DHSC proposes to expand scope of vaccines pharmacies can deliver offsite

The government has proposed new regulations that would enable pharmacies to provide ‘wider outreach vaccination services’ away from the pharmacy premises.

This month the Department of Health and Social Care launched a consultation on a series of amendments to the Human Medicines Regulations (HMRs) 2012 which had been first changed in response to the Covid-19 pandemic.

In 2020, one regulation – R233 – was amended to allow retail pharmacies providing Covid or flu vaccines under a PGD to provide that service away from their registered premises, for example at pop up vaccination sites. In 2022 this became permanent legislation.

In a new proposal, the government has suggested this scope be expanded to include ‘all vaccinations against a vaccine preventable disease’.

The DHSC said the move would ‘help provide parity between pharmacy businesses and other healthcare providers, who can already provide offsite vaccinations in places such as community centres or places of worship’.

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‘It will also help support the health system’s ability to react quickly to emerging outbreaks and allow providers to offer services tailored to local needs,’ the consultation said.

‘This in turn will help to increase access to vaccinations, support uptake and ultimately help to protect the public’s health, while maintaining important safety assurances.’

The consultation also proposes regulation of the movement, preparation and labelling of vaccinations in defined circumstances (R3A and R19), and the use of a flexible workforce for vaccine administration (S17 and the proposed new legal provisions replacing R247A).

The consultation focuses on six regulations within the HMRs:

• Regulation 3A which allows trained healthcare professionals, or staff under the supervision of trained healthcare professionals, to assemble and prepare Covid vaccines without additional marketing authorisations or manufacturer’s licences being required;
• Regulation 19 (4A) to (4D) which allows Covid and flu vaccines to be moved between different NHS service providers operating under NHS arrangements or the medical services of His Majesty’s Armed Forces, without the need for a wholesale dealer’s licence;
• Regulation 247A which enables the use of an extended workforce who are legally and safely able to administer Covid or flu vaccines without prescriber input;
• Regulation 233(8) which enables pharmacy owners to deliver Covid and flu vaccination services off the pharmacy premises under a patient group direction (PGD);
• Regulation 3 which enables doctors, dentists, nurses and midwives to prepare medicines for a patient during their course of treatment without a manufacturers’ licence;
• Schedule 7 which allows occupational health vaccinators – permitted under an occupational health scheme – to administer Covid and flu vaccines.

The government said it was seeking to further amend the HMRs to ‘ensure that lessons learned during [the pandemic] can be used to support the safe supply, distribution and administration of a wider range of vaccines both now and in the future’.

Regulation 233

This consultation proposes to expand the scope of R233(8) to include all viral and bacterial infections that can be prevented with a vaccine.

Responses to the previous HMRs consultation suggested that pharmacies being able to offer Covid and flu vaccinations offsite was ‘useful in supporting outreach opportunities’ and had been regularly used by community pharmacists.

It had also allowed ‘hundreds of pharmacies’ to offer pop up clinics – particularly where there were infection clusters or large groups of unvaccinated patients – and to vaccinate residents and carers in care homes.

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The consultation document added: ‘It is likely that community pharmacies will play an even bigger role in the future, including offering bespoke vaccination services, tailored to the needs of the populations they serve.

‘Equally, the clinical functions of community pharmacists have also been evolving, with many now qualified as independent prescribers.’

Regulation 3

The consultation is also seeking to expand a regulation that would make provision for pharmacists and pharmacy technicians to prepare or assemble medicines for patients without a manufacturer’s license under limited circumstances.

This regulation – Regulation 3 – currently only enables doctors, dentists, nurses and midwives to be able to prepare or assemble medicines for a patient in the course of their treatment without a manufacturers’ licence. They can only do so provided the medicinal product is to supplied to either a patient in the course of the treatment of that patient or to a patient of another doctor who is a member of the same medical practice.

At the same time, the government is looking to lapse part of this regulation which was specifically related to Covid vaccines and allowed trained healthcare professionals to assemble and prepare those vaccines without additional marketing authorisations or manufacturer’s licences.

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The provision was extended twice due to the continued need for a Covid-19 vaccination programme.

However, this consultation proposes to let R3A(1) and (2) end on 1 April 2026 because these regulations are ‘no longer required’.

The proposal to remove the provisions under R3A (1) and (2) means that pharmacists would no longer be able to prepare or assemble a vaccine when working at a location away from the registered pharmacy premises.