NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Medicines
Medicines Update

Off-label or unlicensed use of medicines

The MHRA and the NHS Circular PCA(P)(2015)17 recommend that ‘specials’ and imported unlicensed medicines should only be used where there is no suitable licensed alternative. Clinicians should not routinely use an unlicensed preparation when there is a licensed product available, unless there is a specific clinical reason.

There are clinical situations when the use of unlicensed medicines, or use of medicines outside the terms of the licence (i.e. ‘off-label’), may be judged by the prescriber to be in the best interest of the patient on the basis of available evidence. Such practice is particularly common in patients with swallowing difficulties for example, crushing tablets or opening capsules and mixing the contents with water/food may render a product unlicensed.

NHSGGC ADTC support the prescribing of off-label or unlicensed medicines, as an alternative to using licensed medication, providing there has been an assessment of individual patient circumstances.

When prescribing an unlicensed or off label medicine you must:

  • be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy
  • take responsibility for prescribing the medicine and for overseeing the patient’s care, or ensure that arrangements are made for another suitable prescriber to do so
  • make a clear, accurate and legible record of your reasons for prescribing the medicine.

For further information please contact your Health and Social Care Partnership prescribing team or the central prescribing team at prescribing@ggc.scot.nhs.uk.


Published 26/08/19. Medicines Update blogs are correct at the time of publication.