Off-label prescribing

Off-label prescribing occurs when a medication is used for a purpose that is not approved by the Australian Therapeutic Goods Administration (TGA). It may involve using a medication in a different dosage, route of administration or for a different patient population. While off-label prescribing is legal and sometimes necessary, it may pose ethical and safety considerations. Pharmacists should be aware that off-label prescribing is not uncommon, and that they play a vital role in ensuring patient safety and promoting the appropriate use of medications. This Practice Alert aims to explore the obligations, responsibilities and risk mitigation strategies for pharmacists in relation to the supply of medicines when prescribed off-label. This includes proprietary and compounded medicines.

Pharmacists’ obligations and responsibilities

1. Collaboration with healthcare professionals: Pharmacists should collaborate with prescribers to ensure the appropriateness of off-label prescriptions. Pharmacists can provide valuable input regarding alternative therapies, potential drug interactions or patient-specific considerations. Open communication and teamwork are essential to mitigate the risks associated with off-label prescribing.
2.  Providing accurate information: Pharmacists must ensure they have access to the latest information regarding approved indications, dosages and potential adverse effects of medications. Pharmacists should be proactive in seeking out reliable sources of information, including via drug information centres, and staying updated on emerging evidence.
3. Promoting informed consent: When dispensing medications for off-label use, pharmacists should engage in meaningful conversations with patients or caregivers. Pharmacists should discuss the rationale for the medicine being prescribed outside Australian approved indications, potential risks, benefits and available alternatives. Patients have the right to make informed decisions about their healthcare and pharmacists can play a crucial role in facilitating this process. Informed consent means that a person can ask questions and have those addressed to their satisfaction. It may be worth mentioning to the patient during counselling that the product information may not apply to their situation. Best practice would include documentation that informed consent was discussed and confirmed.

Risk mitigation strategies

1. Consensus recommendations: Pharmacists should familiarise themselves with the consensus recommendations for evaluating the appropriateness of off-label medication use. Utilise a systematic approach to assess the evidence base, clinical need and patient-specific factors for off-label prescribing decisions.
2. Ethical considerations: Pharmacists should consider the patient’s best interest and autonomy while evaluating the appropriateness of off-label prescriptions. Pharmacists should also be aware of any potential pressure to supply from the patients, prescribers, colleagues, employers and family members, and prioritise patient safety.
3. Guiding Principles for quality use: The CATAG ‘Guiding Principles for the quality use of off-label medicines’ offers valuable recommendations for pharmacists. These principles emphasise the importance of evidence-based decision-making, ongoing monitoring and evaluation, documentation and communication within the healthcare team. Some states have a policy on off-label prescribing, for example the ‘Approval Process for Medicines and Their Use’ in NSW. In the absence of state guidelines, individual pharmacists may refer to their local hospital policy or state and territory legislation and guidelines.
4. Compounding guidelines: Refer to the following Pharmacy Board of Australia guidelines, paying special attention to item 3.1 in the joint statement document:

• Guidelines on compounding of medicines (PDF)
• Joint statement on compounded medicines – Pharmacy Board of Australia and Medical Board of Australia (PDF)

PDL would like to remind pharmacists that as autonomous health practitioners, pharmacists are expected to undertake an independent assessment of every order or prescription separately from the prescriber. When it comes to addressing the complexities associated with off-label prescribing, collaboration with prescribers, providing accurate information, promoting informed consent, having robust documentation of conversations with both prescribers and patients, and adhering to risk mitigation strategies are crucial considerations.

By adhering to these recommendations, pharmacists can continue to play a pivotal role in optimising patient outcomes and the quality use of medications.

For immediate advice and incident support, call PDL on 1300 854 838 to speak with one of our Professional Officers. We are here to support our pharmacist members 24/7.