Unlicensed use of medicines (Formularies)

TAM (Treatments and Medicines) NHS Highland
NHS Highland

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 stated.  Where the Formulary suggests a use (or route) that is outside the licensed indication of a product (‘off-label' use), this too is stated.

Unlicensed or off-label use of medicines should only be necessary if the clinical need cannot be met by licensed medicines.

For further information concerning the use of unlicensed medicines in NHS Highland, see: Guidance for prescribing and supply of specials and imported unlicensed medicines NHS Highland intranet access required.

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.scot) for further information.

Any decision to prescribe an unlicensed medicine must consider the relevant regulatory, professional and Board guidance and local governance procedures. Please see the links below for further information: