Prescribing off-label, unapproved or compounded medicines
https://www.ahpra.gov.au/Resources/Prescribing-off-label-unapproved-or-compounded-medicines
Core principle:
These medicines can have a legitimate role in patient-centred care, but require additional care with patient assessment, treatment suitability, informed consent and documentation.
Patient demand alone is not a valid reason to prescribe.
Key revision message
Establish clinical need → Assess thoroughly → Evaluate evidence and alternatives → Obtain informed and financial consent → Document individual reasoning → Monitor benefit and safety.
1. Definitions
| Term | Meaning | Important distinction |
|---|---|---|
| Off-label medicine use | An ARTG-listed medicine used differently from its TGA-approved Product Information. This may involve a different indication, dose, route, or patient age or gender outside the registered use. | The medicine is registered, but the proposed use falls outside its approved Product Information. |
| Unapproved medicine | A medicine not included in the Australian Register of Therapeutic Goods (ARTG). It may be accessed through specified pathways, subject to conditions. | The product itself is not ARTG-listed. |
| Compounded medicine | A preparation, mixture or alteration of ingredients made by a pharmacist or doctor for a specific patient, when commercially available products are unsuitable or unavailable. | Compounded medicines are unapproved medicines and have not been assessed by the TGA for safety, quality and efficacy before supply. |
The key distinction is registration of the product versus approval of its intended use. Compounded medicines fall within the unapproved category.
2. Prescriber responsibilities before prescribing
The guidance applies to registered health practitioners authorised to prescribe scheduled medicines. It complements the relevant National Board’s Code of conduct and the National Prescribing Competencies Framework.
The prescriber must have the necessary knowledge, skills and training, and comply with applicable local, organisational, jurisdictional and national requirements. This includes medicine-specific approval or access processes, requirements involving real-time prescription monitoring (RTPM) in both the prescriber’s and patient’s jurisdictions, and My Health Record. Competency 4.3 specifically addresses maintaining adequate and current knowledge when prescribing these medicines.
3. Establish therapeutic need
When is prescribing appropriate?
The guidance states that these medicines should only be prescribed when an ARTG-listed medicine is unavailable or inappropriate, and adequate evidence supports the proposed treatment. Potential benefits and risks must be identified, evaluated and documented.
There must be clinical justification—not simply a patient request. Consider the clinical indication, supporting evidence, and whether other treatments have failed or are inappropriate for the individual patient.
What should the assessment include?
| Assessment component | What the guidance requires |
|---|---|
| Comprehensive history | Medical history, patient views and relevant physiological factors, together with a social, mental health and substance use history. |
| Examination and investigations | An appropriate physical examination and investigations where relevant. |
| Prescription monitoring | Check RTPM or equivalent services as relevant to the assessment and prescribing requirements. |
| Treatment options | Consider options using the best available information. Recommend treatment only where there is an identified therapeutic need and/or clinically recognised treatment, with a reasonable expectation of benefit. |
| Management plan | Include the diagnosis, treatment, patient information and advice, with investigations and monitoring where relevant. |
A thorough assessment cannot be adequately completed in a brief online consultation.
4. Shared decision-making and informed consent
Obtain and document informed consent through a discussion the patient can understand. The patient must understand the treatment’s status, expected benefits, risks, costs and alternatives in the context of their circumstances.
| Consent topic | What to explain |
|---|---|
| Regulatory status | Explain that the medicine is not approved for the intended use, or that the product has not been assessed by the TGA for safety, efficacy and quality, as applicable. |
| Benefits and risks | Discuss the expected benefits, possible adverse effects and limitations of the proposed treatment. |
| Alternatives | Compare the proposed treatment with other available treatments, including no treatment. |
| Costs | Discuss financial implications. Informed consent includes financial consent. |
| Treatment goals | Explain what the treatment is intended to achieve. |
| Stopping plan | Agree on a plan to discontinue treatment if benefit is not demonstrated. |
The discussion should support a genuine shared decision, rather than simply obtaining agreement to a predetermined prescription.
5. Documentation, continuity and safety
What must be recorded?
Document the reason for use in the patient’s health record, including the digital health record. The record should demonstrate the individual assessment, clinical reasoning, patient-specific risk–benefit analysis, informed consent, and communication about the medicine’s limitations. It must be accurate and contain sufficient information to support continuity of care.
| Documentation area | What the record should demonstrate |
|---|---|
| Clinical justification | Why this treatment was chosen for this patient. |
| Individual risk–benefit assessment | The potential benefits and risks relevant to the patient’s circumstances. |
| Informed consent | What was discussed about the medicine’s status, limitations, benefits, risks, alternatives and costs. |
| Management and monitoring | The treatment plan, relevant investigations and monitoring, treatment goals, and plan to stop if benefit is not demonstrated. |
These elements draw together the guidance’s assessment, consent and documentation requirements. Pre-filled health record templates are not adequate to document an individual patient assessment.
Conflicts of interest
Financial or commercial interests must not influence patient care.
A conflict is inherent when working in an organisation that prescribes and dispenses a single medicine.
Such conflicts must be recognised, managed and disclosed to patients.
A declaration on a website alone is insufficient; the practitioner must be able to demonstrate that commercial interests did not influence treatment.
Coordination and continuity
Explain to patients the importance of communication with their primary care team or other treating practitioners, and facilitate coordinated, continuous care.
Adverse-event reporting
The guidance directs practitioners to report adverse events to the TGA through the Adverse Event Management System (AEMS).
Its adverse-event reporting expectations include off-label, unapproved and compounded medicines.
6. Australian access framework
| Prescribing situation or pathway | Main point |
|---|---|
| Off-label use | A clinical decision made at the treating practitioner’s discretion. Responsibility remains with the practitioner to obtain informed consent and report adverse events. |
| Special Access Scheme — SAS | Allows practitioners to access certain unapproved products for an individual patient on a case-by-case basis. |
| Authorised Prescriber — AP | An Australian-registered medical practitioner may obtain authorisation, in specified circumstances, to supply a specified unapproved therapeutic good or class of goods to a defined class of patients in their immediate care. |
Before applying through SAS or AP, consider clinically appropriate ARTG-listed treatment options. These pathways remain subject to their relevant conditions and prescribing requirements.
7. Examples of poor practice
Ahpra identifies the following examples:
- Prescribing without a legitimate indication, including solely because the patient requested treatment.
- Consultations lasting seconds to a few minutes, making an adequate assessment unlikely.
- Inadequate history-taking, particularly omission of relevant mental health or substance use history.
- Failure to check RTPM before prescribing a monitored medicine, leaving the prescriber unaware of other prescribed medicines.
- Inadequately declaring or managing conflicts, such as only prescribing the product supplied by an associated company.
Single-treatment telehealth models are a particular concern because they may combine restricted treatment options, brief assessments, inadequate risk–benefit information and commercial conflicts.
Regulatory caution: Ahpra and the National Boards may investigate practitioners with high rates of prescribing or compounding scheduled medicines even without receiving a complaint.