Off-label prescribing

J Paul Seale
Med J Aust 2014; 200 (2): . || doi: 10.5694/mja13.00184
Published online: 3 February 2014

Prescribing medications “off label” in some settings is appropriate as long as it is evidence-based

Many medication prescriptions are written for approved indications, as listed in the product information (PI) for the drug. “Off-label” prescribing is the term used when a drug is prescribed for an indication, a route of administration, or a patient group that is not included in the approved PI. There are groups of patients who are not included in the clinical trials undertaken for drug registration, and these groups may not be included in the PI. They typically include children, pregnant women, older men and women, and patients with terminal illness. Prescribing the medication for patients in these categories would be off label if they are not listed in the PI.

  • University of Sydney, Sydney, NSW.


Competing interests:

No relevant disclosures.

  • 1. Gazarian M, Kelly M, McPhee JR, et al. Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust 2006; 185: 544-548. <MJA full text>


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