Questions about signatories of PGDs

Jo Jenkins, Specialist Pharmacist (Patient Group Directions), Medicines Use and Safety (SPS)Published

This page summaries the requirement for signatories on PGDs and roles/responsibilities of those signatories.

Who are the PGD signatories?

Legislation requires that a PGD must be signed by a doctor (or dentist) and a pharmacist and guidance states that they should be involved in the development of the PGD.

Patient group directions (NICE guideline MPG2, 2017) recommends that, although not required by legislation, it is good practice for PGDs to be signed by representative/s of the registered health professional group (s) intended to supply and/or administer the medicine/s under the PGD. Where the representative of the registered health professional group/s is a pharmacist, it would be good practice to involve an additional pharmacist with expertise in the specific clinical area of practice who would use the PGD.

Additionally the PGD must be authorised by a representative of the relevant authorising body. Human Medicines Regulations 2012 Schedule 16 Part 2 defines the organisations on whose behalf a direction must be signed.  An organisation’s structure should determine which individual role incorporates the authority and responsibility to be the signatory in order to state that PGDs are fit for purpose. For example, this signatory is often the clinical governance or patient safety lead who has designated responsibility for signing PGDs on behalf of the authorising body.  Authorising bodies need to consider the knowledge, skills and expertise needed by people who are developing, updating, authorising and using PGDs and ensure that they are aware of their responsibilities and can demonstrate their competency.

Finally, an individual health professional must be authorised in writing to use the PGD by a senior person who is responsible for ensuring that only fully competent, qualified and trained health professionals use PGDs. An individual or multiple practitioner agreement may be used as a declaration of competence on behalf of the practitioner and as a designation of their authority and accountability for their decisions to supply and/or administer medicines using a PGD.

What experience and competencies are expected of signatories of PGDs?

Patient group directions (NICE guideline MPG2, 2017) sets out the experience and competencies expected of signatories. Supporting resources include competency frameworks.

multi-disciplinary PGD e-learning programme is available for all professionals, at whatever stage they might be involved in the process, to understand how to make sure that PGDs are developed, authorised and used safely.

What are the roles and responsibilities of the PGD signatories?

Roles and responsibilities of Patient Group Direction (PGD) signatories are summarised in the attached document as follows:

  1. Role and responsibilities of a doctor (or dentist) signatory
  2. Role and responsibilities of a pharmacist signatory
  3. Role and responsibilities of the signatory who is a representative of the professional group expected to supply medicines under the PGD
  4. Role and responsibilities of a Clinical governance lead involved in the organisational authorisation of the PGD
  5. Role and responsibilities of Managers of areas where PGDs are being developed, implemented and used.
  6. Responsibilities of Practitioners using Patient Group Directions.

To help establish these roles and responsibilities, associated duties are listed in the attached document. This document may be used as a checklist by organisations and individuals involved to ensure that they meet requirements.

Note: When a signatory signs a PGD they are acting within their role as agreed by their organisation/detailed in role specification – as such there is no requirement for a PGD to be resigned if a signatory leaves an organisation. The PGD Service Advisory Board has clarified that there is nothing in legislation to state that a PGD becomes invalid if a PGD signatory leaves their role.

Note: this is only intended a guide and organisations may wish to utilise the NICE PGD Baseline Assessment Tool  and refer to the recommendations in Patient group directions (NICE guideline MPG2, 2017)