Legal implications of deprescribing: a case scenario

Prescribers are increasingly being encouraged to deprescribe unnecessary medication, but a potential barrier is the worry of litigation. This article presents an illustrative case scenario that examines the legal implications of deprescribing.

The practice of deprescribing medication is being encouraged to support reducing inappropriate polypharmacy.1-3 However, the lack of evidence-based guidance4 can mean deprescribing feels risky. Prescribers may be reticent to deprescribe, as they are wary of the potential legal implications if the decision to stop a medicine causes or contributes to an adverse event.5 Experience suggests that both prescribing and deprescribing would lead to similar claims of litigation and the same legal tests will apply. A patient is entitled to receive considered medical advice, application of available relevant evidence, full disclosure of all material risks and to be made aware of any reasonable alternative choices of action. This applies equally whether the decision is being made to start, stop or continue a medication.

The concepts of clinical negligence, informed consent and the potential for litigation in deprescribing are discussed in full in a related article.5 However, in order to illustrate some of the challenges that prescribers face, we describe a clinical scenario, presenting the reader with a number of alternative courses of action involving deprescribing. Different treatment options and potential outcomes illustrate the potential medico-legal consequences of a decision to stop or continue a medication. We have created three versions of one case scenario to illustrate key themes in deprescribing.

Case scenario

Mr A is a 78-year-old man who attends a GP clinic for a scheduled medication review. He lives alone in a third-floor apartment and his wife died six months ago. He has fallen at home a number of times in recent months with no apparent injuries. However, he recently fell while at the supermarket, sustaining bruising with no fractures. He has benign prostatic hyperplasia (BPH) for which he has been taking tamsulosin for the past two years. He also takes furosemide 40mg each morning but cannot remember when this was started or why. The prescriber wishes to discuss the ongoing need for furosemide, given the recent falls and the fact that he has no documented cardiac problems. When this is raised with the patient, he becomes upset and anxious. The patient feels that the furosemide helps with his BPH symptoms because he is passing urine frequently when taking the drug.

What are the options for the prescriber?

1. No change to medication, as the prescriber considers the likelihood of furosemide contributing to the falls as being low.

2. Withhold furosemide for two weeks. Agree to a trial of stopping furosemide, after explaining that the furosemide may increase risk of falls, that it is the tamsulosin helping the BPH and why the furosemide seems to confer a benefit. Agree to meet again in two weeks to discuss BPH symptoms.

3. Stop the furosemide, telling the patient that there is no clinical indication for this medication.

What are the legal implications for each of these three potential actions?

1. No change to medication

Outcome: The patient is 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. All four elements of the test must be met for a claim to succeed (see Box 1).

Box 1. Four elements necessary for a clinical negligence claim

If a reasonable prescriber would have deprescribed the furosemide in these circumstances, and if it can be shown that the furosemide contributed to a further fall, eg he fell again and that fall was not due to something unrelated such as tripping on a wet floor, then that prescriber would be open to a clinical negligence claim 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.

2. Withhold furosemide for two weeks

Outcome: The patient has undocumented heart failure, which is worsened by stopping the furosemide.

In this case, the patient is made fully aware of the decision to stop the medication and the potential for symptoms of cardiac failure are discussed. The patient agrees to a trial of stopping the medication as he is worried about his recent falls and agrees with the prescriber’s advice that the potential benefit could outweigh any potential theoretical risk of worsening heart failure.

A claim for clinical negligence is unlikely in this scenario. A prescriber can 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 the action caused the harm that materialised. In this hypothetical situation, where it could be shown that no other prescriber acting reasonably would have deprescribed the furosemide in the same 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

Outcome: The patient has no further falls but presents to his GP one month later with shortness of breath.

In this scenario, the patient is suffering from mild heart failure, which is not documented in the GP record. This is worsened by stopping the furosemide. The patient is fully aware of the decision to stop the medication, but the potential for symptoms of heart failure are not discussed. The patient lives in an apartment, which requires him to climb three flights of stairs at least daily, and he had told the GP that he finds this difficult. Therefore, the risk of heart failure causing breathlessness is of material importance to him. Similar to the second scenario, 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 the same 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 in this instance, the prescriber is also open to an action based on lack of informed consent. A claim for lack of informed consent requires all four elements in Box 2 to be met. (As discussed in scenario 1, a claim for clinical negligence requires all four elements in Box 1 to be met. For clarity it should be noted that a claim for both clinical negligence and informed consent requires all eight to be met.)

Box 2. Four elements necessary for a claim based on lack of informed consent

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.

Conclusion

We have attempted to outline some key issues concerning reducing the risk of clinical negligence in prescribing and optimising patient consent. This contributes to the continuing discussion in the medical literature around the implications of recent changes in UK law.10,11 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 decisions must be evidence based and/or in line with the decisions 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 risks relevant to that patient and advise of appropriate alternatives.

Claims for negligence and lack of consent can succeed separately or in addition to each other. If a prescriber can demonstrate that their actions (in deprescribing or not deprescribing) were aligned with those of a ‘reasonable prescriber’ then even if the action (or inaction) contributed harm, then that prescriber is unlikely to be open to a claim in clinical negligence. Provided a patient is made aware of all material risks and reasonable alternatives then a prescriber is likely to satisfy the test for informed consent. While prescribers have access to a variety of tools to support safe deprescribing,12-16 and alternative treatments are available for many conditions, the challenge is how we identify risks that are material to our patients. Patient-centred conversations17 in the context of structured review18 may support embedding this in our daily practice.

References

1. Van der Cammen TJ, et al. Drug cessation in complex older adults: time for action. Age Ageing 2014;43:20–5.
2. Page AT, et al. The feasibility and the effect of deprescribing in older adults on mortality and health: A systematic review. Br J Clin Pharmacol 2016;82:583–623.
3. Reeve E. A systematic review of the emerging definition of ‘deprescribing’ with network analysis: implications for future research and clinical practice. Br J Clin Pharmacol 2015;80(6):1254–68.
4. Frailty, polypharmacy and deprescribing. Drug Ther Bull 2016:54(6):69–72.
5. Barnett N, Kelly O. Deprescribing: Is the law on your side? Eur J Hosp Pharm 2016;24(1):21–5.
6. Bolam v Friern Hospital Management Committee [1957] 1 WLR 583.
7. Montgomery v Lanarkshire Health Board [2015] UKSC 11.
8. General Medical Council. 2013 Guidance on consent. Available from: http://www.gmc-uk.org/guidance/ethical_guidance/consent_guidance_index.asp [Accessed 12 December 2016]
9. Tasmin v Barts Health NHS Trust [2015] EWHC 3135.
10. Sokol D. Update on the UK law on consent. BMJ 2015;350:h1481.
11. Sokol D. Let’s raise a glass to the ordinary sensible patient BMJ 2015;351:h3956.
12. Hanlon JT, et al. A method for assessing drug therapy appropriateness. J Clin Epidemiol 1992;45(10):1045–51.
13. De Jong MR, et al. Drug-related falls in older patients: implicated drugs, consequences, and possible prevention strategies. Ther Adv Drug Saf 2013;4(4):147–54.
14. O’Mahoney D, et al. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing 2014;44(2):213–8.
15. Salahudeen MS, et al. Anticholinergic burden quantified by anticholinergic risk scales and adverse outcomes in older people: a systematic review. BMC Geriatr 2015;15:31.
16. McKormack J, et al. Medstopper tool. Available from: http://medstopper.com/ [Accessed 20 February 2017]
17. Grimes L, Barnett N. Section 5. Health coaching in patient consultations. In: Consultation skills for pharmacy practice: taking a patient centred approach. Centre for Pharmacy Postgraduate Education. February 2014. Available from: http://www.consultationskillsforpharmacy.com/docs/docb.pdf
18. Barnett N, et al. Patient-centred management of polypharmacy: a process for practice. Eur J Hosp Pharm 2016;23:113–7.

Declaration of interests

None to declare.

Órla Kelly is.a pharmacist and healthcare litigation solicitor at Cantillons Solicitors in Cork, Ireland, and Professor Barnett is a consultant pharmacist in the care of older people, London Northwest Healthcare NHS Trust and NHS Specialist Pharmacy Service; and visiting professor, King’s College London

Legal implications of deprescribing: a case scenario

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