Close to nine out of 10 GPs (88%) believe the Special Access Scheme and Authorised Prescribing for medicinal cannabis should be significantly modified or tightened – but not necessarily cancelled, while eight out of 10 (82%) reckon they are being misused, according to a new Healthed poll.
The national survey included 1892 GP respondents, but just 5% said they prescribe cannabis.
When it comes to the safeguards that GPs felt could have the biggest impact, clearer clinical guidelines topped the list, followed by tighter regulations on telehealth prescribers and medicinal cannabis manufacturers/sellers.
Last month the TGA published a summary of the feedback from the 790 submissions it received during its consultation reviewing the safety and regulatory oversight of unapproved medicinal cannabis products.
In its submission to the TGA, the RACGP noted that the role of telehealth providers had been omitted from the consultation, NewsGP reported (the submission does not appear to be publicly available on the TGA’s website, and the RACGP did not respond to Healthed’s request for it).
The RACGP said circumventing of TGA regulations was “an area of major concern,” adding that there is “clearly a lack of ethical guidance and professionalism among some prescribers.”
The AMA‘s submission also stated that the risks are “compounded by prescribing models that bypass traditional safeguards, such as vertically integrated telehealth services, which often lack comprehensive patient assessment and continuity of care.”
It argued that prescribing via direct-to-consumer telehealth models should prohibited.
Unscrupulous business practices by medicinal cannabis industry have been strongly implicated in inappropriate medicinal cannabis prescribing – in some cases online clinics are owned by the cannabis companies, creating serious conflict of interest, and marketing has aggressively targeted vulnerable patients.
Associate Professor Vicki Kotsirilos, a Melbourne GP who was one of the first medicinal cannabis prescribers in Australia and contributed to the RACGP submission, said industry companies that employ doctors and sell medicinal cannabis remotely through telehealth were likely driving up inappropriate prescriptions especially category 5 high potency THC products which have the highest risks for patients.
“According to TGA data, permits for the high potency THC dominant products [Category 5] are the most widely accessed, and I am confident it’s not your grassroots GPs who are prescribing these,” she said. “I certainly understand the concerns by authorities.”
Under the existing system, medicinal cannabis should only be prescribed as a last resort treatment when all other options have failed or are unsuitable.
“We do have a problem, and addressing the regulatory system alone may not actually address the problem. Restricting high potency THC products is helpful, but addressing the telehealth companies and the inappropriate prescribing and advertising is the way to address the root problem,” Associate Professor Kotsirilos said.
“It is actually easier to prescribe other drugs of dependency like benzodiazepines and opioids to our patients, than it is an unapproved medicinal cannabis product because it’s not an easy process through the TGA. It’s arduous compared with generating a PBS script.”
However, telehealth companies have developed checklists and questionnaires to make the process much faster – but the doctor prescribing may not know if the patient is lying when filling out documents e.g. if they have a history of mental illness, because they don’t know them like GPs who have continuity of care.
“But if you know the patient, like your grassroots GPs, you know the history of the patient and their family history, e.g. history of psychosis or mental health problems, you’re not going to prescribe high potency THC medicinal cannabis products because you know it’s a contraindication.”
Associate Professor Kotsirilos said that while people sometimes lump all types of medicinal cannabis together, there are significant differences in risk profile – and this was also highlighted in the TGA’s summary of consultation feedback.
“Most stakeholders consider cannabidiol (CBD), a prescription medicine in Australia, to be well tolerated by patients,” the TGA said. “Some submissions highlighted the potential for contraindications and interactions. While CBD was viewed as having a more favourable safety profile compared to THC, stakeholders also emphasised the limited availability of high-quality safety and efficacy data.”
Submissions also noted that “high potency THC products can increase risks of harm, such as acute psychosis and cannabis use disorder.”
“We know that THC aggravates anxiety, aggravates mental health problems. So you wouldn’t prescribe those,” Associate Professor Kotsirilos said.
“So if you’re a cautious prescriber like myself, you wouldn’t even go down that track.”
“If considering prescribing medicinal cannabis, it must be last resort treatment when all other evidence-based treatments have failed, including non-drug approaches such as counselling, lifestyle and behavioural advice. For instance, patients with anxiety are best treated with referral to a psychologist for CBT, and provided non-drug advice as well e.g. diet, avoidance of caffeine, breathing exercises, physical exercise, and sleep hygiene advice,” she added.
Medicinal cannabis products are divided into five categories, depending on the proportion of cannabidiol content compared to the total cannabinoid content of the medicine, as illustrated in the graph below:
“To minimise this risk of adverse events with medicinal cannabis, the correct dose is the lowest dose that may have clinical benefits. Start with CBD dominant products e.g. Category 1-2 products, work from the principle of ‘start low and go slow,’ and monitor and reassess your patient,” Associate Professor Kotsirilos said.
“If the treatment fails, do not keep escalating to higher THC potency products e.g. Category 5 due to the risks such as cannabis use disorder and psychosis especially in sensitive patients.”
Should the Special Access and Authorised Prescribing schemes be scrapped altogether?
In its submission, the Royal Australian New Zealand College of Psychiatrists called for an end to the Special Access Scheme and Authorised Prescribing for medicinal cannabis altogether, citing “the misuse of the current system” and “the limited regulatory oversight available to the TGA.”
In Healthed’s survey, just 18% strongly agreed that the scheme should be cancelled, while 34% slightly agreed – and 47% disagreed.
Associate Professor Kotsirilos will be giving a lecture on medicinal cannabis at Healthed’s Women and Children’s Health Update in Melbourne on 21 March.
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