Authorising Patient Group Directions at organisational level

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

This page provides advice to organisations on the process required to authorise PGDs at organisational level.

Patient group directions (NICE guideline MPG2, 2017) acknowledges that a number of scenarios may exist for developing and authorising PGDs.

To consider the local arrangements required for developing PGDs which require prior agreement of the authorising body, see Quality PGDs – Seven Steps to Success which is a useful resource to consider the actions required for this stage.

There is a separate Q&A covering the responsibilities of independent health care provider organisations who are commissioned to provide an NHS or public funded service. This covers the legal position and the responsibilities of commissioners and providers and the authorisation of PGDs.

Further advice on use of PGDs in complex commissioning scenarios can be found here

In all cases, there should be a robust and transparent process for the authorisation of PGDs.

A locally determined multidisciplinary PGD approval group will be (or will report to) the local decision making committee responsible for clinical governance within the organisation. Each organisation will have its own clinical governance framework that ultimately reports to the Board. The PGD approval group must sit within this clinical governance framework; it is for organisations to decide where it fits best.

The PGD approval group should be able to provide evidence to the clinical governance or patient safety lead (who will sign the PGD on behalf of the authorising organisation) to demonstrate that PGDs have been developed in line with legal requirements, PGD NICE guideline MPG2 2017 recommendations and local governance procedures.

The PGD must include all authorisations and signatures that are required by legislation. Additional signatures may be added when considered to represent good practice. Electronic systems may be used for authorisation.

Failure of organisations to agree and document clear lines of accountability and responsibilities could result in a significant risk to the organisation(s) involved and to delivery of patient care.

Timeframes should be agreed for each stage of the process. Undertaking duties, within those locally agreed timeframes, which account for the required legal and governance processes for PGD authorisation, will help ensure that PGDs can be approved and services delivered in a timely and appropriate manner.

For more information about signatories of PGDs, see link below