legal, professional and ethical aspects of medicines

NAME.............

DATE OF BIRTH

WARD............

Medicines Act 1968 ELIZABETH II

1968 CHAPTER 67

PART IADMINISTRATION

An Act to make new provisions with respect to medicinal

products and related matters, and for purposes

connected therewith. [25th October 1968]

E IT ENACTED by the Queen’s most Excellent Majesty, by and

with the advice ands consent of the Lords Spiritual and

Temporal, and Commons, inthis present Parliament

assembled, and by the authority of the same as follows:—

1.—(1)_ In this Act—

(a) “the Health Ministers” means the following Ministers,

that is to say, Tthe Minister of Health, the Secretary of

S t a t e c o n c e r n e d w i t h h e a l t h i n S c o t l a n d a n d t h e

Minister of Health and Social Services for Northern



B

Ch. 67 1

Medicines Act 1968 CHAPTER 67

ARRANGEMENT OF SECTIONSPART I

ADMINISTRATION

PART IILICENCES AND CERTIFICATES RELATING TO

MEDICINAL PRODUCTSGeneral provisions and exemptions

Section 1. Ministers responsible for administration of Act.

2. Establishment of Medicines Commission.

3. General functions of Commission. 4. Establishment of committees. 5. Supplementary provisions as to Commission and com-

mittees.

Safe and effective medicines management is a team effort that requires knowledge, skill and competence on the part of all the practitioners involved. To ensure that patients remain safe when receiving their medicines, it is vital to adhere to, and practise within the confines of:

• The law;• National guidance, standards and policies, including those produced by the Medicines and Healthcare Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), the Royal College of Nursing (RCN), the Royal College of Midwives (RCM), the Nursing and Midwifery Council (NMC), NHS Improvement, the Care Quality Commission (CQC) and the Royal Pharmaceutical Society (RPS); • The guidance, standards and policies of employers;

Medication use has become increasingly complex and involves many processes and healthcare professionals. Many errors are intercepted before they reach the patient but medication safety remains a worldwide challenge. The World Health Organization’s third global patient safety challenge, “Medication without harm”, aims to reduce severe avoidable medication-related harm by 50 per cent globally by 2022 (WHO, 2017).

Errors in any aspect of the process of medicines management can result in catastrophic outcomes for the patient. A study by Elliott et al. (2018) into the prevalence and financial costs of medication errors in the NHS in England estimated that there were approximately 237 million medication errors per year. Of these, 66 million had potential clinical significance, and approximately 712 deaths per year were attributed to adverse drug reactions (ADRs). Nurses in primary care are in a prime position to influence prescribing of medicines such as non-steroidal anti-inflammatory drugs (NSAIDs), anticoagulants and antiplatelets, which the study revealed to be responsible for over a third of admissions due to avoidable ADRs (Elliott et al., 2018).

The actions of unscrupulous healthcare professionals such as Harold Shipman (DH, 2007) and tragedies associated with poor medicines management, such as prescribing of sodium valproate to women with childbearing potential (MHRA, 2018), have led to more robust regulations and guidance surrounding medicines management. This procedure will outline the key legislation that applies to the various aspects of managing medicines in the UK, before looking at professional guidance, standards of practice and key ethical considerations.

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Medicines ManagementAdults

Legal, professional and ethical aspectsof medicines management

Edited by Martina O’Brien, Associate Professor Adult Nursing, London South Bank University, and Edda Hensler, Senior Lecturer in Nursing, University of Brighton

©2019 Clinical Skills Limited. All rights reserved

Accountability

It is vital to remember that the registered healthcare professional is professionally and personally accountable for their actions and any omissions in care; this includes decisions they make to administer or withhold prescribed medicines. Nursing staff need to be familiar with local policy and guidance so they can justify their practice. Employers have a duty to support staff through training as part of induction and ongoing development, and by making local guidance and policies accessible to staff.

Do not undertake or attempt any procedure unless you are, or have supervision from, a properly trained, experienced and competent person.Always first explain the procedure to the patient and obtain their consent, in line with the policies of your employer or educational institution.

The Medicines Act 1968 sets out the legal framework governing the manufacture, labelling, licensing, prescribing, importation, exportation and supply of medicinal products (SPS, 2019). This legislation largely came about as a result of the thalidomide tragedy in the 1950s and 1960s (Kim & Scialli, 2011). This medicine, which was prescribed to combat morning sickness during pregnancy, caused severe birth defects. The Medicines Act 1968 made it compulsory for all medicines to be licensed before use.

Medicines Act 1968 (and its statutory instruments)

NMC Code Section 1818 Advise on, prescribe, supply, dispense or administer medicines within the limits of your training and competence, the law, our guidance and other relevant policies, guidance and regulationsTo achieve this, you must:18.1 prescribe, advise on, or provide medicines or treatment, including repeat prescriptions (only if you are suitably qualified) if you have enough knowledge of that person’s health and are satisfied that the medicines or treatment serve that person’s health needs18.2 keep to appropriate guidelines when giving advice on using controlled drugs and recording the prescribing, supply, dispensing or administration of controlled drugs 18.3 make sure that the care or treatment you advise on, prescribe, supply, dispense or administer for each person is compatible with any other care or treatment they are receiving, including (where possible) over-the-counter medicines 18.4 take all steps to keep medicines stored securely18.5 wherever possible, avoid prescribing for yourself or for anyone with whom you have a close personal relationshipPrescribing is not within the scope of practice of everyone on our register. Nursing associates don’t prescribe, but they may supply, dispense and administer medicines. Nurses and midwives who have successfully completed a further qualification in prescribing and recorded it on our register are the only people on our register that can prescribe.

Categories of medicinesThe Medicines Act (1968) categorises medicines into the following groups:

General Sales List (GSL): medicines that are considered reasonably safe to sell without the presence of a pharmacist. These medicines can usually be found on the shelves of supermarkets and shops, although there are restrictions for certain medicines on the amounts that can be sold in one purchase. For example, a shop is allowed to sell no more than 16 tablets or capsules of paracetamol or aspirin in one package or container.

Pharmacy Only Medicines (P): medicines that can only be sold under the supervision of a pharmacist from a registered pharmacy.

Prescription Only Medicines (POM): prescriptions by a doctor, dentist or independent prescriber are required in order for these medicinal products to be sold or supplied to the public.

The legal classification of a medicine determines the level of control over its supply. The aim is to maximise timely access to effective medicines while minimising the risk of harm from inappropriate use (MHRA, 2019). The sale status of a medicine sometimes changes based on safety advice. For example, diclofenac was switched from P to POM because of a small increased risk of cardiovascular events (MHRA, 2015); this then required a change to the marketing authorisation.

RISKS BENEFITS RISKS BENEFITS

Medicines Management

Adults

Legal, professional and ethical aspects of medicines management

Licensing a medicine

Misuse of Drugs Act 1971 Misuse of Drugs Regulations 2001

The Misuse of Drugs Act 1971 legislates against misuse of controlled drugs and makes it unlawful to possess or supply a controlled drug unless an exception or exemption applies. Medicines liable to abuse and misuse are controlled by this legislation. Controlled drugs are categorised into one of the above three classes. (Also see clinicalskills.net series on “Management of controlled drugs”.)

The Misuse of Drugs regulations 2001 classify controlled drugs into five schedules. These regulations allow certain people to possess and supply controlled drugs in the practice of their professions. The regulations, updated in 2012, cover prescribing, administration, storage, dispensing, record keeping, destruction and disposal of controlled drugs. Refer to the BNF for further information on prescribing, registering and storing controlled drugs.

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The Misuse of Drugs Act 1971 defines the categories of controlled drugs. Examples include (BNF, 2019c):Class A (drugs in this class are considered the most harmful):Alfentanil, cocaine, diamorphine, fentanyl, lysergide (LSD), methadone, 3,4-methylenedioxymethamfetamine (MDMA, ‘ecstasy’), morphine, oxycodone hydrochloride, pethidine hydrochloride; class B substances when prepared for injection.Class B:Oral amfetamines, barbiturates, cannabis, codeine, dihydrocodeine.Class C:Androgenic and anabolic steroids, most benzodiazepines, buprenorphine, gabapentin, ketamine, pregabalin, tramadol hydrochloride, zolpidem tartrate.

Schedule 1: No recognised medicinal use. Available for research to people licensed by the Home Office. Includes: cannabis, MDMA, LSD.Schedule 2: Subject to full controlled drug requirements relating to prescriptions, safe custody and the requirement to keep a controlled drug register. Includes cannabis-based products for medicinal use (see NHS England, 2019), cocaine, diamorphine, morphine, methadone, pethidine.Schedule 3: Subject to special prescription requirements but fewer safe custody requirements. No need to keep registers. Includes buprenorphine and temazepam.Schedule 4: Subject to minimal control: controlled drug prescription requirements do not apply, not subject to safe custody. Includes: anabolic and androgenic steroids, benzodiazepines.Schedule 5: Exempt from controlled drug requirements except retention of invoices for 2 years. Includes low-strength morphine and codeine.

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Prescribing medicines that are unlicensed or off-label

All medicinal products that are sold in the UK must have a marketing authorisation (formerly product licence)—granted by the Medicines and Healthcare products Regulatory Agency (MHRA)—to certify that they have met safety, quality and efficacy standards. No medicine can be deemed 100 per cent safe, even if it has a marketing authorisation, because all medicines will have side-effects. As people respond differently to medicines, it is not always possible to predict who will suffer a reaction. Medicines continue to be monitored throughout their lifespans as more becomes known about them. The British National Formulary (BNF) highlights important safety concerns issued by regulators such as the MHRA and the Commission on Human Medicines. The BNF annotates newly licensed medicines that require additional monitoring with a black triangle symbol (BNF, 2019a). Such medicines include new active substances, biosimilar medicines, and medicines that the European Medicines Agency considers require additional monitoring.

Healthcare professionals may prescribe a medicine for an indication for which it has not been licensed because clinical trials have found other beneficial effects of the medicine. Such use must be supported by appropriate evidence and experience (BNF, 2019b). Prescribing a medicine outside the recommendations of its marketing authorisation increases the prescriber’s professional responsibility and potential liability; the prescriber must inform the patient if a prescribed medicine is unlicensed or off-label. The BNF describes any use (or route) that is outside the licensed indication of a product as “off-label” use. In paediatric care, many of the medicines used are off-label, as it is difficult for pharmaceutical companies to develop and trial medicines and doses specific for children of different ages and stages of development.

RISKS BENEFITS RISKS BENEFITS

The key factors that must be taken into consideration before licensing a new medicine and then giving it to patients are:

• Do the benefits of the medicine outweigh the risks? • Are the side-effects acceptable?• Are the outcomes of taking the medicine more beneficial to the majority of people taking it than would be the case if they did not take it?

1.—(1)_ In this Act—

(a) “the Health Ministers” means the following Ministers,

that is to say, Tthe Minister of Health, the Secretary of

S t a t e c o n c e r n e d w i t h h e a l t h i n S c o t l a n d a n d t h e

Minister of Health and Social Services for Northern



PART IILICENCES AND CERTIFICATES RELATING TO

MEDICINAL PRODUCTSGeneral provisions and exemptions

ASPIRIN 75mgGASTRO-RESISTANT TABLETSEnteric Coated

28Tablets

ASPIRIN 75 mgGASTR0-RESISTANT TABLETSEnteric-Coated

28Tablets

Recent studies suggest that aspirin (commonly used in the prevention of cerebrovascular accidents and cardiovascular disease) may be beneficial in reducing cancer mortality rates (Tsoi et al., 2018; Rothwell et al., 2012) but, currently, aspirin has no marketing authorisation for cancer prevention.

The Psychoactive Substances Act 2016 makes it an offence to produce, supply (or offer to supply), possess with intent to supply or import or export any substance that is intended for human consumption that has the ability to produce a psychoactive effect. Project Neptune has produced clinical guidance and tools to assist clinicians in managing people who have been harmed by novel psychoactive substances (NEPTUNE, 2015).

Morphine Sulphate Injection BP10mg in 1ml5 ampoules

Morphine Sulphate Injection BP10mg in 1ml5 ampoules

KEEP OUT OF REACH OF CHILDREN

50 Tablet Hospital Pack

ST ORE IN C ONTROLLEDDRUG CUPBOARD

Date

10mg

Ta bletsTe mazepam

SHAKE THE BO

STORE IN A CD CUPBOA

100ML METHODONE MIXT

BN

1MG in 1ML

EXP

CD REQUIRED NO

KEEP OUT OF REACH OF CHILDREN

50 Tablet Hospital Pack

ST ORE IN C ONTROLLEDDRUG CUPBOARD

Date

10mg

TabletsTe mazepam 1311001

UB41053A

Morphine Sulphate Injection B

P10m

g in 1ml

5 ampoules


P10m

g in 1ml

5 ampoules


P10m

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5 ampoules

Adults


Mental Capacity Act 2005

Health Care Act 2006

Although the Mental Capacity Act 2005 is not solely related to medicines management, it creates a framework to protect people who are unable to make decisions for themselves. Such processes are important when decisions need to be made about the treatment and medicines a patient is to receive. For more information, see NHS (2018).

The aim of the Mental Capacity Act is to protect people who are unable to make decisions for themselves or who lack the mental capacity to do so. A person is unable to make a decision if they are unable to:

• Understand the information that is relevant to the decision;• Retain the information for an appropriate length of time in order to make a decision;• Weigh up the information presented in order to make the decision;• Communicate their decision (this can be demonstrated by any method possible, such as talking, sign language or the use of hand gestures).

This Act requires healthcare organisations to appoint an accountable officer who is responsible for the management of controlled drugs; the role of the accountable officer was created as a result of the Shipman case. Standard operating procedures (SOPs) for controlled drugs will apply to ensure that these medicines are used safely, securely and effectively (see, for example, NHS England and NHS Improvement South West, 2019). National guidance has been developed to support healthcare organisations and their staff to meet legislation on controlled drugs with robust governance, improved working practices and risk reduction strategies (NICE, 2016; CQC, 2019).

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All healthcare professionals have a responsibility to raise any concerns about patient safety, including prescribing, administering, dispensing, supplying and disposing of controlled drugs (CQC, 2019). In a recent report about medicines in health and adult social care, the CQC (2019) highlighted problems in medicines safety such as low reporting, a culture of fear, inadequate storage and a lack of governance. The commission recommends that healthcare professionals keep their personal identification badges and passwords secure and report any losses as soon as possible, as diversion of controlled drugs is becoming increasingly sophisticated (CQC, 2019).

Requirements of the legislation on controlled drugs

Victoria and Beckham University Hospitals NHSNHS Trust

Su LiAccountable Officer

Expiry Date: 22/ 7/20

ID Number: 264149467

Psychoactive

Substances Act 2016

CHAPTER 2

Explanatory Notes have been produced to assist in the

understanding of this Act and are available separately

£10.00

NEPTUNENOVEL PSYCHOACTIVE TREATMENT:UK NETWORK

HOME ABOUT US CLINICAL GUIDANCE E-LEARNING CLINICAL TOOLS NEPTUNE IT GROUP RESOURCES CONTACT

About NeptuneNEPTUNE has been developed toimprove clinical practice in the management of harms resultingfrom the use of club drugs and novel psychoactive susbtances.It is aimed at clinicians workingin a range of frontline settings,including drug treatment andrecovery services, emergencydepartments, sexual healthservices, primary care andmental health services.

FundingNEPTUNE is funded byHealth Foundation, anindependent charity working toimprove the quality of healthcare in the UK. Guidancedevelopment has been hostedby Central and North WestLondon NHS Foundation Trust.

Psychoactive Substances Act 2016

Betamethasone

valerate 0.1%w/w cream

Joshua, a 22-year-old man, experiences severe eczema for which conventional medications have not been effective. Joshua’s dermatologist has prescribed betamethasone cream. Joshua has refused this medication, so his dermatologist explains the potential consequences of this. Although he is able to recognise the possible outcomes of refusal, he would like to try alternative herbal remedies first.

ResponseA patient has the right to refuse treatment if it is considered to be an informed choice and they possess the capacity to make this decision (NHS, 2017). Healthcare professionals should endeavour to identify the reasons for refusal and where possible address any identified issues. The reasons for refusal should be documented within the patient’s medical notes.

Case study: The right to refuse medication


Glycerin

Suppositories BP

Glycerin

Suppositories BP

Lubricating Gel

OMINEN BP

Lubricating Gel

Adults


Safe and secure handling of medicines Administration of medicines in healthcare settings

Following the NMC’s withdrawal of Standards for Medicines Management, the RPS and RCN have launched joint principles-based guidance on the administration of medicines in healthcare settings (RPS/RCN, 2019). This shorter guidance document covers administration, covert administration and transcribing of information. It also provides signposts to further resources. See also the clinicalskills.net procedure on “Administration of medicines: key principles”.

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All registered healthcare professionals must adhere to guidelines issued by their regulatory bodies. Nurses and midwives need to ensure that they are fully conversant with The Code: Professional Standards of Practice and Behaviour for Nurses, Midwives and Nursing Associates, which sets out the foundations for good practice to ensure that the needs and safety of the public are met (NMC, 2018). The NMC places great emphasis on the responsibilities and skills required, underpinning the safe management of medicines. Providing a high standard of care and practice in all aspects of medicines management will ensure that patients in your care are kept safe.

Professional issues: The Code (a) (b) The Code: Section 18

Principle 1: Establish assurance arrangements (say what we do and why we do it);

Principle 2: Ensure capacity and capability (train people and ensure they have the necessary competencies and resources);

Principle 3: Seek assurance (do what we say and prove it);

Principle 4: Continually improve (improve what we do).

Professional Guidance on the Safe and Secure Handling of Medicines (RPS, 2018), an update of the RPS’s 2005 guidance, sets out recommended practices across different healthcare settings and outlines four core governance principles (listed above) that healthcare settings should use to underpin their local policies and practice. The RPS makes it clear that safe medicines administration is a team effort and it places strong emphasis on fostering a culture of learning and improvement.

• Prescribe, advise on, or provide medicines or treatment, including repeat prescriptions (only if you are suitably qualified) if you have enough knowledge of that person’s health and are satisfied that the medicines or treatment serve that person’s health needs.• Keep to appropriate guidelines when giving advice on using controlled drugs and recording the prescribing, supply, dispensing or administration of controlled drugs.• Make sure that the care or treatment you advise on, prescribe, supply, dispense or administer for each person is compatible with any other care or treatment they are receiving, including (where possible) over-the-counter medicines.• Take all steps to keep medicines stored securely.• Wherever possible, avoid prescribing for yourself or for anyone with whom you have a close personal relationship.

NMC registrants must advise on, prescribe, supply, dispense or administer medicines within the limits of their training and competence, the law, NMC guidance and other relevant policies, guidance and regulations. Only nurses and midwives who have successfully completed a further qualification in prescribing and recorded it on the NMC register can prescribe. (See also the clinicalskills.net procedure, “Administration of medicines: key principles”.)

Examples of medication errors

When a medication error is made, it is important to consider system factors as well as individual factors. Processes must be in place to ensure that incidents (including near misses) are identified, recorded, investigated, reported and escalated where appropriate (RPS, 2018). Practice must be reviewed, changed and shared, and any corrective or preventative action should be monitored and reviewed (RPS, 2018). Trusts should have a policy that makes it mandatory for staff involved in errors (or those who merely suspect an error has been made) to report these quickly to ensure the safety and wellbeing of the patient. The NMC expects nurses, including student nurses, to report such errors and near-misses (NMC, 2019; 2018). It is important that managers treat staff involved in a patient safety incident in a consistent, constructive and fair way (NHS Improvement, 2018).

Prescribing and/or administering a medicine:

• To the wrong patient;• At the wrong time;• Via the wrong route;• Using the wrong formulation;• At the wrong dose;• That the patient is allergic to;• That is incompatible with other medicines the patient is receiving.

Administering a medicine:

• That is different to the one prescribed;• That has expired;• After the duration of treatment has ended.

Omitting to:

• Sign for medicines administered;• Record that a medicine has not been administered and the reason why;• Administer a medicine that is due.


Datix Incident Reporting Form

Incident details

Incident details (ddMMyyyy)

Time of incident

Trust

Unit

Directorate

Speciality

Location (type)

Location (exact)

Description Enter facts, not opinions. Do not enter names of people

Action taken Enter action taken at the time of the incident

New form Login Register

!

? 02/10/2019

15:50

Acute Healthcare Provider

Acute Hospital Victoria and Beckham

Directorate of Critical Care

Anaesthetics

Anaesthetics Room

Anaesthetics Room

Medicines administration error

Adults


Reporting an error

Reporting an error relies on the honesty and courage of those involved. The NMC (2019; 2018) stipulates that action must be taken promptly to prevent any potential harm to the patient, and the error reported to the prescriber and to the employer. Record the actions taken and apologise to the person affected as well as to the person’s advocate, family or carers, where appropriate. It is necessary to follow the particular policy of the employing organisation; this will include completing an incident report form detailing what happened and actions taken. Electronic reporting systems, such as the Datix incident reporting system and adverse events reporting, are commonly used.

Employers should operate an “open culture” whereby reporting of incidents and near misses is encouraged (NHS Improvement, 2018). It is necessary to investigate the reasons why errors occur in order to review policies and procedures to prevent repeat or similar errors occurring in the future. Slips and lapses, particularly misinterpretation of prescriptions and misidentification of patients, are the most commonly reported type of medication administration error and are frequently related to distractions and work pressures (Keers et al., 2013). Some organisations require nurses to wear a coloured tabard bearing the words “Do Not Disturb” during medicines administration activities, although their effectiveness is debatable (Raban & Westbrook, 2014).

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Henry, a 72-year-old man, is admitted to hospital for investigations due to breathlessness. Henry is prescribed 40 mg furosemide for pulmonary oedema caused by congestive heart failure. The admitting doctor intended to prescribe intravenous furosemide but mistakenly wrote the prescription for oral furosemide. The ward is very busy and staff are yet to have any breaks; the doctor on call discusses with the named nurse the need for the medication to be administered as soon as possible. While reviewing the medication administration record, Henry’s named nurse is interrupted by a colleague regarding the discharge of another patient. Subsequently, the named nurse administers 40 mg furosemide orally. An hour later, the doctor identifies the error during the ward round when she notices that Henry has not responded to treatment (as the oral route is not as effective as the intravenous route). A subsequent dose of intravenous furosemide is requested. What action should be taken?ResponseIt is important to inform Henry of the error, carry out a clinical assessment of his condition to ensure he has come to no harm, and to offer Henry a full apology. Even though Henry has experienced no obvious ill effects as a result of the error, it is good practice to report and share this incident, and to document the error in the medical records. Factors that increase the risk of medication errors include inexperience and lack of training; poor supervision; errors in medicine supply; patient factors, e.g., being asleep/absent during medication round; physical/mental health; poor communication; busy workload; staffing/skill mix; and unsuitable environment (Keers et al., 2013). The named nurse was able to identify the right patient, the right drug, the right dose and the right time; however, they used an incorrect route of administration following a prescribing error. Frequent interruptions and pressures within the busy ward environment contributed to this medication error.

Case study: Actions to take following medication error identification See peer review comments on covering email

18 5 19

21

Reporting an error relies on the honesty and courage of those involved. The NMC (2008) stipulates that action must be taken promptly to prevent any potential harm to the patient; this includes reporting to the prescriber, employer and recording actions taken. It is necessary to follow the particular policy of the Trust; this will include completing an incident report form detailing what happened and actions taken. More commonly electronic reporting systems are in use such as the Datix incident reporting system and adverse events reporting.Employers should operate an ‘open culture’ whereby reporting of such incidents is encouraged. It is important to investigate why such incidents occur. Whilst some errors are as a result of incompetence or recklessness they can also occur due to poor working systems in place or work pressures. It is necessary to investigate the reasons why errors occur in order to review policies and procedures to prevent repeat or similar errors occurring in the future. For example nurses cite interruptions during the medicines administration process as reasons why errors are made. Some hospital trusts require the administering nurse to wear coloured tabards during medicines administration activities with wording such ‘do not disturb’ printed on them in an effort for the nurse to perform this important task uninterrupted. Whether the wearing of such tabards results in a reduction in medicines administration errors remains debatable (Scott et al, 2010).

Drug Round Nurse On

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Alice, a 55-year-old woman, is admitted to hospital with cellulitis. Alice has been prescribed 750 mg of intravenous cefuroxime four times daily with the next dose due at 12.00. Alice's assigned nurse notices at 18.00 that she forgot to administer the 12.00 dose. Is this a medication error?ResponseYes. Every effort must be made to administer medicines according to the “six rights of medication administration”: the right medication, right patient, right dosage, right route, right time and right documentation (see clinicalskills.net procedure: “Administration of medicines: key principles”). While medicine doses may be omitted or delayed for a variety of valid reasons, for some critical medications or in certain conditions, e.g., for patients with the potential for sepsis (as in the case above) or pulmonary embolism, or those with Parkinson's disease, the outcome could be fatal. Healthcare settings are asked to identify local lists of critical medicines where timeliness of administration is crucial (SPS, 2018). See Key reading for resources to help reduce delayed/omitted doses.

Case study: Is it a medication error?


Adults


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When considering covert administration of medication:

• The decision to go ahead should be taken only after a thorough patient assessment with input and agreement from the interprofessional team, including carers and relatives.

• Such decisions should be medicine and patient specific and not considered routine practice.

• The team should make regular efforts to encourage the patient to take their medication.

• The decision should be time limited and reviewed regularly.

Every setting should have a medicines policy, including covert administration, read and understood by staff (CQC, 2020). Covert administration is the defined process whereby healthcare professionals and carers make a formal decision for medicines to be administered in a disguised format without the knowledge or consent of the patient who lacks mental capacity (RPS/RCN, 2019). It should only be used in exceptional circumstances when judged necessary, in accordance with the Mental Capacity Act 2005 (NICE, 2015). Covert administration, to people who actively refuse their medication and lack mental capacity to consent to treatment, must be in accordance with an agreed management plan (RPS/RCN, 2019). Do not confuse covert administration with disguising the medicine administration against a competent patient’s wishes, which would constitute a tort or civil wrong of trespass to the person (UKMi, 2017). The decision to covertly administer medicines must only be made in the best interests of the patient. It should be clear and well-documented (CQC, 2020). RPS/RCN (2019) has a list of useful references about covert administration.

Covert medicines administration

Problems associated with covert administration of medicines

There are many potential adverse consequences associated with covert administration of medicines. It is vital that the pharmacology of the medicine should not be affected by, for example, crushing it and mixing with food: never crush slow-release preparations for this reason. It is also important to consider the market authorisation: altering the format of a medicine may render it unlicensed and liability for any adverse reactions will then fall from the manufacturer to the prescriber and, subsequently, to the registered healthcare professional who administered the medicine. Ask your ward or community pharmacist for advice. Another issue is that trust, honesty and integrity are the fundamental principles underpinning the patient/healthcare professional relationship. Disguising medicines by adding them to a patient’s food may call into question these three principles, leading the patient to lose faith in the healthcare professional. Trustis difficult to regain if broken and may lead the patient to refuse other aspects of care and treatment including the provision of fluid and nutrition.

Rose, a 75-year-old woman, has lived within a care home for the last 3 years and has been diagnosed with dementia. Recently Rose has become more confused, refusing all medication and becoming aggressive when nursing staff endeavour to administer medications. Rose’s assigned nurse has decided to crush her medication and place this in a yoghurt for her to consume. Is this appropriate?

ResponseIf Rose has adequate capacity to make informed decisions, then her refusal should be respected and documented, including the reasons for it, and the prescriber informed (NICE, 2014). However, if there are concerns that Rose is unable to make an informed decision, it is important to inform the prescriber, who may consider whether the formulation of the medication (tablet or liquid) or timing of its administration is hindering consumption, or whether Rose is finding its side-effects intolerable. It is not appropriate for a sole nurse to decide to provide the medication covertly. Instead, the prescriber should arrange for an assessment of Rose’s capacity in line with the Mental Capacity Act Code of Practice (2007). If the assessment concludes that Rose lacks capacity to make decisions, a multidisciplinary meeting should be convened to make decisions in her best interests. It may be necessary to devise a subsequent plan for covert medication administration, with regular reviews at intervals to assess whether covert administration is still required.

Case study: Covert administration


legal, professional and ethical aspects of medicines

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