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.
Checklist for Written Consent: Unregistered Use of Medicine
Click for the PDF Fillable Checklist
Click for the MS Word Fillable Checklist
Click here for Supporting documents for off-label Rituximab use, resources that 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.
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
Page last updated 12 August 2021