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Why pharmacists need to re-evaluate what information they provide to patients

Previous court cases concerning informed consent of treatment have raised questions about what consent means in relation to pharmacists, medicines and prescribing.

Illustration of legal scales

Source: Callie Jones

When prescribing or dispensing a medicine, many practitioners would probably say that consent to treatment has been implied when a patient has accepted medicine. Medicines are labelled with directions and there is a patient information leaflet with every prescribed medicine, but there are other obligations around giving directions for safe use of medicines and outlining important side effects.

The Bolam test

The law surrounding consent to treatment in the UK has, for more than half a century, been based on the famous case of Bolam versus Friern Hospital Management Committee (1957)[1]. Commonly known as the ‘Bolam test’, it required practitioners to act in accordance with a practice accepted at the time as proper by a responsible body of medical opinion. The profession itself set the standard. In practice, this meant that, for example, if giving no specific information about side effects of a medicine was considered “standard practice” among peers, or even if a small body of responsible pharmacists followed that practice, the practitioner would not (with limited exceptions) be acting in a negligent manner.

The problem with the Bolam test is the fact that the medical profession determines the standard but, on rare occasions, what the profession deems to be proper may not be so. For this reason, the a safeguard was introduced in 1998 which allowed the courts to override Bolam if the practice defended by the medics did not withstand logical analysis.

The Supreme Court’s decision in the case of Montgomery vs. Lanarkshire Health Board[2] in 2015 has marked a sea change in consent to medical treatment, which is no longer based on the Bolam test.

Nadine Montgomery, a pregnant diabetic woman, was not told by her obstetrician that she was at 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. Montgomery sued the hospital for failure to obtain valid consent and, after several setbacks in the lower courts, eventually won her case in the Supreme Court.

The Supreme Court found that the obstetrician was negligent in failing to inform 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 requirement for informed consent can been considered to apply to all medical treatments, including prescribing medicines. The inclusion of “material risks” changes how consent discussion will take place and places centre stage the patient’s perspective in his or her specific circumstances. Although the Montgomery case involved obstetric risk and informed consent, the wider medical establishment is only just beginning to discover the far-reaching implications of this change on other aspects of medical practice[3].

The reasons for the shift is one for medical sociologists and medical historians, but it does reflect the greater emphasis on respect for patient autonomy and the decline of paternalistic medicine once prevalent in the UK and the United States and still de rigueur in many parts of the world.

Following Montgomery, one could suggest that all prescribers must now tell patients about reasonable alternatives. As such, when discussing use of a medicine, pharmacists must tell patients about material risks. It is important to define material risk, which is a risk that a reasonable person would want to know or that this particular patient would want to know.

We do not know of any case law involving a pharmacist’s failure to ensure informed consent to medicines-related treatment, but there is no reason, in principle, why one might not emerge.

Despite the seismic consequences for clinical practice of Montgomery, some areas of the medical profession have been slow to adapt. There is often a time lag between a change in the law and a change in the front line. It is important for all healthcare professionals, including pharmacists, to be aware of the change and to ensure that their practice is consistent with the requirements of informed consent. A straw poll at the “Improving the way we inform patients” medicines use and safety team event (NHS Specialist Pharmacy services) on 10 May 2016 in London involving some 60 pharmacists revealed that less than 10% were familiar or had read the General Pharmaceutical Council (GPhC)’s guidance on consent[4].

Reasonable patient

When it comes to discussing side effects, pharmacists are guided by the summary of product characteristics for each medicine although, in practice, they may use accepted texts, such as the British National Formulary (BNF) or information delivered by computerised prescribing and dispensing systems. Pharmacists may advise patients verbally of serious side effects and common side effects but this is not universally carried out.

So, in translating the High Court’s statement for pharmacists, the pharmacist 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”.

Paragraph 87 of the Montgomery judgement says: “The test of materiality is whether, in the circumstances of the particular case, 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.”

But how does the test of materiality apply to a medicines-related consultation? Take the example of a patient who has been prescribed amitriptyline at night for neuropathic pain. Pharmacists must highlight any risks that a reasonable person would probably deem significant or that this particular patient would probably deem significant. The pharmacist must use his or her judgement and common sense to answer those questions.

In Mrs A vs. East Kent Hospitals University NHS Foundation Trust [2015] EWHC 1038[5], the High Court held that the failure to inform the claimant about her foetus’ rare chromosomal abnormality did not result in a failure to obtain valid consent as the risk — which was held to be 1/1,000 — was not material. However, Montgomery states that the assessment of whether a risk is material cannot be reduced to percentages. The assessment will be fact and context-sensitive.

The way consent is sought is also an important factor in the quality and even the validity of the consent. The UK General Medical Council (GMC) guidance advises in section 18(d), that healthcare professionals should “give the patient time to reflect, before and after they make a decision, especially if the information is complex or what you are proposing involves significant risks”.

This raises the question of verbal vs. written information and opportunities for referral, for example to a medicines helpline (many of which are available through local hospitals) for patients once they have read or considered the information. The GMC guidance does not require pharmacists to read warnings on the label or to check the patient can understand them. However, good practice may suggest that where there is a serious or common side effect, pharmacists may wish to mention it.

“You must use clear, simple and consistent language when discussing risks with patients,” the GMC guidance continues. “You should be aware that patients may understand information about risk differently from you. You should check that the patient understands the terms that you use, particularly when describing the seriousness, frequency and likelihood of an adverse outcome. You should use simple and accurate written information or visual or other aids to explain risk, if they will help the patient to understand.”

There are many simple techniques to ensure that patients have understood what has been said to them. In the healthcare context, the “teachback” technique — where health professionals ask patients to explain or demonstrate, using their own words, what has just been discussed with them is often applied to check how well the health professional has explained the information.

Particular patient

However, although the Montgomery case highlights the nature of the patient’s situation as affecting what a “reasonable person” might expect, the GPhC guidance on consent[3] does not provide specific information on this subject. The GMC guidance, which preceded Montgomery, is clear: “Your discussions with patients should focus on their individual situation and the risk to them”[6].

Using the example above, a patient prescribed amitriptyline at night for neuropathic pain would require a consultation that first identified the patient’s situation and specific risks to them. If the patient was a night worker, for example, both sedation and blurred vision may be relevant and a risk. Similarly, if the patient was fasting in the day during Ramadan, dry mouth at night may be a problem because this may affect eating. The issue for pharmacists is to ensure that the clinical consultation around medicines gives the patient the opportunity to highlight was is material to them and to do this effectively you may need to offer information about the medicine.

Discussing alternative treatments

As a pharmacist, particularly one with prescribing rights, conversations about alternative treatments are likely to be part of the consultation. Montgomery expressly requires a healthcare professional to mention reasonable alternatives. In Janet Birch vs. University College London Hospital NHS Foundation Trust [2008] EWHC 2237[7], the High Court held that the doctors who conducted a (non-negligent) catheter angiography that led to a stroke were in breach of duty for failing to inform the patient of the reasonable alternative — in this case magnetic resonance imaging — which would have avoided the risk of stroke.

In pharmacy, this can be translated to the offering of alternatives when a pharmacist is discussing potential medicines with individual patients. Alternatives mentioned need only be the ones that are reasonable in the circumstances. Prescribers have a duty to consider offering reasonable alternatives with patients when prescribing medicines and while many already do this, it may be time to have this conversation openly and to document the outcome.

An example of this is a patient prescribed the anticoagulant warfarin for atrial fibrillation after a recent stroke when a discussion with the patient revealed that he worked in a warehouse moving goods. On explaining how the medicine worked and its clinical effect, the patient identified that he was at risk of bruising and falls in his job and that this medicine could be a significant risk to his health in his current job. He chose to speak to his boss before returning to work to look at alternative roles with lower risks.

Things to consider

Although some pharmacists have access to patient notes in hospital or GP surgeries, community and dispensary-based pharmacists are unlikely to document their clinical conversations with patients. This may change as guidance on informed consent around medicines develops.

Since, to the best of our knowledge, there are no reported cases concerning what information a pharmacist should give to a patient, it is left to the individual practitioner or the organisation to decide how to interpret the current changes in the law to their own practice.

In the absence of professional guidance on the specific issue of medicine conversations, we suggest that the following reflective questions, together with a structured, patient-centred consultation using a coaching approach[8] will improve the quality of the consent obtained:

  1. Does the patient know about material risks of taking the proposed medicine?

i. What sort of risks would a reasonable person want to know in this situation?

ii. What sort of risks would this particular patient want to know about?

  1. Does the patient know about reasonable alternatives to this medicine?

i. Have I taken reasonable care to ensure that the patient actually knows all this?

ii. Have I ensured the patient has understood?

  1. Do any exceptions apply?

i. Have I considered capacity, mental health issues and best interest?

  1. Have I properly documented the consent process?

Evolving laws

The Montgomery ruling has changed the law on patient consent in the UK. Pharmacists, in line with other clinicians, need to understand what a patient might want to know in order to give informed consent to treatment. To keep its clean record and respect the autonomy of our patients, pharmacists and pharmacy organisations must take note of the evolving law on consent and ensure that their standards are consistent with the law and the high ethical standards of medicine.

Now is the time to consider how this Supreme Court judgement might apply to the prescribing and dispensing of medicines. As a pharmacist consulting with a patient when supplying a medicine, what we are required to discuss with patients might change.

Guidance required

Currently the GMC’s guidance on consent explicitly refers to patient-centred conversations[6], while the UK pharmacy regulator GPhC guidelines on consent[4] include discussion of appropriate information provision, the meaning of valid consent and withdrawal of consent.

The implications of the Montgomery ruling are now rippling across other healthcare professions. This is a clarion call to pharmacy to re-evaluate what informed consent means. Since it appears practitioners may no longer be protected by the practice of his or her peers, a rethink of what an “ordinary sensible patient”[9] requires is needed.

To adapt to the changing landscape around patient consent, pharmacists need professional guidance that interprets the Montgomery judgement in the context of prescribing and supplying medicines. The pharmacy regulator and pharmacy organisations should consider revising or producing new guidance around patient consent in light of this.

Nina Barnett is a consultant pharmacist for older people, Medicines Use and Safety Division, NHS Specialist Pharmacy Service, London, and Daniel Sokol is a barrister and medical ethicist in London

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202226

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