Off-label medicine use under a Patient Group Direction

Jo Jenkins, Specialist Pharmacist (Patient Group Directions) SPS Medicines Use and Safety Division Source NHS PGD WebsitePublished

The below summary explains the legislation and guidance on the use of PGDs when a medicine is to be used outside its licence ('off-label')

Licenced medicines can be used under PGDs outside the terms of their Market Authorisation (MA) as detailed in the product’s Summary of Product Characteristics (SPC).  This is also called off-label or off-licence use.

NICE MPG2 (2017) states “1.3.5 Ensure PGDs are consistent with the relevant summary of product characteristics, unless the medicine is being used off-label or relevant national guidance is being followed (see recommendation 1.1.7).”

NICE MPG2 (2017) recommendation 1.1.7 states ‘Ensure that off-label use of a licensed medicine is included in a PGD only when clearly justified by best clinical practice. Clearly state that the medicine is being used outside the terms of the marketing authorisation on the PGD. Consider informing the patient or their carer that the use is off-label, in line with General Medical Council guidance on prescribing unlicensed medicines.’(Note updated in 2021 to ‘Prescribing unlicensed medicines‘)

Therefore any PGD for the off-label use of a licenced medication should clearly state when the product is being used outside the terms of its MA and why this use is recommended with reference to the supporting evidence or guidance.

As practitioners should consider informing the patient or their carer when a medicine is being used off-label, it would be good practice for PGDs which cover off-label use to include a statement to this effect.

Legislation does not permit the use of unlicensed medicines under a PGD – for further advice please refer to Unlicensed medicines and use of PGDs

Note: other guidance may advise that off-label use of a medicine under a PGD is not appropriate, e.g. MHRA statement on supply and administration of Botox™, Vistabel™, Dysport™ and other injectable medicines in cosmetic procedures