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.
- 1. Seale JP. Off-label prescribing. Med J Aust 2014; 200: 65. <MJA full text>
- 2. Hickie IB. Reducing off-label prescribing in psychiatry. Med J Aust 2014; 200: 65-66. <MJA full text>
- 3. Harris IA, Naylor, JM. Double standards in clinical practice ethics. Med J Aust 2014; 200: 76. <MJA full text>
- 4. Council of Australian Therapeutic Advisory Groups. Rethinking medicines decision-making in Australian hospitals. Guiding principles for the quality use of off-label medicines. CATAG, 2013. http://www.catag.org.au/wp-content/uploads/2012/08/OKA9963-CATAG-Rethinking-Medicines-Decision-Making-final.pdf (accessed Mar 2014).
- 5. 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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