Is extension of an expiry date of a PGD allowed without review and re-authorisation of the PGD?

Jo Jenkins, Specialist Pharmacist (Patient Group Directions) SPS Medicines Use and Safety Division · Source NHS PGD Website · Published · Updated

This should be exceptional practice e.g. during organisational or service transition and should be for an agreed and limited period of no longer than one year. In line with the recommendations made in NICE MPG 2 (2017) the total valid period of a PGD should not exceed three years from the date the PGD was authorised.

Extension of expiry dates without review of a PGD is not without risk (e.g. licence of medicine may have changed/national guidance may have changed) but the organisation may deem this necessary where it is in the interests of patient safety; for example there may be a risk where withdrawing the PGD could result in significant service disruption and potential patient safety issues due to lack of access to medicines.

There should be agreed local processes for extension of expiry dates and this is an organisational not an individual responsibility.

If a period of extension is agreed, then this should be formally noted by the organisation alongside an agreed plan of action with timescales for review and re-approval of the PGD. The re-approval process should include a relevant audit of the PGD and its use.

It is not acceptable or legal for an individual practitioner to decide to use a PGD that has expired.

Organisations should ensure that all managers and practitioners working under the PGD are made aware of any expiry date extension of the PGD and any required action e.g. to commence review/audit.

Practitioners who do not wish to practice under a PGD that has had an extended expiry should discuss concerns with their manager in the first instance.