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BACKGROUND: Medicine use is considered off-label when used for an indication, at a dose, via a route of administration or in a patient group not included in the approved product information. Off-label use varies according to therapeutic class and patient group, and often occurs in those who are vulnerable. OBJECTIVE: The aim of this article is to discuss ethical, practice and policy considerations associated with off-label medicine use. DISCUSSION: A number of professional organisations have issued guidance in relation to off-label medicine use. Prescribers should inform patients and document consent when prescribing off-label, including an open discussion about known and unknown benefits and risks. It is important that the prescriber documents the reason for off-label use in the patient's record and ensures that patients are aware of the intended duration and relevant monitoring. Australia's new national health priority of Quality Use of Medicine and Medicine Safety should stimulate all stakeholders including consumers to work together to address off-label medicine use.

Original publication




Journal article


Australian journal of general practice

Publication Date





329 - 331