Monitoring the safety of off-label medicine use.(Pharmacovigilance Focus)

Medicine labels contain important information on the conditions of use. These conditions typically include the indication, dosage, frequency of administration, and route of administration. Other important conditions of use can include the age range of patients, duration of treatment, and contraindications to use of the medicine. Deviations from the conditions of use set forth in the label constitute off-label use.

In the USA, off-label use is legal. While the Food and Drug Administration (FDA) regulates the marketing of medicines, it does not regulate prescribing practices. In one study (1), approximately 21 per cent of drug use in office-based practice was for off-label use. Off-label use may occur for a variety of reasons. For example, there are some diseases for which no adequate, labelled treatment …