Description
Updated Guiding Principles for the off-label use of medicines
Originally published in 2013, the Guiding Principles have been comprehensively revised to support a contemporary, evidence-informed and patient-centred approach to the safe and responsible use of medicines off-label, across a broader range of healthcare settings.
Importantly, the scope of the Guiding Principles has been expanded to support healthcare organisations, clinicians and consumers across public hospital and health services, private healthcare settings and primary care.
The updated Guiding Principles provide a nationally consistent framework for decision-making and support a transparent approach to determining whether an off-label use is appropriate, based on the strength of available evidence and the clinical circumstances. They emphasise:
- Use of the highest quality and most clinically relevant evidence available
- Seeking expert advice when considering use outside routine practice
- Consumer involvement through shared decision-making and informed consent
- Appropriate documentation, monitoring and evaluation of outcomes
- Communication of off-label use at transitions of care
- Consideration of legal and professional responsibilities
The CATAG consumer counselling tool supports healthcare professionals in discussing off-label use od medicines with consumers and facilitating informed, shared decision-making
Download the Guiding Principles for the Off-Label Use of Medicines in Australian Healthcare Settings (Version 2, June 2026) below.