Prescriptions for unapproved medicinal cannabis products in Australia have quadrupled since 2019, with half issued for adults aged 24 and under.
Researchers and GPs’ representatives have questioned whether the boom has led to patients taking cannabis for conditions where there is little evidence it is effective, given large gaps in the data and the role of cannabis manufacturers in promoting their product to practitioners.
Most prescriptions for medicinal cannabis in Australia are for unapproved products, which means they have not been authorised by the Therapeutic Goods Administration for legal supply.
Practitioners must apply to the TGA through the Special Access Scheme for permission to prescribe the products, and show why approved products are not suitable.
Since the start of 2021 the TGA has approved more than 200,000 medicinal cannabis prescriptions through the scheme for people who are not severely ill but who have exhausted evidence-based treatments for their condition. There were 122,486 such prescriptions in 2021 alone, compared with 57,714 in 2020 and 25,516 in 2019.
Doctors treating terminally ill patients or those likely to die prematurely apply through a separate, less commonly used process.
The president of the Royal Australian College of General Practitioners, Karen Price, said medicinal cannabis products should be seen as “last-resort medication for specific illness”.
“Most of the research on medicinal cannabis products is on five clinical conditions: multiple sclerosis, palliative care, epilepsy, nausea and vomiting, and chronic non-cancer pain,” she said.
“The quality of evidence varies and in some cases is inconclusive or insufficient to suggest any benefit to patients. However, if after conventional, evidence-based treatments have failed, and medicinal cannabis products are considered a viable treatment option, it’s reasonable for clinicians and patients to consider medicinal cannabis.”
The most common reason for prescriptions was chronic pain (60% of approvals), but almost one in four were for anxiety. This is despite low-quality and patchy evidence that medicinal cannabis products are effective for anxiety.
A survey from the University of Sydney’s Lambert Initiative, published on Thursday, found 37% of respondents obtained medicinal cannabis with a prescription, compared with only 2.5% in the previous survey, conducted two years earlier. The survey found the main reason for using prescribed medicinal cannabis was chronic pain, followed by mental health and sleep disorders. It found 95% of users reported improved health.
The lead researcher, Prof Nicholas Lintzeris, said people using illicit cannabis were more likely to smoke it, whereas people using prescribed products were more likely to use oral products or vaporised cannabis, “highlighting a health benefit of using prescribed products”.
A separate paper outlining the rise of medicinal cannabis prescriptions, led by Dr Christine Hallinan from the University of Melbourne’s department of general practice, found that of the 277,338 medicinal cannabis prescription approvals between January 2017 and August 2022, 50% were for patients aged between 18 and 24, and 31% were for those aged 45 to 64.
Hallinan said evidence was lacking that medicinal cannabis was an effective treatment for many of the conditions claimed by its manufacturers, although that did not mean clinical trials might not eventually show the products worked.
She said increased prescribing had not been accompanied by strong monitoring of efficacy, side-effects and which conditions specific age groups were using the products for. She said patients should be encouraged to use apps to track their outcomes, and this data could then be combined with deidentified patient data and prescribing data to better understand the use and impact of medicinal cannabis.
“At the moment we can’t tell how many patients are actually filling their scripts,” she said.
“For every product on the Pharmaceutical Benefits Scheme and even many products on the [Special Access Scheme], you have a [deidentified] register of patients so you can see how many people are actually taking the drug, and you can also link this to other drugs they’re on, hospital admissions and deaths data. We can’t do this for medicinal cannabis because there is no patient database.”
Hallinan said the launch of cannabis clinics was one reason for the sharp rise in prescriptions.
Some clinics have a strong online presence, and offer same-day appointments to a prescribing GP. Some claim medicinal cannabis can be useful in treating a wide range of conditions, including migraine, insomnia, stress and pelvic pain, without always highlighting adverse events or the limited evidence.
The RACGP said it was very concerned about the emergence of online prescription services for medicinal cannabis.
“There are numerous risks to these types of services offering prescriptions via telehealth or online,” Price said. “A key concern is that these services are fundamentally responding to a business opportunity rather than delivering healthcare. They won’t have the patient’s medical history and these services can lead to fragmented and poor-quality care.”
Many of the major dispensaries operating in Australia are owned by medicinal cannabis manufacturers and suppliers.
On Wednesday, the TGA issued 73 infringement notices totalling $972,360 to three medicinal cannabis companies for the alleged unlawful advertising of medicinal cannabis products on their websites and social media platforms.
The companies allegedly promoted the use of prescription-only, unapproved medicinal cannabis products, and published references to the treatment of serious diseases such as cancer and epilepsy.
Dr Mark Morgan, a professor of general practice and chair of the RACGP’s quality care expert committee, said the influence of the industry may have led to levels of prescribing not justified by the evidence of efficacy.
“The industry has been guiding a lot of the education, facilitating a lot of the prescribing, and leading the marketing of these products,” Morgan said.
“There’s been marketing to clinicians and pharmacies about medicinal cannabis which is dressed up as ‘education’. But it is not independent, and therefore we have to question whether or not some of the prescribing is following the evidence, or going beyond it.”
