Navigating Ahpra’s new prescribing rules

The TGA has warned of severe allergic reactions and systemic inflammatory response syndrome linked to unapproved peptides promoted online for weight loss, muscle growth and anti-ageing.

In NSW alone, unapproved peptides were linked to 1180 emergency department presentations in just over a year.

In September, Ahpra followed with new guidance on prescribing off-label, unapproved or compounded medicines.

The guidance doesn’t ban these medicines, which remain a legitimate part of clinical practice for patients with specialised needs, those ineligible for clinical trials and those affected by medicine shortages, but it does spell out what’s required of prescribers.

Under the guidelines, patient demand alone is not a valid reason to prescribe. A patient asking for something, however insistently and however well-informed they seem, doesn’t establish that it’s clinically indicated.

Dr Owen Bradfield, Chief Medical Officer of MIPS, said: “We have seen this in recent years with medicinal cannabis, and we are starting to see it now with peptides.”

Need, consent, documentation

The guidance centres on three responsibilities. First, prescribe only when an approved medicine is unavailable or inappropriate and adequate evidence supports the use.

Second, ensure the patient understands the medicine’s status, risks, unknowns, alternatives and cost.

Third, document your reasoning and the consent discussion. Pre-filled templates are not adequate.

“If your notes look identical from patient to patient, that’s a red flag,” Dr Bradfield said.

Prescribers must also comply with the Therapeutic Goods Act and state and territory drugs and poisons laws. In WA, that includes the Medicines and Poisons Act 2014 and Medicines and Poisons Regulations 2016.

Single-treatment telehealth services, with consultations lasting seconds to minutes, are Ahpra’s headline concern. Its view is that a thorough assessment, including mental health and substance use history and a check of ScriptCheckWA, cannot be adequately completed in a brief online consultation.

The principles apply in every setting, including general practice and aged care.

Conflicts must be disclosed

Ahpra’s interim guidance on conflicts of interest applies alongside. Conflicts are common and not inherently wrong, but they must be recognised, disclosed to patients, managed and documented. A declaration on a website isn’t enough.

Practice owners should also note that under section 136 of the National Law, directing or inciting a practitioner to engage in unprofessional conduct is a criminal offence, with penalties of up to $60,000 for individuals and $120,000 for companies.

The guidance also warns that Ahpra may investigate practitioners with high rates of prescribing or compounding of any scheduled medicine, even without a complaint.

“This is proactive, data-driven regulation,” Dr Bradfield said.

If you’re unsure whether your practice meets the standards, calling MIPS early is the best first step.

This content is part of a paid partnership with MIPS.

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MIPS is a member-owned mutual that exists to support healthcare professionals across Australia with comprehensive medical indemnity protection.