With growing concerns over the co-circulation of COVID-19 and flu this winter, pharmacy teams are seeing more and more patients enquire about the flu vaccine. Especially as the impact of flu is predicted to be 50% greater this season, as fewer people will have built up natural immunity to it during the COVID-19 pandemic. If you get flu and COVID-19 at the same time, you are more likely to be seriously ill and therefore it is even more important for pharmacy teams to engage in discussions about vaccination uptake.

From September 2020, the requirement for a patient to sign a consent form before receiving an NHS-provided flu vaccination has been removed from the service requirements – verbal consent will suffice. However, it is important that those administering flu vaccines do not become blasé about the importance of consent. Even when using a consent form (which is good practice), having a patient sign one does not in itself constitute proof that the consent was valid, and on its own it might not be sufficient evidence in a court of law. Whether written, verbal or otherwise, an individual must provide valid, informed consent before they receive any type of medical treatment, test or examination.

In a busy community pharmacy or GP surgery, it is easy to fall into the trap of treating consent as a box-ticking exercise. Such an approach is risky, particularly following the Supreme Court judgment in Montgomery v Lanarkshire Health Board in March 2015, which changed the law in relation to consent. The claimant, a pregnant type 1 diabetic therefore at risk of having a large baby, was not fully advised of the risks of a vaginal delivery (because the obstetrician considered them to be low) and her child suffered a catastrophic brain injury during labour. The claimant won the case on the basis that, had she been fully advised of the risks, she would have elected to undergo a caesarean section rather than a vaginal delivery, and the brain injury would have been avoided.

This landmark case highlighted that patients should be made aware of any risks that are material to them (as distinct from being material to the clinician). Clinicians should take a patient-centered approach and advise patients of alternative treatments, or indeed the option of no treatment. Information should be tailored to the specific, individual needs and wishes of the patient before they decide whether to proceed with treatment. What might constitute a minor risk or disadvantage to a healthcare professional (or indeed another patient) might be an intolerable risk to the individual they are treating. An example would be failing to inform a patient that a vaccine contained egg and checking if they would like to proceed, and later discovering that the patient normally excludes eggs from their diet.

Validity of consent

For consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision:

• Voluntary – the decision to either consent or not to consent must not be influenced by pressure from medical staff, friends or family. It is up to the individual.

• Informed – the person must be provided with all necessary information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead.

• Capacity – the patient must understand the information given to them and be able to use it to make an informed decision. They must be capable of giving consent.

Children

As many pharmacies continue to expand the private services they offer, there has certainly been an increase in the number of pharmacists providing vaccinations to children and this is where the issue of consent becomes even trickier.

Parental responsibility and the consequent right to give consent to a child’s treatment is defined in England and Wales by the Children Act 1989. This can be a tricky issue for healthcare professionals, in terms of whom you are taking consent from, but all mothers (and often, but not always, fathers) have automatic parental responsibility. The 1986 case of Gillick in England is well known and supports the generally-held view that children and adolescents can give consent to treatment, if they can fully comprehend what has been proposed.

Top tips

So, in light of this, here are some tips for pharmacy professionals offering flu vaccinations:

• Take time to understand what is important to your patient – do they have concerns about the ingredients in the vaccine and have you had a conversation about their individual concerns?

• Offer thinking time – ask the patient if they would like to step out of the consultation room or go for a walk before coming back to have their vaccination.

• Document your discussion, whether that be electronically or on paper you need to be confident that the record will remain intact and secure.

This blog is written by pharmacist Thorrun Govind in her capacity as qualified solicitor at Hempsons