NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Medicines
Medicines Update Acute

Compassionate Use of Medicines - NHSGGC Guidance Notes

The European Medicines Agency (EMA) and Medicines and Healthcare Products Regulatory Agency (MHRA) have recently established formal compassionate access programmes that allow early access to a small number of unlicensed medicines for serious medical conditions in advance of the licence.  Examples of previously approved compassionate use programmes include ledipasvir/sofosbuvir and daclatasvir/sofosbuvir combinations for hepatitis C and IV zanamivir for confirmed pandemic H1N1 infection.

In addition, some pharmaceutical companies offer early access to medicines that have not yet been licensed.  This is a more informal "named patient supply" arrangement often made available to clinicians that have been involved with prescribing the medicine as part of a randomised controlled trial. 

There have been a number of requests in recent months, from clinicians in NHSGGC, to use medicines as part of one of these programmes.  Regardless of whether a medicine is supplied through a formal compassionate use programme or as a more informal “named patient” supply, the policy requirements for procurement, authorisation, supply and prescribing are same as for all unlicensed medicines, as described in the NHSGGC Unlicensed Medicines Policy.  In addition, for management of named patient/ compassionate use requests, PPSU has developed supplementary guidance notes that are intended to be implemented across the Acute Division.