It is recognised that vaccination activities around the Pfizer Covid-19 vaccine are not at all routine. Here is a vaccine that has been given approval by the MHRA for use in humans using a regulatory process which includes a rolling review, and which has relied upon emergency Covid-19 legislation passed to assist with the management of the Pandemic. It must be stored at minus 70⁰C and once thawed has a five-day shelf life when stored at between 2⁰C and 8⁰C. It needs to be diluted within two hours of removal from the fridge at which point its shelf life is reduced to only 6 hours, it then needs to be drawn up prior to vaccinating the patient. Unsurprisingly, we are receiving many calls from members checking their indemnity position.
The PDA has, for some time, been in detailed and sometimes daily discussions with Department of Health and senior NHS officials about this very subject and has engaged with the PDA’s indemnity underwriters to ensure that the indemnity arrangements are robust*.
This following clarification has been provided by the underwriters for release to PDA members.
Clarification from the underwriters
1. Pharmacists operating as Covid-19 vaccinators
Pharmacist involvement in the national flu vaccination campaigns has shown that pharmacists can be relied upon to vaccinate patients. However, leaving the extra-ordinary approval and licensing issues aside, the Covid-19 vaccination brings with it many new and hitherto unprecedented operational aspects which represent a significant increase in the risk of liability for pharmacists.
The additional risks of liability to pharmacists
These include;
- The need to store one of the vaccines at minus -70⁰C, to allow it to thaw and then dilute it prior to use.
- The need to draw up the vaccine into a fresh syringe prior to each vaccination.
- The need to use the diluted vaccine within 6 hours.
- Compared to much longer-term clinical trials enjoyed by other vaccinations in the past, the knowledge of the side effects and contra-indications of these new Covid-19 vaccines, especially in the early stages of the programme will be more limited. Less is known about the warnings, contra-indications and guidance that pharmacists should be expected to provide to the public. Additionally, less is known about the nature and style of resuscitation pharmacists may be called upon to deliver.
- That the forthcoming vaccination activities will be large scale, fast pace and large volume throughput operations.
- There is a need to follow through with a second dose within 28 days of the first dose at a time of likely supply pressures.
- That any vaccinators will be responding to a yet untested NHS booking system.
- That the vaccinators themselves will be more exposed to the risk of a Covid-19 infection.
- That some aspects of the service may well be delivered by volunteers who will likely not be healthcare professionals.
Because of these additional risks, the PDA’s insurance underwriters would not allow Covid-19 vaccinations to be treated in the same way as the flu vaccination and consequently, new arrangements have been agreed.
The NHS has also recognised the nature of the novel risks involved and consequently ‘the government’ will provide a significant degree of indemnity protection, this will take three forms;
- Immunity for vaccinators against the liability for any impact of the antigen is being granted through new coronavirus related legislation.
- The UK Vaccine Damage Payment Scheme has recently had the Covid-19 vaccination added to its list, enabling patients to claim up to £120,000 of compensation from the government if they are harmed by the vaccination antigen.
- State Backed Indemnity schemes
The liability for the vaccination activity – for example to include gaining consent for the vaccination from the patient, operating according to the required systems and processes, drawing up or diluting, keeping the details confidential and the act of using a needle on a patient. All these issues represent the risk of liability for a pharmacist who is administering vaccinations. In settings that are currently covered by the Clinical Negligence Scheme for Trusts (CNST or its country equivalent) this will include hospitals and other secondary care NHS settings or those covered by the Clinical Negligence scheme for GP Practice in England and Wales (CNSGP or its country equivalent), this will include GP practices, Federations, Health Boards, Primary Care networks, the pharmacists involved in administering the vaccine will be partially covered by these state backed schemes. However, in such circumstances, there are several important conditions that should be borne in mind: - 1. State backed protection (and/or the UK Vaccine Damage Payment Scheme) will only extend to the indemnity element of cover, providing compensation for patients, it will not cover any elements of medico-legal protection that might be needed by a pharmacist if they are called to face a regulatory hearing, a criminal prosecution, an inquest or even a formal dispute with their employer.
2. The state backed schemes are operated by public bodies, as such they are required to refer pharmacists involved in an incident where their performance may fall into question, to the appropriate regulator or relevant NHS performers authority.
3. The state backed schemes are designed to look after patient’s interests, they are not designed to defend the reputation of a pharmacist.
*The insurance included with PDA membership is arranged and administered by The Pharmacy Insurance Agency (PIA) Ltd who are authorised and regulated by the Financial Conduct Authority (Register No 307063).