Off-label Use of Medicines


The following resources were developed to assist clinicians and Drug and Therapeutics Committees regarding off-label use of Rituximab. They seek to assist the complex medical, ethical and regulatory management issues that arise when using Rituximab in an off-label manner.

Supporting documents for off-label Rituximab use

  • Patient Consent Form for Off-Label Use of Rituximab

    May 2019

  • Patient Information Sheet for Off-Label Use of Rituximab in Auto-Immune Conditions

    May 2019

  • Safety Screening and Monitoring Information for Clinicians Using Rituximab in Auto-Immune Conditions

    May 2019

  • Acknowledgments

    These resources were developed by the NSW Therapeutic Advisory Group (TAG) Off-Label Rituximab Project Team (Dr Kate O’Connor, Consultant Clinical Immunologist and Allergist and Immunopathologist; and members of the NSW TAG secretariat, Dr Alexandra (Sasha) Bennett, Ms Judy Raymond and Ms Sarah Dinh) with support and advice regarding content from the NSW TAG Editorial Committee, chaired by Professor Sarah Hilmer. The contribution of the following experts is gratefully acknowledged: Professor Chris Liddle, Professor of Clinical Pharmacology and Hepatology Medicine, The University of Sydney’s Westmead Clinical School and Chair, Western Sydney LHD Drug and Therapeutics Committee; and, Associate Professor Sean Riminton, Clinical Immunologist, Department Head of Immunology, Concord Hospital.

    Resource development included: a) review of relevant published documents and guidelines; b) input from hospital health professionals with recognised expertise in governance and use of off-label medicines, medicines information and/or clinical pharmacy; and, c) external consultation with subject matter experts.

    NSW TAG acknowledges with thanks the assistance of individuals and organisations who provided comments and constructive suggestions during the external consultation process. The development of these resources was funded by NSW Health.

Guidelines and Publications Regarding 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


  • 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].


  • 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


  • NSW Health Policy Directive PD2016_033


    Approval Process of Medicines for Use in NSW Public Hospitals (Replaces PD2008_037: Evaluation of Medicines for Use in Public Hospitals) Available here

  • 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