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 Processes for the Managed Entry and Use of Medicines in NHS Highland 

  | Publication Date: 18/08/2016 

1. Background

The safety, effectiveness and cost-effectiveness of medicines are controlled by regulatory processes for licensing at national and international levels and by advisory processes in the UK and in NHS Scotland (Appendices 1 and 2).

1.1 Purpose and scope of this guidance

The majority of prescribing in NHS Highland is in accordance with the Highland Formulary. However NHS Highland recognises that there will be times when prescribers may wish to prescribe a medicine that either:

  • has not been licensed,
  • is to be used in clinical circumstances outside of the manufacturer’s license,
  • is licensed but is awaiting Scottish Medicines Consortium (SMC) advice,
  • is the subject of SMC / NHS Healthcare Improvement Scotland (NHSHIS) advice which does not recommend use in NHS Scotland,
  • is contrary to NHS Highland’s local policy e.g. is accepted by SMC but the Formulary Subgroup (FS) decision is not to include in Highland Formulary since suitable alternatives are available.

The processes and associated guidance in this document describe NHS Highland’s policies for the prescribing of medicines in all such circumstances, specifically prescribing of:

  • formulary medicines 
  • licensed non-formulary medicines 
  • unlicensed medicines 
  • licensed medicines prescribed outside of their marketing authorisation (off-licence medicines) 
  • medicines which the SMC or NHSHIS have recommended should not be used in NHSS 
  • medicines for individual patients with significantly different clinical circumstances contrary to agreed local NHS Highland policies 
  • medicines which are awaiting SMC or NHSHIS guidance

NHS Highland makes a distinction between requests to prescribe for groups of patients which normally require a submission to the FS and individual patient treatment requests (IPTRs) for single patients where a number of different routes are available dependent on the circumstances of the request.

Formulary Medicine request form.doc

Submission form for inclusion of medicine in the Highland Unlicensed Medicines List.doc

Primary care non-Formulary medicine supply process.pdf


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Further information