journal of medicines optimisation - pharman
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Journal of Medicines Optimisation
Developing a patient-centred approach to get best outcomes and value from medicines
Volume 6 • Issue 3 December 2020 www.jmedopt.com
In this issue:
ISSN 2396-8613 (Online)ISSN 2398-5445 (Print)
iStock.com/LightFieldStudios
• Ranitidine shortages following international recall: implications on pre-medicationregimens to prevent hypersensitivity reactions for oncology treatments
• Shared decision making
• Optimise, align and strengthen capacity of advanced pharmacy practice to guaranteehigh quality patient care – the IBD model in the UK
• Tackling overuse of short-acting beta-2 agonists (SABAs) in asthma in primary care
Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 2020
AIM OF THE JoMO
Medicines optimisation is a person-centred approach to safe and effective medicines use to ensure that people obtain the best possible outcomes from their medicines.The aim of the JoMO is to contribute to that process and play an influential and key part in shaping better patient care and the role that medicines can play. The JoMOprovides a vehicle to enable healthcare professionals to stimulate ideas in colleagues and/or disseminate good practice that others can adapt or develop to suit their localcircumstances.
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Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 2020 75
Editorial
In recent times, medicines optimisation has regularly faced theproblem of interruption of supply. Such shortages anddiscontinuations represent real challenges to pharmacy,frequently requiring immediate action against a background ofinadequate information.
In this issue, Andrew Walker and Mindaugas Rudokas describeone response to drug shortages, in this case Ranitidine. Nodoubt this is something that many are handling but our authorsare to be applauded for taking the time to record their response.
One area of practice in which there is still often scope forimprovement, is shared decision-making.
The editor can recall an example of a switch programme inwhich patients were informed that their medication was to beswitched and invited to call a number to discuss the move ifthey had concerns but against a background that the decisionhad already been made (without the patient’s knowledge orinput) and the sole purpose of the call was to explain why it wasbeing done.
Laura Picton has a wealth of experience in dealing with patientswith diminished or fluctuating capacity and brings that to bearin her article which is a very practical approach to shareddecision-making. We will say from the outset, that she does notcover decision aids in depth which is another very importanttopic because space does not permit it. Perhaps one of ourreaders would care to contribute something on this subject?
Moving specialist services from the hospital setting into thecommunity is clearly desirable. Indeed, such a shift frequentlyappears in development plans and is a definite target for allintegrated care systems.
What needs to be done to build the capacity and expertise ofcommunity and outreach services?
In her article, Anja St. Clair-Jones, looks at one such servicewhich is looking to develop advanced pharmacy practice ininflammatory bowel disease. There is a model for the UnitedKingdom which Anja explains in an article brimming withhelpful information.
Finally, the overuse of short-acting beta-2 agonists (SABAs)in asthma has been a major concern for almost every healtheconomy.
Mihir Varia describes a project on a large scale which hastackled this subject with some success. This kind of work isnever really finished; after one project or process newopportunities arise to take the work forward in a slightlydifferent direction and so it continues.
This emphasises one of the key aims of this journal.
We understand that sometimes work is still ongoing but that isno reason why not to publish work to date. There can always bea follow-up article later, if desirable.
With that in mind, let me urge you once again to contact us ifyou have work that you would like to publish. We will workwith you to make the best of it, so please do not let a lack ofexperience in publishing put you off.
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Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 202076
Contents
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Developments in Practice
Ranitidine shortages following international recall: implications on pre-medicationregimens to prevent hypersensitivity reactions for oncology treatments Andrew Walker and Mindaugas Rudokas
Shared decision makingLaura Picton
Optimise, align and strengthen capacity of advanced pharmacy practice to guarantee highquality patient care – the IBD model in the UKAnja St. Clair Jones
Tackling overuse of short-acting beta-2 agonists (SABAs) in asthma in primary careMihir Varia
Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 2020 77
Ranitidine shortages following international recall:implications on pre-medication regimens to preventhypersensitivity reactions for oncology treatments Andrew Walker, Oncology Specialist Pharmacist, The Rotherham NHS
Foundation Trust, Mindaugas Rudokas, Oncology Specialist Pharmacist,
Sheffield Teaching Hospitals NHS Foundation Trust
Correspondence to: [email protected]
Developments in Practice
Ranitidine has become an establish feature in pre-medicationregimens intended to reduce the risk of hypersensitivityreactions to a variety of chemotherapy agents. The ongoingsupply issues with ranitidine and alternative H2 antagonists hasled to healthcare providers reviewing these pre-medicationregimens and adopting alternative strategies to reduce therisk to patients. This article sets out to review the backgroundto the supply issues with ranitidine, provide a brief review of thepublished evidence base around its inclusion as a component inpre-medication regimens, consider the potential implications topractice in terms of the management strategy options and theneed for greater understanding around the its true value inreducing the risk to patients.
Background to the recallIn October 2019 the Department of Health and Social Careissued a supply disruption alert informing healthcare providersin the UK that all oral formulations of ranitidine were likely to beout of stock for an extended period of time.1 This announcementwas made following an investigation of ranitidine-containingproducts by several international regulatory agencies includingthe US Food and Drug Administration (FDA) and the EuropeanMedicines Agency (EMA) following reported contaminationwith low levels of a potentially carcinogenic compound.2,3 Thisannouncement was followed by additional alerts throughout2019 and into 2020 which extended the remit to cover allranitidine-containing formulations, which have now beenunavailable on the international market for a prolonged period.The shortage has had an impact on the provision of care topatients across multiple specialities, including those who areundergoing treatment for malignant disease.
In October 2019 the US-based independent laboratoryinvestigation service Valisure submitted a citizen petition tothe FDA raising concerns that batches of ranitidine products,which had been subjected to analysis, had been found tocontain N-nitrosodimethylamine (NDMA).4 The same compoundhas previously been isolated in valsartan-containing productsproduced by Novartis in 2018 and led to an MHRA and FDA
recall in July5,6 then in valsartan products from othermanufacturers which were also recalled and was later identifiedin irbesartan and losartan which was subject to recall in Januaryand February 2019.7
NDMA has been classified as a probable carcinogen by theInternational Agency for Research on Cancer8 and the WorldHealth Organisation.9 Based on the results of animal modelstudies, NDMA promotes tumour formation primarily in tissuesin the gastrointestinal tract and liver and, less frequently, inthe lungs and kidneys.10,11 Nitrosamine chemical continuants,including NDMA, have been demonstrated to activate RASoncogene pathways thereby promoting malignant conditions.12
In addition to its primary carcinogenic potential, enzymaticmetabolism of NDMA by CYP2E1 has been shown to result inthe formation of methyldiazonium, a chemical inducer ofmethylation which promotes DNA point mutations, therebyconferring a systemic carcinogenic risk.13
The risk that NDMA poses to human health based on the levelsof contamination which have been detected in ranitidineproducts have been the subject of some debate in the scientificcommunity.14 NDMA is a ubiquitous environmental chemicalcontaminant found in air, water, soil in trace amounts withestimated average daily intake being around 1 microgram.16 Theinitial assessments conducted by Valisure on ranitidinecontaining products reported NDMA contamination in excess of3 million nanograms per tablet thereby exceeding the FDAsacceptable daily intake limit of 96 nanograms.4 However, theseresults were generated from samples which were subject toconditions beyond those that could be reasonably expectedduring manufacturing, transportation, storage or ingestionthereby introducing potential limitations around the accuracy inreal-world conditions. As part of the analysis technique, samplesof ranitidine products were heated to 130°C, a process which isknown to increase the NMDA levels though heat-activatedchemical degradation pathways in molecules which containnitrile and dimethylamine group, such as ranitidine.17 To addressthe potential unrepresentative nature of the results publishedby Valisure, the FDA shared guidance around alternative
Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 202078
analysis methods recommending liquid chromatography–highresolution mass spectrometry (LC-HRMS) or liquidchromatography–tandem mass spectrometry (LC-MS) withmanufactures to assist the pharmaceutical industry to reportNDMA levels achieved via standardised analysis techniques.16
While initial FDA testing of several ranitidine-containing productsachieved results which indicated NDMA levels similar to thosefound in common food, such as smoked or grilled meats,18
several pharmaceutical manufacturers announced voluntaryproduct recalls as a precautionary measure. In the UK the MHRAannounced voluntary recalls for products from a number ofmanufacturers through October and November 2019 and into2020 while the extent and potential impact of NDMAcontamination is assessed and regulatory agencies providefurther guidance. The impact of manufacturer led recalls hasresulted in a lack of available ranitidine products on theinternational pharmaceutical market. In the UK, the Departmentof Health and Social Care have issued a number of supply alertsaround ranitidine formulations advising healthcare providers ofthe extent and duration of the shortages and providingrecommendations around alternative treatments.1,18 Lack ofavailable ranitidine products has impacted on patient care acrossa range of treatment groups but has had a significant effect onpatients undergoing treatment for malignant disease where it isused as a pre-medication to reduce incidence of reactions tochemotherapy or as part of a desensitisation regimen.19
H2 antagonists in pre-medication regimens Ranitidine is primarily used as a premedication for paclitaxel-containing regimens, but can be included in other regimens,such as those containing other taxanes and/or those containingplatinum-based agents, which carry a risk of hypersensitivityreactions.20 Paclitaxel is a chemotherapy agent from the taxanefamily used to treat a range of malignant conditions includingtumours which arise in ovarian, breast, lung cervical andpancreatic tissues. It exerts activity through stabilisation oftubulin mitotic spindle assembly thereby inhibiting progressionof mitosis and promoting apoptosis. Paclitaxel is associatedwith a significant risk of hypersensitivity reactions with initialclinical trial data demonstrating a reaction rate of up to40%.21 To address the potential for treatment-limitinghypersensitivity reactions healthcare providers implementedpre-medication regimens with a combination of corticosteroidsand antihistamines (both anti-H1 and H2), which has reducedincidence of hypersensitivity reactions to <3%.22
Given the success of reducing the incidence of hypersensitivityreactions with other appropriate pre-medications, ranitidine hasbecome as an established component of paclitaxel-containingchemotherapy regimens where it is utilised for its H2 antagonistproperties.21,22 The recent shortages of ranitidine products haveforced healthcare providers to consider alternative courses ofaction to ensure the safe and effective use of paclitaxel-containing regimens and other regimens where it has also beenadded as a pre-medication. In the UK, the British OncologyPharmacists Association (BOPA) has compiled guidance to assisthealthcare providers in determining the most appropriatestrategies to manage the situation.23 This guidance advocates avariety of strategies including rationalising use of ranitidine,using alternative H2 antagonists to replace ranitidine in pre-
medication regimens and considering the risk of removing H2antagonists from regimens altogether.
Rationalising or restricting access to stock based on clinicalrequirement is a common response from healthcare providers inthe UK and internationally in times of product shortages.24 Thisresponse helps to support the prioritisation of remainingmedication and, hopefully, to maintain supply to the highest riskpatient groups until restriction can be lifted and normalprovision recommenced. In the case of the ongoing ranitidineshortage, this approach has allowed many healthcare providersto maintain supply to oncology services for a number of monthswith many switching between IV and oral formulations basedon remaining local supplies. However effective this approachmay prove, it is clear that rationalising use of ranitidine cannotlast indefinitely. Given the length of the ongoing shortage,which is now greater than 12 months at the time of publicationof this article, it is likely that many healthcare providers havenow exhausted any remaining supplies meaning they will havehad to adopt alternative strategies.
Management strategies and overview ofpublished evidenceThere are a variety of alternative H2 antagonist medicationavailable which may provide a similar effect to ranitidine aspart of the pre-medication regimen. Published evidence toestablish the safety and efficacy of these alternative agents inchemotherapy pre-medication regimens is limited but hasprovided some data to support use given the ongoing ranitidineshortage. A small-scale study of patients receiving paclitaxelfor gynaecological cancers suggests comparable rates ofhypersensitivity reactions for patients treated with famotidine aspart of a pre-medication regimen to those treated withranitidine.25 Other similar small-scale studies have suggestedthat regimens containing cimetidine and nizatidine providesimilar levels of efficacy against hypersensitivity reactions.27
The results provided by these studies are limited due to lack ofstandardisation of the non-H2 antagonist elements of the regimensdescribed and by the small sample sizes. No comparativehead-to-head studies between different H2 antagonists aspart of pre-medication regimens for chemotherapy have beenpublished to establish superiority of any particular H2antagonists to inform practice at a national or local level. ACochrane review of ranitidine and cimetidine in the treatmentof urticaria also failed to establish superiority due to lack ofhigh-quality published evidence.28 Published evidence regardingsecondary considerations, such as the impact of differentH2 antagonists (ranitidine, famotidine and cimetidine) on themetabolism of paclitaxel has concluded that there is littleimpact on the pharmacological and toxicity profile betweenthese agents.29 Wider consideration should be made whenreviewing alternative H2 antagonists to minimise the impactthat potential drug interactions, particularly when using potentCYP450 enzyme inhibitors such as cimetidine, on patients’chemotherapy treatment and other regular medications fornon-malignant conditions which can limit the choice ofpremedication agents.
The availability of alternative H2 antagonist agents followinginternational recall of ranitidine has also presented a barrier to
Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 2020 79
their widespread adoption as part of premedication regimens. Inthe UK, the Department of Health have included updatesaround the availability of famotidine, cimetidine and nizatidinein a number of medicine supply notification in 2019 and 2020,informing healthcare providers of limited stock within the UKmarket.1,18 The guidance issued by BOPA provides healthcareproviders with advice around switching to alternative H2antagonists but does suggest that organisations may findchallenges in obtaining stock in sufficient quantity to make along-term switch a viable option while ranitidine productsremain unavailable.23
Given the challenges of locating suitable alternatives manyhealthcare providers have been left with limited choices otherthan to consider administering chemotherapy with a pre-medication regimen without an H2 antagonist component.Published evidence defining the impact of H2 antagonists onrates of hypersensitivity reactions from chemotherapy regimensis limited and conducted in relatively small, non-randomisedstudies or case reports. The lack of high-quality published datahas made interpretation of the impact of ranitidine on the ratesof hypersensitivity reactions across different chemotherapyagents problematic and is a longstanding issue within the fieldof oncology. In the UK, ranitidine has generally been restrictedto paclitaxel-containing regimens, which has the strongestevidence base, and from the lack of evidence for otherchemotherapy agents,21 although local treatment centres maychoose to adopt ranitidine based on preferences of clinicians.International practice is more variable with ranitidine beingemployed as a pre-medication in chemotherapy regimens whichinclude taxanes, platinum-based compounds, monoclonalantibodies and immunotherapy agents.
Larger reviews conducted into hypersensitivity reactions followingadministration of radiocontrast media by Greenberg et al30
suggest that H2 antagonists may not provide additional benefit topatients as part of a pre-medication regimen, casting doubt as tothe value of these agents in pre-medication regimens altogether.In a review of 857 cases of hypersensitivity reactions followingadministration of radiocontrast media, a combination ofprednisolone, diphenhydramine and ephedrine successfullyreduced the rate of hypersensitivity reaction from 10.8% to 5%while the addition of cimetidine was associated with a reactionrate of 14%, although it should be noted these results wereobtained from a smaller sample size of 100 patients which maylimit the reliability.30 Retrospective studies in patients receivingpaclitaxel as part of breast cancer treatment regimens by Bergeret al described the impact of discontinuing pre-medicationsentirely for all cycles following patients’ second dose. In twostudies, Berger et al demonstrated that discontinuing pre-medications post second cycle does not adversely impact on therate of hypersensitivity reaction for patients receiving paclitaxel31,32
providing evidence to support an alternative managementstrategy not currently described in the BOPA guidance.
The ongoing international shortage of ranitidine and alternativeH2 antagonists has had an impact on the manner in whichhealthcare providers manage premedication regimens intendedto reduce the rate of hypersensitivity reaction followingadministration of chemotherapy. In the UK, BOPA haveadvocated a variety of strategies to help hospitals to safelymanage the shortage and reduce the potential risk to patients.
As the duration of the shortages continue, the true impact onrates of reported hypersensitivity reactions are likely to becomemore apparent as healthcare providers are more likely toexhaust alternative approaches and adopt managementstrategies which remove H2 antagonists from pre-medicationregimens entirely. While the true value of H2 antagonistsremains an area of debate, it is clear that further research tocharacterise the impact that they have, separate from the widercocktail of pre-medications, is important to inform evidence-based practice. To this end, BOPA intend to conduct a nationalservice evaluation to assess the impact of removal of H2antagonist across the UK and Ireland which will provide furtherevidence to identify the place and impact of H2 antagonists inpre-medication regimens.
Acknowledgements The authors of this article would like to acknowledge thecontribution of David Allwood, Lead Procurement Pharmacist,The Leeds Teaching Hospitals NHS Trust, in reviewing thecontent of this article.
Declaration of interests
The authors have no interests to declare.
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27. Quock J. Dea G. et al. Premedication strategy for weekly paclitaxel.Cancer Investigation. 2002. 5; 666-72. [online]. Available from:https://pubmed.ncbi.nlm.nih.gov/12197222/
28. Fedorowicz Z. Van Zureen EJ. et al. Histamine H2-receptorantagonists for urticaria. Cochrane Database Systemic Review.2012. [online]. Available from:https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD008596.pub2/full
29. Slichenmyer WJ. Donehower RC. et al. Pretreatment H2receptor antagonists that differ in P450 modulation activity:comparative effects on paclitaxel clearance rates andneutropenia. Cancer Chemotherapy and Pharmacology. 1995.36(3); 227-32. [online]. Available from:https://pubmed.ncbi.nlm.nih.gov/7781143/#:~:text=Abstract,reactions%20in%20patients%20receiving%20paclitaxel.
30. Greenberger PA. Patterson R. et al. Prophylaxis against repeatedradiocontrast media reactions in 857 cases. Adverse experiencewith cimetidine and safety of beta-adrenergic antagonists. Archivesof Internal Medicine. 1985. 145(12);2197-200. [online]. Availablefrom: https://pubmed.ncbi.nlm.nih.gov/2866755/
31. Berger MJ. Dunlea LJ. et al. Feasibility of stopping paclitaxelpremedication after two doses in patients not experiencing aprevious infusion hypersensitivity reaction. Supportive Care inCancer. 2012. 20; 1991-97. [online]. Available from:https://link.springer.com/article/10.1007%2Fs00520-011-1303-9
32. Berger MJ. Vargo C. et al. Stopping paclitaxel premedication aftertwo doses in patients not experiencing a previous infusionhypersensitivity reaction. Supportive Care in Cancer. 2015. 23(7);2019-24. [online]. Available from:https://link.springer.com/article/10.1007%2Fs00520-014-2556-x
Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 202082
Shared decision makingLaura Picton, Pharmacist Specialist, Care Quality Commission
The National Institute for Health and Care Excellence (NICE) says“Shared decision making is when health professionals andpatients work together. This puts people at the centre ofdecisions about their own treatment and care.”1
NHS England says “Shared decision making ensures thatindividuals are supported to make decisions that are right forthem. It is a collaborative process through which a cliniciansupports a patient to reach a decision about their treatment.”2
A shared decision should be one where clinicians and patientsshare information, concepts and ideas; where joint agreementsare made. But I wonder how often shared decision makingbetween a clinician and patient feels a bit more unbalanced?Whether the power dynamic, or the accessibility of information,leaves the recipient in a position where they are not able tomake a truly informed choice.
In 2010 the Secretary of State for Health, Andrew Lansley, said“No decision about me, without me”. Yet the 2019 adultinpatient survey3 found that although communication betweenstaff and patients was improving in certain circumstances, therewere areas in need of improvement. These included the needfor improved communication at the point of discharge andinformation sharing in relation to medicines.
Legislation
The Health and Social Care Act 2008 (Regulated Activities)Regulations 2014 require providers to deliver person-centredcare. These regulations introduce the fundamental standards,which describe requirements that reflect the recommendationsmade by Sir Robert Francis following his inquiry into care atMid Staffordshire NHS Foundation Trust. They pinpoint moreclearly the fundamental standards below which the provisionof regulated activities and the care provided to people mustnot fall.
The intention of regulation 9 – person-centred care4 is to makesure that people using a service have care or treatment thatis personalised specifically for them. Providers must work inpartnership with the person to:
• Assess their needs and preferences
• Deliver care and treatment with a view to achievingpreferences and meeting needs
• Understand the balance of risks and benefits
• Support participation to the maximum extent
• Provide reasonable information
• Make any reasonable adjustments
Principles and guidance
Shared decision making brings together the expertise of theclinician and the patient and can involve negotiation andcompromise. The Kings Fund report ‘Making shared decisionmaking a reality’5 explains that the clinician’s expertise is basedon knowledge of the diagnosis, likely prognosis, treatmentand support options and the range of possible outcomes basedon population data, whereas the patient knows about theimpact of the condition on their daily life, and their personalattitude to risk, values and preferences. In shared decision-making the patient’s knowledge and preferences are taken intoaccount, alongside the clinician’s expertise, and the decisionsthey reach in agreement with each other are informed byresearch evidence on effective treatment, care or supportstrategies. See Figure 1.6
The General Medical Council has recently published newguidance to support doctors to make shared decisions withpatients.7 This guidance describes seven principles that shouldbe applied when making decisions about care and treatment.
• Principle one - All patients have the right to be involved indecisions about their treatment and care and be supportedto make informed decisions if they are able.
• Principle two - Decision making is an ongoing processfocused on meaningful dialogue: the exchange of relevantinformation specific to the individual patient.
• Principle three - All patients have the right to be listened to,and to be given the information they need to make a decisionand the time and support they need to understand it.
Figure 1
Journal of Medicines Optimisation • Volume 3 • Issue 3 • September 2017 83
• Principle four - Doctors must try to find out what mattersto patients so they can share relevant information about thebenefits and harms of proposed options and reasonablealternatives, including the option to take no action.
• Principle five - Doctors must start from the presumptionthat all adult patients have capacity to make decisions abouttheir treatment and care. A patient can only be judged tolack capacity to make a specific decision at a specific time,and only after assessment in line with legal requirements.
• Principle six - The choice of treatment or care for patientswho lack capacity must be of overall benefit to them, anddecisions should be made in consultation with those who areclose to them or advocating for them.
• Principle seven - Patients whose right to consent is affectedby law should be supported to be involved in the decision-making process, and to exercise choice if possible.
These same principles form the basis of the GeneralPharmaceutical Council professional standards. To delivereffected shared decision making, a pharmacy professionalwould demonstrate actions from each of these standards. Seefigure 2.8
Understanding the patient’s experience is the first of the fourprinciples of medicines optimisation described by the RoyalPharmaceutical Society and is key to taking a person centredapproach and improving patient outcomes. See figure 3.9
Consent to treatment and Mental Capacity
Providers must make sure that they consider people's capacityand ability to consent, and that either they, or a personlawfully acting on their behalf, must be involved in theplanning, management and review of their care and treatment.Providers must make sure that decisions are made by those withthe legal authority or responsibility to do so, but they must workwithin the requirements of the Mental Capacity Act 2005,
which includes the duty to consult others such as carers, familiesand/or advocates where appropriate. Healthcare professionalsmust follow the five statutory principle of The Mental CapacityAct 2005. These are:
1. A person must be assumed to have capacity unless it isestablished that they lack capacity.
2. A person is not to be treated as unable to make a decisionunless all practicable steps to help him to do so have beentaken without success.
3. A person is not to be treated as unable to make a decisionmerely because he makes an unwise decision.
4. An act done, or decision made, under this Act for or onbehalf of a person who lacks capacity must be done, ormade, in his best interests.
5. Before the act is done, or the decision is made, regard mustbe had to whether the purpose for which it is needed can beas effectively achieved in a way that is less restrictive of theperson’s rights and freedom of action.
Decisions made under the Mental Capacity Act are decision andtime specific. This means you cannot presume incapacity justbecause a decision has been made in a person’s best interestbefore. Each decision should be a considered a new taking allinformation into account.
What does good look like?
A systematic review found that shared decision makinginterventions significantly improve outcomes for disadvantagedpeople. Addressing people’s level of health literacy when sharingdecisions can also reduce health inequalities.
The principles of shared decision making should be embeddedin all parts of the healthcare system, from commissioning,
Figure 2 Figure 3
through care pathways, to teams delivering care and treatmentand to patients. The NHS England shared decision makingimplementation framework provides some best practice advice.Figure 4.10
Supportive systems and processes
The implementation of shared decision making is a complexintervention. Implementation should be clinically-led and allimprovement efforts should be coproduced with people withlived experience. There should be measurement and monitoringof shared decision making within services to make sure it istaking place to a high standard.
Commissioned services
Shared decision making should be built into points along a carepathway when a decision needs to be made. This is particularlyrelevant when people face ‘high value’ decisions where thechoice can have a significant impact (positive or negative) ontheir lives. At these decision points, options should includemedical treatments, doing nothing and (where relevant) theoption of psychosocial or community support.
Trained teams
Most health and care staff will need to receive accreditedtraining to confidently take part in shared decision makingconversations. The skills required involve training in motivationaland health coaching approaches, alongside specific training inrisk communication and in working with people at lowlevels of health literacy. A barrier to the uptake of training is‘unconscious incompetence’- in other words many clinicians donot understand that they might benefit from training. Pharmacyspecific shared decision making learning can be found via theCentre for Pharmacy Postgraduate Education (CPPE).
Prepared public
Individuals should be supported to play as active a role as theywish in decisions about their care. Staff should use health-literate decision support materials (when such materials areavailable) and tailor their conversations to take account of low
health literacy by using specific techniques, building on thehealth literacy toolkit.
Ask 3 Questions
Patient education was key to The Health Foundation's MAGIC(Making good decisions in collaboration) programme.11 Themain aims of the campaign were to increase patients’awareness of shared decision making; increase theirexpectations for a shared decision making consultation; andprovide them with a way of taking part in shared decisionmaking. This was achieved by encouraging patients to getanswers to three simple questions when they are asked to makea healthcare decision:
1. What are my options?
2. What are the possible benefits and risks of those options?
3. How likely are the possible benefits and risks of each optionto occur?
It also encouraged patients to think about ‘what’s important tome’ when making the decisions.
This programme demonstrated that a campaign that focuses onchanging patients’ behaviours and expectations has thepotential to engage patients, health care professionals and thewider organisation, if it is launched systematically and linkedwith strategic aims.
Patients reported that the Ask 3 Questions campaign gave them‘permission’ to be involved in the decisions.
BRAN
Another tool that can be used to engage patient’s in decisionmaking is described by Choosing Wisely UK;12 part of a globalinitiative aimed at improving conversations between patientsand their doctors and nurses. Choosing Wisely was created inpart to challenge the idea that more is better or in the case ofmedical intervention: just because we can, doesn’t always meanwe should.
Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 202084
Figure 4
Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 2020 85
The Choosing Wisely principles encourage patients get the bestfrom conversations with their doctors and nurses by askingfour questions.
• What are the benefits?
• What are the risks?
• What are the alternatives?
• What if I do nothing?
Patient decision aids
For more complex decisions, and where there as a risk or benefitof a particular treatment to weigh up, patient decision aids canbe really useful. The NICE website has a number of patientdecision aids available that pictorially illustrate the risk ofdeveloping a side effect to a particular medicine or the mortalityrate with a certain condition.
Accessible Information
All providers of NHS care or other publicly-funded adult socialcare must meet the Accessible Information Standard (AIS). AISapplies to people who use a service and have information orcommunication needs because of a disability, impairment orsensory loss. Providers must make sure that they identifypeople’s communication needs and ensure they are met.Reasonable adjustments must be made to ensure thatinformation is communicated in a way that people canunderstand and use to make a shared decision.
Conclusion
Shared decision making is like a jigsaw. It's where eachparticipant brings their own experience and their expertise to fitthe pieces together to make the complete picture. Duringshared decision-making, it's important that care and treatmentoptions are fully explored with patients, along with their risksand their benefits. Accessible information must be madeavailable to inform and educate, leading to a decision reachedtogether, between the person and the healthcare professional.By fully implementing shared decision making, healthcareproviders can improve outcomes for disadvantaged people andreduce health inequalities.
Declaration of interests
The author has no interests to declare. Although she is employedby CQC this article represents her personal views.
References
1. National Institute for Health and Care Excellence (NICE) Shareddecision making https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-guidelines/shared-decision-making[Accessed 25 Nov 2020]
2. NHS England Shared decision makinghttps://www.england.nhs.uk/shared-decision-making/ [Accessed 25Nov 2020]
3. Care Quality Commission Adult Inpatient Survey 2019https://www.cqc.org.uk/publications/surveys/adult-inpatient-survey-2019 [Accessed 25 Nov 2020]
4. Care Quality Commission Regulation 9: Person centred carehttps://www.cqc.org.uk/guidance-providers/regulations-enforcement/regulation-9-person-centred-care [Accessed 25 Nov 2020]
5. Coulter A, Collins A. Making shared decision-making a reality.London: King's Fund. 2011.
6. Haynes RB, Devereaux PJ, Guyatt GH (2002). ‘Physicians’ andpatients’ choices in evidence based practice’. British MedicalJournal, vol 324, no 7350, p 1350.
7. General Medical Council. Guidance on professional standards andethics for doctors. Decision making and consent. 2020https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/decision-making-and-consent [Accessed 25 Nov 2020]
8. General Pharmaceutical Council. Standards for PharmacyProfessionals. May 2017.https://www.pharmacyregulation.org/standards/standards-for-pharmacy-professionals
9. Royal Pharmaceutical Society. Medicines Optimisation: Helpingpatients to make the most of medicines. May 2013https://www.rpharms.com/Portals/0/RPS%20document%20library/Open%20access/Policy/helping-patients-make-the-most-of-their-medicines.pdf
10. NHS England and NHS Improvement. Shared Decision MakingSummary Guide. 2019. https://www.england.nhs.uk/wp-content/uploads/2019/01/shared-decision-making-summary-guide-v1.pdf[Accessed 25 Nov 2020]
11. Joseph-Williams N, Lloyd A, Edwards A, Stobbart L, Tomson D,Macphail S, Dodd C, Brain K, Elwyn G, Thomson R. Implementingshared decision making in the NHS: lessons from the MAGICprogramme. British Medical Journal. 2017 Apr 18;357:j1744.
12. Ask 3 questions. British Medical Journal.2013.https://improve.bmj.com/sites/default/files/resources/sdm_case_study_ask_3_qs.pdf [Accessed 25 Nov 2020]
13. Choosing Wisely UK https://www.choosingwisely.co.uk/ [Accessed25 Nov 2020]
WRITE UP YOUR GOOD WORKAND SPREAD IT TO YOUR
COLLEAGUES
Is it about managerial good practice, service developments and processesinvolved in the management of medicines?
THINK JOURNAL OF PHARMACY MANAGEMENT (JoPM)!This is distributed quarterly throughout the UK to senior pharmacists in primaryand secondary care.
Is it about good practice in medicines optimisation with a focus on ‘optimisation’,which relates to quality and improving patient care, rather than cost aspects?
THINK JOURNAL OF MEDICINES OPTIMISATION (JoMO)!This is distributed biannually throughout the UK to clinical pharmacists, doctors,nurses and other healthcare professionals.
Why not write an article that addresses the medicines optimisation initiative for specific therapeutic areas?
Sharing such targeted work will hopefully facilitate discussion and the implementation of best practice within specialisms.
If you have something to say to readers, we will help you say it!About 3,000 words is good but full Guidance for Authors is available on the PharmacyManagement website under the Journals tab at https://www.pharman.co.uk/ .Any queries? Just contact the Senior Editorial Assistant ([email protected])
Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 2020 87
Optimise, align and strengthen capacity of advancedpharmacy practice to guarantee high quality patientcare - the IBD model in the UKAnja St. Clair Jones, Dip.Pharm, MSc, FFRPS, MRPharmS (IPresc), Consultant
Pharmacist Gastroenterology, Brighton & Sussex University Hospitals NHS Trust
Correspondence to: [email protected]
In 2016 the World Health Organisation (WHO) published theGlobal Strategy on Human Resources in Health: Workforce20301 to enable the vision that by 2030 all communities haveuniversal access to health workers, without stigma anddiscrimination. The document estimates that globally 40 millionnew jobs in health are needed to obtain Universal HealthCoverage (UHC) by 2030 requiring countries to developnational plans for health workforce development. This fits inwith nine of the seventeen Sustainable Development Goals2 setby the United Nations General Assembly in 2015 for the year2030 and health policy makers will have to refer to both thesedocuments when developing strategies for health services intheir country.
The objective of the WHO Health Workforce strategy is todescribe policy levers to shape health labour markets:
1. Optimize the existing workforce in pursuit of theSustainable Development Goals and universal healthcoverage (e.g. education, employment, retention)
2. Anticipate and align investment in future workforcerequirements and plan the necessary changes (e.g. a fit forpurpose, needs-based workforce)
3. Strengthen individual and institutional capacity tomanage HRH policy, planning and implementation (e.g.migration and regulation)
4. Strengthen data, evidence & knowledge for cost-effective policy decisions (e.g. labour market analysis,National Health Workforce Accounts)
The question now to answer is how do we ‘optimise’ pharmacypractitioners, align investment and develop the capacity inpractice.
We have made progress in developing advanced specialistpractitioners in some countries reported in a global report3 in2015 by the International Pharmaceutical Federation (FIP). Thesubsequent FIP document describing Education in the Contextof Workforce Development4 in 2017 states: the continueddevelopment of pharmacy services and the pharmaceuticalsciences relies on a well educated, competent, sufficient andwell distributed pharmaceutical workforce.
To achieve the thirteen ambitious goals set out in the FIPdocument it will require country specific solutions and to enablethis transformation of the workforce we need to look at thebehaviour change model, figure 1.
As a profession we need to develop:
Capability through education and describe clear developmentpathways from foundation to advanced practice
Motivation through professional and financial recognition(credentialing)
Opportunity through inclusion of well described pharmacyservices in policies & mandate the commissioning of services
This may feel new for a majority of the pharmacy workforce butwe would not expect other medical practitioners to stay static intheir competencies.
The strategy highlights the common competencies needed forall pharmaceutical practitioners irrelevant of area of practice to
Abstract
TitleOptimise, align and strengthen capacity of advanced pharmacy practice to guarantee high quality universal health coverage
Author listAnja St. Clair Jones.
The Goal of excellent pharmacy practice is to ensure our patients have the best possible outcomes from their treatment and care. Toachieve this we have to define quality (what does 'good' look like and how is it measured?), embed quality improvement in IBDservices and care, share good practice, raise the political profile of advanced practice and monitoring and reporting on progressgenerating impactful data. Using national service standards and a benchmarking tool to facilitate these goals is an effective way toenable, mandate and commission advanced practice.
Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 202088
be developed to ‘optimise the workforce. In the UK the RoyalPharmaceutical Society (RPS) has set out in the AdvancedPharmacy Framework (APF) of the RPS Faculty the six clusters ofcompetencies advanced practitioners need to demonstrate tobe credentialed as stage 1 or stage 2 Faculty members or FacultyFellows, figure 2.
Optimise, align and strengthen capacity of advanced pharmacy practiceThe Gastroenterology - IBD model
Ongoing research is revealing that over 500,000 people in theUK have inflammatory bowel disease (IBD), the two main formsof which are Crohn’s Disease and Ulcerative Colitis; that is atleast one in every 133 people.
IBD is a long-term, fluctuating condition, with periods of relapse(flare) and remission. The cause is not yet fully understood butis considered to be a mix of genetic susceptibility, gut bacteria,environmental factors and a defective immune response.Crohn’s causes painful ulcers and inflammation in the gutanywhere from the mouth to the anus but is most common inthe small bowel and colon. The inflammation can affect alllayers of the bowel wall. Ulcerative Colitis causes inflammationand ulceration of the inner lining of the rectum and colon (thelarge bowel).
Symptoms include urgent and frequent diarrhoea often withblood and mucus, severe abdominal pain, extreme fatigue andweight loss. IBD does not just affect the gut. It can affect almostevery part of the body and every aspect of life: from digestion,eyes and joints to energy levels and mental health. People livingwith IBD face a lifetime of medication and, in many cases, majorsurgery. If left untreated, complications from the conditions canbe life-threatening. With many of these symptoms “invisible”, itcan appear that someone looks healthy, but they are in factincredibly unwell. This creates stigma and misunderstandingsurrounding IBD, with thousands of people suffering in silence.
You can develop IBD at any age, but most people are diagnosedwhen they are in their 20s – meaning it has a significant impacton their working life. In a Crohn’s & Colitis UK survey, nearly20% of people with IBD reported being unable to work due toill health. Additionally, 43% of people with IBD had to make anadjustment to their working life (e.g. home working or flexiblehours) because of their condition.
There is as yet no cure for IBD. Treatment may be medical,surgical or a combination of both. It aims to manage flare-ups,support people to stay well and monitor long-term risks.Medical treatment includes steroids, immunosuppressants andbiologic medicines. Up to 8 in 10 people with Crohn’s are likelyto require surgery at some point during their lives. People withextensive disease are at risk of potentially life-threateningcomplications such a complete blockage or perforation of thebowel. Lifetime costs for IBD are comparable to those for heartdisease and cancer.
National service standards are currently set for a range ofdisease areas and the case study of pharmacy services inInflammatory Bowel Disease (IBD) services demonstrates howadvanced specialist practice can be enabled, promoted andrecognised. Through embedding advanced pharmacy practice inthe UK IBD Standards5 2019 we are optimising thepharmaceutical workforce in IBD, aligning the IBD pharmacyservices to national standards and mandate the commissioningof expert pharmacy skills in each IBD service. Evidence showsthat people with long-term conditions and using multiplemedicines have better clinical and personal outcomes following
Capability
Motivation
Opportunity
Behaviour
The COM-B system - a framework for understanding behaviour
Figure 1
The Continuum of Practice
FOUNDATION ADVANCED CONSULTANT
APPLYING CLINICALKNOWLEDGE AND SKILLS
EVIDENCE INFORMEDDECISION MAKING
PERSON CENTRED CAREEXPERT
PROFESSIONALPRACTICE
EXPERTPROFESSIONAL
PRACTICE
COMMUNICATION ANDCONSULTATION SKILLS
COLLABORATIVEWORKING
COLLABORATIVEWORKING
RELATIONSHIPS
COLLABORATIVEWORKING
RELATIONSHIPS
LEADERSHIP
MANAGEMENT
LEADERSHIP
MANAGEMENT
LEADERSHIP ANDMANAGEMENT
EDUCATION, TRAININGAND DEVELOPMENT
RESEARCH ANDEVALUATION
EDUCATION, TRAININGAND DEVELOPMENT
RESEARCH ANDEVALUATION
EDUCATION, RESEARCHAND EVALUATION
RESILIENCEAND ADAPTABILITY
PROFESSIONALACCOUNTABILITY
GPHC PROFESSIONAL STANDARDS
Figure 2
Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 2020 89
a structured medication review (SMR). A surgery will only havea few IBD patients registered and the skill to look after thismainly young and active but very ill when flaring patient groupis underdeveloped. Personalised care plans and shared care aswell as up-skilling of community health care providers isessential to prevent hospital admission. Expert pharmacists inIBD are ideally place to educate, upskill and support primarycare colleagues and promote best care for this patient cohort.A survey of GPs conducted as part of the RCGP and Crohn’s &Colitis UK IBD Spotlight Project found that 52% of GPs reportedbeing less than or not confident in helping a patient withknown Inflammatory Bowel Disease when they came to a clinicwith a flare.
The use of personalised care and self-management planscompetently explained to patients, locally developed treatmentguidelines and an effective flare management pathway as wellas accessible advice for patients and health care providers has aconsiderable impact on IBD patients’ lives. IBD is complex andfluctuating, and its physical and emotional effects can varyhugely from one person to another. This means that goodmultidisciplinary team (MDT) working – both within the core IBDteam, between specialities in secondary care, betweenpaediatric and adult services and between primary andsecondary care - is essential to deliver high-quality, coordinated,and personalised care. Pharmacists have a crucial role in advisingthe MDT on protocols and optimising medication. They are thekey to providing information about medicines to patients ondischarge, which has been found to be lacking in past IBDaudits, and provide information and support to patients tofacilitate shared decision making, for example when consideringstarting a biologic drug. With more and more new treatmentsbecoming available, their role will only increase.
The first national IBD standards were developed in 2008describing minimal pharmacy input. Pharmacy was recognisedonly once in the IBD team requiring ‘1 pharmacist with specialinterest in IBD’ without any description of the requiredcompetencies or service parameters.
In 2018 a multidisciplinary alliance of 17 organisations andpatients (IBDUK) was convened to update the current IBDstandards. To inform the development of medicinesoptimisation related standards IBD units with developed expertpharmacy services were surveyed through the UK ClinicalPharmacy Association (UKCPA) network to identified quantityand quality of advanced practice requesting information ofservice provision and the relevance of the RPS Framework forAdvanced Practice (APF). An e-Delphi consensus process wasundertaken over 3 rounds by IBDUK to refine a set of evidence-and expert opinion-based recommendations for optimal servicedelivery across the patient journey with 80% agreement forstatements to be retained. The new standards identifiedinformed the benchmarking tool to enable self-assessmentsupporting quality improvement and additional resourcesrequests where needed. Descriptors were developed in 2consensus workshops by IBDUK with expert pharmacyrepresentation. Due to development of IBD pharmacy services6
in the intervening years it has been possible to achieve aconsensus on pharmacy as an integral part of the IBD services.4 units, 2 teaching and 2 district hospitals with developed IBDpharmacy services were surveyed informing 4 relevant standards
• Statement 1.5: The IBD leadership team should workwith a consultant pharmacist in IBD to ensure goodmedicines governance, including medicines optimisationand cost-effectiveness.
https://ibduk.org/ibd-standards/the-ibd-service/ibd-service-leadership-team
Does the IBD leadership team work with a pharmacist? (No = D)
Does the IBD leadership team work with an expert orconsultant pharmacist in IBD (or equivalent) with annualformulary review? (No = C)
Does the IBD leadership team work with a consultantpharmacist or equivalent in IBD on annual protocol/policyreview, with actions and outcomes, to actively developpharmacy services within IBD? (No = B, Yes = A)
• Statement 3.1: All newly diagnosed IBD patients shouldbe seen by an IBD specialist and enabled to see anadult/paediatric gastroenterologist, IBD nurse specialist,specialist gastroenterology dietitian, surgeon,psychologist and expert pharmacist in IBD as necessary.
https://ibduk.org/ibd-standards/newly-diagnosed/specialist-assessment
Are all newly diagnosed IBD patients seen by a member ofthe IBD team? (No = D)
Are all newly diagnosed IBD patients seen in a dedicated IBDclinic with access to adult/paediatric gastroenterologist, IBDnurse specialist, surgeon, dietitian, psychologist and expertpharmacist in IBD as necessary? (No = C)
Are patient reported outcomes recorded following newdiagnosis and access to the specialist team? (No = B, Yes = A)
• Statement 6.10: All IBD inpatients should have theirprescribed and over the counter medications reviewedon admission by a pharmacist who has access to anexpert pharmacist in IBD for advice, with regularreview of medications during their inpatient stay andon discharge.
https://ibduk.org/ibd-standards/inpatient-care/medication-review
Does the ward pharmacist have access to an advancedgeneralist pharmacist to seek advice for medication reviewand optimisation? (No = D)
Does the ward pharmacist have access to an expertpharmacist in IBD to seek advice for medication review andoptimisation and personalised consultation? (No = C)
Do the patient and ward pharmacist have access toconsultant pharmacist in IBD or equivalent on admission andduring their stay for medication review, optimisation andpersonalised consultation? (No = B, Yes = A)
• Statement 7.3: Clear protocols should be in place forthe supply, monitoring and review of medicationacross primary and secondary care settings?
h t t p s : / / i b d u k . o r g / i b d - s t a n d a r d s / o n g o i n g - c a r e -monitoring/shared-care
Are shared care protocols in place for the review andmonitoring of all IBD medications across primary andsecondary care? (No = D)
Are these agreed between primary and secondary care, withall relevant information recorded? (No = C)
Are arrangements for shared care discussed and agreed withpatients, with written information provided? (No = B, Yes = A)
Box 1
Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 202090
key to pharmacy leadership, medicines expert roles andMultidisciplinary Team (MDT) working for patient from diagnosisto long-term care. Proposed standards were submitted to theDelphi process and IBDUK agreed 59 standards in total. All 4(7%) describing expert practice were incorporated with 100%agreement.
IBDUK defined 0.6 WTE MDT expert pharmacist (Faculty stage 2or above) per 250,000 population based on the pharmacysurvey results. It was agreed to define high quality practicethrough the Royal Pharmaceutical Society Framework forAdvanced Practice.
The benchmarking tool defined A-D descriptors for expertpractice, demonstrating A = ‘excellent, proactive’ to D = ‘minimal,inadequate’ care developed and agreed by IBDUK.
The four statements (Box 1) describing IBD pharmacy servicesuse the benchmarking tool to promote and mandate advancedpractice developed according to Faculty agreed competencies toensure high quality patient care.
IBDUK Standards 2019 (ibduk.org) for the first time embed anddescribe expert practice as an integral part of the IBD MDTmanaging IBD patients. The benchmarking tool encourages thedevelopment of advanced competencies in pharmacy practice.This in turn supports behaviour change through describingcompetencies needed to gain required capability, enablingrecognition and commissioning of advanced pharmacy practiceproviding motivation and opportunities.
Declaration of interests
The author has no interests to declare.
References
1. WHO. Global Strategy on Human Resources for Health: Workforce2030. World Health Organisation 2016.https://www.who.int/hrh/resources/globstrathrh-2030/en/ (accessed15/09/2019)
2. UN. Sustainable Development Goals 2030. United Nations GeneralAssembly 2015https://www.un.org/sustainabledevelopment/sustainable-development-goals/ (accessed 15/09/2019)
3. FIP Advanced Practice and Specialisation in Pharmacy practice:Global report. Fédération Internationale Pharmaceutique 2016.https://www.fip.org/files/fip/PharmacyEducation/Adv_and_Spec_Survey/FIPEd_Advanced_2015_web_v2.pdf
4. FIP. Transforming Pharmacy and Pharmaceutical Sciences Educationin the Context of Workforce Development. FédérationInternationale Pharmaceutique 2017.https://www.fip.org/www/streamfile.php?filename=fip/publications/FIPEd_Nanjing_Report_2017_11.10.17.pdf
5. IBDUK. IBD standards 2019.IBDUK.org (accessed 15/09/2019)
6. A St.Clair Jones, M Smith, (2015), Embedding pharmaceutical careinto the multidisciplinary team, ECCO 2015 Abstract P306.
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Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 202092
Tackling overuse of short-acting beta-2 agonists(SABAs) in asthma in primary careMihir Varia, MRPharmS, IPresc, MBA, Senior Pharmaceutical Advisor, Pharmacy
& Medicines Optimisation Team, Herts Valleys Clinical Commissioning Group
Correspondence to: [email protected]
Overview
There are more than 5 million people with asthma in the UK,with more than 800,000 (17%), suffering from severe ordifficult to control asthma.1 It is these patients with the moresevere, exacerbation prone disease that are more likely to beadmitted to hospital and account for the most significant healthservice utilisation.
Evidence base
Overuse of SABAs has been recognised as a problem for manyyears. The National Review of Asthma Deaths (NRAD)2 foundthe following evidence
“There was evidence of excessive prescribing of relievermedication. Among 189 patients who were on short-actingrelievers at the time of death, the number of prescriptions wasknown for 165, and 65 of these (39%) had been prescribed morethan 12 short-acting reliever inhalers in the year before they died,while six (4%) had been prescribed more than 50 reliever inhalers.Those prescribed more than 12 reliever inhalers were likelyto have had poorly controlled asthma.”
As a result the NRAD report advises - “All asthma patients whohave been prescribed more than 12 short-acting reliever inhalersin the previous 12 months should be invited for urgent review oftheir asthma control, with the aim of improving their asthmathrough education and change of treatment if required.”
The management of asthma in the UK is based on guidancefrom NICE3 and BTS/SIGN guidance.4 As management of asthmahas evolved (in line with national guidance), it is clear thatSABAs play a smaller role in the management of asthma. Theiruse in monotherapy is not generally supported in the guidelines,although there are those with infrequent, short-lived wheezeand normal lung function in whom monotherapy with a SABAmay be sufficient.
National strategy
NHS England has outlined a programme to improve thetreatment and support of people with respiratory disease anddeliver the commitments outlined in the NHS long term plan.5
Hospital admissions for lung disease have risen over the pastseven years at three times the rate of all admissions generallyand therefore medicines optimisation in relation to respiratorymedicines remains a key focus for the NHS.
In relation to asthma and Medicines Management the NHS longterm plan advises –
“We will do more to support those with respiratorydisease to receive and use the right medication. 90% ofNHS spend on asthma goes on medicines, but incorrect useof medication can also contribute to poorer health outcomesand increased risk of exacerbations, or even admission.Pharmacists in primary care networks will undertake a range ofmedicine reviews, including educating patients on the correctuse of inhalers and contributing to multidisciplinary working. Aspart of this work, they can also support patients to reduce theuse of short acting bronchodilator inhalers and switch to drypowder inhalers where clinically appropriate, which usesignificantly less fluorinated gases than traditional metered doseinhalers. Pharmacists can also support uptake of new smartinhalers, as clinically indicated.”
Review of the use of SABAs in patients is therefore supported bythe national long term strategy. When reviewing SABA use it isimportant to consider the type of device a patient is using andwhere possible encourage (with education) to have all thepatients inhalers switched to those which use significantly lessfluorinated gases. It is important that when switches take place tominimise patients being left on different types of devices (mixtureof MDI and DPI) as this would affect outcomes in these patients.
Pharmacological management of asthma
The aim of asthma management is control of the disease. Inpractice subjective asthma control is defined by the Royal Collegeof Physicians (RCP) questions – this tool is also recommendedby NICE.6
The usual primary care measure (QOF indicator) measures thepercentage of patients with asthma, on the asthma register,who have had an asthma review in the last 12 months with anassessment of asthma control using the three RCP questions.
Good control is defined as – over the last month
• no daytime symptoms
• no night-time awakening due to asthma
• no need for rescue medication
• no asthma attacks
• no limitations on activity including exercise
• a normal lung function (in practical terms FEV1 and/or PEF>80% predicted or best)
Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 2020 93
• minimal side effects from medication.
BTS/SIGN guidance advises to consider moving up thepharmacological management ladder if using three doses aweek or more of the SABA.
The average salbutamol inhaler contains 200 puffs and eachdose is two puffs. Therefore controlled asthma would be wherea person uses one inhaler per year (taking two or less doses aweek). In other words individuals who use more than oneinhaler per year indicate an episode of uncontrolled or partiallycontrolled asthma. This suggests a restriction of twelve inhalersper year is a high limit and in practice supports the idea thatonce we have very few patients using 12 SABA inhalers a yeara lower future threshold could be defined.
Inhaler technique
Poor inhaler technique is associated with poor asthma control.It is vital that patients receive the appropriate training to usetheir prescribed inhaler properly. This may take severalconsultations and regular checks on technique for success to beachieved and maintained. It is widely recognised thatdeficiencies in inhaler technique exist in both patients andhealthcare professionals.7 Broadly speaking using inhalers wellcan be problematic for many patients, even those who believethey have good technique!
There are two main types of inhaler device: Metered doseinhalers (MDI) and dry powder inhalers (DPI). These twodifferent device types require very different inhaler technique.Studies suggest that patients who are prescribed both types ofinhaler have less good outcomes.8 It is likely that this is becauseof poor inhalation technique with at least one, if not bothdevices. Therefore at medication review it can be useful tostandardise the inhaler device.
Explore other factors
If the patient has good inhaler technique and is adherent totheir preventative medication, a search for other factors mayhelp. For example
• The possibility of occupational asthma
• Smoking cessation
• Other triggers like allergen.
Local Picture in Herts Valleys CCG
Asthma is a major driver to acute care episodes. A local reviewof the latest available NHS Right Care commissioning for value– Respiratory focus pack9 indicated that NHS Herts Valleys CCGwas an outlier in 2016 as
• Prevalence of asthma was lower than that of similar CCGs
• Non-elective spend on asthma was 20% higher than similarCCGs.
• Spend on SABAs at Herts Valleys CCG was higher than thatof the best 5 CCGs &
• Acute care episodes were higher than comparable CCGs.
Implementation of a local project
The above information was discussed with GP stakeholders andit was agreed to prioritise and support work in this area. Thefollowing steps were taken to support the work:
1.1 Using prescribing records to identify over-prescribingof SABAs.
Prescribing data was run using EMIS Enterprise tounderstand the number of SABA inhalers that were beingissued to patients with a diagnosis of asthma over a periodof 12 months. EMIS Enterprise is a system that allows theCCG to pull information from the computerised notes andprescribing system most commonly used in our area (EMIS).The information enables us to ask clinical staff to focus ondoing clinical work without them needing to submit data todemonstrate the changes made, as we can pull informationcentrally. Consents have to be in place to use this system,but because the data produced is anonymous patient levelconsent is not required. We have a small number ofSystmOne practices where we do not have the pull systemin place these practices had to provide audit data todemonstrate their achievement of the targets set.
This information was shared with the individual practices sothat they could understand the scale of the problem.
EMIS Enterprise searches run in the CCG use pseudo-anonymised data and for the searches to be relevant to thepractice the data would need to be attributable to anindividual patient. Therefore a search was also designed thatcould be shared with all practices to upload so that theycould have the details at an individual practice and patientlevel.
Practices were supported to upload the data andinstructions were provided on how to manipulate the dataso that the practices could see number of inhalers issued perpatient over the last 12 months. Practices were encouragedto review all patients who had been issued 8 or moreinhalers over the last 12 months. They were advised toprioritise the patients by number of inhalers issued.
It was agreed that the review of these patients aligns withthe strategic vision of the CCG for respiratory care andwould be included in the CCGs long term conditionsspecification. The long term conditions specificationfinancially incentivises member GP practices to deliverevidence based best quality outcome for patients.
By following this process practices could plan ahead andover time book in the higher risk patients for review at theirpractice and by following the stepwise guide in local andnational guidance reduce the overuse of SABA inhalers,while identifying any patients that had uncontrolled orpartially controlled asthma. This was supported witheducation for health care professionals.
1.2 Local guidelines to support management of chronicasthma in adults10 and education
It was agreed that respiratory training events will bedeveloped together with the consultant led community
Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 202094
respiratory service to provide training to general practice staffto improve respiratory outcomes. The training aimed atincreasing awareness of local guidelines on management ofchronic asthma and supporting healthcare professionals inaddressing safety concerns related to SABA overuse. Formalfeedback on the training sessions went directly to theconsultant led community respiratory provider and wereceived a summary which suggested that the trainingsessions were well received. We became aware though thetraining that we needed to reach the specialist nurses inrespiratory care not just GP leads, who are the traditionalgroup that we usually provide prescribing training sessions for.
Separately a community pharmacy training event onrespiratory medicines was conducted as this would supportwith medication review in line with local and nationalguidelines and inhaler technique support when conductingMedicines Use Reviews (MURs) and New Medicines Services(NMS). It was also recognised that the Centre for PharmacyPostgraduate Education (CPPE) provide a session on inhalertechnique that community pharmacists and clinicalpharmacists in GP practices were encouraged to undertake.
For patients it was recognised that patients could besignposted to right breathe or asthma UK to access trainingon appropriate inhaler and spacer use. The right breathewebsite11 also includes an on-line app that patients may alsofind useful.
1.3 Regular feedback sessions
The GP prescribing lead for each practice attends a localityprescribing meeting that is held every two months. Thesemeetings provide an opportunity to benchmark progress withCCG objectives, to share knowledge and/or discuss anyconcerns.
Meetings were therefore used to develop shared learning andhighlight areas like:
• Reviews need to be individualised. For example patientsmay have misunderstood the instructions and be taking theSABA twice daily and the preventer on an as needed basis.
• When conducting the review, monitor quantities of thepreventer medication. The patient may be taking theirpreventer medication only sporadically. In particular this maybe due to misconceptions with use of steroid containingmedication. In such situations, the rationale for preventertreatment must be made known to the patient in thecontext of an individual personal risk / benefit assessment.
Outcomes
• An overall reduction in the use of SABAs
The project was run in 2017 to 2018 and it resulted in a 7%(12,000 inhalers) reduction in the number of SABA inhalersprescribed by practices in the CCG. This reduction in use ofSABAs has continued to further improve as data from 2019shows a further 3% (5,000 inhalers) reduction in SABA use.
At the end of the project a number of practices wereaudited. The audits demonstrated a reduction in the numberof patients who were on 12 or more inhalers. The projecthelped increase awareness of the need to monitor SABA useand it has been incorporated into asthma reviews.
Open prescribing is a national database that is freelyavailable to the public and has a safety indicator that looksat prescribing of SABA compared to prescribing of inhaledcorticosteroids and SABA. The indicator provides a trend andencouragingly for Herts Valleys CCG (see Graph 1 below)
Graph 1 on Short Acting Beta Agonist inhalers from the Safety section of Open Prescribing12
Journal of Medicines Optimisation • Volume 6 • Issue 3 • December 2020 95
demonstrates that since the work was undertaken in 2017-2018 there has been a decrease in SABA use (emergencyreliever therapy) compared to inhaler corticosteroid(maintenance therapy) and SABA use. This suggests thatpatients who have poor control are more likely to be on amaintenance therapy (than the national average).Furthermore, it is encouraging to see that there has beenprogressive improvement in this indicator and that the CCGare now performing better than the national average. Thetrend has been downwards in general apart from during theacute phase of Covid-19 where both national and local datahad a spike in SABA use.
• A reduction in asthma related emergency activity andcosts
The project was run in 2017-2018 and the correspondingemergency asthma related activity (and cost) across the CCGshowed a 25% (£110k) reduction. This continued toimprove in 2018-2019 with a further 10% decrease inactivity (£26k reduction in cost). In 2019-2020 there hasbeen an increase in activity although reassuringly the activityremains 25% (£100k) below that at 2016-2017 (period priorto undertaking the project). Overall the data is encouragingand in line with clinical expectations. The project hassupported identification and review of patients who over useSABAs and have poorly controlled asthma. Patients have hadtheir treatments optimised resulting in better outcomes asreflected in lower emergency activity and costs.
When setting up a project of this nature it is importantthat commissioners work with the delivery partners e.g.Specialist respiratory services, GPs, third sector support(Asthma UK) and that the plan is co-ordinated with localguidelines and education to support the change. It isencouraging to see that there has been a decrease in thenumber of patients who have a high use of SABAs, reducedasthma related emergency activity and that the change hasbeen maintained. This suggests there has been an overallimprovement in asthma control and that the project hassupported healthcare professionals deliver better care andpatients achieve better respiratory outcomes. It alsodemonstrates that while reducing overuse of SABA inhalerssounds simple to do - it needs considerable support to bedthis into routine practice. We believe this work will be ofinterest to others because it could be replicated and we feelit is important because overuse of SABAs is a risk factor forsudden death in asthmatic patients.
Declaration of interests
NICE guideline development group member for - Emergencyand acute medical care in over 16s: Service delivery andorganisation [NG94 – Published March 2018].
References
1. Asthma UK – Asthma facts and statistics -https://www.asthma.org.uk/about/media/facts-and-statistics/
2. Royal College of Physicians. Why asthma still kills: the NationalReview of Asthma Deaths (NRAD) confidential enquiry report.London: RCP, 2014. Available athttps://www.rcplondon.ac.uk/projects/outputs/why-asthma-still-kills
3. NICE guideline NG80 – Asthma: diagnosis, monitoring and chronicasthma management – Published 29th November 2017https://www.nice.org.uk/guidance/ng80
4. SIGN158 British guideline on the management of asthma - Revisededition published July 2019 https://www.brit-thoracic.org.uk/quality-improvement/guidelines/asthma/
5. NHS Long term Plan – Respiratory disease -https://www.longtermplan.nhs.uk/online-version/chapter-3-further-progress-on-care-quality-and-outcomes/better-care-for-major-health-conditions/respiratory-disease/
6. NICE Quality and Outcomes Framework related to Asthma (QOF)https://www.nice.org.uk/standards-and-indicators/qofindicators/the-percentage-of-patients-with-asthma-on-the-register-who-have-had-an-asthma-review-in-the-preceding-12-months-that-includes-an-assessment-of-asthma-control-using-the-3-rcp-questions
7. M Baverstock, N Woodhall, V Maarman - Do healthcareprofessionals have sufficient knowledge of inhaler techniques inorder to educate their patients effectively in their use? ThoraxDecember 2010 Vol 65 Suppl 4https://thorax.bmj.com/content/65/Suppl_4/A117.3.abstract
8. Price D, Chrystyn H, Kaplan A et al. Allergy Asthma Immunol Res2012; 4 (4): 184–191.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3378924/
9. NHS RightCare Focus Packs by CCG. Available at -https://www.england.nhs.uk/rightcare/products/ccg-data-packs/focus-packs/focus-packs-for-cvd-neurological-respiratory-maternity-april-2016/
10. Herts Valleys CCG Guidelines for management of Chronic Asthmain adultshttps://hertsvalleysccg.nhs.uk/application/files/9115/6389/0139/Guidelines_for_the_Management_of_Chronic_Asthma_in_Adults_HVCCG_042019.pdf
11. RightBreathe - https://www.rightbreathe.com/
12. OpenPrescribing.net, EBM DataLab, University of Oxford, 2020https://openprescribing.net/ccg/
Activity - Total
Costs - Total
2016-17
697
£727,109
2017-18
522
£616,272
2018-19
467
£590,480
2019-20
524
£626,681
Table 1 showing admissions data for asthma related emergency activity and costs by financial year for Herts Valleys CCG
Admissions - Asthma related emergency activity and costs by financial year
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