Off-label prescribing guidance in pipeline, Medical Board says

Doctors will be reminded of their responsibilities to patients when prescribing off-label products in soon-to-be-released guidance, the Medical Board of Australia has said.
 
The Board has flagged that guidance is ‘coming soon’, with its Chair Dr Susan O’Dwyer speaking of ‘surging patient interest in peptides’.
 
‘There is also temptation for practitioners to cut corners to meet demand for these products,’ she wrote.
 
‘We’re encouraging patients to turn to a registered health practitioner for guidance, and practitioners to make sure this trust is well placed.’
 
The Board says it is working with the Australian Health Practitioner Regulation Agency and the Therapeutic Goods Administration (TGA), and that new guidance will set out ‘professional responsibilities when prescribing in new pharmaceutical frontiers’.
 
‘There’s been a massive uptick in unapproved peptide use that raises safety concerns,’ it states.
 
‘Some consumers are sourcing illicit substances directly online, without adequate health advice.
 
‘Others are sourcing them from registered practitioners who are not meeting their professional responsibility to only prescribe peptides when there is a clinical need and evidence to support the treatment.’
 
RACGP President Dr Michael Wright said he shared ‘real concerns’ around the rise in patients accessing substances such as peptides.                                                                 
 
‘There is a lot of interest in these substances but you’ve really got to be sure there is clinical evidence and a proper indication for patients to be using them,’ he told newsGP.
 
‘Frankly, many of them are untested and potentially unsafe.’
 
He said discussions about peptides and other unapproved products have become ‘a common conversation’ in many GPs’ practice and welcomes the Medical Board’s plan to issue clearer guidelines.
 
He also echoes the Board’s emphasis on encouraging patients to seek input from registered health practitioners, saying GPs are in the right position to advise on the risks.
 
‘As clinicians, it’s often our job to explain to patients why something might not be appropriate for them, as well as recommending the appropriate treatment,’ Dr Wright said.
 
‘It’s really a caution for anyone involved in this industry that more guidance is coming and likely more regulation.’
 
While the prescribing of unapproved products such as medicinal cannabis has been in the media spotlight for years, scrutiny on peptides has increased significantly in recent months.
 
This month, an ABC Four Corners investigation demonstrated how easily the products could be accessed via telehealth clinics.
 
Legal online suppliers are using loopholes in compounding rules to supply products that are unapproved but not banned in Australia, while there is also a thriving black market.
 
Earlier this year, the huge expansion in unapproved peptide use in Australia prompted the TGA to revise its compliance priority focus areas for 2026 to include the issue.
 
It has also issued other warnings about the treatments, including one directed at practitioners who compound, prescribe or supply unapproved peptide products.


The Medical Board’s most recent update is the latest warning for prescribers it says are trying to ‘side-step’ their responsibilities.
 
‘By putting profits ahead of patients, these practitioners are putting public safety at risk and could face regulatory action,’ it states.
 
‘Most practitioners want to put their patients first, but commercial and financial pressures can affect clinical judgement.
 
‘Professional responsibilities don’t vanish in the face of patient demand and off-label prescribing should only follow a thorough clinical assessment.’
 
The Board said the guidance will bring ‘clear focus’ rather than new rules and will remind practitioners of the need ‘to assess patient and medicine suitability, gain informed consent and document the consultation’.
 
‘Existing professional obligations are well established and provide a very clear framework to guide prescribing of off-label, unapproved and compounded medicines, including peptides,’ the Board stated.
 
‘You need to meet the professional standards set out in the Board’s codes and guidelines, practise within the law, comply with TGA rules, and meet state and territory drugs and poisons regulations.’
 
In an interview earlier this year, TGA Chief Medical Adviser Professor Robyn Langham also highlighted the risks of using unapproved peptides.
 
‘What we are seeing on our voluntary database is mainly around anaphylaxis, systemic inflammatory responses – both of those will land you in intensive care,’ she previously told newsGP.
 
‘There are a range of products that never made it to the level where they would be considered useful, or safe, or actually work … someone’s making them up in the Thermomix out the back and selling them. 
 
‘Putting labels on them like “not for human use” or “for research only”, that doesn’t take away the absolute legal requirement for someone to abide by all of the laws in Australia around therapeutic products.’
 
A release date for the new Medical Board guidance is yet to be confirmed.
 
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