Clinicians wishing to access a medicine not routinely available on the formulary, but available via a One Wales decision, will be obliged to collect/monitor patient outcomes. Evidence of clinical outcomes will be taken into consideration when reviewing the One Wales decision.
The responsibility that falls on healthcare professionals when prescribing an unlicensed medicine or a medicine off-label may be greater than when prescribing a licensed medicine within the terms of its licence.
Prescribers should pay particular attention to the risks associated with using unlicensed medicines or using a licensed medicine off-label. These risks may include: adverse reactions; product quality; or discrepant product information or labelling (e.g. absence of information for some unlicensed medicines, information in a foreign language for unlicensed imports, and potential confusion for patients or carers when the Patient Information Leaflet (PIL) is inconsistent with a medicine’s off-label use).