Vaccinations: what are the medicolegal risks?

Dr Heidi Mounsey, Medicolegal Consultant at Medical Protection, looks at two recent cases linked to the COVID-19 vaccination programme, where members have called on Medical Protection for advice.

At the time of writing in June 2021, the gov.uk website states that 44,078,244 first COVID-19 vaccinations have been given, and 32,244,223 second doses have been administered.   The role of GPs in this has been remarkable and is to be hugely commended. Like any aspect of clinical practice we have had a number of requests for assistance relating to the vaccination programme. In this article, we look at some real cases (with details changed to preserve anonymity). 

Administering vaccinations to friends and family

A GP volunteered for a number of shifts at her local vaccination hub and completed her first few without incident. The hub at this time was administering the Pfizer vaccine and had a policy that in the event there were unused doses remaining towards the end of the day, the staff and volunteers were welcome to contact people they knew in order to invite them to receive a vaccination before the hub closed.

At her next shift, when it was apparent there would be a number of doses remaining, the GP contacted her friend, who she knew lived close to the centre, to attend for vaccination. The friend, however, was shopping at the time and was unable to return to be vaccinated before the hub closed for the day. Knowing that her partner would also be unable to get to the hub in time due to work commitments, the GP took two doses of the Pfizer vaccine out of the centre and administered one to her friend on her way home, and then administered the second to her partner.

When the GP next worked at the centre, she documented the vaccinations she had given. The clinical director at the hub identified that the vaccinations had not been given at the centre itself, and undertook an investigation into her actions.

What are the issues to consider? 

Removing the vaccinations from the hub was against the policy of the centre, and the GP had been made aware of this policy at the time of her first shift. Concerns were raised not only about the breach in policy but also by the time the GP administered the vaccination to her partner, the vaccine had been out of the fridge for more than six hours. A question was therefore raised over the efficacy of the vaccine. 

And although the GP had waited with her friend for 15 minutes following the injection, she had no emergency equipment or medications with her, meaning that treatment for any severe or life-threatening reaction to the vaccination would have been delayed.
 
The GP also acted against GMC guidance, which states in Good Medical Practice at paragraph 16g:  “Wherever possible, avoid providing medical care to yourself or anyone with whom you have a close personal relationship.”

Following investigation, the GP’s further shifts at the vaccination hub were cancelled, and the clinical director considered referring the matter to NHS England and the GMC. The GP provided an insightful reflection and it appeared that the case would not progress further; however, it highlights the need to abide by local policies and be mindful of GMC guidance even in these unusual times.

COVID-19 vaccination and consent

A GP had a number of care home residents as patients and wished to go into the home to vaccinate the residents against COVID-19. Consent was sought from those in the home with capacity and the vaccinations administered. One patient, whom the care home staff said lacked capacity, had children who were opposed to the COVID-19 vaccine, and had stated to the care home staff that they did not wish their relative to be vaccinated. The GP contacted Medical Protection to ask for advice. 

In such a situation, it is still important to assess the capacity of the patient as this is decision-specific and time-specific. The GP did assess the patient’s capacity and concluded that he did not have the capacity to make an informed decision about whether or not to receive the COVID-19 vaccination. 

The GMC’s guidance Decision Making and Consent came into effect on 9 November 2020. This sets out that, when making a decision in the event a patient lacks capacity, overall benefits should be considered. This term is used to describe the ethical basis in relation to decision making for adult patients who lack capacity to make such decisions themselves. The risks of harm and the potential benefits of each available option (including taking no action) should be weighed up for the individual patient. The guidance highlights that reasonable steps should be taken to establish if the patient has previously made a statement that may be legally binding, such as an advance decision, or whether another individual has the legal authority to make the decision on behalf of the patient or who has been appointed to represent them. 

There was no evidence that the patient had made an advance decision to refuse treatment, and the patient’s relatives did not hold power of attorney for health and welfare. There was no indication in the patient’s medical records that they were anti-vaccination in general, and he had consented to the flu vaccination the previous year when he was considered to have held capacity.

In this situation, the GP was responsible for deciding what would be of overall benefit to the patient, but was still required to consult with the patient’s relatives and other members of the healthcare team with the aim of reaching agreement. 

The GP discussed the scenario with colleagues and the healthcare team were in agreement that it would be preferable for the patient to be vaccinated. The GP then discussed the possible risks and benefits with the patient’s relatives and ultimately the relatives agreed that it would be of overall benefit for the patient to be vaccinated against COVID-19. 

In the event the patient’s relatives had continued to disagree, the possible approaches the GP could take next would be to involve an independent advocate or mediation service, or offer a case conference. 

Ensuring that the relevant GMC guidance has been followed, and appropriate steps taken to determine and discuss any previously expressed values and preferences of the patient, should reduce the risk of any complaint arising when making decisions in the event a patient lacks capacity. The rationale for the decision and the discussions held should be clearly and comprehensively documented, and this will also assist should the decision be questioned at a later date.  


If you need assistance with any similar situations, please call the Medical Protection advice line on 0800 561 9090.