A pharmacist often does not need express consent from a patient, as the handing of a prescription to a pharmacist is deemed to be giving ‘implied consent’ for the dispensing of a medicine. But what is the legal position when the service is carried out remotely and ‘express consent’ is required?

The emphasis on consent changed with the Montgomery v Lanarkshire court case in 2015, which established that the patient is an active participant in the treatment process. It moved the focus from the decisions made by the reasonable healthcare professional to the wishes of the sensible ordinary patient.

There are some things a pharmacist must consider to ensure that they have valid consent. Guidance issued by the General Pharmaceutical Council in 2018 highlights that to give consent the patient must:

• “Have the capacity to give consent
• “Be acting voluntarily – they must not be under any undue pressure from a pharmacy professional or anyone else to make a decision
• “Have sufficient, balanced information to allow them to make an informed decision. This includes information about any material risks involved in the recommended treatment, and about any reasonable alternative treatments. Material risks are those a reasonable person would think are significant in the circumstances, but also those the particular person would find significant
• “Be capable of using and weighing up the information provided
• “Understand the consequences of not giving consent.”

Assessing patient needs

The pharmacist must establish an opportunity for the needs and wishes of the patient to be discussed. Each of the factors above becomes more difficult to gauge if the conversation is not face to face.

Ensuring the patient is acting voluntarily is to some extent covered by the directions in the pharmaceutical services legislation, amended last year. The directions ask the patient to put themselves in a position “where the telephone or video link conversation cannot be overheard (except by someone whom the patient wants to hear the conversation, for example a carer)”.

However, this is clearly much more difficult for pharmacists to know compared with face-to-face meetings. The most obvious difficulties arise when assessing whether a patient has ‘capacity’ to consent.

Generally, the pharmacist can assume that adults have the capacity unless they have reason to believe the contrary. The Mental Capacity Act 2005 says a person over the age of 16 has capacity if they can do the following:

a) Understand information relevant to the decision in question

b) Retain that information

c) Use the information to make their decision

d) Communicate the decision.

Missed warning signs 

The Association of Clinical Psychologists said in guidance published last year – not aimed at pharmacists specifically but with helpful comments nonetheless – that assessments over the phone risk missing some important cues such as olfactory signs. For example, an overwhelming smell of alcohol may be a clue about capacity that would be missed over the phone.

There was a consideration of how capacity could be assessed remotely in the court case BP v Surrey County Council last year. The case involved an 83 year-old-man with Alzheimer’s disease. The patient was in a care home, but his daughter wanted to move him to her home, declaring the change was in his best interests. A doctor said he was not prepared to assess the patient’s capacity to consent remotely. The patient was deaf but used a “communication board” to communicate.

However, Sir Justice Anthony Hayden said that with “careful and sensitive expertise” it should be possible for patients to provide enough information for an assessment of their remote capacity. His guidance for judges on legal issues arising from COVID-19 says that capacity can be assessed by video when the patient is happy for this to happen and they can be seen on camera alone or with a trusted person.

It is evident that the pharmacist will have to make the basis of assessment clear in their notes. Obtaining consent has become much more complex during the COVID-19 pandemic. Pharmacists will have to apply all their skills in liaising with patients in this difficult context.

Susan Hunneyball is consultant solicitor at Gordons Partnership law firm