newsGP AHPRA launches new guidance in peptide prescribing crackdown - Royal Australian College of General Practitioners (RACGP)

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AHPRA launches new guidance in peptide prescribing crackdown

Amid warnings that ‘reckless’ prescribing jeopardises clinicians’ right to practise, it’s released practical guidance and case studies for prescribing off-label and unapproved medicines.

AHPRA is ramping up its oversight of ‘reckless’ peptide prescribing, with the watchdog launching new guidance and a warning for practitioners ‘departing from established professional standards’.

On Wednesday, AHPRA published the guidance for practitioners when prescribing off-label or unapproved medicines, or medicines to be compounded, backed by several case studies to help practitioners ‘reflect on their prescribing decisions’.

The regulator says its fresh crackdown follows growing concerns around consumer demand for the medicines, as well as the rise in high-volume and single-treatment business models.

The new guidance walks clinicians through establishing therapeutic need, shared decision-making and informed consent, documentation, and ‘a word of caution’.

‘We may investigate the practice of practitioners with high rates of prescribing or compounding of any scheduled medicine, even if we have not received a complaint,’ it says.

‘Patient demand alone is not a valid reason to prescribe a medicine.’

Its published case studies include a GP who is working in an aged care facility routinely prescribing medicines being used outside of their indicated purpose, and a doctor prescribing a range of unapproved peptides promoted for ‘anti-ageing’ and ‘faster muscle repair’.

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

‘Existing professional and legal obligations apply to practitioners who are active in these new pharmaceutical frontiers,’ she 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.’

RACGP President Dr Michael Wright welcomed the move, saying many of these medications are prescribed outside of Medicare consultations and the PBS, leading to a ‘no man’s land of regulation’.

‘I don’t think this is going to come as a surprise because we’ve seen the growth of a number of providers of medicines which have been off-label or single-disease,’ he told newsGP.

‘We’ve heard stories of people being prescribed cannabis when they’ve got mental health conditions, or people being prescribed weight-loss agents over the phone when there’s been no ability to verify their history, and consultation has taken a few minutes.

‘This highlights AHPRA’s concerns about all health professionals, not just GPs, not meeting the appropriate standards or acting consistently with the code of conduct.’

Dr Wright said the case studies will be particularly useful for GPs.

‘It’s really helpful that they highlight what are examples of poor practice and really point out the consequences of poor prescribing, as well as outlining the implications of this on your registration and work as a health professional,’ he said.

AHPRA’s guidance comes amid a peptide boom sweeping Australia, with reports piling up of the unintended and serious consequences of using the unapproved products.

Most recently, a patient was hospitalised with a torn oesophagus after using a fake weight-loss peptide which caused uncontrolled vomiting.

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

The regulator’s Chief Executive Justin Untersteiner is now warning Australians against taking chances on black-market peptides or advice from online influencers with ‘zero clinical knowledge or training’.

‘They should be supported by registered health practitioners who exercise sound clinical judgement and justify the trust placed in them by the community,’ he said.

‘Anyone with concerns about a practitioner should alert us so that we can take appropriate action.

‘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.’

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