Rethinking Off-Label Prescribing: New National Guidance Supports Safer, Smarter Decision-Making

A significant update to Australia's leading guidance on off-label medicine use has been released, providing clinicians with a contemporary framework for making informed prescribing decisions across a broad range of healthcare settings.

The new publication, Rethinking Medicines Decision-Making: Guiding Principles for the Off-label Use of Medicines in Australian Healthcare Settings (Version 2 – June 2026), has been developed by the Council of Australian Therapeutic Advisory Groups (CATAG) following extensive consultation with healthcare experts from across Australia. The update recognises the vital role that off-label medicine use plays in modern healthcare while reinforcing the safeguards needed to support high-quality patient care. 

Why Off-Label Prescribing Matters

Off-label prescribing occurs when a medicine is prescribed in a manner that differs from its approved product information. This may include prescribing for an unapproved indication, age group, dosage, route of administration or patient population.

For many clinicians, including nurse practitioners, off-label prescribing can be an essential component of practice, particularly where emerging evidence supports use, treatment options are limited, or regulatory approvals have not kept pace with clinical need. The updated CATAG guidance acknowledges that off-label medicine use is an established and important part of contemporary Australian healthcare. 

What's New in the 2026 Update?

The revised document substantially expands and modernises the original guidance. Key updates include:

• Recognition of the important role of off-label medicine use in contemporary Australian healthcare.
• Stronger guidance on obtaining and using expert clinical advice when high-quality evidence is limited.
• Expanded discussion of medico-legal considerations, including documentation requirements and informed patient consent.
• Greater reflection of current decision-making challenges across diverse healthcare environments. 

Importantly, the scope of the guidance has widened considerably. While earlier versions were primarily focused on public hospital practice, the updated principles now explicitly address the needs of clinicians working in public hospitals, private hospitals and primary care settings. This expansion reflects the reality that off-label prescribing decisions occur across the healthcare system and require consistent, evidence-informed approaches regardless of practice setting. 

Relevance for Nurse Practitioners

For nurse practitioners, the updated principles provide valuable support in navigating complex prescribing decisions. The guidance reinforces the importance of balancing available evidence, clinical expertise, patient preferences and organisational governance frameworks when considering off-label medicine use.

The stronger focus on documentation and patient consent is particularly pertinent, offering practical considerations for demonstrating transparent decision-making and shared care planning. The emphasis on expert consultation where evidence is limited also aligns closely with the collaborative, multidisciplinary approach that underpins advanced nursing practice. 

A Collaborative National Effort

The updated guidance represents more than 12 months of review and consultation involving members of CATAG's Expert Advisory Group from across Australia. In announcing the release, Lisa Pulver, CATAG National Coordinator, thanked contributors for their expertise and commitment to revising one of CATAG's most widely accessed resources. 

Access the Resource

The updated guidance is available through CATAG and is intended to support clinicians, health services and decision-makers across Australia in navigating off-label medicine use while maintaining appropriate safeguards for patients. 

The resource can be accessed via CATAG's website: Off-label Guiding Principles. 

As prescribing practice continues to evolve, these updated principles provide a timely and practical framework to support safe, patient-centred and evidence-informed care.