HEALTHCARE professionals in the UK form a key part of the urgent drive to administer Covid-19 vaccinations over the coming months. There may be political pressure to roll-out the vaccinations at speed but this should not blind doctors and other prescribers to the risks attached to mass administration of a very new, prescription-only, injectable medication. Guidance and legislation is subject to rapid change and members should consult government advice and guidance relating to the process (England). While legal frameworks may be different in other jurisdictions, the clinical advice and guidance here is applicable throughout the UK.
Access to vaccinations
There are nine priority groups to receive the vaccine in order and these are subject to continuous tweaking by the government. Doctors should keep abreast of any changes to the guidance from time to time and ensure that they verify eligibility requirements for patients falling within each priority group. Further details can be found in a new section of the Green Book dealing with Covid-19 vaccinations and patient priority groups.
Full efficacy of the vaccines requires two doses. The manufacturers have specified a minimum separation between the doses (21 days for the Pfizer and 28 days for the AstraZeneca products). Evidence from Phase 3 trials indicate high levels of protection against serious disease and death from around two weeks after the first dose, but the duration of protection is not known. To maximise vaccine availability to individuals, current government guidance is to wait for up to 12 weeks before a second dose is given. Theoretically, giving a different second vaccine from the first should not affect the immunity that develops but this should be avoided if possible.
Both vaccines are unlicensed, prescription-only medications with temporary authorisation. They will be given in GP surgeries and rolled out for mass vaccination at large centres. That requires two changes to the usual mechanisms for legally prescribing vaccines. Covid-19 vaccines can be prescribed as usual by appropriate prescribers and can be administered under the terms of a Patient Specific Direction (PSD). The requirement that each patient named on a PSD is individually assessed as suitable for the vaccine by the prescriber authorising the PSD is unchanged.
Emergency legislation has amended Patient Group Directions (PGDs) for Covid-19 vaccinations and has created national protocols. Unlicensed medications cannot generally be given under standard PGDs, but Covid-19 vaccines can now be administered under PGDs and these should be completed and authorised in the usual way. National protocols allow appropriately trained and registered clinicians who are not prescribers to assess individual patients as suitable for the vaccines and so legally to authorise their administration. This administration can be by the registered clinicians themselves or can be delegated to suitably trained support staff, including those with no clinical background. This mechanism should allow the very rapid throughput that is required at mass vaccination hubs. A registered prescriber is required to oversee the process at these hubs, and separate oversight of the process of preparation and dilution of the vaccines is also required.
Obtaining consent while advising on the contraindications, risks and benefits of the Covid-19 vaccines for each individual patient is no different from the process for any other medication. Hypersensitivity to the vaccine or any of the other components of the medication is an absolute contraindication. The vaccines should not be used in pregnancy unless the woman is at such high risk from Covid-19 (due to pre-existing medical conditions or occupation) that vaccination can be justified. There is no need to test for pregnancy before administration but inadvertent administration to pregnant women should be reported to Public Health England. Possible adverse effects are listed in the data sheets, which are available via MRHA or government websites. Patients who have concerns about the vaccine are encouraged to discuss these concerns with their GP, rather than waiting until they attend a mass vaccination centre. GPs and practices will need to decide how they can keep themselves up to date most efficiently as information develops regarding the risks and benefits of the Covid-19 vaccines.
Much of the actual administration of Covid-19 vaccines will be delegated by prescribers to other staff, both clinical and non-clinical. Prescribers must be satisfied that the person providing care has the appropriate qualifications, skills and experience to provide safe care for the patient.
The vaccines require careful handling. Errors or incidents in vaccine storage, preparation or administration should be reported promptly so that patients can be counselled and revaccinated if needed.
As with any new medication, monitoring of side effects is important. Coronavirus Yellow Card reporting should be completed if there are any complications other than the mild, early problems anticipated in the data sheets. The problem should be reported to the patient’s own GP and documented in the records.
MDDUS will continue to offer its members indemnity in respect of matters other than claims (e.g. complaints, inquests and GMC/GDC investigations), in all four jurisdictions in the UK.
The indemnity situation for claims is fluid and up-to-date guidance will be posted on the MDDUS Coronavirus Hub. The advice provided below is as current as possible and is subject to change and confirmation (or otherwise) by the devolved administrations.
Claims arising from the administration of the vaccine in England and Wales will be indemnified by state-backed schemes wherever the vaccine is administered.
Generally employed doctors (e.g. those working in hospitals) will be covered for claims through their employer’s indemnity arrangements. In Scotland and Northern Ireland, GPs providing Covid-19 vaccinations to their own patient population need their own indemnity (through MDDUS, provided in the correct grade of membership and the work is within your sessional declaration). Those in primary care commissioned by health boards or the public health agency / HSC will likely be provided with indemnity through those organisations.
Practices are being asked about indemnity for non-clinical issues in respect of their staff redeployed to other sites within a primary care network. Concerns about this should be discussed with public liability and employer liability insurers.
Mr Desmond Watson, senior medical adviser, MDDUS