Legal framework for administering vaccinations
Healthcare assistants (HCAs) can administer flu vaccines, provided robust protocols are in place that follow the legal framework for administration.
As we explain below, it's necessary to confirm that an assessment of the patient has taken place by the prescriber and that the patient's individual suitability to receive the vaccine has been assessed.
Flu vaccinations are usually prescribed using a patient group direction (PGD). This allows licensed medicines to be supplied or administered by a named health professional to a group of patients who meet the criteria defined in the PGD.
The health professional is responsible for selecting appropriate patients and for obtaining the consent or parental authority. The Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the use of PGDs. Public Health England has also produced PGD templates to support national immunisation programmes.
Assessing patient suitability
HCAs can administer vaccinations to a named patient or several named patients but can only do so following instruction and assessment from a GP or independent nurse prescriber using a patient specific direction (PSD). As part of the PSD there needs to be evidence to confirm that the patient was considered on an individual basis.
The prescriber's written or electronic instruction to the person administering the vaccine should be included in the clinical record. A verbal instruction or letter of invitation to the patient cannot replace this.
Guidance from CQC and NHSE also makes clear that a PSD can be an instruction to administer a medicine to a list of patients, but each patient on the list must be individually assessed by the prescriber. To do this, the prescriber must have knowledge of the patient's health and be satisfied the medicine meets the individual needs of each patient on that list.
If a HCA is running a flu immunisation clinic, the prescriber must review the patients attending the clinic and sign a list of those who they authorise to be immunised.
Indemnity
GP members can come to the MDU for advice and support with complaints, disciplinary investigations, adverse incidents or other issues relating to HCA vaccinations.
If a claim arises in NHS practices in England and Wales, these are covered by the state indemnity scheme. In Northern Ireland and Scotland, the MDU can provide GP members whose HCA staff administer vaccines with indemnity, provided certain safeguards are in place and that our membership department is informed.
It's worth noting that the state indemnity scheme excludes practices vaccinating their own staff. However, providing immunisations to practice staff is included within the benefits of MDU membership for GP members at no additional charge. It is important that all GP partners have their own indemnity in place in respect of their potential vicarious liability for such services.
Subject to the right safeguards, practices can ensure the efficient running of the flu vaccination programme by involving trained staff, such as healthcare assistants.
Read our guide to flu vaccinations for GP practices.
A version of this article first appeared on GP online.
This page was correct at publication on 12/01/2022. Any guidance is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.
by Dr Kathryn Leask Medico-legal adviser
BSc (Hons) MBChB (Hons) LLB MA MRCPCH FFFLM RCPathME DMedEth
Kathryn has been a medico-legal adviser with the MDU since 2007 and is a team leader, trainer and mentor in the medical advisory department. Before joining the MDU, she worked in paediatrics gaining her MRCPCH in 2002 and holds a CCT in clinical genetics. She has an MA in Healthcare Ethics and Law, a Bachelor of Law and a Professional Doctorate in Medical Ethics. She is also a fellow of the Faculty of Forensic and Legal Medicine and has previously been an examiner and deputy chief examiner for the faculty. Kathryn is currently a member of the faculty’s training and education subcommittee and a member of the Royal College of Pathologists (medical examiner).