Deprescribing and the law.

Deprescribing and the law.
Professor Nina Barnett Consultant Pharmacist, Care of older people London North West University Healthcare NHS Trust Medicines Use and Safety Division, NHS Specialist Pharmacy Service Visiting Professor, Kingston University, London • Changes in the legal requirements for consent • Polypharmacy and challenges in managing these patients • Polypharmacy and deprescribing in suitable patients • Managing polypharmacy in frail elderly patients • Interface issues with polypharmacy prescribing

“The process of stopping medicines”
Definition of deprescribing? “The process of stopping medicines” Drug and Therapeutics Bulletin DTB 2014;52:25. Describing deprescribing ). Deprescribing can be described as the process of stopping medicines (Anonymous, 2014) or, more informatively, as “the process of tapering, stopping, discontinuing, or withdrawing drugs, with the goal of managing polypharmacy and improving outcomes” (Thompson and Farrell, 2013). Thompson and farrell 2013 Deprescribing: What Is It and What Does the Evidence Tell Us? Describing deprescribing

Other definitions The complex process required for the safe and effective cessation (withdrawal) of inappropriate medication. Takes into account the patient’s physical functioning, co-morbidities, preferences and lifestyle See DTB 2014;52:25 and Frailty, polypharmacy and deprescribing DTB 2016;54: “The process of tapering, stopping, discontinuing, or withdrawing drugs, with the goal of managing polypharmacy and improving outcomes” Thompson W and Farrell B 2013 Deprescribing: What Is It and What Does the Evidence Tell Us? Can J Hosp Pharm May-Jun; 66(3): 201–

What do we think about deprescribing?
Prescribing vs deprescribing How are prescribers taught? Pre and post NHS.... What do patients think about deprescribing? Welcome? Fearful? Attaching other meaning? What are your experiences?

What about the term? “There was a clear consensus, and many comments, that the term is not appropriate for use with patients and carers, and that from the PR / public domain perspective it would be open to misinterpretation as cost-oriented rather than toward the quality of care or safety of the patient.” Cahill. L Prescqipp Polypharmacy and Deprescribing landscape review

Changing the conversation
Deprescribing From “stopping your medicines” to “a trial of reducing or stopping medicines with review of symptoms”

What about Evidence Based Practice?
Integrating best research evidence with clinical expertise and patient values (Sackett et al. BMJ 1996) Best available research evidence Clinical judgement of the practitioner Patient's circumstances, goals, values & wishes As prescribing adviser way back in in the days of switching, generic prescribing etc concept was hard to grasp

Strategies and Resources for managing Polypharmacy: Key Publications
NHS Scotland and The Scottish Government 2012, Updated April Polypharmacy Guidance, realistic prescribing Kings Fund 2013 Polypharmacy and medicines optimisation : Making it safe & sound. NHS Wales Health Board 2013 Polypharmacy: Guidance for Prescribing in Frail Adults Practical guide, full guidance, BNF sections to target PrescQIPP NHS Programme 2011-Safe and appropriate medicines use, Polypharmacy & Deprescribing NHS Specialist Pharmacy Services 2013: Polypharmacy and deprescribing resources. Deprescribing.org RPS polypharmacy Guidance Getting our medicines right

NHS Scotland Polypharmacy App

NHS Scotland Polypharmacy App
7 Steps Aims 1. What matters to patient? Need 2. Identify essential meds? 3. Does patient take unnecessary meds? Effectiveness 4. Are therapeutic objectives met? Safety 5. Any ADEs or risks of ADEs? Cost effectiveness 6.Is med cost-effective? Patient centredness 7. Is patient willing and able to take med? Shows prompts for what to consider by therapeutic drug groups or examples of drugs for each step 2-7 Eg essential drugs- thyroxine

Royal Pharmaceutical Society Polypharmacy guidance 2018 for health and social care professionals involved in medicines Key messages (problematic polypharmacy) Message from PATIENTS Best practice Recommendations Signposting Appendices Tools Algorithms Polypharmacy & People Healthcare Systems Healthcare Professionals Appendices Tools Algorithms Message from patients: Peter Hawkes | Fran Husson | Graham Prestwich | Nigel Westwood Medicines are taken to help people feel better, recover or to better manage long-term illnesses and prevent complications. Medicines have transformed, for the better, the lives of millions of people around the world. However, it is increasingly understood that multiple medicines taking can pose a risk to some people. Polypharmacy is a term used to describe the situation when people are taking a number of medicines. More people are taking more medicines than ever, and this trend is likely to continue as people are now living longer with multiple conditions. For example: A person may be taking medicines that are no longer suitable or the best available for them The benefit of a particular medicine is lower than its possible harm Sometimes taking a combination of medicines has the potential to harm, or actually cause harm The practicalities of using the medicines are no longer manageable or are causing harm or distress. In addition to the benefits to individual patients from tackling problematic polypharmacy, there are benefits to the wider health economy. Waste can be reduced, both in medicines related hospital admissions and in the associated prescribing and management costs. The time and money saved would then be available to benefit other people and the wider health system Because of this, problematic polypharmacy is a subject of growing concern to patients, healthcare professionals and regulators. A lot of work is being done to address problematic polypharmacy and there is a lot of evidence-based guidance recognised in this document. To add to, and supplement, this body of work, the Royal Pharmaceutical Society established a multi-disciplinary group, including public representatives, to develop recommendations to all involved so that problematic polypharmacy can be more easily understood, identified and dealt with. One of the key features of this work was recognition that this is a complex and difficult issue to manage successfully since so many different professional groups can prescribe, or are involved with the provision of medicines – Hospitals, General Practitioners, Pharmacists, Nurses and any other health care professional who can prescribe. However, there is no single person or body with a clear and unambiguous line of responsibility for identifying and dealing with polypharmacy when it becomes a problem or a potential problem. People and their carers also have a role in dealing with this, by ensuring that they are honest about any problems with the medicines being taken, or if they are reluctant or unwilling to take them. People should also be ready to ask questions of their prescriber to ensure they know why the medicine is recommended for them and be clear about how and when to take them so that their consent is fully informed. This means that they are more likely to take the right medicines at the right dose and the right time. For problematic polypharmacy to be tackled successfully a collaborative, broad and multidisciplinary approach is needed involving specialists, generalists, policy makers, regulators and patients with all players accepting and addressing their responsibilities. Polypharmacy is everyone’s responsibility. As people, we recognise that we have responsibility to be honest about our medicines taking and we also have to take greater action to understand that if we made better lifestyle choices this would negate the need for some medicines. However, any health care professional who thinks that they can ignore problematic polypharmacy and leave this to somebody else is failing in their duty to their patients. This report provides targeted guidance for different groups of health care professionals, Health and social care organisations, policy makers and people who are at risk from multiple medicines. Please read this report and reflect on your role in addressing this complex issue. We commend it and hope you will find it useful.

Tools to identify potentially inappropriate medicines
STOPP/START tool vs * (O’Mahony et al) STOPPFrail 2017 (O’Mahony et al) Anticholinergic Burden (ACB) Risk Scales CRIME (Criteria to assess appropriate Medication use among complex Elderly patients) Age and Ageing Onder G. Italy Beers Criteria (Updated 2015, 2019). US FORTA (Fit fOR The Aged) 2015 App. Germany Explicit tools -provide background, context and evidence based framework for optimal use of medicines to support safe reviews Medication appropriateness index (Implicit) Medstopper Deprescribing.org

Beers Criteria (AGS 2019) https://nursinghomehelp
Update is more nuanced that previous lists: eg avoid PPIs for more than 8 weeks except for certain high risk patients. Authors caution against strict use: Includes medicines which: are potentially inappropriate in most older adults typically should be avoided in older adults with certain conditions are for use with caution have drug-drug interactions require dose adjustment for kidney function Implications. What's Changed? The 2019 update drops 25 medications or medication classes included in earlier versions because they are no longer available in the United States or because concerns with the drugs are not limited to the older population alone. Otherwise, the new recommendations do not differ extensively from those of 2015.[5] "That reflects the stability of our recommendations and a maturity in the evidence for many of the drugs," Steinman contended. He did caution, however, that "the literature isn't as robust as we would like for some of these medications." The rationale for each recommendation, the quality of supporting evidence, and the graded strength of the recommendation are clearly noted. For example, the criteria list 15 first-generation antihistamines as drugs to avoid, noting, among other reasons, that they are highly anticholinergic and that clearance is reduced with advanced age. While the quality of evidence is determined to be moderate, the Beers committee grades the recommendation as strong. Another example: proton-pump inhibitors. These drugs are associated with a risk for Clostridium difficile infection as well as bone loss; evidence is high. But the strong recommendation to avoid is more nuanced, noting that scheduled use for more than 8 weeks should be avoided except for certain high-risk patients. However, the Beers Criteria are not intended to be taken as gospel. In an accompanying editorial,[6] Steinman and his AGS panel co-chair Donna Fick, PhD, RN, caution against strict adherence to the criteria without considering individual patient circumstances. In practice, the quality of the evidence is probably not the primary driver of clinician decision-making, Steinman believes. "It's a question of doing the best with the evidence that is out there. The vast majority of recommendations in most guidelines do not have a strong evidence base to support them."

STOPPFrail criteria for Frail adults with Limited Life expectancy: consensus validation Lavan AH et al. Age Ageing (2017) 1-8. DOI: 27 indicators of potentially inappropriate prescribing in ≥65 years (usually mod-severe frail) who End-stage irreversible pathology Poor one year survival prognosis Severe functional impairment or severe cognitive impairment or both Symptom control is priority vs preventing disease progression Deprescribe if ….. Risk of medication outweighs benefit Administrating medication is challenging Monitoring medication effect is challenging Drug adherence/compliance is difficult Examples Lipid lowering therapies (statins, ezetimibe, fibrates etc) Alpha-blockers for hypertension Diabetic oral agents Aim for monotherapy. Target of HbA1c < 8%/64 mmol/mol ACE-inhibitors for diabetes if only for prevention and treatment of diabetic nephropathy.

Deprescribing guides Geriatric medication evaluation algorithm
Newton PF, Levinson W, Maslen D. The geriatric medication algorithm: a pilot study. J Gen Intern Med 1994;9:164–7. The good palliative-geriatric algorithm Garfinkel D, Zur-Gil S, Ben-Israel J. The war against polypharmacy: a new cost-effective geriatric-palliative approach for improving drug therapy in disabled elldery people. Is Med Assoc J 2007;9:430–4. Prescribing optimisation method Drenth-van Maanen AC, van Marum RJ, Knol W, et al. Prescribing optimization method for improving prescribing in elderly patients receving polypharmacy: results of application to case histories by general practitioners. Medications Aging 2009;26:687–701 Assess, review, minimise, optimise, reassess Haque R. ARMOR: a tool to evaluate polypharmacy in elderly persons. Ann Long Term Care 2009;17:26–30. armor-a-tool-evaluate-polypharmacy-elderly-persons Geriatric Risk Assessment MedGuide Tobias DE, Feinberg JL, Troutman WG. The MDS-Med Guide. Consult Pharm 1999;14:831–60. Reducing polypharmacy in mental health Rush AJ, Rago WV, Crismon ML, et al. Medication treatment for the severely and persistently mentally ill: The Texas medication algorithm project. J Clin Psychiatry 1999;60:284–91. Confirm estimate assess sort eliminate (10 step) Scott IA, Martin JH, Gray LA, et al. Minimising inappropriate medications in older populations—a 10 step conceptual framework. Am J Med 2012;125:529–37

Deprescribing & the law
In terms of medicines –related consultations, how does the law of informed consent apply? How does it relate to deprescribing within consultations? How does clinical negligence fit in?

Focus on informed consent
What was the law about consent? Free, full, informed “Bolam test” Practitioners to act in accordance with a practice accepted at the time as proper by a responsible body of medical opinion. See Bolam v Friern Hospital Management Committee (1957) Before 2015, the ‘Bolam’ test was applied to determine cases where it was questioned whether there had been adequate information disclosure and whether the patient was able to provide informed consent The Bolam test states ‘a medical professional is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a reasonable body of medical men skilled in that particular art’ Since the decision in Montgomery v Lanarkshire Health Board (2015), Bolam no longer applies to information disclosure Bolam still applies to other areas of clinical negligence such as diagnosis and treatment. Bolam v Friern Hospital Management Committee [1957] 1 WLR 583 The claimant was undergoing electro convulsive therapy as treatment for his mental illness. The doctor did not give any relaxant drugs and the claimant suffered a serious fracture. There was divided opinion amongst professionals as to whether relaxant drugs should be given. If they are given there is a very small risk of death, if they are not given there is a small risk of fractures. The claimant argued that the doctor was in breach of duty by not using the relaxant drug. Held: The doctor was not in breach of duty. The House of Lords formulated the Bolam test: "a medical professional is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art Putting it the other way round, a man is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion who would take a contrary view.“ Sidaway Sidaway v. Board of Governors of the Bethlem Royal Hospital [1985] AC 87 Facts[edit] The claimant suffered from pain in her neck, right shoulder, and arms. Her neurosurgeon took her consent for cervical cord decompression, but did not include in his explanation the fact that in less than 1% of the cases, the said decompression caused paraplegia. She developed paraplegia after the spinal operation. Judgment[edit] Rejecting her claim for damages, the court held that consent did not require an elaborate explanation of remote side effects. In dissent, Lord Scarman said that the Bolam test should not apply to the issue of informed consent and that a doctor should have a duty to tell the patient of the inherent and material risk of the treatment proposed. Bolitho v City & Hackney Health Authority [1997] 3 WLR 1151 House of Lords A 2 year old child was admitted to hospital suffering from breathing difficulties. A doctor was summoned but did not attend as her bleep was not working due to low battery. The child died. The child's mother brought an action claiming that the doctor should have attended and intubated the child which would have saved the child's life. The doctor gave evidence that had she attended she would not have intubated. Another doctor gave evidence that they would not have intubated. The trial judge applied the Bolam test and held that there was no breach of duty. The claimant appealed. Held: In applying the Bolam test where evidence is given that other practitioners would have adopted the method employed by the defendant, it must be demonstrated that the method was based on logic and was defensible.

The Montgomery case Nadine Montgomery: The story The outcome
The journey through courts... Brief facts: Mrs M was of slight statute and a pregnant insulin dependent diabetic. Likely to have a larger than average baby. Increased risk of 9-10% of shoulder dystocia; ‘ a major obstetric emergency associated with a short and long term neonatal and maternal morbidity’ Associated risk in 0.1% of cases of hypoxia, cerebral palsy or death. Mrs M was advised of the risk of a larger than average baby but not of the risk of shoulder dystocia. She was not offered a caesarean section as an alternative. Had Mrs M been offered a caesarean section, she would have chosen this method of delivery. During labour, shoulder dystocia occurred, the baby suffered significant injury and Mrs M sued for damages. Successful – awarded £5.25m damages This case raised the legal standard for informed consent in medicine. The facts are tragic and simple. Nadine Montgomery, a pregnant diabetic woman, was not told by her obstetrician of a 9-10% risk of shoulder dystocia, a situation when the baby’s shoulders are unable to pass through the mother’s pelvis. The obstetrician did not mention this risk because she deemed it too small and she also did not want the patient to opt for a caesarean section, which itself carried risks. The risk eventuated and the baby’s brain was starved of oxygen for 12 minutes before it could be pulled out of the birth canal with forceps. The baby was born with cerebral palsy. Had the patient had a caesarean section, the baby would probably have been healthy. Mrs Montgomery sued the hospital for failure to obtain valid consent and, after several setbacks in the lower courts, eventually won in the Supreme Court. The Supreme Court found that the obstetrician was negligent in failing to inform Mrs Montgomery of the 9-10% risk of shoulder dystocia. The Court held that doctors must take ‘reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.’

The Montgomery Judgement
Supreme court judgement 2015 Changes in the law pertaining to informed consent include: From what “a reasonable practitioner” would do to what “ a reasonable patient” would expect From informing patient about serious and/or common risks to risks “material to that patient” Move to offering of “reasonable alternatives” Montgomery versus Lanarkshire Health Board 2015 ‘An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken’. Patient at the centre of the decision making process Shared decision making Final rejection of paternalism Bolam v Friern Hospital Management Committee [1957] 1 WLR 583 The claimant was undergoing electro convulsive therapy as treatment for his mental illness. The doctor did not give any relaxant drugs and the claimant suffered a serious fracture. There was divided opinion amongst professionals as to whether relaxant drugs should be given. If they are given there is a very small risk of death, if they are not given there is a small risk of fractures. The claimant argued that the doctor was in breach of duty by not using the relaxant drug. Held: The doctor was not in breach of duty. The House of Lords formulated the Bolam test: "a medical professional is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art Putting it the other way round, a man is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion who would take a contrary view.“ Sidaway Sidaway v. Board of Governors of the Bethlem Royal Hospital [1985] AC 87 Facts[edit] The claimant suffered from pain in her neck, right shoulder, and arms. Her neurosurgeon took her consent for cervical cord decompression, but did not include in his explanation the fact that in less than 1% of the cases, the said decompression caused paraplegia. She developed paraplegia after the spinal operation. Judgment[edit] Rejecting her claim for damages, the court held that consent did not require an elaborate explanation of remote side effects. In dissent, Lord Scarman said that the Bolam test should not apply to the issue of informed consent and that a doctor should have a duty to tell the patient of the inherent and material risk of the treatment proposed. Bolitho v City & Hackney Health Authority [1997] 3 WLR 1151 House of Lords A 2 year old child was admitted to hospital suffering from breathing difficulties. A doctor was summoned but did not attend as her bleep was not working due to low battery. The child died. The child's mother brought an action claiming that the doctor should have attended and intubated the child which would have saved the child's life. The doctor gave evidence that had she attended she would not have intubated. Another doctor gave evidence that they would not have intubated. The trial judge applied the Bolam test and held that there was no breach of duty. The claimant appealed. Held: In applying the Bolam test where evidence is given that other practitioners would have adopted the method employed by the defendant, it must be demonstrated that the method was based on logic and was defensible.

Key theme of the judgement
‘An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken’ Requires patient-centred consultations and shared decision making Legal update on risk and informed consent In March 2015, a unanimous decision in the United Kingdom Supreme Court (Montgomery v Lanarkshire Health Board) made it clear that doctors must ensure their patients are aware of the risks of any treatments they offer and of the availability of any reasonable alternatives. This means that doctors can no longer rely on the support of a responsible body of medical opinion - the Bolam test - in deciding what information they should give to patients. Montgomery v Lanarkshire Health Board Mrs Montgomery was an insulin-dependent diabetic. Diabetic women frequently have larger-than-normal babies, which leads to a heightened risk of a condition called shoulder dystocia where the baby’s head may descend but the shoulders cannot pass through the pelvis without medical intervention. Her consultant did not inform her of the 9-10% risk of shoulder dystocia, or of the possibility of delivery by caesarean. During delivery, following shoulder dystocia, the umbilical cord was occluded and her son was born with cerebral palsy and a paralysis of the arm resulting from the vigorous manipulation required to deliver him. Had he been delivered by caesarean section, he would have been a healthy baby. The court held that the consultant should have informed Mrs Montgomery of the risks of shoulder dystocia and discussed the possibility of a caesarean. What this means for doctors This case set out doctors’ legal obligations in relation to information provision when seeking a patient’s consent to a specific intervention. Doctors must 'take reasonable care to ensure that the patient is aware of any material risks involved in any treatment, and of any reasonable alternative or variant treatments'. A 'material risk' is one in which 'a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it'. In Mrs Montgomery’s case, the risk of shoulder dystocia, and the risk of the harm to the child, were relevant to her decision making. Assessing risk When assessing risks, doctors cannot rely on percentages. The significance of a risk cannot be reduced to its likelihood. Important factors will include: the nature of the risk, the effect which its occurrence would have upon the life of the patient the importance to the patient of the benefits sought to be achieved by the treatment the alternatives available and the risks involved in those alternatives. Discussing treatment with patients When discussing treatment with patients, doctors are under an obligation to provide information in a form the patient can understand. 'The doctor’s duty is not … fulfilled by bombarding the patient with technical information, which she cannot reasonably be expected to grasp, let alone by routinely demanding her signature on a consent form.' Seeking consent When seeking the consent of a patient, doctors therefore need to ask themselves three questions. Is the patient aware of any risks relevant to his or her decision regarding the proposed treatment? Is the patient aware of any reasonable alternatives and their associated risks and benefits? Have I taken all reasonable measures to ensure that I have presented this information in a form the patient understands? Exceptions There are some exceptions. In an emergency, where the patient may lack capacity, the obligation can be set to one side where the intervention is necessary and in the best interests of the patient. Patients also retain the right not to be informed of the risks — if a patient does not want to know doctors are under no obligation to tell them — although, according to GMC guidance, a certain minimum of information may need to be given. Lastly, where a doctor has a reasonable belief that informing a patient would cause them serious harm, legally the information can be withheld. The Supreme Court makes it clear, however, that this exception should not be abused; it is designed to protect patients from serious harm, not as a means for steering patients away from decisions the doctor disagrees with.

From reasonable clinician to reasonable person…..
How do we know what a “reasonable person in the patient’s position ” would attach to? How do we ensure patients are informed of: What we think they need to know? What they want to know? What they might want to know but don’t know what questions to ask?

What does “material” mean?
A reasonable person in the patient’s position would be likely to attach significance to the risk or, The doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it’.

Reasonable care, alternatives
The new law requires, for informed consent to be given, that the: “Practitioner is required to take “reasonable care” to ensure the patient is made aware of any material risks of a proposed intervention”. The patient is aware of “reasonable alternatives” to the proposed treatment. BRAN More recent case law has supported the Montgomery judgement The below applies to anyone who ‘treats’ ‘The doctor is under a duty to take reasonable care to ensure that a) the patient is aware of any material risks involved in any recommended treatment and b) of any alternative or variant treatments. USE BRAN Benefits Risks Alternatives No treatment The test of materiality is whether a) a reasonable person in the patient’s position would be likely to attach significance to the risk or, b) the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it’. Continued in the decision in Spencer v Hillingdon Hospital NHS Trust [2015] EWHC 1058 (QB) Case Background The Claimant, Mr Spencer, sought damages for personal injury caused by the alleged negligent actions of the Defendant hospital in the lead up to an operation and in the aftermath. The Claimant underwent an operation to correct a hernia in his right groin. The operation was initially undertaken with use of a laparoscope but during the course of the procedure it was necessary to change to an open procedure as visibility deteriorated. The possibility of this change was discussed with the Claimant in the build up to the operation and there was no question of negligence during the course of the operation. Unfortunately, in the aftermath of the surgery the Claimant developed a deep vein thrombosis and was admitted to hospital as suffering from bilateral pulmonary emboli. It was alleged by the Claimant that the Defendant had failed to provide any written or verbal information as to the signs and symptoms of deep vein thrombosis and pulmonary embolism. During the course of the trial there was a dispute between the parties as to the precise warnings that had been given to the Claimant on discharge. In addition, the Defendant argued that the risk of developing a DVT was so remote that it was unnecessary to warn in all cases as this could influence the patient’s decision over the operation without basis. The judge HHJ Collender QC concluded that the Claimant had not been given adequate information on the likelihood of a DVT or the warning signs associated with such a condition and, as such, the Defendant had their duty. The decision is Montgomery has been followed in a number of cases. Webster v Burton Hospitals NHS Foundation Trust 2017 Failure to advise the patient of anomalies in a scan or arranging follow up scans during her pregnancy denied the patient the opportunity to request an induced pregnancy. Had the baby been at the time the patient would have requested, injury to the baby would have been avoided. Hassell v Hillingdon Hospitals NHS Foundation Trust 2018 Mrs H was not advised of the risk of paralysis as a result of spinal cord injury as a result of spinal surgery. She was not advised of the possibility of conservative treatment and the surgeon had failed to take reasonable care and skill to ensure Mrs H was aware of the material risks and alternatives, The man on the Clapham omnibus is a hypothetical ordinary and reasonable person, used by the courts in English law where it is necessary to decide whether a party has acted as a reasonable person would – for example, in a civil action for negligence. The man on the Clapham omnibus is a reasonably educated and intelligent but nondescript person, against whom the defendant's conduct can be measured. The term was introduced into English law during the Victorian era, and is still an important concept in British law. It is also used in other Commonwealth common law jurisdictions, sometimes with suitable modifications to the phrase as an aid to local comprehension. The route of the original "Clapham omnibus" is unknown but London Buses route 88 was briefly branded as "the Clapham Omnibus" in the 1990s and is sometimes associated with the term.[1][2][3] What is required for consent to be informed? The law in the UK has recently been examined and clarified this concept. In March 2015, a seven-judge UK Supreme Court handed down the landmark decision of Montgomery v Lanarkshire Health Board.9 The Court unanimously decided that to satisfy the criteria of informed consent, patients must be made aware of any material risks of a proposed intervention, however small that risk may be, and be made aware of any reasonable alternative or variant treatments. This was endorsed shortly afterwards in the case of Spencer v Hillingdon Hospital NHS Trust,10 which expanded the concept to a postoperative setting. The focus is now on the particular patient and what that individual ‘ordinary sensible patient’ in their position would want to know. The information must be explained in a way that the patient understands. Practitioners can no longer hide behind ‘prescriber knows best’ or provide a selective generalised disclosure of what a reasonable practitioner thinks a patient should be told. If a patient is not told of a risk, and that risk subsequently materialises, they may well succeed in a case for failure of the practitioner to fully inform them of the options. However the claimant will still have to establish that had they been informed of the risk, that they would have chosen a different option. It is not enough to establish that they had not been told of a certain risk, it must be established that if the particular patient had known of that risk they would have opted for a different treatment or course of action. To succeed in a claim of lack of informed consent, a claimant must establish all of the elements in box 2. Box 2 Legal test for informed consent Lack of informed consent obtained for procedure/treatment—The healthcare professional failed to take reasonable care to ensure that the particular patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. AND Harm was caused—that risk, which was not outlined, materialised. Causation arises where the claimant can establish that had they been informed of the risk which materialised that they would have chosen a different option.

And how are you feeling now?

Consent and negligence in deprescribing
In relation to informed consent, as with negligence, poor outcomes can happen and they generally do not give rise to any legal implications. Often a patient agrees to a course of action in the full knowledge of all potential risks and benefits. See full article Barnett, N. & Kelly, O., Legal implications of deprescribing: a case scenario. Prescriber, 28 March, Volume March, pp Duty of care Breach of duty of care Harm caused Did the breach cause the harm Was the patient informed about the potential risks (serious, common, material to them), benefits, alternatives, do nothing

Informed consent and deprescribing
Transparency with patient regarding rationale for the changes and patient offered opportunity to discuss impact of changes if that is an issue Not a carte blanche for patients to demand treatment, requirement for discussion about treatments

What about advising about risks
No longer use percentages ALONE Consider: The type of the risk If it happened, effect on the patient’s life Importance of treatment benefits to the patient What alternatives are available and risks related to the alternatives

How does this fit with GMC guidance?
Consent: patients and doctors making decision together 2008 The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment. The doctor may recommend a particular option which they believe to be best for the patient, but they must not put pressure on the patient to accept their advice. The patient weighs up the potential benefits, risks and burdens of the various options as well as any non-clinical issues that are relevant to them. The patient decides whether to accept any of the options and, is so, which one’ para 5 Updated in GMC “Good Medical Practice 2013” – duties of a doctor See current consultation GPhC 2017 Standard one – person-centred care Emphasis on patient centred care and: obtain consent to provide care and pharmacy services involve, support and enable every person when making decisions about their health, care and wellbeing listen to the person and understand their needs and what matters to them give the person all relevant information in a way they can understand, so they can make informed decisions and choices

A patient-centred approach to deprescribing
The patient centred approach to polypharmacy To provide practical support for clinicians in embedding medicines optimisation into everyday practice through patient centred, safe, evidence based medication review in the management of polypharmacy Each of the 7 steps provides practical support for clinicians to embed MO into everyday practice through patient centred, safe, evidence based medication review Provides points to consider, Actions to take and Questions to ask Allows the practitioner to Prioritise the issues based on the importance to the patient, risks, benefits and current evidence Focus on one or a small number of key concerns vs. solving all the problems at once. Emphasises need for effective communication incl. patient, family/carers and other practitioners Ensure any changes made are actioned and followed up. The guide supports the use of the process in practice. It describes the purpose behind each of the seven steps and gives guidance on points to consider, actions to take and questions to ask in order to reduce polypharmacy and undertake deprescribing safely. Although patients with polypharmacy often have multiple medicines-related issues, the guide allows the practitioner to prioritise the issues based on the importance to the patient, risks, benefits and current evidence and then focus on one or a small number of key concerns rather than trying to solve all the problems at once. The guide emphasises the need for effective communication with the patient, their family/carers and other healthcare professionals at all seven steps of the process to ensure any changes made are actioned and followed up. Barnett NL, Oboh L, Smith K Patient-centred management of polypharmacy: a process for practice Eur J Hosp Pharm 2016;23:

Assess needs and review therapy
Check relevant information Medicines reconciliation Patient’s narrative of their experience identifies problems, priorities, impact on daily life Define overall goals & priority for the review Review the research evidence e.g STOPP START, NICE clinical database Apply clinical judgement and personalise therapy

Joint decision making Don’t just tell- ASK!
Discuss benefits and harms Use appropriate tool Older persons’ willingness to take medicines for 10 CVS prevention (risk of MI in 5years)  relatively insensitive to its benefit but highly sensitive to its adverse effects Fried TR et al 2011 3% willing to take medicines if ADE impacts on functioning 48% – 69% unwilling or uncertain about taking medication with average benefit if there is a risk of mild fatigue, nausea or fuzzy thinking Fried, Terri R. et al. “Effects of Benefits and Harms on Older Persons’ Willingness to Take Medication for Primary Cardiovascular Prevention.” Archives of internal medicine (2011): 923–928.

Collaboration and Care co-ordination
Summarise agreed care plan Communication & Coordination Monitoring and follow up - Withdraw slowly & sequentially Record and share information

Deprescribing in practice (short consultation)
Agree to prioritise one or two deprescribing issues Balance of Importance to patient Current evidence Risk/benefits of both (your clinical judgement) Communicate with patient/carers and other health professionals (actions and follow up) Decisions are shared and values-based.

Conducting person-centred deprescribing consultations in practice
Using person-centred methods such as goal setting motivational interviewing health coaching Changing clinician mindset about how many experts there are in the room..... For examples see Centre for Postgraduate Pharmacy Education Feb 2016 Polypharmacy media wall References: Barnett, N. & Sanghani, P., A coaching approach to improving concordance. International Journal of Pharmacy Practice, 21(4), p. 270–272. Barnett, N. & McDowell, A., Developing your consultation skills to support medicines adherence.. Clinical Pharmacist , 4(9), pp .

Support for deprescribing consultations
Tools for person-centred consultations Person-centred process for consultations Four E’s Questions to support medicines-related consultations Five A’s p 72 Structure to support challenging consultations

Prescribing and deprescribing
Evidence base for (de)prescribing in multimorbidity NICE multimorbidity guidance and database of treatment effects Consider stopping when you start BEGIN algorithm Parekh N, Page A, Ali K, Davies K, Rajkumar C A practical approach to the pharmacological management of hypertension in older people. Therapeutic advances in drug safety Apr;8(4):

Frailty State of reduced functional reserve
BGS Fit for Frailty 1&2 State of reduced functional reserve Less resilient to external stressors Frequent hospital admissions with geriatric syndromes Falls, Immobility, Delirium, Incontinence, Increased Susceptibility to adverse drug events (ADEs) Also Inability to cope, Cognitive impairment, Depression Balance between medicines needed to treat underlying conditions vs. increasing vulnerability to stressors and risks ! Lelly Oboh 20/6/18

So where to now? Consider your role in promoting medicines optimisation through safe deprescribing: what’s matters to your patient (“what’s the matter with me AND matters to me”) the key clinical issues from your perspective Remember “materiality” and “reasonable alternatives” Agree to focus on one or small number of goals for consultation as appropriate Come to a collaborative decision, document, communicate, monitor and review

References General Medical Council Guidance on consent Sokol D. Let’s raise a glass to the ordinary sensible patient BMJ 2015;351:h3956doi: /bmj.h3956 (Published 28 July 2015) General Pharmaceutical Council Standards for Pharmacy Practice May Lee A ‘Bolam’ to ‘Montgomery’ is result of evolutionary change of medical practice towards ‘patient-centred care’ Postgraduate Medical Journal 2017;93: Barnett N, Kelly O. Deprescribing: is the law on your side? Eur J Hosp Pharm 2017;24: Barnett N and Sokol D. Why pharmacists need to re-evaluate what information they provide to patients 25 Jan patients/ article Barnett N and Kelly O. Legal implications of deprescribing: a case scenario Prescriber 28 March Adams D and Carr C. The implications fo the Montgomery Judgement on pharmacy practice and patients with learning disability. Published in Clinical Pharmacist 28 Nov implications-of-the-montgomery-judgment-on-pharmacy-practice-and-patients-with-learning-disability/ article Barnett N and Carr C. The Montgomery judgement and pharmacist consultations Prescriber Published 29th January Munro R. Montgomery: a wake-up call for pharmacists? Prescriber Published 29th January content/uploads/sites/23/2018/01/Editorial-Jan-lsw.pdf Barnett N. Person-centred care over patient-centred care: not just semantics. Clinical Pharmacist 29 March semantics/ article

Deprescribing? On a scale of 1-5, HOW CONFIDENT are you with managing deprescribing in your practice? Discuss the REASONs for your score What would you like to KNOW or HAVE at the end of the session to shift towards a 5 Table discussions Post it notes on tables Capture reasons why Capture what would like to know or have Show of hands- 5, 4, 3 …. Ask to feedback from tables one or 2 themes re reasons why and what to have What Useful concepts

Case Scenarios Group work and Feedback
Lelly Oboh 20/6/18

Case scenario : 75 year old, Mrs Anon 1
Routine medicines review (Oct) Female resident in nursing home on dementia floor Vascular dementia (moderate), T2DM, BPSD 2010, Bilateral cataracts, BP 131/80 (Mar) 114/80 (Sep) BMI 30.4, MMSE 12/30 HbA1c 7.3% eGFR 45mL/min (current) Cholesterol 4.1, HDL 1.11 Allergy trimethoprim Oxybutinin 10mg m/r tablets od Bendroflumethazide 2.5mg tabs od Sertraline 50mg tablets od Promethazine HCL 25mg 1bd (3 & 9pm) Losartan 100mg od Gliclazide 80mg 1 bd pc Amilsulpiride 50mg tablets 1 bd Salbutamol inhaler 2qds prn Dermol 500 lotion soap substitute to skin Zerobase 11% cream apply prn Thick and easy powder as directed Eumovate cream Cetraben cream prn Context frail older people with complex needs

1. Identify or receive referral
Triggers and critical points that vulnerability to medicines risks Frailty or experiencing 1 or more frailty syndromes GP contract NHSE Target, Frailty tools- Moderate, CFS 6/7 Dementia Polypharmacy ?? 10+ Multi-morbidities Care home Specific drugs Anticholinergics, Diuretics, ARB, Antipsychotics Recent discharge/transfer of care  MRH up to 30 days after Parekh N et al 2018 MRHarm 17% within First week, 68% within 30 dayspost discharge  1:6, over 85+ permanently live in care homes

1. Assess identify medicines related problems and establish the patient’s perspective and priorities Can verbalise when she wants to use toilet, wears pads Dry mouth asking for water Mobile but shaky Not tearful or signs of depression Previously on residential floor Shouting, difficult to deliver personal care etc. recently moved to nursing floor  calmed down and can be managed if she is left alone Experience of taking medicines and how it affects their functionality? What they wants from their medicinesWhat matters? Problems? Benefits? Functional history from patient and/or carer. Medication reconciliation to establish what they are taking and how use MAR chart

2. Define context and overall goals
Establish overall health goals and functionality, life expectancy, frailty and how medicines fit in Palliative or symptomatic relief? Rehabilitation or recovery? End of life? To prevent adverse effects of hypo/hyperglyceamia To improve functionality by reducing risk of falls, cognitionBP tabs & targets, lorazepam- risk of falls, ACB > 7 effects of anticholinergic /antipsychotics Improve QoL- agitation, dry mouth, Keep skin moist & prevent breakdown Reduce polypharmacy burden/ADR Reduce risk of frailty syndromes and unnecessary hospital admission Improve adherence & therapeutic outcomes Where the answer to the question ‘would you be surprised if this person were to die in the next 6 to 12 months?’ is ‘no’. Choice/ need – where a patient with advanced disease is making a choice for comfort care rather than ‘curative’ treatment. One clinical indicator often associated is patients requiring help with multiple activities of daily living either at home or in care home due to: Advanced organ failure Multiple co-morbidity giving significant impairment in day to day function Advanced dementia

4. Assess risks & benefits for the patient
3. Identify medicines with potential risks 4. Assess risks & benefits for the patient Confirm or refute the inappropriateness of each drug, based on patient priorities and any immediate clinical priorities. Tailor EACH medicine to the patient’s needs functionality, clinical/social situation, co-morbidities, preferences and ability to adhere 5. Agree actions to stop, reduce dose continue or start

Oxybutinin 10mg m/r tablets od ACB-3
Promethazine HCL 25mg 1bd (3pm & 9pm)-ACB 3 Amilsulpiride 50mg tablets 1 bd- ACB 0 Sertraline 50mg tablets od ACB1 Increased risk of falls Antipsychotic- worsens cognition re existing dementia, increased mortaliy, ACB effects evident, increased risk of pneumonia  for severe BPSD only or risk of harm, off label Trigger for BPSD is known, 80% of nursing home patients will have BPSD at some point Oxybutinin  Worsens Urinary problems  Wears pad and can ask to toilet Not currently depressed- evidence for withdrawal, risk of GI bleed Promethazine  often used but no robust evidence  can cause aggression (phenothiazine like) Sertraline  GI bleed The most clinically significant symptoms of BPSD are depression, apathy, and anxiety. BPSD are expressions of unmet needs and rarely occurs for no reason When describing and documenting behavioral expressions, it is essential to identify the actual/specific behavioral expression being exhibited; the frequency, intensity, duration, and impact of the behavior; and the location, surroundings, or situation in which the behavioral change occurs.3 Avoid general terms such as "agitated" or "anxious" that may be interpreted differently among caregivers and change over time. Agitation may be manifested as verbal or nonverbal expressions such as cursing, yelling, grabbing, and striking out. Describing the details and possible consequences of resident behaviors helps to distinguish expressions such as restlessness or continual verbalization from potentially harmful actions such as kicking, biting, or striking out at others. The frequency and intensity of these expressions can be assessed during the evaluation of various interventions. Other descriptors such as apathetic, repeating statements, questions, or gestures are also common. The more descriptive the terminology, the greater the likelihood of determining what may be causing the behavioral expression. For example, noting that the person is generally "violent," "agitated," or "aggressive" does not identify the specific behavior exhibited by a resident. Noting instead that the person responds in crowded, busy group activities by yelling or throwing furniture reflects not only a potential safety issue but should result in providing the resident with alternative activities to meet his or her needs.3 Stop oxybutinin Withdraw amilsulpride/promethazine slowly- seek advise from specialist, keep behaviour monitoring chart Review long term need of sertraline depending on if first episode

South London And Maudsley (SLAM) NHS Trust Anticholinergic burden tool www.Medichec.com

Bendroflumethazide 2.5mg tabs od Losartan 100mg od
BP 131/80 (Mar) 114/80 (Sep) Higher Risk in frailty with 2 antihypertensives and BP< 130Relaxed targets in dementia/frailty NICE 150/90, Olgivieri et al168/90 optimum in dementia Losartan good choice in T2DM ?? AKI Diuretic urinary problems, not 1st line, risk of falls, dehydration/AKI Stop Bendroflumethazide Keep monitoring BP Implement Sick days rule

Gliclazide 80mg 1 bd pc Sulphonylurea- high risk of hypoglycaemiahigher mortality, CVS disease, falls, accidents, hospital admissions. Metfomin considered but not needed re eGFR Recent Hb1ac 7.3% Frailty or <10 years Life span do not target HbA1c  avoid hypo/hyperglyceamia,  <7% no benefit vs 8%. May not benefit from long term microvascular or death but could cause harm. Lipid management better than glycaemic control re increased risk of CVS events. Not refusing medicines yet consider statin Vascular dementia- highest risks of CVS disease HBA1c below 6.5 not good, keep between 7-8 Reduce antidiabetic if lower than 6.5 Do not target HBA1C if < 10years life expectancy, care home, dementia, cancer, end stage renal disease, severe COPD or CHF Metformin considered but not prescribed re kidney and goo HB1Ac Reduce to 80mg od Start Atorvastatin 40mg om

Dermol 500 lotion soap substitute & apply to skin Zerobase 11% cream apply prn Eumovate cream Cetraben cream prn Use emollient regularly and liberally even when skin is clear vs PRN Bath emollients in old people may increase risk of slipping and fallsNo evidence to justify-for extensive dry skin/eczema, can supplement not replace emollients. Quantities deposited on the skin during bathing are far less than for directly applied emollients Eumovate not signed for out of stock. managing o/s items in short or long term so patient doesn’t suffer harm ? community critical drug list (? adapt hospital list) Is it still needed?  rashseverity ? less potent Order of application The optimal order and timing of application of emollients and topical steroids is not known. There is a theoretical risk that if the topical steroid is applied immediately after the emollient or vice versa then there is a risk of diluting the steroid or possibly transferring it to areas that do not require treatment. Stop Eumovate, Stop Cetraben Stop Dermol Appy Zerobase regularly up to QDS

Bone Health/Risk of falls Salbutamol inhaler 2qds prn Thick and easy powder as directed
Calcium and vitamin D- bone health and fracture prevention Considered Alendronate but not prescribed No apparent indication for Salbutamol, always been ordered not used in last month, no hx of respiratory problems Thick and easy not for medicines but for swallowing food Prescribed Vit D 800units of Stop Salbutamol Refer for by SALT re swallow

6. Communicate Actions Agree a way forward with the patient .
Document clearly: problem, outcome, rationale, agreed action, monitoring Inform others who need to know about the changes and/or act on them (with the patient’s consent re local policy). Ensure changes are clear, esp. if no prescription will follow

Care co-ordination post review : Practicalities
GP to send prescription to community pharmacist for new medicines prescribing pharmacists? Limitations re Scope If medicines are stopped Inform community pharmacists to prevent ‘re-prescribing’ Request for blood tests/BP etc GP pharmacist can action Communication with care givers about changes carers, relatives, DNs, Agree who takes responsibility for follow up UNTAPPED RESOURCESRole for community pharmacists, GP practice pharmacists, patients and their carers!

Outcome 4 weeks later Oxybutinin 10mg m/r tablets od STOPPED
Dry mouth stopped *Reduced pill burden *No deterioration in BPSD *Save money Oxybutinin 10mg m/r tablets od STOPPED Bendroflumethazide 2.5mg tabs od STOPPED Sertraline 50mg tablets od Promethazine HCL 25mg 1bd REDUCED od Losartan 100mg od Gliclazide 80mg 1 bd pc REDUCED od Amilsulpiride 50mg tablets 1 bd After promethazine Salbutamol inhaler 2qds prn STOPPED Dermol 500 lotion soap substitute STOPPED Zerobase 11% cream apply prn Thick and easy powder as dir Referred to SALT Eumovate cream STOPPED Cetraben cream prn STOPPED

Over to you – deprescribing dilemmas
For example: Where you have wanted to stop or reduce a medication and the patient hasnt Where the patient wants to stop taking something (or has already stopped) and you think they should continue Where there is disagreement between family about medication for a patient with dementia

A patient-centred approach to managing polypharmacy
Identify or receive referral for frail older person To provide practical support for clinicians in embedding medicines optimisation into everyday practice through patient centred, safe, evidence based medication review in the management of polypharmacy The guide supports the use of the process in practice. It describes the purpose behind each of the seven steps and gives guidance on points to consider, actions to take and questions to ask in order to reduce polypharmacy and undertake deprescribing safely. Although patients with polypharmacy often have multiple medicines-related issues, the guide allows the practitioner to prioritise the issues based on the importance to the patient, risks, benefits and current evidence and then focus on one or a small number of key concerns rather than trying to solve all the problems at once. The guide emphasises the need for effective communication with the patient, their family/carers and other healthcare professionals at all seven steps of the process to ensure any changes made are actioned and followed up. Each step provides practical support for clinicians to embed med opt into everyday practice through patient centred, safe, evidence based medication review Provides points to consider, actions to take and Qs to ask Allows the practitioner to Prioritise the issues based on the importance to the patient, risks, benefits and current evidence Focus on one or a small number of key concerns vs. solving all the problems at once. Emphasises need for effective communication incl. patient, family/carers and other practitioners Ensure any changes made are actioned and followed up. © N Barnett L Oboh K Smith NHS Specialist Pharmacy Service 2015

1. Identify or receive referral
Priority for review in General practice people living with Frailty & Multi-morbidities GP contract 2017/18 (England) For those patients identified as living with severe frailty the practice will deliver a clinical review, providing an annual medication review Practices and local care services may include those with moderate frailty based on individual need and professional judgement Lelly Oboh 20/6/18

What are the triggers and critical points that vulnerability to medicines risks
Inability to cope e.g. Request for ‘blister packs’ Transfer of care/handovers Changing medications Refusing to engage New/increased care package New pathway/diagnosis Psychosocial crisis ?10+ drugs Recent discharge/transfer of care  increased medicines related harm up to 30 days after Parekh N et al 2018 Post discharge -Critical 30-day period Krumholz HM. N Engl J med. 2013;368(2): Morbidity and functional disability are the most common risk factors for readmission. Garcia-Perez L et al. Risk factors for hospital readmissions in elderly patients: a systematic reviewQ J Med 2011; 104:639–651 Harlan M. Krumholz, Post-Hospital Syndrome – A Condition of Generalized Risk N Engl J Med Jan 10; 368(2): 100–102.. doi: /NEJMp The causes of readmission, regardless of the original admitting diagnosis, commonly include heart failure, pneumonia, COPD, infection, gastrointestinal conditions, mental illness, metabolic derangements, and trauma. Further evidence of the distinctiveness of this syndrome is that information about the severity of the acute illness that led to the hospitalization predicts poorly who will experience an adverse medical event soon after discharge. At a minimum, we should assess a patient's condition at discharge by soliciting details far beyond those related to the initial illness. As we determine readiness for transition from the inpatient setting, we should be aware of functional disabilities, both cognitive and physical, and align care and support appropriately. We should also use risk-mitigation strategies that stretch beyond the cause of the initial hospitalization and seek to prevent infections, metabolic disorders, falls, trauma, and the gamut of events that commonly occur during this period of generalized risk. Lelly Oboh 20/6/18

NHSE Frailty toolkit suggestions

Joint decision making Don’t just tell- ASK!
Discuss benefits and harms Use appropriate tool Older persons’ willingness to take medicines for 10 CVS prevention (risk of MI in 5years)  relatively insensitive to its benefit but highly sensitive to its adverse effects Fried TR et al 2011 3% willing to take medicines if ADE impacts on functioning 48% – 69% unwilling or uncertain about taking medication with average benefit if there is a risk of mild fatigue, nausea or fuzzy thinking Fried, Terri R. et al. “Effects of Benefits and Harms on Older Persons’ Willingness to Take Medication for Primary Cardiovascular Prevention.” Archives of internal medicine (2011): 923–928.

Other important considerations
Care coordination and follow up Informed consent Housebound Time Evidence Workforce capacity (Primary care, General practice)

On going monitoring and adjustments
Maintain continuity of care by ensuring a robust chain of professional responsibility. By whom and when? How often? Look out for improvement and side effects Establish who is care co-ordinator ??Role of GP Pharmacists, Community Pharmacists, Carers, family, patient

Time Factor- Value of short patient-centred consultations
The 2-3 minute consultation What’s most important to you? The 5-10 minute consultation Prioritise and focus on 1 or 2 goals The minute consultation Explore multiple goals, resolve ?? MUR and NMS consultations in community pharmacy Two to Three minutes community hospital outpatients Five to Ten minutes hospital admission (medicines reconcilation) MUR/NMS Hospital discharge GP clinic Twenty minutes Home visit Clinic (GP or hospital) Ward MUR and NMS How much of your (new) medicine have you felt able to take so far, if any? How are you getting on with it? /How do you use/take it? What changes have you noticed since you starting taking the medicine? (cf what problems, they may not identify side effects) How well do you think the medicine is working 5. What side effects or unexpected effects have you had? 6. How many doses of your medicine have you missed in the last week? 7. What else would you like to discuss or revisit? . How are you getting on with your medicines? This is an open question to get the patient talking and bringing out any issues which are important to them. These can be dealt with here rather than waiting until the appropriate question below. It is also a good opportunity to find out if they are taking any OTC medicines. NMS have you started taking your new medicine???? 2. How do you take or use each of these medicines? This is an opportunity to get users of inhalation devices to demonstrate their usage and for any technique issues to be explored. 3. Are you having any problems with your medicines, or concerns about taking or using them? GROUP BY THERAPEUTIC AREAS 4. Do you think they are working? (Prompt: is this different from what you were expecting?) This gives a chance to discuss that some patients will not feel any different if some of their medicines are working. Do they know what it is for? It would be useful to say a little about how the medicines work. Some patients may feel happier and more content to take the medicine if they have a rational explanation of how it helps their condition. 5. Do you think you are getting any side effects or unexpected effects? If the patient feels different it may lead them to change their behaviour, even though it is not a side effect of the medicine. This may also be an opportunity for you or the patient to fill in a Yellow Card. This is an opportunity to discuss whether side effects are likely to be transitory and what can be done to minimise them. If severe, the pharmacist could suggest a return to the prescriber and possibly cessation of the medicine. This could also alert to serious side effects that may occur and would involve an immediate need to take action. 6. People often miss taking doses of their medicines, for a wide range of reasons. Have you missed any doses of your medicine, or changed when you take it? (Prompt: when did you last miss a dose?) This question may be a bit challenging so is further down the interview schedule – however on the other hand it may not need to be asked as the issues may already have emerged. It is necessary to explore the reason(s) why this has happened. Was it intentional or not? Was it appropriate (e.g. missing a morning dose of a diuretic because they had a long bus journey)? Does the patient understand why the medicine is necessary? 7. Do you have anything else you would like to know about your medicines or is there anything you would like me to go over again? (Prompt: Are you happy with the information you have on your medicines?)

Reflection and Final words
What ONE thing are you are taking away to improve your practice? ONE WORD to describe how you feel about managing deprescribing in your practice now. Either or both depending on time left

Additional Case Scenario Group work and discussion
Anon 3 Uncontrolled LTCs -BP, T2DM and pain Use the information obtained from the GP records and a recent discharge letter to review the medicines list focusing on these 3 areas Discuss your recommendations? Lelly Oboh 20/6/18

Patient centred conversations….
At Visit Moderately frail, housebound, articulate and very knowledgeable re medicines, reads PILs Feels she takes too many drugs, Convinced that a lot of them interact Wants to feel listened to and taken seriously about how she experiences her meds. Gets upset when shes treated as ignorant and so she doesn't tell people much Desperate to travel home abroad Very precious about keeping her kidney ok- doesn’t want anything to make worse Cardiovascular Bisoprolol 10mg od - Re thyrotoxicosis in 2011, not reviewed since- half dose, monitor 2 weeks & stop Ramipril 2.5mg od- Just increased in july, ??ARB, candersaratan ++ 8mg=Gp too expensive. Increase ACEI after 2 weeks if needed Nifedipine 20mg m/r od and Nifedipine 10mg od Pt own monitoring– 164/82, 67, , 167/89,65, 159/92 66 Added Nifedipine 10mg in July, not started- increase to LA 30mg od TDM Gliclazide 120mg om 80mg eve- Only taking 80mg od. Gliclazide LA 30mg=80mg- Gp says too expensive, went back to pt to take 80mg bd- agreed Pain Pregabalin 100mg bd- Recently increased from 75 bd to 100mg bd, but only taking 100mg om. Told verbally to increase to 100mg Sharp pain, at its worst 10/10, can’t even pull underwear down to go to toilet. Not entirely gone now but bearable @6/10. Feels pain has robbed her of life Will increase to bd and see if pain much better Butec 10mg patches weekly- feels this is working, no constipation as such or drowsiness. Lidocaine patches prn x30- Was using 8hours only as she read SE re kidney. Hasn't used for >2 weeks-STOP Pantoprazole 40mg om Thought for thrush. Not sure if working for stomach but sometimes feels bloated. Monitor & stop in 2 weeks

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