‘A very difficult beast to cover’: TGA addresses GPs’ role in peptide boom

The medicines watchdog is speaking out directly to GPs as its compliance efforts hone in on the escalation of unapproved goods being imported into Australia, including by healthcare professionals.
 
Illegal imports are streaming into the country, with a recent two-week crackdown seizing more than 900,000 units of unlawfully imported therapeutic goods.
 
A high proportion of these were melatonin products, as well as nicotine pouches, weight-loss products, erectile dysfunction medicines, vitamins and supplements, and various wellness, cosmetic and performance‑enhancing products.
 
In response, Therapeutic Goods Administration (TGA) Chief Medical Adviser Professor Robyn Langham sat down with newsGP to discuss current laws and what GPs can do, whether they are an importer or seeing impacted patients.
 
‘In Australia there is a very big law that says, unless you have a product in Australia that’s registered, you cannot supply it. That’s rule number one,’ she said.
 
‘There are a couple of caveats in our law recognising some small individual examples of products that patients might need that allow you to access them, even though they’re not approved in Australia.
 
‘Our laws allow the patient, together with your doctor, to access those products with a prescription.
 
‘In prescribing an unapproved good, [clinicians] need to understand that they are the ones making the decisions around safety, quality, and efficacy.’
 
Those strict pathways include a compounding exemption and the Personal Importation Scheme.
 
As Australia’s peptide craze shows no sign of slowing down, Professor Langham said patients are joining the trend, in part, due to social media, where the health claims are fake, but the consequences are real.
 
‘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 said.
 
‘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.’
 
The peptide boom is something Professor Caroline Johnson, a member of the RACGP Expert Committee – Quality Care, has seen firsthand.
 
‘My advice as the GP is, if it hasn’t been approved by the TGA for safety, quality and effectiveness, you are taking potentially quite big risks and they’re very hard for us to quantify,’ she told newsGP.
 
‘There are obviously other ways peptides are being used that may have no contact at all with a general practice system other than that we might see people experiencing adverse effects from these drugs.
 
‘These are the kind of things that we won’t know unless we’ve got a really good relationship with our patient and we can say, “look, is there anything else I should know here, anything else you’ve tried, anything you’ve used that you’ve bought online?”.’
 
Currently, the Personal Importation Scheme allows individuals to import therapeutic goods, provided strict conditions are met.
 
Fake medicines are prohibited from being imported under any circumstances, even if someone has a prescription for the medication or is not aware they purchased a counterfeit product.
 
Meanwhile, compounded medicines are exempt from being included on the Australian Register of Therapeutic Goods (ARTG) where they are supplied to an individual patient on receipt of a valid prescription or request.
 
‘The TGA encourages the use of medicines included in the ARTG. However, the legislative framework recognises that compounding may be necessary in limited circumstances to meet an individual patient’s clinical needs,’ the TGA said in new guidance, issued earlier this month.
 
Professor Langham said the TGA also continues to work closely with social media platforms to shut down law-breaking influencers and advertising.
 
‘There is a problem, though – this is a very difficult beast to cover, and to completely wrangle, and sometimes we do see websites that are shut down a few months later popping up under a different guise, but that’s a real challenge,’ she said.
 
‘The other thing that we are doing is we’re working very closely with the Australian Border Force in order to ensure that any illegal imports are being seized at the border.’
 
Meanwhile, Professor Johnson said this rise in peptide use amplifies the importance of the role GPs have in their own communities.
 
‘Being registered as a medical practitioner in Australia does come with certain responsibilities,’ she said.
 
‘It’s a real privilege to be allowed to prescribe things and write certificates and do all those things that GPs are allowed to do, and the counter side of that responsibility is not doing things that are outside of what would be considered by our peers to be good professional medical practice.’
 
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