Membership information 1800 932 916
Medicolegal advice 1800 936 077

ARTICLES

Read articles on a range of medicolegal topics.

Vaccinations: what are the medicolegal risks?

09 September 2021

Dr Rachel Birch, 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 July 2021, Ireland’s COVID-19 data hub1 reports that 2,920,641 first COVID-19 vaccinations had been given, and 2,257,426 second doses had 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

Dr H, a GP, volunteered for a number of shifts at her local HSE vaccination centre and completed her first few without incident. The centre 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 centre closed. 

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

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

What were the investigation findings? 

Removing the vaccinations from the hub was against the policy of the centre, and Dr H 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 Dr H administered the vaccination to her partner, the vaccine had been out of the fridge for greater than six hours. A question was therefore raised over the efficacy of the vaccine. 

Further, although Dr H 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. 

Dr H also acted against Medical Council guidance, which states in paragraph 60.1 of Guide to Professional Conduct and Ethics for Registered Medical Practitioners2: “You should not treat or prescribe for members of your family or others with whom you have a close personal relationship except in emergencies.”

Following investigation, Dr H’s further shifts at the vaccination centre were cancelled, and the clinical director considered referring the matter to the Medical Council. However, Dr H provided an insightful reflection and the clinical director felt that  she would be unlikely to repeat the behaviour and therefore did not make a Medical Council referral; however, this case highlights the need to abide by local policies and be mindful of Medical Council guidance even in these unusual times.

COVID-19 vaccination and consent

Dr Z 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 were administered. One patient, Mrs G, 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 Mrs G to be vaccinated. Dr Z contacted Medical Protection to discuss the case. 

Advice

In such a situation, it was important for Dr Z personally to assess Mrs G’s capacity of the patient as this was decision-specific and time-specific. Dr Z did assess Mrs G’s capacity and concluded that she did not have the capacity to make an informed decision about whether or not to receive the COVID-19 vaccination. 

The Medical Council provides guidance2 on making decisions for patients lacking capacity. This sets out that when making a decision for a patient lacking capacity, the patient’s best interests need to be considered. Some patients may have fluctuating capacity, and it is important to involve them in decisions about their healthcare as much as they are willing and are able. The risks of harm and the potential benefits of each available option (including taking no action) should be weighed up for the individual patient. If there is anyone with legal authority to make decisions on the patient’s behalf, then their consent should be sought for the proposed treatment; however, in the absence of such a person, their past wishes, if known, should be considered, as well as the views of people close to the patient and the healthcare professionals involved in their care. 

There was no evidence that Mrs G had made an advance decision to refuse treatment, and her relatives did not hold power of attorney for health and welfare. There was no indication in Mrs G’s medical records that she was anti-vaccination in general; in fact, she had consented to the flu vaccination the previous year when she had held capacity for that decision. 

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

Dr Z discussed the scenario with the other GPs and the care home staff, all of whom were in agreement that it would be preferable for Mrs G to be vaccinated. Dr Z discussed the possible risks and benefits with Mrs G’s children and, ultimately, they agreed that it would be of overall benefit for Mrs G to be vaccinated against COVID-19. 
In the event that Mrs G’s relatives had continued to disagree, the possible approaches Dr Z could have taken would be to involve an independent advocate or mediation service, or offer a case conference. 

Ensuring that the relevant Medical Council 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.  

 

1Vaccines Administered
2Medical Council Guide to Professional Conduct and Ethics for Registered Medical Professionals.