Off-licenced drug

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In any country, an off-licenced drug does not have a licence for human use for any indication or age group in that country.

Possible uses

An unlicenced drug should only be used under certain circumstances:

• As part of a clinical trial.
• When it has been imported from a country where it does have a licence.
• When it has been prepared extemporaneously (e.g. a specialist dermatological mixed formulation for topical use or a mixture of a corticosteroid and local anaesthetic for injection into a joint).
• When it is prepared under a special licence (e.g. a liquid formulation for patients with difficulty in swallowing or a reduced-dose formulation for children).
• When the licence has been suspended, revoked, or not renewed, but the product is made available for named patients under specific circumstances (e.g. thalidomide is used for the treatment of multiple myeloma, leprosy, HIV infection).
• If the drug is not considered a medicine but is used to treat a rare condition (e.g. a rare metabolic disease).

Prescription

Off-licence prescribing should usually be limited to consultant-level specialists who are familiar with all the alternatives and prevailing expert opinion. In some circumstances it may be appropriate to continue this prescribing in primary care (general practitioner-level), but this should always be by mutual agreement between both parties concerned.

It is standard practice to tell the patient that the drug is being used off-licence and why it is thought to be appropriate to use the drug. This is important both from the medico-legal point of view and because the patient information leaflet may not make sense to the patient if the drug is used off-licence.

See also

Off-label use, the practice of prescribing drugs for a purpose outside the scope of the drug's approved label.