Current status: Answered by Jenni Minto on 11 June 2025
To ask the Scottish Government what guidance is provided to clinicians who are considering prescribing a medicine off-label when unlicensed for a particular condition, when there is a Scottish Medicines Consortium approved medicine available, which is licensed for that indication.
Guidance to clinicians to support prescribing medicines off-label is provided by the General Medical Council (GMC) . The guidance states that doctors should usually prescribe licensed medicines in accordance with the terms of their licence but they may prescribe medicines off-label where, on the basis of an assessment of the individual patient, they conclude, for medical reasons, that it is necessary to do so to meet the specific needs of the patient. In addition, extant guidance states that, unless there is a specific clinical reason, clinicians should prescribe a licensed medicine which has been accepted for routine use in the NHS in Scotland by the Scottish Medicines Consortium (SMC) as opposed to prescribing off-label or unlicensed medicines.