Covid-19 vaccinations

Risk and Indemnity arrangements. Understanding the risk and Indemnity arrangements for members involved in administering Covid-19 vaccinations

 

CLICK TO AppLY FOR COVID-19 VACCINATION EXTENSION 

The context

At a time, where parts of the primary care service were either closed or only operating a limited virtual service, pharmacy has shown itself to be an adaptable and reliable operator. Despite deteriorating conditions and often with little in the way of PPE to rely upon, pharmacists and their staff have been available to the public in all the nation’s community pharmacies while other pharmacists, those working for GP Practices, primary care organisations and hospital pharmacies have participated in many new Covid-19 related services.

Whilst at times, at the coal face during the crisis, it will have been difficult to cope with some of the privations faced by pharmacists, we can be sure of one thing; our profession will come out of this crisis with a lot of credit to its name and going forward, the PDA will be working hard to secure for pharmacists a new positioning in healthcare.

The Covid-19 vaccination programme is the next demand that is now being placed upon the profession, one which many pharmacists view as a game changing opportunity to take on the pandemic and help overcome the virus. It is evident that if we are to be involved, then pharmacists will want to undertake this task safely and competently.

Pharmacists have recognised that their 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 indemnity position

A core regulatory requirement placed upon all pharmacists is that their work is protected by professional indemnity insurance. We have, for some time, been in detailed and sometimes daily discussions with Department of Health and senior NHS officials about this very subject and we have engaged with the PDA’s indemnity underwriters to ensure that the indemnity arrangements are robust.

A different approach to vaccination delivery across the UK

The feedback that we are receiving from the NHS across the four countries of the UK indicates a fluid and rapidly developing situation with each country approaching the vaccination programme in a slightly different way. The plans will likely change over time as more vaccines become available. In Scotland, Wales and Northern Ireland the overall position at this time appears to be that the NHS will be operating the vaccination programme largely through secondary care centres with support from primary care hubs and some GP practices supported by Health Boards. In England, this programme is being additionally supplemented by a community pharmacy led vaccination service; this will not be delivered primarily from the ‘regular’ community pharmacy as such, but from a re-purposed facility (e.g., a church hall, a marquee or even another area from within a larger retail operation). In England, the current plan for the community pharmacy led vaccination service is that it will mainly deliver the Astra Zeneca vaccine once it has been approved.

Pharmacists will be involved in a variety of ways and in considering this, we offer clarification on our indemnity arrangements.

Pharmacists involvement in the vaccination programme

At this initial stage, there appear to be two main ways in which pharmacists will be supporting the Covid-19 vaccination programme.

1. Administration of the pharmaceutical oversight service

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 of the vials, cold chain and storage issues, the monitoring of expiry dates and times, keeping a check on batch numbers, providing advice and guidance, training, SOP supervision and implementation. Possibly even delivering elements of pharmacovigilance; such as monitoring and recording of adverse events. These are classic pharmacy roles and thus far hundreds of pharmacists across the UK have already risen to the challenge to undertake these tasks, much to the relief of their other healthcare colleagues.

The underwriters have accepted that pharmacists involved in these services, 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 PDA membership.

Pharmacists will always be required to ensure that they are competent to undertake such tasks through participation in the requisite training.

2. 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 many novel and as yet unquantifiable risks of liability to pharmacists, 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 this and the government’ will provide a significant degree of protection, this will take three forms.

  1. Immunity for vaccinators against the liability for any impact of the antigen is being granted through new 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.
  3. 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 or to anyone else 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. In England, on 22nd of December, NHS England announced the launch of the Clinical Negligence Scheme for Coronavirus which is applicable solely to support the establishment and operation of a community pharmacy led NHS Covid-19 vaccination service. All these schemes are designed to cover all staff that are employed or engaged by Trusts, GP practices or community pharmacies to deliver the vaccination programme.

Concerns for pharmacists about state backed arrangements

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.

In recognising the new and currently unquantifiable risks for pharmacists involved in the newly emerging activity of injecting Covid-19 vaccinations, as well as the state provisions being put in place alongside the limitations of the ‘state backed’ indemnity schemes, the PDA has sought to secure the appropriate indemnity and medico-legal protection arrangements for pharmacist vaccinators. It is recognised that as the vaccination programmes gather momentum, we will see the largest mobilisation of healthcare personnel that the UK has seen in its history. We expect that thousands of pharmacists from all sectors will eventually be involved directly in the vaccination programmes.

The PDA has therefore developed a solution that is designed to protect all members, and it has been achieved by establishing an extension to enable PDA members involved in Covid-19 vaccinations to enjoy independent protection if something goes wrong during their vaccination duties.

The PDA Covid-19 pharmacist vaccination extension

The Covid-19 pharmacist vaccination extension is designed to sit on top of any State Backed Schemes (where applicable), the UK Vaccine Damage Payment Scheme and the immunity provision protections. Because the risk of the effects of the antigen is shared with the state in this way, the PDA scheme provides indemnity for the process of the vaccination itself. In this way, it keeps costs to members low as well as protecting future membership fees from the unnecessary impact of the extra-ordinary risks involved by providing a lower limit of indemnity protection.

The extension will provide;

£250,000 limit for indemnity claims brought by patients claiming that they have been harmed by the pharmacist that delivered the injection of the vaccination.

Such a limit would enable the PDA to handle all claims caused by errors in the vaccination injection process, ensuring that the pharmacist’s interests were always at the heart of any claims handling exercise. Any additional costs caused by more expensive claims would be covered by state backed or other government provided indemnity schemes.  Overlaid on top of existing PDA membership indemnity, the Covid-19 vaccination extension would cover;

  • 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

£500,000 limit of cover for legal defence costs

  • Providing cover for all the medico-legal costs such as Regulator referrals, inquests, criminal prosecution and employment disputes.

Added to these specific Covid-19 vaccination injection related benefits are the wide range of additional PDA membership benefits to include PDA Union membership.

At £35, the PDA Covid-19 pharmacist vaccination extension offers protection for PDA member pharmacists who will provide Covid-19 vaccinations whichever sector of pharmacy, primary care or secondary care setting they are working in. As well as sharing the risk of claims with the state at this extra-ordinary time, identifying those pharmacists who are involved in Covid-19 vaccinations allows the PDA to provide members with risk management advice and any breaking news updates on incidents that have occurred. This means that the claims and incidents of the few, turn into the important risk management lessons of the many.

We know that the emergence of the pharmacy profession, driven by the actions of pharmacists at the coal face during the Covid crisis has been received very positively by the public and the government alike. At the PDA, we will work hard to ensure that this will become one of the enduring legacies of the pandemic and that these accomplishments are recognised when the future of healthcare delivery in a post pandemic world is considered.

CLICK TO AppLY FOR COVID-19 VACCINATION EXTENSION 

The Pharmacists' Defence Association is a company limited by guarantee. Registered in England; Company No 4746656.

The Pharmacists' Defence Association is an appointed representative in respect of insurance mediation activities only of
The Pharmacy Insurance Agency Limited which is registered in England and Wales under company number 2591975
and is authorised and regulated by the Financial Conduct Authority (Register No 307063)

The PDA Union is recognised by the Certification Officer as an independent trade union.

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