It is hugely encouraging to see the COVID-19 vaccination programme getting underway but there can be no doubting the scale of the task ahead.
Primary care staff have a critical role in its successful rollout with some PCNs gearing up to administer the vaccine from designated sites. Unsurprisingly, the speed of events has prompted some MDU members to seek advice about their ethical and legal responsibilities.
Here we respond to some of the initial queries. However, with the situation changing quickly, some guidance is still awaited and GPs are advised to ensure they check relevant websites for the latest updates.
Who can prescribe and administer the vaccine?
The vaccine is a prescription only medicine. It will be administered under a new national protocol issued by Public Health England and Public Health Wales and a patient group direction has been published.
The national protocol is a new mechanism which will enable more healthcare professionals and allied health staff to administer the COVID-19 vaccine as part of a mass programme by allowing the different stages of the vaccination process to be split into parts i.e. clinical assessment and consent, preparation of the vaccine and administration of the vaccine.
The protocol explains that a clinical supervisor, who must be a registered doctor, nurse or pharmacist trained and competent in all aspects of the protocol, must be present and provide clinical supervision for the overall provision of clinical care provided under the legal authority of the protocol.
Further guidance is awaited in Northern Ireland and Scotland.
How should we prioritise patients?
The Joint Committee of Vaccination and Immunisation (JCVI) has set out a list of vaccine priority groups. Practices are responsible for identifying patients for the priority cohort, starting with all those aged 80 years and over.
If demand is likely to exceed supply, practices may need to consider patients by co-morbidities or take into account health inequalities. Where there are unfilled appointments, NHS England suggests residual supply is used to vaccinate staff who have been identified as being at high risk.
How should patient consent be obtained?
In FAQs about the vaccine the GMC says doctors must be satisfied they have consent or other valid authority for vaccination, as is the case for any treatment.
This includes ‘speaking with patients to find out about allergies, their medical history and any contraindications.’ The GMC says it expects there to be further guidance on how consent should be recorded across the four countries of the UK and whether to use a standard consent form.
The current NHS standard operating procedure clarifies that all patients who are able to are required to give informed consent. It outlines that those being vaccinated should be able to understand, retain, and communicate:
- the anticipated benefits of vaccination in the simplest of terms,
- the likely side effects from vaccination and any individual risks they may run should be addressed, and
- the disbenefits of not consenting to the vaccination.
In terms of documentation it reminds us that there is no legal requirement for consent to be in writing and a signature on a consent form is not conclusive proof that consent has been given, but serves to record the decision and the discussions that have taken place.
It further clarifies that consent should, however, be recorded and that the patient should be provided with written information about the vaccination.
Public Health England has also produced a range of patient information leaflets and consent forms (including for care home residents) although these should not be a substitute for talking to patients about any specific concerns.
What happens with patients who lack capacity to consent?
Where patients have been assessed as lacking capacity to make a decision the GMC says you should determine whether there is someone with legal authority to consent to vaccination on their behalf.
If there is not, you will need to decide what option would be of overall benefit to them in consultation with other staff, those close to them and anything you know about their previously expressed views.
If you're responsible for delivering vaccination programmes in settings where a number of patients could lack capacity, make sure you allow enough time before a vaccination clinic to inform relatives and for any concerns to be discussed and documented.
In its letter to PCN designated sites, NHS England says it expects GP practices to highlight patients who may lack capacity when identifying patients for the initial vaccine cohort. Staff will then proceed according to its standard operating procedures.
What should we do to ensure patient safety?
Public Health England has published detailed guidance for healthcare practitioners on the vaccination programme and we expect the health services in other nations of the UK to do the same. The PHE guidance includes sections on the safe administration of the vaccine, contraindications and precautions.
Immunisation against infectious disease (the Green Book) includes a new chapter on the coronavirus vaccine covering contraindications, precautions and adverse events and the MHRA has published specific information for healthcare professionals about the Pfizer/BioNTech vaccine which includes excipient information.
Speaking to patients about any allergies, medical history and contra-indications is necessary when seeking consent. Good record-keeping is also essential in case problems arise during or after vaccination.
Details of vaccinations – the vaccine type, dose, batch number, patient details and vaccinator - should be recorded using the recommended system. NHS England expects PCN vaccine services to use the Pinnacle point of care system which will sync to the relevant GP record within 24 hours.
What should we do in the event of an error or adverse reaction?
If something goes wrong when administering the vaccine, tell the patient or their representative, apologise and explain the steps you will take to arrange appropriate treatment and follow-up. Follow Duty of Candour processes if you believe it to be notifiable patient safety incident. If in doubt, contact the MDU or your medical defence organisation for further advice.
The MHRA has issued guidance to vaccination centres that any person with a history of anaphylaxis or severe allergic reactions to a vaccine, medicine or food should not receive the Pfizer/BioNTech vaccine.
Patients also need to be monitored for 15 minutes after vaccination or longer if clinically indicated.
Short-term pain at the injection site and mild fever are common following the Pfizer/BioNTech vaccination but you should report suspected adverse reactions such as anaphylaxis to the MHRA using its dedicated Coronavirus Yellow Card reporting site.
NHS England guidance sets out procedures for escalating COVID vaccine incidents. It’s important to include the vaccine brand and batch number to assist any investigation.
What about indemnity?
We anticipate that for most members, indemnity for clinical negligence claims will be provided under one of the State indemnity schemes (e.g. CNSGP scheme in England).
Check what the position is with your medical defence organisation. In the MDU’s case you only need to inform us if your hours or sessions have changed, or you are doing private COVID-19 vaccinations (if and when these become available). You don’t need to tell us if you are vaccinating NHS patients within your usual hours or sessions.
