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Off-label Use of Medicines

The following documents are provided to inform off–label use of medicines. They discuss clinical, safety, legal and ethical issues surrounding off–label use as well as those specific to the paediatric population.

  • CATAG: Rethinking medicines decision-making in Australian Hospitals; Guiding Principles for the quality use of off–label medicines, November 2013
    Available here
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  • Gazarian M. Off-label use of medicines in the paediatric population: recommendations for assessing appropriateness. Discussion paper for consultation, 7 May 2007 [WHO Expert Consultation on Essential Medicines for Children, 9-13 July 2007, Geneva].
    Available here
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  • Gazarian M, Kelly M, McPhee JR, et al. Off–label use of medicines: consensus recommendations for evaluating appropriateness.
    Med J Aust 2006; 185(10): 544-548
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  • NSW Health Policy Directive PD2008_037:
    Evaluation of Medicines for Use in Public Hospitals
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  • NSW TAG Discussion Paper: Off–Label Use of Registered Medicines and Use of Medicines under the Personal Importation Scheme in NSW Public Hospitals, September 2003
    PDF ~ 512 KB  |  MS_Word ~ 357 KB