Why Covid-19 vaccinations are being treated differently by insurance underwriters.

It is recognised that vaccination activities around the Covid-19 vaccines are not at all routine. Here are vaccines that have 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 is unsurprising that Pharmacy Technicians are asking for the PIA to provide clarity around their indemnity for Covid-19 vaccinations. The underwriters will be treating Covid-19 vaccinations with caution and have taken additional precautions because;

Pharmacy Technicians operating as Covid-19 vaccinators.

The additional risks of liability to Covid-19 vaccinators include;

• The need to store one of the vaccines at minus -70°C, 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 that Pharmacy Technicians 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 – 84 days of the first dose at a time of likely supply pressures.
• That any vaccinators will be responding to a national 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, insurance underwriters would not allow Covid-19 vaccinations to be covered as standard and new arrangements have now 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 Pharmacy Technician 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 Pharmacy Technician 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 vaccinators 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 an individual practitioner.

Excluding the effects of the Antigen

Due to the extra-ordinary way in which this vaccine has been approved, there is understandably a considerable amount of concern from insurers about taking responsibility for any side effects of a Covid-19 vaccination.

Consequently, the indemnity that has been arranged for Pharmacy Technicians is designed to sit on top of any State Backed Schemes (where applicable), any employer provided indemnity, the UK Vaccine Damage Payment Scheme and the immunity provision protections. These state provisions have been delivered by the government because there is a widespread recognition that the Vaccine has been approved for use in an extra-ordinary way in extra-ordinary times without the usual much longer-term clinical trials. Because of this, the responsibility for the effects of the antigen will sit elsewhere. Nevertheless, Pharmacy Technicians may still need legal support where claims regarding the effects of the antigen come from claimants, even if it is only to defend Pharmacy Technicians by pointing claimants’ solicitors in the direction of the state provisions.

However, Pharmacy Technicians would quite legitimately be held responsible as vaccinators in situations associated with the activity around the process and the administration of the vaccination itself and this is the risk that would be covered by the PIAs indemnity scheme. Separating out these two risks (effects of the antigen and administering the injection) and sharing the risks with the state means that the £250,000 limit per claim for vaccinating provides appropriate and proportional protection and keeps the costs of indemnity low.

COVID-19 VACCINATION FREQUENTLY ASKED QUESTIONS

Q1. Will my existing Pharmacy Technician indemnity policy cover me for providing services associated with the Covid-19 vaccination clinics that do not directly involve me in vaccinating patients?

Answer. Yes.

Pharmacy Technicians that are supporting a vaccination service (where others are vaccinating) that is operating lawfully by acting within the parameters of a PGD or a national protocol 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 their standard PIA Pharmacy Technician indemnity scheme.

Here, Pharmacy Technicians will not be vaccinating patients, but will likely be working in one of the vaccination hubs, GP Practices or community pharmacies and providing support services to other members of the team or may be engaged in technical aspects of the process.

Q2. Will my existing PIA indemnity 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 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 of cover at a cost of £35 for Pharmacy Technicians will provide cover for administering COVID-19 vaccine in any pharmacy sector.

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;

1. The need to store one of the vaccines at minus -70C, to allow it to thaw and then dilute it prior to use.
2. The short expiry date of only 6 days of the thawed vaccine presenting operational challenges.
3. The need to draw up the vaccine into a fresh syringe prior to each vaccination.
4. The need to use the diluted vaccine or that which has a vial commenced within 6 hours.
5. 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 Pharmacy Technicians should be expected to provide to the public. Additionally, less is known about the nature and style of resuscitation they may be called upon to deliver.
6. That the forthcoming vaccination activities will be large scale, fast pace and large volume throughput operations.
7. There is a need to follow through with a second dose within 28 – 84 days of the first dose at a time of likely supply pressures.
8. That any vaccinators will be responding to a national NHS booking system.
9. That the vaccinators themselves will be more exposed to the risk of a Covid-19 infection.
10. 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 PIA’s insurance underwriters would not allow Covid-19 vaccinations to be delivered as part of the standard indemnity cover.

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 PIAs lawyers.

Q5. What state backed provisions are available?

Answer.

1. Immunity for vaccinators against the liability for any impact of the antigen is being granted through new UK-wide coronavirus related legislation.
2. 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)
3. State Backed Indemnity schemes (Differing arrangements exist in different parts of the UK)

Q6. Why should I not rely solely on the state backed protection?

Answer.

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 Pharmacy Technician 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 or the NHS, as such they are required to refer vaccinators 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 practitioner.

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.

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 find links to all key NHS documents for the COVID Vaccination programme on the Future NHS collaboration platform (requires registration): COVID-19 Vaccination Programme