The attached document provides guidance for IHPs and commissioning organisations where the IHP agrees to take responsibility for development and authorisation of PGDs, prior to the necessary authorising organisation sign off by the commissioning organisation for NHS and public health services.
It is intended that the attached document with additional appendices should be considered as a whole. The aim is to help both IHPs and commissioning organisations achieve the requirements of PGD legislation and guidelines.
This document is not a substitute for Patient group directions (NICE guideline MPG2, 2017) and all organisations involved are responsible for ensuring that they comply with legal requirements and recommendations of the guideline.
The Medicines and Health Regulatory Agency (MHRA) takes the view that where a PGD is used for NHS/public health funded healthcare under arrangements made with an NHS or public health body, the law requires that the PGD is authorised by that body. This applies to PGDs used for the provision of NHS and public health funded services under arrangements between NHS bodies/local authorities and CQC registered independent medical agencies. Therefore, independent healthcare providers cannot provide organisational authorisation for PGDs used to deliver NHS or public health commissioned services.
The organisational authorisation in this case is the responsibility of the commissioning organisation who must be listed in the legislation as able to authorise a PGD in England. These are:
- clinical commissioning groups (CCGs)
- local authorities
- NHS trusts or NHS foundation trusts
- Special health authorities
- NHS England
- Public Health England
IHPs should note that each PGD must be authorised by each organisation which commissions the service. Commissioning in some circumstances may be across a number of organisational boundaries. Where this is the case, commissioners may wish to take advice to explore how to develop a formal agreement for sign off using a “single operating model” approach.
A number of scenarios exist for the development and authorisation of PGDs, depending on how services are commissioned and the organisations involved. It is not possible to provide advice for each and every one within this document.
Specialist Pharmacist (Patient Group Directions), Medicines Use and Safety Team