because itis soluble in some plastics. The lid of the bottleshould be lined with aluminium foil, and thepatient should be advised to keep the tablets attemperatures below 25°C. Even with all of theseprecautions in place, however, the tablets have a
Introduction . . . . . . . . . . . . . . . . . . . . . 109
Choice of packaging during dispensing . 109
Types of packaging . . . . . . . . . . . . . . . 110
Definition of terms applied to packaging. 111
Types of packaging materials . . . . . . . . 111
Environmental concerns . . . . . . . . . . . . 115
Practicalities of packaging. . . . . . . . . . . 115
References. . . . . . . . . . . . . . . . . . . . . . 116
Useful resources. . . . . . . . . . . . . . . . . . 116
11Packaging of medicines
Sam E Weston
109
shelf life of only 8 weeks once the packaging hasbeen opened.
Who will be taking the medication?
Elderly or arthritic patients may need non-child-resistant closures (CRC) or may want theirmedication to be dispensed into a monitoreddosage system (MDS) box (see Figure 11.1). AnMDS box is used to provide 1 week’s medicationin different time slots (breakfast, lunch, dinnerand night). They are an essential means forsome patients to retain their independence inmedication taking.
Method of administration
Patients with insulin-dependent diabetes haveto administer insulin by subcutaneous injectionat specific times throughout the day in order toregulate their blood sugar. Insulin ‘pens’ allowpatients to easily change the number of units ofinsulin they are injecting (see Figure 11.2).
Types of packaging
Packaging materials are divided into two cate-gories – primary and secondary packaging –
and have different roles in the protection anddelivery of the medication to the patient.
Primary packaging
Primary (or immediate) packaging is materialthat comes into direct contact with the medi-cine, which also includes the closure (defined aspart of the primary packaging by the BritishPharmacopoeia (BP) (BPC, 2007)). This materialmust protect the medicine from damage andfrom external interactions with chemical orbiological sources. Primary packaging shouldalso be convenient for patients, as describedabove.
Pharmacists have little choice in primarypackaging materials, as most pharmaceuticalproducts are now supplied by manufacturers inthe correct packaging to ensure that productstability, safety and quality are maintained fromthe time of manufacture until the time of use bythe patient.
Secondary packaging
Secondary packaging is additional material thatimproves the appearance of the medicine; itincludes boxes, wrappers and labels that do notmake direct contact with the dispensed product.These are often used to supply information to
110 Chapter 11 • Packaging of medicines
Figure 11.1 Non-child-resistant caps can be used onplastic dispensing bottles for elderly or arthritic patients.Elderly patients may also ask for their medicines to bedispensed in a monitored dosage system, two examples ofwhich are shown here.
Figure 11.2 Three examples of insulin delivery pens;these allow patients to change the number of units theydeliver.
the patient about the product, and, as often aspossible, clearly show if the packaged producthas been tampered with.
Definition of terms applied topackaging
Appendix XX of the BP (BPC, 2007) details theregulation of materials to be used in packaging of
different materials and defines several terms foruse in the description of containers. Table 11.1shows the most frequently used terms.
Types of packaging materials
As mentioned in Chapter 12, some medication(mainly tablets and capsules) is packaged inpatient packs. This is typically a 28-day supply
Types of packaging materials 111
Table 11.1 Definition of terms applied to packaging
Term Definition Example of use
Single dose Containers hold a quantity of the preparation Preservative-free eye drops intended for total/partial use in a single administration (Figure 11.3)
Multidose Containers hold a quantity of preparation suitable for Injection (Figure 11.4)two or more repeated administrations
Airtight Containers are impenetrable to solids, liquids and gases Closure on a tub of cream/ointmentunder normal conditions of handling, storage and transport (Figure 11.5)
If intended to be opened more than once, the container must remain airtight after reclosure
Sealed Containers are closed by fusion of the container material Blister packs (Figure 11.6)Tamper evident Containers are closed and fitted with a device which Seal on creams before initial
reveals irreversibly that the container has been opened perforation (Figure 11.5)
Adapted from the British Pharmacopoeia, 2005
Figure 11.3 Single-dose vials of eye drops allow instillation of sterile drops at each point of administration.
of medication and is often supplied in a blisterpack (see Figure 11.6): the tablets are containedwithin a moulded plastic base layer and heat orpressure sealed with a thin foil layer. In addition,a patient information leaflet is supplied withinthe cardboard carton used to protect theblister pack. This combination of primary andsecondary packaging is the most commonly seenwhen dispensing medicines. Other materialsused for packaging are discussed below.
Paper
Paper has been used as a packaging material inpharmacy for longer than any other material.Although in modern day pharmacies paper isused largely as a secondary packaging materialas a carton to hold the primary packaging mater-ial, early medicines of dried herbs or mineralssuch as chalk were powdered and supplied inpaper packets. Indeed, paper has also been usedas part of the dosage form – unpleasant tastingpowders were sometimes taken wrapped in arice-paper wafer, softened by dipping in water,then swallowing with a draught of water. Thisidea was further developed in France byLimousin of Paris in the 1870s with the cachet,two rice-paper cups which were joined togetherwith powder inside; the early ancestor of thecapsule (RPSGB, 2007a).
Glass
Glass has been widely used as a primary pack-aging material and is particularly useful for liquidformulations, as it is rigid, has superior protectivequalities and allows for easy inspection of thecontents. It is also impermeable to air and mois-ture, does not react with most medicinal prod-ucts, and can be coloured in order to protect thecontents from light when required. Moreover, itis easy to clean, can be sterilised by heat andeven sealed to completely enclose a dosage form(e.g. injection liquids; see Figure 11.7). Glass formedicinal packaging is currently divided intofour main categories defined by the EuropeanPharmacopoeia (Council of Europe, 1991).
112 Chapter 11 • Packaging of medicines
Figure 11.5 A tamper-evident seal; the metal containeraround the product is continuous until first administrationby the patient, who breaks the seal using the point insidethe cap.
Figure 11.6 An example of a blister pack: tablets areheld in individual moulded pockets on a plastic strip, heatsealed in place with a foil cover.
Figure 11.4 A multidose vial for repeated administrationof the same medicine at different times.
• Type I – neutral or borosilicate glass. This isthe least chemically reactive type of glass andalso does not expand or crack on exposure totemperature changes. It is used mainly topackage fluids for injection.
• Type II – sodalime-silicate glass. This type ischemically treated so that the inside surfaceis as unreactive as Type I glass. It is usedlargely to produce containers for eye, ear andnasal drops. This type of glass may react withchemicals in the medicines and it is recom-mended they are used only once beforedisposal, because of the possibility of break-down of the internal surface layer.
• Type III – sodalime-silicate glass. This issimilar in composition to Type II glass, buthas lower alkali content. It contains somechemicals that may leach (move out of theglass) into the preparation it contains. It isused to package liquids dispensed fromWinchester bottles (large volumes of liquiddrug formulations) (see Figure 11.8) in phar-macies. Although it is of a lower quality thanTypes I and II glass, it is much cheaper toproduce and is therefore ideal for the quickturnover of large-volume liquid products.
• Type IV – sodalime-silicate glass. This glassis also similar in composition to Types II andIII, but has even higher capability to leachchemicals into the contained product. Itshould not be used to package materials for
injection, but is suitable for packaging solids(tablets) and semisolid formulations (creams,ointments).
Types of glass container commonly used inthe pharmacy
• Bottles can be amber metric medical bottlesor ribbed oval bottles. Amber bottles are usedto package a wide range of oral medications.Ribbed (or fluted) bottles are used to packagemedicinal products that should not be takenorally (e.g. menthol and eucalyptus inhala-tion) and were traditionally used to dispensepoisons. Historically, poison bottles weredistinguishable by touch by attaching sand-paper to the surface, by painting thick lineson the outer surface or even by attachingbells to them (RPSGB, 2007b). Preparations tobe dispensed in ribbed bottles are listed insection 1.2.7 of Medicines, Ethics and PracticeGuide for Pharmacists and Pharmacy Techni-cians. Pharmacists are advised to refer to thislist in the event of dispensing medicines intoa bottle, as it is updated every 6 months.Figure 11.9 shows some of the glassdispensing bottles commonly in use today.
• Dropper bottles (see Figure 11.10) are used tocontain medicinal products for application tothe eye, ear or nose, and are usually hexag-onal and fluted on three sides. They are fitted
Types of packaging materials 113
Figure 11.7 A selection of glass ampoules; ampoulesare sealed by heat fusing Type I glass, producing a singleunit dose that is protected from air and moisture. Colouredglass is used to protect light-sensitive medications.
Figure 11.8 Examples of Winchester dispensing bottles;pharmacists can dispense the volume of liquid prescribedfrom these bulk-packed medications.
with a combined cap, rubber teat and dropperas the closure mechanism.
• Jars (see Figure 11.11). Creams and ointmentsare supplied in wide-mouthed cylindricaljars in situations where contamination from
patients’ fingers will not affect the productstability.
• Ampoules (see Figure 11.7). Single-use injec-tions are often supplied in ampoules, ineither liquid or powder form. The neck ofthe ampoule provides a weak area where theglass can be snapped easily, allowing eitherwithdrawal of the solution by syringe, oraddition of a diluent in the case where theampoule contents require reconstitutionbefore administration.
• Multidose vials (see Figure 11.4) are used tostore injection solutions that will be usedmore than once. They are usually sealed witha rubber plug that is held in place by analuminium sealing ring (Winfield & Richards,2003).The bung is made of special materialthat can be pierced by needle many times,without any loss of sealing properties,allowing for continued protection againstmoisture and bacteria.
Plastic
Plastics have been widely used for several yearsas primary and secondary packaging for medi-cines. They come in many forms, includingrigid bottles that loose tablets and capsules aredispensed into, squeezable bottles for eye dropsand nasal sprays, jars, sachets, blister packs, and
114 Chapter 11 • Packaging of medicines
Figure 11.11 Jars for creams and ointments.
Figure 11.10 Dropper bottles for eye, ear or nose drops.The arrow indicates the combination cap closure used inmany dropper bottles, composed of a plastic screw threadcap, a rubber teat and the glass dropper.
Figure 11.9 Glass dispensing bottles come in a range ofsizes. Amber bottles are used for medicinal products thatare light-sensitive; clear bottles can be used for those thatare not light-sensitive. Ribbed or fluted bottles are used formedicinal products that should not be taken orally. Bottlescan be closed with child-resistant closures or normal caps.
infusion bags for the delivery of large volumesof fluid intravenously. Plastics are resistant tobreakage and can be made opaque in order toprotect light-sensitive medications. They aredivided into two classes: thermosets and thermo-plastics. Thermoset plastics are used for screwcaps for glass and metal containers. Thermoplas-tics are used for packaging such as rigid bottles(see Figure 11.1), flexible eye-drop bottles, heat-sealable containers (as used to seal some types ofMDS), intravenous solution bags and bottles,and containers for oils and creams.
Metal
Metal is often used in the form of a collapsiblemetal tube as a primary packaging material forcreams and ointments. The tubes are made fromaluminium, which remains collapsed as theproduct is used by the patient.
Aluminium foil is used in blister packaging(see Figure 11.6) to form a moisture-impermeablebarrier that protects tablets and capsules heldin plastic strips. Strip packaging of medicinessensitive to light and moisture involves sealingeach individual dosage unit (tablet or capsule)in a foil ‘pouch’ on a strip of 7–10 units. Thisindividual wrapping of the medicine protectsthe medicine from exposure to light and/ormoisture, which cause breakdown of the drug.Epilim tablets (which contain the anticonvul-sant sodium valproate, used to treat epilepsy) arepackaged in this way.
Closures
Closures are defined as part of medicines pack-aging material by the BP. They should providean effective seal to retain the dispensed medica-tions within the packaging, and also protect thecontents from contamination. The majority ofloose medication dispensed from a bulk supplyprovided by a manufacturer is packaged into aplastic or glass bottle with a CRC (the mostcommon ‘push down and turn’ cap is known asa ‘Clic Loc’). Use of a CRC is a professionalrequirement for dispensing solid and liquidmedications in the UK, but should not be
considered as an absolute barrier to children.Patients should always be advised to storemedications in a safe place that is out of thereach and sight of children.
Other closures include the rubber stopperused to seal multidose injection vials, whichreseals after perforation by a needle. It can alsoundergo heat sterilisation – once the medicationhas been placed into the vial by the manu-facturer and the rubber stopper inserted, thecomplete package is usually heat sterilised inorder to remove any bacterial contamination.
Environmental concerns
Packaging is obviously a necessity in order toallow safe transport and storage of medicationsfrom the manufacturer, via wholesalers, on todispensaries and ultimately to the patient. Ithas a negative impact on the environment inits consumption of raw materials and energyduring production, and ends up as waste mate-rial requiring suitable disposal. As yet, there isno requirement or facility in place for pharma-cies to dispose of pharmaceutical packaging.
Under the third essential service of the newPharmacy Contract (see Chapters 3 and 6), everypharmacy must provide facilities for the disposalof unwanted medicines. Pharmacists shouldremind patients to bring back unused medica-tions to the pharmacy for safe disposal.Unwanted medicines are disposed of via phar-maceutical waste specialists, contracted to thelocal health authority.
Practicalities of packaging
A large proportion of medicines that passthrough a pharmacy will require repackaging insome way. Patient packs are the exception tothis. Blister-packed tablets may need dispensinginto appropriately sized cartons; bulk liquidswill need decanting into bottles of differentvolumes; bulk quantities of loose tablets andcapsules will be transferred into plastic bottles ofa variety of sizes.
Practicalities of packaging 115
Factors to consider when choosingpackaging
Pharmacists need to consider many factorswhen choosing packaging materials for medi-cines dispensing.
Patient needs
The majority of patients will be able to useblister packs or CRC bottles with few problems.However, consider use by elderly patients orthose with poor manual dexterity; these patientsmay need you to transfer the tablets or capsulesfrom the blister packs into an MDS or simplyinto a plastic bottle with a non-CRC lid.However, pharmacists must then consider howthe stability of the tablets may be affected –changing the storage conditions of some medi-cines may make them unsuitable for use forpatients. For example, controlled-release sodiumvalproate tablets (Epilim, used to treat epilepsy)interact with moisture in the air as soon as theyare exposed to the atmosphere and within aweek contain a subtherapeutic dose of medica-tion. In this situation, patients should beadvised not to take tablets that have beenopened for more than 7 days.
If repackaging a medicine, choose appropri-ately sized packaging. If the prescription requiresonly a few tablets or capsules that are in a blisterpack, then choose a suitable sized dispensingcarton to package them in. A small number oftablets or capsules in a large box may possiblyrattle around, causing mechanical damage tothe dosage form and possible rendering themunsuitable for use. A prescription asking for100 mL calamine lotion should be dispensedinto the appropriately sized bottle, which isboth easier to transport and easier for thepatient to use when administering the lotion.
During the final packaging procedure, afterthe medication has been checked against the
prescription, the pharmacist should carefullypack the medication into a dispensing bag,ensuring that the bag bears the correct patient’sname. Placing medicine in the wrong bag couldresult in a patient taking the wrong medication,with potentially disastrous consequences.Remember to make the bag as anonymous aspossible. It is vital to consider patient confiden-tiality at all times; patients may not want otherpeople to know that they have medication, orwhat it may be for.
References
BPC (British Pharmacopoeia Commission) 2007.British Pharmacopoeia. London: Stationery Office.
Council of Europe (1991). European Pharmacopoeia: 6thedition. Luxembourg: 2007.
RPSGB (Royal Pharmaceutical Society of Great Britain)(2007a). Powders and cachets. Information sheet 8.www.rpsgb.org/pdfs/mussheet08.pdf (accessed 1May 2007).
RPSGB (Royal Pharmaceutical Society of Great Britain)(2007b). Dispensary bottles. Information sheet 12.www.rpsgb.org/pdfs/mussheet12.pdf (accessed 1May 2007).
Winfield A J, Richards R M E (2003). PharmaceuticalPractice, 3rd edn. Edinburgh: Churchill Livingstone.
Useful resources
British Pharmacopoeia Commission; provides onlineaccess to the full text of the British Pharmacopoeiafor registered users and links to other nationalpharmacopeias and regulatory agencies. www.pharmacopoeia.org.uk
Royal Pharmaceutical Society of Great Britain (2007).Medicines, Ethics and Practice Guide for Pharmacistsand Pharmacy Technicians, 31st edn. London:Pharmaceutical Press.
116 Chapter 11 • Packaging of medicines
Introduction
This chapter introduces labelling of medicinalproducts; at this stage the pharmacist needs toclearly pass on directions for use from theprescriber to the patient. Apart from the manylegal issues surrounding medications andlabelling requirements, you should by nowrealise the importance of communicating accu-rate information to patients. The informationsummarised on a label is available to the patientevery time they take a dose of a medicine.In addition to covering requirements fordispensing labels, this chapter also addresses thelegal (UK and European Union) and professionalrequirements for the labelling of medicinalproducts:
• dispensed medications• pre-packed bulk medications• chemists’ nostrums• manufacturers’ labels• medicines: general sales list (GSL), pharmacy-
only (P) and prescription-only medicines(POM)
• veterinary-prescribed medications.
Containers of medicinal products sold orsupplied in the UK must be labelled in accor-dance with the Medicines (Marketing Autho-risations and Miscellaneous Amendments)Regulations 1994 (OPSI, 2004). Medicinal prod-ucts classified as Schedule 2 or 3 controlleddrugs must also be labelled in accordance withthe Misuse of Drugs Regulations 2001 (OPSI,2001). The Medicines, Ethics and Practice Guide forPharmacists and Pharmacy Technicians providesthe most recently published information regard-ing the categorisation of medicines and changesto labelling requirements (RPSGB, 2007).
The primary purpose of good labelling isdefined by the Medicines and Healthcareproducts Regulatory Agency (MHRA) (2002) as‘. . . the clear unambiguous identification of themedicine and the conditions for its safe use’.
The importance of labelling
Labels are an important factor to consider inthe final presentation of a medication that willbe released to a patient. A clearly worded,
Introduction . . . . . . . . . . . . . . . . . . . . . 117
The importance of labelling . . . . . . . . . . 117
Labelling requirements for differentcategories of medicinal products . . . . . . 118
Manufacturers’ labelling requirements . . 120
Other labelling requirements . . . . . . . . . 123
Practicalities of labelling . . . . . . . . . . . . 123
References. . . . . . . . . . . . . . . . . . . . . . 123
12Labelling of medicines
Sam E Weston
117
professionally finished label, which is affixed inline with the edges of the container or packageof the medication, will give the patient confi-dence that the preparation of the medicationhas been handled in a professional manner.
A label can be considered as a mechanism forpassing on information from the physician tothe patient in the event of the medicine beingprescribed. It is used to identify who the medica-tion is for (patient’s name), what the product is(drug name, strength and pharmaceutical form),the date it was dispensed to the patient and asan aide memoir in how to take the medicationcorrectly (directions for use).
In the event the product has been passed frommanufacturer to the pharmacist, labels onoriginal packaging materials contain identify-ing details of the product stored within thecontainer, its date of expiry and licensing details.
From this, it can be seen that accuratelabelling is of the utmost importance. TheMHRA’s Best practice guidance on labelling andpackaging of medicines covers current labellingrequirements in depth (MHRA, 2007).
Labelling requirements for differentcategories of medicinal products
All labels must be written indelibly; the majorityare now computer generated and should there-
fore be easily legible. The following sectiondescribes the information required on labels fordifferent classes of medicines.
Dispensed medicinal products
A dispensed medicinal product is defined inseveral ways:
• a product prepared or dispensed by a pharma-cist
• a product prepared or dispensed by a physi-cian or prepared or dispensed in accordancewith a prescription supplied by a physician
• a product for use by human beings suppliedby a doctor or dentist to a particular patientunder their care, or to a representative of thepatient (e.g. a parent or carer).
The labelling requirements for such medicinalproducts are found in the Medicines (MarketingAuthorisations and Miscellaneous Amend-ments) Regulations 1994 (as amended in 2004).An adapted list of the legal requirements isprovided in Box 12.1 (see also Figures 12.1 and12.2).
The pharmacist should also take care with thewording of instructions on the label. The RoyalPharmaceutical Society of Great Britain haspublished a Working Party Report which madeseveral recommendations regarding the way inwhich directions for use should be worded
118 Chapter 12 • Labelling of medicines
Box 12.1 The legal requirements for labelling of medicinal products
• name of patient• name and address of supplier (usually the
dispensing pharmacy registered premises)• Date dispensed• the phrase ‘Keep out of reach and sight of
children’*• name, strength and pharmaceutical formulation of
the product• directions for use, such as ‘Shake the bottle before
use’ for liquids or suspensions• the phrase ‘For external use only’ within a box if
the medication is not a general sales list
medication and is an embrocation, liniment,lotion, liquid antiseptic or other liquid preparationor gel that is for external use only
• warning labels – these are usually producedautomatically by the electronic labelling softwareused to prepare labels for dispensed medications;a list of these can be found at the back of theBritish National Formulary in abbreviated form orin Appendix 9 in their full form
* Note that ‘and sight’ is added as good practice butis not a legal requirement
(RPSGB, 2001). For example, ‘take’ is more easilyunderstood by patients than ‘to be taken’; ‘apply’is preferred to ‘to be applied’. Also, the recom-mended directions for taking tablets and capsulesare: ‘Take one tablet/capsule twice each day’(rather than ‘Take one twice daily’). Research hasshown that inserting the dosage form between
the number of dosage units to be taken (one),and the frequency of administration (twice)ensured the patient did not mix up the twonumbers. Finally, the importance of verballycommunicating the information provided on thelabel directly to the patient should not be under-estimated. Best practice guidelines suggest that a
Labelling requirements for dif ferent categories of medicinal products 119
28 Flucloxacillin Capsules 50MG
Take ONE tablet dailyOne hour before food or on empty stomach
Do not stop taking this medicationexcept on your doctors advice
Keep out of reach of children
Mr J Bloggs 12 May 2007
The Pharmacy, 1 High StreetSomewhere. Tel: 0118 456 7890
Quantity Drug name, strength, dosage form
Keep out of reach of children
Patient’s name Date of dispensing
Registered address of pharmacy
Directions for use
Warning labels
Figure 12.1 An example of a dispensing label, showing the layout of information seen on most labels on dispensedmedication.
28 Atenolol 50 mg
Take ONE tablet daily
Do not stop taking this medicationexcept on your doctor’s advice
Keep out of reach of children
Mr J Bloggs 12 May 2007
The Pharmacy, 1 High StreetSomewhere. Tel: 0118 456 7890
Figure 12.2 A sample dispensing label for a medicinal product. The information is clear and concise for the patient tounderstand easily.
pharmacist should consult with a patient whohas not taken a particular medication before, inorder to ensure that they understand how to takethe medication. This consultation also providesthe patient with the opportunity to ask any ques-tions about any concerns they might have abouttheir illness or possible side-effects from theirmedication, and contributes to the process ofconcordance (discussed in Chapter 14).
Prepacked bulk medications
As mentioned in Chapter 11, some medicinesare packaged by manufacturers in large bulkcontainers, which are then used as stock fromwhich pharmacists dispense. In some dispensariesthese bulk stocks are packed down into moreeasily handled amounts for dispensing againstprescriptions – a term known as ‘assembly’.Medicines repackaged in this way require labelsto contain the following information:
• name of product• ingredients of product• quantity in container• special requirements with regard to handling
or storage• expiry date• batch number (starting with the letters ‘BN’).
Before dispensing to a patient, these medicinesmust be relabelled according to the requirementsfor dispensed medications (Box 12.1).
Chemists’ nostrums
A ‘nostrum’ is rather unflatteringly defined in theOxford English Dictionary as a ‘quack remedy orpatent medicine, usually of secret ingredient,with unproven efficacy’. The preparation ofchemists’ nostrums, which remain popular withmany patients, and their sale or supply must becarried out under the supervision of a pharma-cist. The label of the container of these medicinalproducts must show the following details:
• name of the product• the pharmaceutical form: ingredients –
including concentrations and strengths – andquantity
• directions for use• handling and storage requirements• the phrase ‘Keep out of reach and sight of
children’• the phrase ‘Warning. Do not exceed the
stated dose.’ in a box (this is necessary whereone or more of the ingredients is a POM thathas been used in such a way as to allow it tobe used without POM restrictions)
• the name and address of the registered phar-macy
• the letter ‘P’ in a box (to indicate that a phar-macist must be present when it is dispensed).
Some examples of chemists’ nostrums include‘Turlington’s Balsalm of Life’ – an alleged ‘cure-all’ that could be taken internally or rubbed onto affected parts of the body to relieve pain inthe joints, and ‘Robertson’s Infallible WormDestroying Lozenges’ – which could be used atone dose by humans and at a higher dose fortreating horses.
Manufacturers’ labelling requirements
The labelling requirements for manufacturedmedications are comprehensive and are definedby the Medicines (Marketing Authorisations andMiscellaneous Amendments) Regulations 1994(as amended in 2004). Figure 12.3 shows a sampleof the information that would be contained on amanufacturer’s bulk supply of a POM. At the timeof writing the legal requirements include:
• name, strength and pharmaceutical form ofthe medicine
• ingredients – quantities of each excipientincluded in the dosage unit
• quantity of product – by weight, volume ornumber of doses contained within thepackaging
• a list of all excipients with a known pharma-cological effect
• the method or route of administration of theproduct
• warning ‘keep out of reach and sight ofchildren’
• any special warnings required by the market-ing authorisation for the product concerned
120 Chapter 12 • Labelling of medicines
• the expiry date of the product, clearly statingmonth and year
• any special storage details• any information about special disposal
requirements• name and address detail of the market autho-
risation holder and any number as allocatedby the licensing authority
• manufacturer’s batch reference.
Manufacturers are also encouraged to label prod-ucts with a summary of product characteristics,useful for health education purposes. Labellingof a promotional nature is not permitted. Inaddition these labels must contain informationpresented in a legible format that is easily under-stood by all of those involved in its supply anduse, and this information must be in English(and one or more additional languages; the sameinformation must be reproduced in all languagesused).
General sales list products
Medicinal products that are available as GSLproducts (i.e. sold in other retail outlets in addi-tion to pharmacies) and that contain aloxiprin,paracetamol or aspirin require the followinglabels on the packaging:
• if containingaloxiprin,paracetamoloraspirin,the words ‘If symptoms persist, consult yourdoctor’ and details of the recommendeddosage
• if containing aloxiprin, the words ‘Containsan aspirin derivative’
• if containing aspirin, the words ‘Containsaspirin’
• if containing aloxiprin or aspirin, the words‘Do not give to children under the age of 16years, unless on the advice of a doctor’ – aspirinand its derivatives are not recommended forchildren under 16 years of age because of anassociation with Reye’s syndrome; this infor-mationshouldalsobecontainedonthepatientinformation leaflet (PIL)
• if containing paracetamol, the words‘Contains paracetamol’
• if the medicine is paracetamol-based and isintended to be used for children under 12years of age, the warnings ‘Do not give withany other paracetamol-containing product’and ‘Immediate medical advice should besought in the event of an overdose, even ifthe child seems well, because there is a risk ofdelayed, serious liver damage’ – the latter partof this information can be contained on thePIL one is supplied with the product
• if the medicine is paracetamol-based andintended to be used for adults, the warnings
Manufacturers’ labelling requirements 121
Drug name, strength, dosage form Quantity
Expiry mm/yy
Batch number
Ingredients – active
Ingredients – excipients
Route of administration
Warnings – e.g. store at 2–8°C
Disposal instructions – e.g. not for incineration
Keep out of reach of children Manufacturer’s details
POM
Figure 12.3 An example of the information required on a manufacturer’s label for the bulk supply of a prescription-onlymedicine (POM).
‘Do not take with any other paracetamol-containing product’ and ‘Immediate medicaladvice should be sought in the event of anoverdose, even if you feel well, because thereis a risk of delayed, serious liver damage’;the latter part of this information can becontained on the PIL if one is supplied withthe product
• any product containing paracetamol shouldcarry the label ‘Do not exceed the stated dose’,positioned next to the dosage instructions.
Pharmacy medicines
Medicinal products for sale as ‘P’ medicines (forsale only under the supervision of a pharmacist),must carry the following labels on the packaging:
• the packaging must contain the letter ‘P’ in abox
• if the medicinal product contains aloxiprin,aspirin or paracetamol, the same labellingrequirements that apply to GSL medicinesapply
• if the product contains a POM in a quantitythat allows it to be exempt from POMcontrols, the label ‘Warning. Do not exceedthe stated dose’ must be on the packaging
• if the product contains ephedrine (or anyof its salts), or is to be used for the treat-ment of asthma or conditions associatedwith bronchial spasm, the label ‘Warning.Asthmatics should consult their doctorbefore using this product’ should be on thepackaging
• products containing ingredients that maycause drowsiness should be labelled with thephrase ‘Warning. May cause drowsiness. Ifaffected do not drive or operate machinery.Avoid alcoholic drinks’
• any embrocation, liniment, lotion, liquidantiseptic or other liquid preparation or gelfor use on the skin should contain the label‘For external use only’
• products containing hexachlorophane (e.g.some alcohol-free hand sanitisers) must belabelled with the phrase ‘Not to be used forbabies’ or a warning that it should not be used
in children under 2 years of age (hexachloro-phane has the potential to cause brain damageduring the early stages of child development).
Prescription-only medicines
Many of the labelling requirements for POMshave been addressed in earlier sections of thischapter. In addition, packaging should containthe following labels:
• the letters ‘POM’ in a box• ‘For external use only’ if the medication is to
be used on the surface of the skin• if the product contains hexachlorophane, the
warning label ‘Not to be used for babies’ or awarning that the product is not to be admin-istered to children under 2 years of age.
Veterinary products
In 2002 the Competition Commission publisheda report on veterinary medicines which outlineda monopoly situation in which veterinarianswere prescribing and supplying medicines toowners of pets. Recommendations have there-fore been made to encourage the supply ofveterinary medications from pharmacies, andpharmacists are increasingly being presentedwith veterinary prescriptions. Containers ofmedicines dispensed for animal use must show:
• the name of the person controlling theanimal/herd
• the address of the location where theanimal/herd resides or the named person’saddress
• the name and address of the supplier• date dispensed• directions for use• the phrase ‘Keep out of the reach and sight of
children’ • the phrase ‘for animal treatment only’• at the request of the veterinary surgeon, the
label should contain details of:– product name– directions for use– precautions.
122 Chapter 12 • Labelling of medicines
In the event that the medicinal product is beingsupplied in bulk form, containers of medicinessupplied for animal use must show:
• product name• quantities of various ingredients• quantity of dosage units supplied• directions for use• contraindications, warnings and precautions• the phrases ‘For animal treatment only’ and
‘Keep out of reach and sight of children’• an appropriate withdrawal period before
slaughter (if necessary)• handling and storage requirements• expiry date• marketing authorisation number• batch reference number• manufacturer’s name and address• species of animal for which it is to be used• legal classification (e.g. ‘P’, POM, pharmacy
and merchants’ list (PML), GSL, medicatedfeedingstuff medicine (MFS), MFS exemptedfrom prescription-only status (MFSX)
• any further information required by themarketing authorisation licence.
Other labelling requirements
In the event that a medication is dispensedusing emergency supply procedures, the words‘Emergency supply’ must appear on the label.The Medicines, Ethics and Practice Guide forPharmacists and Pharmacy Technicians providesdetails of the procedure to be followed when amedication is supplied on an emergency supplybasis. In the case of a private prescription beingdispensed, a reference number corresponding tothe relevant entry in the private prescriptionsregister should appear on the label.
Practicalities of labelling
The following factors should be considered withdispensed medications – the area in which the
pharmacist has the most influence in labellingmedicinal products.
• Who will read the label: Is their visionimpaired? Do they read English? Translationsof many patient information leaflets are avail-able to the pharmacist (for printing) frommanufacturers’ websites. The Royal NationalInstitute for the Blind Medicine InformationLine (http://xpil.medicines.org. uk/RNIBInfo;telephone 0800 198 5000) provides patientinformation leaflets in large clear format orBraille; in addition, patients can have apatient information leaflet read to them overthe telephone.
• Where will the label will be placed? Don’tobscure important manufacturer’s informa-tion (e.g. expiry date, storage conditions, etc.).
• Which part of the medicine will be labelled?For example, for ointments, creams andinhalers, should the label go on the tubeor the box? Best practice suggests doublelabelling of products that come in an externalpackage, so that both the box and the iteminside are labelled, in order to ensure thatpatients retain a label with instructions evenif they discard external packaging.
References
Competition Commission (2002). Veterinary Medicines:A report on the supply within the United Kingdom ofprescription-only veterinary medicines Volumes 1 & 2. –www.competition-commission. org.uk/rep_pub/reports/2003/478vetmeds.htm (accessed 11 May 2007).
Medicines and Healthcare products Regulatory Agency(MHRA) (2002). www.mhra.gov.uk (accessed 8 May2007).
Medicines and Healthcare products Regulatory Agency(MHRA) (2007). Labels, patient information leafletsand packaging for medicines. www.mhra.gov.uk/home/idcplg?IdcService�SS_GET_ PAGE&nodeId�
164 (accessed 9 May 2007).Office of Public Sector Information (OPSI) (2001).
Statutory Instrument 2001 No. 3998. The Misuse ofDrugsRegulations2001.www.opsi.gov.uk/si/si2001/20013998.htm (accessed 8 May 2007).
Office of Public Sector Information (OPSI) (2004).Statutory Instrument 2004 No. 3224. The Medicines
References 123
(Marketing Authorisations and MiscellaneousAmendments) Regulations 2004. www.opsi.gov.uk/si/si2004/20043224.htm (accessed 8 May 2007).
Royal Pharmaceutical Society of Great Britain (RPSGB)(2001). The Way Forward in the New Millennium.Report of the Royal Pharmaceutical Society’s Working
Party on Drug Delivery. www.rpsgb.org/pdfs/sciwpdrugdel-i.pdf (accessed 9 May 2007).
Royal Pharmaceutical Society of Great Britain (RPSGB)(2007). Medicines, Ethics and Practice Guide forPharmacists and Pharmacy Technicians, 31st edn.London: Pharmaceutical Press.
124 Chapter 12 • Labelling of medicines
What is extemporaneous dispensing?
The word ‘extemporaneous’ is derived from theLatin ‘ex tempore’ meaning ‘on the spur of themoment’. The Oxford English Dictionary defini-tion is ‘spoken or done without preparation’(Oxford University Press, 2005). In pharmacy,it refers to the preparation of small quantitiesof a medicine from its constituent ingredients(Winfield & Richards, 2004).
Most pharmaceutical products are now madein large-scale manufacturing facilities, with highstandards of quality assurance. It is not possiblefor individual pharmacies to match these stan-dards and so it is preferable for a licensedmedicine to be prescribed and dispensed fromcommercial stocks rather than for an extempo-raneous preparation to be made. Indeed, theMedicines, Ethics and Practice Guide for Pharma-cists and Pharmacy Technicians specifies that alicensed product must always be prescribed anddispensed when one is available. It is neverthelessimportant that pharmacists learn and maintainthe skills required to make extemporaneouspreparations, or ‘extemps’, as they are oftenreferred to. This chapter describes some of the
techniques used in the manufacture of somerelatively commonplace extemporaneous pre-parations: oral liquids (e.g. suspensions andsyrups) and topical semisolids (e.g. creams andointments).
Legal factors involved inextemporaneous preparation
Standards for extemporaneous preparation andcompounding are set out in the Medicines, Ethicsand Practice Guide for Pharmacists and PharmacyTechnicians, and are outlined in Box 13.1.
Where possible, all calculations and measure-ments should be double checked by a secondappropriately trained member of staff., exceptwhere methadone mixture is prepared extempor-aneously in accordance with Appendix 1 (avail-able at www.rpsgb.org.uk/protectingthepublic/ethics/).
The Medicines, Ethics and Practice Guide forPharmacists and Pharmacy Technicians (RPSGB,2007) should be consulted for the most currentlegal guidelines, which are often subject tochange or amendment.
What is extemporaneous dispensing?. . . 125
Legal factors involved inextemporaneous preparation. . . . . . . . . 125
Liquid preparations . . . . . . . . . . . . . . . 126
Topical semisolids. . . . . . . . . . . . . . . . . 127
The practice of extemporaneouspreparation . . . . . . . . . . . . . . . . . . . . . 128
Dispensing extemporaneouspreparations . . . . . . . . . . . . . . . . . . . . 133
References. . . . . . . . . . . . . . . . . . . . . . 133
13Extemporaneous dispensing: a beginner’s guide
Sam E Weston and Kate E Fletcher
125
Liquid preparations
Oral liquids
An oral liquid is a preparation containing one ormore active ingredients in a suitable vehicle andis intended to be swallowed (Lund, 1994). Thethree main types of oral liquids are solutions,suspensions and emulsions. A few oral liquidsmay be a pure liquid that is the activeconstituent (e.g. liquid paraffin).
Advantages of oral liquids
Oral liquids are generally easier to swallow thana solid dosage form such as a tablet or capsule,and the active constituent is absorbed morerapidly from the gastrointestinal tract. Liquids
can be particularly useful for children, theelderly, and patients with conditions such asParkinson’s disease because of relative ease oftaking the preparation.
Disadvantages of oral liquids
Bottles of liquid can be bulky and heavy and aretherefore less portable than tablets and capsules.Glass bottles are also prone to breaking if nothandled carefully. It is more difficult to mask theunpleasant taste of some medications in a liquidthan in a solid dosage form, and liquids are lessstable, both microbiologically and chemically(Lund, 1994). The liquid must be measured care-fully by the patient to ensure the correct dose istaken, which some patients might find difficult,particularly if they have conditions that affectmanual dexterity, such as rheumatoid arthritis.
126 Chapter 13 • Extemporaneous dispensing
Box 13.1 Extemporaneous preparation or compounding standards as set out in the Medicines, Ethics andPractice Guide for Pharmacists and Pharmacy Technicians
This standard is not intended to cover the reconstitutionof dry powders with water or other diluents. Patientsare entitled to expect that products prepared extempor-aneously in a pharmacy are prepared accurately andare suitable for use. If you wish to be involved in extem-poraneous preparation you must ensure the following.
1. A product is extemporaneously prepared onlywhen there is no product with a marketingauthorisation available and where you are able toprepare the product in compliance with acceptedstandards.
2. You and any other staff involved are competent toundertake the tasks to be performed.
3. The requisite facilities and equipment areavailable. Equipment must be maintained in goodorder to ensure that performance is unimpaired,and must be fit for the intended purpose.
4. You are satisfied as to the safety andappropriateness of the formula of the product.
5. Ingredients are sourced from recognisedpharmaceutical manufacturers and are of a qualityaccepted for use in the preparation andmanufacture of pharmaceutical products. Whereappropriate, relevant legislation must be compliedwith.
6. Particular attention and care is paid to substanceswhich may be hazardous and require specialhandling techniques.
7. The product is labelled with the necessaryparticulars, including an expiry date and anyspecial requirements for the safe handling orstorage of the product.
8. If you are undertaking large-scale preparation ofmedicinal products, all relevant standards andguidance are adhered to.
9. Records are kept for a minimum of 2 years. Therecords must include:
• the formula• the ingredients• the quantities used• their source• the batch number• the expiry date• where the preparation is dispensed in response
to a prescription, the patient’s and prescriptiondetails and the date of dispensing
• the personnel involved, including the identity ofthe pharmacist taking overall responsibility.
Oral solutions
There are several different types of oral solutions(Lund, 1994; Winfield & Richards, 2004).
• An elixir is a clear flavoured liquid thatcontains one or more active ingredientsdissolvedinavehiclecontainingahighpropor-tion of sucrose or a polyhydric alcohol or alco-hols (containing more than one hydroxylgroup). Elixirs may also contain ethanol,which means that the majority of theseproducts are considered less suitable forprescribing. An example is Chloral Elixir,Paediatric BP, used for the short-term treat-ment of insomnia in children.
• A linctus is a viscous liquid used to treatcough. Linctuses contain a high proportionof sucrose, other sugars or a suitable poly-hydric alcohol or alcohols. To have a fullsoothing effect on a cough, a linctus shouldbe sipped and swallowed slowly, and mustnot be diluted. An example of a commonlydispensed linctus is Simple Linctus BP, usedfor the symptomatic relief of dry ticklycoughs.
• A mixture describes a pharmaceutical oralsolution or suspension, for example Magne-sium Trisilicate Mixture BP (which is used torelieve the symptoms of indigestion andheartburn).
• Oral drops are oral solutions (or suspensions)that are to be administered in small volumes,using a suitable measuring device, oftencalled a ‘dropper’. For example, Cipramil®oral drops are used to treat depressive illnessand panic attacks.
• Syrups are aqueous solutions that containsugar. An example of a syrup is TenorminSyrup, a beta-blocking drug that is used totreat hypertension, angina and arrhythmias.
Oral suspensions
A suspension contains one or more active ingre-dients suspended in a suitable vehicle. Thesuspended particles will often settle on standing,but can usually be redispersed easily by shaking(e.g. Trimethoprim suspension, an antibiotic).
Oral emulsions
Oral emulsions are oil-in-water dispersions, andone or more active ingredients are dissolved inone or both phases of the dispersion. Emulsionsare a useful formulation in which to presentwater-insoluble or unpalatable drugs, as thetaste can be masked with a more pleasant tastingflavouring (Lund, 1994).
Liquids for other pharmaceutical uses
Liquids are also formulated for topical applica-tion for use in body cavities such as the nose,mouth or ears, or on the surface of the skin.Examples include nasal drops, mouthwashes,ear drops, soaks, lotions, paints, tinctures andliniments. Liquid formulations can be adminis-tered rectally, as an enema.
Topical semisolids
Topical semisolids are designed to have a localtherapeutic effect at the site of application tothe skin or mucous membranes. They come inseveral pharmaceutical formulations, describedbelow.
Creams
A cream is a viscous semisolid, which can beeither an oil-in-water emulsion (aqueous cream)or water-in-oil emulsion (oily cream). They areused to deliver drug on to the skin, allowing thedrug to be delivered very closely or directly tothe required site of action.
Ointments
As well as delivering a drug to the skin, oint-ments have the added benefit of being moreeffective emollients than creams (i.e. softeningor soothing the skin) because they tend to bemore greasy. This is because they generallycontain a higher quantity of oil-based products
Topical semisolids 127
than creams. Because ointments are greasy, theyoften contain a surfactant (a substance thatreduces the surface tension of the product)allowing them to be washed off more easily.Ointments are often used for delivery of medica-tion to deeper layers of the skin, such as thedermis or subcutaneous layer, as ointmentscause hydration of the skin, increasing thepermeability of the skin to drug molecules.
Gels
Gels are usually aqueous in nature and are usedas lubricants, for example to lubricate the probeof an ultrasound machine, or to deliver a drug tothe surface or deeper layers of the skin.
Pastes
A paste is a semisolid vehicle with a large concen-tration of solid material added. Pastes are there-fore relatively thick, so they do not spread easily,which can result in localised drug delivery;this has advantages in that the drug is not deliv-ered to healthy areas of the skin. For example,Magnesium Sulphate Paste BP used as a ‘drawing’poultice for boils can be irritant when applied tohealthy skin.
The practice of extemporaneouspreparation
‘The pestle and mortar days of preparing medi-cines have been overtaken by pharmaceuticalindustrial technology . . .’ (Roberts, 1988). Thisgloomy statement reflects the current position ofcompounding or extemporaneous preparation incommunity pharmacy, but not in hospital phar-macy. Whereas the traditional image of extem-poraneous preparation conjures up images ofcreams and unguents mixed patiently by hand(adding ingredients and ensuring thoroughmixing, before careful packing into colouredjars and bottles for presentation to the patientwith an enigmatic label of ‘The Ointment’),
extemporaneous preparation is a thrivingactivity in hospital pharmacies. For example,many patients receiving intravenous chemo-therapy for cancer treatment have a ‘custom-made cocktail’ of medication prepared for themon an individual basis by specially qualified phar-macy staff. Chapter 4 outlines the roles ofmembers of the pharmacy team involved in suchpreparation. Patients receiving parenteral nutri-tion may have deficiencies of particular essentialnutrients that can be added to the infusion bags,which are prepared on a daily basis.
This section of Chapter 13 introduces theequipment used in small-scale extemporaneouspreparation and the techniques used in themanufacture of medications, and outlines someof the challenges facing pharmacists involved inthis area of pharmacy practice.
Compounding equipment
This section outlines the five principal itemsof equipment required for extemporaneouspreparation:
• balances – for weighing ingredients• measuring cylinders – for accurate checking
of volumes of liquid ingredients• mortar and pestle – for reducing particle size
of solid ingredients, and for mixing emulsions• ceramic or glass slab and palette knife or
spatula – for thorough mixing of creams andointments
• heat sources – to melt solid ingredients forincorporation into other solid ingredients.
Balances
Originally, balances used in dispensing consistedof Class B balances (Figure 13.1), which are stillused today in the majority of community phar-macies for weighing powders and other solidsin the range 10–100 g. Quantities larger thanthis are more commonly weighed on a top-panbalance (also known as a Class II balance)(Figure 13.2). Newer balances, such as these top-pan balances, must be calibrated in metric unitsand marked with maximum and minimumweights that can be measured accurately.
128 Chapter 13 • Extemporaneous dispensing
Quantities of less than 10 g should only bemeasured using a Class I balance (Figure 13.3),although these are rarely found in a communitypharmacy setting.
Measuring cylinders
Conical measures (Figure 13.4) are used todispense liquids, although they can be less accu-rate than cylindrical measures if not used appro-priately. This is because cylindrical measureshave regular graduations, marked in individualmillilitre measurements, whilst conical measuresoften have uneven divisions in their graduations(Figure 13.4). It is important to understand thecorrect measuring technique in order to ensurethat the correct volume of liquid is dispensed.The level of the liquid should be read from thebottom of the meniscus (see Figure 13.5) with themeasure placed on a flat horizontal surface, andwith the eye level parallel to that of the liquid’ssurface.
When pouring the liquid into the dispensingbottle, the cylinder should be allowed to drainthoroughly. Significant quantities of the liquidmay adhere to the sides of the measure (espe-cially if the liquid is viscous) and can thereforebe lost in transfer. Where possible, only use asingle cylinder or conical measure to dispense aliquid, as this significantly reduces error margins
The practice of extemporaneous preparation 129
Figure 13.1 A Class B balance used for weighing smallquantities of powders.
Figure 13.2 A top-pan balance used for measuring morethan 10 grams of an ingredient.
Figure 13.3 A Class I balance used to measure less than10 grams of an ingredient.
– liquids will adhere to the inner surface of ameasure, so using more than one measureincreases the volume of liquid that will not bedispensed.
Always select the smallest measure possible tocontain the required volume of liquid as thisalso reduces error margins. The use of a largecylinder to measure a small volume of liquidincreases the surface area that the liquid musttravel across before it reaches the dispensing
bottle, increasing the potential for the liquidto adhere to the inner surface. In the case ofmeasuring highly viscous liquids (e.g. glycerol),it is a good idea to measure an excess of theliquid required, and then pour off the volumerequired into a dispensing bottle, leaving justthe excess volume in the measuring cylinder.Don’t forget to allow the liquid time to drainback down the sides of the measure to ensurethat the correct volume has been dispensed.
Two rules of good practice should be observedwhen measuring liquids.
• When pouring from a stock bottle, hold thelabel away from the edge from which youare pouring. This will ensure that the labelis not damaged or spoiled by liquids thatmay run down the outside of the bottle(see Figure 13.6). In the event that a labelbecomes damaged or hard to read, the labelshould be replaced immediately. This ensuresthat anyone using the stock bottle knowswhat it contains, and the expiry date andbatch numbers of the product.
• Hold the cap of the stock bottle in your handwhilst pouring out the required volume. Thispractice ensures that you put the right capback on the right bottle, particularly as youmay be using more than one liquid. If thewrong cap is put back on a bottle, the bottlemust not be used for any further dispensing,as the contents may have been contaminatedby any liquids on the inner surface of the cap.
130 Chapter 13 • Extemporaneous dispensing
Figure 13.4 A selection of measuring cylinders andconical measures.
Figure 13.5 The volume is read from the bottom of themeniscus.
Figure 13.6 Correct pouring technique: protecting thelabel from spillage or drips.
All measures for liquids used in dispensingprocedures must comply with the Weights andMeasures Regulations (OPSI, 1994) and bestamped as such.
Mortar and pestle
Historically, the piece of equipment mostcommonly associated with the pharmacist is themortar (bowl) and pestle (pounding device)(Figure 13.7), used to reduce the size of solidparticles, mix powders, mix powders withliquids and prepare emulsions. Two types arecurrently available.
• Glass mortar and pestle combinations aresmall and are only suitable for size reductionof crystalline materials, given their smoothsurface and low friction. They are ideal forpreparations that contain dyes or that stain(e.g. iodine) as the surface does not becomediscoloured by absorption of the material.
• Porcelain (or composition) mortar andpestle combinations are normally muchlarger than the glass versions and have arougher surface. They can be used for sizereduction, mixing solids and liquids andpreparing suspensions and emulsions.
Different sorts of mortar and pestle are available,and it is important to select a ‘matching pair’.Some mortars are flat bottomed, whilst othersare rounded. The ends of pestles can be flattenedor rounded. In order to get the greatest sizereduction with the least effort, a flat mortarshould be used with a flat pestle. Rounded
combinations are more effective for combiningsolids with liquids.
The correct method of combining the ingredi-ents should also be considered.
• If two small quantities of roughly the samesize are to be combined, the ingredients canbe added to a suitably sized mortar and mixedwell.
• If a small quantity of powder is to be added toa larger quantity of a second ingredient, theprocess of ‘doubling up’ is used, to ensureeven dispersion of the ingredients. To do this,the smaller quantity is put in the mortar first.Approximately three times as much of thesecond ingredient is then added and the twomixed carefully using the pestle. Once thesetwo ingredients have been sufficiently wellcombined, a further quantity of the secondingredient is added (roughly the samevolume as that already in the mortar). Thisshould then be mixed carefully using thepestle. This process should be repeated untilall the larger quantity has been added.
Box 13.2 provides some hints and tips onworking with powders.
Slab and palette knife/spatula
The slab (which may be glass or ceramic) andpalette knife or spatula (Figure 13.8) are used
The practice of extemporaneous preparation 131
Figure 13.7 A selection of mortars and pestles.
Box 13.2 Hints and tips for working with powders
• If powdered ingredients have become clumpedor gritty, sieve before use with a 180 µm sieve.
• Powders containing a lot of moisture (e.g.starch) should be dried carefully to improvemixing properties.
• If combining a coloured material into a palebase, break down the coloured materialcarefully first using a mortar and pestle,otherwise the product may appear speckled.
• Whilst ‘doubling up’, make sure there is two orthree times the volume of base to powder toavoid ‘crumbling’ of the final product.
when combining semisolids into a single prepa-ration, in a process known as trituration, used,for example, in the preparation of an ointment.In this process, powders that have been finelyground in a mortar and pestle can be combinedwith a cream or ointment base (e.g. menthol inaqueous cream, used for the relief of itchingfrom allergic reactions or chickenpox). Thepowdered crystals and the cream base are placedon the slab and combined using the doubling upprocedure described above (see Mortar andpestle). The powdered crystals are rubbed inusing the palette knife to ensure even distribu-tion throughout the cream. This processcontinues until all the crystals have been added.Once the mixing process has been completed,the cream can be smoothed out into a very thinlayer so that any large particles can be easily
seen and the mixing process resumed until nosolid particles are visible to the naked eye (Figure13.9).
Heat sources
It is rare in today’s pharmacies for a pharmacistto need a heat source to produce an extempor-aneous product. In the event that such a productis prescribed for a patient, the pharmacist wouldnormally order it from a ‘specials’ manufacturer.(A list of special-order manufacturers is providedat the back of the British National Formulary.) Thissection provides a brief overview of heat sourcesused during the preparation of extemporaneouspreparations, as you may be expected to makesuch products during your undergraduatetraining. Box 13.3 provides some hints and tipson heating.
An excess quantity of the product required fordispensing should be made, as some materialwill inevitably be lost during transfer into thedispensing container – a 10% excess of theproduct should allow for this problem.
• Bunsen burners (Figure 13.10) are used tomelt small amounts of solids (e.g. mentholcrystals) directly in a test tube, or to heat asmall water bath mounted on a tripod. Formost extemporaneous preparations, a coolflame is sufficient to melt the solid, so thefierce blue flame is not required. When not in
132 Chapter 13 • Extemporaneous dispensing
Figure 13.8 Glass slab and palette knives used fortrituration.
Figure 13.9 A well combined cream (left) – all the ingre-dients are combined homogeneously, creating a smoothcream – and a poorly combined cream (right) – note thesplitting (separation) of the constituents.
Figure 13.10 A Bunsen burner. In the ‘on’ position it hasa blue flame and in the ‘standby’ position it has a highlyvisible orange flame.
use, the Bunsen burner should be turned off,or set to the orange or pilot flame so that itcan easily be seen.
• Water baths (Figure 13.11) are used whenmelting large quantities of solids, usually inthe preparation of creams and ointments.The ingredients to be melted are usuallyplaced in a porcelain basin and placed in thewater at a temperature of 60–80°C to avoidrisk of scalding.
• Electric hot plates (Figure 13.12) have theadvantage that it is easy to control thetemperature. In addition, many electric hotplates have a built-in magnetic stirrer sothe addition of a ‘magnetic flea’ allows forconstant stirring if two or more solids have tobe incorporated into the product.
Dispensing extemporaneouspreparations
This chapter outlines the methods and proce-dures that you will use during your degreecourse, and defines forms of extemporaneouspreparation that are commonly seen in pharma-cies today. You are encouraged to learn and usethese techniques, even though they are notused often in today’s community pharmacysetting. The discipline and accuracy developedin this exciting part of your undergraduatestudies can be applied to many other parts ofthe everyday practice carried out in pharmacy.Pharmaceutical Compounding and Dispensing(Marriot et al., 2006) is a comprehensive text onextemporaneous preparation and covers in greatdetail other factors that should be consideredby a pharmacist involved in extemporaneouspreparation of medications.
References
Lund W (1994). The Pharmaceutical Codex, 12th edn.London: Pharmaceutical Press.
Marriot J, Wilson K, Langley C, Belcher D (2006)Pharmaceutical Compounding and Dispensing.London: Pharmaceutical Press.
Oxford University Press (2005). Compact Oxford EnglishDictionary of Current English, 3rd edn. Oxford:Oxford University Press.
Dispensing extemporaneous preparations 133
Box 13.3 Hints and tips on heating
• When melting ingredients to make a cream,ensure all ingredients are heated to about thesame temperature before combining.
• Mix slowly and carefully during cooling, toavoid incorporation of air into the product,which will show up as air bubbles in your ‘set’product.
• If a product is cooled too rapidly, materials ofdifferent melting points will separate out, givingyour final product a granular appearance.
Figure 13.11 A water bath used for melting large quan-tities of solid ingredients.
Figure 13.12 An electric hot plate with magnetic flea(stirrer), which allows for constant gentle stirring.
Roberts D (1988). Dispensing by the community phar-macist: an unstoppable decline? J R Coll Gen Pract38: 563–564.
Royal Pharmaceutical Society of Great Britain (2007).Medicines, Ethics and Practice: A Guide for Pharma-cists and Pharmacy Technicians, 31st edn. London:Royal Pharmaceutical Society of Great Britain.
OPSI (1994). Statutory Instrument 1994 No. 1258. TheWeights and Measures (Packaged Goods) (Amendment)Regulation. London: Stationery Office. Availableat: www.opsi.gov.uk/SI/si1994/Uksi_19941258_en_1.htm
Winfield A J, Richards R M E, eds (2004). PharmaceuticalPractice, 3rd edn. Oxford: Churchill Livingstone.
134 Chapter 13 • Extemporaneous dispensing
Introduction
Medicines are one of the most frequently usedinterventions in UK health care, and their use isincreasing every year. In 2006, 752 millionprescription items were dispensed in Englandalone (The Information Centre, 2006a), which isequivalent to every person in England collecting14 prescription items in a year (The InformationCentre, 2006b). This is an increase of 40% since1995, when an average of 10 prescription itemsper person were dispensed in England. Themajority of these medicines were dispensed toolder patients: equivalent to 38 prescriptions perperson aged 60 years or over in 2005, nearlydouble the number dispensed in 1995.
Medicines represent a significant cost to theNational Health Service (NHS); £10.3 billion wasspent on medicines in 2005, equivalent to £200per person (The Information Centre, 2007).Over three-quarters of this cost is for medicinesdispensed in primary care; 90% of prescriptionswere dispensed free of charge to patients.
Although medicines are one of the mostfrequently used interventions in the developedworld, about half of patients do not take theirmedicines as prescribed, regardless of the condi-tion they are prescribed for, or how long thepatient is expected to live (Conrad, 1985;Vermeire et al., 2001; WHO, 2003; Haynes et al.,2005). It is thought that in the developing worldeven fewer patients take their medicines asprescribed.
Many patients who do not take their medi-cines will continue to collect their prescriptionsfrom the pharmacy, representing an enormouscost burden to the NHS. Not only do these medi-cines have to be paid for by the NHS, but medi-cines that are not taken as prescribed may notwork as intended (therapeutic failure) and thepatient is less likely to gain benefit. This hasbeen clearly demonstrated in a study exploringthe use of immunosuppressant medicines takento stop the body from rejecting transplantedkidneys. Rovelli et al. (1989) found that 18% ofpatients with a kidney transplant did not take
Introduction . . . . . . . . . . . . . . . . . . . . . 135
What is compliance? . . . . . . . . . . . . . . 136
What is adherence? . . . . . . . . . . . . . . . 137
What is concordance? . . . . . . . . . . . . . 137
Why do people not adhere toprescribed medicine regimens? . . . . . . . 139
What are the consequences ofpoor adherence to medication? . . . . . . . 143
How can adherence to medication beimproved?. . . . . . . . . . . . . . . . . . . . . . 143
What does concordance mean,in practice, for pharmacists? . . . . . . . . . 146
Developing a concordant approach . . . . 147
Summary . . . . . . . . . . . . . . . . . . . . . . 149
References. . . . . . . . . . . . . . . . . . . . . . 149
14Compliance, adherence and concordance
Rachel L Howard
135
their medicines as prescribed, resulting in eitherrejection of the transplanted kidney or death innine out of ten of these patients.
For centuries, the medical profession has beenaware that patients do not always do as they aretold. Even Hippocrates (who lived in the 5thcentury BC) was aware that patients sometimespretended to take their medicines. A numberof different terms have been used to describethe behaviour of patients who do not taketheir medicine as prescribed, including non-compliant and non-adherent. This chapterdescribes these terms in detail, and introducesthe concept of concordance and why it is impor-tant. It goes on to consider why patients do notadhere to their medication, and what the con-sequences of poor adherence might be, andsuggests some strategies that can help improvepatient adherence, and ways in which pharma-cists can use concordance in their daily practice.
What is compliance?
The term compliance has been defined as, ‘theextent to which a person’s behaviour (takingmedications, following a recommended dietor executing lifestyle changes) coincides withmedical or health advice’ (Kyngas et al., 2000).Until recently patients who did not follow theirdoctor’s instructions were described as ‘non-compliant’. However, this term has been criti-cised because of its negative connotations. ‘Itsuggests yielding, complaisance and submission. . . Non-compliance is a failure or refusal tocomply and can imply disobedience’ (Vermeireet al., 2001). Use of the term non-compliance alsosuggests that health professionals have the rightto authority over the patient’s behaviour (Kyngaset al., 2000). This means that patients have noright to participate in decisions about theirhealth or the medicines they take. By describingpatients as non-compliant, we are saying thatwe expect patients to follow the prescribers’orders unquestioningly. If patients do not, thenthey may be viewed by health professionals asbeing irrational and deviant; this contrasts withthe patient’s perspective of making a rationaldecision based on their own understanding of
their condition, the treatment, their lifestyleand how they will be affected (Conrad, 1985).This attitude held by health professionalssuggests that patients do not have the right tomake their own decisions about how they andtheir bodies will be treated; it is increasinglyrecognised that this is not appropriate.
The term non-compliance also assumes thatprescribed medicines are always beneficial topatients, which is not always the case. Adversereactions to medicines are the cause of about 5%of admissions to hospital (Pirmohamed et al.,2004); two-thirds of which could be avoidedby better management of medicines (Wintersteinet al., 2002). Sometimes the alterations patientsmake to a prescribed regimen can be desirable.For example, Wynne and Long (1996) foundthat patients who had a stomach bleed whilsttaking non-steroidal anti-inflammatory drugs(NSAIDS, e.g. ibuprofen) were more likely tohave continued taking their medicine at thedose prescribed than those who did not – thosepatients who chose to reduce the dose wereless likely to experience a serious adverse drugreaction (ADR).
The Royal Pharmaceutical Society of GreatBritain (RPSGB, 1997) has described the tradi-tional approach to medicine taking impliedby compliance (from a medical perspective) asfollows:
The patient presents with a significant medicalproblem for which there is a potentially helpfultreatment. What the doctor or other healthprofessional brings to the situation – scientificevidence and technical expertise – is classed asthe solution. What the patient brings – ‘healthbeliefs’ based on qualities such as culture,personality, family tradition and experience – isclassed by clinicians as the impediment to thesolution. The only sensible way out of this diffi-culty would appear to be to bring the patient’sresponse to the doctor’s diagnosis and proposedtreatment, as far as possible into line with whatmedical science suggests.
Unfortunately, since patients have been non-compliant with medicines for centuries, thisapproach is unlikely to work. As a result, therehas been a gradual shift in thinking in the worldof health care. One of these shifts has been toreplace the term compliance with adherence.
136 Chapter 14 • Compliance, adherence and concordance
What is adherence?
The term adherence was introduced in anattempt to reduce the amount of power attrib-uted to health professionals in their relation-ships with patients (Vermeire et al., 2001).Adherence implies that health professionalshave a responsibility to form a ‘therapeutic rela-tionship’ with patients, in order to encouragethem to agree to a recommended treatmentregimen. This means that patients should bebetter informed about their medicines and, intheory, have greater power to decline treatment.This is reflected in the World Health Organiza-tion (WHO, 2003) definition of adherence (seeBox 14.1). The wording of this definition issimilar to the definition for compliance exceptfor two important differences: the definition ofadherence:
• incorporates ‘agreed recommendations’ asopposed to ‘medical or health advice’
• recognises the relationship between patientsand all health professionals in patient care,not just doctors, by referring to ‘healthcareproviders’.
The terms ‘non-adherence’ and ‘poor adherence’still refer to patients who do not take theirmedicine according to the prescribed regimen
but are intended to be less judgemental thannon-compliance. However, poor adherence stillimplies that health professionals hold greaterpower than patients over making decisions thatcould affect patients’ lives (Kyngas et al., 2000).
In the 1990s a working party convened by theRPSGB explored the literature and current exper-tise on medicine taking (RPSGB, 1997). Theworking party recommended a shift in perspec-tive away from a compliance/adherence modelof medicine taking to ‘concordance’, which isdescribed in more detail below.
What is concordance?
Concordance was intended to introduce a‘distinct change in culture [and] . . . in teachingabout the relationship between prescribing andmedicine taking, between patient and prescriber’instead of a ‘more politically acceptable way oftalking about a technically and morally complexproblem’ (RPSGB, 1997). Concordance describesthe relationship between health professionalsand patients. Instead of patients either submit-ting (compliance) or agreeing (adherence) todecisions made by health professionals, in aconcordant relationship the patient is an equalpartner with the health professional in decisionmaking. This brings greater responsibility forpatients and health professionals – patients mustbegin to take greater responsibility for the conse-quences of their treatment decisions; healthprofessionals must take greater responsibility forthe quality of diagnosis, treatment and explana-tion (RPSGB, 1997). It must be remembered,however, that not all patients will want greaterinvolvement in decisions about their treatment.In a concordant consultation this preferenceshould be identified – and respected – by thehealth professional.
In concordant consultations, patients andhealth professionals contribute different types ofexpertise and knowledge, which help them toselect the most appropriate treatment option.Patients have the opportunity to describe theirown (lay) health beliefs and how they experiencetheir condition, and health professionals mustenable them to do this. Health professionals
What is concordance? 137
Box 14.1 Definitions of compliance and adherence
Compliance
The extent to which a person’s behaviour (takingmedications, following a recommended diet orexecuting lifestyle changes) coincides with medicalor health advice (Kyngas et al., 2000).
Adherence
The extent to which a person’s behaviour – takingmedication, following a diet, and/or executinglifestyle changes, corresponds with agreed recom-mendations from a healthcare provider (WHO,2003).
must describe their (professionally informed)health beliefs, and the patient should considerthese. At the end of a concordant consultation,the patient and health professional will agree atreatment regimen that is acceptable to bothparties. This may mean that the patient choosesnot to accept the treatment regimen that thehealth professional believes to be best clinicalpractice. This differs from a compliance or adher-ence model in which the patient would makethis decision after leaving the consultation(often with inadequate information) and withoutinforming the health professional. Within aconcordant consultation the treatment decisionis made with the health professional’s knowledgeand documented in the patient’s medical record.This allows future discussion about this deci-sion, more appropriate monitoring of the condi-tion being treated, and an outcome that isacceptable to the patient. If a patient chooses atreatment regimen that the health professionalbelieves will be harmful to the patient, it isstill the health professional’s right to refuse toprescribe or supply this medicine.
Concordant consultations are challenging forpatients and health professionals because theyrequire a dramatic change in the roles andresponsibilities of each party. Patients mustlearn to be open with health professionals, inter-pret evidence for treatment options, and makedecisions about their treatment. Health profes-sionals must learn to be non-judgemental, tohelp patients be open, to communicate evidencefor treatments in non-technical language, and toaccept that patients can have the final decisionon treatment regimens. Health professionalsmay be concerned that concordant consultationswill take longer than traditional consultations(most consultations in general practice only last10 minutes) although there is some evidence thathealth professionals experienced in conductingconcordant consultations need not use moretime than in a traditional consultation (Dowellet al., 2002).
Finally, because concordance describes theinteractions and agreement between patientsand health professionals, patients cannot bedescribed as non-concordant, only consultationscan be non-concordant.
Why is concordance important?
Misunderstandings can occur if patients andhealth professionals do not communicateopenly. In traditional consultations, healthprofessionals choose the information given topatients about treatment decisions, and patientschoose which information about their use ofmedicines and symptoms they give to healthprofessionals. This minimal communication hasled to many misunderstandings (see Box 14.2)(Britten et al., 2000). These misunderstandingscan result in patients taking medicines inappro-priately, symptoms of ADRs being missed,
138 Chapter 14 • Compliance, adherence and concordance
Box 14.2 Examples of misunderstandings that canoccur when patients and health professionals arenot open with each other (Britten et al., 2000)
• Patient information not known to the healthprofessional – doctor or pharmacist unawarethat patient takes less medication thanprescribed
• Health professional information unknown topatient – patient unaware they should reducethe dose of medication they take
• Patient receives conflicting information – patientgiven different advice by general practitionerand pharmacist
• Disagreement about cause of symptoms –doctor or pharmacist does not accept thatsymptoms are caused by a medicine, becausethey believe the computer record (whicherroneously says the medicine was firstprescribed 2 days earlier) rather than thepatient (who correctly says the medicine hasbeen taken for over 2 weeks)
• Failure to communicate health professional’sdecision: patient misunderstands the diagnosisand therefore cannot understand why themedicine has been prescribed
• Relationship factors: patient continues to take amedicine because they believe the doctor wantsthem to, whilst the doctor continues to prescribethe medicine because they believe stopping itwill upset the patient
conditions being managed suboptimally andpatients’ anxieties about their illness remain-ing unresolved. For example, Pollock (2001)describes a lady with gastro-oesophageal refluxdisease (a relatively common condition in whichstomach acid is regurgitated into the oesophagus,causing heartburn) whose anxieties about thepossible causes of her condition are not identi-fied by her doctor. This resulted in her feelingdissatisfied with her treatment and worried abouther future, even though her symptoms are wellcontrolled.
Good communication between patients andhealth professionals about medicines canimprove (Stevenson et al., 2004):
• satisfaction with care• knowledge of the condition and treatment• adherence to medication or lifestyle changes• health outcomes• fewer medication-related problems.
Why do people not adhere toprescribed medicine regimens?
As a health professional, it is easy to feel frus-trated when patients do not take their medicinesas prescribed. Understanding why patients don’ttake their medicines can help to avoid some ofthis frustration and, in some cases, enablehealth professionals to improve patient adher-ence. A great deal of research has been under-taken to explore why patients don’t adhere totheir medicines, and more than 200 differentreasons have been studied since 1975 (Vermeireet al., 2001). Despite this, however, no singlefactor can reliably predict whether or not apatient will adhere to their medicine, high-lighting the complexity of patients’ decisionsabout medicine taking.
Different types of poor adherence have beendivided into a number of categories, which arebriefly described in Box 14.3. Although thesecategories can help us to understand thedifferent ways in which patients are non-adherent, they do little to help us understandwhy patients do not take their medicines. For
this, we need to dig a little deeper. The WHO(2003) has identified five dimensions of factorsthought to influence patient adherence (see Box14.4), these are described in more detail below.
Social and economic factors
Social and economic factors include age, socialclass, level of education, employment status,income, level of literacy, lack of effective socialsupport networks, unstable living conditions,and family dysfunction. Many of these factorshave been found to impact on patient adherence,although they do not consistently predict whichpatients will be poorly adherent to medication.
Why do people not adhere to prescribed medicine regimens? 139
Box 14.3 Categories of non-adherence
Primary vs secondary
• Primary non-adherence: patient does not haveprescription for medicine dispensed
• Secondary non-adherence: patient has medicinedispensed but does not take it according to theprescribed regimen
Intentional vs unintentional non-adherence
• Intentional non-adherence: patient chooses notto take their medicine according to theprescribed regimen
• Unintentional non-adherence: patient eitherforgets, or is unable, to take their medicineaccording to the prescribed regimen
Box 14.4 Five dimensions of adherence (WHO,2003)
• Social/economic factors• Health system/healthcare team factors• Condition-related factors• Therapy-related factors• Patient-related factors
Age
Age is associated with different levels of adher-ence. Poor adherence to medicines is higher inadolescents and elderly patients (but stillpresent in all age groups). In adolescents thiscould reflect rebellion against the control that amedication regimen can impose on their lives.In elderly patients this can be due to thecomplexity of medication regimens and pres-ence of multiple disease states.
Poverty
Poverty can have an impact on patients’ abilityto pay for prescriptions. Within the NHS,prescriptions are provided free of charge forpatients on low incomes, which should lessenthe impact of poverty on adherence. In otherhealthcare systems (such as the USA), however,inability to pay for prescriptions continues to bea problem (Wamala et al., 2007).
Ethnic origin
Ethnic origin has also been found to influenceadherence, and this has been linked to culturalbeliefs about medicines and causes of disease,and levels of trust in the medical profession.
Healthcare team and system-relatedfactors
As suggested in the section on concordance,good relationships and communication betweenpatients and health professionals are importantin helping patients to adhere to their medica-tion (Conrad, 1985; Vermeire et al., 2001).Haynes et al. (2005) suggest that maintainingcontact between patients and health profes-sionals is likely to be the most important factorin helping patients adhere to medication.Brookhart et al. (2007) support this view: theyfound that patients were 3–6 times more likelyto restart statin therapy (medicine used to lowercholesterol levels) following an appointmentwith a doctor.
Conversely, healthcare systems with poorlytrained or overworked health professionals,
short consultation times, inadequate patienteducation and follow-up, and lack of help forpatients to pay for treatment can contribute topoor adherence.
Condition-related factors
Many conditions and diseases create demandson patients that affect their ability or desire toadhere to their medicines. Patients with particu-larly severe symptoms or rapidly progressingdisease may be more likely to adhere to agreedtreatment regimens, whilst patients with depres-sion are often less likely to be adherent tomedication. This can be particularly importantin patients with other conditions such as heartdisease and diabetes who are also likely to havedepression.
Therapy-related factors
The medicines prescribed can also influencepatients’ ability or desire to adhere. Complexregimens are associated with poor adherence.Medication regimens can be complex becausethey contain multiple different medicines, orbecause they need to be taken several times aday. Levels of adherence decrease as the numberof times a medication should be taken each dayincreases. Although there is not much differencebetween levels of adherence between once andtwice daily regimens (75% and 69% of all dosesare taken, respectively), adherence is muchlower with regimens that require medication tobe taken three or four times daily (65% and 51%of all doses taken, respectively) (Claxton et al.,2001). Adverse effects from medicines are infre-quently cited as a cause of poor adherence(Vermeire et al., 2001).
Patient-related factors
Patient-related factors include patients’ knowl-edge and beliefs about, and attitudes to,medicines and disease. Patients’ beliefs areincreasingly thought to be the most importantfactor influencing adherence (RPSGB, 1997;
140 Chapter 14 • Compliance, adherence and concordance
Horne & Weinman, 1999; Vermeire et al., 2001)(see Box 14.5 and detailed descriptions below).Often, patients’ beliefs contribute to pooradherence because they are not recognised byhealth professionals. This can cause a break-down in communication and misunderstand-ings between patients and health professionals(RPSGB, 1997).
Perceived efficacy
Patients’ beliefs about whether their medicinewill work are particularly important. This percep-tion will not just affect a patient’s initial deci-sion of whether or not to take a medicine; it willalso be reviewed at regular intervals whilst theyare taking their medicine. Patients may decidewhether or not to continue taking their medi-cine on the basis of how well their symptoms arecontrolled. In some cases, this may seem rela-tively straightforward. For instance, if a patienthas pain that is then relieved by painkillers, itmight seem obvious to a health professionalthat the patient should continue to take themedicine. However, some patients who takepainkillers for a long time and no longer experi-ence pain may wonder if they need thepainkillers any more, and may therefore ‘test’the efficacy of their painkillers by stopping themand seeing if the pain returns. If the pain doesnot return, then they will stop taking thepainkillers. If the pain does return, however, itcan sometimes take a number of days for thepatient to regain adequate pain control.
Testing the efficacy of a painkiller is relativelysimple for a patient to do. It is more difficult,however, for patients to assess the efficacy of an
antihypertensive. Hypertension is rarely associ-ated with symptoms (although patients oftenassociate it with headaches). If a patient believesthat they can tell when their blood pressure israised, and only takes their medication whenthey believe they are experiencing symptoms,then they may stop taking the medication. Thismay seem inappropriate from a health profes-sional’s perspective.
Immunity over time
Patients may believe that they will becomeimmune to the effects of a medicine if they takeit for prolonged periods of time. This may berelated to government messages about over-prescribing of antibiotics leading to increasedbacterial resistance (RPSGB, 1997); however,patients can hold the belief that they willdevelop immunity to many different types ofmedicine. This belief leads some patients to take‘holidays’ from their medicines, leading to dete-rioration in disease control which in some casescan be dangerous. For instance, if a patientsuddenly stops taking their beta-blocker, reflextachycardia (a fast heart rate) may result, exacer-bating a patient’s angina pain. Not only canpatients experience symptoms from their illness(sometimes warranting hospital admission), butwhen they do start taking their medicationagain, it can be more difficult to regain controlof their symptoms.
Unnaturalness of manufactured medicines
Patients may believe that Western medicines,many of which are manufactured from syntheticcompounds, are ‘unnatural’. In this sense, somepatients may perceive such medicines to beunhealthy and therefore avoid taking them. Incontrast, non-Western medicines such as herbalremedies are considered to be natural and there-fore less likely to be harmful. Patients whobelieve this can be reluctant to take Westernmedicines prescribed by their doctor.
Danger of addiction and dependence
Some patients perceive themselves to havebecome dependent on their medicines (Conrad,
Why do people not adhere to prescribed medicine regimens? 141
Box 14.5 Types of patients’ beliefs about medicines(RPSGB,1997)
• Perceived efficacy of medicine• Danger of becoming immune over time• Unnaturalness of manufactured medicines• Danger of addiction and dependence• Anti-drug attitude• Balancing risks and benefits
1985), and they may therefore feel that theyhave lost control of their lives. Some patientswill alter their medicine regimen in order tohelp regain some control. This has been particu-larly noted in chronic diseases such as epilepsy.In addition, patients fear that they may becomeaddicted to their medicine. This includes medi-cines for which addiction is not thought to bepharmacologically plausible. For example, manypatients believe that they can become addictedto selective serotonin reuptake inhibitors (SSRIs,e.g. paroxetine) used to treat depression becausethey experience adverse effects if they stoptaking them suddenly. In some cases, theseadverse effects can make it difficult for a patientto stop taking SSRIs. However, SSRIs do notinduce addiction in the pharmacological sense.Patients prescribed medicines, such as SSRIs,that can precipitate adverse effects if stoppedsuddenly should be counselled about thehazards of stopping their medicine suddenly.
Anti-drug attitude
Many patients perceive the word drug negativelybecause of an association with illicit drugs. Illicit(or recreational) drugs such as amphetamines,cocaine and opioids are frequently associatedwith a risk of physical, mental and moral harm(RPSGB, 1997). This perception can be trans-ferred to medicines used for therapeutic reasons,creating a fear of taking ‘drugs’, or beingperceived as a ‘drug user’. Referring to prescribeddrugs as medicines is unlikely to overcome thisstigma, but is preferable to calling them drugs.
Managing everyday life
Everyday life can make it difficult for somepatients to follow their doctor’s instructions. Forexample, Bissell et al. (2004) describe how anAsian patient struggled to follow the dietdictated to her by health professionals to helpcontrol her type 2 diabetes because she had tocook separate meals for herself and the rest ofher family. Patients may also experience difficul-ties incorporating their medicines into a busydaily routine, particularly if medicines need tobe taken more than twice a day. Adjustments to
medicine regimens are perhaps best illustratedby patients who take diuretics to help controlfluid retention in congestive cardiac failure.These patients experience a diuresis (increasedurine flow) which can make it difficult to be farfrom a toilet. Many of these patients will alterthe timing of their diuretic if they need to goshopping. This alteration is rarely discussed withhealth professionals, although the majority ofhealth professionals would recommend thatpatients amend their regimen in this way.
Alternatively, some patients may use drugssuch as tranquillisers to control the symptomsof everyday life, particularly during stressfulevents such as divorce or bereavement.
Non-acceptance and stigma of illness
Admitting that they have an illness can impacton a patient’s sense of identity, and some patientsmay be unwilling to accept that they are unwell.This can be a particular problem when the treat-ment for the illness is perceived to be obvious toothers, for example inhaler therapy for asthma orinjecting insulin for diabetes. In addition, someillnesses are perceived to be heavily stigmatised.For instance the seizures that characteriseprimary generalised epilepsy (which used to becalled grand mal epilepsy) have been consideredto be signs of demonic possession (Jilek-Aall,1999). Other illnesses in which the patient isin some way perceived to be at fault, suchas HIV/AIDS can also be heavily stigmatised.Hence, some patients can be reluctant to admitthey have a stigmatised illness. Where patientsdo not accept that they have an illness, they aresignificantly less likely to take the prescribedmedicine (Horne & Weinman, 1999).
Balancing risks and benefits
Most patients who take medicines will have aview about the risks of taking medicines gener-ally, or the specific medicine they have beenprescribed. This view will be based on varioussources of information, including relatives,friends, the media, the internet and healthprofessionals. Patients will usually make arisk–benefit assessment on the basis of their
142 Chapter 14 • Compliance, adherence and concordance
understanding about the risks of taking the medi-cine against the perceived benefits. Patients mayinclude the following in their risk assessment:
• possibility of experiencing adverse effects(and their severity)
• effect on lifestyle and quality of life• taste, smell, size and shape of medicines.
Patients may not make their risk–benefitanalysis immediately; instead they may chooseto ‘trial’ the medicine and assess the impact ofadverse effects on their lifestyle. From a healthprofessional’s perspective, this can be particu-larly problematic when patients are likely toexperience short-term adverse effects such asflatulence with statins, or drowsiness andnausea with opioid analgesics. Warning patientsthat they may experience short-term adverseeffects (and when they are likely to resolve) mayhelp to prevent patients from deciding that therisks of medicine taking outweigh the benefits.Horne and Weinman (1999) found that patientswho perceived the risks of a medicine tooutweigh the potential benefits were signifi-cantly less likely to be adherent to the prescribedregimen.
Communication between doctors andpatients about medicines may affect patients’risk–benefit analysis. In particular, focusingmore on the adverse effects of medicines, ratherthan the benefits, may encourage patients tochoose not to take them. The informationcontained in patient information leaflets (PILs)has been criticised for having a greater focus onthe risks (adverse effects) of medicines than onthe benefits. As a result, PILs are being changedto redress this balance (Connelly, 2005). Less isknown, however, about whether communica-tion between health professionals and patientsis changing.
What are the consequences of pooradherence to medication?
In general, patients who are poorly adherent totheir prescribed medicine regimens have pooreroutcomes than patients who are considered to
have good adherence. Table 14.1 shows theoutcomes of poor adherence to medication for avariety of conditions. In most of these studies,poor adherence is defined as taking less than75–80% of the prescribed doses, although somestudies define poor adherence as taking less than100% of doses (Simpson et al., 2006).
How can adherence to medication beimproved?
Despite our better understanding of the causes ofpoor adherence to medication regimens, findingways to help patients take their medicines asprescribed remains a challenge. Strategies toimprove patient adherence differ depending onwhether a patient is prescribed short-termtherapy (such as a course of antibiotics) orlong-term therapy (Haynes et al., 2005).
Counselling patients and giving them writteninformation about their medication have provedeffective. Phone calls to remind patients to taketheir medicines have also been shown to help,for example, telephone reminders after 3 daysof treatment with Helicobacter pylori eradicationtherapy have improved patient adherence(Haynes et al., 2005). (H. pylori is a bacteriumassociated with an increased risk of peptic/gastriculcers.)
Strategies to improve adherence to long-termtherapy have limited efficacy. Even the mosteffective strategies offer only small improve-ments in medication use and health outcomes.In general, successful strategies to improvemedication adherence with long-term therapyinvolve multiple interventions:
• more convenient care• increased information• reminders to take medication• self-monitoring of effectiveness (such as
blood pressure)• psychological therapy• telephone follow-up.
Examples of some successful interventions areshown in Table 14.2 and are discussed in moredetail below.
How can adherence to medication be improved? 143
144 Chapter 14 • Compliance, adherence and concordance
Table 14.1 Consequences of poor adherence to prescribed medicine regimens
Reference Reason for medication How adherence Consequences of poor adherencewas assessed
Vik et al., 2004 Multiple conditions Unknown 8–11% of hospital admissions in older patients were attributed to poor adherence to medication
Simpson et al., Multiple conditions Unknown Patients with poor adherence to active or 2006 comparing active placebo medication were twice as likely
and placebo to die as patients with good medication adherence
Kimmel et al., Anticoagulation Percentage of bottle Poorly adherent patients (those with 20% 2007 openings compared with fewer or 10% more bottle openings than
prescribed frequency prescribed) were more than twice as likely to have a subtherapeutic INR, andnearly twice as likely to have asupratherapeutic INR
Hope et al., Congestive cardiac Percentage of prescribed Poor adherence was associated with 2004 failure doses collected from more frequent emergency hospital visits
pharmacy and percentage for cardiovascular diseaseof bottle openings compared with prescribedf requency
Ho et al., Diabetes mellitus Percentage of prescribed Poorly adherent patients were 1.6 times 2006a doses collected from more likely to be hospitalised and 1.8
pharmacy times more likely to die than patients with good adherence (defined as thosewho collected � 80% of theirprescriptions)
Nachega et al., HIV Percentage of prescribed Poor adherence to medication was 2007 doses collected from associated with fewer patients achieving
pharmacy suppression of HIV load. With each 10% increase in prescription collection above 50%, an additional 10% of patientsachieve viral load suppression
Ho et al., Post-MI Percentage of prescribed Patients who stopped taking aspirin, 2006b doses collected from beta-blockers or statins after an MI were
pharmacy nearly 4 times more likely to die than patients who continued treatment.
Rasmussen Post-MI Percentage of prescribed Patients with poor adherence to beta-et al., 2007 doses collected from blockers or statins were 25% more likely
pharmacy to die than patients with good adherence
No difference was found in mortality between patients with good or pooradherence to calcium channel blockers.
INR, international normalised ratio, a measure of blood clotting; MI, myocardial infarction
Patient education
Educating patients about their medicines isunlikely to be effective on its own (Schroederet al., 2004; Haynes et al., 2005) although it hasbeen successful in some patient groups (Clarket al., 2007). Indeed, the traditional model ofa pharmacist counselling about medication(without assessing patients’ existing knowledgeor desire for information) has been found toalienate patients (Salter et al., 2007). This doesnot mean that educating patients about theirmedicine is not important, but it needs to becombined with an attempt to elicit what patientswant from their treatment, how their beliefswill affect their medication taking, their currentlevel of understanding, and to help patientsdecide whether or not to take the recommendedmedication (RPSGB, 1997).
Multicompartment compliance aids
Multicompartment compliance aids (MCAs)(also known as monitored dosage systems(MDSs)) such as dossett boxes, NOMAD systems
and Medidos, are generally considered to beoverused (Nunney and Raynor, 2001). Patientsusing them often think they would remembertheir medicines without them, and some havedifficulties opening the medicine compartments.This may be because patients are rarely askedwhich MCA they would prefer (often pharmaciesonly keep one type of MCA). In addition, usingMCAs reduces patients’ knowledge about themedicines they take. However, MCAs do helppatients in some groups to remember theirmedicines and are likely to be beneficial.
Regular contact with health professionals
Haynes et al. (2005) argue that maintainingcontact between health professionals andpatients is likely to be the most effective strategyto improve adherence to medication. This viewis supported by Brookhart et al. (2007), whofound that patients who had stopped taking theirmedication after a myocardial infarction weremost likely to start taking it again if they had hadrecent contact with a doctor, and particularly ifthis was with the prescribing doctor.
How can adherence to medication be improved? 145
Table 14.2 Examples of interventions that have improved patient adherence
Patient group Successful interventions Reference
Patients with tuberculosis Pharmacist education about medication Clark et al., 2007Multiple patient groups Medication reminder packaging Heneghan et al., 2006Patients with hypertension Dispensing medicines in blister pack; pharmacist-led Lee et al., 2006
or hyperlipidaemia education about medicines; regular follow-up with a pharmacist
Multiple patient groups Motivational interviewing Rubak, 2005Patients with HIV/AIDS Improving practical medication management skills Rueda et al., 2006
with individual patients over at least 12 weeksPatients with hyperlipidaemia Simplified medication regimens; improved patient Schedlbauer et al., 2004
information and education; remindersPatients with hypertension Simplifying dosage regimens; medicine reminder Schroeder et al., 2004
charts; social support and family support
Is improving adherence to medicationalways beneficial to patients?
Health professionals assume that improvingpatient adherence to medication will be benefi-cial to patients, but this may not always betrue. In some cases, increased adherence mayhave no impact on clinical outcomes, whilst inothers it may lead to more adverse effects. Forexample:
• a pharmacy care programme improved patientadherence to statins, but did not improvelipid control (Lee et al., 2006)
• directly observed therapy for tuberculosis(where patients take three-times weeklydoses of medication under health profes-sional observation) and standard therapy(where patients take daily therapy at home)showed no differences in terms of coursecompletion or clearance of tuberculosisinfection (Volmink & Garner, 2006)
• patients with gastrointestinal bleeding associ-ated with NSAIDs are more likely to havetaken the prescribed dose of NSAID thanpatients without gastrointestinal bleeding(Wynne & Long, 1996)
• good adherence in clinical trials to medica-tion that was subsequently found to beharmful tripled the risk of death (Simpsonet al., 2006).
Simpson et al. (2006) also found that patientswith poor adherence to placebo and activemedication were both twice as likely to dieas patients who had good adherence. Thissuggests that the positive benefit of good adher-ence to medication is likely to be due to goodoverall healthy behaviour. Rasmussen et al.(2007), however, found that patients with goodadherence to beta-blockers and statins (bothknown to reduce mortality after a myocardialinfarction) had better outcomes than patientswith good adherence to calcium channelblockers (medicines for which there is noevidence that they reduce mortality risk after amyocardial infarction). This study suggests thatgood adherence to effective and safe medica-tion is beneficial irrespective of other healthbehaviours.
What does concordance mean, inpractice, for pharmacists?
So far this chapter has described the differentmeanings of compliance, adherence and concor-dance, why patients do not adhere to prescribedregimens and the potential consequences ofthis. In addition, it has introduced some of theinterventions that may help patients adhere totheir medication. But what does concordancemean, in practice, for pharmacists?
It is clear from multiple studies that the tradi-tional approach to medicine taking, whichexpects patients to adhere to the prescribedmedication regimen, is ineffective. Pharmaciststherefore need to adopt a more concordantapproach to their interactions with patients. Atfirst glance, it may be difficult to see howthe traditional pharmacist role lends itself toconcordant consultations. However, every timea pharmacist interacts with a patient they havean opportunity for a concordant consultation.Some of these opportunities, and how they canbe used, are described below.
Dispensing medication
When pharmacists dispense medication forpatients, they are ideally placed to identify anypractical problems that patients might experi-ence with their medicines. Such practical prob-lems could include not knowing when or howto take their medication, and inability to openmedicine containers or to read labels. Pharma-cists can ask patients about these issues whendispensing medicines for the first time, and alsowhen patients present with a repeat prescrip-tion. In addition, patients’ understanding ofinformation provided by the doctor can bechecked. This can provide patients with anopportunity to ask their pharmacist questionsabout medicine efficacy or side-effects. Whenanswering such questions, it is important toidentify what the patient has been told by thedoctor, to avoid giving conflicting information.Pharmacists can also take the opportunity totalk to patients about their expectations for the
146 Chapter 14 • Compliance, adherence and concordance
medicine and their perspective on whether ornot to take the medicine.
Repeat dispensing
Pharmacists are increasingly involved in repeatdispensing systems. In this case, the pharmacistmay be the only contact the patient has with ahealth professional for up to 6 months. It istherefore important that the pharmacist askssimple questions such as, ‘How are you gettingon with your medicines?’, to help identify anypractical problems the patient may be experi-encing, or symptoms that could be adverseeffects of the medication. In addition, pharma-cists can use this opportunity to discuss with thepatient whether they are taking the medicationas prescribed; if not, why not; and if the level ofnon-adherence is likely to pose a risk to thepatient.
Medicine use reviews
Under the new Pharmacy Contract, pharmacistscan provide medicines use reviews (see Box 6.7).These provide an ideal opportunity to sit downwith a patient in private and talk with themabout their medicines as part of a concordantconsultation. This allows pharmacists to iden-tify any problems that a patient is experiencing,talk to them about their understanding of theirmedicines and why they take (or do not take)them.
Prescribing
Pharmacists can now qualify as supplementary orindependent prescribers (see Chapter 2), whichprovides an ideal opportunity for a concordantconsultation. Pharmacists can discuss patients’health beliefs, and the benefits and risks of theavailable treatment options, in order to agreewith patients their preferred treatment strategy.This can also include anticipating (and resolving)practical problems with treatment, such asadministering medication several times a day.
Taking medication histories when patientsare admitted to hospital
Hospital pharmacists are increasingly involvedin making accurate records of what medicationsa patient who is admitted to hospital has beentaking at home. This is an ideal time for a concor-dant consultation, which can help to inform howthe patient is treated throughout their admis-sion. Pharmacists can identify whether patientstake their medicine as prescribed, why they maychoose to alter the prescribed regimen, whatpractical difficulties they may experience, andtheir beliefs about their medicines. This infor-mation can then be used to help doctors agreesuitable treatment regimens with patientsduring the admission, and on discharge fromhospital.
Counselling patients about medicines ondischarge from hospital
Hospital pharmacists are often involved inmedication counselling before patients aredischarged home. This provides an opportunityto discuss patients’ beliefs and understandingabout their medicines and conditions, theirintention to take the medication, and any prac-tical difficulties they may anticipate when theyreturn home.
Developing a concordant approach
Pharmacists need to develop new skills in orderto have concordant consultations with patients(Weiss, 2004). The skills required at each stageof a concordant consultation are described inBox 14.6. In addition, pharmacists must carefullyexamine their attitudes to patients and theimpact these attitudes could have on a consul-tation. It is important that pharmacists carefor, respect and trust the patient (Weiss, 2004).Pharmacists should also be aware of their ownvalues, beliefs, history, needs and culture, andhow these can influence interactions withdifferent patients. This awareness should allow
Developing a concordant approach 147
148 Chapter 14 • Compliance, adherence and concordance
Box 14.6 Pharmacists’ skills for a concordant approach
Greet the patient
• Greet the patient appropriately and introduceyourself as the pharmacist
• Ensure the patient’s comfort and privacy• Reassure the patient so that they feel you have
time for them; treat them as an equal partner• Identify barriers to communication, such as
deafness or language barriers• Establish how involved the patient wants to be in
decision making• Set boundaries for the discussion, such as subjects
you can discuss and how much time is available• Be alert to the patient’s reactions and tailor your
approach to each individual (try not to scarethem)
Explore the patient’s issues
• Identify why the patient has come to see you• Elicit the patient’s view of their illness, their
psychosocial and emotional issues• Discuss their expectations
Question the patient
• Use open questions, and avoid leading questions,wherever possible (see Chapter 8, page 78)
Actively listen to the patient
• Give the patient your full attention• Do not interrupt them• Respond to verbal and non-verbal cues (see
Chapter 8, page 78)
Empathise with and support the patient
• Acknowledge the patient’s views and concerns ina non-judgemental fashion, using appropriate non-verbal cues such as nodding, leaning forward andopen posture to encourage patients to speak
• Ask probing questions to elicit further responses • Discuss the patient’s concerns and views, and
encourage them (and allow them time) to ask youquestions
Clarify and summarise the patient’s responses
• Check your understanding of what the patient hassaid (and show you have been listening) bysummarising your understanding
Know your limitations
• Ensure that your knowledge is up-to-date• Avoid discussing topics you do not understand
(refer the patient to someone else if necessary)
Share information with the patient
• Offer to share your thinking on the problem• Explain why examinations are needed• Discuss the benefits and risks of the treatment
options with the patient in language they canunderstand (avoid jargon)
• Check that the patient has understood what youhave said
Agree the issues with the patient
• Elicit the patient’s reaction to, and feelings about,the information given
• Negotiate a treatment plan that is acceptable toboth you and the patient
• Identify (and resolve) any practical difficulties thepatient may experience in adhering to thetreatment
Finish the consultation and plan for the future
• Summarise the decision that has been reached• Explore whether the patient has anything else to
discuss (offer an additional consultation ifnecessary)
• Agree with the patient what happens next(when/if they come back to see you, what they doif there is a problem)
• Communicate the outcome of the consultation toother relevant health professionals (with thepatient’s agreement)
(Weiss, 2004; Clyne et al., 2007)
pharmacists to adapt their communication styleto individual patients’ needs.
Summary
This chapter has shown that taking medicines isa complex issue, influenced by many factors.How patients take their medicines can have posi-tive and negative impacts on both their healthand their relationships with health professionals.Health professionals’ approach to patients’ medi-cine-taking behaviour is changing, illustrated bythe change in terminology from compliance,through adherence, to concordance. Concor-dance remains a challenging model of care forpatients and professionals, with as-yet uncertainbenefits. Pharmacists can engage in concordantconsultations in most aspects of their work, butfor pharmacists to be truly concordant in theirapproach to patients they will need to learn newskills and reflect on their attitudes to theirpatients.
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150 Chapter 14 • Compliance, adherence and concordance
Introduction
The sale and supply of medicines is an impor-tant part of the pharmacist’s role. It is also oneof the most potentially dangerous roles thatpharmacists undertake. It is therefore importantfor pharmacists to be aware of:
• the potential risks associated with medicines• how the sale and supply of medicines is
controlled to minimise these risks• the roles and responsibilities of pharmacists
when selling or supplying medicines.
The sale and supply of medicines has manysources of risk for pharmacists, pharmacyemployees and customers; examples are shownin Box 15.1. In addition, there are risks associ-ated with the services that pharmacists provide,such as supplying prescriptions, selling medi-cines over the counter (OTC), and counsellingpatients about medicines or other public healthissues. If these services are not delivered to thehighest standards, there is a risk of harm tomembers of the public. In addition, there is alsoa risk of financial loss to pharmacists through
compensation claims from injured patients,lost earnings because of suspension from work,and loss of business. Pharmacists who do notprovide pharmacy services to a high enoughstandard also risk being removed from thePharmaceutical Register. Many factors will affectthe ability of a pharmacist to deliver theseservices to the highest standards, some of whichare described in Box 15.2.
Introduction . . . . . . . . . . . . . . . . . . . . . 151
Legal and ethical considerations whenselling and supplying medicines. . . . . . . 152
Selling over-the-counter medicines . . . . . 155
Supplying prescribed medicines . . . . . . . 157
Preventing errors when selling orsupplying medicines . . . . . . . . . . . . . . . 160
When mistakes are made . . . . . . . . . . . 163
Summary . . . . . . . . . . . . . . . . . . . . . . 167
References. . . . . . . . . . . . . . . . . . . . . . 167
15Sale and supply of medicines: risk and adviceprovision
Rachel L Howard
151
Box 15.1 Examples of sources of risk in a communitypharmacy
• People: customers and staff members may carryinfections or be aggressive
• Equipment: lifting heavy objects, or liftinginappropriately, risks injury
• Materials: pharmacies may contain a numberof hazardous materials in addition tomedications, including compressed gases
• Building design: fire precautions must be takeninto account
This chapter concentrates on managing therisks associated with the sale and supply ofmedicines. A detailed discussion of other risksthat may impact on pharmacy businesses isavailable in Butler (2005). In this chapter weintroduce the legal and ethical considerationsrelevant to the sale and supply of medicines, riskmanagement, how to respond if an error reachesa patient and what constitutes negligence.
Legal and ethical considerations whenselling and supplying medicines
This section presents a brief overview of thelegal and ethical considerations relevant to thesale and supply of medicines. More detaileddescriptions can be found in the Medicines,Ethics and Practice Guide for Pharmacists and Phar-macy Technicians (MEP) and Dale and Appelbe’s
Pharmacy Law and Ethics (Appelbe & Wingfield,2005a).
Legal considerations
The sale and supply of medicines and othersubstances offered for sale by registered phar-macies is controlled by a wide variety of laws,acts and regulations that implement Europe-wide directives and regulations within England,Scotland and Wales (although the implementa-tion of these recommendations differs slightlyacross the UK). These include the Medicines Act1968, Misuse of Drugs Act 1971, and the Medi-cines for Human Use Regulations 2005, whichcontrol the manufacture, labelling, distribution,sale and supply of medicines. Although the dateson some of these acts and regulations may seemold, they are updated regularly through amend-ments. For example, the regulations governingthe sale and supply of controlled drugs haveundergone dramatic changes in recent yearsfollowing the Shipman Inquiry. (More informa-tion can be obtained from www.the-shipman-inquiry.org.uk.) It is therefore essential forpharmacists to maintain up-to-date knowledgeof the laws, acts and regulations that influencetheir practice. An overview of how these laws,acts and regulations influence the sale andsupply of medicines is given in Table 15.1.
Licensed products (marketing authorisations)
Wherever possible, pharmacists should supplylicensed medicinal products to the public. Theseare products that have been granted a marketingauthorisation (MA) (formerly known as a productlicence). This guarantees the safety, quality andefficacy of the medicine. An MA is granted whena manufacturer submits the necessary paper-work confirming the safety, quality and efficacyof the medicine to either the Medicines andHealthcare products Regulatory Agency (MHRA)in the UK, or the European Medicines Evaluation
152 Chapter 15 • Sale and supply of medicines
Box 15.2 Factors that affect a pharmacist’s abilityto deliver services
• Dispensary design – cramped conditions impairthe flow of dispensing work and increase therisk of dispensing errors
• Availability of a well-equipped privatecounselling area to ensure customer privacyand confidentiality
• Good systems of communication betweenmembers of staff in the pharmacy, and withprescribers, nurses, patients and carers
• Reporting systems to record near misses,dispensing errors, interventions on prescriptionsand advice given to customers if feltappropriate
• Skill mix – ensuring appropriate members ofstaff are on duty to allow work to flow smoothlyand safely
• Leadership: the pharmacy will run moresmoothly and safely if well managed
Legal and ethical considerations when selling and supplying medicines 153
Table 15.1 A selection of laws and regulations that affect the practice of pharmacy and the sale and supply ofmedicines by pharmacists
Law, act or regulation What the law, act or regulation means for pharmacists supplying medicines
European Community Dictates the procedures for authorisation and supervision of medicinal products for Council Directives and human and veterinary use. Includes:Regulations (enacted in the • requirements for a marketing authorisation UK through the acts and • good manufacturing practice for human and veterinary medicinesregulations listed below) • standards and protocols for tests on medicines for human use
• requirements for medication advertising, labelling and leaflets; wholesaledistribution of medicines; colouring agents that can be added to medicines;manufacture, sale and supply of controlled drugs; data protection
Medicines Act 1968 (and Applies to all medicines for human use (when they are being used as medicines); its subsequent amendments) defines three classes of medicines for human use:
• general Sales List (GSL): available for sale without a pharmacist’s supervision• pharmacy medicines (P): only available for sale from a registered pharmacy
under the supervision of a pharmacist (GSL medicines purchased from aregistered pharmacy can only be sold when a pharmacist is on the premises)
• prescription-only medicines (POM): only available for supply in response to aprescription written by an authorised prescriber
Also imposes controls on the sale and supply of herbal and homoeopathic remedies (Appelbe & Wingfield, 2005a).
Veterinary Regulations 2005 Replaces the Medicines Act 1968 for medicines for veterinary usePoisons Act 1972 Controls the sale of non-medicinal poisons. A list of non-medicinal poisons is
published in the MEP. Poisons are listed in two parts.• Poisons in Part I and Part II can be sold by a person lawfully conducting a
retail pharmacy business.• Poisons in Part II can also be sold by a listed seller (a person whose name is
entered on a local authority list). Also defines seven schedules that impose different restrictions on the sale of
non-medicinal poisons. Schedules 1 and 4 are most relevant to pharmacies:• Schedule 1: Details special restrictions on storage, sale and record keeping.• Schedule 4: Details products that are exempt from controls under the
Poisons Act.
Chemical (Hazard CHIP controls the classification, packaging and labelling of substances that are Information and Packaging dangerous to supply (except medicinal products and those covered by thefor Supply) Regulations Medicines Act 1968). Where these are stored in a pharmacy, CHIP regulations 1994 (CHIP) must be adhered to.
Control of Substances Under COSHH regulations, employers must assess the risk of chemicals which Hazardous to Health employees are exposed to in the workplace, and limit those risks through the Regulations 1999 (COSHH) implementation of appropriate procedures, which employees must follow.
Medicines for Human Use Controls the sale and supply of medicines by ensuring all products have a Regulations 2005 marketing authorisation (except for products exempt under Schedule 1, which
can be supplied on a named-patient basis (unlicensed medicines), and setting guidelines for the wording of labelling (Schedule 3) and patient information leaflets (Schedule 4). Schedule 2 sets out the penalties for failure to comply with these regulations.
Agency (EMEA) in Europe. If insufficientevidence is supplied, a MA will not be granted.
Medicinal products with a MA can be identi-fied from the MA number, which is printed onthe packaging of all authorised medicines (unlessthe packaging is considered too small to con-tain all the relevant information). There may,however, be circumstances where a licensedproduct is not available. In this case, a supply ofan unlicensed medicine can be made (see sectionon supplying unlicensed medicines, page 159).
The MA specifies (amongst other things):
• the product description• the conditions for which the medicine may
be used – the licensed indications• the dose range for each licensed indication –
the licensed doses• how the packaging should be labelled (see
Chapter 12).
It also specifies the need for a patient informa-tion leaflet (PIL) and the specific product charac-teristics (SPC) (also known as the summary of
product characteristics), which details licensedindications and doses, cautions and contraindi-cations, drug interactions, mode of action, andpharmacokinetics of the medicine. SPCs and PILsfor the majority of licensed medicines are avail-able free of charge via www.medicines.org.uk.Further information on the process for obtainingan MA is available from MHRA (2006a) and theEMEA (2007).
Ethical considerations
In addition to the legal considerations, the saleand supply of medicines is guided by biomedicalethics and the ethical principles of the pharmacyprofession, which are described in the MEP. Thekey ethical responsibilities of the pharmacist areshown in Box 15.3. The code of ethics for phar-macists has recently been amended followingconsultation with members of the profession andhas been published in the Code of ethics for phar-macists and pharmacy technicians (RPSGB, 2007),
154 Chapter 15 • Sale and supply of medicines
Table 15.1 Continued
Law, act or regulation What the law, act or regulation means for pharmacists supplying medicines
Misuse of Drugs Act 1971 Classifies controlled drugs into five schedules with different levels of control applied to them:
• Schedule 1 (CD Lic)• Schedule 2 (CD POM)• Schedule 3 (CD No Register)• Schedule 4 Part I (CD Benz)• Schedule 4 Part II (CD Anab)• Schedule 5 (CD Inv)Changes have been made to the Misuse of Drugs Act in response to the Shipman
Inquiry and extension of prescribing rights to supplementary and independentnon-medical prescribers. Details of the restrictions on controlled drugs are available in the MEP.
Alcoholic Liquor Duties Act Controls the manufacture, sale and supply of denatured alcohol. Both methylated 1979 spirits and isopropyl alcohol can be supplied by pharmacists. Sale and supply of
these denatured alcohols is controlled by this act.
Denatured Alcohol Sets out the requirements for manufacture, supply, receipt, sale, and storage of all Regulations 2005 forms of denatured alcohol.
Civil and statutory Includes the Medicines, Poisons and Misuse of Drugs Acts because transgressing from(criminal) law these acts may result in prosecution.
MEP, Medicines, Ethics and Practice Guide for Pharmacists and Pharmacy Technicians published by the Royal Pharmaceutical Society of Great Britain.
which is is supplemented by the Professionalstandards and guidance documents (available viathe RPSGB website (www.rpsgb.org)).
Indemnity insurance
One aspect of the code of ethics that iscommonly overlooked by newly qualified phar-macists is the requirement to have adequatepersonal professional indemnity insurance(RPSGB, 2007). This ensures that the pharmacistis able to pay compensation if a patient isinjured as a result of the pharmacist’s actions.Before 1991, pharmacists employed by hospitalswere exempt from prosecution under statutorylaw because they had Crown immunity, andmany viewed professional indemnity insuranceas unnecessary. This is no longer the case,however, as all hospital staff, including pharma-cists, can now be prosecuted. Prosecution is rare,but can occur when a pharmacist commits anoffence under the Medicines Act. Such an offencecan include a dispensing error that reaches thepatient.
Some pharmacists wrongly believe themselvesto be covered by their employer’s indemnity
insurance. Under some circumstances theemployer may try to recoup the costs of alawsuit from the employee pharmacist respon-sible for an injury. Also, the employing phar-macy may not be at fault. In this case, the injuredpatient may bring a civil case for compensationagainst the individual pharmacist. All pharma-cists should therefore ensure they have personalprofessional indemnity insurance that givesthem adequate cover for the type of work theydo. Different policies are available dependingon the area of pharmacy worked in and the typeof work done (such as community, hospital,primary care or locum pharmacists).
Selling over-the-counter medicines
Medicines sold from a pharmacy (as opposed tothose supplied in response to a prescription) arecollectively described as OTC medicines. Thereis no formal list of Pharmacy (‘P’) medicines, ora statutory list of medicines that may be soldfrom a pharmacy. Instead, any medicines on thegeneral sales list (GSL), and any medicines notincluded on the prescription-only medicines(POM) list, are eligible for sale from a registeredpharmacy. The classification of a medicine canbe found in the British National Formulary (BNF)or SPC. (‘P’ medicines will be those not classifiedas GSL or POM.) In addition, a list of medicinalproducts classified as GSL, P or POM is availablein the MEP.
Pharmacists are also able to sell herbal reme-dies and food supplements (vitamins andminerals). Although there are some controlsunder the Medicines Act, the sale of these islargely unregulated. Many patients view herbalremedies and food supplements as harmlessalternatives to licensed medicines. Manufac-turers of herbal remedies and food supplementsoften make claims that their products will helpa variety of conditions, although these may notnecessarily be supported by any evidence. It isimportant that pharmacists who sell these prod-ucts are aware of their associated risks. Theseinclude potentially toxic ingredients, interac-tions with licensed medicines such as warfarin,and adverse effects.
Selling over-the-counter medicines 155
Box 15.3 Ethics for pharmacists
‘Ethics is the science of morals, or moral philosophy’(Appelbe & Wingfield, 2005a).
The Code of Ethics for pharmacists published bythe RPSGB sets out seven key ethical principles thatpharmacists should adhere to (RPSGB, 2007):
• Make the care of patients your first concern• Exercise your professional judgement in the
interests of patients and the public• Show respect for others• Encourage patients to participate in decisions
about their care• Develop your professional knowledge and
competence• Be honest and trustworthy• Take responsibility for your working practices.
OTC sales of licensed medicines can only bemade by a registered pharmacist or an appropri-ately qualified member of pharmacy supportstaff (see Box 15.4) under the supervision of apharmacist. Even GSL products cannot legallybe sold from a registered pharmacy unless apharmacist is in control of the premises; atpresent this means that a pharmacist must bephysically on the premises when a sale is made.
Members of the public sometimes expect allOTC medicines to be completely safe for themto take. It is the pharmacist’s job to ensure thatthe medicine which is sold is appropriate for thepurchaser to use, effective and safe (or as safe asis practicable). No medicine is completely safe.Aspirin, for example, can cause gastrointestinalbleeding in an otherwise healthy young person,although the risk is much higher in an olderperson who has had a stomach bleed in the past.The pharmacist should therefore ensure thatcustomers are aware of how to take their medi-cine, the risks associated with that medicine,
and what to do if a problem occurs. As part ofthe sale, the pharmacist should obtain sufficientinformation from the customer to satisfy them-selves that the medicine is safe and appropriate.The RPSGB Practice Committee (2000) has issuedguidance on the sale of OTC medicines (alsoknown as counter prescribing).This identifiesfive stages in the counter-prescribing process:
• recognising and interpreting the condition• determining the goal of treatment• recommending a treatment• providing advice• recording the intervention (if appropriate).
These stages are described in more detail inBox 15.5.
Pharmacist supervision of OTC sales hasincreased in importance with a series of ‘POM toP switches’ in which a medicine that has previ-ously been available only on prescription (POM)is made available through a pharmacy (P). Thesedrugs have been carefully assessed for their
156 Chapter 15 • Sale and supply of medicines
Box 15.4 Roles and qualifications of pharmacy support staff
Medicines counter assistants
Defined as any assistant who is delegated to sell medi-cines under a protocol (RPSGB, 2006a). They shouldhave taken, or be undertaking, an accredited courserelevant to their duties. Such courses should cover theknowledge and understanding associated with Phar-macy Services S/NVQ Level 2 units entitled; ‘assist inthe sale of OTC medicines and provide information tocustomers on symptoms and products; assist in thesupply of prescribed items (taking in a prescription andissuing prescribed items)’ (RPSGB, 2006a).
Dispensing/pharmacy assistants
These assistants should have completed or be workingtowards qualifications in:
• sale of OTC medicines and provision ofinformation to customers on symptoms andproducts
• prescription receipt and collection, assembly ofprescribed items (including label generation)
• ordering, receiving and storing pharmaceuticalstock
• supply of pharmaceutical stock• preparation for manufacture of pharmaceutical
products (including sterile and non-sterileproduction).
They should be enrolled on a suitable trainingprogramme (e.g. Pharmacy Services S/NVQ Level 2, oran equivalent accredited programme) within 3 monthsof commencing their role and should complete theirtraining within 3 years.
Pharmacy technicians
Should have successfully completed PharmacyServices S/NVQ Level 3 (or equivalent qualifications).Once complete, technicians can volunteer to be onthe Pharmaceutical Register. (There are plans to makeregistration of pharmacy technicians compulsory in thefuture.)
safety to the public, but have the potential tomask more serious conditions if used inappro-priately. Examples of POM to P switches includeomeprazole (sold OTC to treat heartburn, butcould mask stomach cancer if used inappropri-ately) and simvastatin (a cholesterol-loweringdrug available OTC at a dose that has noevidence of benefit; it should not be taken bypatients with, or at a high risk of developing,cardiovascular disease).
Supplying prescribed medicines
In addition to being sold OTC, GSL and ‘P’medicines can also be supplied in response to avalid prescription signed by an appropriatepractitioner such as a doctor, dentist, supple-mentary or independent prescriber. By contrast,POMs can only be supplied in one of threesituations:
Supplying prescribed medicines 157
Box 15.5 Guidance on counter prescribing
Recognise and interpret the condition
• Find out who the patient is – it may not be theperson in front of you.
• Ask what symptoms the patient has, and how longthey have had them for.
• Find out what (if any) other medication they aretaking (or have taken recently) – could this becausing the symptom, or is this another treatmentfor the symptoms?
• Ask if the patient has any other symptoms. If thepatient is in front of you, look for other signs suchas whether or not they look unwell.
• Take particular care if the patient is a baby, infantor child, pregnant or breastfeeding, or elderly.Refer patients who present with potentially serioussymptoms, symptoms of long duration, or from ahigh risk group (if appropriate).
Determine the goal of treatment
• Ask the patient (or their representative) what theywant to achieve with the medicine. Do they wantto cure, reduce, or eliminate their symptoms; arrestor slow the progression of their condition; preventa disease or pregnancy?
• Consider whether the patient’s goal is achievablewith the medicines available from you.
Recommend a treatment
Based on your assessment of the information you haveobtained in the previous two stages, you should recom-mend a treatment for the patient. This could involve:
• giving advice on how to manage the symptomswithout a medicine (self-care) and/or reassurance,
without recommending a medicine or othertreatment
• recommending a medicine or other treatment • referring to someone else such as the patient’s
general practitioner or hospital emergencydepartment, depending on the urgency of thesymptoms.
Provide advice
When making a recommendation, the following adviceor information should be given to the customer:
• why you have chosen this course of action andhow the customer can best achieve the intendedoutcomes
• what assessment you have made of theircondition, any changes that they should monitorfor and what to do if they occur
• how to use the recommended treatment• under what circumstances the customer should
seek further advice, and who they should seekadvice from.
Record the intervention
In order to allow monitoring of the treatment that hasbeen recommended and allow audit of interventions, arecord of the intervention should be made (in appro-priate cases) on a patient medication record system.Reflecting on these interventions can also help developa pharmacist’s continuing professional developmentrecord.
(RPSGB Practice Committee, 2000)
• if a valid prescription is issued by anappropriate practitioner
• under a patient group direction (PGD)• as an emergency supply.
The requirements for a valid prescription aredescribed in Chapters 9 and 10 and in the MEP.
A PGD is a written direction relating to supplyand administration (or administration only) of aPOM to a patient, signed by a doctor or dentist,and a pharmacist. This allows the supply oradministration of a POM to a patient where theconditions specified in the PGD are met.
Pharmacists can make emergency supplies ofPOM medicines at the request of a patient,doctor or a prescribing nurse or pharmacist (butnot a dentist). In order to do this, a pharmacistmust be confident that there is a valid reason forthe request (such as running out of tablets whilston holiday or over a bank holiday), and that avalid prescription has been issued to the patientfor that medicine in the past. Further informa-tion about emergency supplies is available inthe MEP.
Patients’ expectations for the supply ofprescribed medicines
When a patient receives a supply of a prescribedmedicine there is a basic level of service thatthey can expect, governed by the legal andethical considerations of medication supply.Patients expect medication supplies to be acces-sible, accurate, prompt, of appropriate quality,of sufficiently long expiry date, and packagedand labelled for the recipient. Each of theseexpectations is described in more detail below.
• Accessible: patients expect the pharmacy tobe open at the times advertised. If a phar-macy is not open at these times, there are twoconsequences: a breach of the contract withthe primary care trust (PCT) for dispensingNational Health Service (NHS) prescriptions,and loss of revenue because the patient islikely to go elsewhere.
• Accurate: medication supplied to the patientshould be an accurate reflection of themedication prescribed. Patients do not expectdispensing errors to occur.
• Prompt: patients do not expect to wait forlong periods of time for their prescriptions.Where there is likely to be a delay in supplyinga medicine, the patient should be informed ofthis (and the reason why). The patient shouldalso be given the opportunity to take theirprescription elsewhere if this is the case.
• Appropriate quality: patients expect thesupplied medicines to be of a quality that issafe for them to take. Therefore, patientsshould never be supplied with medicines thathavebeenstored inappropriately. Forexample,if fridge monitoring shows that a medicinestored in the fridge has not been kept at theappropriate temperature (usually 2–8°C), themedicine should not be supplied. In addition,medicines returned from patients’ homesshould not be reused because the conditions ofstorage cannot be guaranteed.
• Sufficiently long expiry date: patientsexpect their medicines to be within theexpiry date for the duration of the course. Ifthis is not possible, for example if a 14-daycourse of an antibiotic liquid with a 7-dayexpiry is prescribed, the patient should beable to collect a further supply to enablethem to complete the course.
• Packaged and labelled for the recipient:patients expect to be able to identify whichmedicines are theirs. All dispensed medicinesshould therefore be individually packaged forthat patient, with a label stating only thepatient’s name, name of the medication anddirections stating how to take the medication(also see Chapter 11). Directions should begiven in language that patients can under-stand. This means avoiding legal jargon andcomplex medical or pharmaceutical termi-nology or abbreviations. Even simple direc-tions can be misunderstood by patients, sounderstanding should be checked diplomati-cally before a patient leaves the pharmacy(Davis et al., 2006).
Service expectations for the supply ofprescribed medicines
Simply meeting patients’ expectations for thesupply of prescribed medicines is not enough. In
158 Chapter 15 • Sale and supply of medicines
addition, there are legal and ethical considera-tions associated with the supply of medicinesthat patients may be unaware of. These set theminimum standards for supplying prescribedmedicines to patients and are described in detailbelow.
• A prescribed medicine should always besupplied under the supervision of a pharma-cist. This means that the pharmacist musthave assessed the prescription, either beforeor after the medicine has been dispensed (butbefore it is supplied to the patient).
• A pharmacist must make a professionalassessment of the prescription. This shouldencompass whether the prescription is legal(is all the appropriate information on theprescription and is the pharmacist confidentthat the prescription is not a forgery?) andwhether the prescription is appropriate.Judgements regarding the appropriatenessof the prescription should be made based onthe available information, such as patientage, other medication on the prescription,medication on the patient medication record(PMR), prescription charge exemption (preg-nancy, diabetes, etc.), and questioning thepatient if appropriate.
• Every pharmacy should have procedures inplace to minimise the risk of a dispensingerror, or contamination of a medicine withanother substance.
• If the prescribed medicine is a product withan MA, then this product should be supplied(rather than a product prepared in thepharmacy or a cheaper product without anMA).
• Prescribed medicines cannot be substituted ina community pharmacy. Thus the specificbrand or strength of medicine prescribedshould be dispensed. If that brand or strengthis not available, it should be ordered in, orthe prescriber should be contacted to confirmthat an alternative brand or strength can besupplied (and the prescription amendedaccordingly). (See Chapter 10, page 104, forguidelines on endorsing prescriptions.)
• Child-resistant closures (CRCs) should beused on all medicines, unless a patient specif-ically requests otherwise. If such a request
is made, it should be documented on thepatient’s PMR.
• All dispensed medicines should be suppliedwith clear, legible, indelible labels. Labelsshould include appropriate additionalcautions and warnings. A list of additionalwarning labels is provided in Appendix 9 ofthe BNF (see Chapter 11).
• If the full quantity required on a prescrip-tion cannot be supplied, the patient shouldbe offered the opportunity to take theprescription elsewhere.
• The dispensed medicines should be supplieddirect to the patient or carer whereverpossible.
Supplying unlicensed medicines
Under the Medicines for Human Use (MarketingAuthorisations, etc.) Regulations 1994, certainmedicinal products that do not have an MA canbe supplied in response to a valid prescriptionsigned by a doctor, dentist or supplementaryprescriber for use by an individually namedpatient (MHRA, 2006b). When a prescriberissues such a prescription, they take on respon-sibility for any adverse events resulting from theuse of the medicine. (If a medicine has an MA,then the manufacturer will take some responsi-bility for adverse events resulting from the use ofthe medicine within its licence.) The pharmacistsupplying the unlicensed medicine may alsotake on some responsibility for adverse events.
When a pharmacist supplies an unlicensedmedicine they should consider the followingpoints.
• Is supplying the medicine in the best interestof the patient? This decision should be basedon the evidence base for the prescribed medi-cine; the availability of alternative treatmentsfor the patient’s condition; and whether thepatient has tried these alternatives.
• A pharmacist can refuse to supply the medi-cine if the risks to the patient appear tooutweigh the potential benefits.
If the pharmacist decides to supply the medicine,they should:
Supplying prescribed medicines 159
• ensure that the patient is aware the medicineis unlicensed, but without underminingconfidence in the medicine or the prescriber
• keep a record for 5 years of the: source of theproduct; person to whom, and the date onwhich, the product was sold or supplied;quantity of each supply; batch number of theproduct supplied; details of any adverse reac-tions to the product (any serious suspectedadverse reactions should be reported to theMHRA via the Yellow Card Scheme (seeChapter 3, page 27), indicating that theproduct is unlicensed).
Further information on the supply of unlicensedmedicines is available from the MHRA (2006b),and the RPSGB (2004).
Preventing errors when selling orsupplying medicines
As discussed in Chapter 6, errors are inevitableduring the working life of a pharmacist.However, every pharmacist has an ethicalresponsibility to minimise the risk of errorsoccurring. Pharmacists can be removed from thePharmaceutical Register if they repeatedly makeerrors in the course of their work (this has seriousimplications for their conscience as well as theirfinancial wellbeing). There is also a legal incen-tive to minimise errors because pharmacists canbe prosecuted if a patient is harmed as a result ofa dispensing error or failure to correct a high-riskprescription (see Boxes 15.11–15.14).
Dispensing errors
Dispensing errors are a relatively uncommon –but nevertheless important – area of risk incommunity pharmacy, with the potential tocause harm to the patient and possibly result incriminal proceedings against the pharmacist. Incommunity pharmacy, at least four incorrectitems per 100 000 items dispensed will behanded out to patients (Ashcroft et al., 2005),with a further 22 incorrect items per 100 000items dispensed identified at the checking stage
(near misses). These figures are likely to under-estimate the actual number of near misses anddispensing errors that occur in communitypharmacy.
The most common types of dispensing errorare:
• selecting the wrong drug, or wrong quantityor strength of drug
• making a mistake on the label• putting the wrong medicines in a patient’s
bag.
Pharmacists are more likely than any othermember of the pharmacy support staff to makedispensing errors that reach patients becausethe medicines they dispense often do notreceive a second check from another person(Ashcroft et al., 2005). Pharmacy support staffalso make a large number of errors that aresubsequently identified at the final check. Manyfactors are associated with an increased risk ofdispensing errors; some of which are shownin Box 15.6 (Ashcroft et al., 2005). Althoughsecond checking of prescriptions is known toreduce the risk of dispensing errors reachingpatients, over a quarter of prescriptions aredispensed by the pharmacist alone, with nosecond check by another member of staff(Ashcroft et al., 2005). This practice should beavoided wherever possible. To help pharmacistsreduce the risk of errors occurring, a frameworkof practice called clinical governance (describedbelow) has been introduced.
160 Chapter 15 • Sale and supply of medicines
Box 15.6 Factors that may contribute to dispensingerrors in community pharmacy
• Poor lighting• Distractions and interruptions• Look-alike and sound-alike medicines• Inexperienced staff• Stress• High workload or insufficient staff members• Dispensing large numbers of prescriptions• Pharmacist fatigue• Misreading prescriptions• Selecting the wrong medication from a patient
medication record
Clinical governance
Clinical governance is one of the ways in whichpharmacists ensure the delivery of a high-quality service to members of the public. Itincorporates a number of tools that individualpharmacists and pharmacy employees can useto improve the level of service they provide.When the level of service is improved, the riskof errors occurring is reduced. Further infor-mation on clinical governance is availablefrom the RPSGB website (www.rpsgb.org/registrationandsupport/clinicalgovernance) andthe MEP. The different processes involved inclinical governance are described below.
Accountability
Pharmacists are accountable for their individualprofessional practice and the standards of serviceprovision in their pharmacy. They are thereforeresponsible for ensuring that the dispensingof medicines, policies and procedures, clinicaladvice given to patients and professionals abouttreatment, and sale and supply of medicines areperformed to such a level that the risk of errorsis minimised.
Audit
Audit is defined by the RPSGB as the ‘systematicevaluation of professional work against set stan-dards’ (MEP). Every community pharmacy mustcarry out at least two audits annually. The subjectof one of these audits will be directed by thelocal PCT as part of the community PharmacyContract; the subject of the second audit can beselected by pharmacy staff to make it relevant totheir practice and customer base. Communitypharmacies are not limited to conducting twoaudits a year. The RPSGB has prepared a numberof audit templates that pharmacies may wishto undertake, including: the accuracy andcompleteness of PMRs, the dispensing process,recording of interventions on prescriptions,provision of patient counselling, and prescrip-tion waiting times. The templates for theseand many other audits are available fromwww.rpsgb.org/registrationandsupport/audit/index.html.
Clinical effectiveness
For a pharmacist to be able to identify prescribingerrors (or high-risk prescriptions) and to be ableto provide a safe counter prescribing service, theymust be aware of current evidence for treatmentsand apply this to their practice. Part of the appli-cation of this knowledge to their practice shouldinvolve monitoring patients’ care, includingdrug interactions and adverse drug reactions.Where a pharmacist judges it to be clinicallynecessary, they should contact the patient’sgeneral practitioner and advise them of any riskto the patient. This contact should be recorded asan intervention on the patient’s PMR. Guidanceon recording interventions is available from theRPSGB (2006a).
Continuing professional development
One way to ensure clinical effectiveness isto undertake continuing professional develop-ment (CPD), defined in the MEP as a ‘frameworkfor maintaining professional competence’. CPDinvolves a cyclical process of learning (seeFigure 15.1) which allows you to identify learningneeds from day-to-day practice instead of relyingon the provision of continuing education.
CPD can be undertaken in a number ofdifferent forms, including workshops, distancelearning courses, conferences, structured read-ing, talking to colleagues, everyday practice,staff meetings, professional audits and researchprojects, preparing teaching for others, and
Preventing errors when selling or supplying medicines 161
Reflect on whatyou need to know
Plan how youwill learn
Learn
Evaluate what youhave learned
Figure 15.1 Learning cycle for CPD.
work shadowing. Individual pharmacists shouldselect the type of learning that suits them best.Pharmacists are advised to record 12 entries overthe course of a year in order to comply with themandatory CPD framework. Further informa-tion on CPD is available from the CPD websitewww.uptodate.org.uk.
Patient and public involvement
Knowing whether the service you providemeets patients’ expectations is difficult if youdon’t ask them. The RPSGB therefore expectspharmacists with an NHS contract to undertakea patient satisfaction survey at least annually.This will help pharmacists to tailor the servicesthey provide to meet the needs of the localpopulation.
Remedying underperformance
Pharmacists should use CPD to ensure that theyupdate themselves on subject areas that theyare unsure about. Pharmacists who are notperforming to the standards expected by theRPSGB should be identified at a local level andthe cause of their substandard performanceaddressed. Where lapses in standards are shortterm and do not pose a risk to patients, these
can be dealt with informally. If, however, thelapse is long term (e.g. related to a drug oralcohol problem) then it should be dealt withformally and, if necessary, the pharmacistremoved from duties to prevent any risk topatients whilst the problem is addressed. Furtherinformation on how underperformance is dealtwith is available from the RPSGB (2005b).
Risk management
Risk has been defined in numerous ways, butone of the most simple approaches is to think ofrisk as, ‘the potential for an unwanted outcome’(Butler, 2005). The aim of risk management is toget it right first time, avoiding an unwantedoutcome. Risk management is an opportunity toassess whether an unwanted outcome is possible(evaluating the potential risk of it occurring),how likely it is to occur, and how the unwantedoutcome can be avoided (developing potentialsolutions). Pharmacists should ensure thatrobust risk management procedures are in place.These should include:
• proactively identifying potential risks• retrospectively recording (see Box 15.7):
– errors (e.g. where the wrong medicine isgiven to a patient)
162 Chapter 15 • Sale and supply of medicines
Box 15.7 Near miss and error reporting
All pharmacies should maintain a record of near missesand errors. For this record to be useful, it should be regu-larly reviewed to identify common trends. This informa-tion can then be used to develop new working practicesto avoid these near misses and errors in the future. Forexample, two drugs with similar names may be storedclose to each other on the shelves, resulting in frequentdispensing errors. By separating these drugs, or stickingwarning labels on the shelves, the number of dispensingerrors could be reduced. In some cases (particularlywhere an error has reached a patient, or where a nearmiss is particularly common) an in-depth investigation ofthe cause of the error or near miss will be warranted.This will involve talking to members of staff (and thepublic) involved in the incident, collating relevant docu-mentation such as standard operating procedures and
dispensing records, and reviewing this evidence to iden-tify possible causes of the error. The ultimate aim of thisprocess, known as root cause analysis, is to amendworking practice to avoid a similar error occurringagain. This process is time consuming and thereforecannot be applied to all near misses.
Some chains of pharmacies (or independent phar-macies who work closely together) may share theirnear miss reporting across the group. This allows indi-vidual pharmacies to learn from mistakes that havehappened elsewhere, further reducing the risk topatients. In addition, some pharmacies may submittheir near miss and error reports to the NationalReporting and Learning Scheme, which is a nationalerror reporting scheme that receives error reports fromall areas of healthcare practice in England.
– near misses (e.g. where the wrong medicineis dispensed, but identified duringchecking)
– adverse events (e.g. where a patient,member of the public or staff member isinjured)
• developing potential solutions, including:– standard operating procedures (SOPs) (see
Box 15.8)– recording interventions made with
prescribers (RPSGB, 2006b)– developing a procedure for dealing with
complaints– adequate procedures for checking stock
rotation and expiry dates– keeping appropriate records of fridge
temperatures, which are reviewed regularlyand acted on if fridge temperatures areoutside the recommended range.
Staff management
Community pharmacists are responsible formanaging the staff working in their store(s).
Managers of individual pharmacies are res-ponsible for managing the pharmacy supportstaff (medicines counter assistants, dispensing/pharmacy assistants and technicians). Managersof chains of stores are also responsible formanaging other pharmacists, including locums.Part of a manager’s responsibility is to ensurethat all staff are appropriately qualified and allstaff (including locums) receive an appropriateinduction before they start work. Further infor-mation on the necessary qualifications for phar-macy support staff can be found in the MEP(also see Box 15.4).
When mistakes are made
It is inevitable that every pharmacist will make amistake at some point in their career, althoughwith luck and good risk management thesemistakes will not result in patient harm. Whenmistakes do reach patients, however, they arelikely to be upset, whether or not they have
When mistakes are made 163
Box 15.8 Standard operating procedures (SOPs)
SOPs provide a detailed description of the processes tobe followed within individual pharmacies. The topicswhich should be covered, as a minimum, include:
• prescription handling • assessing the prescription for validity, safety and
clinical appropriateness (the clinical orprofessional check)
• making interventions and problem solving • assembling and labelling the required medicine or
product • accuracy (or final) checking• transfer of the medicine or product to the patient.
Individual pharmacists or pharmacy managers maychoose to develop additional SOPs for other areas ofpractice. Pharmacists who delegate tasks to membersof the pharmacy support staff must detail within theirSOPs the necessary qualifications for an individual toundertake that task.
SOPs should be followed wherever this is practi-cable, irrespective of whether the pharmacist who
wrote the SOP is present within the pharmacy. SOPsshould, however, allow sufficient flexibility to avoid asituation in which staff deliberately do not follow theSOP because it is too onerous. This is best achieved byincluding staff in the development of SOPs.
Well-written and appropriately used SOPs can helpto:
• assure the quality and consistency of the serviceprovided by a pharmacy
• ensure that good practice is achieved at all times• fully utilise the expertise of all members of the
pharmacy team• enable pharmacists to delegate appropriate tasks,
freeing up time for other activities• clarify who does what in the pharmacy • provide advice and guidance to locums and
part-time staff and train new members of staff.
Guidance on producing SOPs is available from theRPSGB (2001).
been harmed. Sometimes mistakes will be iden-tified by the pharmacy staff, but more often thepatient or their relative will identify the errorand return to the pharmacy.
When a patient experiences a physical injuryas a result of a dispensing error, this is a majorthreat to trust between the patient and the phar-macist or pharmacy. ‘Trust is the cornerstone ofthe [pharmacist]–patient relationship . . . thattrust is sharply challenged when things gowrong’ (Leape, 2007). When a patient is harmedby a medication error, there is likely to be anemotional injury in addition to a physicalinjury, both of which must be treated appropri-ately to reduce the risk of long-term harm to thepatient and their relationship with the pharma-cist. But it is not just the patient who will bedistressed; relatives and the members of staffinvolved can also become distressed (Leape,2007). How pharmacy staff respond to apatient or relative informing them of an errorcan dramatically impact on the patient’s well-being, the staff’s wellbeing and the likelihoodof litigation.
Process for complaints
Patients have a number of different routes bywhich they can report a dispensing error. Somewill come direct to the pharmacy, others to theirgeneral practitioner, the PCT, their solicitoror the RPSGB. The RPSGB provides guidanceto members of the public on how to makecomplaints (2005a). Each move up thiscomplaint chain is an escalation in terms of theseverity of the complaint and potential impacton career and finances. If a patient or relativebrings a complaint direct to the pharmacy it isbest to mitigate the risk of an escalation at firstcontact through good communication.
The RPSGB (2006c) has produced guidanceon how to handle patient complaints in orderto minimise the distress caused to all parties,summarised in Box 15.9. Further guidance isoffered by Leape (2007) who highlights theimportance of apologising and maintainingopen communication with the patient. Manypeople faced with a complaint are frightened ofapologising in case this increases the risk of
litigation. There is no evidence to support thisrisk, however. Instead, studies have shown thatapologising reduces the risk of litigation (or ifa claim is made, the cost of the claim) (Leape,2007). By apologising, you are showingcompassion to the patient for what hashappened. In addition, explaining to the patientwhat has happened, why it happened, and whatyou will do to prevent a recurrence showsrespect to the patient and mitigates theirsuffering. In contrast, withholding informationor pretending that nothing has happened showsarrogance and disrespect, destroys patients’ trustin you and confirms their suspicion thatsomething has gone wrong.
Professional negligence
One of the biggest fears a pharmacist may haveduring a complaint is the risk of an action forprofessional negligence through the civil courtsor a conviction through the criminal courtsunder the Medicines Act (or for manslaughter).This is possible if negligence can be proved.Fortunately, civil court proceedings are rare, andcriminal court proceedings even rarer. In 2002,the Chemists Defence Association received 241claims for compensation against pharmacistsor employers (Thompson, 2003). Of these,197 involved medication-related incidents, themajority of which were dispensing errors; only13 related to OTC sales. Although court proceed-ings are rare, the incidence is increasing year onyear.
Charges of misconduct made by the StatutoryCommittee of the RPSGB are more likely thancourt proceedings. A charge of misconduct iseven more likely if a pharmacist has mademultiple mistakes, failed to address the causesof these mistakes, or appeared indifferent tothe consequences of these mistakes (Appelbe &Wingfield, 2005b). Examples of pharmacistsreceiving reprimands (or being struck off thePharmaceutical Register) can be found in thePharmaceutical Journal. These serve as a usefulwarning to trainee pharmacists.
When a court determines professional negli-gence, three factors are taken into account(Appelbe & Wingfield, 2005b):
164 Chapter 15 • Sale and supply of medicines
• Was the patient owed a duty of care?• Did the pharmacist fail to discharge that
duty?• Has the patient suffered harm as a result?
Where all three factors are found, negligence canbe proved. If a pharmacist has supplied a medi-cine to a patient (either on a prescription orthrough an OTC sale) they will be deemed tohave a duty of care to that patient (this may alsobe true if they have refused or failed to supply amedicine that a patient has requested). A phar-macist (or pre-registration pharmacist) may beliable for prosecution for inaccurately dispensinga safe prescription, or for accurately dispens-ing a harmful prescription without querying it
with the doctor. Examples of cases where phar-macists have been prosecuted are shown inBoxes 15.10–15.14. These cases illustrate theimportance of both the professional (clinical)and accuracy (final) checks when dispensingprescriptions. In a case where a doctor haswritten a potentially harmful prescription that isunquestioningly dispensed by the pharmacistand causes harm to the patient, both the doctorand the pharmacist will be liable.
How is blame apportioned between prescribersand pharmacists?
In cases where a pharmacist dispenses a pre-scription and a patient is injured as a result, the
When mistakes are made 165
Box 15.9 How to manage complaints about dispensing errors
When a patient makes a complaint about a dispensingerror, this must take precedence over other tasks awaitingyour attention. If you are seen to take the complaintseriously, and act professionally, the complaint is lesslikely to escalate.
1. Establish whether the patient has taken themedicine.
2. If the patient has taken the medicine, have theybeen harmed by it? This may require someinvestigation, including contacting the localmedicines information service to identify possibleeffects of the drug taken.
3. If the patient has been harmed, recommend anappropriate course of action (e.g. referral to thegeneral practitioner (GP) or hospital emergencydepartment, depending on the severity of theharm.
4. If the patient has taken the medicine, report this totheir GP, irrespective of whether you believe thepatient to have experienced any harm.
5. Ask to inspect the medicine that has beendispensed in error. Explain this will help you toidentify what has gone wrong. Do not dispose ofthe medicine.
6. If an error has been made, apologise to thepatient on behalf of the owner of the pharmacyand the pharmacist who made the error (even ifyou have made the error). This is not an admissionof liability, but is likely to reduce the chance of the
complaint escalating. Do not minimise theseriousness of the error, as this is likely toantagonise the patient, undermine theirconfidence in you, and increase the risk oflitigation.
7. Explain to the patient that you need toinvestigate the cause of the error further, in orderto prevent such an event happening again. Aspart of this investigation, it would be useful tospeak to whoever presented the prescription inorder to find out more about conditions in thepharmacy on that day (e.g. was it busy, werethere any obvious distractions?) This does notneed to be done immediately. Instead, it may behelpful to take contact details for the patient andcontact them at a more convenient time.
8. Dispense the correct medicine against theoriginal prescription to ensure that the patienthas a safe supply.
9. If the patient wishes to make a complaint toanother body, give them the contact details ofthe Fitness to Practise and Legal AffairsDirectorate at the RPSGB and the complaintsoffice at the local primary care trust.
10. Inform your professional indemnity insurers thatyou have made a mistake, in case a claim ismade against you.
11. Follow the procedures in the pharmacy forreporting dispensing errors.
pharmacist may be considered jointly liablewith the prescriber. There have been a numberof cases in which pharmacists have been heldjointly liable with the doctor when a patient hasbeen injured as a result of a prescribed drug. Theproportion for which the pharmacist is liablevaries from case to case, depending on indi-vidual circumstances. In the cases illustrated inBoxes 15.11–15.14, the pharmacist’s liabilityranged from 25% to 75%, on the basis of howlikely it was that the pharmacist could haveaverted the injury. For instance, in the casewhere a prescription for Amoxil was misread asDaonil (Box 15.13), the pharmacist carried 75%liability because they dispensed the wrong drug.The prescriber carried 25% liability because theywrote an illegible prescription. In the casespresented in Boxes 15.11 and 15.12, the phar-macist carries a little under half the liabilitybecause they dispensed what was prescribed, buthad adequate information available to them torecognise that the prescription was an overdose.Based on this information, the pharmacistshould have intervened and contacted theprescriber.
166 Chapter 15 • Sale and supply of medicines
Box 15.10 Case study: preparing peppermintwater with concentrated chloroform water
In 1998, a pharmacist and pre-registration pharma-cist were charged with manslaughter after dispensingto a 3-week-old child peppermint water that had beenprepared incorrectly with concentrated chloroformwater (PJ, 2000). The manslaughter charges wereeventually dropped but both parties were chargedunder the Medicines Act 1968 for supplying a medi-cine not of the nature or quality demanded. Twoyears later, the pharmacist was fined £1000 and thepre-registration pharmacist £750, based on theirability to pay. Their employer, Boots the Chemist,subsequently paid an undisclosed sum in damages tothe family.
Box 15.11 Case study: dispensing a dexamethasoneoverdose
In July 2001 a GP in the UK prescribed 28 days’supply of dexamethasone at a daily dose of 4 mg(PJ, 2006a). This was eight times the maintenancedose of 0.5 mg that the patient had taken for anumber of years. The prescription was dispensedwithout contacting the doctor.
The increased dose was continued by thepatient’s regular doctor in the USA after he read thedispensing label. By the end of October, the patientdeveloped Cushing’s syndrome, requiring multiplehospital admissions and leaving her unfit for workfor many months.
In this case the GP responsible for prescribing theexcessive dexamethasone dose paid an undisclosedsum to the patient in an out-of-court settlement. LloydsPharmacy Ltd was subsequently required to paydamages because it was reasonably expected thatthe pharmacist should have questioned the doseincrease (despite the dose being in the usualtherapeutic range for dexamethasone) rather thandispensing the dexamethasone as prescribed (PJ,2006b).
Box 15.12 Case study: dispensing an overdose ofMigril
In 1982, a pharmacist dispensed Migril (ergot-amine, cyclizine and caffeine) for a patient onthe basis of a GP prescription (Ferguson, 1997).Neither the GP nor the pharmacist noted that theprescribed dose was an overdose and neitherwarned the patient about the maximum daily doseof Migril. The patient subsequently took too muchMigril and developed gangrene in both legs,requiring extensive surgery.
The patient was awarded £100 000 indamages. The owner of the pharmacy was liable for40% of these damages (£40 000) because theyshould have queried the maximum dose with the GPand provided adequate counselling to the patient(PJ, 1982).
Summary
Supplying medicines to members of the publicis a major role for pharmacists that carries amassive responsibility to ensure that theirsupply is safe and effective. Whilst undertakingthis role, pharmacists should be aware of thenumerous laws, acts and regulations that governmedicine supply in the UK. Pharmacists shouldensure that they use effective risk managementstrategies to reduce the risk of errors occurring.This in turn reduces the risk of harm tomembers of the public. Even with stringent riskmanagement strategies in place, however, errorswill occur. Pharmacists need to be aware of howto deal with these errors to minimise harm tothe patient, themselves and their business. Incases where patients are injured as a result of anerror, pharmacists may be subject to prosecutionand liable to pay damages. The amount paid willdepend on the severity of injury and the assess-ment of shared liability between the pharmacistand prescriber.
References
Appelbe G E, Wingfield J (2005a). Dale and Appelbe’sPharmacy Law and Ethics, 8th edn. London:Pharmaceutical Press.
Appelbe G E, Wingfield J (2005b). Professionalconduct. In: Dale and Appelbe’s Pharmacy Law andEthics. London: Pharmaceutical Press, 284–296.
Ashcroft D, Morecroft C, Parker D, et al. (2005). Patientsafety in community pharmacy: Understanding errorsand managing risk. University of Manchester.www.rpsgb.org/pdfs/patsafcommph.pdf
Butler C P (2005). Practical risk management. In:Kayne, SB, ed. Pharmacy Business Management.London: Pharmaceutical Press, 123–153.
Chemist & Druggist (2000). Pharmacy contributes tooverdose damages. Chemist Druggist 253: 5.
Davis T C, Wolf M S, Bass P F III, et al. (2006). Literacyand misunderstanding prescription drug labels.Ann Intern Med 145: 887–894.
European Medicines Evaluation Agency (EMEA)(2007). EPARs for authorised medicinal productsfor human use. www.emea.europa.eu/htms/human/epar/eparintro.htm (accessed 30 May2007).
References 167
Box 15.14 Case study: dispensing an overdose ofEpilim without contacting the doctor
In 1989, a GP prescribed Epilim (sodium valproate)500 mg four times daily, which was dispensed by thepharmacist without question (Chemist & Druggist,2000). The patient normally took Epilim 200 mg fourtimes daily, and suffered irreversible injuries as aresult of the 2.5-fold increase in dose.
The patient sued the GP, who claimed that thepharmacist should have identified the inappropriatedose increase and intervened.
The pharmacy agreed to contribute 25%towards the final damages awarded to the patient.
Box 15.13 Case study: dispensing Daonil insteadof Amoxil
In 1983, a GP prescribed Amoxil (amoxicillin) for apatient for a chest infection. The prescription wasbadly written and the pharmacist mistakenlydispensed Daonil (glibenclamide, a drug used totreat non-insulin-dependent diabetes) instead ofAmoxil.
The patient fell into a coma, was in hospital for5 months and suffered irreversible brain damage asa result. Following this, he was unable to care forhimself, let alone work.
The judge presiding over the case determinedthat the pharmacist had not been paying sufficientattention to his work. The judge felt that the dose(one to be taken three times a day instead of oncea day as would be normal for Daonil) (Ferguson,1997) and quantity prescribed should have alertedthe pharmacist to the error. The pharmacist claimedhe had contacted the GP to check the prescriptionand warned the patient’s relative of the potentialdanger of the prescription when the Daonil wascollected. There was, however, no written evidenceof this.
The judge declared that the pharmacist’s negli-gence had been triggered by the GP’s poor hand-writing and therefore that both parties were culpable.The patient received £138 147 in compensation,75% from the pharmacist.
Ferguson P R (1997). The legal liability of the commu-nity pharmacy for personal injury caused by medi-cinal products: (1) Liability for negligence. Pharm J258: 133–135.
Leape L (2007). When things go wrong. InternationalForum on Quality and Safety in Health Care.Barcelona, Spain.
Medicines and Healthcare products Regulatory Agency(MHRA) (2006a). Marketing authorisations. Latestversions available from www.mhra.gov.uk.
Medicines and Healthcare products Regulatory Agency(MHRA) (2006b). The supply of unlicensed relevantmedicinal products for individual patients. MHRAGuidance note no. 14. Available from www.mhra.gov.uk
PJ (1982). 40 Percent of damages in overdose caseawarded against pharmacy company. Pharm J 228:205.
PJ (2000). Boots pharmacist and trainee cleared ofbaby’s manslaughter, but fined for dispensing adefective medicine. Pharm J 264: 390–392.
PJ (2006a). Lloyds pharmacy fighting £5m damagescase. Pharm J 277: 440.
PJ (2006b). Lloyds pharmacy ordered to pay compen-sation after steroid error. Pharm J 277: 595.
Royal Pharmaceutical Society of Great Britain PracticeCommittee (2000). Guidance on counter pre-scribing. Pharm J 265: 359.
Royal Pharmaceutical Society of Great Britain (RPSGB)(2001). Developing and implementing standardoperating procedures for dispensing. www.rpsgb.org/pdfs/sops.pdf.
RPSGB (2004). The use of unlicensed medicines inpharmacy. www.rpsgb.org/pdfs/factsheet5.pdf.
RPSGB (2005a). Royal Pharmaceutical Society of GreatBritain guidance on making complaints against regis-trants and owners of pharmacies. www.rpsgb.org/pdfs/ftpcomplaintsprocsguide.pdf.
RPSGB (2005b). Interim guidance from the RPSGB:Identifying and remedying pharmacist poor perfor-mance in England and Wales. www.rpsgb.org/pdfs/pharmpoorperf0501.pdf.
RPSGB (2006a). Improving pharmacy practice. In:Medicines, Ethics and Practice. A Guide for Pharma-cists and Pharmacy Technicians, 30th edn. London:Pharmaceutical Press, Chapter 4, 105–111.
RPSGB (2006b). Guidance on recording interventions.www.rpsgb.org/pdfs/recinterventionsguid.pdf.
RPSGB (2006c). Dealing with dispensing errors. www.rpsgb.org/pdfs/factsheet8.pdf.
RPSGB (2007). Code of ethics for pharmacists andpharmacy technicians. London: Royal Pharmaceu-tical Society of Great Britain; www.rpsgb.org/protectingthepublic/ethics/
Thompson M (2003). Trends in claims for pharmacists’errors. Pharm J 270: 9.
168 Chapter 15 • Sale and supply of medicines
Aims of drug administration
The aim of drug administration is to deliver atherapeutic concentration of drug to the desiredsite of action. The route selected will determinetime to onset of action and plasma concentrationachieved (Winfield & Richards, 2004). A detaileddescription of drug absorption and distributionis beyond the scope of this book; however, themajor routes of drugs administration will bedescribed and discussed. Basic Clinical Pharmaco-kinetics (Winter, 2003) provides more detailedinformation about pharmacokinetics andpharmacodynamics.
The route chosen depends on several factors(Winfield & Richards, 2004):
• how quickly the drug’s action is required• routes available • site of action• properties of the drug • desired duration of drug action.
Note: Commonly used abbreviations for eachroute, derived from the English or Latin for thatroute, are provided in brackets.
Enteral routes
Enteral routes refer to the administration of adrug via the gastrointestinal (GI) tract.
Oral
The oral route (sometimes given as p.o., fromthe Latin per os) is the most frequently usedroute for the administration of drugs. It involvestaking a dosage form by mouth and swallowingit. The most common oral dosage forms aretablets, capsules and liquids. Drugs taken orallymay have a local or systemic effect. For example,liquid antacids are taken to have a local effect byreducing pH in the stomach, whereas an anti-hypertensive tablet is taken to be absorbed intothe circulation and thus have a systemic effectto reduce blood pressure.
Solid dosage forms taken for a systemic effectmust dissolve or disperse in the stomach so thatthe drug can be absorbed into the blood, andexert an effect; most absorption occurs in thesmall intestines. Some tablets or capsules have a
Aims of drug administration . . . . . . . . . 169
Enteral routes . . . . . . . . . . . . . . . . . . . 169
Drug delivery across mucousmembranes . . . . . . . . . . . . . . . . . . . . . 171
Topical drug delivery . . . . . . . . . . . . . . 172
Inhalation drugs. . . . . . . . . . . . . . . . . . 175
Parenteral routes . . . . . . . . . . . . . . . . . 176
References. . . . . . . . . . . . . . . . . . . . . . 180
16Major routes of drug administration
Kate E Fletcher
169
special coating (enteric coating) that is resistantto acid, thus preventing its breakdown in theacidic environment of the stomach, allowing itto pass into the more alkaline environment ofthe small intestine before dissolving and beingabsorbed. An enteric coat may be used to protecta drug that is made inactive by acid (e.g.omeprazole); to ensure that a tablet containing adrug that irritates the stomach lining does notdissolve in the stomach and therefore causeirritation (e.g. aspirin or prednisolone); or toprotect a drug that exerts a local effect in thesmall or large intestine (e.g. mesalazine used forthe treatment of ulcerative colitis).
The oral route has the following advantages:
• it is safe, easy and non-invasive• tablets and capsules are easily portable• patients can administer the drug to them-
selves easily
and the following disadvantages:
• relatively slow onset of action• absorption may be affected by stomach
contents• absorption may be irregular• drugs absorbed from the GI tract are subject
to metabolism in the liver, which may reduceefficacy (‘first-pass effect’)
• not suitable for patients with compromisedswallow (e.g. patients who have had a strokeor are unconscious or vomiting) (Winfield &Roberts, 2004).
Enteric tubes
If a patient is not able to swallow normally, it issometimes necessary to place a tube into theirGI tract, which enables food, in the form ofenteral feeds (a liquid containing the completenutritional needs of the patient, i.e. lipids,proteins, glucose, vitamins, minerals and fibre)and medications to be given. Patients might notbe able to eat normally for various reasons: theymay have a compromised swallow (as above),they may be unconscious (e.g. a patient inintensive care), or they may have had surgery tothe oesophagus.
The most common tube used is a nasogastric(NG) tube, which is passed through the nose
and down into the stomach. Less commonlyused is the nasojejunal (NJ) tube, which passesthrough the nose and down into the jejunum.Following the insertion of a NG tube, a smallamount of the tube contents are withdrawn(aspirated) from the tube to check the pH; a pHbelow 5 indicates that the tube is in thestomach; a pH above 5 indicates the tube hasbeen misplaced into the lungs. This method canbe unreliable however, and the best way tocheck the placement of any tube is by X-ray. Aradio-opaque strip renders the tube visible on X-ray. A NJ tube may be used instead of a NG tubeif the patient has gastroparesis (failure of thestomach to empty into the duodenum due tolack of gastric motility), as fluids passed down aNG tube would not be absorbed.
If a tube cannot be passed through the nose,or if long-term enteral feeding is anticipated, anenterostomal tube may be placed. This entailsforming a stoma (opening) through the skin ofthe abdomen, and placing the tube directly intothe stomach or small intestine. A commonexample of this type of tube insertion is the
170 Chapter 16 • Major routes of drug administration
Nasogastrictube
Percutaneousendoscopicgastrostomytube
Nasojejunaltube
Jejunum
Colon
Ileum
Rectum
Anus
Stomach
Figure 16.1 Positioning of a nasogastric tube, nasoje-junal tube and a percutaneous endoscopic gastrostomytube. A percutaneous endoscopic gastrostomy tube canalso be placed in the jejenum.
percutaneous endoscopic gastrostomy (PEG):the patient is sedated or anaesthetised and,using an endoscope to visualise the interior ofthe stomach, the tube is passed through a stomaformed between the stomach and the skin of theabdomen. Internal and external retainers holdthe tube in place. Placement of a tube into thejejunum in a similar fashion is known as apercutaneous endoscopic jejunostomy (PEJ).
Drugs may also be given via PEG and PEGtubes, but certain criteria must be considered.
• It is important not to block the tube; it istherefore important to consider whether thedrug is available in a form suitable for givingvia a tube (i.e. a liquid, soluble or dispersibleform). Some liquid or dispersible formula-tions are quite thick, and so may not be suit-able for tube administration, or may need tobe diluted before administration. If a suitableliquid, soluble or dispersible form of a drugdoes not exist, it might be possible to crusha tablet form or open a capsule, mix thepowder in water and, using a syringe, givethe mixture via the tube. Note however thatthis renders the drug unlicensed, as itinvolves manipulation of the product.
• Some drugs (e.g. the anticonvulsant pheny-toin), can interact with the enteral feed,which can reduce the efficacy of the drug.This can be avoided by stopping the feed foran interval (typically 2 hours) to allow thefeed to pass from the tube site along theGI tract, giving the drug, waiting another2 hours for the drug to leave the tube site,and then restarting the feed. This can be diffi-cult to manage, especially if the drug is givenmore than once a day, because enteral feedsoften run for most of the day. This can beresolved in some patients running the feedovernight, but the patient must be able totolerate a higher flow rate for the feed.
• Drugs delivered via a PEJ directly into thesmall intestine can have an osmotic effect onthe GI tract and cause diarrhoea. The mecha-nism of this is the same as that of osmoticlaxatives: the drug, which has a higherosmotic potential than the GI tract contents,absorbs water and increases in volume. Thisincrease in bulk stimulates peristalsis andtherefore stimulates evacuation of the bowels.
Particular care should be taken with liquidscontaining sweeteners such as sorbitol, asthese can have a pronounced osmotic laxativeeffect.
More detailed advice on administration of drugsvia feeding tubes is provided in the Handbook ofDrug Administration via Enteral Feeding Tubes(White & Bradnam, 2007) and The NEWT Guide-lines for Administration of Medication to Patientswith Enteral Feeding Tubes or Swallowing Difficulties(Smyth, 2006).
Drug delivery across mucousmembranes
This includes the sublingual (SL) and buccalroutes and vaginal and rectal administration.
Sublingual and buccal routes
These routes deliver drugs across the oral mucousmembrane to the systemic circulation. The SLroute involves placing a tablet or directing aspray under the tongue. Glyceryl trinitrate (usedto treat angina) is administered in this way. Forbuccal delivery, the tablet is placed between theupper lip and gum. This route is used to admin-ister prochlorperazine (used to treat nausea andvomiting). A solid dosage form placed sublin-gually or buccally will dissolve in the saliva andthe drug is then able to cross the mucousmembrane of the mouth into the circulation. Aspray directed under the tongue will disperseinto the saliva and then the drug will beabsorbed in the same way.
The buccal route may be used to give a moreprolonged action than with the SL route. Drugssuch as nicotine, in the form of nicotine replace-ment therapy, can be formulated as a lozenge orchewing gum that is sucked or chewed periodi-cally, and rested in the buccal cavity when notin use.
The advantages of the SL and buccal routesare:
• fast absorption and onset of action• avoiding of first-pass effect (see above)
Drug delivery across mucous membranes 171
• can be used in unconscious patients• as dosage form is not swallowed, antiemetics
such as prochlorperazine can be givenbuccally.
The disadvantages of the SL and buccal routesare:
• poor adherence if the medication hasunpleasant taste
• some drugs are ineffective if swallowedbecause of metabolism by the liver (e.g.glyceryl trinitrate)
• route is not effective if patient has a drymouth, as saliva is required to dissolve dosageform to facilitate absorption (Winfield &Roberts, 2004)
Rectal administration (Latin per rectum; PR)
Two main dosage forms can be used to deliverdrugs to the rectum: suppositories and enemas(liquid or foam). In the UK, most drugs deliveredrectally are for local action, for example steroidsin inflammatory bowel disease; laxatives forconstipation. Rectal administration can also beuseful for systemic drug delivery in situationswhere other routes are not safe or possible, suchas giving diazepam during an epileptic seizure.
The rectal route is generally not popular in theUK as many patients do not feel comfortablewith the idea of administering medication thisway. It is used more frequently in other parts ofEurope such as France and Germany.
The blood supply to the rectum is composedof three veins, two of which drain directly intothe systemic circulation, and one directly to theliver. Therefore, not all the drug absorbed inthe rectum will undergo first-pass metabolism,which may increase bioavailability comparedwith other routes (Winfield & Roberts, 2004).
There are currently two schools of thoughtabout the best way to insert a suppository:rounded end first, as indeed they are designed tobe inserted, for ease and comfort; or blunt endfirst, which some practitioners believe aidsretention in the rectum. It may well be easierfor patients to self-administer round-end first;in hospital, however, most suppositories areinserted by nurses, and it is equally easy for
nurses to insert them round- or blunt-end first(Wright et al., 2006). Whichever method is used,it is important that the suppository is retainedin the rectum for long enough for it to melt, sothe drug can be absorbed. As enemas are liquidor foam, the drug is already in a form whichmakes it available for absorption.
Absorption from the rectum can be erratic andunreliable, so this route is not suitable for drugswith a narrow therapeutic index (see Box 16.1).The rectal route may also be contraindicated inpatients after recent colorectal surgery because ofthe risk of rupturing anastomoses (see Box 16.1).
The rectal route has the following advantages:
• useful for local administration of drug to therectum
• may be used when other routes unavailable(e.g. during an epileptic seizure)
and disadadvantages
• patients may not be keen to use this route• absorption is erratic• less convenient than oral route• suppository or enema must be retained in
rectum long enough for drug to be absorbed• some rectal dosage forms might be irritant
and can only be used for a limited time (e.g.carbamazepine suppositories).
Vaginal (Latin per vagina; PV)
The formulations most commonly used todeliver a drug vaginally are the pessary, vaginaltablet, cream or ointment. This route is usuallyused for local action of the drug (e.g. anti-fungal pessary to treat vaginal candidiasis; seeBox 16.1).
Pessaries and vaginal tablets are often suppliedwith an applicator to aid insertion; applicatorsshould be used in pregnancy because of the riskof miscarriage or induction of premature labourdue to mechanical stimulation of the cervix.
Topical drug delivery
Topical drug delivery refers to administration ofdrugs to the skin or mucous membranes (Hall &
172 Chapter 16 • Major routes of drug administration
Morton 2002). There are several topical routes:ears, eyes, nose, skin and transdermal.
Delivery of drugs to the ear
The main indications for the use of drops in theears are for treatment of otitis externa or otitismedia (see Box 16.1), and to soften ear wax. Thedrugs are used for a local effect. Examples areanti-inflammatory agents such as corticosteroids(e.g. prednisolone, betamethasone) to treat otitisexterna; antimicrobials such as gentamicin totreat otitis media; sodium bicarbonate and oilssuch as almond or olive oil are used to softenear wax.
Technique for application of ear drops
The usual dose of drops used in the ear is two orthree drops, the frequency depending on thedrug being administered. The person adminis-tering the drops should first wash their hands.The patient’s head should be tipped sidewayswith the ear to be treated uppermost; ideallythey should lie down. Instil two or three dropsinto the ear, taking care not to touch the tipof the bottle on the skin, as this will increasethe risk of contaminating the ear drops. Thepatient’s head should remain in position for afew minutes to allow the drops to disperse intothe ear and be absorbed.
Delivery of drugs to the eye
Two formulations are used to deliver drugs to theeye: drops and ointment. Drops are usually easierto apply; ointment is suitable for use at night as itmay have a prolonged contact time, but it can bemore difficult to apply and may interfere withvision for longer than eye drops, because of theusually greasy nature of the formulation. Absorp-tion of the drug occurs through the epithelium ofthe conjunctival sac (Rang et al., 2007).
Eye preparations can be used to treat dryeyes, infection, inflammation and glaucoma (seeBox 16.1), or to facilitate eye examination orprocedures, for instance, mydriatics to dilate thepupil; local anaesthetics prior to minor surgery.
Technique for application of eye drops
The dose is usually one drop – any more willflood out of the eye and be wasted. Frequencydepends on the drug being administered. Theperson administering the drops should firstwash their hands. If the patient is wearingcontact lenses, they should remove them. Thepatient’s head should be tipped back – ideallythey should sit or lie down – and they shouldlook upwards. Gently pull down the lower lid ofthe eye to be treated, to form a pouch. Thepatient should look away from the dropper,without moving their head, to stop themblinking too soon. Squeeze one drop into thepouch and gently release eyelid. Be careful notto touch the tip of the bottle on the eye, as thiswill increase the risk of contaminating the eyedrops. The patient should keep the eye closedfor about 30 seconds to allow the drop todisperse over the eye and be absorbed. Wipeaway any excess with a clean tissue.
If more medication is to be administered intothe eye at the same time of day, allow about 5 minutes between applications of the productsto allow time for absorption. If the drugs areadministered too closely together, the drops willoverflow the eye and the efficacy of each dropwill be reduced. A device called an autodropperis available for patients who have difficultyadministering eye drops to themselves, or theymay find that resting the bottle across the nosemakes application easier.
Technique for the application of eye ointment
The process for application of eye ointment isbroadly similar to that described above for theadministration of eye drops. A line of ointmentshould be squeezed along the inside of the pouchformed with the lower eyelid, being careful not totouch the tip of the tube on the eye (as this willincrease the risk of contaminating the ointment).The patient should close their eye, and allowthe ointment to disperse over the eye. Blinkingseveral times will help spread the ointment.
If drops and ointment are to be applied at thesame time of day, administer the eye drop about5 minutes before the ointment. This allows theeye drop to be absorbed before the ointment is
Topical drug delivery 173
applied, reducing the risk of the drop beingdisplaced by the ointment.
Patients may experience stinging when eyedrops or ointment are applied, but this is usuallytransient. However, they should be advised tosee their doctor if the stinging continues orredness and itching develop, as this could indi-cate that they are allergic to the preparation. Theallergen could be the drug or one of the excipi-ents. The preservative is often the cause of anallergy to eye preparations. The risk of devel-oping an allergy is increased by very frequentadministration (e.g. every hour in severe infec-tions) because of repeated exposure to thepreservative in the drops. Some eye drops arealso available as preservative-free formulations;many prescribers will choose these formula-tions for patients who use the drops frequently,to reduce the risk of developing an allergy.However, preservative-free drops are not used asa first choice for several reasons: they tend to bemore expensive than drops with preservatives;they may not be commercially available andtherefore an unlicensed product must be used;they often have to be stored in the fridge or mayneed to be frozen, making transport and storagedifficult and expensive; they often have a shortshelf life (especially unlicensed products) andso may have to be disposed of 24 hours afteropening; they may be packaged in single doseunits, which makes them bulky, and these mustbe used once only and then discarded.
Delivery of drugs to the nose
Drugs may be delivered to the nose using dropsor a spray. Currently there are few indicationsfor topical delivery to the nose; some patientsbenefit from drops or sprays to treat rhinitis or toreduce nasal polyps (see Box 16.1). More recently,however, drugs for systemic action are beingdeveloped as intranasal formulations, exploitingthe good blood supply to the nasal tissue. Oneexample is desmopressin (an analogue of vaso-pressin (antidiuretic hormone) used in the treat-ment of conditions such diabetes insipidus). It isthought that absorption of the drug occurs acrossthe mucosa covering nasal-related lymphoidtissue (Rang et al., 2007).
Technique for the application of nasal drops
The patient should blow their nose gently, tomake sure it is clear. The person administeringthe drops should wash their hands. The patient’shead should be tipped back. Hold the dropperjust above the nose and squeeze in three of fourdrops, being careful not to touch the dropper onthe nose, as this will increase the risk of conta-minating the drops. The patient should keep thehead tipped back for a few minutes to help thedrops run to the back of the nose.
Skin
Creams, ointments, lotions, gels and powderscan be used to deliver drugs to the skin for localaction. Drugs delivered in this way includecorticosteroids used to treat eczema and anti-microbials used to treat a skin infection. Emol-lient preparations, used to soothe and soften theskin, such as aqueous cream or Diprobase, do notdeliver any drug to the skin but contain ingredi-ents that help hydrate and soften the skin, suchas white soft paraffin and liquid paraffin. Theseare used for dry skin conditions such as eczemaand psoriasis.
The advantage of drug delivery to the skin isthat local effects are achieved. The disadvantagesare:
• some areas are hard to reach (e.g. the back)• some preparations are messy (e.g. ointments
or lotions) or stain clothing and bedding (e.g.dithranol, coal tar)
• some preparations may cause irritation whenapplied, especially in conditions such aseczema.
Transdermal drug delivery
Systemic drug action can be obtained by deliv-ering the drug using a transdermal system, suchas a patch or gel. Transdermal means ‘acrossthe skin’. Patches are used to deliver drugs suchas hormones (e.g. oestradiol), analgesics (e.g.fentanyl) and glyceryl trinitrate to the systemiccirculation. As the drug enters directly into theblood stream, the first-pass effect is avoided.
174 Chapter 16 • Major routes of drug administration
Patches are designed to deliver a drug over asustained period, ranging from a few hours to7 days. Drug activity is sustained for severalhours after the patch is removed because of areservoir of drug that forms in the skin.
Advantages of transdermal drug delivery are:
• prolonged drug delivery that is convenientfor patient – the patch can be changed everyfew days, rather than taking an oral prepara-tion several times a day
• constant rate of drug delivery• non-invasive.
Disadvantages are:
• slow onset of action – some drugs may takeup to 12 hours to reach therapeutic levels
• fixed dose of drug, therefore additionalroutes may be required (e.g. additionaldoses of analgesia for breakthrough pain) (seeBox 16.1)
• limited number of drugs can be given via thisroute.
Inhalation drugs
The lungs have a very large surface area and richblood supply, making them an ideal site for theabsorption of drugs; however, because of thedifficulty of delivering drugs to the lungs, mostdrugs delivered by inhalation are for local action– for the treatment of respiratory diseases such asasthma and chronic obstructive pulmonarydisease. Drugs delivered in this way include corti-costeroids (e.g. beclometasone and fluticasone)and beta-agonists (e.g. salbutamol and terbu-taline). Local delivery of these drugs reduces theoccurrence of side-effects; because the drug isdelivered directly to the site of action, a muchsmaller dose can be used to exert the same effecta larger dose would produce if given systemically,therefore reducing systemic side-effects.
Drugs inhaled for a systemic action havefor many years been restricted to volatile andgaseous anaesthetics; however, a recent develop-ment has been the delivery of insulin by inhaler.Insulin is a polypeptide and therefore cannot betaken orally, as it would be inactivated by
stomach acid and digestive enzymes. Conse-quently, administration has been restricted tosubcutaneous injection or intravenous infusion.A new inhaled formulation therefore offers aless invasive route which may be particularlyuseful for patients who are needle phobic orhave difficulty injecting themselves.
Drugs delivered to the lung for local action areusually administered as an aerosol, using either asmall handheld inhaler device, or a nebuliser.Several types of handheld inhaler are avail-able, with different mechanisms: the pressurisedmetered-dose inhaler (MDI), the breath-actuatedmetered-dose powder inhaler (Turbohaler),breath-actuated pressurised MDI, e.g. Easi-Breathe. Instructions on how to use these devicesare provided in the patient information leafletpackaged with each device. A nebuliser makesan aerosol by blowing air or oxygen through asolution of a drug, and delivering the aerosol tothe patient’s mouth for inhalation via a mask ormouthpiece (Marcovitch, 2005). Nebulisers areused in two situations: by patients with verysevere symptoms, as the dose of drug deliveredis higher than that delivered by an inhaler; orwhen a patient is acutely unwell during anasthma attack or infection that exacerbates theirsymptoms, and needs a higher dose but also istoo unwell to use an inhaler properly.
A spacer device can make an MDI easier touse. A spacer is a plastic chamber with a hole atone end into which the inhaler nozzle fits; atthe other end is a mouth piece with a one-wayvalve. The inhaler is actuated into the chamber,and the patient breathes through the mouth-piece to inhale the drug aerosol. Spacers mayincrease drug delivery to the lungs by 50%(Wright et al., 2006).
The advantages of the inhaled route are:
• large surface area and rich blood supply forabsorption
• direct delivery to lung tissue for local action• smaller dose used therefore fewer systemic
side-effects.
The disadvantages of the inhaled route are thatinhaler devices can be difficult to use properly,therefore reducing efficacy, and equipment suchas spacer devices and nebulisers are not veryportable.
Inhalation drugs 175
Parenteral routes
Parenteral refers to administration by injection.The most commonly used parenteral routes willbe discussed in this section.
Intravenous (IV)
The IV route involves injection of a drug directlyinto the venous circulation. The bioavailability(see Box 16.1) of a drug given IV is 100%. It isthe fastest way to administer a drug: a bolusinjection (a small-volume injection given overless than 5 minutes) will produce very high drugconcentrations, first of all in the right side of theheart and lungs, and then the systemic circula-tion (Rang et al., 2007).
Large volumes (� 20 mL) to be given IV aregiven by infusion, which may take from 10minutes to 24 hours (i.e. continuous). Contin-uous infusions are used to deliver large volumesof fluids to rehydrate and maintain hydration inpatients who are acutely dehydrated or unableto take fluids by other routes. Infusions are alsoused to deliver drugs that need to be diluted toavoid irritating the veins, drugs that need to begiven slowly to avoid side-effects, and drugs thathave a short elimination half-life (see Box 16.1)and so need to be delivered frequently orcontinuously to maintain action.
Access into the venous system must beachieved in order to administer drugs IV. Forsingle injections, a needle is inserted into asuperficial vein in the internal flexure of theelbow. If drugs are to be given IV for severaldays, a cannula will be placed into a superficialvein either in the internal flexure of the elbowor on the back of the hand. A central venouscatheter can be used if long-term IV access isrequired.
The advantages of IV administration are:
• rapid delivery and onset of action• 100% bioavailability• large volumes may be given.
The disadvantages are:
• it is painful and invasive• risk of infection at injection site
• patient is more dependent on nurses• patient mobility reduced when infusions are
running• injectable formulations of some drugs are
more expensive than oral formulations• risk of acute overdose if drug given too
quickly.
Subcutaneous (SC)
The SC route may be used to administer a drugby injection, or to administer large volumes offluids by infusion.
An SC injection is given into the tissuedirectly under the skin, most commonly on theabdomen or the upper arms. Because the fluidhas to be forced into the tissue, the maximumvolume that can be administered by this route isusually 1 mL – it can be painful and difficult toadminister more than this to one site. Volumesof more than 1 mL must be given in multiplesmaller volumes at different sites.
Drugs given SC are absorbed more quicklycompared with the oral route. The rate ofabsorption is related to the blood flow at theinjection site; therefore, a site that is warm, hasa good blood supply, or is massaged after injec-tion, will have a higher blood flow and the rateof drug absorption will be increased. Conversely,drug absorption will be slower from an injectionsite that is cold or has a poor blood supply.
SC infusions are used to administer 2–3 litresof fluids a day to patients who are dehydratedand unable to take adequate fluids orally, butwho do not require rapid fluid replacement.(The IV route would be used in this situation asfaster infusion rates can be used.) This is alsoknown as hypodermoclysis. Examples in whichhypodermoclysis may be used include patientswho have had a stroke and may not be able toswallow safely, and terminally ill patients whorequire fluids as part of palliative care (see Box16.1). Commonly used sites are the abdomenand thigh. Fluids given by SC infusion should beisotonic to extracellular fluid. Examples include0.9% or 0.45% sodium chloride solution and5% glucose, although this should be limitedto 2 litres in 24 hours and maximum rate of2 mL/minute, as higher rates and concentrations
176 Chapter 16 • Major routes of drug administration
may lead to shock. The following fluids are notsuitable for SC infusion:
• colloids• solutions containing potassium concentra-
tions above 40 mmol/litre• solutions with a pH below 5.3 or above 8.2• glucose solutions stronger than 5%• solutions with osmolality above 280 mOsmol/
kg (Wright et al., 2006).
Infusion sites should be monitored regularly(several times a day, and at least at every bagchange) and changed if any of the followingoccur: pain, irritation, site becomes inflamed,white or hard, or blood is seen in giving set, asthese might indicate an infection (Wright et al.,2006).
The enzyme hyaluronidase is sometimes usedto enhance permeation of fluids into the subcu-taneous tissues. It breaks down the intercellularmatrix, and therefore increases diffusion anddrug absorption (British National Formulary;Rang et al., 2007)
The advantages of the SC route are that accessis easier than IV, and absorption is relativelyuniform. The disadvantages are discomfort andpain, risk of infection at the injection site andinjections are limited to small volumes.
Intramuscular (IM)
This is an injection into a muscle. Common sitesare the upper arm (deltoid muscle), thigh (vastuslateralis) and buttocks (gluteal muscles). Themaximum injection volume depends on the siteused: 5 mL for the thigh; 2 mL for the deltoid.Larger volumes must be given in several smallervolumes at different sites, otherwise they willnot be effectively absorbed, and can lead toabscess formation (Wright et al., 2006). IM injec-tions are avoided in children as the muscles arenot adequately developed, and should not begiven to patients with deranged blood clot-ting, as a haematoma is likely to develop (seeBox 16.1).
As with SC injections, absorption of drugfollowing IM injection is increased by increasingthe blood flow; therefore exercising the muscleafter an injection will increase absorption, butthis may or may not be desirable, depending onthe drug.
The major advantage of the IM route is thataccess is easier than with IV administration. Thedisadvantages are that it is painful, there is a riskof infection at the injection site and injectionsare limited to small volumes.
Intradermal
This route is used for diagnostic testing ofallergy and immunity, and also to administersome vaccines. It involves injection of a smallvolume, typically 0.1 mL, between the epidermisand the dermis. Absorption is slow as the drugmust diffuse through this tissue to enter thecirculation (Wright et al., 2006).
Intrathecal (IT)
This involves injection into the subarachnoidspace via a lumbar puncture (see Box 16.1). Thisroute is potentially dangerous, as a needle mustbe placed near the spinal cord, and incorrectplacement can lead to permanent damage andparalysis. It is used to treat some central nervoussystem (CNS) infections, such as meningitis,and may be used to administer local anaesthesia,
Parenteral routes 177
Intradermal
SubcutaneousIntramuscular
Intravenous
Vein
Muscle
Adiposetissue
Subcutaneoustissue
Dermis
Epidermis
Figure 16.2 Drugs can be injected into the skin, subcu-taneous fat, muscle or a vein.
or to administer chemotherapeutic drugs toprevent relapse of certain childhood leukaemiasin the CNS (Rang et al., 2007).
A great deal of care must be taken whenadministering a drug by IT injections. As well asthe risk of incorrect placement of the needle,adminstration of the wrong drug via this routecan prove fatal, as has unfortunately happenedon several occasions when chemotherapeuticdrugs have been mixed up. In one case the vincaalkaloid vincristine was given IT, resulting in theslow death of the recipient. Vincristine is safewhen given IV, but causes irreversible damage tobrain tissue. As a result of these errors, strict poli-cies and procedures are now in place in UKhospitals to prevent this happening again(Department of Health, 2003).
Epidural
This involves injecting a drug into the epiduralspace around the spinal column via a lumbarpuncture (see Figure 16.3). It carries similarrisks to an IT injection because of the closeproximity of the needle to the spinal cord. Themost common use of the epidural route is to
administer a local anaesthetic to women duringlabour.
Intraperitoneal (IP)
This involves injection or infusion of drugs orfluid directly into the peritoneal cavity, via acatheter placed through the abdominal wall.The peritoneal cavity contains the abdominalorgans, and is lined by a membrane called theperitoneum. This route is used in patientsundergoing continuous ambulatory peritonealdialysis (CAPD), to administer dialysis fluids,and antibiotics in the treatment of infections(i.e. peritonitis that can occur as a result of theCAPD).
Intra-articular (IA)
This refers to injection into the synovial fluid ofa joint cavity, used for the administration ofanti-inflammatory drugs such as the cortico-steroids triamcinolone and methylprednisolonein the local treatment of rheumatoid arthritis.Injection volume differs according to the size ofthe joint (Wright et al., 2006). IA injections canbe painful, and there is a risk of damaging thecartilage. They should not be given if there isinfection in the joint or surrounding tissue(Wright et al., 2006).
Intra-osseous (IO)
This route is used in children under 6 years of ageand requires a special needle to be placed into thetibia (thigh bone), with the tip extending intothe marrow cavity. This cavity is continuous withthe venous circulation, so provides a route foradministering fluids and drugs when the IV routeis difficult to obtain and when rapid infusionsare necessary, such as in trauma. Infusions mustbe administered under gentle pressure, whichcan be exerted by hand using a syringe, orby inflating a blood pressure cuff around aninfusion bag (Vreede et al., 2000; Wright et al.,2006).
178 Chapter 16 • Major routes of drug administration
Vertebraldisc
Dura and Arachnoidmater
Epiduralspace
Spinousprocess ofvertebra
IntrathecalspaceSpinal
cord
Vertebra
Figure 16.3 Intrathecal administration involves injectioninto the subarachnoid space of the spine via a lumbarpuncture. Drugs, particularly local anaesthetics, can alsobe injected into the epidural space.
Parenteral routes 179
Box 16.1 Definitions of terms relating to drug administration
anastomoses: the surgical connection of separate orsevered tubular hollow organs to form a continuouschannel, as between two parts of the intestine
bioavailability: the proportion of drug administeredthat is available at the site of action
breakthrough pain: intermittent pain experienceddespite the patient receiving regular analgesia; mayoccur for example on movement or during dressingchanges. Extra doses of analgesia may be given toalleviate this pain
colloids: solutions containing molecules with largemolecular weights that contribute to the oncotic pres-sure at the microvascular endothelium; used mainlyfor plasma expansion; examples include gelatine solu-tions (Gelofusine, Haemaccel); starches (hexastarch,pentastarch); dextrans (dextran 40 or 70); albumin5% or 20%
continuous ambulatory peritoneal dialysis (CAPD): arenal replacement therapy (dialysis) method forremoving waste such as urea and potassium from theblood, as well as excess fluid, when the kidneys areincapable of this (i.e. in renal failure)
glaucoma: loss of visual field associated with cupping ofthe optic disc and optic nerve damage; it is often asso-ciated with increased intra-ocular pressure
half-life: the time taken to remove 50% of a drug fromthe plasma
haematoma: a solid swelling of clotted blood within thetissues
lumbar puncture: the insertion of a hollow needlebeneath the arachnoid membrane of the spinal cord in
the lumbar region to withdraw cerebrospinal fluid fordiagnostic purposes or to administer medication
therapeutic index: the ratio between the toxic dose andthe therapeutic dose of a drug, used as a measure ofthe relative safety of the drug for a particular treatment.A narrow therapeutic index indicates a small differencebetween therapeutic and toxic doses
nasal polyps: growths of a soft jelly-like character: theyarise from chronic inflammation associated withallergic rhinitis, chronic sinusitis, asthma and aspirinmisuse. (Marcovitch, 2005)
otitis externa: inflammation of the meatal skin of the ear(the skin of the ear canal)
otitis media: infection of the middle ear
palliative care: treatment given to improve the quality oflife of patients and families who face life-threateningillness, by providing pain and symptom relief andspiritual and psychosocial support from diagnosis tothe end of life and bereavement
rhinitis: inflammation of the mucous membrane of thenose
subarachnoid space: the space between the arachnoidand the pia mater, two of the three membranescovering the brain and spinal cord (the third is the duramater); this space is filled with cerebrospinal fluid
vaginal candidiasis: a fungal infection of the vagina,characterised by vulval itchiness and a whitish, creamydischarge from the vagina, caused by Candidaspecies, particularly Candida albicans; also known as‘thrush’
References
Hall J M, Morton I K M (2002). The Royal Society ofMedicine: Medicines. London: The Medicines GuideLtd.
Department of Health (2003). HSC 2003/010 – Updatednational guidance on the safe administration ofintrathecal chemotherapy. Available via www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_4064931.
Marcovitch H, ed (2005). Black’s Medical Dictionary,41st edn. London: A&C Black Publishers.
Rang H, Dale M, Ritter J, Flower R (2007). Rang andDale’s Pharmacology, 6th edn. Oxford: ChurchillLivingstone.
Smyth J (2006). The NEWT Guidelines for Administra-tion of Medication to Patients with Enteral FeedingTubes or Swallowing Difficulties. North East WalesNHS Trust.
Vreede E, Bulatovic A, Rosseel P, Lassalle X (2000).Intraosseous infusion. Update in Anaesthesia 12:38–40.
White R, Bradnam V (2007). Handbook of DrugAdministration via Enteral Feeding Tubes. London:Pharmaceutical Press.
Winfield A J, Richards R M E, eds (2004). PharmaceuticalPractice, 3rd edn. Oxford: Churchill Livingstone.
Winter M E, ed. (2003). Basic Clinical Pharmacokinetics,4th edn. Lippincott Williams and Wilkins.
Wright J, Gray A H, Goodey V (2006). Clinical Pharmacy.London: Pharmaceutical Press.
180 Chapter 16 • Major routes of drug administration
Accreditation training Training to acquire the list of skills that a dispensing technician shouldbe competent to carry out in order to become an accredited technician.As part of the training, student technicians produce a portfolio ofevidence to demonstrate their competence.
Accuracy check The final check that a pharmacist (or appropriately qualified techni-cian if a prescription has already been clinically checked by a pharma-cist) makes to ensure the dispensed medicinal product is the same asthat requested by the prescriber on a prescription.
Active listening This involves giving the person who is speaking to you your full atten-tion and includes the use of both verbal encouragers (such as ‘yes’,‘aha’ and ‘mm’) and non-verbal acknowledgements such as nodding,smiling and receptive body language.
Acute trust See NHS acute trust.Adherence The extent to which a person’s behaviour – taking medication, follow-
ing a diet, and/or executing lifestyle changes – corresponds with agreedrecommendations from a health professional.
Administering The process of giving a medicine to a patient.Advanced service The middle tier of service provision under the new Pharmacy Contract,
which includes services that can be commissioned from communitypharmacies by primary care trusts according to the needs of the localpopulation.
Adverse drug reaction An unintended unpleasant reaction to a drug which occurs at doses(ADR) used in humans for prophylaxis, diagnosis or therapy of disease, or for
the modification of physiological function.ADRs can range in severity from a minor inconvenience (such as aheadache) to death.
Adverse-effect profile The range of ADRs that are known to occur with a medicinal product.Adverse event An event that results in patient harm; this could include an ADR or
may be caused by an error on the part of a health professional or thepatient.
Agenda for change Process through which the employment contracts for non-medicalNHS employees were reviewed, with a view to streamlining pay scalesand conditions of employment.
Ambulance Trusts Thirteen trusts that provide transport and emergency care for patients,including the 999 ambulance service and transport for patients tohospital appointments if required.
Anaesthetise Render a patient unable to feel pain; this may be local anaesthesia, inwhich a local anesthetic is applied (either to the skin or by injection)
181
Glossary of terms commonly used in PharmacyPractice
to a specific area of the body, or general anaesthesia, in which a patientis put into a deep sleep using a general anaesthetic.
Analgesic Medication used to relieve pain (painkiller).Anastomosis The surgical connection of separate or severed tubular hollow organs to
form a continuous channel, such as two parts of the intestine.Anticoagulant clinic A place where patients taking blood-thinning medications (such as
warfarin) have their blood tested. The blood sample is used to checkthe international normalised ratio (INR), which is a measure of clottingability.
Antiemetic Medication used to stop vomiting.Apothecary Apothecary (from the Latin apothecarius: a keeper of an otheca (a store))
is an historical name for a medical practitioner who formulates anddispenses materia medica to physicians, surgeons and patients – a rolenow served by a pharmacist.
Arterial aneurysm A weakening in the wall of an artery, causing it to stretch under thepressure of the blood flow.
Aspirate To withdraw fluid by the use of suction, usually by using a syringe (e.g.the liquid contents in the stomach can be aspirated by drawing themup through a tube inserted down through the nose into the stomach,using a large syringe). Also refers to the inhalation of fluid or stomachcontents into the lungs, and to the withdrawal of cells or fluid from thebody, for instance from a cyst.
Assistant technical An unqualified member of the pharmacy support staff (usually workingofficer (ATO) in a hospital pharmacy) who is able to perform a limited number of
tasks under the supervision of a more senior member of the pharmacystaff.
Audit A process of comparing what currently happens in practice with whatshould be happening, with a view to improving the delivery of services.
Bioavailability The relationship between the dose administered and the concentrationof unchanged drug in plasma, usually expressed as a percentage.
Biotechnology Laboratory-based techniques being developed in biological research,such as processes using recombinant DNA technology or tissue culture.
‘Black listed’ medicines Medicines that cannot be prescribed on an NHS prescription.‘Black triangle’ drugs Medicinal products that have recieved marketing authorisation in the
past 2 years (indicated in the British National Formulary and on theirpackaging by a black triangle). Any suspected adverse effects that occurin patients taking these drugs should be reported to the MHRA (seebelow) via the Yellow Card Scheme.
Blame-orientated An approach which, when an error occurs, focuses on the individualapproach responsible for the error and often involves punishing that individual,
for example through suspension or dismissal.Bolus injection A small volume of fluid injected over a short period of time (up to
5 minutes).Borderline substances A list of products that have been defined by the Advisory Committee
for Borderline Substances as medicinal products and that can beprescribed on an NHS prescription.
Brand-to-generic The process of changing a prescription from a branded medication toswitches the equivalent generic medication, which may result in cost savings
to the NHS.Branded medication A medicine where the formula and mode of manufacture are the
property of the manufacturer.
182 Glossary
British National A compendium of the licensed medicinal products and appliances thatFormulary are available for prescription in the UK, published every 6 months
(includes clinical indications, recommended doses, preparations,prices, licensed category, adverse drug reactions, cautions and contra-indications); often referred to as the BNF; medicines for children aredescribed in the C-BNF.
British Pharmaceutical Annual meeting for pharmacists and other scientists working withinconference the pharmaceutical industry, where research is presented and
professional issues discussed.Buccal Administration of a medication by placing it in the mouth between the
gum and top lip or cheek.Bulk medication Large quantity of medication provided in large bottles, which are then
dispensed into smaller quantities to individual patients; also known asbulk stock.
Bulk stock See Bulk medication.Care trusts Organisations that provide a link between local government authorities
and primary care trusts to improve the delivery of social care to patients.Caution Conditions where care should be exercised in using a particular drug
(e.g. existing disease state).Central venous catheter An intravenous line that is inserted into a large vein above the heart,
through which injections and infusions of drugs and blood productsmay be given, and blood samples withdrawn, without causing pain tothe patient.
Ceramic slab A slab made of a ceramic material upon which creams and ointmentsare made (commonly known as a tile).
Chemist’s nostrum See Nostrum.Chief Medical Officer Principal medical adviser to the Government on health care in England.
(CMO)Chief Pharmaceutical Professional lead for Pharmacy at the Department of Health.
Officer (CPO)Child-resistant closure Lids or other seals on primary packaging of medication that are
(CRC) designed to be difficult for children to open, such as lids which have tobe pushed down before they can be turned.
Clic Loc® A brand of CRC commonly used on bottles.Clinical check The process of evaluating a prescription for the clinical appropriateness
for use in an individual patient. This is ideally done when a prescrip-tion is first received by a pharmacist.
Clinical governance A series of tools that help pharmacists (and other health professionals)to deliver a high-quality service to patients, with a focus on continu-ally improving the quality of service delivered.
Clinical management A plan for the treatment of an individual patient that specifies whichplan (CMP) medications a supplementary prescriber can prescribe and under which
circumstances; the CMP is agreed with both the patient and theirdoctor.
Clinical pharmacy The activities and services undertaken by a clinical pharmacist toensure rational and appropriate use of medicines; may take place inmany settings, such as hospitals, community pharmacies, nursinghomes and clinics.
Clinical training rotation Term used to describe the training of junior pharmacists in a numberof different clinical specialities by working in different clinical areas ona rotational basis.
Glossary 183
Closed question A question that can only be answered with a small number of responses,such as yes or no.
Closure The lid or other method of sealing a medicinal product in the primarypackaging.
Colloid A suspension containing molecules with large molecular weights.Colorectal surgery Surgery on the lower part of the intestine – the colon and rectum.Commissioner The person who is responsible for commissioning health services
within a primary care trust.Commissioning The process by which primary care trusts and general practices
purchase health services for the general population that they serve.Community pharmacist A pharmacist working in the community sector of pharmacy.Community pharmacy A premises registered with the RPSGB (see below) for the provision of
pharmaceutical services to the general public; a term used to describethe skills specifically used by a community pharmacist in their day-to-day work.
Complementary A general term for an extensive list of medical systems that differ frommedicines allopathic (Western) medicine, including acupuncture, Ayurvedic,
tribal traditional medicine, herbal or phytotherapeutic, homoeopathicand other treatments. Complementary medicine is not the same asholistic medicine.
Compliance The extent to which a person’s behaviour – taking medications,following a recommended diet or executing lifestyle changes – coincideswith medical or health advice.
Composition The proportion and combination of elements or components that forma substance.
Compounding The process of combining more than one chemical agent to produce amedicinal product.
Compromised swallow Patients who have difficulty swallowing are described as having a‘compromised swallow’ (e.g. after a stroke), and may require non-oraldosage forms.
Concordance Describes an equal relationship between a patient and a health profes-sional in which decisions about health care, including medicationtaking, are made in partnership, with each person contributing theirown type of expertise and both parties agreeing on the final decision.
Confections A sweetened medicinal product; a sweet preparation.Conical measure A type of laboratory glassware that consists of a conical cup with a notch
on the top to allow for the easy pouring of liquids; conical measures havegraduated markings on the side to allow easy and accurate measurementof volumes.
Conserve A product that has been preserved with sugar.Continuing professional The process of life-long learning that will soon be mandatory for
development (CPD) pharmacists who wish to continue to practise in the UK.Contraindication A medical condition or factor that increases the risk involved in using
a drug to the extent that the risks are likely to outweigh the benefits;The risk–benefit ratio of using the drug must be considered in individualpatients and may prohibit the use of the drug.
Controlled drug (CD) A medicinal product that is categorised in Schedules 1–5 of the Misuseof Drugs Regulations 2001 because it is considered to be dangerous orotherwise harmful.
184 Glossary
Controlled drug (CD) A record of CDs that are kept in a pharmacy or hospital ward, whereregister they have been received from, and who they have been supplied to.
The number of dose units in the register must agree with the numberof physical dose units in the pharmacy.
Cost-effectiveness The relative cost of a treatment compared with the therapeutic effect itwill have. Ideally, a treatment should be low cost and provide a strongbenefit to the majority of patients it is intended for.
Counter prescribing The process of recommending over-the-counter (OTC) treatments (orother non-prescription remedies) for patients.
Critical care The area of the hospital where patients who require intensive care aretreated (such as the intensive care/therapy init (ICU/ITU)).
Critical event An occasion where something significant has occurred that is outsidenormal experience. The occurrence can be positive (such as unusuallyexcellent patient service) or negative (such as an adverse event resultingin patient harm).
Decongestant A medication used to relieve a blocked nose.Demijohn A large narrow-necked bottle made of glass or earthenware, usually
encased in wickerwork.Dental Practitioners’ A list of medicinal products that can be prescribed by a dentist on an
Formulary NHS prescription.Department of Health Government department that runs the NHS in England.
(DH)Dependent prescriber See Supplementary prescriber.Deranged blood clotting An abnormality in the ability of the blood to clot. This is indicated by
abnormal blood test results, and the presence of signs such as bruisingand bleeding gums (blood clotting is decreased) or an increasedtendency to clot, producing clots in the legs (deep venous thrombosis).
Deregulated A term used to describe the down-grading in classification of a medica-tion from prescription only (POM) to a pharmacy medicine (‘P’), orfrom ‘P’ to general sales list (GSL).
Destruction of old Bins used in pharmacies to contain drugs that need to be destroyedpharmaceuticals (e.g. out-of-date medications, and medications returned by patient).(DOOP) bins
Diagnosis The identification of a condition or disease state that a patient has.Diploma in clinical A postgraduate qualification available to both hospital and community
pharmacy pharmacists that provides in-depth knowledge on how to manage theuse of drugs in patients with a variety of disease states.
Disintegration testing Measurement of the time taken for a dosage form (e.g. tablet) to fullybreak apart under specific experimental conditions. Disintegration isoften required for the drug to be released and absorbed.
Dispensary The area within a pharmacy where medicines are dispensed.Dispensary receptionist Member of the pharmacy support staff who answers the telephone and
greets patients and health professionals who visit the hospital pharmacy.Dispensing The process of supplying a medicine to a patient in accordance with
the directions on a prescription.Dispensing assistant Member of the pharmacy support staff who has undergone limited
training that allows them to order and dispense medicines, in additionto the role performed by a medicines counter assistant.
Dispensing doctor A practitioner, typically in a rural area, who is licensed to dispense medi-cines to patients who live more than 1 mile from their nearest pharmacy.
Glossary 185
Dispensing error An error in the dispensing of a medication.Dispersible Describes a dosage form, usually a tablet, that breaks down into small
particles in water and forms a suspension of those particles.Dissolution The kinetic process in which the molecules of a solid dissolve in a
solvent such as the gastric fluid.Domiciliary visit Visit to a patient’s home to provide a service, for example a medica-
tion review carried out in a patient’s home would be a domiciliarymedication review.
Dosage The prescribed amount of medicine, including the dose (amount)and the timing (e.g. two tablets three times a day).
Dose The amount of medication that a patient should take (e.g. one tablet).Doubling-up The process used when combining a small amount of one ingredient
with a larger amount of another in order to ensure even distribution. Drug chart The prescription chart used in a hospital; this is a record of the medica-
tion that a patient is prescribed during their hospital stay. Each drugorder is signed by a doctor (or other authorised prescriber) and a nursesigns the drug chart each time a medicine is administered. A pharma-cist signs the drug chart and endorses it with additional instructions,an indication of where the medicine is available from (such as ‘stockon the ward’, ‘patient’s own’, or the number of dose units supplied bythe pharmacist) and the date.
Drug order In a hospital setting, this refers to a prescription written for an individualpatient on a drug chart.
Duration The length of time for which a patient will take a medication (e.g. 1 week).Duty of care A legal obligation to provide a reasonable standard of care to a patient
when providing a service such as dispensing a prescription or counterprescribing.
Efficacy The ability to produce a desired outcome. In terms of medicines, thisrefers to the ability of a medicine to produce the desired therapeuticoutcome.
Elective admission Routine planned admission to hospital, usually for surgery or otherplanned treatment.
Elixir A sweet-tasting liquid preparation of a pharmaceutical product. Similarto a linctus, but containing less alcohol.
Embrocation A medicinal liquid that is rubbed into the skin to relieve muscular stiff-ness and pain.
Emergency admission Non-routine unplanned admission to hospital for an illness or injury(e.g. by ambulance or through the Emergency department).
Emergency department Point of contact for emergency care provided by hospitals (formerlycalled A&E – Accident and Emergency).
Emergency supply A supply of a medication usually taken by a patient that is provided bya pharmacist in an emergency where the patient does not have aprescription.
Emollient A substance composed of fat or oil that soothes and softens the skin.Emulsion A mixture of oil and water, generally of a milky or cloudy appearance.Endoscope An instrument that is inserted into the body to view internal parts.Enema Liquid or foam dosage form that is administered via the rectum.Enhanced service The highest tier of service provision under the new Pharmacy Contract,
which contains services that can be commissioned from community
186 Glossary
pharmacies by primary care trusts according to the needs of the localpopulation.
Enteral Administration of food or medication via the gastrointestinal tract.Enteric coating A special coating applied to tablets or capsules to protect the dosage
form from degradation by stomach acid or to protect the stomach fromirritant drugs. The coating is susceptible to degradation by the alkalineenvironment of the small intestine, where the drug is released andabsorbed.
Enterostomal tube A tube that runs from an opening in the skin of the abdomen into thestomach or jejunum.
Enzyme enhancement Increase in the ability of enzymes to carry out their required function.Enzyme inhibition Prevention or reduction of an enzyme’s ability to carry out a process,
as a result of the interaction of some substance with the enzyme.Epidural Administration of a medication (usually an anaesthetic) by injection
into the epidural space around the spinal column via a lumbar puncture.Essential service The lowest tier of service provision under the new Pharmacy Contract,
which contains services which must be provided by all communitypharmacies.
Excipient A biologically inactive substance used as a carrier for the active ingre-dients of a medication (i.e. the drug). Excipients are included in aformulation for their specific properties such as bulking, improvingpowder flow, solubility, disintegration and mechanical strength.
Expiry date The date after which a drug product should not be used or taken. Theperiod of time between manufacture and the expiry date depends onthe stability of the product.
Extemporaneous The preparation of a medicinal product from individual ingredientspreparation within a pharmacy in response to a prescription for an individual
patient. Products are either prepared to recipes from the standard formu-laries (e.g. British Pharmacopeia) or to recipes written by the prescriber.These are unlicensed products.
Food and Drug The organisation that grants marketing authorisations in the USA.Administration (FDA)
Final check The final check that a pharmacist (or appropriately qualified techni-cian if a prescription has already been clinically checked by a pharma-cist) makes to ensure that the dispensed medicinal product is the sameas that requested by a prescriber on a prescription.
First-pass effect Metabolism in the liver of a drug that has been absorbed via the gastroin-testinal tract and is carried directly to the liver via the portal vein, beforereaching the target organ. Efficacy may be reduced by first-pass effect(also known as first-pass metabolism); some drugs are activated by thisprocess (e.g. tramadol).
Formulary A list of medications that are approved for prescription/supply in alocal area, for example within a hospital trust.
Formulation The quantities and sources of ingredients used to make a product; theact, process, or result of formulating or reducing to a formula.
Foundation hospital trust Management structure for highly performing hospitals that providesgreater independence and financial control compared with NHS acutetrusts.
Frequency How often a patient should take their medication (e.g. twice a day).
Glossary 187
Friability The resistance of a product to being broken into smaller pieces bymechanical force such as a tablet breaking in a tablet jar.
General Medical Services The contract under which general practitioners provide a medical contract service within the NHS.
General practice The team of general practitioners and staff such as practice nurses,practice pharmacists, and receptionists who provide primary healthcare.
General practitioner A doctor who practises in a primary care environment (the generalpractice).
General sales list (GSL) A list of medicinal products that are available for sale without thesupervision of a registered pharmacist; however, if they are being soldfrom a registered pharmacy, a pharmacist must be present.
Generic medication Medication known by its official (non-brand) name. This name isnot protected by trademark (e.g. propranolol slow-release (generic) vsInderal (branded)).
GP fundholder General practice that has responsibility for its own budget.Granulation Process by which a primary powder of drug and excipients adheres
by the addition of a solvent(s) to form larger multiparticulates calledgranules. Granules usually have superior flow properties to powders.
Haematology The clinical speciality or area of the hospital where patients withdiseases of the blood are treated.
Haematoma A collection of blood under the skin that forms a swelling.Half-life The time taken for the concentration of drug in the plasma to decrease
by 50%.Healthcare Commission Independent watchdog that oversees the provision of health care and
public health services by the NHS; accountable to the Secretary of Statefor Health.
Health screening Testing members of the general public for the presence of commonconditions such as diabetes, raised cholesterol or hypertension.
High-risk prescription A prescription where there is a high risk of injury to a patient if themedication is administered as prescribed.
Hypertension High blood pressure.Independent prescriber Non-medical prescriber who has undergone a structured training
programme that allows them to prescribe medications within theconstraints of their clinical knowledge and professional judgement(includes pharmacists and nurses amongst others).
Independent sector Privately run treatment centre commissioned by a primary care trust totreatment centre (ISTC) provide services (such as minor surgery) that have traditionally been
associated with long waiting times when provided by hospitals.Infusion A fluid injected slowly over a long period of time via the intravenous
or intraperitoneal route (more than 5 minutes; may last for manyhours). Infusions are usually large volumes of fluid.
Inpatient A patient who stays in hospital for one or more nights.Integrated care pathway A flow diagram which allows the care provided to a patient to be recorded
on a document that provides evidence-based practice guidelines forpatient care.
Intentional Non-adherence in which a patient chooses not to take their medicationnon-adherence according to the prescribed regimen.
188 Glossary
Interaction The effect of a medication on the body; the effect of a reaction (chemicalor physical) between two or more medications (drug–drug interaction)or a medication and a food substance (food–drug interaction).
Intercellular matrix The substance around cells of the body, composed of tissue fluid andstructural macromolecules such as collagens and glycoproteins; alsoreferred to as interstitial fluid.
International normalised A measure of how well a person’s blood clots, used to determine howratio (INR) much anticoagulant (blood-thinning medication) a patient should take.
Intervention See Prescription intervention.Intra-articular Administration of medication by injection into a joint.Intradermal Administration of medication by injection into the layer of the skin
known as the dermis.Intramuscular Administration of a medication by injection into a muscle.Intra-osseous (IO) Administration of a medication by injection into a bone (only used in
children under 6 years of age).Intraperitoneal (IP) Administration of a medication by injection or infusion into the
abdominal cavity (the peritoneum).Intrathecal (IT) Administration of medication by injection into the cerebrospinal fluid
surrounding the spinal column.Intravenous (IV) Administration of a medication by injection into a vein.Isotonic Describes a fluid that contains the same concentration of salts as the
plasma.Jejunum A section of the gastrointestinal tract; the first part of the small intestine.Leading question A question that guides the response of the person answering, such as
‘Is your inhaler brown?’ See Closed question.Licensed dose The dose (or dose range) specified in the marketing authorisation.Licensed indication The clinical condition(s) specified in the marketing authorisation.Linctus A sweet-tasting liquid preparation of a pharmaceutical product; similar
to an elixir, but less sweet and containing more alcohol.Liniment A medicinal preparation meant for external use that is thinner in
consistency than an ointment (from the Latin linere: to anoint).Local effect The effect of a medication when it occurs in the area surrounding the
point of administration, rather than having a systemic effect (i.e.spreading through the body via the circulation and affecting manyareas).
Lotion An oil-in-water emulsion; a powdered, insoluble solid held in suspension.Lubricant An oily or slippery substance that reduces friction.Lumbar puncture Insertion of a hollow needle into the spinal cord in the lower back.Magnetic flea A plastic-coated magnetic object that can be placed in a container
of liquid and used with a magnetic stirring device to combine othermaterials into the liquid.
Marketing authorisation The licence granted to a pharmaceutical manufacturer by the MHRA(MA) when they provide sufficient evidence to satisfy the regulatory agencies
of the safety and efficacy of a medicinal product. Ideally, only productswith an MA should be supplied to patients, unless there is no licensedalternative.
Medical gases Gases used to produce a therapeutic effect, such as oxygen, nitrousoxide (‘laughing gas’, used as an anaesthetic and analgesic, especiallyduring labour) and gaseous anaesthetics, such as sevoflurane.
Glossary 189
Medical record A record of a patient’s care, including details of consultations withhealth professionals, current and past treatments, and current and pastillnesses. At present, separate records are held in hospitals and generalpractices.
Medicated water A water extraction of a solid medicinal substance.Medication error An error in the provision of a medication to the patient; can occur at
any stage in the medication use process (prescribing, dispensing,administering or monitoring).
Medication history A record of the medication which a patient takes at home, includingprescribed medication, medication bought OTC, herbal and othercomplementary therapies, and vitamin supplements. In addition, thisrecord should also include medication which has recently been stopped.
Medication review The process of reviewing a patient’s medication, either with orwithout the patient present, to assess whether the medication is safeand appropriate to continue.
Medicinal chemistry The design, synthesis and development of pharmaceutical drugs.Medicinal chemistry lies between chemistry and pharmacology.
Medicinal product A chemical with a medicinal use which has been formulated to enableit to be taken by humans or animals (as appropriate).
Medicinal substance A chemical which has a medicinal use.Medicines and The organisation in the UK that deals with the licensing and regulation
Healthcare products of medicines and medical devices; marketing authorisations for newRegulatory Agency drugs are granted by the MHRA.(MHRA)
Medicines counter Member of the pharmacy support staff who has undergone limitedassistant training that allows them to sell over-the-counter medicines within the
constraints of a protocol.Medicines information The team within a hospital pharmacy who answer queries from health
(MI) professionals and patients about medicines.Medicines management The systematic provision of medicines therapy through a partnership
effort between patients and health professionals to deliver best patientoutcome at minimum cost.
Medicines use review A review of how a patient takes their medicines at home, undertaken (MUR) by a community pharmacist with the patient present.
Meniscus The curved surface of the liquid at the fill point of a glass container; thefluid level next to the glass is higher than in the centre and the level ina container is read from the centre of the meniscus.
Mental health trusts Provide specialist health and social care to patients with mental healthproblems.
Minor ailment/illness An illness that does not have serious health implications for a patientand can be safely treated by a community pharmacist with the rangeof medications available over the counter.
Minor ailment scheme A scheme that allows patients to obtain treatments for minor ailments(such as hay fever, or cold and flu symptoms) free of charge from apharmacy without a prescription from their GP.
Mixture A combination of two or more substances that have not combinedchemically and that can be separated by physical means.
Monitoring The process of assessing the response of a patient to a medicine orother treatment.
Morbidity An illness or disease.
190 Glossary
‘Morning-after pill’ A one-off dose of progesterone given to women within 72 hours ofunprotected sex to reduce the risk of an unwanted pregnancy (alsoknown as emergency hormonal contraception).
Mortality Death.Mortar (and pestle) A bowl-shaped vessel in which substances can be ground (and mixed
with a pestle).Multiple-item A prescription that has more than one prescription item on it.
prescriptionMydriatic A medication that dilates the pupil.Nanotechnology Control of matter at the molecular level, in scales smaller than 1
micrometre, normally 1–100 nanometres, and the fabrication ofdevices within that size range.
Narrow therapeutic A narrow drug plasma concentration range at which a drug is effective.index At concentrations below this range the drug may not be effective; it is
likely to exert toxic effects at concentrations above the therapeuticrange. Some drugs used to treat epilepsy (e.g. phenytoin) have a narrowtherapeutic range.
Nasogastric (NG) tube A tube from the nose into the stomach for administering liquids ormedications.
Nasojejunal (NJ) tube Atube from the nose into the jejunum (the first part of the small intestine,just below the stomach) for administering liquids or medications.
National Institute for Special Health Authority that makes recommendations on whichHealth and Clinical treatments should be used in the NHS on the basis of their cost-Excellence (NICE) effectiveness.
National Service National standard of care for the treatment of a specific patient group, Framework (NSF) such as the elderly, children, and patients with heart disease.
Near miss An error that is identified before causing harm to a patient (or havingthe potential to cause harm to a patient).
Net ingredient cost (NIC) The cost of each ingredient contained on a prescription.New chemical entity A drug molecule that is new and chemically unique (i.e. does not contain
an active part that has previously been licensed by a governmentagency, such as the MHRA or FDA).
NHS acute trusts Management structure for hospitals (or groups of hospitals) that arecommissioned by primary care trusts to provide acute health care.
Non-adherence Describes a situation in which patient does not take their medication(or follow other recommendations about their health) as they havepreviously agreed to during consultation with a health professional.This is a less negative term than non-compliance.
Non-clinical speciality An area of pharmacy that does not involve direct patient contact onwards or in hospital clinics, such as management and sterile and non-sterile production.
Non-compliance Describes a situation in which a patient does not take their medication(or follow other health advice) as directed by a health professional.This is a negative term implying disobedience on the part of thepatient. The preferred term is non-adherence (described above).
Non-concordance Describes a consultation where a patient and health professionalcannot agree on decision about the patient’s care.
Non-sterile production The area within a hospital pharmacy where non-sterile medicinal prod-ucts (such as creams and ointments) are made in a clean environment.
Nostrum A favourite but untested remedy for problems or evils, traditionallyformulated by a pharmacist.
Glossary 191
Oncology The clinical speciality relating to study and treatment of cancer. Onset of action The point at which a drug starts to exert its therapeutic effect. This is
usually the time from when the dose was taken.Open and fair approach An approach which, when an error occurs, encourages staff to explore
why the error occurred and to report this centrally, to help organisationslearn from the experience. Instead of focusing on the individual directlyresponsible for the error, an open and fair approach focuses on thefactors that contributed to the error, such as the working environmentand staff resources.
Open question A question that has no right or wrong response and therefore usuallyencourages the person answering to give a detailed answer (e.g. ‘Tell meabout. . .’).
Optimising pack sizes The process of ensuring that prescriptions are written for the numberof dose units contained in an original pack of medication. This avoidspharmacists having to split original packs of medication.
Oral Administration of a medication by swallowing.Oral drops A liquid formulation of a pharmaceutical product, usually at a high
concentration, to reduce the volume needed to be taken by the patient.Oral liquid A liquid formulation of a pharmaceutical product.Organisational structure The management structure of an organisation which influences the
working conditions of staff.Orthopaedics The clinical speciality that deals with fractured bones and bone diseases.Osmotic effect In the context of pharmacy, this is the effect of a medicine with a high
concentration, such as lactulose, to draw water into the gastrointestinaltract, and therefore increase the volume of the gastrointestinal contents.
Osmotic potential The capability of a solution to draw water into it when divided fromanother solution by a semi-permeable membrane, such as a cellularmembrane, or the mucous membrane of the intestinal wall.
Outpatient A patient who attends hospital during the day but does not stayovernight (e.g. for minor surgery or specialist clinics).
Over-the-counter The supply of a GSL or ‘P’ medicine that can be sold from a registered(OTC) sale pharmacy under the supervision of a registered pharmacist (see separate
entries for definitions of GSL and ‘P’ medicines).Palette knife A blunt knife with a flexible steel blade and no sharpened cutting edge,
used for combining ingredients of creams or ointments on a ceramicslab.
Parenteral nutrition The administration of nutrients intravenously.Patent (drug) A licence that restricts the manufacture of a particular drug product
to the company that registers the patent for a set period of time (e.g.10 years).
Patented remedy A medicine containing one or more ingredients, designed by a particularpharmacist and protected by law from reproduction by other parties.
Paternalistic Treating patients in a ‘fatherly manner’, particularly making decisionsfor patients without giving them the opportunity to contribute to thedecision or to take any responsibility for the decision.
Patient Advisory and Provides a point of contact for patients to comment on the care theyLiaison Service (PALS) have received within the NHS. Also provides information about NHS
services and support to patients and their carers. Acute NHS trusts andprimary care trusts will have a PALS.
192 Glossary
Patient counselling The process of advising patients about their medicines, including whatthe medicine is for, how and when to take it, what side-effects to expectand what to do if they occur.
Patient group direction A written instruction that allows the legal sale, supply or administration(PGD) of a medicine to a patient (or group of patients) in a clearly defined
clinical situation without the necessity for a legal prescription.Patient information An information sheet supplied with a medication which informs
leaflet (PIL) patients about what the medication is for, how it should be taken, andwhat side-effects might occur.
Patient medication An electronic record of the medication that has been dispensed for anrecord (PMR) individual patient by a pharmacy.
Patient pack Usually a 28-day supply of a medication in a blister pack, alsocontaining a patient information leaflet (defined above).
Payment by results (PBR) The process by which healthcare providers are paid for the servicesthey provide (e.g. surgical operations; each service is assigned a tariff(the average cost of the service)).
Peak flow A measure of how fast a patient can blow air out of their lungs.Percutaneous Through the skin.Percutaneous endoscopic Insertion of a feeding tube from an opening in the skin of the abdomen
gastrostomy (PEG) into the stomach; the abbreviation PEG is also used to refer to the tubeitself.
Percutaneous endoscopic Insertion of a feeding tube that goes from an opening in the skin of thejejunostomy (PEJ) abdomen into the jejunum; the abbreviation PEJ is also used to refer to
the tube itself.Perfumes Scents added to pharmaceutical products to mask unpleasant odours.Peritonitis Inflammation of the peritoneal wall (the wall surrounding the
abdominal cavity), often caused by an infection.Pestle (mortar and pestle) A club-shaped hand tool for grinding and mixing substances (in a
mortar).Pharmaceutical care The responsible provision of drug therapy for the purpose of achieving
definite outcomes that improve a patient’s quality of life.Pharmaceutics The science of dosage form design (i.e. the processes of turning a new
chemical entity into an efficacious medicine that can be administeredsafely).
Pharmacokinetics The study of the fate of substances such as drugs within the body. Themain phases are absorption, distribution, metabolism and excretion(sometimes abbreviated to ADME).
Pharmacology The science of the properties of drugs and their effects on the body.Pharmacopoeia A pharmacopeia (literally, the art of the drug compounder) is, in
its modern technical sense, a book containing directions for theidentification of samples and the preparation of compounded medi-cines, published by the authority of a government or medical orpharmaceutical society.
Pharmacy Contract The contract under which community pharmacies provide a pharma-ceutical service to patients under the NHS. This contract includes threetiers of service provision: essential, advanced and enhanced.
Pharmacy support staff Members of the pharmacy team who have undergone varied levels oftraining to allow them to perform tasks traditionally undertaken bypharmacists.
Glossary 193
Pharmacy technician Member of the pharmacy support staff who has completed more exten-sive training than other pharmacy support staff, allowing them toperform a wide range of tasks traditionally undertaken by pharma-cists; pharmacy technicians are encouraged to register with the RoyalPharmaceutical Society of Great Britain.
Phase A distinct state of matter in a system (e.g. the solid phase, the liquidphase).
Physicochemical The particular profile of physical and chemical behaviour associ-characteristics ated with a compound (e.g. melting point, solubility, ionisation
characteristics).Pills A medicinal or other active substance mixed with binder powders and
pressed into a (spherical) tablet form. Placebo A substance that has no known biological activity, but may help relieve
a condition because the patient has faith in its ability to do so (the so-called placebo effect). Wherever possible, new drugs are compared witha placebo in clinical trials; the placebo tablet will appear identical tothe tablets containing the active drug.
Plasma concentration The level of a substance in the blood plasma.Plaster A paste-like mixture applied to a part of the body for healing or
cosmetic purposes.Polymorph A solid, such as a drug, that shares its chemical composition with
another material but is composed of a different crystal lattice or form.The polymorph solid will have different properties such as solubilityand lattice energies.
Polypharmaceuticals/ The use of more than one clinically justified medication concurrently.polypharmacy
‘POM to P’ switch Deregulation of a medicinal product that has previously been licensedfor prescription only use to a pharmacy medicine, available for saleover the counter.
Powder A medicinal substance consisting of ground, pulverised or otherwisefinely dispersed solid particles.
Practice-based The process by which general practices purchase healthcare services forcommissioning (PBC) the general population that they serve.
Pre-registration A 12-month period of vocational training undertaken as part of the placement training to become a pharmacist. The type of training is outlined in
criteria from the Royal Pharmaceutical Society of Great Britain. Phar-macy students undertake the training either in a 1 year block aftergraduation (4 years at university and 1 year’s training ‘on the job’) oras two 6 month blocks integrated into the undergraduate education(5 years in total).
Prescribing The process of choosing and writing a prescription for a medicine togive to a patient.
Prescribing errors An error in the prescription of a medication.Prescription chart See Drug chart.Prescription intervention The process by which a pharmacist requests that a prescriber change a
prescription in order to make the prescription legal, to reduce the costof the prescription, or to ensure that the prescribed medication is safeand effective for a patient to take.
Prescription item A single named medicinal product (or appliance) on a prescription.
194 Glossary
Prescription laboratory A room or area of the dispensary dedicated to making up specialproducts on the order of a physician.
Prescription-only A medicinal product that can only be supplied in response to a Medicine (POM) prescription written by an authorised prescriber.
Preventable drug-related An adverse event caused by an error in the provision of a medicationmorbidity (PDRM) to a patient where the patient harm was foreseeable and avoidable.
Primary care The first point of contact with health care for the general public (e.g.general practice surgeries, dentists, nurses, opticians, pharmacists).
Primary care trust (PCT) One of 152 geographic areas that provide local management of healthcare and commission health services. PCTs are accountable to thestrategic health authorities.
Primary non-adherence Non-adherence (defined above) in which a patient does not have aprescription dispensed.
Primary packaging Packaging material that comes into direct contact with a medicinalproduct.
Private prescription A prescription that is not written on an official NHS prescription formand is therefore not paid for by the NHS.
Private prescription A record of private prescriptions (and the individual items on these)register dispensed by a pharmacy.
Privy Council A body that advises the head of state. In the UK, the Privy Council iscomposed of all the members of the Cabinet, former cabinet ministers,and other distinguished persons appointed by the sovereign. Its func-tions include granting royal charters and acting as a court of appealfrom British courts in oversees territories.
Probing question A question that is intended to get more detailed information aboutsomething, such as ‘How many times a day do you use your inhaler?’See Open question.
Product licence The old name for a marketing authorisation.Professional check The check which a pharmacist makes to ensure that a prescription is
legal and clinically appropriate for an individual patient, and that thedispensed medicinal product is the same as that requested by theprescriber.
Professional fee A payment made to a pharmacy for dispensing a prescription item onan NHS prescription.
Prophylaxis The use of a medicinal product or other form of treatment with theintention of avoiding a future illness, for example taking medication tocombat malaria before, during and after travel to countries known tohave a malaria problem.
Proprietary remedy A remedy to which the manufacturer has exclusive rights, usuallymarketed under a name that is registered as a trademark.
Public health The health needs of the population as a whole (as opposed to individ-uals). Public health usually refers to the delivery of services targeted atpreventing disease, such as smoking cessation.
Qualitative testing Testing the quality of a substance or product, for instance the purity ofa medicine.
Quality and Outcomes Part of the contract that employs general practitioners within the NHS,Framework (QOF) providing financial incentives to general practices for the provision of
excellent patient care.Quality assurance The provision of evidence that an item or product conforms with the
established technical requirements.
Glossary 195
Quality control The inspection, analysis and action required to ensure the quality of aproduct.
Quantitative testing Testing the amount, or quantity, of a substance in a product.Rectal administration Administration of a medication via the rectum (back passage).
(PR (per rectum))Register of This document, held and controlled by the Royal Pharmaceutical
Pharmaceutical Society of Great Britain, is a statutory database that is updated onChemists an ongoing basis throughout the year, with the prime purpose of
providing assurance to the public that pharmacists in practice areregistered health professionals who fulfil the requirements of health,character and education, and are bound by the profession’s code ofethics.
Renal failure A medical condition in which the kidney(s) is no longer able to workat an optimal level. This can be acute (where it occurs suddenly) orchronic (where it is a longstanding condition).
Repeat dispensing The process by which patients can collect medicines that are prescribedfor long-term use, direct from the pharmacy, without the need tocollect a prescription from their GP each time (as is the case with repeatprescribing).
Repeat prescription A prescription for a medication that a patient is taking over a longperiod of time, which they can request from their general practicesurgery without needing to see the doctor. Repeat prescriptions areauthorised for a limited time period or number of issues, after which apatient should be reviewed by their general practitioner (or otherprescriber) to ensure that it is appropriate to continue taking themedication.
Reservoir of drug An area in the body where a drug accumulates before being dispersedthroughout the body. This may happen in the skin, when the drugbeing delivered by a patch passes into the skin more quickly than it isdispersed by the blood supply.
Retailing The process of selling goods to customers.Reye’s syndrome A rare condition that predominantly occurs in young children follow-
ing a viral infection. Patients initially have severe persistent vomitingand fever, followed by outbursts of wild behaviour, which progressesinto convulsions and finally death. It is known to be associated withaspirin, particularly in children.
Risk factors Factors (such as another disease or illness or behaviour such as smoking)that increase the risk of a patient developing a medical condition.
Risk management The process of assessing whether something can go wrong, how likelyit will go wrong, how severe the consequences might be, and how theunwanted outcome can be avoided.
Risk–benefit analysis The process of assessing the risks and benefits of an action or treatmentand deciding what to do in light of the balance between the two.
Royal Charter of A Charter is an authority directly from the monarch for a body to takeIncorporation certain powers. A Charter of Incorporation enables a body to function
as a corporation (i.e. a large company or group of companies autho-rised to act as a single entity and recognised as such in law). The RoyalPharmaceutical Society of Great Britain operates under a Charter ofIncorporation.
196 Glossary
Royal Pharmaceutical The Royal Pharmaceutical Council governs the Royal PharmaceuticalCouncil Society of Great Britain and is responsible for deciding on policy and
practice relating to the society.Royal Pharmaceutical The professional and governing body for pharmacists and pharmacy
Society of Great Britain technicians in Great Britain.(RPSGB)
Secondary (acute) care Care provided by hospitals.Secondary Non-adherence (defined above) in which a patient has a prescription
non-adherence dispensed but does not take the medication according to the directionsagreed with the health professional.
Secondary packaging Packaging material that encloses the primary packaging and does notcome into direct contact with the medicinal product.
Secretary of State for Senior government minister in charge of the Department of Health.Health
Sedate Put a patient to sleep, or otherwise calm them, using a medication suchas a benzodiazepine.
Selected list A list of medications that can be prescribed on an NHS prescription forpatients with a restricted list of conditions.
‘Sick day rules’ Guidance given to diabetic patients on how to adjust their insulin doseto help maintain control of their blood glucose when they are ill.
Sick role The role that a patient takes when they are unwell. The sick role meansthat they no longer have to perform their usual tasks, but in return theymust make every effort to get well again (e.g. by taking medication).
Side-effects Unanticipated effects of a medication – can be beneficial or harmful.Signed order A request to purchase a prescription-only medicine or a Schedule 1
poison.Signposting Referring patients to the most appropriate health or social care
provider in order to reduce the inappropriate use of health and socialcare services.
Single electronic patient A single electronic record of a patient’s medical and medication history record available online. Health professionals will be able to access the infor-
mation that they need in order to deliver effective care to patients fromthis record (not yet in existence at the time of writing).
Solubility A chemical property referring to the ability for a given substance (thesolute) to dissolve in a solvent.
Special health authority An organisation that provides a range of centralised services to the NHSin England, for example (NICE, defined above).
Standard operating A protocol that describes how (and by whom) a task, such as dispensingprocedure (SOP) a medicinal product, should be carried out.
Sterile production The area within a hospital pharmacy where sterile medicinal products(such as injections and eye drops) are made in a very clean environ-ment to avoid contamination with bacteria or other microbes.
Sterility The absence of pathogenic organisms.Stock list List of stock that is kept within the pharmacy.Stoma A surgically created opening from an area inside the body to the
outside. For example, a colostomy is an opening from the colonthrough the abdominal wall to the outside the body.
Strategic health authority One of ten geographic areas that provide local management and(SHA) strategic direction for the NHS, accountable to the Department of Health.
Glossary 197
Strength The amount of drug contained in a given dosage unit (e.g. a 50 mgtablet, or a 5 mg/mL liquid).
Subarachnoid space The space between two of the three membranes covering the brain andspinal cord, which is filled with cerebrospinal fluid.
Subcutaneous (SC) An injection from a needle placed underneath the skin (i.e. into theinjection subcutaneous connective tissue).
Sublingual (SL) Administration of a medication by placing it underneath the tongue.Substance misuse The administration of a substance by a person for purposes other than
a therapeutic effect (e.g. solvent abuse, excessive alcohol intake, heroinaddiction).
Sub-therapeutic dose A dose of medication that is too low to produce the desired therapeuticeffect.
Supplementary prescriber A non-medical prescriber who has undergone a structured trainingprogramme that allows them to prescribe medications within theconstraints of a clinical management plan agreed by the patient, theirdoctor and the supplementary prescriber (includes pharmacists andnurses amongst other others).
Suppository A solid dosage form that is administered via the rectal route.Suspension A solid dosage form suspended in a liquid, usually water.Symptomatic relief Relief of symptoms of an illness or disease rather than treating the
underlying condition.Synovial fluid Fluid within a joint that provides lubrication and nutrition of the joint.Systemic circulation The circulation that supplies blood to all parts of the body except the
lungs.Systemic effect A generalised effect of a drug throughout the body, compared with a
local effect which is restricted to the area of the body where the drug isdelivered.
Syrup A liquid dosage form containing a high percentage of sugar.Targeted delivery Where a drug molecule is modified (such as by association with a
polymer) to preferentially target a specific site of action (e.g. a tumour).The Society A commonly used term that refers to the Royal Pharmaceutical Society
of Great Britain.Therapeutic The concentration of a drug in the blood plasma required for therapeutic
concentration effect.Therapeutic decision Making a decision about how to treat a patient, based on evidence,
experience and the therapies available.Therapeutic failure A therapeutic failure occurs when treatment does not have the desired
effect. In the case of medication, this might be because the prescribeddose is too low, the patient is not taking the medication or is taking itincorrectly, or an interaction occurs.
Therapeutic index The ratio between the toxic dose and the therapeutic dose of a drug,used as a measure of the relative safety of the drug for a particulartreatment.
Therapeutic response When a positive clinical change is seen after the administration of amedicine (e.g. an antibiotic causing a reduction in bacterial load).
Therapeutic objective The result desired when a drug is taken by a patient.Therapeutics The branch of medicine concerned with the treatment of disease with
medicinal products (as opposed to surgery).Tincture A solution prepared by steeping or soaking plant materials in alcohol
and water.
198 Glossary
Topical Administration of a medication by placing it on the skin or a mucousmembrane.
Toxicology The study of adverse effects (toxicity) of chemicals on living organisms.Treatment regimen The medication(s) (or other forms of therapy) that are recommended
or prescribed to treat a patient’s condition.Trituration The grinding of powders in a mortar with a pestle, before combining to
make a cream, ointment or other pharmaceutical product.Unguent A soothing preparation spread on sores, burns, irritations or other
topical injuries; an ointment. It is usually delivered as a semi-solid pasteand is often oily to suspend the medication or other active ingredients.
Unintentional Non-adherence (defined above) in which a patient either forgets, or isnon-adherence unable, to take their medication according to the prescribed regimen.
Unlicensed dose A dose of a licensed medication that is outside the dose range specifiedin the marketing authorisation.
Unlicensed indication A clinical use of a medicinal product that is not included in themarketing authorisation.
Unlicensed medicine A medicinal product that has not been granted a marketing authorisation.Veterinary medicinal A medication used to treat animals.
productViscosity A measure of the ease with which a liquid can be poured or stirred. The
higher the viscosity, the less easily a liquid pours.Ward round When doctors and/or other health professionals review the patients on
a ward.Yellow Card Scheme The system used by patients and health professionals to report
suspected adverse drug reactions to the Medicines and Healthcareproducts Regulatory Agency (MHRA).
Glossary 199
accessibility of pharmacy, 158accountability, 161accredited checking technician, 34, 38, 106accuracy of dispensed prescription, 34, 106–7,
158acute NHS trusts, 12, 14adherence, 3–4, 135–49
definition, 137dimensions, 139
condition-related, 140patient-related, 140–1social/economic, 139–40therapy-related, 140
improvementbenefit to patients, 146strategies, 143, 145
influence of health-professional relationships,140, 145
problems, 59, 139health consequences, 143, 144
see also compliance; concordanceAdjudicating Committee of RPSGB, 73administration of medication, 169
errors, 59medicines information services, 49
administration routes, 169–79across mucous membranes, 171–2drug development process, 44–5enteral, 169–71inhalational, 175parenteral, 176–8selection, 169terminology, 179topical, 172–5
adolescents, non-adherence, 140adverse drug reactions, 6–7, 43, 56, 98–9, 161
clinical trials, 48, 49compliance/non-compliance influence, 136,
140
identification of patients at risk, 64–5medicines information services, 49national reporting systems, 7, 27prevention, 56short-term effects, 143unlicensed medicines, 159, 160
advice from pharmacist, 20, 27associated risks, 151medicines management, 63over-the-counter medicines, 20, 23, 28
counter prescribing process, 157see also information for patients
Advisory Committee on Borderline Substances(ACBS), 94
airtight containers, 111Alcoholic Liquor Duties Act (1979), 154Allen, William, 72aloxiprin, 121, 122aluminium foil/tube packaging, 115amber bottles, 113ambulance trusts, 12, 15ampoules, 114animated presentations, 81antibiotics, 21, 28anticoagulant clinics, 37anticoagulants, 98
see also warfarinanticonvulsants, 171antihistamines, 85antihypertensives, 141arthritic patients, packaging selection, 110‘as required’ medication, 91aspirin, 98, 156, 170
labelling requirements, 121, 122assistant technical officers (ATOs), 35, 40, 41asthma, 142, 175
pharmacy medicines (P) labelling, 122audit, 29
clinical governance, 161
Index
201
audit (cont.)medicines management, 61, 65RPSGB templates, 161
Audit Committee of RPSGB, 73–4authorised prescribers, 85–6
balances, 128–9beclometasone, 175beta-blockers, 141, 146Beveridge Report, 9bioavailability
clinical trials, 48drug development process, 44
biotechnology, 45‘black triangle drugs’, 27‘blacklisted’ medicines, 26, 86, 93blister packs, 111, 112, 115, 116blood cholesterol screening, 30blood pressure screening, 30blood sugar screening, 30body language, 78
presentations, 83–4borderline substances prescription, 94borosilicate glass, 113bottles
glass, 113, 126plastic, 114, 115
breastfeeding patients, 65British National Formulary (BNF), 26, 65, 86, 98
classification of medicines, 155dosage regimens, 105drug interactions information, 105packaging terminology, 111special-order manufacturers, 132
British National Formulary for Children, 105British Pharmacopoeia (BP), 26, 50buccal drug delivery, 171–2Building a safer NHS for patients, 58Bunsen burner, 132–3
cachet, 112calcium channel blockers, 146capsules, 169carbamazepine, 172cardiovascular disease
advice on risk factors, 28diagnostic testing, 20
care homes, advice on/supply of medication, 30,67
care trusts, 12, 18case presentations, 37ceramic slab, 128
Chemical (Hazard Information and Packaging forSupply) Regulations (1994), 153
chemists’ nostrums, 26labelling, 120
chemotherapyextemporaneous preparation, 128intrathecal administration, 178
Chief Medical Officer (CMO), 10, 12Chief Pharmaceutical Officer (CPO), 10chief pharmacist, 35, 40child-resistant closures, 110, 115, 159children
aspirin contraindications, 121hexachlorophane contraindications, 122medicines management, 65prescriptions, 100
checking dosage, 105product labelling requirements, 121, 122
Chloral Elixir, Paediatric BP, 127chronic obstructive pulmonary disease, 175Cipramil Oral drops, 127clinical governance, 3, 17, 161–3
community pharmacy setting, 29, 66clinical interventions, 4–5
definition, 4clinical medicines management, 60clinical pharmacy
hospital setting, 36pharmaceutical care, 36–7training, 38, 39
clinical services manager, 35, 36, 40clinical training rotations, 39clinical trials, 43, 47–9
ethics committee review, 47–8informed consent of participants, 48–9Medicines and Healthcare products Regulatory
Authority (MHRA) regulation, 50pharmacist’s role, 48, 49
closed (convergent) questions, 79closures, 115
child-resistant, 110, 115, 159Code of ethics for pharmacists and pharmacy
technicians, 154key principles, 155
communication skills, 2–3, 6, 24, 77–84active listening, 77–8clinical trial participant recruitment, 48–9good prescribing principles, 99health-professional interactions, 79–80medicines information services, 49medicines management, 62–4over-the-counter/pharmacy medicine advice, 28
202 Index
patient interactions, 77–9pharmacist ward rounds, 37presentations see presentationsquestioning, 78–9responding/explaining, 79
community pharmaciesaccessibility, 158audit, 161factors affecting delivery of services, 152patient satisfaction surveys, 162sale and supply of medicines see sale and supply
of medicinessources of risk, 151staff management, 163storage of medicines, 158
community pharmacists, 20–1, 23–31access to health records, 23–4, 65business management, 20–1
retailing activities, 29counter-prescribing, 156–7dispensing, 26future role development, 31historical aspects, 24–6medication review, 60medicine sales supervision, 156–7medicines management see medicines
managementnew contract see Pharmacy Contractservices
advanced, 65enhanced, 26, 65, 67essential, 26, 27–9, 65, 66identification of local needs, 66locally enhanced, 29–31minimum standards, 158–9patient expectations, 158
training, 26compensation claims, 155, 164complaints procedure, 164complex medication regimens, 140compliance, 3–4, 63, 135–49
definition, 136, 137see also adherence; concordance
compoundingequipment, 128–33historical aspects, 24, 26, 72see also extemporaneous preparations
concordance, 3–4, 6, 63, 99, 135–49definition, 137–8importance for patient–health professional
communication, 138–9pharmacist’s role, 146–9
concordant consultation, 137–8skills development, 147–9
Conference Committee of RPSGB, 74conferences, 39conical measures, 129continuing professional development (CPD), 5,
29, 161–2hospital pharmacy departments, 38–9medicines management, 65
continuous ambulatory peritoneal dialysis, 178Control of Substances Hazardous to Health
Regulations (1999), 153controlled drug register, 105, 106controlled drugs
labelling regulations, 117NHS prescription form, 89–90regulations, 152
cost of prescribed medicines, 135cough linctus, 127counselling patients see advice from pharmacistcounter-prescribing process, 156–7creams, 127
extemporaneous preparation, 132, 133topical, 174vaginal, 172
Creating a Patient-led NHS, 18–19Crown Report, 31, 86
decongestants, 85definition of pharmacy practice, 1–2Denatured Alcohol Regulations (2005), 154Dental Practitioner Formulary, 86, 94dental prescriptions, 94Department of Health (DH), 10, 12depression, 142
non-adherence to medicine regimens, 140desmopressin, 174destruction of old pharmaceuticals (DOOP) bins,
29diabetes, 26, 142
advice on risk factors, 28diagnostic testing, 20insulin delivery pens, 110‘sick day rules’, 59
diazepam, 172directions for use, 118
prescription interpretation, 104–5verbal communication of information, 119,
158wording, 118–19
disease management, 4dispensary management, 38
Index 203
dispensingcommunity pharmacist services, 26, 66concordant approach, 146–7packaging selection, 109–10see also prescription, interpretation procedure
dispensing assistants, 156dispensing bags, 116dispensing errors, 59, 155, 158
complaints procedure, 164contributing factors, 160legal aspects, 59management of complaints, 163–4, 165near misses, 59, 160
reporting, 162patient harm, 164, 165
liability, 4, 165–6prevention, 159, 160
district nurse prescribers, 94diuretics, 142domiciliary medication reviews, 62dosage
clinical trials, 48medicines information services, 49prescription interpretation, 104–5
dosage forms, drug development process, 44‘doubling up’ procedure, 131, 132dropper bottles, 113–14drowsiness, warning labels, 122drug administration see administration of
medication; administration routesdrug development, 43
focus groups, 50pharmacist’s role, 44, 45regulatory processes, 50–1
drug holidays, 141drug misuse, 6
support services, 20, 30treatment programmes, 6warning signs, 6
Drug Tariff, 86, 102‘black list drugs’, 26, 86, 93borderline substances, 94professional fees, 107selected list, 93
drug–drug interactions, 6, 98, 161checking prescriptions, 105clinical trials, 48community pharmacist’s role, 27–8pharmacy medicines (P), 85
drug–enteral feed interactions, 171drug–food interactions, 6, 37
community pharmacist’s role, 27–8
drug–herbal remedy interactions, 155community pharmacist’s role, 27–8
ear drops, 127, 173application technique, 173dropper bottles, 113–14packaging, 113
economic factors in non-adherence, 139–40Education Committee of RPSGB, 73electric hot plates, 133electronic labelling systems, 105electronic patient medication records, 105electronic prescriptions, 41, 86–7elixirs, 127embrocations, 122‘emergency drug cupboard’, 37emergency hormonal contraception, 30, 67emergency supply, 158
labelling, 123empathy, 79enemas, 127, 172England
national pharmacy board, 74NHS prescription forms, 88
enteral drug administration, 169–71enteral feeds, 170, 171enteric coating, 170enteric tubes, 170–1enterostomal tube, 170ephedrine, 122epidural drug administration, 178ethical issues, 4
clinical trials, 47–8non adherence to medicine regimens, 140sale and supply of medicines, 154–5
European Community Council Directives andRegulations, 153
European Medicines Evaluation Agency (EMEA),51
marketing authorisation, 152, 154European Pharmacopoeia, 50excipients, drug development, 44expiry date, 47, 158explaining skills, 79extemporaneous preparations, 5, 33, 34, 125–33
compounding equipment, 128–33hospital pharmacy practice, 128legal guidelines, 125–6oral liquids, 126–7professional fees, 107standards, 125, 126topical semisolids, 127–8
204 Index
eye contact, 78presentations, 82, 83
eye drops, 173application technique, 173dropper bottles, 113–14flexible plastic bottles, 114, 115glass packaging, 113
eye ointment, 173application technique, 173–4
final accuracy check of dispensed prescription,34, 106–7, 158
first aid, 26fitness to practice, 72, 73fluid for injection
glass packaging, 113multidose vials, 114
fluid replacement therapy, 176–7fluticasone, 175focus groups in drug development, 50Food and Drug Administration (FDA), 51food supplements, 155formulation scientists, 44, 45formulations
drug development process, 44–5prescription interpretation, 102
gatekeeper role, 4gels, 128
labelling requirements, 122topical delivery, 174
General Dental Council register, 91General Medical Council List, 91General Pharmaceutical Council (GPhC), 75general practitioner relationships, 64general sales list (GSL) medicines, 85, 155
labelling, 121–12prescribed medicines, 157
generic drug prescribing, 102glass mortar and pestle, 131glass packaging, 112–13, 126
categories (types I-IV), 113containers, 113–14
glass slab, 128glossary of terms, 181–99glyceryl trinitrate, 109, 171, 172good manufacturing practice (GMP) guidelines,
47, 50good prescribing principles (prescribing pyramid),
97–9Governance Committee of RPSGB, 74Guernsey, NHS prescription forms, 89
Health Act (1999), 71Health Protection Agency (HPA), 15health psychology, 5–6health visitor prescribers, 94Healthcare Commission, 14, 16, 17healthcare systems, 2heat sources for compounding, 128, 132–3heating for extemporaneous preparations, 133Helicobacter pylori eradication, 143herbal remedies, 155
associated risks, 155see also drug–herbal remedy interactions
hexachlorophane, 122historical aspects
community pharmacies, 24–6hospital pharmacies, 33–4medicines management, 56Royal Pharmaceutical Society of Great Britain,
72–3holistic needs of patients, 98homocystinuria, 94hospital pharmacies, 21, 33–41
assistant technical officers (ATOs), 35, 40, 41department structure, 34–6dispensary management, 38historical background, 33–4medicines information services, 39out-of-hours on-call system, 37pharmacy stock lists, 35senior management team, 35–6sterile/non-sterile production units, 40technician’s role, 34, 38, 40, 41
hospital pharmacists, 21clinical pharmacy, 36–7, 38clinical training rotations, 39concordant consultation, 147extemporaneous preparation, 128future role extension, 41management roles, 40medication counselling before discharge, 147specialisation, 38–40teaching activities, 37–8
hospital pharmacy technicians, 34, 38, 40, 41hospital prescription forms, 91hyaluronidase, 177hypodermoclysis, 176
immunosuppressant medicines, 135–6indemnity insurance, 155independent prescribers, 18, 21, 41, 86
concordant approach, 147nurses, 94
Index 205
industrial sector pharmacy, 43–53business/management opportunities, 51–2clinical trials, 47–9manufacturing, 45–6medicines information, 49pharmacist’s roles, 44, 45, 46, 50, 51product transfer process, 46quality assurance, 46–7regulatory processes, 50–1research and development, 44–5sales/marketing, 49–50training, 45
career pathways, 52–3work experience placements, 52
influenza vaccination promotion, 28, 62Information Centre for Health and Social Care
(IC), 15information for patients, 3–4, 17
adherence/non-adherence influence, 137, 143community pharmacists
education sessions, 20signposting role, 28, 66
concordant consultation, 137–8, 146, 147hospital pharmacists, 21labels, 117, 118medicinal products dispensing procedure,
119–20medicines management, 31see also advice from pharmacist
informed consent, clinical trial participants, 48–9infusion bags, 115
extemporaneous preparation, 128infusions, subcutaneous administration, 176–7inhalation drugs, 44–5, 175inhaler devices, 175insulin
delivery pens, 110inhalational delivery, 44–5, 175
integrated care pathways, 60intra-articular drug administration, 178intradermal drug administration, 177intramuscular drug administration, 177intra-osseous drug administration, 178intraperitoneal drug administration, 178intrathecal drug administration, 177–8intravenous drug administration, 176
new chemical entity (NCE) formulations, 44Investigating Committee of RPSGB, 73Isle of Man, NHS prescription forms, 89
jargon, 79jars, 114
Jersey, NHS prescription forms, 89
labelling, 20, 117–23chemists’ nostrums, 120directions for use, 118dispensed medicinal products, 118–20, 159emergency supply, 123general sales list products, 121–2importance, 117–18legal requirements, 118manufacturers’ requirements, 120–3pharmacy medicines, 122placement on product, 123practical aspects, 123prepacked bulk medications, 120prescribed medicines, 105, 158prescription-only medicines, 122stock bottles, 130verbal communication of information provided,
119veterinary products, 122–3
labelling system interaction alerts, 105Law and Ethics Committee of RPSGB, 73lead compounds, 44legal aspects, 4
dispensing errors, 59, 165–6extemporaneous dispensing, 125–6labelling requirements, 118
manufacturers’ bulk products, 120–1prescriptions, 100, 101
records, 105professional negligence claims, 164–5sale and supply of medicines, 152–4
licensed medicines, 152, 156licensing of medicines, 50
MHRA submissions, 50, 51linctuses, 127liniments, 127
labelling requirements, 122liquids
measuring procedure, 130–1oral administration, 126, 169
listening skills, 77–8local formulary guidelines, 86local services, 29–31, 66lotions, 127
labelling requirements, 122topical delivery, 174
lumbar puncture, 177
Magnesium Sulphate Paste BP, 128Magnesium Trisilicate Mixture BP, 127
206 Index
magnetic stirrer, 133management roles
community pharmacists, 20–1, 29hospital pharmacists, 40industrial sector, 51–2
manufacturing, 45–6marketing, 49–50marketing authorisation (MA), 152, 154mathematical skills, 5measuring cylinders, 128, 129–31medical representatives, 50medication reviews/medicines use reviews, 60, 62,
63, 64community pharmacist’s role, 20, 29, 31, 67concordant consultation, 147good prescribing principles, 99levels, 61patient privacy, 64
medicinal chemistry, 43, 44medicine categories, 85–6Medicines Act (1968), 85, 152, 153, 155, 164–5medicines counter assistants, 156Medicines, Ethics and Practice Guide for Pharmacists
and Pharmacy Technicians, 93, 113, 117,123, 125, 126, 152, 154, 158
Medicines and Healthcare products RegulatoryAuthority (MHRA), 34, 50
adverse effects reporting see Yellow Card SchemeBest practice guidance on labelling and packaging of
medicines, 118clinical trials regulation, 47, 50drug licence submissions, 50, 51marketing authorisation (MA), 152Rules and Guidance for Pharmaceutical
Manufacturers and Distributors (OrangeGuide), 39–40
Medicines for Human Use Regulations, 152, 159medicines information services, 39, 49medicines management, 20, 31, 55–68
clinical approaches, 60communication
with health professionals, 62, 64with patients, 63–4
continuing professional development, 65definition, 55–6errors, 58–9
frequency, 58monitoring, 59prevention, 56, 64
historical development, 56information resources, 65methods, 62–5
objectives, 55patients at risk of adverse drug reactions, 64–5public health approaches, 61–2record-keeping, 65systems and processes approach, 60–1
Medicines (Marketing Authorisations andMiscellaneous Amendments) Regulations(1994), 117, 118, 120, 159
medicines use reviews see medicationreviews/medicines use reviews
mental health trusts, 12, 15mesalazine, 170metal containers, 115metered-dose inhalers, 175methadone
administration supervision, 20, 30extemporaneous dispensing, 125
methylprednisolone, 178minor ailments
advice concerning over-the-counter/pharmacymedicines, 28
community pharmacist services, 20, 30, 67historical aspects, 26
misconduct, 164Misuse of Drugs Act (1971), 152, 154Misuse of Drugs Regulations (2001), 117mixtures, 127modified-release preparations, 44monitored dosage systems (multicompartment
compliance aids), 110, 145monitoring errors, 59mortar, 128, 131mouthwashes, 127multicompartment compliance aids (monitored
dosage systems), 110, 145multidose containers, 111, 114, 115multiple-item prescriptions, 86
nanotechnology, 45nasal drops, 127, 174
application technique, 174packaging, 113
nasal drug delivery, 174nasal sprays, 174nasogastric tube, 170National Health Service see NHSNational Institute for Health and Clinical
Excellence (NICE), 15, 17, 21National Library for Health, 17, 98National Patient Safety Agency (NPSA), 15national pharmacy boards, 74National Research Ethics (NRE) service, 47
Index 207
National Service Frameworks (NSFs), 17, 20, 22,66
National Treatment Agency for Substance Misuse(NTA), 15
nebulisers, 175needle exchange services, 20, 67neutral glass, 113new chemical entity (NCE)
development, 43, 44preclinical testing, 47
The New NHS Modern Dependable, 17NHS Blood and Transplant (NHSBT), 15NHS Direct, 14, 16, 17, 28NHS (General Medical Services Contract) (Prescription
of Drugs) Regulations 2004Schedule 1, 93Schedule 2, 93–4
NHS (National Health Service), 9–22centralised versus localised management, 10, 16historical aspects, 9–10pharmacist roles, 19–22recent changes, 16–19
infrastructure, 18staffing, 17–18
structure, 10–16The NHS Plan, 17–18, 86NHS prescription forms, 85, 86, 87
for controlled drug supply, 89–90essential information, 87fraudulent reproduction, 88restrictions, 93–4
Schedule 1 products, 93Schedule 2 products, 93–4
used in Channel Islands, 89used in England, 88used in Isle of Man, 89used in Northern Ireland, 89, 90used in Scotland, 89, 90used in Wales, 88–9
NHS walk-in centres, 14, 16NHSnet, 17nicotine replacement therapy, 171non-steroidal anti-inflammatory drugs, 136, 146Northern Ireland, NHS prescription forms, 89, 90Nurse Practitioner Formulary, 86, 94
obesity management, 20ointments, 127–8
extemporaneous preparation, 132, 133eye, 173topical, 174vaginal, 172
older adultschecking prescription dosage, 105medicines management, 65non-adherence, 140packaging selection, 110prescribed medicines, 135
omeprazole, 157, 170open questions, 79operational manager, 35, 36oral drops, 127oral drug administration, 169–70
new chemical entity (NCE) formulations, 44oral emulsions, 127oral liquids, 169
advantages/disadvantages, 126extemporaneous dispensing, 126
oral solutions, 127oral suspensions, 127Orange Guide (Rules and Guidance for Pharmaceutical
Manufacturers and Distributors), 39–40An organisation with a memory, 56, 57‘original packs’, 100out-of-hours services
community pharmacy, 67hospital pharmacy on-call system, 37
out-patient clinics, 10, 37over-the-counter medicine
advice from pharmacist, 20, 23, 28counter-prescribing process, 156–7marketing, 49prescribed medicines, 157safety, 151, 156sales, 155–7
overhead projectors, 81
packaging selection, 110chemical nature of product, 109–10closures, 115environmental concerns, 115materials, 111–15patient convenience, 110, 116position of labels, 123practical issues, 115prescribed medicines, 158primary, 110secondary, 110–11selection, 109–10, 116
for repackaging, 116terminology, 111
pain relief, 141palette knife, 128, 131–2paper packaging, 112
208 Index
paracetamol, 121–2parenteral drug administration, 176–8pastes, 128patient advisory and liason services (PALS), 17patient decision-making, 136, 137, 139
concordance approach, 137–8patient details, prescription interpretation,
99–100patient education
adherence improvement, 144community pharmacist’s role, 20medicines management, 62see also information for patients
patient feedback, 66patient group directives, 30, 62, 158patient information leaflets, 121, 143, 154
translations, 123for visually impaired patients, 123within patient packs, 112
patient medication records (PMRs), 65, 105‘patient packs’, 100, 111patient satisfaction surveys, 162patients’ beliefs about medicines, 140–3
addiction risk, 141–2anti-drug attitude, 142associated problems of everyday life, 142immunity over time, 141non-acceptance of illness, 142perceived efficacy, 141risk–benefit balance, 142–3unnaturalness of synthetic compounds, 141
payment by results (PbR), 19percutaneous endoscopic gastrostomy, 171percutaneous endoscopic jejunostomy, 171pessaries, 172pestle, 128, 131pharmaceutical care, 4, 36–7
definition, 4Pharmaceutical Journal, 72, 105, 164Pharmaceutical Society of Great Britain, 26pharmacist prescribing, 18pharmacist roles, 2
within NHS, 19–22pharmacopoeias, 25, 26pharmacy assistants, 156Pharmacy Contract, 20, 60, 115
audit, 161medicines management, 65–7medicines use reviews, 63, 64, 147
Pharmacy in the Future, 10, 13, 19, 56pharmacy (P) medicines, 85, 155
advice from pharmacist, 28
labelling, 122marketing, 49prescribed medicines, 157recent switches from prescription-only
medicines (POM), 156–7pharmacy practice overview, 1–7pharmacy support staff, 156, 163
dispensing errors, 160pharmacy technicians, 156phase I clinical trials, 48phase II clinical trials, 48phase III clinical trials, 48phase IV clinical trials (postmarketing
surveillance), 48, 49phenytoin, 171placebo, 48plastic packaging, 114–15point of care testing, 20poison bottles, 113Poisons Act (1972), 153poisons (Schedule 1), signed orders, 91, 93porcelain mortar and pestle, 131postmarketing surveillance (phase IV clinical
trials), 48, 49poverty, non-adherence influence, 140powders
extemporaneous preparation, 131topical delivery, 174
practice-based commissioning (PBC), 19prednisolone, 170pregnant patients, 65prepacked bulk medications, 120prescribers, 85–6
non-general practitoners, 94see also independent prescribers; supplementary
prescribingprescription, 20, 31, 85–94, 97–107
accuracy, 34, 106–7, 158alternative non-drug therapy, 98borderline substances, 94contact with prescribing GP, 64, 102, 104, 161electronic, 86–7endorsement, 102, 104
electronic, 107errors, 59follow-up consultation/review, 98, 99good practice principles (prescribing pyramid),
97–9industrial sector promotional activities, 49–50interpretation procedure, 99–107
checking dosage and directions, 104–5checking for interactions, 105
Index 209
prescription (cont.)checking legal requirements, 100, 101, 159checking patient details, 99–100checking product details, 100, 102final checks, 34, 106–7, 158second checking, 160see also dispensing
items, 86labels, 105, 159minimum standards for service, 159with missing information, 102, 104pharmacist supervision, 159product appropriateness, 98, 159product safety, 98–9promptness of supply, 158quality of supply, 158record keeping, 99, 105–6, 161reimbursement, 107required information, 87, 91signed orders, 91suggesting alternatives to health professionals,
80veterinary medicines, 91
prescription charges, 140prescription exemptions, 65, 93prescription forms, 85, 86–94, 97
hospital, 91private, 91types, 87–93
Prescription Pricing Division (PPD), 107prescription-only medicines (POM), 85, 155
labelling, 122recent switches to pharmacy (P) medicines,
156–7supply by pharmacists, 157–8
presentations, 37, 80–4body language, 83–4equipment, 84notes/cue cards, 81–2planning, 80–1prior practice, 82, 83room layout, 84slides, 80
preparation, 81use as prompts, 82
voice skills, 82–3preventable drug-related morbidity (PDRM), 58,
59identification of patients at risk, 65
preventive care, 10see also public health
primary care, 10
pharmacists’ role in NHS, 21–2Primary Care Groups (PCGs), 17primary care trusts (PCTs), 12, 13–14, 18, 19
community pharmacist commissioning, 20,65–7
locally enhanced services commissioning,29–31
private prescription register, 105–6private prescriptions, 85, 86, 87
forms, 91essential information, 91veterinary medicines, 91
private sector care, 18probing questions, 79prochlorperazine, 171, 172professional negligence, 164–5Professional standards and guidance documents, 155professional underperformance, 162professionalism, 77, 78project presentations, 37public health, 2
community pharmacist services, 20, 28, 66medicines management services, 61–2
‘qualified person’ (QP) qualification, 47quality assurance
hospital pharmacy departments, 33, 39–40industrial sector pharmacy, 46–7
Quality and Outcomes Framework (QOF), 18, 22,60
questioning skills, 78–9communicating with health professionals, 80
record keepingcounter prescribing, 157electronic labelling systems, 105near misses/dispensing errors, 162supply of prescriptions, 99, 105–6unlicensed medicines supply, 160
rectal drug administration, 172reflection, 99Register of Pharmaceutical Chemists, 71, 72regulatory agencies, 51
see also Medicines and Healthcare productsRegulatory Authority (MHRA)
regulatory processes in drug development, 50–1reimbursement for prescriptions, 107Remuneration Committee of RPSGB, 74repeat prescription, 31, 60, 99
community pharmacist services, 20, 27, 66concordant approach to dispensing, 147medication review, 60
210 Index
research and development, 44–5Research Findings Electronic Register, 98residential homes, pharmacist advice on/supply of
medication, 30respect, 79responding skills, 79Reye’s syndrome, 121ribbed (fluted) bottles, 113rice-paper packaging, 112risk management, 162–3risk–benefit assessment, 99
clinical trials, 48Medicines and Healthcare products Regulatory
Authority (MHRA), 50medicines information services, 49patients’ beliefs about medicines, 142–3
robotic dispensing, 41Royal Pharmaceutical Council, 73Royal Pharmaceutical Society of Great Britain,
71–5branches, 74Charter of Incorporation, 72–3committees, 73–4future developments, 74–5historical aspects, 72–3journal, 72national pharmacy boards, 74objectives, 71regions, 74registration procedure, 71regulatory activities, 72structure, 73–4supplemental charters, 73
Rules and Guidance for Pharmaceutical Manufacturersand Distributors (Orange Guide), 39–40
salbutamol, 175sale and supply of medicines, 151–67
by pharmacy support staff, 156ethical aspects, 154–5industrial sector activities, 49–50legal aspects, 152–4licensed products, 152, 154, 156over-the-counter medicines, 155–7prescribed medicines, 157–60
patient expectations of service, 158unlicensed medicines, 159–60
prevention of errors, 160–3Science Committee of RPSGB, 73Scotland
national pharmacy board, 74NHS prescription forms, 89, 90
screening, 30–1sealed containers, 111secondary (acute) care, 10Secretary of State for Health, 10selected list scheme (SLS), 93selective serotinin reuptake inhibitors (SSRIs), 142self-care support, 66Shifting the balance of power, 18Shipman Inquiry, 106, 152side effects see adverse drug reactionssigned orders, 91, 93signposting, 28, 66Simple Linctus BP, 127simvastatin, 157single electronic patient record, 17single-dose containers, 111single-use injections, 114skin, topical drug delivery, 174–5slab, 128, 131–2slides, 80, 81, 82smoking cessation clinics, 20, 28, 30, 61–2, 67social care, 12, 14
medicines management services, 62social factors in non-adherence, 139–40social pharmacy, 5–6sodalime-silica glass, 113sodalime-silicate glass, 113sodium valproate, 115, 116spacer devices, 175spatula, 128, 131–2special health authorities, 14, 15specialist disease management clinics, 60specific product characteristics (SPC), 154A spoonful of sugar, 57stability of medicines, 47staff development programmes, 29standard operating procedures (SOPs), 3, 29, 163
industrial manufacturing processes, 47risk management, 163
statins, 146sterile production units, 40stigmatised illness, 142stock lists, 35Stockley’s Drug Interactions, 65storage of medicines, 158Strategic health authorities (SHAs), 10, 13, 18, 19strength of prescribed medication, 102strip packaging, 115study days, 39subcutaneous drug administration, 176–7sublingual drug delivery, 171–2summarising skills, 78
Index 211
supervised medication administration, 20, 30, 67
supplementary prescribing, 18, 21, 41, 67, 86concordant approach, 147products that can be prescribed, 94
suppositories, 172swallowing difficulty, 37, 170symposia, 39syrups, 127
tablets, 169sublingual, 171vaginal, 172
tablettingmanufacturing problems, 46quality assurance, 47
tamper evident containers, 111teacher practitioners, 38teaching activities, 37–8
continuing professional development, 38–9Tenormin Syrup, 127terbutaline, 175therapeutic targets, 98thermoplastics, 115thermoset plastics, 115topical drug delivery, 172–5topical liquids, 127topical semisolids, 127–8training, 43–4
industrial sector pharmacy, 45, 52–3‘qualified person’ (QP), 47
tranquilisers, 142transdermal drug delivery, 174–5triamcinolone, 178
Trimethoprim Suspension, 127trituration, 132Trust, assurance and safety – the regulation of health
professionals in the 21st century, 74tuberculosis, 146
unlicensed medicines, 34, 86, 159–60adverse effects, 159, 160
unused medicines, 59unwanted medicines disposal, 28–9, 66, 115
vaginal applicators, 172vaginal drug administration, 172veterinary medicines
labelling requirements, 122–3prescription, 91
checking dosage and directions, 105Veterinary Pharmacopoeia, 105Veterinary Regulations (2005), 153vincristine, 178voice skills, 82–3
Walesnational pharmacy board, 74NHS prescription forms, 88–9
ward rounds, 37warfarin, 37, 65, 98, 155water baths, 133Weigths and Measures Regulations, 131West Midlands Centre for Adverse Drug reactions,
98Winchester dispensing bottles, 113
Yellow Card Scheme, 7, 27, 49, 160
212 Index