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Extent of non-compliant medicinal cannabis clinics revealed
New research has highlighted the need for more stringent monitoring and regulation when it comes to advertising practices around the prescribing of medicinal cannabis products.
Australia has seen a spike in medicinal cannabis use since it became available, with 22% of people receiving prescriptions in 2022–23, compared to 1.8% in 2019.
Medicinal cannabis has been available under prescription in Australia since 2016. However, it has remained regulated as an ‘unapproved’ prescription-only medicine.
This means advertising to the public is strictly prohibited under the Therapeutic Goods Act. But new research has found that, of the clinics it examined, almost half of those prescribing these products are failing to comply with the Therapeutic Goods Administration’s (TGA) guidelines.
The study, published in the Australian & New Zealand Journal of Psychiatry, evaluated 54 clinics against six of the TGA’s guidelines for the promotion and advertisement of medicinal cannabis and found that 47% were classified as ‘high breach’.
This means they were breaching at least two guidelines.
Associate Professor Vicki Kotsirilos, who became Australia’s first authorised GP prescriber of medicinal cannabis in 2018, told newsGP that while the findings are not surprising, they are deeply concerning.
‘The problem with these practice models is that there’s a business model behind them all,’ she said.
‘They feature clinics that prescribe and dispense single medicines for patients to meet patient demand and for direct supply. This is totally unethical and unacceptable.
‘GPs will never advertise a single medication on their website, so there should be no exemption for these clinics.’
The study found most breaches occurred under the TGA’s guideline prohibiting the promotion of medicinal cannabis. This often involved providers displaying images of cannabis plants or logos, referencing industry awards or using abbreviations for cannabinoids.
Almost half of the clinics also provided information on their social media channels that included details on medicinal cannabis or its uses. In attempts to obscure this promotion, many clinics were found to be using terms like ‘green medicine’ or ‘plant medicine’.
Meanwhile, another frequent breach was clinics making unsubstantiated claims about the benefits of cannabis for specific health conditions.
Associate Professor Kotsirilos said this is worrying, as medicinal cannabis is not guaranteed to help everybody. But she says when the business model is aimed at selling a product, rather than treating the patient holistically, that it can lead to over prescribing.
‘It should be used as a last resort treatment when all other treatments have been trialled, including lifestyle and behavioural changes,’ Associate Professor Kotsirilos said.
‘Particularly for chronic pain and insomnia, the two conditions that medicinal cannabis is widely prescribed for according to the TGA statistics, there’s a lot of good evidence-based therapies out there that could help these conditions.
‘But when you produce a business model with the aim to prescribe only medicinal cannabis, we can miss those other treatments that are available.’
In the wake of the research findings, a TGA spokesperson told newsGP it is ‘aware of, and concerned about’ the rise of unlawful advertising of prescription medicines, including medicinal cannabis, to consumers.
‘Deterring and disrupting unlawful advertising of medicinal cannabis is a priority for the TGA,’ the spokesperson said.
‘We have taken, and will continue to take, strong enforcement actions, to address unlawful advertising of medicinal cannabis, consistent with our regulatory compliance framework.
‘Advertising prescription-only medicines directly to consumers could create an inappropriate demand for these medicines and lead to unnecessary or harmful prescribing. Appropriate treatment options should be determined by a health professional in consultation with their patient.’
In the last two years, up to June 2024, the TGA had issued 165 infringement notices to organisations and individuals for the alleged unlawful advertising of medicinal cannabis, totalling more than $2.3 million in penalties.
Since medicinal cannabis became available in Australia, its use has skyrocketed, with a 10-fold increase observed in the number of people receiving prescriptions in 2022–23, up from 1.8% in 2019 to 22%, with approximately 3% of Australians having used medicinal cannabis.
That number increased further in 2024, with TGA data showing 2.87 million units of medicinal cannabis were sold in the first six months of 2024 compared to 1.68 million recorded in the second half of 2023. The ‘Cannabis in Australia 2024’ report from the Penington Institute revealed this jump was largely driven by a high-volume of telehealth prescriptions.
The new research also found that many clinics offer services such as after-hours delivery, no need for medical practitioner’s referrals, half-price promotions and discreet delivery.
‘These could undermine the TGA guidelines for medical cannabis that are designed to ensure that medicinal cannabis is used appropriately,’ the authors highlighted.
The study concluded that while medicinal cannabis clinics have improved patient access, the widespread non-compliance with TGA guidelines highlights a need for more stringent monitoring and regulation of advertising practices.
‘Ensuring adherence to these guidelines is essential for maintaining the integrity of medical practice and protecting public health,’ the authors said.
The TGA spokesperson urged consumers to ‘exercise extreme caution’ and not to access unapproved therapeutic goods from unknown websites, social media or other digital platforms.
‘We strongly advise consumers not to use prescription medications offered or issued without a prescription and consultation from a health practitioner,’ they said.
However, while the TGA has expressed its commitment to cracking down on non-compliance, is it doing enough?
According to Associate Professor Kotsirilos its actions are appropriate, but like the study, they could go one step further.
‘What this study didn’t identify is whether they were walk-in or telehealth-style clinics,’ she said.
‘So, the next step, based on this study, is to actually look at what were the clinics that did not comply with the guidelines.
‘If there’s a trend towards certain types of clinics … then really the Government needs to step in and look at preventing these clinics from being set up because they have a conflict of interest and they’re basically unethical.’
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