1. Polypharmacy and deprescribing safely: a patient-centred method
Professor Nina Barnett
Consultant Pharmacist,
Care of Older People, London North West Healthcare NHS Trust
Medicines Use and Safety Team, Specialist Pharmacy Service
Visiting Professor, Institute of Pharmaceutical Science,
Kings College London
My session will be entitled Listen to your patient: polypharmacy for older people
I will include information about the patient centred approach to managing multiple medicines, identifying risks  and how to make the best of short consultation about multiple medicines.
Facts figures – scale of the problem
What’s out there already kings fund Scottish welsh indiv CCG (not grouped) Stopp/start, clarhc deprescribing
Seven steps – how this works in practice
care homes, long term condition furosemide
What can we do:
Meds optimisation agenda – what is most important to you? realisation that there may be a gap.
GP and Pharms together practical guide to managing this – how do RPS suggest we can move it from published guide to implementation
Evidence based and patient centred prescribing (is the gap)
Clinician thinks there is a problem – pt. doesn’t
Pt thinks there is problem (ADR/ineffective meds) that clinician isn’t aware of

2. Polypharmacy and patient care
“Do listen to your patients; always have them at the centre of your thinking, that’s what makes the big, big difference”
NHS Improving Quality (NHS Institute for Innovation and Improvement)
…. an NHS that is 'genuinely centred on patients and carers’
Kings fund comment on White Paper Equity and Excellence: liberating the NHS July 2010

3. The importance of language
Polypharmacy
“too many medicines”
the right amount for you
Deprescribing
“stopping your medicines”
trial and review
Multimorbidity......
……?
“the presence of two or more long-term health conditions”
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
MULTIMORBIDITY (From prescriber article Barnett Payne and Rutherford)
Firstly, NICE have taken a relatively straightforward approach to defining multimorbidity as “the presence of two or more long-term health conditions”. This includes physical and mental health problems, and other conditions arguably not readily classified as either, such as learning disability or symptom complexes (e.g. frailty).
The guidance advocates tailoring care for those multimorbid individuals who have difficulties with day-to-day activities, those who receive care from multiple services, and those with both physical and mental health problems. It also recommends considering tailored care for those patients identified through factors such as frailty, use of frequent unplanned or emergency care, or the prescription of multiple medicines. Patients should be identified either opportunistically during routine care, or proactively using electronic records, and the guidance suggests the use of approaches such as validated frailty or admission risk assessment tools, or numbers of regular medications prescribed. In general, the guideline does not differentiate management in primary and secondary care, although does specifically recommend a comprehensive assessment of older people with complex needs at the point of hospital admission.

4. What about Deprescribing?
Be careful with terminology……
“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 2014.Prescqipp Polypharmacy and Deprescribing landscape review
113 respondents East Anglia Survey monkey CCG pharmacists, GPs, practice pharms, nurses and others
Some views stated that publicity and public education would be needed to aid understanding of the real ethos, and that patient groups in particular would need to be heavily engaged to gain their support.
• Suggestions made that the approach would need to consider not just the patient but other key stakeholders, such as carers and family in education / information in an easy to understand way.
• Patient friendly terminology and narrative would be needed for communication with patients, and that it would need to be clear that the activity is a discussion not a decision on their behalf.
• Strong support for a central, coordinated or national debate to help patient groups fully understand what this work is trying to achieve. • Consideration is needed around following up after deprescribing and helping the patient understand that changes are not definitive.
• Suggested consideration is required when ‘targeting’ and how different kinds of patients should be involved/approached - e.g. more vulnerable patients in care homes, as opposed to more active patients living independently.
DTB deprescribing in
DTB 2016;54:69-72 doi: /dtb
The term ‘deprescribing’ has been suggested in recognition that the skills utilised in stopping medicines need to be as sophisticated as those used when initiating drug treatment.3 Key to deprescribing, as with all medical interventions, is the active participation of the patient to ensure that their preferences and choices are taken into account. Particular care is needed when end-of-life considerations apply, so that treatment is optimised and the burden of taking medicines is minimised.4 Although evidence is sparse, this article provides some practical observations on deprescribing.

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

6. Prescqipp Polypharmacy and Deprescribing landscape review
What is Deprescribing?
DTB 52:2014
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
Prescqipp Polypharmacy and Deprescribing landscape review
“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 2014.

7. Read about Deprescribing
A themed issue on
Deprescribing
EJHP 2017:24 (1) including
Tools to support deprescribing
Multiple deprescribing
UK primary care setting
Law and deprescribing
Patient perspective
Falls……

8. Focus on Consent: The Montgomery Judgement
What was the law about consent?
“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)
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.

9. Consent: The Montgomery Judgement
What’s changed?
“Practitioner is required to take “reasonable care” to ensure the patient is made aware of any material risks of a proposed intervention”.
What would an “ordinary, sensible patient” want to know?
Montgomery versus Lanarkshire Health Board 2015
Sokol D. Let’s raise a glass to the ordinary sensible patient BMJ 2015;351:h3956doi: /bmj.h and Barnett N, Kelly O Deprescribing: is the law on your side? Eur J Hosp Pharm 2017;24: and Barnett N and Sokol D. Why pharmacists need to re-evaluate what information they provide to patients 25 Jan 2017
pharmaceutical-journal.com/opinion/comment/why-pharmacists-need-to-re-evaluate-what-information-they-provide-to-patients/ article
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 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 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.

10. Case scenario Mr A, 78yr, medication review
Lives alone, 3rd floor, recently widowed
Fallen x4 in 3 months, no injuries
Has BPH, Rx tamsulosin
Also prescribed furosemide 40mg om
No indication for diuretic in the notes
No HF or hypertension noted

11. Case scenario continued
Medication review – stop furosemide
Patient became upset and anxious
Furosemide helps BPH symptoms
 ????
What are the options for the prescriber?

12. Case scenario – option 1
No change to medication -prescriber considers the likelihood of furosemide contributing to the falls as low. 

13. Withold furosemide for two weeks.
Case scenario – option 2
Withold furosemide for two weeks.
Agree with the patient to a trial of stopping furosemide, following an explanation that it is the tamsulosin helping the BPH and why the furosemide seems to confer a benefit. 
Explain that the furosemide may increase risk of falls and agree to meet again in two weeks to feed back with regard to BPH symptoms.
. Withold furosemide for two weeks. Agree with the patient to a trial of stopping furosemide, following an explanation that it is the tamsulosin helping the BPH and why the furosemide seems to confer a benefit. Explain that the furosemide may increase risk of falls and agree to meet again in two weeks to feed back with regard to BPH symptoms.
Result: The patient had undocumented heart failure which was worsened by stopping the furosemide.
The patient was fully aware of the decision to stop the medication and the potential for symptoms of cardiac failure had been discussed. The patient had agreed to a trial of stopping the medication as he was worried about his recent falls and agreed with the prescribers advice that his potential benefit could outweigh any potential theoretical risk of worsening heart failure.
In this scenario, a claim for clinical negligence is unlikely. A prescriber can be only be open to a claim of clinical negligence (regardless of any consent from the patient) if the course of action taken was not one that a reasonable prescriber would have taken and if that action caused the harm which materialised. In the hypothetical situation of the above scenario where it could be shown that no other prescriber acting reasonably  would have deprescribed the furosemide in those circumstances and that the lack of furosemide caused damage such as the worsening heart failure then a claim of clinical negligence could succeed. It is helpful to note that the law acknowledges that poor outcomes commonly occur for non-negligent reasons . All decisions have the potential to confer benefit but equally all decisions entail risks. As prescribers we need to consider all options and the clinical implications of stopping or not stopping a medication. Prescribers need to ensure they are acting reasonably and where possible in line with evidence based guidelines. 
3.Stop the furosemide, telling the patient that there is no clinical indication for this medication and that the change may decrease his risk of falls.
Result: The patient had no further falls but presented to his GP one month later with shortness of breath. 
In this scenario, the patient was suffering from mild heart failure which was not documented in the GP record. This was worsened by stopping the furosemide. The patient was fully aware of the decision to stop the medication but the potential for symptoms of heart failure were not discussed. The patient lives in a apartment which requires him to climb three flights of stairs at least daily, which he has told the GP that he finds difficult. Therefore the risk of heart failure causing breathlessness was of material importance to him. The prescriber would be open to a claim of negligence, if it can be shown that no other prescriber acting reasonably  would have deprescribed the furosemide in those circumstances and that the lack of furosemide caused damage due to the worsening heart failure.
In addition to (or instead of) a claim of negligence the prescriber is also open to an action based on lack of informed consent. This requires three elements to be met including:
The patient did not give full informed consent to the action. In the UK the law in relation to informed case is outlined in the Supreme Court decision of Montgomery v Lanarkshire Health Board. To satisfy the criteria of informed consent, a prescriber must take reasonable care to ensure the patient is 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 standard is also explicit in the General Medical Council’s guidance on consent.
In this scenario the prescriber failed to take reasonable care to ensure this patient was aware of any material risks to him involved in stopping the furosemide, such as breathlessness which would cause difficulty with access to his property. In this case the prescriber also failed to make the patient aware of any reasonable alternative or variant treatments.
Harm was caused – the risk, which was not outlined, materialised. In this scenario, shortness of breath occurred.
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. In this case, if the patient had known of the risk of worsening his cardiac failure causing shortness of breath, notwithstanding the continuing falls risk with this medication, he would have not agreed to the deprescribing of furosemide. 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.  
Provided a patient is made aware of all material risks and alternatives then a prescriber is likely to satisfy the test for informed consent. However it must be remembered that a claim of negligence can succeed separately, or in addition to, a claim based on lack of informed consent
All decisions have the potential to confer benefit but equally all decisions entail risks.  In order to optimise safe practice, a prescriber should always consider two aspects of their actions:
To avoid a claim of negligence, prescribing decisons must be evidence based and/or in line with the decsions of a reasonable body of their peers.
To ensure full informed consent, a prescriber must discuss clinically appropriate options with the patient, outlining all the the risks relevant to that patient and advise of appropriate alternatives.

14. Case scenario – option 3
Stop the furosemide, telling the patient that there is no clinical indication for this medication.

15. Option 1 - result
The patient was admitted to hospital one week later following a fall.
Is there a claim for medical negligence?
Duty of care
Breach of duty of care
Harm was caused
Did the breach cause the harm?
What would a “reasonable” prescriber do?
1. No change to medication as the prescriber considers the likelihood of furosemide contributing to the falls as low. 
Result: The patient was admitted to hospital one week later following a fall.
In this situation, would the prescriber be open to a claim of clinical negligence?
In order to understand the potential for a clinical negligence claim, we need to apply the four elements of the test for a claim of negligence:
Does the prescriber have a duty of care to the patient? In this scenario, as the patient has attended a clinical appointment with the prescriber, the duty of care is clear.
Has the prescriber breached their duty? A breach exists where it can be shown that no other reasonable practitioner of like expertise, skill and experience, faced with the same set of circumstances would have acted likewise. In the UK the test to assess the appropriate standard of reasonable care is known as the Bolam test* (from the case Bolam v Friern Hospital Management Committee.  Therefore the question to ask is in this scenario is: “Would a reasonable prescriber in the above situation have deprescribed the furosemide?
Was harm caused? In this scenario the patient actually fell and required a hospital admission which constitutes the harm
Causation: did the breach in duty cause the adverse outcome which arose. In this scenario “Did the furosemide ultimately cause/contribute to the fall?”
If a reasonable prescriber would have deprescribed the furosemide in these circumstances and if it can be shown that the furosemide contributed to the fall (eg the fall was not due to something unrelated such as by tripping on a wet floor), then that prescriber is open to a claim in clinical negligence for not deprescribing. This is because a reasonable prescriber would have done so and because the consequences of that inaction caused harm to the patient. This scenario underlines the need to consider the implications of not deprescribing.

16. Option 2 – result
The patient had undocumented heart failure which was worsened by stopping the furosemide
What about clinical negligence now?
Was the course of action taken not one that a reasonable prescriber would have taken
Can it be shown that no other prescriber acting reasonably  would have deprescribed the furosemide?
Did the lack of furosemide caused damage i.e. the worsening heart failure
. Withold furosemide for two weeks. Agree with the patient to a trial of stopping furosemide, following an explanation that it is the tamsulosin helping the BPH and why the furosemide seems to confer a benefit. Explain that the furosemide may increase risk of falls and agree to meet again in two weeks to feed back with regard to BPH symptoms.
Result: The patient had undocumented heart failure which was worsened by stopping the furosemide.
The patient was fully aware of the decision to stop the medication and the potential for symptoms of cardiac failure had been discussed. The patient had agreed to a trial of stopping the medication as he was worried about his recent falls and agreed with the prescribers advice that his potential benefit could outweigh any potential theoretical risk of worsening heart failure.
In this scenario, a claim for clinical negligence is unlikely. A prescriber can be only be open to a claim of clinical negligence (regardless of any consent from the patient) if the course of action taken was not one that a reasonable prescriber would have taken and if that action caused the harm which materialised. In the hypothetical situation of the above scenario where it could be shown that no other prescriber acting reasonably  would have deprescribed the furosemide in those circumstances and that the lack of furosemide caused damage such as the worsening heart failure then a claim of clinical negligence could succeed. It is helpful to note that the law acknowledges that poor outcomes commonly occur for non-negligent reasons . All decisions have the potential to confer benefit but equally all decisions entail risks. As prescribers we need to consider all options and the clinical implications of stopping or not stopping a medication. Prescribers need to ensure they are acting reasonably and where possible in line with evidence based guidelines. 

17. Option 3 – result
The patient had no further falls but presented to his GP one month later with shortness of breath. What about clinical negligence? Potential for heart failure not discussed Patient lives on the 3rd floor (no lift) = material What about patient consent to deprescribing?
3.Stop the furosemide, telling the patient that there is no clinical indication for this medication and that the change may decrease his risk of falls.
Result: The patient had no further falls but presented to his GP one month later with shortness of breath. 
In this scenario, the patient was suffering from mild heart failure which was not documented in the GP record. This was worsened by stopping the furosemide. The patient was fully aware of the decision to stop the medication but the potential for symptoms of heart failure were not discussed. The patient lives in a apartment which requires him to climb three flights of stairs at least daily, which he has told the GP that he finds difficult. Therefore the risk of heart failure causing breathlessness was of material importance to him. The prescriber would be open to a claim of negligence, if it can be shown that no other prescriber acting reasonably  would have deprescribed the furosemide in those circumstances and that the lack of furosemide caused damage due to the worsening heart failure.
In addition to (or instead of) a claim of negligence the prescriber is also open to an action based on lack of informed consent. This requires three elements to be met including:
The patient did not give full informed consent to the action. In the UK the law in relation to informed case is outlined in the Supreme Court decision of Montgomery v Lanarkshire Health Board. To satisfy the criteria of informed consent, a prescriber must take reasonable care to ensure the patient is 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 standard is also explicit in the General Medical Council’s guidance on consent.
In this scenario the prescriber failed to take reasonable care to ensure this patient was aware of any material risks to him involved in stopping the furosemide, such as breathlessness which would cause difficulty with access to his property. In this case the prescriber also failed to make the patient aware of any reasonable alternative or variant treatments.
Harm was caused – the risk, which was not outlined, materialised. In this scenario, shortness of breath occurred.
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. In this case, if the patient had known of the risk of worsening his cardiac failure causing shortness of breath, notwithstanding the continuing falls risk with this medication, he would have not agreed to the deprescribing of furosemide. 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.  
Provided a patient is made aware of all material risks and alternatives then a prescriber is likely to satisfy the test for informed consent. However it must be remembered that a claim of negligence can succeed separately, or in addition to, a claim based on lack of informed consent
All decisions have the potential to confer benefit but equally all decisions entail risks.  In order to optimise safe practice, a prescriber should always consider two aspects of their actions:
To avoid a claim of negligence, prescribing decisons must be evidence based and/or in line with the decsions of a reasonable body of their peers.
To ensure full informed consent, a prescriber must discuss clinically appropriate options with the patient, outlining all the the risks relevant to that patient and advise of appropriate alternatives.

18. Option 3 – legal perspective
What about patient consent to deprescribing? The patient did not give full informed consent The adverse effect of stopping the medicine was material to the patient and he was not informed Harm was caused – the risk, which was not outlined, materialised (SOB) Causation - if the patient had known of this risk, they would have made a different decision (continue) despite the falls risk
3.Stop the furosemide, telling the patient that there is no clinical indication for this medication and that the change may decrease his risk of falls.
Result: The patient had no further falls but presented to his GP one month later with shortness of breath. 
In this scenario, the patient was suffering from mild heart failure which was not documented in the GP record. This was worsened by stopping the furosemide. The patient was fully aware of the decision to stop the medication but the potential for symptoms of heart failure were not discussed. The patient lives in a apartment which requires him to climb three flights of stairs at least daily, which he has told the GP that he finds difficult. Therefore the risk of heart failure causing breathlessness was of material importance to him. The prescriber would be open to a claim of negligence, if it can be shown that no other prescriber acting reasonably  would have deprescribed the furosemide in those circumstances and that the lack of furosemide caused damage due to the worsening heart failure.
In addition to (or instead of) a claim of negligence the prescriber is also open to an action based on lack of informed consent. This requires three elements to be met including:
The patient did not give full informed consent to the action. In the UK the law in relation to informed case is outlined in the Supreme Court decision of Montgomery v Lanarkshire Health Board. To satisfy the criteria of informed consent, a prescriber must take reasonable care to ensure the patient is 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 standard is also explicit in the General Medical Council’s guidance on consent.
In this scenario the prescriber failed to take reasonable care to ensure this patient was aware of any material risks to him involved in stopping the furosemide, such as breathlessness which would cause difficulty with access to his property. In this case the prescriber also failed to make the patient aware of any reasonable alternative or variant treatments.
Harm was caused – the risk, which was not outlined, materialised. In this scenario, shortness of breath occurred.
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. In this case, if the patient had known of the risk of worsening his cardiac failure causing shortness of breath, notwithstanding the continuing falls risk with this medication, he would have not agreed to the deprescribing of furosemide. 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.  
Provided a patient is made aware of all material risks and alternatives then a prescriber is likely to satisfy the test for informed consent. However it must be remembered that a claim of negligence can succeed separately, or in addition to, a claim based on lack of informed consent
All decisions have the potential to confer benefit but equally all decisions entail risks.  In order to optimise safe practice, a prescriber should always consider two aspects of their actions:
To avoid a claim of negligence, prescribing decisons must be evidence based and/or in line with the decsions of a reasonable body of their peers.
To ensure full informed consent, a prescriber must discuss clinically appropriate options with the patient, outlining all the the risks relevant to that patient and advise of appropriate alternatives.

19. 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.
3.Stop the furosemide, telling the patient that there is no clinical indication for this medication and that the change may decrease his risk of falls.
Result: The patient had no further falls but presented to his GP one month later with shortness of breath. 
In this scenario, the patient was suffering from mild heart failure which was not documented in the GP record. This was worsened by stopping the furosemide. The patient was fully aware of the decision to stop the medication but the potential for symptoms of heart failure were not discussed. The patient lives in a apartment which requires him to climb three flights of stairs at least daily, which he has told the GP that he finds difficult. Therefore the risk of heart failure causing breathlessness was of material importance to him. The prescriber would be open to a claim of negligence, if it can be shown that no other prescriber acting reasonably  would have deprescribed the furosemide in those circumstances and that the lack of furosemide caused damage due to the worsening heart failure.
In addition to (or instead of) a claim of negligence the prescriber is also open to an action based on lack of informed consent. This requires three elements to be met including:
The patient did not give full informed consent to the action. In the UK the law in relation to informed case is outlined in the Supreme Court decision of Montgomery v Lanarkshire Health Board. To satisfy the criteria of informed consent, a prescriber must take reasonable care to ensure the patient is 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 standard is also explicit in the General Medical Council’s guidance on consent.
In this scenario the prescriber failed to take reasonable care to ensure this patient was aware of any material risks to him involved in stopping the furosemide, such as breathlessness which would cause difficulty with access to his property. In this case the prescriber also failed to make the patient aware of any reasonable alternative or variant treatments.
Harm was caused – the risk, which was not outlined, materialised. In this scenario, shortness of breath occurred.
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. In this case, if the patient had known of the risk of worsening his cardiac failure causing shortness of breath, notwithstanding the continuing falls risk with this medication, he would have not agreed to the deprescribing of furosemide. 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.  
Provided a patient is made aware of all material risks and alternatives then a prescriber is likely to satisfy the test for informed consent. However it must be remembered that a claim of negligence can succeed separately, or in addition to, a claim based on lack of informed consent
All decisions have the potential to confer benefit but equally all decisions entail risks.  In order to optimise safe practice, a prescriber should always consider two aspects of their actions:
To avoid a claim of negligence, prescribing decisons must be evidence based and/or in line with the decsions of a reasonable body of their peers.
To ensure full informed consent, a prescriber must discuss clinically appropriate options with the patient, outlining all the the risks relevant to that patient and advise of appropriate alternatives.

20. What’s out there to help?
Reminder:
What’s out there to help?
NHS Scotland and The Scottish Government 2012, updated 2015 : Polypharmacy Guidance, update 2017…
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 201: Polypharmacy & Deprescribing webkit, Improving Medicines and Polypharmacy Appropriateness Clinical Tool (IMPACT)
Organisation: NHS Scotland and The Scottish Government
Website:
Title: Polypharmacy Guidance October  
Overview: This is a comprehensive and robust 47 page document is presented in three sections. The first outlines the rationale for addressing polypharmacy, identifies patient groups who may benefit from polypharmacy related medicines review and the general content of the review. While the document recommends using SPARRA (Scottish Patients at Risk of Readmission and Admission) prediction tool data to identify local high risk groups, this concept is readily transferable to other localities where different tools are used. The second section gives clinical information using evidence based sources to support conducting a review explaining the meaning of and including numbers needed for to treat (NNT) and numbers needed to harm (NNH) for individual drugs and drug groups. . The drug review process described is clinically focussed and supports practitioner with the clinical information needed to conduct an effective review. Risk from high risk medication is discussed individually and by BNF categories, as well as identification of clinical conditions of patients which can increase the risks from polypharmacy. Primary references are given. The final section on administrative consideration includes useful information on how to conduct reviews however embedded documents are not available directly through the link.
See
Update March 2015
The new guidance provides additional background information about the interplay between polypharmacy, frailty and multimorbidity. More detail on populations to target when identifying high risk groups is given and there is a new approach to polypharmacy medication review in the form of a seven steps approach to managing medication.
This is useful method of considering each medication in terms of the benefit and risk to an individual patient, including an evidence based approach and while it discusses a patient centered approach to polypharmacy, the seven steps are written from a clinician perpspective.
The updated guide also includes key issues for medication review on a drug by drug and drug class basis listed by BNF categories A new addition to the guidance is the 'hot topics' section which highlights key conditions and drugs which merit special attention, such as review of antipsychotic medication, falls risks with medication etc.
The Numbers needed to treat information has stayed in and as with the first version, the guide is beautifully presented and well referenced.
While one of the methods of identifying high risk populations is based on Scottish data, this is easily transferable for use with local tools eg PARR, BIRT 2
Organisation: NHS Wales Health Board
Website:
Title : Polypharmacy: Guidance for Prescribing in Frail Adults Practical guide, full guidance, BNF sections to target
Overview: An excellent summary is a practical introduction to practitioners who are interested in implementing polypharmacy reviews in their workplace. The document covers similar ground to the Scottish guidance and presents the information in one page flow –chart based summaries of background; drug review process; high risk medication; Frailty and shortened life expectancy, ending with useful links.
The more detailed full guidance is also available which describes key considerations around polypharmacy, provides a medicines effectiveness summary table (with numbers needed to treat for specified conditions) and gives explains the practicalities for stopping specific groups of medicines. The appendices contain an example medicines review leaflet for patients and a list of helpful resources as well as references.
The supplementary guidance is set out in BNF order and describes key risks for each drug group and points for consideration during medication review to reduce inappropriate polypharmacy. Links to relevant guidelines including NICE are given together with advice on deprescribing and follow up/monitoring.
See  practical guide
Full guidance
BNF guidance
Organisation: PrescQIPP NHS Programme
Website:
Title: Polypharmacy and Deprescribing
Overview: PrescQIPP has produced a number of resources in a web kit to support practitioners in reducing polypharmacy. The current web pages outline the background to this area and describe the current work of the project, including a landscape review of polypharmacy and deprescribing, a review of the evidence for medication reviews to understand and address not only patients' beliefs and behaviours, but also those of their healthcare professionals and their carers, such as family or friends, who help support them, production of a bulletin about how to withdraw medicines, support for GP practice audit to identify patients at risk and tools to support improved practice.
The original ‘Optimising Safe and Appropriate Medicines Use’ (OSAMU) bulletin from 2011 and 2013 used BNF classes to highlight potential clinical and cost issues with medication to support medicines optimisation and reduce polypharmacy. Following a review in 2016, the bulletin has been updated and relaunched as the ‘Improving Medicines and Polypharmacy Appropriateness Clinical Tool’ (IMPACT). A ‘landscape review’ in 2014 surveyed CCGs and CSUs about the systems and tools used for deprescribing, meaning of and attitudes to polypharmacy and deprescribing, local projects and challenges to implementation. Key findings include the difficulty of the terminology for patients and the need for public education and the desire for sharing resources.
See
Organisation: Kings Fund
Website
Title: Polypharmacy and medicines optimisation : Making it safe and sound
Overview: This 68 page 2013 report is a detailed look at how polypharmacy manifests in different care settings, key issues and areas for development. It introduces the concept of appropriate and problematic polypharmacy. It highlights both the benefits of appropriate polypharmacy and the risks of problematic polypharmacy in clinical and patient-centred term and both medicines waste and poor adherence to treatment are included in the problems of problematic polypharmacy. Recognising that most evidence for use of medicines is for single conditions it identifies the gap in multi-morbidity guidelines (which is currently being addressed by NICE). Recommendations for practice are given regarding shortened life expectancy and managing long term conditions, including the importance of overview by one clinical team of all long term conditions. The need for clinician training in multimorbidity is highlighted. The document specifically addresses polypharmacy and use of monitored dose systems, polypharmacy in care homes and discusses issues around stopping medicines
See

21. What are the main tools? Beers criteria Medication appropriateness
(explicit, US)
Medication appropriateness
index (implicit)
STOPP/START tool
(recently revised)
Medstopper
RxISK Polypharmacy Index
Mark H Beers 1991 Geriatrician - used delphi method to create AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults 2012 List of drugs to avoid in older people
Drugs Aging Nov;30(11): doi: /s JT Hanlon et al PharmD
The medication appropriateness index at 20: where it started, where it has been, and where it may be going.
The main findings were that the MAI has acceptable inter- and intra-rater reliability, it more frequently detects potentially inappropriate prescribing than a commonly used set of explicit criteria, it predicts adverse health outcomes, and it is able to demonstrate the positive impact of interventions to improve this public health problem. We conclude that the MAI may serve as a valuable tool for measuring potentially inappropriate prescribing in older adults. Score each drug and get summated score ‘implicit’
STOPP/START criteria for potentially inappropriate prescribing in older people: version /5 (vs ) Denis 0’Mahoney Cristin Ryan Stephen Byrne Paul Gallagher
STOPP: Screening Tool of Older People’s potentially inappropriate Prescriptions. START: Screening Tool to Alert doctors to Right
i.e. appropriate, indicated Treatments.
List of medicines adapted by many ccgs as a guide eg nhs cumbriahttp://
Screening Tool for Older People’s Inappropriate Treatments (STOPIT) Abdul Saheb, Barry Jubraj, Vanessa Marvin etc. Adapted from ImPE tool
• It is anticipated that at least 72% patients will take fewer medications as a result of this work • Each medication review saves the NHS £250 per year in medication costs alone • Prompt cards for medication review were developed and are being distributed to doctors and pharmacists • Rollout of a patient held Medication Passport as part of an initiative across Northwest London to provide patients with more accurate personalised information about their medicines in a format they can use easily with any healthcare professional
metabolic disturbance, falls, bleeding, constipation, sedation, confusion – drugs associated with these
Linked to deprescribing and bottom up approach – we can link to this
Medstopper is a tool to help clinicians and patients make decisions about reducing or stopping medications. By entering the list of medications a patient is receiving, Medstopper sequences the drugs from "more likely to stop" to "less likely to stop", based on three key criteria: the potential of the drug to improve symptoms, its potential to reduce the risk of future illness and its likelihood of causing harm. Suggestions for how to taper the medication are also provided. See also
RxISK Polypharmacy Index
Could you be on too many drugs?
Answer the following 10 questions to assess the risk of your taking a mixture of drugs that is of more harm than benefit to you. We will you a record of your answers along with your RxISK Polypharmacy Index.
The higher the number, the more important it is that you have a conversation with your doctor.

22. Focus on the patient perspective
Where is the gap?
Polypharmacy resources provide
Background and context for the issues
Evidence for optimal use of medicines
Tools to support safe review
Deprescribing resource
Few available, even less validated
consideration of the law
How to conduct a “Montgomery compliant” consutlation
Focus on the patient perspective

23. Managing polypharmacy and deprescribing collaboratively with patients
Clinician identifies a problem (evidence based). Patient is not aware of the problem
Patient identifies a problem (patient centred, ADE, adherence) Clinician isn't aware of the problem
Use of the patient centred approach combines an evidence based and patient centred approach to optimising medicines medication review and safe, concordant deprescribing.

24. Patient-centred polypharmacy process
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.
© N Barnett L Oboh K Smith EJHP: 23 December

25. Identify medicines for review
Assess patient: identify medicines related problems and establish the patient’s perspective and priorities first
Define goals: discuss how medicines use fits in with or impacts on the patient’s overall health goals
Identify medicines of concern: consider ALL the medicines the patient is taking and identify potential risks vs benefits according to the best evidence and patient perspective
Agree priorities for review: identify medicines according to appropriateness based on the patient’s current priorities and immediate clinical priorities

26. Agree and action
Agree to stop, reduce, continue dose or start medicine: this is a collaborative decision between clinician and patient - communicate to prescriber as appropriate
Communicate with other relevant parties: facilitate the implementation of medication-related actions and ensure support from all relevant parties as appropriate
Monitor and adjust regularly: maintain continuity of care by ensuring a robust chain of professional responsibility

27. Collaborative care
Clinician identifies a problem (evidence based) but the patient is not aware of the problem
Patient identifies a problem (ADE, adherence) and the clinician isn't aware of the problem
This method is an optimal combination of an evidence based and patient centred approach to medication review and safe, concordant deprescribing.

28. Process in practice Consultations usually short (5-15 min)
Agree to prioritise one or two issues per consultation
Balance of
Importance to patient
Current evidence
Risk/benefits
Communication with patient/carers and other health professionals is key to success (actions and follow up)

29. Link to medicines optimisation…..

30. RPS four principles Aim to understand the patient’s experience
Evidence based choice of medicines
Ensure medicines use is as safe as possible
Make medicines optimisation part of routine practice
The four guiding principles of medicines optimisation Principle 1. Aim to understand the patient’s experience To ensure the best possible outcomes from medicines, there is an ongoing, open dialogue with the patient and/or their carer about the patient’s choice and experience of using medicines to manage their condition; recognising that the patient’s experience may change over time even if the medicines do not.
Principle 2. Evidence based choice of medicines Ensure that the most appropriate choice of clinically and cost effective medicines (informed by the best available evidence base) are made that can best meet the needs of the patient.
Principle 3. Ensure medicines use is as safe as possible The safe use of medicines is the responsibility of all professionals, healthcare organisations and patients, and should be discussed with patients and/or their carers. Safety covers all aspects of medicines usage, including unwanted effects, interactions, safe processes and systems, and effective communication between professionals
Make medicines optimisation part of routine practice Health professionals routinely discuss with each other and with patients and/or their carers how to get the best outcomes from medicines throughout the patient’s care.
NICE
1.1 Systems for identifying, reporting and learning from medicines‑related patient safety incidents
1.2 Medicines-related communication systems when patients move from one care setting to another
1.3 Medicines reconciliation
1.4 Medication review
1.5 Self-management plans
1.6 Patient decision aids used in consultations involving medicines
1.7 Clinical decision support
1.8 Medicines-related models of organisational and cross-sector working
NHS England MO dashboard
The dashboard is presented to allow local NHS organisations to highlight variation in local practice and provoke discussion on the appropriateness of local care. It is not intended as a performance measurement tool and there are no targets.   The primary aim of the programme is to improve patient outcomes, quality and value from medicine use, guided by the principles of medicines optimisation, and to create a clinical pull to accelerate the optimal use of innovative, clinical and cost effective medicines which maximises the benefits of the PPRS Agreement.

31. Key messages
Clinicians identify medicines for review supported by evidence based tools Patient identifies what they want from their medicines for their health and well being. Working together is the route to medicines optimisation
The four guiding principles of medicines optimisation Principle 1. Aim to understand the patient’s experience To ensure the best possible outcomes from medicines, there is an ongoing, open dialogue with the patient and/or their carer about the patient’s choice and experience of using medicines to manage their condition; recognising that the patient’s experience may change over time even if the medicines do not.
Principle 2. Evidence based choice of medicines Ensure that the most appropriate choice of clinically and cost effective medicines (informed by the best available evidence base) are made that can best meet the needs of the patient.
Principle 3. Ensure medicines use is as safe as possible The safe use of medicines is the responsibility of all professionals, healthcare organisations and patients, and should be discussed with patients and/or their carers. Safety covers all aspects of medicines usage, including unwanted effects, interactions, safe processes and systems, and effective communication between professionals
Make medicines optimisation part of routine practice Health professionals routinely discuss with each other and with patients and/or their carers how to get the best outcomes from medicines throughout the patient’s care.
NICE
1.1 Systems for identifying, reporting and learning from medicines‑related patient safety incidents
1.2 Medicines-related communication systems when patients move from one care setting to another
1.3 Medicines reconciliation
1.4 Medication review
1.5 Self-management plans
1.6 Patient decision aids used in consultations involving medicines
1.7 Clinical decision support
1.8 Medicines-related models of organisational and cross-sector working
NHS England MO dashboard
The dashboard is presented to allow local NHS organisations to highlight variation in local practice and provoke discussion on the appropriateness of local care. It is not intended as a performance measurement tool and there are no targets.   The primary aim of the programme is to improve patient outcomes, quality and value from medicine use, guided by the principles of medicines optimisation, and to create a clinical pull to accelerate the optimal use of innovative, clinical and cost effective medicines which maximises the benefits of the PPRS Agreement.

32. Thank you