Background
The safety, effectiveness and cost-effectiveness of medicines are controlled by regulatory and advisory processes, for more information click here.
NHS Grampian recognises that there will be times when prescribers may wish to prescribe a medicine that:
- has not received a marketing authorisation (not been licensed),
- is to be used in clinical circumstances outside of the marketing authorisation,
- is licensed but is awaiting SMC advice,
- is licensed but where SMC/Healthcare Improvement Scotland has advised the medicine should not be used in NHS Scotland.
- is contrary to NHS Grampian's local policy.
The processes and associated guidance describe NHS Grampian's policies for the prescribing of medicines in such circumstances, specifically prescribing of:
- licensed non-formulary medicines
- unlicensed medicines
- off-label medicines
- licensed medicines which the SMC or NHS Healthcare Improvement Scotland have recommended should not be used in NHS Scotland
- licensed medicines which are awaiting SMC or NHS Healthcare Improvement Scotland guidance
- licensed medicines for individual patients contrary to agreed local NHS Grampian policies.
NHS Grampian makes a distinction between requests to prescribe:
- for groups of patients which normally require a submission to the Grampian Formulary Group (see group requests)
- for single patients where a number of different routes are available dependant on the circumstances of the request (see flowchart for more information).
Guidance documents
- Flowchart - Non-formulary medicines request process
- PACS Tier One and Tier Two
- Staff guidance for requests to prescribe unlicensed off-label or non-formulary medicines (including medicines awaiting consideration by or not recommended for use by the SMC)