In any country, an off-licensed drug does not have a licence for human use for any indication or age group in that country.
Contents
Possible uses
An unlicensed drug should only be used under certain circumstances:
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.