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National Minimum Standards for Medication Review v2.10 June 2020

1.0 ACTION FOR CONSULTEES

Consultees are asked to consider and comment on the National Minimum Standards for Medication Review.

2.0 PURPOSE This guidance has been developed to aid medication review in all clinical settings. This paper is pertinent to the AWMSG Five-year strategy 2018-2023: Supporting prudent prescribing to obtain the best outcomes from medicines for patients in Wales. AWMSG is committed to promoting medication safety by ensuring all health professionals in Wales have access to a nationally agreed standard for medication review. 2.1 Process • December 2018: Project proposal discussed at AWPAG • June and September 2019: Task and Finish group meetings • October – December 2019: Draft standards developed, feedback received from Task

and Finish group members • March 2020: Draft document presented to AWPAG • June – July 2020: Draft document circulated for consultation • September 2020: Draft document and consultation comments presented to AWPAG • October 2020: Draft document to be presented to the AWMSG Steering Committee • November 2020: Final document presented to AWMSG for endorsement 2.2 Stakeholders

• Assistant Medical Directors • Chief Pharmacists and Medicines Management teams • Community Health Councils • Community Pharmacy Wales • Directors of Public Health • General Practitioners Committee Wales • GPs • Local Medical Committees • Medical Directors • Medicines and Therapeutics Committee Chairs and Secretaries • Nurse Directors Wales • Nursing and Midwifery Council • Patients and public • Pharmacists • Royal College of General Practitioners • Royal College of Nursing • Royal Pharmaceutical Society • Welsh Government

Enclosure No: XX/XXXXX/XXXX Agenda item No: National Minimum Standards for Medication Review Author: All Wales Prescribing Advisory Group Contact: Tel: 02920 716900 awttc@wales.nhs.uk

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National Minimum Standards for Medication Review v2.10 June 2020

3.0 SUMMARY The medication review standards have been prepared in consultation with key stakeholders from various healthcare professions in Wales. Two workshops were held in 2019 where attendees gave input to the drafting of the standards and identified activities to support their completion. Attendees were then asked to comment on the standards and activities developed, based on the workshop outputs. To ensure multi-professional standards, the All Wales Prescribing Advisory Group (AWPAG) convened a Task and Finish group to develop medication review standards for use by healthcare professionals in Wales. The standards developed result from the discussions of the T&F group meetings.

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CONTENTS 1 2 1.0 INTRODUCTION ................................................................................................. 3 3

1.1 Aims ................................................................................................................ 3 4 1.2 General principles............................................................................................ 3 5

2.0 STANDARD 1. INVOLVING PATIENTS AND CARERS ...................................... 5 6 2.1 Activities and checklist ..................................................................................... 5 7 2.2 Aims ................................................................................................................ 6 8 2.3 Evidence base ................................................................................................. 6 9 2.4 Shared decision making .................................................................................. 6 10 2.5 Adherence ....................................................................................................... 7 11 2.6 Social prescribing ............................................................................................ 8 12 2.7 Patient decision aids ........................................................................................ 8 13 2.8 Comments from T&F group ............................................................................. 9 14

3.0 STANDARD 2. SAFETY ...................................................................................... 9 15 3.1 Activities and checklist ..................................................................................... 9 16 3.2 Aims .............................................................................................................. 10 17 3.3 Evidence base ............................................................................................... 10 18 3.4 Potential risk reduction .................................................................................. 10 19 3.5 Reporting adverse drug reactions and medicines-related safety incidents ..... 11 20 3.6 Comments from T&F group ........................................................................... 11 21

4.0 STANDARD 3. REVIEW OF MEDICINES ......................................................... 12 22 4.1 Activities and checklist ................................................................................... 12 23 4.2 Aims .............................................................................................................. 13 24 4.3 Evidence base ............................................................................................... 13 25 4.5 Need – are all medications essential? ........................................................... 14 26 4.6 Other tools for polypharmacy ......................................................................... 14 27

4.6.1 Quality indicators .................................................................................... 14 28 4.6.2 Deprescribing ......................................................................................... 15 29

4.7 Comments from T&F group ........................................................................... 15 30 5.0 STANDARD 4. REDUCING WASTE ................................................................. 15 31

5.1 Activities and checklist ................................................................................... 15 32 5.2 Aims .............................................................................................................. 16 33 5.3 Evidence base ............................................................................................... 16 34 5.4 Comments from T&F group ........................................................................... 17 35

6.0 STANDARD 5. MEDICATION REVIEW DOCUMENTATION ............................ 17 36 6.1 Activities and checklist ................................................................................... 17 37 6.2 Aims .............................................................................................................. 17 38 6.3 Evidence base ............................................................................................... 17 39 6.4 Resources ..................................................................................................... 18 40

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6.5 Comments from T&F group ........................................................................... 18 41 REFERENCES ........................................................................................................ 19 42 Appendix 1. AUDIT OF ACTIVITIES ....................................................................... 24 43 Appendix 2. Audit of activities GUIDANCE NOTES ................................................. 26 44 Appendix 3. Patient information leaflet .................................................................... 29 45 46 47 48

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1.0 INTRODUCTION 49 50 The All Wales Medicines Strategy Group (AWMSG) is committed to ensuring that 51 patients in Wales have access to clinically effective and cost-effective medicines 52 which improve patients’ health outcomes. The AWMSG five-year strategy 2018-2023 53 ‘Supporting prudent prescribing to obtain the best outcomes from medicines for 54 patients in Wales’ includes a recommendation to develop nationally agreed, multi-55 professional standards for medication review1. 56 57 The General Medical Council (GMC) guideline Good Practice in Prescribing and 58 Managing Medicines and Devices2, notes that when prescribing with repeats or on a 59 one off basis, suitable arrangements must be in place for monitoring, follow up and 60 review, taking account of the patients’ needs and any risks arising from the 61 medicines. In addition, the Royal Pharmaceutical Society’s Competency Framework 62 for All Prescribers3 highlights the importance of medication reviews, including 63 establishing and maintaining a plan for reviewing the patient’s treatment, and 64 adapting the management plan in response to ongoing monitoring and review of the 65 patient’s condition and preferences. 66 67 This document sets out the proposed minimum standards for patient medication 68 reviews that are delivered in a range of settings in Wales. Medication reviews can 69 have several different interpretations and different types, which vary in their quality 70 and effectiveness4.The standards have been developed to facilitate face-to-face 71 medication reviews, in any setting, including reviews conducted through telehealth. 72 The standards provide a structured approach, but are flexible enough to allow the 73 medication review to be tailored to the patient. 74 75 1.1 Aims 76 The medication review standards aim to ensure a consistent approach, resulting in 77 high-quality medication reviews by: 78

• involving patients and carers; 79 • considering medicines safety; 80 • reviewing all prescribed and non-prescribed medicines; 81 • reducing waste; 82 • updating patient records and completing documentation. 83

84 The standards should be benchmarks for quality, performance and consistency of 85 medication reviews. A high-quality service includes mechanisms to improve it by 86 regular review, audit and review of incidents, and through the feedback of service 87 users and staff. Implementing standards for medication review will help audit and 88 service review and thereby ensure continuous improvement. 89 90 1.2 General principles 91

• Although listed as separate standards, they are complementary and will be 92 most effective if used collectively. 93

• The standards do not have to be followed in a stepwise fashion. There is 94 interaction and overlap between the standards and it may be possible to 95 share responsibility or delegate a particular standard to a suitably qualified 96 member of the healthcare team, ensuring that communication and 97 documentation are considered. 98

• Each standard has a number of suggested activities to support achievement, 99 although the activities listed are suggestions. Alternative or additional 100 activities may be appropriate. 101

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• Patients are individuals with differing needs and levels of understanding. The 102 medication review process should be tailored to each person and therefore 103 completing all activities may not be appropriate in all circumstances. 104

105 These standards were developed by a multi-professional Task and Finish (T&F) 106 group of healthcare experts who attended two workshops to share their experience 107 and insight and give feedback on the draft standards. 108 109 The NICE guideline on medicines optimisation defines medication review as: 110 ‘a structured, critical examination of a person's medicines with the objective of 111 reaching an agreement with the person about treatment, optimising the impact of 112 medicines, minimising the number of medication-related problems and reducing 113 waste’4. The T&F group used this definition to develop the following standards. 114 115 Standard 1: Involving patients and carers 116 Reach agreement with the patient (or carer, or both) on the aims and goals of 117 treatment. 118 119 Standard 2: Safety 120 Minimise medication-related problems. 121 122 Standard 3: Review of medicines 123 Maximise the benefit of medicines. 124 125 Standard 4: Reducing waste 126 Consider activities and actions that contribute to waste and work to address them. 127 128 Standard 5: Medication review documentation 129 Complete documentation and update the patient record. 130 131 132

Figure 1. Medication review standards 133 134

135 136

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2.0 STANDARD 1. INVOLVING PATIENTS AND CARERS 137 138 STANDARD 1. INVOLVING PATIENTS AND CARERS 139 Reach agreement with the patient (or carer, or both) on the aims and goals of 140 treatment. 141 142 2.1 Activities and checklist 143 144

Standard 1: Involving patients and carers Reach agreement with the patient (or carer, or both) on the aims and goals of treatment Activities Checklist Shared decision making with patients and carers. Healthcare professionals and patients/carers share knowledge, experience, understanding, options and desired expected outcomes of the review. Consider:

• A Three-Talk Model of shared decision making5 • Making Choices Together6

Patient/carer face-to-face review recorded

Establish patient/carer views and understanding • What shall we focus on? What is most important to you

(the patient) to talk about today? • What do you (the patient) want to achieve? What do you

already know or do to manage the problem? • What do you (the patient) think is the benefit of taking the

medication? • What does the prescriber want to achieve (opinions and

expectations)?

Patient/carer views and expectations recorded

Establish patient /carer concerns, questions, problems about treatment and condition Following an effective shared decision making discussion, the patient should have had the following questions about their treatment answered:

• What are the potential benefits? • What are the potential harms? • What will happen if nothing is done? • Are there any alternative options to consider?

Consider: • Have I (the healthcare professional) clarified and

acknowledged concerns? • Have I (the healthcare professional) addressed concerns

where possible? • Have I (the healthcare professional) managed the patient’s

or carer’s expectations?

Concerns/problems recorded

Assess adherence Consider the COM-B model7 and the World Health Organization: Adherence to Long-Term Therapies8 Take into account:

• Socioeconomic factors – level of education, access to transport, employment issues etc.

• Healthcare factors – accessibility of services, information sharing, continuity of care etc.

• System -related factors – mechanisms for obtaining prescriptions and medication, accessibility of services, support with taking medication, methods of communication etc.

• The condition – impact of condition on daily functioning and motivation to adhere etc.

• The treatment - ease of taking, possible side effects, interactions, timing of benefit etc.

Patient-related factors – such as age, gender, ethnicity, level of literacy, mobility, religion.

Adherence assessed

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Standard 1: Involving patients and carers Reach agreement with the patient (or carer, or both) on the aims and goals of treatment Consider the social model of health (ecobiopsychosocial) Dahlgren and Whitehead model & factors9:

• Proactive care: non-medical factors affecting wellbeing such as transport, food, pollution, poverty, education, living conditions, housing, road safety, employment, exercise spaces.

• Consider social determinants of health. • Prevention • Behavioral risk factors: smoking, alcohol, diet, physical

activity.

Lifestyle prescription/support considered

Signpost or give information that the patient can understand, preferably co-created by patients and clinicians.

Information given

Link indication to diagnosis / problem Medication linked to diagnosis / problem on clinical system

Consider healthcare professional and patient pre-review preparation, appropriate to the patient’s needs

• AWMSG Example Patient Information Leaflet on Medicines Review

• What to ask your doctor

Leaflet given to patient before review

145 2.2 Aims 146 The patient (and carer) is central to the medication review. Use shared decision 147 making to take into account their views and understanding of their medicines, their 148 concerns, questions or problems, including any issues that may affect their 149 adherence to taking their medication, in the context of a social model of health. 150 151 2.3 Evidence base 152 Patient involvement is central to developing agreement with the healthcare 153 professional about their medication care plan. Involving patients requires information 154 that is tailored to the patient’s understanding. According to a Public Health England 155 report, ‘Improving health literacy to reduce health inequalities’, 42% of working-age 156 adults are unable to understand and make use of everyday health information, rising 157 to 61% when numeracy skills are also needed for comprehension10. 158 159 Involving patients in their care is not only important during the medication review, but 160 research has shown that patients with greater knowledge, skills and confidence in 161 managing their long-term conditions had 18% fewer general practice appointments 162 and 38% fewer emergency admissions that patients who were least able to manage 163 their condition11. 164 165 2.4 Shared decision making 166 NICE guideline NG5 states that medicines reconciliation, medication review, 167 supporting adherence and self-management plans should all be carried out using 168 shared decision making4. The key messages are that shared decision making is 169 about more than tools: skills trump tools, but attitudes trump skills. Successful 170 implementation relies on a combination of interventions supporting the organisation, 171 clinicians, and patients; organisational support and local ownership are vital for 172 engagement12. 173 174 Evidence-based shared decision making is advocated by Making Choices Together6. 175 This is an NHS Improvement Cymru programme designed to encourage open 176 conversation between patients and their clinicians and advocates that patients ask 177 three questions when considering tests or treatments: 178

• “What are my options?” 179 • “What are the pros and cons of each option for me?” 180

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• “How do I get support to help me make a decision that is right for me?” 181 Similarly, clinicians are encouraged to use the following to guide their opening 182 questions to their patients: 183

• “What matters to you?” 184 • “How can we decide together how to improve things?” 185

186 To complement shared decision making, the Me and My Medicines campaign has 187 developed The Medicines Communication Charter which aims to help people raise 188 concerns and use their medicines better with the aim of helping everyone benefit 189 from more effective and safer care13. 190 191 2.5 Adherence 192 Once a medication plan has been agreed the patient’s adherence should be 193 assessed. According to the NICE guideline on Medicines adherence14: 194

• “Patients do not always take their medicines exactly as prescribed, and 195 healthcare professionals are often unaware of how patients take their 196 medicines. 197

• The purpose of assessing adherence is not to monitor patients but rather to 198 find out whether patients need more information and support. 199

• Recognise that non-adherence is common and that most patients are non-200 adherent sometimes. 201

• Routinely assess adherence in a non-judgmental way whenever you 202 prescribe, dispense and review medicines. 203

• Consider assessing non-adherence by asking the patient if they have missed 204 any doses of medicine recently. Make it easier for them to report non-205 adherence.” 206

207 A 2003 World Health Organization (WHO) report, Adherence to long term therapies, 208 highlighted that studies have shown that patients are more likely to be motivated to 209 take their medicines correctly as prescribed when they: 210

• understand and accept the diagnosis; 211 • agree with the treatment proposed; and 212 • have been able to address and discuss seriously their concerns about the 213

specific medicines8. 214 215 It has been shown that people usually adhere better to prescribed treatment if they 216 have a good relationship with their prescribing doctor. When people participate in 217 their healthcare planning, they also assume responsibility for it and are therefore 218 more likely to stay with the plan. Getting clear explanations in a language they 219 understand and understanding the rationale for the treatment also help to increase 220 adherence8. 221

222 The WHO report concludes that: 223

• patients need to be supported, not blamed 224 • adherence is simultaneously influenced by several factors 225 • patient-tailored interventions are required 226 • adherence is a dynamic process that needs to be followed up 227 • health professionals need to be trained in adherence 228 • family, community and patient organisations are key factors for success in 229

improving adherence. 230 231 A multidisciplinary approach to adherence is needed involving all healthcare 232 professionals. 233 234

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2.6 Social prescribing 235 There are calls for rethinking the roles of doctors and, rather than prescribing 236 medication, considering other determinants of ill health. Social circumstances are an 237 important factor in patient healthcare15. It has been estimated that social 238 circumstances account for 24% of the determinants of health16. Re-defining the role 239 of the doctor, recognising the limitations of the traditional medical model as well as its 240 benefits, enabling the assets for health and wellbeing which lie outside health 241 services and encouraging a more central role for people in making decisions about 242 their health and care have been advocated17. 243 244 The Royal College of General Practitioners is partnering with the Royal Australian 245 College of GPs to provide UK GPs with access to the Handbook of Non-Drug 246 interventions (HANDI), an online formulary of non-drug interventions for use in 247 primary care, which have solid evidence of their effectiveness18. 248 249 2.7 Patient decision aids 250 Giving information to patients to ensure that the person understands the seriousness 251 of his or her condition, the anticipated benefits and risks to the specific individual of 252 the proposed treatment, and any reasonable alternatives, has been highlighted by 253 the decision of the Montgomery v Lanarkshire Health Board judgment19. The 254 judgment concluded that “the doctor is therefore under a duty to take reasonable 255 care to ensure that the patient is aware of any material risks involved in any 256 recommended treatment,” and that information provided has to be comprehensible. 257 “The doctor’s duty is not therefore fulfilled by bombarding the patient with technical 258 information”. 259 260 A risk is a “material” one in this context if, in the circumstances of the particular case: 261 a reasonable person in that person’s position would be likely to attach significance to 262 the risk, or, the doctor is, or should be, reasonably aware that the particular person in 263 front of him or her would be likely to attach significance to it20. 264 265 To comply with the duty to provide information, healthcare professionals are required 266 to enter into dialogue with the person, aiming to ensure that the person understands 267 the seriousness of his or her condition, the anticipated benefits and risks to the 268 specific individual of the proposed treatment, and any reasonable alternatives. This 269 will help to put the person in a position to make an informed decision, but only if the 270 information provided is comprehensible. 271 272 Patient decision aids can support healthcare professionals to adopt a shared 273 decision-making approach, to ensure that patients and their carers are able to make 274 well-informed choices that are consistent with the person’s values and preferences4. 275 Patient decision aids inform people about the available options, from an evidence-276 based perspective; encourage active engagement with the decision making process 277 and help people think about what is important to them so that they can make choices 278 that reflect their values and preferences21. Compared to usual care across a wide 279 variety of decision contexts, people exposed to decision aids feel more 280 knowledgeable, better informed, and clearer about their values, and they probably 281 have a more active role in decision making and more accurate risk perceptions22. 282 283 When considering using a patient decision aid, the NICE guideline on Medicines 284 optimisation4 advises: 285

• Determine what level of involvement in decision making the person would like 286 and avoid making assumptions about this. 287

• Offer the patient, family or carers the opportunity to use a patient decision aid. 288

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• Ensure the decision aid is appropriate in the context of the consultation as a 289 whole. 290

• Do not use a patient aid to replace discussions with a person. 291 • Ensure that patient decision aids used have followed a robust and transparent 292

development process, in line with International Patient Decision Aids 293 Standards criteria. 294

• Ensure that the necessary knowledge, skills and expertise have been 295 obtained before using a patient decision aid. 296

297 A number of patient decision aids are available on the NICE website. 298 299 2.8 Comments from T&F group 300 The T&F group considered how to engage the patient in the medication review. They 301 felt the patient must want to help themselves and work in partnership with the 302 prescriber. To do this the patient’s expectations need to be addressed: they need to 303 be aware of why the review is being done and its benefits to them. 304 305 The medication review should be a positive experience for the patient, focusing on 306 the benefits of the review. The T&F group felt it important that the expectations of 307 each party should be made clear at the outset of a review. 308 309 The T&F group questioned whether prescribers understood a patient’s lifestyle and 310 expectations when prescribing medication, and felt that the review should not just 311 look at medicines but consider other services such as social and housing services. 312 The T&F group noted a lack of evidence-based guidance when dealing with 313 multimorbidity, and thought that multimorbidity guidelines, including information 314 leaflets for patients, would be helpful. 315 316 317 3.0 STANDARD 2. SAFETY 318 319 STANDARD 2. SAFETY 320 Minimise medication-related problems by considering real or potential medicine-321 related harms and actions taken to reduce them. 322 323 3.1 Activities and checklist 324 325

Standard 2. Safety Minimise medication-related problems by considering real or potential medicine related harm(s) and action taken to address or reduce them. Activities Checklist List all medicines and their indications This includes all prescribed, purchased and over-the-counter medicines, herbal remedies and any other non-prescribed medicines.

Record all medicines including prescribed and non-prescribed

Establish patient or carer views and understanding Using open questions, find out how the patient takes their medicines.

Record any issues identified

Reducing potential risk • Consider potential risk reduction • Consider inappropriate medication, incorrect dosage,

incorrect storage, method of administration, non-adherence.

• Check relevant NPIs have been addressed, including the Prescribing Safety Indicators (PSIs) and Quality Assurance and Improvement Framework (QAIF).

Risk reduction implemented

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Standard 2. Safety Minimise medication-related problems by considering real or potential medicine related harm(s) and action taken to address or reduce them.

• Consider STOPP (Screening Tool of Older Persons Prescriptions) / START (Screening Tool to Alert doctors to Right i.e. appropriate, indicated Treatment).

Monitoring Monitoring should be appropriate and timely, ensuring results are reviewed. Check relevant monitoring including:

• disease control • blood biochemistry • therapeutic drug monitoring.

Monitoring addressed

Adverse drug reactions (ADRs) considered, including those related to drug-drug or drug-food interactions

• Complete a Yellow Card if appropriate, via practice computer system or MHRA website.

Identification of ADRs Identification of interactions Yellow card completed and submitted

Consider shared care protocols Consider relevant shared-care protocols, primary-secondary care ownership, and how they are kept up-to-date.

Monitoring and specialist reviews undertaken as per shared care protocol

326 3.2 Aims 327 To minimise medicine-related harms. 328 329 3.3 Evidence base 330 In 2018, the Policy Research Unit in Economic Evaluation of Health and Care 331 Interventions estimated that in England there were 237 million medication errors per 332 year, of which 66 million were potentially significant errors with 71% occurring in 333 primary care23. The WHO Global Patient Safety Challenge, launched in 2017, aims 334 to reduce the level of severe avoidable harm related to medications by 50% over 5 335 years globally24, it is anticipated that implementation of medication review standards 336 will help contribute to this reduction. 337 338 An observational prospective cohort study of 1,280 older adults followed up for 8 339 weeks post-discharge from hospital, demonstrated that 37% of patients experienced 340 medication-related harm25. The study noted that ppatients are particularly vulnerable 341 to problems with their medication in the period following hospital discharge due to 342 medication changes and poor information transfer between hospital and primary 343 care. Undertaking medication reviews, particularly post-discharge will likely reduce 344 the number and severity of medication-related harms. Extrapolating the results, the 345 study’s authors estimated that post-discharge medicines-related harm in older adults 346 costs the NHS £396 million annually, of which, £243 million is potentially 347 preventable25. 348 349 The current AWMSG National Prescribing Indicators (NPI) include safety indicators 378 based on the PINCER study26. This study highlights potential medication safety 379 issues and using general practice software Audit+ allows GPs to review patients’ 380 medication and decide on whether a treatment should be discontinued. Because this 381 is an AWMSG NPI, an additional step to examine medicines included in the AWMSG 382 NPI has been included in the safety review process for patients in Wales. 383 384 3.4 Potential risk reduction 385 Anticholinergic medicine use in older people has been associated with: constipation, 386 urinary retention, dry mouth or eyes, sedation, confusion, delirium, photophobia, an 387 increased risk of cognitive impairment, dementia and falls, with research also 388 suggesting a link to increase mortality with the number and potency of anticholinergic 389 agents prescribed. To reduce the risk from anticholinergic medications one of the 390

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AWMSG National Prescribing Safety Indicators looks at patients aged 75 years and 391 older with an Anticholinergic Effect on Cognition (AEC) score of 3 or more for items 392 on active repeat, as a percentage of all patients aged 75 and older. The indicator 393 aims to encourage a review of patients with an AEC score of 3 or more, to reduce 394 anticholinergic use where appropriate. GPs can use Audit + to identify their patients 395 who have a high anticholinergic score and then review their medication. 396 397 In the future, genome sequencing will be available27 and may enable prescribers to 398 tailor their choice of medication to take account of any polymorphisms and prevent 399 potential adverse drug reactions28. 400 401 3.5 Reporting adverse drug reactions and medicines-related safety incidents 402 Healthcare professionals are encouraged to identify and report adverse drug 403 reactions and medicine-related safety incidents. Wales is currently the highest 404 adverse drug reaction-reporting region in the UK, using the MHRA Yellow Card 405 reporting scheme. 406 407 The NICE guideline on Medicines optimisation outlines the importance of identifying, 408 reporting and learning from medicines-related safety incidents (MRSI)4 It advises that 409 “Organisations should support a person-centred, 'fair blame' culture that encourages 410 reporting and learning from medicines-related patient safety incidents”4. 411 412 3.6 Comments from T&F group 413 Helping the patient to understand the concept of risk was considered important. 414 Patients should be aware that all medicines can cause harm and therefore the aim is 415 to optimise the benefit/harm ratio; and that each patient is unique and what works for 416 one patient may not work for another. The review should also include a discussion 417 with the patient about the risks of taking or not taking a medicine. 418 419 Information technology (IT) and education were seen as important to help primary 420 care and secondary care prescribers. It was felt that clinical support systems were 421 currently only available in primary care and e-prescribing in secondary care was 422 needed. They also thought that an app to support medication review would be useful, 423 especially in secondary care, but could help both secondary and primary care. 424 Education on interactions, and on assessing risk by numbers-needed-to-harm 425 through national workshops would be helpful, and there should be easy access to 426 information. 427 428 429

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4.0 STANDARD 3. REVIEW OF MEDICINES 430 431 STANDARD 3. REVIEW OF MEDICINES 432 Maximise the benefit of medicines by considering the aim and intended outcomes, 433 whether the dose is optimised and how the patient takes their medicines. 434 435 4.1 Activities and checklist 436 437

Standard 3. Review of medication Maximise the benefit of medicines by considering the aim and intended outcomes, whether the dose is optimised and how the patient takes their medicines. Activities Checklist List all medication, including prescribed (consider all sources i.e. secondary care, tertiary care) and non-prescribed (including purchased medication, ‘over the counter’, herbal remedies and any other non-prescribed medicines) and indication.

Record all medications including prescribed and non-prescribed

Consider the aims Review aims and intended outcomes of treatment for each medicine and confirm they are still relevant and in line with the patient’s views and goals. Consider:

• National Institute for Health and Care Excellence guidelines

• All Wales Medicines Strategy Group Polypharmacy: Guidance for Prescribing

• European Medicines Agency herbal monographs

Aims of each medicine considered

Consider need Review the need of all medicines. Are all medicines essential29? Are there any that could be managed at a lower dose? Consider:

• National Institute for Health and Care Excellence guidelines

• All Wales Medicines Strategy Group Polypharmacy: Guidance for Prescribing

• STOPP (Screening Tool of Older Persons Prescriptions) / START (Screening Tool to Alert doctors to Right i.e. appropriate, indicated Treatment) guidelines

• All Wales Medicines Strategy Group National Prescribing Indicators

• NHS Wales Quality Assurance and Improvement Framework

• NHS Scotland Polypharmacy Guidance - Medicines Review

Need of all medicines considered

Consider evidence and effectiveness Are therapeutic objectives being met in line with current guidelines to achieve effective therapy? Are there more effective alternatives? Could the dose be adjusted? Are the therapeutic objectives in line with the patient’s views and goals? Consider:

• National Institute for Health and Care Excellence guidelines

• All Wales Medicines Strategy Group Polypharmacy: Guidance for Prescribing

• STOPP (Screening Tool of Older Persons Prescriptions) / START (Screening Tool to Alert doctors to Right i.e. appropriate, indicated Treatment) guidelines

Effectiveness of all medicines maximised

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Standard 3. Review of medication Maximise the benefit of medicines by considering the aim and intended outcomes, whether the dose is optimised and how the patient takes their medicines.

• All Wales Medicines Strategy Group National Prescribing Indicators

• NHS Wales Quality Assurance and Improvement Framework

• All Wales Medicines Strategy Group Low Priority for Funding in NHS Wales guidelines

• NHS Scotland Polypharmacy Guidance - Medicines Review

Identify unnecessary medication • All Wales Medicines Strategy Group Polypharmacy:

Guidance for Prescribing • STOPP (Screening Tool of Older Persons Prescriptions) /

START (Screening Tool to Alert doctors to Right i.e. appropriate, indicated Treatment) guidelines

• All Wales Medicines Strategy Group Polypharmacy: Supplementary Guidance – BNF Sections to Target

• All Wales Medicines Strategy Group Low Priority for Funding in NHS Wales guidelines

• Deprescribing guidelines • NHS Scotland Polypharmacy Guidance - Medicines

Review

Unnecessary medicines stopped

438 4.2 Aims 439 To ensure that the therapeutic objectives are being achieved, by identifying and 440 optimising essential drug therapy and reviewing the need for medication of limited 441 benefit; also identifying the need for adding or intensifying drug therapy 442 443 4.3 Evidence base 444 A medication review must include all medicines that are taken by the patient; this 445 should include any over-the-counter, homeopathic and herbal medicines. 446 447 Many patients are reluctant to inform their healthcare professional that they use 448 herbal medicines, therefore it is important to ask about them because these products 449 have the potential to cause adverse drug reactions, as well as to interact with 450 conventional medicines30. Herbal medicines marketed in the UK must have a 451 traditional herbal registration (THR) granted by the MHRA31. For other herbal 452 medicines that have been prescribed by a herbalist, information can be found in the 453 EMA’s herbal monographs32. 454 455 4.4 Guidelines 456 Prescribers must have access to the latest guidelines. NICE Bites is a monthly 457 bulletin which summarises key prescribing points from NICE guidance. The bulletins 458 are prepared by the North West Medicines Information Centre33. However, 459 prescribers need to use their clinical judgment in all cases. One study showed that 460 53% of 839 clinical studies explicitly excluded older people and concluded that 461 despite the high burden of ischaemic heart disease in older people, most drug trials 462 do not enroll participants that reflect the age-related prevalence of the 463 disease34. AWMSG’s Polypharmacy Guidance For Prescribing contains a section on 464 medicines effectiveness35 and AWMSG’s Polypharmacy: Supplementary Guidance – 465 BNF Sections to Target, provides advice on individual medicines36. 466 467 468 469 470

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4.5 Need – are all medications essential? 471 Several prescribing tools are available to help the healthcare professional decide if a 472 medicine is essential, and when to stop or start a medicine. Examples of some of the 473 tools used are shown below: 474 475

• Beers’ criteria 476 In 1991, Beers and colleagues published the first set of explicit criteria for 477 determining potentially inappropriate medicine use in nursing home residents37. 478

479 • Improved prescribing in the elderly tool (IPET) 480 Referred to as the “Canadian Criteria”, the IPET is a list of the 14 most prevalent 481 prescription errors identified from a long list of inappropriate prescription 482 instances drawn up by an expert Canadian Consensus Panel in 199738. 483

484 • Screening Tool of Older Persons Prescriptions (STOPP) / Screening 485

Tool to Alert doctors to Right i.e. appropriate, indicated Treatments 486 (START) 487

The STOPP/START tool was developed by a multidisciplinary team of 488 geriatricians, pharmacists, pharmacologists, and primary care physicians39,40. The 489 STOPP incorporates commonly encountered instances of potentially 490 inappropriate medicines (PIM) in older adults that include drug–drug and drug–491 disease interactions, drugs that adversely affect older patients at risk of falls, and 492 duplicate drug class prescriptions. 493

494 • Medication appropriateness index (MAI) 495 Developed by Dr Joseph Hanlon and colleagues41, the MAI is a validated 496 measure of prescribing appropriateness that assesses a number of elements of 497 prescribing: indication, effectiveness, dose, correct directions, practical drug 498 interactions, drug–disease interactions, duplication, duration, and costs. 499

500 Many of these medication review tools criteria are similar. One study concluded that 501 “Because of the minimal overlap between 2012 Beers and STOPP criteria, a 502 modified PIM tool that integrates 2012 Beers and STOPP criteria and considers 503 cancer diagnosis, prognosis, and cancer-related therapy is needed to identify and 504 minimize PIM use”42. 505 506 NHS Scotland has developed an online support tool for medication reviews, ‘The 7 507 Steps’, as part of their Polypharmacy Guidance29. This provides online access to 508 drug group information which can be used during the consultation and is also 509 available as a mobile software application. Unlike other available tools shown below, 510 this also includes consideration of cost effectiveness. 511 512 4.6 Other tools for polypharmacy 513 514 4.6.1 Quality indicators 515

• ACOVE‐3 contains a set of quality indicators to comprehensively measure the 516 care provided to vulnerable older people at the level of the health system, 517 health plan, or medical group43. 518

• BEGIN algorithm44 519 • Hedis Dae Criteria42 520 • The Canadian criteria38 521 • Zhan Criteria45 522 • Assessing Care of Vulnerable Elders-346 523

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4.6.2 Deprescribing 524 Multiple studies of polypharmacy or deprescribing have shown that interventions by 525 pharmacists, doctors, or multidisciplinary teams can reduce the number of 526 medications that patients take and reduce the prevalence of potentially inappropriate 527 prescribing47. The D-PRESCRIBE study used a patient brochure coupled with 528 pharmacists making evidence-based recommendations to physicians and resulted in 529 deprescribing among 43% of chronic sedative-hypnotic users, 58% of non-steroidal 530 anti-inflammatory drug users and 31% of glyburide users48. However other studies 531 demonstrate small reductions in prescribing; in one meta-analysis patients were 532 taking an average of 7.4 drugs at baseline; during follow-up this fell by 0.2 drugs in 533 intervention groups and increased by 0.2 drugs in control groups. 534 535 To help prescribers to deprescribe, the Bruyere Research Institute in Canada has 536 developed a number of deprescribing guidelines and algorithms and videos to aid 537 deprescribing49. 538 539 4.7 Comments from T&F group 540 Involving the patient so that they understand the purpose and process of the review, 541 and managing their expectations was considered important. Patients need to value 542 the medication review and understand 'what's in it for them'. There should be shared 543 agreement between the patient and prescriber providing maximum benefit and 544 limited harms, based on evidence and patient perspectives. 545 546 It was noted that although there were a lot of resources available, prescribers 547 needed a simple pathway through the 'systems’ so that the resources were easily 548 available and up-to-date. Ideally there would be one resource in one place with 549 multiple tools, for example, to assess risk/benefit, cost effectiveness of individual 550 treatments and de-prescribing guidelines for high-risk medicines. 551 552 Using technology to prepare a 'pre-review’ for example, being able to run a report to 553 identify high-risk medicine combinations, adverse drug reactions, medicines that 554 have not been issued / dispensed , or those with a high risk of falls, would help. 555 556 It was noted that genetic testing would alter the whole approach to prescribing and 557 medication reviews, and that better primary and secondary care interaction would 558 also help. 559 560 5.0 STANDARD 4. REDUCING WASTE 561 562 STANDARD 4. REDUCING WASTE 563 Consider activities and actions that contribute to waste and work to address them. 564 565 5.1 Activities and checklist 566 567

Standard 4: Reducing waste Consider activities and actions that contribute to waste and work to address them. Activities Checklist Consider cost and value • Ensure that allocated resources are used optimally. • Consider the most cost effective medicines in line with local and

national prescribing schemes /guidelines. • Consider NICE guidelines and provide medicines with a low

acquisition cost if recommended by NICE. • Consider whether unnecessary appointments or monitoring are

undertaken.

Cost and value considered

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Standard 4: Reducing waste Consider activities and actions that contribute to waste and work to address them. • Consider anything that does not add value to the outcome for the

patient. • Consider over-diagnosis which may result in anxiety for the

patient, over-treatment and side effects of unnecessary care. Consider patient factors • How does the patient order their prescription? Does the patient

have any difficulties ordering their prescription? • Where patients have indicated that they have not been fully

adherent with their medication, consider whether stockpiles have built up.

• Are prescriptions ordered appropriately for housebound patients or care home residents to ensure there is no over-ordering or stockpiling?

Patient factors considered

Consider prescribing factors • Prescribe appropriate quantities taking into account daily dose

and length of prescription, for example, 28 days. Particular consideration should be given to inhalers.

• Synchronise quantities of all medicines to ensure they can all be ordered at the same time.

• Try to address stockpiling i.e. separate regular medication from ‘when required’ medication on repeat prescriptions.

Prescribing factors considered

Consider environmental factors Consider the environmental risk and carbon footprint of the medication:

• NICE Patients decision aid – Inhalers for asthma including information on carbon footprint and recycling

• Draft Guideline on the environmental risk assessment of medicines products for human use

• Consider the environmental cost of wasted resources

Environmental factors considered

568 5.2 Aims 569 To avoid and reduce waste associated with prescribing medication. 570 571 5.3 Evidence base 572 Medication waste can occur in all stages of the process from prescribing medication, 573 to dispensing medication and finally to medication being taken by the patient. There 574 is increasing awareness of the financial and environmental impact of medicines 575 waste, and although an element of waste is unavoidable, steps can be taken to 576 minimise avoidable waste. In addition to medicine waste, consideration should also 577 be given to wasted appointments, tests, and time for patients and healthcare staff as 578 these also have an impact on the healthcare economy. 579 580 In 2009, York Health Economics Consortium and School of Pharmacy, University of 581 London evaluated the scale, causes and cost of wasted medicines and estimated 582 that the gross annual cost of NHS primary and community care prescription 583 medicines wastage in England was around £300 million per year50. In Wales, the 584 Welsh government has estimated that around £10 million in possible savings is 585 available by reducing wasted medicines51. 586 587 Medicines waste not only results in material loss, but potential therapeutic loss where 588 dispensed medicines are only partially consumed or are consumed in ways which 589 limit or negate their therapeutic effect, or are left completely unconsumed52. On 590 average, 50% of medication for chronic diseases are not taken as prescribed8. By 591 reviewing medications regularly to ensure clinical requirements are unchanged, 592 pharmaceutical waste is significantly reduced52. 593 594

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The greatest social and economic returns are to be gained when reducing medicines 595 waste can be effectively linked to improving care quality and health outcomes50. 596 597 5.4 Comments from T&F group 598 It was felt that patients may not take their medication because they do not know what 599 their medicines are for, or are not aware of the risks of not taking them. Therefore it 600 is important to outline to the patient what each medicine is for and the risks of not 601 taking it. Adding the indication for the drug on each prescription may help. It was 602 suggested that separating repeat medication from ‘when required’ medication on the 603 repeat prescription form may help the patient to identify which medication should or 604 shouldn’t be ordered every month. 605 606 System factors are important and understanding the processes in general practice, 607 because the 'system', not the 'person', generates the waste. 608 609 610 6.0 STANDARD 5. MEDICATION REVIEW DOCUMENTATION 611 612 STANDARD 5. MEDICATION REVIEW DOCUMENTATION 613 Complete documentation and update the patient record. 614 615 6.1 Activities and checklist 616 617

Standard 5. Medication review documentation Complete documentation and update the patient record. Activities Checklist Record the date and who is undertaking the medication review.

Recorded

Record the reason for taking each medicine. Recorded Record any changes made, with a reason. Record patient / carer agrees with

changes made Record advice and supporting information given to the patient or carer (for example, leaflets, enrollment in a Pregnancy Prevention Programme).

Record patient / carer agrees with advice given

Record the date when the next review is due. Recorded 618 6.2 Aims 619 The patient and healthcare professional undertaking the review should be clear 620 about the medicines that are being taken, the reason for each medicine being 621 prescribed, and when they should be reviewed. To do this, all patents should have a 622 written summary of their medication. 623 624 6.3 Evidence base 625 The medication review process requires clear and transparent documentation in 626 patient records. Incomplete or incorrect medication documentation may contribute to 627 inappropriate clinical decision-making and adverse events53. The General Medical 628 Council guidance Good practice in prescribing and managing medicines and devices 629 (2013) states that clinical records should include relevant clinical findings; decisions 630 made and actions agreed; details of the person making the decisions and agreeing 631 the actions; the information given to patients; any drugs prescribed or other 632 investigation or treatment; and who is making the record and when. Records should 633 be clear and accurate and should be made at the same time as the events being 634 recorded, or as soon as possible afterwards2. 635 636

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Ensuring that the patient record is updated with details of the medication review is 637 vital for subsequent medication reviews and dealing with patient or healthcare 638 professional queries after the medication review. 639 640 6.4 Resources 641 Various patient passports are available. The National Institute of Health Research 642 (NIHR) Applied Research Collaboration Northwest London has produced a 643 medication passport available as a booklet and an app54. 644 645 6.5 Comments from T&F group 646 The group felt that they can know what a patient is prescribed but they don’t know 647 what is dispensed or taken. Documentation is important for the patient to know what 648 their medicines are for, and the risks of not taking them. Documenting the indication 649 for each medicine and the date of review as part of a shared agreement between 650 patient and prescriber was thought important. A template for medication review, 651 incorporating the standards, for use in the GP practice clinical system was felt to be 652 useful and would help to implement the standards. 653 654

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REFERENCES 655 656 1. All Wales Medicines Strategy Group. AWMSG Five-year strategy 2018-2023. 657

Supporting prudent prescribing to obtain the best outcomes from medicines 658 for patients in Wales. 2018. Available 659 at: http://www.awmsg.org/docs/awmsg/awmsgdocs/AWMSG%20Five%20Ye660 ar%20Strategy%202018-2023.pdf. Accessed Sep 2018. 661

2. General Medical Council. Good practice in prescribing and managing 662 medicines and devices. 2013. Available at: https://www.gmc-uk.org/-663 /media/documents/prescribing-guidance_pdf-664 59055247.pdf?la=en&hash=958C4EED51E3D145EA8798A1AFD85887D3A5665 77B2. Accessed 02/2020. 666

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12. Joseph-Williams N, Lloyd A, Edwards A et al. Implementing shared decision 708 making in the NHS: lessons from the MAGIC programme. BMJ. 709

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19. The Supreme Court. Judgement. Montgomery (Appelant) v Lanarkshire 734 Health Board (Respondent) (Scotland). 2015. Available 735 at: https://www.supremecourt.uk/cases/docs/uksc-2013-0136-judgment.pdf. 736 Accessed Feb 2020. 737

20. Welsh Government. Guide to consent for examination or treatment. Jul 2017. 738 Available 739 at: http://www.wales.nhs.uk/sitesplus/documents/1064/Welsh%20Governmen740 t%20Guide%20to%20Consent%20for%20Examination%20or%20Treatment741 %20%28July%202017%29.pdf. Accessed Feb 2020. 742

21. An introduction to patient decision aids. BMJ : British Medical Journal. 743 2013;347:f4147. Available 744 at: https://www.bmj.com/content/bmj/347/bmj.f4147.full.pdf. 745

22. Stacey D, Légaré F, Lewis K et al. Decision aids for people facing health 746 treatment or screening decisions. Cochrane Database of Systematic 747 Reviews. 2017(4). Available 748 at: https://doi.org//10.1002/14651858.CD001431.pub5. 749

23. Policy Research Unit in Economic Evaluation of Health & Care Interventions 750 (EEPRU). Prevalence and economic burden of medication errors in the NHS 751 in England. Feb 2018. Available at: http://www.eepru.org.uk/wp-752 content/uploads/2020/03/medication-error-report-edited-27032020.pdf. 753 Accessed Feb 2020. 754

24. World Health Organization. Medication without harm. WHO global patient 755 safety challenge. . 2017. Available 756 at: https://apps.who.int/iris/bitstream/handle/10665/255263/WHO-HIS-SDS-757 2017.6-758 eng.pdf;jsessionid=5960AB899ED1A6C517B9239EACBBB25B?sequence=1. 759 Accessed Feb 2020. 760

25. Parekh N, Ali K, Stevenson JM et al. Incidence and cost of medication harm 761 in older adults following hospital discharge: a multicentre prospective study in 762 the UK. British Journal of Clinical Pharmacology 2018;84(8):1789-1797. 763 Available 764

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at: https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1111/bcp.13613. 765 Accessed September 2018. 766

26. Avery AJ, Rodgers S, Cantrill JA et al. A pharmacist-led information 767 technology intervention for medication errors (PINCER): a multicentre, cluster 768 randomised, controlled trial and cost-effectiveness analysis. The Lancet. 769 2012;379:1310-1319. Available 770 at: https://www.thelancet.com/pdfs/journals/lancet/PIIS0140673611618175.pd771 f. Accessed September 2018. 772

27. Government W. Genomics for Precision Medicines Strategy. 2017. Available 773 at: https://gov.wales/sites/default/files/publications/2019-04/genomics-for-774 precision-medicine-strategy.pdf. Accessed 05/2020. 775

28. Alfirevic A, and Pirmohamed M. Genomics of adverse drug reactions. Trends 776 in Pharmacological Sciences. 2017;38(1):100-109. Available 777 at: https://www.sciencedirect.com/science/article/abs/pii/S016561471630161778 4. Accessed Feb 2020. 779

29. NHS Scotland. Polypharmacy guidance: medicines review. The 7-steps 780 medication review. Available 781 at: http://www.polypharmacy.scot.nhs.uk/polypharmacy-guidance-medicines-782 review/for-healthcare-professionals/principles/the-7-steps-medication-review/. 783 Accessed Feb 2020. 784

30. Agency MaHpR. Herbal products: safety update. 2014. Available 785 at: https://www.gov.uk/drug-safety-update/herbal-products-safety-update. 786 Accessed 02/2020. 787

31. Agency MaHpR. 2019. Herbal medicines granted a traditional herbal 788 registration (THR). 2019. Available 789 at: https://www.gov.uk/government/publications/herbal-medicines-granted-a-790 traditional-herbal-registration-thr. Accessed 05/2020. 791

32. European Medicines Agency. EU herbal monographs,. Available 792 at: https://www.ema.europa.eu/en/medicines/field_ema_web_categories%25793 3Aname_field/Herbal/field_ema_herb_outcome/european-union-herbal-794 monograph-254. Accessed Feb 2020. 795

33. North West Medicines Information Centre. NICE Bites. A summary of 796 prescribing information from NICE guidance. Available 797 at: http://www.elmmb.nhs.uk/elmmb-information/nice-bites-798 bulletins/?assetdetc02b482b-69a7-4802-8648-32dca0f9155c=20626. 799 Accessed Feb 2020. 800

34. Bourgeois FT, Orenstein L, Ballakur S et al. Exclusion of Elderly People from 801 Randomized Clinical Trials of Drugs for Ischemic Heart Disease. Journal of 802 the American Geriatrics Society. 2017;65(11):2354-2361. Available 803 at: https://onlinelibrary.wiley.com/doi/abs/10.1111/jgs.14833. 804

35. All Wales Medicines Strategy Group. Polypharmacy: Guidance for 805 Prescribing. 2014. Available 806 at: http://awmsg.org/docs/awmsg/medman/Polypharmacy%20-807 %20Guidance%20for%20Prescribing.pdf. Accessed September 2018. 808

36. All Wales Medicines Strategy Group. Polypharmacy: Guidance for 809 Prescribing. Supplementary guidance - BNF sections to target. 2014. 810

37. American Geriatrics Society 2015 Beers Criteria Update Expert Panel. 811 American Geriatrics Society 2015 Updated Beers Criteria for Potentially 812 Inappropriate Medication Use in Older Adults. Journal of the American 813 Geriatrics Society. 2015;63(11):2227-2246. Available 814 at: https://www.ncbi.nlm.nih.gov/pubmed/26446832. Accessed Feb 2020. 815

38. Page II R, Linnebur SA, Bryant LL et al. Inappropriate prescribing in the 816 hospitalized elderly patient: defining the problem, evaluation tools, and 817 possible solutions. Clinical Interventions in Aging. 2010;2010(5):75-87. 818

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Available at: https://www.dovepress.com/articles.php?article_id=4131. 819 Accessed Feb 2020. 820

39. O’Mahony D, Gallagher P, Ryan C et al. STOPP & START criteria: A new 821 approach to detecting potentially inappropriate prescribing in old age. 822 European Geriatric Medicine. 2010;1(1):45-51. Available 823 at: https://www.sciencedirect.com/science/article/pii/S1878764910000112. 824 Accessed September 2018. 825

40. O’Mahony D, O'Sullivan D, Byrne S et al. STOPP/START criteria for 826 potentially inappropriate prescribing in older people: version 2. Age and 827 Ageing. 2015;44(2):213-218. Available 828 at: https://academic.oup.com/ageing/article/44/2/213/2812233. Accessed Feb 829 2020. 830

41. Hanlon JT, Schmader KE, Samsa GP et al. A method for assessing drug 831 therapy appropriateness. Journal of Clinical Epidemiology. 1992;45(10):1045-832 1051. Available 833 at: https://www.sciencedirect.com/science/article/abs/pii/089543569290144C834 ?via%3Dihub. Accessed Feb 2020. 835

42. Nightingale G, Hajjar E, Swartz K et al. Evaluation of a Pharmacist-Led 836 Medication Assessment Used to Identify Prevalence of and Associations With 837 Polypharmacy and Potentially Inappropriate Medication Use Among 838 Ambulatory Senior Adults With Cancer. Journal of Clinical Oncology. 839 2015;33(13):1453-1459. Available 840 at: https://ascopubs.org/doi/10.1200/JCO.2014.58.7550. Accessed Feb 2020. 841

43. Higashi T, Shekelle PG, Adams JL et al. Quality of care is associated with 842 survival in vulnerable older patients. Annals of Internal Medicine. 843 2005;143(4):274-281. Available 844 at: https://www.ncbi.nlm.nih.gov/pubmed/16103471. Accessed Feb 2020. 845

44. Parekh N, Page A, Ali K et al. A practical approach to the pharmacological 846 management of hypertension in older people. Therapeutic Advances in Drug 847 Safety. 2017;8(4):117-132. Available 848 at: http://journals.sagepub.com/doi/full/10.1177/2042098616682721. 849 Accessed Feb 2020. 850

45. Zhan C, Sangl J, Bierman AS et al. Potentially Inappropriate Medication Use 851 in the Community-Dwelling Elderly. Findings from the 1996 Medical 852 Expenditure Panel Survey. JAMA. 2001;286(22):2823-2829. Available 853 at: https://jamanetwork.com/journals/jama/fullarticle/194458. Accessed Feb 854 2020. 855

46. Wenger NS, Roth CP, Shekelle P et al. Introduction to the Assessing Care of 856 Vulnerable Elders‐3 Quality Indicator Measurement Set. Journal of the 857 American Geriatrics Society. 2007;55(s2):S247-S252. Available 858 at: https://onlinelibrary.wiley.com/doi/full/10.1111/j.1532-5415.2007.01328.x. 859 Accessed September 2018. 860

47. Avery AJ, and Bell BG. Rationalising medications through deprescribing. 861 BMJ. 2019;364(ISSUE):1570. Available 862 at: https://www.bmj.com/content/364/bmj.l570.long. Accessed Feb 2020. 863

48. Martin P, Tamblyn R, Benedetti A et al. Effect of a pharmacist-led educational 864 intervention on inappropriate medication prescriptions in older adults: the D-865 PRESCRIBE randomized clinical trial. JAMA. 2018;320(18):1889-1898. 866 Available at: https://www.ncbi.nlm.nih.gov/pubmed/30422193. Accessed Feb 867 2020. 868

49. Bruyère Research Institute Deprescribing Guidelines Research Team. 869 Deprescribing Guidelines and Algorithms. 2018. Available 870 at: https://deprescribing.org/resources/deprescribing-guidelines-algorithms/. 871 Accessed Feb 2020. 872

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50. York Health Economics Consortium, and The School of Pharmacy University 873 of London. Evaluation of the scale, causes and costs of waste medicines. 874 20010. Available 875 at: https://discovery.ucl.ac.uk/id/eprint/1350234/1/Evaluation_of_NHS_Medici876 nes_Waste__web_publication_version.pdf. Accessed Feb 2020. 877

51. Wales AGf. Managing medicines in primary and secondary care. 2016. 878 Available at: https://www.audit.wales/system/files/publications/Medicines-879 management-2016-english.pdf. Accessed 02/2020. 880

52. Bertie Hazell RR. Pharmaceutical waste reduction in the NHS. 2015. 881 Available at: https://www.england.nhs.uk/wp-882 content/uploads/2015/06/pharmaceutical-waste-reduction.pdf. Accessed 883 02/2020. 884

53. Hammer A, Wagner A, Rieger MA et al. Assessing the quality of medication 885 documentation: development and feasibility of the MediDocQ instrument for 886 retrospective chart review in the hospital setting. BMJ Open. 887 2019;9(11):e034609. Available 888 at: https://bmjopen.bmj.com/content/bmjopen/9/11/e034609.full.pdf. 889

54. National Institute for Health Research, and Collaboration for Leadership in 890 Applied Heath Research and Care in Northwest London. My Medication 891 Passport. Available at: http://clahrc-892 northwestlondon.nihr.ac.uk/resources/mmp. Accessed Feb 2020. 893

894

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APPENDIX 1. AUDIT OF ACTIVITIES 895 896

Medication review standards - Audit Patient ID: Patient’s age: 897

General questions: Who did the medication review for example, GP, pharmacist, nurse?

Was it evident from the record whether or not the patient’s carer was present?

How long did the medication review take (if known)? Which Read code(s) were used to record the medication review? How many medicines (acute and repeat) was the patient taking before the review?

898 Standard 1: Reach agreement with the patient (or carer, or both) on the aims and goals of treatment a Is there evidence of shared decision making?

[ ] Yes [ ] No

b Is there evidence that the patient’s views, understanding and expectations were considered?

[ ] Yes [ ] No

c Is there evidence that the patient’s concerns, questions or problems were considered?

[ ] Yes [ ] No

d Is there evidence that adherence was assessed and recorded?

[ ] All meds [ ] Some meds

[ ] No

e Has consideration been given to the ecobiopsychosocial model?

[ ] Yes [ ] Some elements

[ ] No

f Signposting or patient information given?

[ ] Yes [ ] No

g Problem linking?

[ ] All [ ] Some [ ] None

h Pre-consultation preparation provided?

[ ] Yes [ ] No

Standard 2: Minimise medication related problems by considering real or potential medicine-related harms and actions taken to reduce them a Are all medicines listed and indication recorded?

(You may tick more than one answer) [ ] Prescribed meds listed with indication [ ] Prescribed meds listed, no indication [ ] OTC/herbal/ other meds listed with indication [ ] OTC/herbal/ other meds listed with no indication [ ] Medication not listed

b Was the patient asked how they take their medication?

[ ] All [ ] Some [ ] None

C Risk reduction considered? [ ] Yes [ ] No d Were any risk reduction strategies implemented as

a result of risks identified? [ ] Yes [ ] No [ ] N/A

e Monitoring – evidence that this was checked? [ ] Yes [ ] No [ ] N/A f Adverse drug reactions - evidence that these were

considered and Yellow Card submitted if appropriate (You may tick more than one answer).

[ ] ADRs considered

[ ] ADRS not considered

[ ] Yellow Card submitted

g Shared care protocols – if the patient is under shared care, has consideration been given to the protocol?

[ ] SCP in place and considered

[ ] SCP in place, but NOT considered

[ ] N/A SCP not in place

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Standard 3: Maximise the benefit of medicines by considering the aim and intended outcomes, whether the dose is optimised, how the patient takes their medicines a Aims of each medicine – evidence that these have

been reviewed and confirmed as still relevant? [ ] Yes, all [ ] Yes, some [ ] No

b Need for each medicine – evidence that the continued need has been considered?

[ ] Yes, all [ ] Yes, some [ ] No

c Evidence and effectiveness – evidence that these have been considered?

[ ] Yes, all [ ] Yes, some [ ] No

d Unnecessary medication – evidence that consideration has been given to unnecessary medicines and where apparent, unnecessary medicines were stopped?

[ ] Yes considered

[ ] Yes considered and stopped

[ ] Not considered

Standard 4: Consider activities and actions that contribute to waste and work to address them a Cost and value – is there evidence that these were

considered? [ ] Yes [ ] No

b Patient factors – is there evidence that these were

considered? [ ] Yes [ ] No

c Prescribing factors – is there evidence that these

were considered? [ ] Yes [ ] No

d Environmental issues - is there evidence that

these were considered? [ ] Yes [ ] No

Standard 5: Complete documentation and update the patient record a Has the name and date of the person undertaking

the review been recorded? [ ] Yes name [ ] Yes date

[ ] No name [ ] No date

b Reason for prescribing each medicine recorded? [ ] Yes all [ ] Yes some [ ] No

c Any changes made recorded? [ ] Yes [ ] No

d Evidence that patient or carer was asked and agreed with any changes made?

[ ] Yes [ ] No

e Record of advice and supporting information given for example, leaflets, enrollment in Pregnancy Prevention Programme, signposting.

[ ] Yes [ ] No

f Record that the patient or carer agreed with advice given?

[ ] Yes [ ] No

g Date of next review recorded? (You may tick more than one answer)

[ ] Yes on GP system

[ ] Yes in patient held information

[ ] Not recorded

899

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APPENDIX 2. AUDIT OF ACTIVITIES GUIDANCE NOTES 900 901 • Please complete a review sheet for each patient who has undergone a face-to-

face medication review. • The additional information below is intended to help you answer each question. • You may not be able to answer the questions in order. If that is the case,

please return to the question at the end - you may find that you can then answer it.

902 Standard 1. Reach agreement with the patient (or carer, or both) on the aims 903 and goals of treatment 904

a. Is there evidence of shared decision making? 905 After an effective shared decision-making discussion, the patient should be 906 able to answer these questions about their treatment: 907 - What are its potential benefits? 908 - What are its potential harms? 909 - What will happen if nothing is done? 910 - Are there any alternative options to consider? 911

b. Have the patient’s views, understanding and expectations been 912 considered? 913 There should be evidence that the reviewer has found out what is most 914 important to the patient, what they want to achieve, what their expectations 915 are, and what they understand about their treatment and condition. 916

c. Have the patient’s concerns, questions and problems been recorded? 917 There should be evidence that the patient has been asked and given the 918 opportunity to express their concerns, ask questions and discuss any 919 problems about their treatment and condition. 920

d. Adherence assessed and recorded? 921 There should be evidence that adherence has been assessed: the patient 922 has been asked how they take each medication, if they have any problems 923 remembering to take their medication, or accessing their medication etc. 924

e. Has consideration been given to the ecobiopsychosocial model? 925 Were behavioral risk factors (for example smoking, alcohol, diet, physical 926 activity) and prevention discussed? Were non-medical factors affecting 927 wellbeing (for example poverty, pollution, living conditions etc) discussed? 928

f. Signposting / information given 929 Was the patient signposted to or given any information? 930

g. Problem linking 931 Is each medication linked to a problem(s) on the clinical system? 932

h. Pre-consultation preparation 933 Was the patient given any pre-consultation (medication review) information? 934 935

Standard 2: Minimise medication-related problems by considering real or 936 potential medicine-related harms and actions taken to address or reduce them 937

a. Medication listed 938 Has all medication been recorded and indication noted for each, including 939 prescribed (consider all sources: secondary care, tertiary care, private) and 940 non-prescribed, including purchased medication, ‘over the counter’ 941 medicines, and herbal remedies. 942

b. Was the patient asked how they take their medication? 943 The patient should have been asked how they specifically take each of their 944 medicines, including any over-the-counter, herbal, and non-prescribed 945 medication. 946

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c. Risk reduction 947 Is there evidence that the following has been considered: inappropriate 948 medication, incorrect dosage, incorrect storage, method of administration, 949 and non-adherence. 950 Consideration given to relevant National Prescribing Indicators (NPIs), 951 STOPP (Screening Tool of Older Persons Prescriptions) / START (Screening 952 Tool to Alert doctors to Right i.e. appropriate, indicated Treatment) medicines 953 etc. 954

d. Have any risk reduction strategies been implemented as a result of risks 955 identified in 2c? 956 Risk reduction in relation to medication. 957

e. Monitoring 958 Is there evidence that relevant monitoring has been checked, including 959 disease control, blood chemistry, therapeutic drug monitoring. 960

f. Adverse drug reactions 961 Is there evidence that adverse drug reaction (ADRs) have been considered, 962 including those due to drug-food and drug-drug interactions? If a possible 963 ADR has been identified, has a Yellow Card been submitted? 964

g. Shared care protocols 965 Is the patient under a shared-care protocol? If so, has consideration been 966 given to monitoring and specialist reviews undertaken as stated in the 967 protocol? 968 969

Standard 3: Maximise the benefit of medicines by considering the aim and 970 intended outcomes, whether the dose is optimised, how the patient takes their 971 medicines etc. 972

a. Aims of each medicine 973 Have the aims and intended treatment outcomes of each medicine been 974 reviewed and confirmed that they are still relevant and in line with the 975 patient’s views and goals? Consider NICE guidelines and AWMSG 976 guidelines. 977

b. Need of each medicine 978 Is there evidence that the need for each medicine has been considered? Are 979 all the medicines essential? Are there any that could be managed at a lower 980 dose? 981

c. Evidence and effectiveness 982 Is there evidence that the therapeutic objectives have been considered? Are 983 they in line with current guidelines and the patient’s views and goals? Are 984 there more effective alternatives? Could the dose be adjusted? 985

d. Unnecessary medication 986 Is there evidence that consideration has been given to unnecessary 987 medicines and, where apparent, unnecessary medicines were stopped? 988 989

Standard 4: Consider activities and actions that contribute to waste and work 990 to address them 991

a. Cost and value 992 Have cost and value been considered? Are the most cost-effective medicines 993 being used in line with local and national prescribing guidelines; with 994 consideration given to anything that doesn’t add value to the outcome for the 995 patient? 996

b. Patient factors 997 Has consideration been given to patient factors which may result in waste? 998 For example, does the patient have difficulty ordering their prescription? 999 Where patients have indicated that they have not been fully adherent, 1000

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consider whether stockpiles have built up. Does the patient understand that 1001 medication returned to the pharmacy cannot be reused? 1002

c. Prescribing factors 1003 Has consideration been given to whether medication is synchronised, and 1004 appropriate quantities prescribed for daily dose and length of prescription, for 1005 example 28 days? Consider inhaler quantities. 1006

d. Environmental issues 1007 Has information been given about appropriate disposal of unwanted 1008 medication, inhaler recycling schemes, cost of wasted resources? Has 1009 consideration been given to the carbon footprint of inhalers? 1010 1011

Standard 5: Complete documentation and update the patient record 1012 a) Has the name of the person undertaking the review, and the date of the 1013

review, been recorded? 1014 b) Has the reason for prescribing each medicine been recorded? 1015 c) Have any changes made been recorded, including the reason(s) why? 1016 d) Is there evidence that the patient or carer has been asked if they agree with 1017

any changes made? 1018 e) Is there a record of any advice and supporting information given, such as 1019

leaflets, or enrolment in the Pregnancy Prevention Programme etc? 1020 f) Is there a record that the patient or carer agrees with the advice given? 1021 g) Is the date of the next review recorded, on the GP system and patient record? 1022

1023

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APPENDIX 3. PATIENT INFORMATION LEAFLET 1024 1025

YOUR MEDICATION REVIEW 1026 1027

A medication review is a meeting with a healthcare professional to talk about your 1028 medicines and any concerns, problems or questions you may have. If you take 1029 medication regularly, you should have a medication review every year, although this 1030 may vary depending on the medicine you take. It’s important that you have a 1031 medication review to make sure you are getting the best from the medicines you are 1032 taking. 1033 1034 Every medication review should be conducted in line with the agreed National 1035 Standards (Table 1). 1036 1037

About your medication review

• A medication review is a collaborative process through which the reviewer will support you to reach decisions about your treatment (shared decision making).

• Your medication reviewer may be a GP, pharmacist, or nurse.

• The reviewer will think about each medicine you are taking and what it is being given to treat. They will review and check whether it is still appropriate for you to take it, depending on whether you still have the condition, or if anything has changed.

• The reviewer will also ask if there are any non-medical factors that may be affecting your health. Such as: smoking, alcohol, diet, physical activity, transport, food, pollution, living conditions, housing, and employment.

• You may wish to have a carer present during the review. If so, please tell the reviewer and say if you’re happy to talk about your medicines and your condition in front of your carer.

• A medication review may take up to 45 minutes.

Preparing for your medication review

• The reviewer wants to understand your views, understanding and expectations about your medicines.

• Please be prepared to tell the reviewer about all the medicines you take including: o medicines you buy from a pharmacy or supermarket; o medicines prescribed by a hospital; o herbal medicines; and o any other alternative medicines.

If you can, you should take these medicines with you to the review. The reviewer will already know about the medicines prescribed by your GP.

• Please think about concerns, questions or any problems you have before coming to your medication review. You may wish to write these down to help you remember.

During your medication review Reviewing your medicines

• The reviewer will make sure you know the reason why you have been prescribed each medicine.

• The reviewer will think about whether you need any blood tests or other investigations to monitor your treatment or condition.

• The reviewer will ask if you would like extra information about any of your medicines or health conditions. They may give you supporting information, such as: internet webpage links for advice, or patient information leaflets.

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Taking your medicines • The reviewer will ask you how you take each of your medicines. For example, how many

times a day, what time of day do you take it, do you take it before or after food. Please tell them about any problems you may have with taking your medication.

• The reviewer will think about ways to reduce any risk of harm related to the medicines you’re taking. If they identify any risks, the reviewer will talk to you about them.

• The reviewer will ask if you have had any unwanted effects (side effects) from your medicines. If you have they will fill out a report (called a Yellow Card report). Yellow Card reports do not contain any personal details about you, but the information about your medicines will be used to help monitor medicines safety concerns across the UK.

Changes to your medicines • The reviewer will review how well each medicine is working for you, and will check the latest

treatment guidelines.

• The reviewer will talk to you about your continued need for each medicine you’re taking. If they find you are taking unnecessary medications, the reviewer will talk to you about stopping them.

• The reviewer will check whether you have understood the reasons for any changes and whether you agree with the changes. You should tell the reviewer if you have any concerns and you are not happy with the changes.

Collecting and disposing of medicines • The reviewer will ask you if you have had any problems ordering your medicines or

collecting your prescription or medicines from the pharmacy.

• The reviewer will think about whether you are being prescribed the most cost-effective medicines and discuss this with you.

• The reviewer will ask if you have any medicines at home that you no longer need, and will explain how you should dispose of them safely.

After your medication review

• The reviewer will make a record of the medication review in your medical records. The reviewer will record any changes made to the medicines you are taking, for example, any new medicines, or any medicines that you no longer need to take.

• You are have a right to look at, or receive, a copy of your medical records. If you wish to do this, ask the reviewer for more information. A leaflet explaining your rights is available: Your Information, Your rights - What you Need to Know

• The reviewer will explain when your next medication review will take place and how the appointment will be arranged.

1038 Table 1. National standards for medication reviews 1039 1040

National standards for medication reviews

Standard 1 Involving patients and carers Reach agreement with the patient (or carer, or both) on the aims and goals of treatment.

Standard 2 Safety Minimise medication-related problems.

Standard 3 Review of medicines Maximise the benefit of medicines.

Standard 4 Reducing waste Consider activities and actions that contribute to waste and work to address them.

Standard 5 Medication review documentation Complete documentation and update the patient record.

1041 1042