The head of the AMA called for a regulatory system that is “fit for purpose” around the prescribing of medicinal cannabis.
AMA President Dr Danielle McMullen welcomed the Therapeutic Goods Administration’s (TGA) consultation into the use and prescribing of medicinal cannabis.
Following AMA advocacy on the issue, head of the TGA Professor Tony Lawler announced the consultation at the AMA25 national conference earlier this month.
The consultation seeks to understand whether current regulatory arrangements that enable patients to access medical cannabis via the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme provide adequate oversight for the more than 1000 unapproved products currently supplied in Australia.
The schemes were initially designed to provide access to experimental products often used in clinical trials, or for exceptional circumstances at the discretion of the prescribing practitioner.
However, there are concerns around whether there is appropriate regulatory oversight of the products being accessed via the SAS and AP schemes in Australia and the safety risks associated with the products.
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The issues have been highlighted by the large numbers of Australians accessing and using these products and the growing number of ‘product-specific’ telehealth and digital services prescribing unapproved medicinal cannabis, or other medicines, through direct-to-consumer business models.
Last month, Ahpra provided updated guidance to address unsafe prescribing of medicinal cannabis, reminding practitioners to treat medicinal cannabis with the same caution as other drugs of dependence.
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Dr McMullen said medicinal cannabis was “being prescribed at alarming rates through direct-to-consumer telehealth models”.
“Telehealth is an important mechanism to improve access to health services, but these direct-to-consumer, single-issue models lack clear referral pathways or a feedback loop to GPs and, as the TGA has acknowledged, this requires much broader consideration by government,” she said.
At the AMA25 conference, Professor Lawler said only two medicinal cannabis products were approved by the TGA, meaning most medicinal cannabis products are accessed through the unapproved goods scheme, which is not within a regulatory control mechanism.
Dr McMullen said the evolution of Australia’s healthcare system had outpaced current regulatory schemes, which were built around in-person consultations and community pharmacy dispensing.
“Clearly, the health landscape has changed dramatically in Australia, so it is vital we look at our regulatory settings and find out what needs to be done to address any gaps, including in the medicinal cannabis space,” Dr McMullen said.
“We are seeing increasing reports of patient harm from cannabis, including psychosis, so this current surge in prescriptions is highly concerning. This is despite the reality there is very little evidence to support the use of medicinal cannabis other than in a small number of conditions.”
The consultation is open until October 7. Have your say here.
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