The use of off-licensed and unlicensed medicines

Before any medicine is authorised for adult use, the product must have undergone clinical testing to ensure that it is safe, effective and of high quality. This is not the case with all medicines for hospitalised children as, depending on specialty, hetween 15 and 80% are not licensed for purpose (termed off-license or off-label [OL] in the USA) or have not been licensed at all (termed unlicensed [UL]). This is also the case in the community but possibly to a lesser extent. 

Ideally, if there is no appropriate dosage form for a drug, another drug with the same therapeutic spectrum but adequate formulation, such as liquid, effervescent, dispersible tablets, is recommended in accordance with the prescriber. 

The term OL medicine may be used to describe a drug in an adequate dosage form for administration to children (e.g. liquid formulation) but which is being used outside the specification terms of the product licence (or marketing authorisation). For example, in the UK, there is an adult licensed liquid preparation of atenolol but it is not licensed for children. OL may also be given  

UL medicines are medicines under an rmlicensed dosage form obtained after manipulation of the original dosage form (e.g. crush-ing/cutting tablets, extemporaneous preparations, special ). Sometimes the drug itself may have no licence at all (e.g. chemicals used in metabolic diseases, such as betaine to treat homocystinuria, and novel medicines). Imported medicines become rmlicensed in the country into which they are imported. 

In general, it is not necessary to obtain the explicit consent from children, parents or carers to prescribe or administer UL or OL medicines. Nevertheless, a clear explanation should be given. 

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