Ethics and consent in off-label prescribing
What off-label means in Australia and how it differs from unapproved medicines, the CATAG framework (revised 2026), PBS and legal consequences, what consent should cover, and examples from adult medicine where regulators have stepped in.
Tier 2Topic overview
Written with AI assistance and fact-checked against the sources below. For exam study, not clinical decisions. How notes are made
At a glance
- Off-label means prescribing a TGA-registered medicine outside its approved product information: a different indication, dose, route, age group or duration.
- It's legal and common, and sometimes it's standard care. The TGA regulates supply and advertising, not clinical prescribing.
- The prescriber carries more responsibility: the decision must rest on evidence, the patient must give informed consent, and the plan must include monitoring and documentation.
Loading the rest of the note…
Finished reading?
Sources
- Guiding Principles for the off-label use of medicines, Version 2AU/NZCouncil of Australian Therapeutic Advisory Groups (CATAG), June 2026 (published July 2026; replaces the 2013 guiding principles)
- Rethinking medicines decision-making in Australian hospitals: guiding principles for the quality use of off-label medicinesAU/NZCouncil of Australian Therapeutic Advisory Groups (CATAG), 2013 (archived)
- Day RO. Off-label prescribing. Aust Prescr 2013;36:182-3AU/NZAustralian Prescriber, 2013
- Good medical practice: a code of conduct for doctors in Australia (section 4.5, informed consent)AU/NZMedical Board of Australia, 2020
- Special Access Scheme and Authorised Prescriber Scheme guidanceAU/NZTherapeutic Goods Administration, 2026
- Rogers v Whitaker (1992) 175 CLR 479AU/NZHigh Court of Australia, 1992
- Last updated
- 14 November 2026
What changed
- 14 November 2026 Turnstile bot check on sign-in and signed-out feedback