Prescribing - off-label and unlicensed

Off-label drugs are drugs that are prescribed for a different condition or in a different way than is stated in their marketing authorization. For example, a drug that is licensed to treat high blood pressure may be prescribed off-label to treat migraines.

Unlicensed drugs are drugs that do not have a marketing authorization in the UK. This means that they have not been assessed by the Medicines and Healthcare products Regulatory Agency (MHRA) for safety and efficacy.

Examples:

• Off-label drug: The drug sildenafil (Viagra) is licensed in the UK to treat erectile dysfunction. However, it is also commonly prescribed off-label to treat pulmonary arterial hypertension (PAH).

• Unlicensed drug: The drug cannabidiol (CBD) is an unlicensed drug in the UK. However, it is available on prescription for certain medical conditions, such as severe childhood epilepsy.

Similarities:

• Both off-label and unlicensed drugs may be used to treat conditions for which there is no licensed treatment available.

• Both types of drugs may be prescribed by doctors, but they are not routinely available on the NHS.

• Both types of drugs may have risks and side effects, even if they have been extensively tested for other conditions.

Differences:

• Off-label drugs have been assessed by the MHRA for safety and efficacy, but they have not been licensed for the specific condition or use for which they are being prescribed.

• Unlicensed drugs have not been assessed by the MHRA for safety and efficacy.

• Off-label drugs are more widely used than unlicensed drugs.