Covid-19 Vaccination Frequently Asked Questions
Q1. Will my existing indemnity* (which I enjoy as part of my standard PDA membership) cover me for providing advice and oversight to Covid-19 vaccination clinics?
Answer. Yes.
Pharmacists involved in providing advice and oversight services regarding Covid-19 vaccinations will be automatically covered for both indemnity (settling of any compensation claims made by patients) and medico-legal exposure (the costs of any regulatory hearings, criminal proceedings, public inquests and employment disputes) by the standard indemnity scheme that supports their PDA membership.
Here, pharmacists will not be vaccinating patients, but will likely be working in one of the vaccination hubs and providing the pharmaceutical oversight of the vaccine and the vaccination process. This may include reconstitution, cold chain and storage issues, the monitoring of expiry dates and batch numbers, providing advice and guidance, training, SOP supervision and implementation, and possibly even delivering elements of pharmacovigilance; such as monitoring and recording of adverse events.
*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).
Q2. Will my existing indemnity* (which I enjoy as part of my standard PDA membership) cover me for administering Covid-19 vaccine?
Answer. No.
Underwriters were unable to include cover for vaccinating patients with these novel and unlicensed vaccines within current insurance policies due to the potential for both predictable and as yet unknown risks associated with a programme which aims to vaccinate an unprecedented number of citizens in a matter of months. An extension to the standard indemnity has therefore been negotiated an extension of cover at a cost of £35 for pharmacists administering COVID-19 vaccine in any pharmacy sector.
*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).
You can read more about the new insurance policy here: https://www.the-pda.org/insurance/insurance-risk-and-indemnity-for-administering-covid-19-vaccinations/
Q3. Why are underwriters nervous about indemnifying Covid-19 related activities?
Answer. Because there are many novel and as yet not fully understood 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 short expiry date of only 6 days of the thawed vaccine presenting operational challenges.
- 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.
Q4. Why has my indemnity limit* for vaccinating patients with the Covid-19 vaccine been set at £250,000?
Answer. In light of the concerns related to the novel and as yet unknown risks of this vaccine, underwriters were extremely nervous about indemnifying the risks and were only prepared to provide a much lower limit of indemnity. The good news, however, is that because there are a number of state backed provisions available to patients, devised by the government as part of their Covid-19 preparations, any claims in excess of the £250,000 will be referred to these schemes by the specialist lawyers who will have been handling the cases on behalf of PDA members.
*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).
Q5. What state backed provisions are available?
Answer.
- Immunity for vaccinators against the liability for any impact of the antigen is being granted through new UK-wide 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. (UK-wide legislation)
- State Backed Indemnity schemes (Various provisions have been devised in each UK country)
Q6. Why should I not rely solely on the state backed protection?
Answer.
- 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.
- The state backed schemes are operated by public bodies or the NHS, 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.
- The state backed schemes are designed to look after patient’s interests, they are not designed to defend the reputation of a pharmacist.
Q7. What kind of things will my Covid-19 vaccination extension cover me for?
Answer.
It would provide indemnity* that would respond to patients claiming that they have been harmed by your error or omission in matters related to injecting a patient with the vaccination. Examples include;
- Administering injections to vaccinate against Covid-19.
- Shoulder Injury related to vaccine administration or equivalent vaccination site (SIRVA)
- Operating the associated vaccination procedures and processes
- Activities around gaining consent
- Clinical pre-assessments
- Maintaining patient confidentiality
And
Medico-legal costs cover
Often, an error can lead to exposure to matters which are not directly linked to compensation for a patient. The Covid-19 vaccination extension would also provide you with £500,000 worth of Legal Defence Costs insurance to protect you by covering all of your medico-legal costs for matters such as Regulator referrals, inquests, criminal prosecution and employment disputes.
*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).
Q8. Common side effects of the vaccination are generally mild or moderate and shouldn’t last longer than a week. Is there any advice I should be giving patients about aftercare?
Answer.
You should explain to all patients that they may well experience some common side effects:
- a sore arm where the needle went in
- feeling tired
- a headache
- feeling achy or running a temperature
All recipients of the vaccine should be advised of these potential side-effects and told that they may last for up to a week. They should be re-assured that this is quite normal and that it can be managed by taking paracetamol. If that fails to control their symptoms, then they should call NHS 111. As well as assisting patients in their attempts to manage their own health, being candid about these matters helps to avoid patients wrongly reaching a conclusion that their sore arm or high temperature must have been caused through an erroneous vaccination procedure.
Q9. The clinic I work in has different people preparing the vaccine and then drawing up the doses into syringes ready for the vaccinators to use. How can we minimise the risk of needle stick injuries when passing the filled syringes to the vaccinators?
Answer.
The most important thing is to either avoid re-sheathing needles altogether or to use a safety device such as a needle recapping block which allows one-handed re-sheathing of needles. Some clinics are passing the unsheathed syringes to vaccinators using a kidney dish. Since there are no stability data on storage of the vaccine in plastic syringes, the vaccine should be administered as soon as possible after drawing up into the syringe. Once the dose has been administered, the syringe and needle should be placed straight into a sharps bin without re-sheathing.
Additional useful links
You can read more here: https://www.the-pda.org/insurance/insurance-risk-and-indemnity-for-administering-covid-19-vaccinations/
You can find links to all key NHS documents for the COVID Vaccination programme on the Future NHS collaboration platform (requires registration): COVID-19 Vaccination Programme