Ahpra updates prescribing framework for off-label use

The framework, published on Ahpra’s website on 29 September 2025, embeds ‘quality use of medicines’ as a central principle and sets out the competencies expected of prescribers across all health professions. It is designed to guide safe, person-centred and effective prescribing in contemporary practice.

‘This framework is part of the foundational building blocks that educators, regulators, practitioners and even the public can use to understand what’s expected in safe and effective prescribing,’ said Ahpra CEO Justin Untersteiner. ‘The principles in this framework guide what is expected of any prescriber so it’s important that it keeps pace with the evolving healthcare landscape.’

The framework includes a new competency around the prescribing of unapproved therapeutic goods, compounded products and medicines for unregistered indications. An Ahpra press release makes specific mention that the new competency follows Ahpra’s recent guidance in other areas with high volumes of prescribing, including medicinal cannabis and non-surgical cosmetic procedures.

Key changes

For the first time, the framework explicitly includes competencies addressing:

• prescribing of unapproved therapeutic goods, such as medicines not on the Australian Register of Therapeutic Goods (ARTG)

• prescribing for unregistered indications (off-label use)

• prescribing of compounded products.

Under the revised competencies, prescribers must ensure:

• off-label or unapproved prescribing is only considered when a registered medicine is unavailable or inappropriate

• adequate information is available to support the use, with risks and benefits documented

• informed consent is obtained and recorded

• the rationale for use is clearly documented in the person’s health record, including digital health records.

The framework also strengthens requirements around cultural safety, transitions of care (where medication errors are more common), and the role of technology such as telehealth and electronic prescribing.

Implications for aesthetic practice

The updates carry particular weight for aesthetic practice, where medicines are often used beyond their original ARTG indication. Practitioners must now:

• apply heightened standards of evidence when prescribing off-label

• clearly communicate the rationale and risks to patients, and document consent in detail

• ensure prescribing decisions align with professional standards, scope of practice and the National Medicines Policy principle of quality use of medicines.

The framework makes clear that prescribers remain accountable for their decisions and that patient safety must take precedence over all other considerations.

Implications for aesthetic practice

The updates carry particular weight for aesthetic practice, where medicines are often used beyond their original ARTG indication. Practitioners must now:

• apply heightened standards of evidence when prescribing off-label

• clearly communicate the rationale and risks to patients, and document consent in detail

• ensure prescribing decisions align with professional standards, scope of practice, and the National Medicines Policy principle of quality use of medicines

The updated framework reinforces that prescribers remain accountable for all prescribing decisions, particularly when using medicines in unapproved or off-label contexts. Ahpra emphasises that the patient’s needs and safety must take precedence over all other considerations.

‘The framework applies to prescribers regardless of their professional background, and the setting in which they choose to practise,’ Mr Untersteiner said. ‘It is evidence-based and emphasises the need for quality and safe use of medicines, now and into the future.’

Intended use of the framework

Ahpra has positioned the framework as more than a reference document. The framework ‘may contribute generally to a shared understanding of the prescribing process and more specifically to the following’:

• The development of education and training programs The framework provides important information for those responsible for curriculum design and may inform decisions about program content, assessment and expected outcomes, for programs that lead to health practitioner registration and/or endorsement.
• Continuing professional development The framework provides structure to the development of formal professional development programs such as those provided by professional organisations.
• Self-reflection The framework may be used by individual prescribers to develop personal learning plans. Because it clearly describes expected competencies and provides examples of what the competencies may look like in practice, individuals are able to use the framework in their own self-reflection and professional development.
• Health professional regulation The framework may be used by Ahpra, National Boards and other registration bodies for regulatory purposes.
• Recognition and understanding of the prescribing role By clearly describing the important aspects of prescribing, the framework may contribute to a greater understanding of the role of the prescriber within the collaborative healthcare team.

These updates follow a series of recent regulatory changes, including Ahpra’s new cosmetic practice guidelines and advertising standards, and a renewed push for consistent national laws in the cosmetic injectable sector, underscoring the increasing scrutiny on prescribing and compliance in aesthetic medicine.

The updated framework will remain available on Ahpra’s website until December 2029. Ahpra has indicated it will publish further information on where the framework sits within the wider regulatory landscape shortly.

In the meantime, you can register here to attend one of Ahpra’s upcoming information sessions on the revised framework, scheduled for Wednesday 22 October (6.00–7.00pm AEDT) and Thursday 23 October (3.00–4.00pm AEDT).