Introduction

All injectable medicines are Prescription Only Medicines (POM). Therefore they must be prescribed prior to administration or administered under an alternative legal mechanism.
Below we summarise the available mechanisms, signpost to available resources that describe them, and give common points of clarification concerning their use for COVID-19 vaccination.
This page should be read in conjunction with NHS England’s Summary of the legal mechanisms for administering the COVID-19 vaccine(s).

Option 1: National Protocol

This is the primary mechanism for the majority of mass vaccination deployment models. It can be used by a single registered healthcare professional undertaking all stages of the vaccination process, or by up to four persons undertaking different stages, as detailed in the national protocol. It has been introduced specifically to support the vaccination programme and is a new legal mechanism following amendment of the Human Medicines Regulations.

Hence, the protocol allows a wider range of suitably trained and competent persons to deliver the vaccination programme. The operational stages of activity that can be undertaken by registered and non-registered persons are detailed in the national protocol.

Active National Protocols for COVID-19 vaccines

Common national protocol clarifications

Local authorisation

The National Protocol does not require local authorisation.

Option 2: National Patient Group Direction (PGD)

This mechanism fits the deployment method where a single registered healthcare professional undertakes the entire process. The registered HCP must be listed in Patient Group Directions: Who can use them.

Under a PGD all stages must be undertaken by the same registered healthcare professional; if any part of the process is undertaken by another person, then the National Protocol should be used and not the PGD.

The PGD is an option where a specified registered healthcare professional is working without the clinical supervision of a doctor, nurse or pharmacist which is a requirement of the National Protocol.

Active national PGDs for COVID-19 vaccines

You can find more background information about PGDs in our guide

Common PGD clarifications

Delegation

Delegation of responsibilities to another healthcare professional is not permissible. All aspects of use covered by the PGD including clinical assessment, preparation (drawing up), administration, and record keeping must be undertaken only by the same registered healthcare professional working under this direction. See our guide Delegation of roles under a PGD.

Exception to delegation for COVID-19 vaccines requiring reconstitution/dilution

If dilution/reconstitution of a COVID-19 vaccine is required, this can be undertaken by another suitably trained person, under the supervision of a doctor, nurse or pharmacist (Regulation 3A) The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020.

Local authorisation

The national PGD does not require local authorisation.

Doctors, dentists, and PGDs

Doctors and dentists cannot work under a PGD. See our guide Doctors, dentists, and use of PGDs

Option 3: Patient Specific Directions (PSDs)

Where an individual falls outside the inclusion criteria stated in the National Protocol or PGD, they need to be clinically assessed on an individual basis to receive vaccine by a prescriber. If this results in a decision to vaccinate, a PSD should be used.
For background on PSDs, refer to our guide Patient Specific Directions (PSD)

Common PSD vaccination clarifications

Doctors and independent prescribers can write a PSD for a COVID-19 vaccine with a UK marketing authorisation if clinically competent. Dentists should see our specific advice.

Use for health and social care staff

A PSD is a suitable mechanism to vaccinate health and social care staff. See also Patient Specific Directions (PSD)

Use of a PSD including when the prescriber is working remotely

A PSD is a suitable mechanism for use by prescribers, including those working remotely, across PCN sites. However, the prescriber must:

• accept their duty of care and professional and legal accountability—they should ensure that the person to whom they delegate has the qualifications, experience, knowledge and skills to provide the care or treatment involved.
• the practitioner issuing the PSD remains responsible for the care delivered under it and should be contactable should issues arise.
• be mindful that the delivery model may require Regulation 3A The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 to be met (i.e. where the vaccine is not prepared and administered by the same person acting under the PSD).

Retaining records following vaccine administration

The individual’s clinical record is maintained for 8 years for an adult and up to the 26th birthday if given to a child under the age of 18, as per general retention of clinical records.

If a paper PSD is completed, this needs to be included in the individual’s electronic clinical record as this is the legal authorisation for administration. Records Management Code of Practice 2021 has further advice on scanning documents into clinical records.

Other mechanisms: Written Instructions

Common written instruction clarifications

Vaccinating health and social care staff using a written instruction

A written instruction is not the correct mechanism for the provision of COVID-19 vaccination to health and social care staff.
This is because all COVID-19 vaccination is part of the nationally commissioned vaccination programme and is not being provided as an Occupational Health Service (OHS). Therefore the mechanism for health and social care staff vaccination will be via the national protocol, national PGD or PSD.

Further reading

Information on legal mechanisms for supply and administration of medicines by staff group can be found in the relevant SPS articles:

• Supply and administration of medicines by staff group (A to G)
• Supply and administration of medicines by staff group (H to O)
• Supply and administration of medicines by staff group (P to Z)

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