Rising safety concerns – occurring alongside rapid growth in access to unapproved medicinal cannabis products – have prompted the TGA to launch a public consultation last week.
They cite a reported increase in patients presenting to health services with psychosis, dependency, and other mental health issues following medicinal cannabis use. In particular, there are concerns about mental health risks associated with products with a high THC potency.
These concerns, mounted by state and territory health departments, peak medical bodies, industry stakeholders and community members, have been echoed by GPs in a Healthed survey this month.
When legislation for medicinal cannabis access in Australia was introduced, only a small number of practitioners were expected to prescribe it — and only for patients with specific clinical needs, the consultation paper notes.
But things have not gone quite as planned.
In 2018, 2559 applications for unapproved medicinal cannabis products were approved, but that number has since skyrocketed to 177,762 in 2024 — a near 70-fold increase.
AHPRA recently revealed some practitioners were doling out an extraordinary number of medicinal cannabis prescriptions, including one who apparently wrote 31,000 scripts in six months.
The number of conditions medicinal cannabis is being prescribed for is also expanding. Meanwhile, there are now over 1000 products for prescribers to choose from — with a wide range of dosages, CBD/THC proportions, and formulations (e.g., dried herb, oil, oral liquid, capsules etc).
Only two of these have been registered on the Australian Register of Therapeutic Goods – Epidyolex (CBD) to treat certain epileptic conditions, and Sativex (nabiximols) to treat some symptoms of multiple sclerosis.
Over 99% of medicinal cannabis products prescribed in Australia are unapproved, “and have therefore not undergone any pre-market assessment by the TGA to establish their quality, safety, efficacy or performance.”
Their sponsors do not necessarily have to provide samples to the TGA when asked, for example, nor do they need to report adverse events related to their product—unless they also prescribe it.
Despite this difference in regulatory oversight, many patients and providers assume unapproved products have been evaluated and ‘approved’ by the regulator, the paper points out.
Gold Coast based GP Dr Bryce Joynson, an experienced adult and paediatric cannabis prescriber and clinical educator on neurodiversity and endocannabinoid medicine, says patients often think products are safe because they have been prescribed by a doctor or clinic.
“Patients will often say, ‘It’s ok because it’s medicinal. It was prescribed to me. That means it’s safe to use.’ That doesn’t always mean it is the most appropriate treatment option for the patient,” he says.
The fact that most products are unapproved has contributed to the lack of evidence about their risks, the paper adds, noting there is not much incentive for companies to run pricy clinical trials while people can access the products through the special access scheme and the authorised prescriber scheme.
Peak medical bodies, state and territory health departments, industry, and community members have all raised concerns about medicinal cannabis’s safety, especially regarding mental health issues related to its use such as psychosis and dependency.
The report also cites some research linking daily cannabis use with higher risk of MI, CHD and stroke, and points to other potential harm such as lung damage from smoking cannabis, and the potential for cannabis use disorder. However Dr Joynson notes there is limited evidence to support these claims, and more studies are needed in this area.
In a Healthed survey this month, 85% of more than 1500 GP respondents were either ‘very’ or ‘moderately’ concerned about safety monitoring and adverse event reporting for medicinal cannabis. Additionally, 81% were ‘very’ or ‘moderately’ concerned with high THC concentrations, while more than two-thirds were ‘very’ or ‘moderately’ concerned about the quality and consistency of the products.
Several GPs reported that their patients had experienced concerning symptoms, including psychosis, dependency, vomiting, headaches, cognitive impairment, insomnia, worsening respiratory function, dementia, and mental health issues.
Others said patients seeking medicinal cannabis had been angry or aggressive towards them.
The AMA is seeing more reports about patient harms from cannabis, saying the “current surge in prescriptions is highly concerning.”
Dr Joynson says cannabis is very safe compared to many other drugs — but stresses it’s not risk-free.
“You can’t overdose and die from consuming cannabis, but there are other harms associated with it,” he says, including dependency and medication interactions.
“Patients who are prescribed a high amount of THC dried herb can be at increased risk of developing side effects of therapy, as it can blunt the endocannabinoid receptors—and you may need escalating doses of THC to activate those receptors next time,” he says.
Dependency on THC can lead to worsening of the very symptoms cannabis was prescribed for, such as insomnia, chronic pain and mental health issues, he adds.
“More education around the benefits of CBD and minor cannabinoids such as CBG and CBN and responsible prescribing/use of THC is required, for patients and medical professionals,” Dr Joynson notes.
According to the consultation paper, 1101 adverse events linked to medicinal cannabis use were recorded between 2016 and 31 July 2025—24% of which were serious.
They add that adverse events are probably underreported due to stigma, fear of losing access, lack of clarity about adverse events associated with medicinal cannabis, and not enough regulatory controls.
In the consultation, the TGA will specifically consider the safety of ‘high’ potency THC-containing products, noting “large numbers” of patients are accessing and using them.
Currently, there is no maximum limit for THC concentration in medicinal cannabis products, and concentrations in unapproved products vary widely.
They are sometimes much higher than that found in cannabis plants, the paper notes—up to 88% weight in weight for extracts, 60% weight in weight for dried herb, and 880 mg/ml in inhalation products.
Risks linked with high-potency THC products include depression, anxiety, psychosis, suicidal ideation and adverse effects on the cardiac, respiratory and neurological systems.
Dr Joynson says average THC concentrations in products are trending upwards, driven by patient demand—with patients seeking cannabis through direct-to-consumer telehealth providers for what is possibly recreational rather than genuine medicinal use.
In other words, patients are accessing cannabis through these platforms when it may not be medically appropriate.
“The appropriate checks and safeguards may not be followed by some clinics, putting profits above patient safety,” Dr Joynson says.
“When I first started prescribing in 2019, there was not much use of THC dried herb. Most scripts were for CBD or CBD/THC oil. The cannabis flower was around about 18% THC concentration and patients were being prescribed much more conservatively. Now in clinical practice we are seeing many more prescriptions for 25 to 30% THC flowers.”
“Patients are also being prescribed much higher monthly limits of THC dried herb and often without accompanying CBD preparations. We are dealing with much more potent cannabis strains which produce more potent psychoactive effects.”
Almost nine in 10 (89%) GPs in Healthed’s survey said they were very or moderately concerned about the impact of direct to consumer telehealth in relation to medicinal cannabis.
This issue has been brought to the TGA’s attention, but their consultation will not deal with it. Because their role is to regulate therapeutic goods, they will focus only on appropriate regularity oversight and safety concerns about unapproved medicinal cannabis products, they write.
The TGA has said it will take “prompt and appropriate regulatory actions” if the consultation identifies safety signals with certain products. It does not, however, plan to take away access to medicinal cannabis products.
The TGA is calling for submissions from stakeholders regarding their experiences, observations and knowledge of the use of unapproved medicinal cannabis products to help inform regulatory reform options. The consultation period runs until 7 October 2025.
You can read the consultation paper and make your submission here.
Listen to expert interviews.
Click to open in a new tab
Browse the latest articles from Healthed.
Once you confirm you’ve read this article you can complete a Patient Case Review to earn 0.5 hours CPD in the Reviewing Performance (RP) category.
Select ‘Confirm & learn‘ when you have read this article in its entirety and you will be taken to begin your Patient Case Review.
