Off-label prescribing in dental practice
‘Off-label’ use refers to use of a drug in a manner (eg indication, dose, route of administration, patient group) that is not approved by the Australian Therapeutic Goods Administration (TGA)–listed product information. The manufacturer of the medicine does not carry any legal responsibility for off-label prescribing—should an issue arise, such as a serious adverse reaction, legal liability lies solely with the prescriber. Appropriate off-label prescribing requires sufficient evidence to support efficacy and safety, an overall favourable harm-benefit ratio and the consent of the patient1 .