The COVID-19 vaccination programme will be more ambitious than any undertaken before. The two-dose regimen plus storage requirements for some vaccines adds to the logistical difficulties
The UK government has ordered 40 million doses of the Pfizer/BioNTech vaccine. To put this number in perspective, in the 2018-19 season approximately 1.7 million annual flu jabs were given in England, according to the Pharmaceutical Services Negotiating Committee.
So how do legislative changes help? Firstly, in changes to Patient Group Directions (PGDs). It is already well known that pharmacists can administer vaccines, which are prescription-only medicines, under a PGD.
On October 16, the Department of Health and Social Care (DH) announced changes to the Human Medicines Regulations 2012 to allow pharmacists to supply the COVID-19 vaccinations – the Prizer/BioNTech version of which has been temporarily authorised – under a PGD. The direction for the COVID-19 vaccine was published on December 11.
Secondly, the DH introduced national protocols. For pharmacists, theirs is the “pandemic treatment protocol”, which contains details about service provision such as labelling and the obligation to supply with “reasonable promptness”.
These two amendments are picked up in a letter published on November 27 by NHS England and NHS Improvement (NHSE&I) that sets out how community pharmacy will be involved in COVID-19 vaccinations. The letter sets out three routes for pharmacy professionals:
- Join the COVID-19 vaccination programme.
- Support the primary care network (PCN) to deliver vaccinations though the GP service or at vaccination centres.
- Work in pharmacy-led COVID-19 vaccination sites.
Smaller independent pharmacies will struggle with pharmacy-led sites without collaborative groupings, as the sites will be running 12 hours a day, seven days a week and have significant staffing and infrastructure requirements.
The legal process behind the vaccine delivery is partly laid out in the COVID-19 standard operating procedure (SOP), which covers the details of administration.
The SOP also clarifies that with the COVID-19 vaccine there is “no legal requirement for consent to immunisation to be in writing”. However, consent has to be informed and recorded. When patients are unable to give consent, the decision to vaccinate must be made on the basis of the patient’s best interests in line with the Mental Capacity Act 2005.
There are also changes to the Human Medicines Regulations regarding logistics. The requirement for those providing the vaccines to have a wholesale dealer’s licence has been removed in some circumstances.
This amendment was required because usually, if there are regional shortages, then one supplier’s excess vaccines have to be returned to the wholesaler before they can be sent to another supplier with too few vaccines. This is time consuming and, where there are strict storage requirements, not feasible.
The legal change permits authorised entities at the end of the supply chain to distribute the vaccine without a wholesale dealer’s licence. This aims to prevent backlogs and would open the way to bring in the army to assist the vaccination programme. The change is scheduled to cease effect in April 2022.
Given the logistical challenges and the significant expertise and experience that pharmacists have to offer, their support for the vaccination programme is crucial.
And assistance is needed – the impact assessment looking at the effect of the Human Medicine Regulation changes made an “optimistic” estimation that it will take only to 21 weeks to deliver COVID-19 and flu injections to the at-risk population following the legal changes.
Susan Hunneyball is consultant solicitor at Gordons Partnership law firm, this article represents her views alone