Unlicensed use of medicines

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Medicines included in the Formulary are supported by a valid SPC and the indications and/or dosing information reflect those in the corresponding Market Authorisations (formerly known as Product Licences). Where an unlicensed drug is included in the Formulary, this is indicated. Where the Formulary suggests a use (or route) that is outside the licensed indication of a product (‘off-label' use), this too is indicated. Unlicensed or off-label use of medicines should only be necessary if the clinical need cannot be met by licensed medicines.

Further information concerning the use of unlicensed medicines in NHS Highland can be found on the NHS Highland intranet

Prescribing medicines outside the terms of their Market Authorisation alters (and may increase) the prescriber's professional responsibility and potential liability; see advice at www.gov.uk/drug-safety-update. The prescriber should be able to justify, and feel competent in using such medicines. Prescribers have a responsibility to advise patients of the status of the product being provided. Prescribers and those dispensing unlicensed medicines or medicines used off-label are advised to consult the current BNF and/or contact the lead pharmacist for your area or Medicines Information (nhshighland.medicineinformation@nhs.net) for further information.