The Medicines and Healthcare Products Regulatory Agency (MHRA) has sought legal advice and has confirmed that local authorities cannot delegate responsibility for organisational authorisation of PGDs to Clinical Commissioning Groups (CCGs) under a Section 75 agreement.
Organisational authorisation of PGDs by a local authority should be carried out by the Chief Executive or Director of Public Health of the local authority. However, this responsibility may be delegated to a clinical governance lead such as a Medical or other Clinical Director in the local authority. The Chief Executive or Director of Public Health would need to determine and note formally which individual would have the authority and responsibility to be the signatory in order to state that PGDs are fit for purpose.
For further information about PGD signatories, see the link below.
A Clinical Commissioning Group (CCG) can support the writing, checking and clinical authorisation of PGDs by doctor /pharmacist signatories who are employed by them. This should be a formal arrangement between the local authority (LA) and the CCG with agreed processes and policies to support this arrangement and to comply with Patient Group Directions (NICE guideline MPG2 2017). For further information also please refer to Patient Group Directions in Complex Commissioning Scenarios
The medicines decision-making committee of the CCG such as the Medicines Management Committee cannot extend the expiry dates of PGDs for services commissioned by the LA. The committee may provide clinical opinion or guidance to the LA as to whether this is safe or appropriate. For further information about extension of expiry dates, see Is extension of an expiry date of a PGD allowed without review and re-authorisation of the PGD?
Specialist Pharmacist (Patient Group Directions) SPS Medicines Use and Safety Division