Off-label prescribing

Madlen Gazarian and Steve Morris
Med J Aust 2014; 200 (11): 637. || doi: 10.5694/mja14.00577
Published online: 16 June 2014

To the Editor: Off-label prescribing is a complex paradigm, with important clinical, safety, ethical, legal and financial dimensions. The articles by Seale,1 Hickie,2 and Harris and Naylor3 highlight some associated controversies and the need for a rigorous approach.

The Council of Australian Therapeutic Advisory Groups (CATAG) has recently developed national guiding principles that provide a structured framework to support judicious, appropriate, safe, effective and cost-effective off-label use of medicines.4 This framework will facilitate a more rigorous and consistent approach to decision making by health professionals, consumers, and drug and therapeutics committees in their evaluation and use of medicines that are prescribed off label. CATAG's guidance provides an important expansion and update on previous Australian recommendations.5

There are seven overarching guiding principles, including a core principle of systematic evaluation of the evidence base and risk–benefit ratio for proposed off-label uses. Comprehensive advice for involving patients and carers in shared decision making and systematic outcomes evaluation is also provided. Applying these principles in routine practice will help address the clinical, safety and ethical concerns that have recently been highlighted. CATAG anticipates undertaking future work to support wider implementation of the guiding principles.

  • Madlen Gazarian1,2
  • Steve Morris1

  • 1 Council of Australian Therapeutic Advisory Groups, Sydney, NSW.
  • 2 School of Medical Sciences, University of New South Wales, Sydney, NSW.



CATAG is supported by funding from NPS MedicineWise, an independent not-for-profit public company funded by the Australian Government Department of Health. This funding is managed through a services agreement between NPS MedicineWise and the New South Wales Therapeutic Advisory Group, an independent, not-for-profit member-based organisation supported by the NSW Ministry of Health.

Competing interests:

No relevant disclosures.


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