Medicines that do not have a marketing authorisation (or product licence) in the UK are subject to unlicensed medicine (ULM) requests and require completion of a ULM form. These are (not exhaustive):
- Sertindole
- Ziprasidone
- Clozapine IM
A number of blanket unlicensed protocols exist within MHS to allow use of some ULMs in certain clinical situations without submitting a full ULM form. These are:
Off-label use of medicines occurs when medication is used outside the terms of its marketing authorisation. Where the off-label use is supported by evidence-based texts, the use is generally considered low risk and a ULM form will not be required. Where the off-label use is higher risk, a ULM form may be required.
Please contact the Mental Health Prescribing Management Group for further advice.(prescribingmanagementgroup.mentalhealth@ggc.scot.nhs.uk)