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Health professionals delivering unlicensed vaccines need government protection, say health bodies

The Royal Pharmaceutical Society said clarity was needed on how indemnity for healthcare professionals providing COVID-19 vaccines would apply to UK healthcare professionals “once we exit the EU”.

Open access article

The Royal Pharmaceutical Society has made this article free to access in order to help healthcare professionals stay informed about an issue of national importance.

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The British Medical Association said it supported the principle of expanding the range of people able to give immunisations, but that GPs should oversee this

Pharmacists and other health professionals administering unlicensed vaccines must be reassured that they will not be liable for any harm that results, health bodies have told the UK government.

Proposals to expand the range of people to deliver vaccines are part of a wider consultation document around changes to the human medicine regulations to support the roll-out of COVID-19 vaccinations. The proposals said that an expanded workforce was needed to ensure that the COVID-19 vaccine could be “safely deployed widely” as soon as it becomes available, and to ensure that the recently announced expanded flu vaccination programme could be delivered.

The proposals would also alter regulations on patient group directions (PGDs) to allow staff to provide vaccines that have only received temporary authorisation.

Responding to the consultation, which closed on 18 September 2020, the British Medical Association (BMA) said it supported the principle of expanding the range of people able to give immunisations, but that GPs should oversee this.

It also welcomed the recognition in the proposals that it would be “unfair” for healthcare professionals to take responsibility for the consequences of an unlicensed medicine or vaccine.

However, it said it would “welcome further explicit clarification” that this liability would lie with governments and health departments across the UK rather than individual healthcare professionals.

The Royal Pharmaceutical Society (RPS) echoed this call for clarification in its response to the consultation.

“It is vital that individual healthcare professionals supplying and administering the vaccination are also protected under the specified circumstances,” the RPS said.

“Indemnity insurance for individual healthcare professionals needs to be amended to cover this activity and be state-funded. There also needs to be clear communication to healthcare professionals, so they clearly understand that they are covered and under which circumstances this applies.”

The RPS highlighted that European legislation to provide blanket indemnity for all healthcare professionals providing COVID-19 vaccination services was “being considered”, but that clarity was needed on how this would apply to UK healthcare professionals “once we exit the EU”.

The RPS also said that any expansion of the workforce eligible to provide vaccinations should not affect pharmacies or pharmacists financially.

Both organisations highlighted the requirement for high-quality training for “any person administering the vaccination, whether a registered healthcare professional or not”, and asked for details on how this training would be provided “in times of social distancing” and how people would be assessed as competent.

The BMA also said that there needed to be an “understanding of the pressures” from delivering a potential COVID-19 vaccine programme alongside the flu programme, and that it would be “helpful” to use the delivery of the programme as an opportunity to “reduce the bureaucracy related to PGDs” by developing “an alternative, simpler system”.

Also responding to the consultation, the Association of Pharmacy Technicians UK said that once a COVID-19 vaccine was developed and mass immunisation programmes were required, the pharmacy technician workforce, although not specifically named in the government proposals, would be “an invaluable resource in all sectors”.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2020.20208381

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