The administration of all medicines in the UK is regulated through the Medicines and Health Care products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care (DHSC). The legislation applies across the UK and includes authorisation and licencing of medicines.
The Medicines Act first came into legislation in 1968 (Medicines Act 1968), following concerns about the use of the drug thalidomide in pregnancy and the resulting fetal damage. It was introduced as a way of regulating the pharmaceutical industry and the supply of medicines to the public. Since 1968 there have been a number of amendments to the legislation. The current medicines legislation relating to the supply and administration of prescription only medicines is in the Human Medicines Regulations 2012 (HMR 2012) and subsequent Statutory Instruments providing amendment to the Regulations. Notably, this includes the emergency legislative changes in the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020.
The majority of clinical care involving supplying and/or administering medicines should be undertaken on an individual, patient-specific basis (ie the medicine is prescribed to an individual by a prescriber). Getting a prescription signed for each vaccine being given in a busy clinic is not practical and was in the past a barrier for nurses taking on the role of vaccination (Nursing Standard, 1989). There are now clear legal mechanisms allowing for the safe supply and/or administration of medicines in specific situations by specified registered healthcare professionals without the need for a prescription. This has enabled vaccine clinics and vaccine administration to become increasingly non-prescriber-led, particularly by registered nurses and pharmacists.
Legal administration of vaccines
All vaccines are classified as Prescription Only Medicines (POM) under the legislation (HMR 2012), as such they cannot be supplied and/or administered unless there is a valid prescription/patient specific direction (PSD) or appropriate legal mechanism available.
Medicines are authorised for use in the UK by the MHRA. This will be based on the information submitted by the manufacturer. The detail of the authorisation is available from the MHRA in the public assessment report (PAR) and on how the medicine should be used in the Summary of Product Characteristics (SmPC) (MHRA and Department of Health and Social Care, 2022).
There may be occasions where it is in the best interests of patients to receive a medicine outside the terms of the SmPC. This is known as ‘off-label’ use of a medicine.
For example, the ‘Green Book’ sometimes differs in its recommendations on the use of vaccines from that given in the manufacturer's SmPC. Recommendations in the Green Book are themselves based on those from the Joint Committee on Vaccination and Immunisation, based on the best available evidence. Where such ‘off-label’ use occurs Patient Group Directions (PGDs), protocols, Written Instructions and Patient Specific Directions (PSDs), further described in this article, should reflect recommendations in the Green Book. Very occasionally vaccines without a UK license may be imported for use in a national immunisation programme, usually to mitigate shortages of UK licensed vaccines. Unlicensed medicines must only be prescribed.
Patient specific direction/prescription
A patient specific direction (PSD) is the traditional and preferred way that medicines are supplied and/or administered to a named individual(s) after a prescriber has assessed them on an individual basis – PSDs may be referred to as prescriptions in practice. A PSD is written and then signed by an authorised prescriber. A PSD can be for one individual at a time or several named patients; for example, a single PSD can be prepared for a number of named individuals booked to attend an influenza vaccine clinic, who the prescriber has individually assessed as being suitable to receive the vaccine. The record of the administration needs to be clearly stated in each individual's clinical record, alongside the PSD.
A PSD may be utilised where an individual does not fulfil the inclusion criteria for vaccine administration under one of the other legal mechanisms, such as a PGD, outlined below.
The prescriber is responsible for the assessment of the individual(s) named and the PSD provides directions in writing, detailing the medicines to be supplied or administered. The prescriber can delegate the administration of a medicine they have prescribed to an appropriately trained and competent individual. See below for more information and the Specialist Pharmacy Service (SPS) guidance on the use of PSDs.
In summary, in vaccination services:
- A PSD provides a written instruction from a prescriber to another healthcare practitioner to legally authorise them to administer a vaccine directly to a named individual/several named individuals
- PSDs are individually tailored to the needs of a single individual, or a specific list of individuals and should be considered preferable to a PGD, where they can be provided in a timely manner without compromising patient access to vaccination services
- The prescriber is responsible and accountable for the decision to prescribe and is also accountable for any delegation of the administration of the medicine to another health care practitioner.
Alternative legal authorisation for medicines relevant to vaccination
The HMR (2012) includes several legal medicine mechanisms which can be utilised to administer vaccines without the need for a PSD. These mechanisms are detailed in Box 1.
Box 1.Summary of alternative authorisation mechanisms relevant to vaccination
- Patient group direction (PGD): medicines may be supplied and/or administered in accordance with a PGD (Schedule 16 of HMR 2012 legislation)
- Written instruction: medicines may be supplied and/or administered by certain registered practitioners in accordance with the written directions of a doctor in the course of an occupational health scheme (Schedule 17 of HMR 2012 legislation)
- National protocol: Under the emergency legislative changes in the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 a new regulation, 247A allows for COVID-19 and influenza vaccine delivery under a protocol in specific circumstances such as a pandemic
- Emergency medicines: Certain medicines can be administered by anyone in an emergency without the need for any legal authorisation. This includes adrenaline 1 in 1000, which can be administered in an emergency for the purpose of saving life (Schedule 19 of HMR 2012 legislation)
Patient group direction
A patient group direction (PGD) provides a legal framework for certain registered healthcare professionals, listed in the legislation, to supply and/or administer medicines without the need for them to be prescribed.
A PGD is a written instruction for the supply or administration of medicine to individuals in a defined group, who may or may not be individually identified before presentation for treatment.
- The use of a PGD should be reserved for situations where this offers an advantage for patient care without compromising patient safety
- PGDs are not appropriate for use in all settings or for all medicines – for further advice see the webpage from the SPS (2022a)
- Organisations should have governance processes in place to consider all options before a service is designed or commissioned using PGDs
- Before use of a PGD is authorised, the organisation must ensure that PGDs are appropriate, legal and that relevant governance arrangements are in place.
SPS have a range of resources supporting PGD use (SPS, 2022b).
The legislation is specific on who can work under a PGD. Registered nurses (RNs) can use PGDs, but unregistered staff, such as healthcare support workers (HCSW) or nursing associates (NA), cannot. Where these staff are supporting vaccination clinics they will need a PSD or to be working under a National Protocol (see more detail later in the article).
The MHRA (2017) state that only fully competent, qualified, trained professionals can use PGDs for the supply and/or administration of vaccines; PGDs cannot be used as part of training. National Institute for Health and Care Excellence (NICE) guidance on PGDs (NICE, 2017) recommends that a comprehensive and appropriate training programme be provided for all people involved in using PGDs, with an assessment of competency used post-training. Additionally, the Nursing and Midwifery Council (NMC) Code states that nurses must be up to date with skills and knowledge and use the best available evidence (NMC, 2022). Having relevant training in immunisation and vaccination is a key requirement for use of vaccine PGDs.
- The healthcare professional authorised to use the PGD must be the one to undertake the complete episode of care. This includes: clinical assessment of the individual; ensuring the person has given consent; the administering or supplying of the vaccine; and completion of the records
- A healthcare professional working under a PGD cannot delegate any part of the process to another person, whether this is a support worker, a student or another registered professional able to work under the PGD
- Where a vaccine is not an injection, a PGD may be written to allow the healthcare professional to supply the vaccine to an individual, or their carer, for subsequent self-administration or administration by another person; an example of this in practice is the administration of the intranasal flu vaccine
- Good clinical governance must be in place to ensure all immunisers are appropriately trained and have support and supervision available.
PGDs are a useful tool to allow for vaccines to be administered to those who need them in a timely manner. The legislation is clear on how PGDs should be developed and used. PGDs have to include specific information and have a clear governance process to support their use.
There are national PGD templates for all the vaccines recommended in the routine immunisation schedule for use in England (UK Health Security Agency (UKHSA), 2022).
The UKHSA templates have been signed by a doctor, nurse and pharmacist, from the national immunisation team, who have led their development. The templates must have organisational authorisation in accordance with Schedule 16 of HMR 2012 from the local/national commissioner or provider before they can be used, for example, the NHS Trust or commissioning organisation. See the SPS implementation guidance for more advice (SPS, 2022c).
These templates are also provided as a reference resource to NHS organisations in Wales (Public Health Wales, 2022) when developing their own PGDs. There is a similar arrangement in Northern Ireland where the UKHSA templates are used as a reference and amended and authorised accordingly by a multi-disciplinary team. In Scotland, national specimen PGDs for vaccines are produced by Health Protection Scotland to assist NHS boards to develop local PGDs (Public Health Scotland, 2022).
Written instructions
Under the legislation, occupational health services or schemes (OHS) may utilise an exemption from the restrictions that apply to the supply and administration of prescription only medicines (Schedule 17 HMR 2012).
An OHS is designed to help protect and promote workers' physical, mental and social health and well-being. Medicinal products can be supplied or administered in the course of an OHS by a registered practitioner acting in accordance with the written and signed instruction of a doctor, commonly documented as a written instruction. A written instruction is not subject to the legislated framework of a PGD and a written instruction is not interchangeable with a PGD. A written instruction template is available from the BMA (2019) document ‘The Occupational Physician’ appendix 6.
With the exception of flu and coronavirus vaccines, a written instruction is an arrangement between a named registered nurse or group of named registered nurses and an authorising OHS doctor to allow for the supply and/or administration of a medicine for an occupational health purpose. No other healthcare professionals can work under an OHS written instruction.
Vaccines given in the course of an OHS should be undertaken using a written instruction or a PSD (SPS, 2020).
Where influenza or coronavirus vaccines are given as part of an NHS or local authority OHS, including peer to peer vaccinations, then the legislation allows for a wider group of healthcare professionals to work under these specific written instructions – this group of registered healthcare professional are termed ‘occupational health vaccinators’ and they include registered midwives, pharmacists and nursing associates (SPS, 2022d).
To support the delivery of the influenza vaccine and peer to peer vaccination, there is a written instruction template specifically for influenza vaccine, which can be adopted by organisations (SPS, 2022d).
National protocol
The national protocol option comes under the emergency legislative changes in the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020. The new regulation – 247A – allows for COVID-19 and influenza vaccine delivery under a national protocol in specific circumstances such as a pandemic.
The national protocol allows the vaccination process to be separated into specific tasks or stages (consent and clinical assessment, preparation, administration and record keeping). The national protocol details who can undertake each stage (ie listed registered healthcare professionals, unregistered healthcare professionals etc). Only registered healthcare professionals listed in the protocol are able to undertake the consent and clinical assessment stages; they may also undertake the other stages or these may be subsequently undertaken by another healthcare professional, as detailed in the national protocol. This is in contrast to a PGD where the entire process has to be undertaken by a single registered healthcare professional working under the PGD.
This separation of stages of the vaccination process can improve workflow and increase the available workforce.
Medicines that may be administered in an emergency
The legislation (Schedule 19 HMR 2012) allows certain medicines to be administered by anyone in an emergency without the directions of a prescriber or other legal authorisation. Specifically for the administration of vaccines, vaccinators need to be aware of this in relation to adrenaline that needs to be administered in the event of an anaphylactic event following vaccine administration. While anaphylaxis after a vaccination is rare, adrenaline must always be available (UKHSA, 2013). If it is needed there is no requirement for any practitioner to have any specific authorisation to administer it. All vaccinators must therefore ensure they are appropriately trained in how and when to use adrenaline and how to manage anaphylaxis following national guidance (Resus Council, 2021).
Best practice guidance on vaccine administration
The person administering a vaccine needs to follow best practice, know what the vaccine is for, how it works, how it should be used and any possible side effects. The standards for best practice on medicines administration are set out in the joint RCN and RPS guidance (2019).
When administering a vaccine, the quick guide in the RCN ‘Managing childhood immunisation clinics’ (RCN 2021) and the RCN immunisation services delivery resource (RCN, 2022) includes a useful check list using 8 rights (Rs) (Table 1).
Table 1. The 8 Rs for vaccine administration
| Before giving a vaccine always check: |
|---|
| 1. Right patient |
| 2. Right vaccine and diluent (where applicable) |
| 3. Right to give (ie no contraindications) |
| 4. Right time (including correct age and interval, as well as before the product expiration date) |
| 5. Right dose |
| 6. Right route (including correct needle gauge, length and technique) |
| 7. Right site |
| 8. Right documentation (to ascertain what the patient has already had/needs) |
Although best practice is for any medicine or treatment to be provided on a named patient basis, this is not always supportive of easily accessible and timely vaccine administration. The provision of vaccination should be readily available so that individuals can receive vaccines easily and not have to wait for long periods of time for appointments. It is not always easy to predict who will be coming into the clinic, so obtaining a PSD either in advance or at the time of presentation may put unnecessary barriers in the way, and as such a PGD is an accepted tool for vaccination (Kenny, 2013).
In practice, therefore, unless the healthcare professional administering the vaccine is a prescriber, it has become common practice for the supply and/or administration of vaccines in non-prescriber led clinics or school-based vaccination sessions to be under a PGD or other legal mechanism.
The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020, introduced in response to the COVID-19 pandemic, offer an advantage over PGDs in that the resulting national protocols for the administration of COVID-19 and influenza vaccines allows the separation of tasks within the vaccination process as detailed in the national protocol. In turn, this has facilitated an expanded vaccination workforce necessary to provide a rapid and mass response during the COVID-19 pandemic.
Conclusion
The legal administration of vaccines causes some concern in practice settings. This is often because people do not fully understand the legal requirements and the rationale behind these. This article details the legal mechanisms healthcare professionals may utilise to support vaccine administration. The ultimate goal of safe and effective vaccine administration is to optimise the benefits that treatment offers and attain the best outcome for each individual and it is an integral part of healthcare practice.
Effective medicines management places the individual as the primary focus, thus delivering timely, targeted care and better informed individuals. It is recognised that while the majority of prescribing should be provided on an individual, patient-specific basis, PGDs and other medicine mechanisms may offer an advantage for individuals by making vaccines readily accessible without compromising safety.
KEY POINTS
- As prescription only medicines, the preferred way for vaccines to be authorised for administration is under a patient specific direction (PSD) following an individual assessment
- Patient group directions (PGDs) provide an alternative legal mechanism for administration without a PSD
- PGDs can only be used by certain registered health care professionals who need to complete the full direction and cannot delegate any part of the process
- Written instructions and national protocols are other limited legal mechanisms use for vaccination
- All immunisers need to understand the legal authorisation routes for safe supply and or administration of vaccines
CPD reflective practice
- How confident are you that you understand the legal requirements around the administration of vaccines?
- Are there any particular topics that you are still unsure about? Where could you get more information on these topics?
- Could you discuss this article with your colleagues and share any issues surrounding this in your practice?
Further guidance and resources
Royal College of Nursing (RCN) ‘Medicine supply and administration’ resource: https://www.rcn.org.uk/clinical-topics/medicines-management/medicine-supply-and-administration
RCN ‘Immunisation services delivery’: https://www.rcn.org.uk/clinical-topics/Public-health/Immunisation/Immunisation-services-delivery
GP mythbuster 19: Patient Group Directions (PGDs)/Patient Specific Directions (PSDs): https://www.cqc.org.uk/guidance-providers/gps/nigels-surgery-19-patient-group-directions-pgds-patient-specific-directions
National Institute for Health and Care Excellence. Medicines Practice Guideline 2 (MPG2) Patient group directions: https://www.nice.org.uk/guidance/MPG2
UK Health Security Agency national PGD templates: https://www.gov.uk/government/collections/immunisation-patient-group-direction-pgd
Resources from Specialist Pharmacy Service (SPS):
- An introduction to PGDs: definitions and examples of use: https://www.sps.nhs.uk/articles/what-is-a-patient-group-direction-pgd/#:~:text=Definitions%20and%20guidance,-A%20Patient%20 Group&text=PGDs%20allow%20health%20care%20professionals,an%20instruction%20from%20a%20prescriber
- When to use a PGD: https://www.sps.nhs.uk/articles/when-to-use-a-pgd-2/
- Questions about Patient Specific Directions (PSD): https://www.sps.nhs.uk/articles/questions-about-patient-specific-directions-psd/
- Questions about signatories of PGDs: https://www.sps.nhs.uk/articles/questions-about-signatories-of-pgds/#:~:text=Who%20are%20the%20PGD%20signatories,the%20development%20of%20the%20PGD
- Written Instruction for the administration of the seasonal flu vaccination: https://www.sps.nhs.uk/articles/written-instruction-for-the-administration-of-seasonal-flu-vaccination/
- PGDs and Occupational Health Services: https://www.sps.nhs.uk/articles/pgds-and-occupational-health-schemes/