‘Deeply concerns me’: Original prescriber’s alarm over cannabis trends

Associate Professor Vicki Kotsirilos was at the vanguard of changes surrounding the prescription of medicinal cannabis.
 
In 2018, she became Australia’s first authorised GP prescriber and welcomed the broadening of treatment options for the right type of patient when other clinical options have been exhausted.
 
But as prescription rates continue to skyrocket – driven by high-volume telehealth prescriptions – her unease has grown.
 
That was brought into focus by the latest ‘Cannabis in Australia’ report from the Penington Institute, a Melbourne-based public health research organisation, which highlighted a huge leap in sales in the past year.

It published data provided by companies to the Therapeutic Goods Administration (TGA), showing 2.87 million units sold in the first six months of 2024 – a huge climb on the 1.68 million recorded in the second half of 2023.

It also estimates Australians spent around $402 million on medicinal cannabis prescriptions from January to the end of June this year.
 
The total for all of 2023 was estimated at $448 million, which itself was a big leap from $234 million in 2022, with the report indicating the market for illicit cannabis stands at around $5 billion annually.
 
‘The high-volume access of medicinal cannabis products by clinics set up solely for prescribing these products deeply concerns me,’ Associate Professor Kotsirilos told newsGP.
 
For her, a particular issue is companies selling their products directly to consumers, including via telehealth or other means.
 
‘This set up presents a significant conflict of interest – it is modelled around prescribing high volumes of medicinal cannabis products on demand for profit,’ she said.  
 
‘Federal Government laws and tighter regulations must urgently be introduced to stop this model of dispensing.’
 
The Penington Institute, which argues that general cannabis supply should be decriminalised but strictly regulated, reaches a similar conclusion.
 
‘Some medicinal cannabis clinics are clearly prioritising high-volume access over high-quality medical care,’ its report states.
 
The Institute’s CEO, John Ryan, said while there are ‘legitimate concerns’ about the conduct and sales methods of a small number of medicinal cannabis companies, ‘most operators in the space conducted themselves ethically and professionally’.
 
‘It is important that we have stringent regulations, so that anyone who breaches those standards is held accountable for their actions,’ he said.
 
‘Patient health and safety must always be front-of-mind.
 
‘As it stands the medicinal cannabis industry is thriving – what is crucial is to ensure it is focused on catering first and foremost for patients, rather than revenue growth.’
 
The report comes at a time when health officials are considering the current settings.
 
In February, the Australian Health Practitioner Regulatory Authority (AHPRA) convened a forum to discuss whether regulations strike the right balance between protection from inappropriate prescribing and legitimate access.
 
It cited the rise from 18,000 Australian patients using prescribed medicinal products in 2019 to more than one million patients as of the start of this year January 2024 – a number that is likely to have risen given the latest TGA data.
 
In June, a further AHPRA statement raised further concerns over ‘emerging models of care’, again citing the rise of large-scale telehealth models dedicated to the prescription of medicinal cannabis.
 
‘The emergence of services designed solely to provide customers with access to a pre-determined medicine raises concerns that some practitioners may be putting profit ahead of patient welfare,’ it said.
 
Since then, several stories have emerged casting further concerns on the current settings for medicinal cannabis prescribing.
 
In October, Nine Newspapers reported that a doctor had prescribed medicinal cannabis scripts to 12,000 patients over six months.
 
Doctors have also recently warned of more people going to hospital with psychosis after being prescribed medicinal cannabis containing tetrahydrocannabinol (THC), a psychoactive ingredient.
 
Associate Professor Kotsirilos believes tightening access is particularly pressing for products with higher doses of THC.
 
‘There are not enough barriers to prescribing high-risk medicinal cannabis products – that is, those with the highest levels of THC as found in Category 5 medicinal cannabis products,’ she said.
 
‘Furthermore, in the last year, there is an unacceptable rapid rise for prescribing the higher potency Category 5 THC medicinal cannabis products, especially to men for chronic pain and anxiety in Australia.
 
‘There are real risks associated with prescribing THC, such as addiction, heightened anxiety, and psychosis particularly in susceptible individuals.’
 
In February, TGA head Professor Tony Lawler said only two medicinal cannabis products had been evaluated for safety and efficacy and included in the Australian Register of Therapeutic Goods.
 
While most products are unregistered, with the majority imported from Canada, many have been approved for supply in Australia under the two TGA existing clinical pathways: the Special Access Scheme and via Authorised Prescribers.
 
According to the latest data from the Department of Health and Aged Care, there are currently 3062 Authorised Prescribers. They accounted for more than 2.5 million of the units sold in the first half of 2024, the vast majority of the 2.87 million total. 
 
For Associate Professor Kotsirilos, GPs remain in a key position to provide appropriate management and continuity of care, as well as to ensure all safe alternatives have been explored.
 
She emphasises a cautious approach.
 
‘Medicinal cannabis products should be prescribed only when all other treatments have failed,’ she said.
 
‘If the decision is made to prescribe medicinal cannabis, start with cannabidiol, the non-toxic phytocannabinoid.
 
‘If needed, incorporate lower doses of THC, along the principles of “start low, go slow” with close monitoring of patients to ensure they are safe.’
 
She again noted the impact of the current settings.
 
‘Unfortunately, patients will resort to the telehealth and online clinics when they cannot access medicinal cannabis from their own GP,’ she said.
 
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cannabis medicinal cannabis telehealth TGA Therapeutic Goods Administration Vicki Kotsirilos