New guidance aims to tackle 'unsafe' peptide prescribing

Ahpra has issued new guidance that sets clear expectations of practitioners, including that these drugs should only be prescribed when there is a clear clinical indication or when other treatments have not worked or are inappropriate for the patient.

The regulator said it had been investigating unsafe prescribing practices, particularly in high-volume and single-treatment business models, including the provision of unapproved peptides, medicinal cannabis and GLP-1 weight-loss drugs.

It is concerned that growing consumer demand for certain medicines, coupled with undue commercial influence, has led some practitioners to depart from established professional standards.

Ahpra has warned it will take regulatory action against practitioners for unsafe prescribing.

Chief executive Justin Untersteiner said anyone with concerns about a practitioner should alert the regulator.

"We don’t need to wait for a notification to be received. If we see red flags, such as unusual prescribing patterns or inappropriate advertising, we can take it up with the practitioner directly or notify other agencies where businesses are involved," he said.

Mr Untersteiner said patients relied on registered health practitioners to exercise sound clinical judgment.

"People should not be taking chances on black-market peptides or advice from online influencers with zero clinical knowledge or training," he said.

Ahpra is working with the Therapeutic Goods Administration (TGA) to identify where concerns about prescribing may also involve the unlawful advertising, importation or supply of therapeutic goods.

It comes after the Medical Board warned it was concerned that high consumer demand for peptides was leading some practitioners to put profits ahead of patients.

Medical Board of Australia Chair Dr Susan O’Dwyer reminded practitioners prescribing medicines outside their approved use to be vigilant about meeting existing professional standards set by the Board.

A spate of adverse events including liver toxicity, severe allergic reactions, inflammation and other health complications requiring medical attention have been linked to unregulated peptides.

"Existing professional and legal obligations apply to practitioners who are active in these new pharmaceutical frontiers,’ Dr O’Dwyer said.

"Peptides are like other drugs. A patient may want peptides, but that doesn’t mean they need peptides. It doesn’t mean that peptides are clinically justified. Practitioners need to use their judgement, skills and experience to do what is best for their patient."

Practitioners are expected to maintain adequate health records, recognise and manage any conflicts of interest and facilitate coordination and continuation of care. They must also understand and critically evaluate the clinical rationale and supporting evidence for treatment, and report any adverse events to the TGA, the guidance states.

Prescribers must also comply with legal obligations under the Therapeutic Goods Act 1989, associated TGA requirements, and state and territory drugs and poisons laws.

The guidelines list examples of poor practice in prescribing, highlighting that even if a patient requests a medication it should not be prescribed without a legitimate indication.

Failing to obtain mental health or substance use history where relevant and not checking Real-Time Prescription Monitoring systems before prescribing are also considered poor practice.

The guidelines also cover conflict of interest, stating it is poor practice for doctors to only prescribe the product supplied by a company they are associated with.

Ahpra will shortly release new conflict of interest guidance, as well as information for patients on what to expect from telehealth.

This follows last year’s compliance initiatives in relation to medicinal cannabis and non-surgical cosmetic procedures.

Ahpra and the National Boards have also published a number of case studies designed to help practitioners reflect on their prescribing decisions, understand their professional responsibilities and apply good practice principles.