‘Major public health risk’: RACGP backs medicinal cannabis reform

The RACGP has called for major reforms to the way medicinal cannabis is prescribed, including a requirement for all products to be approved on the Australian Register of Therapeutic Goods (ARTG).
 
In a submission to a Therapeutic Goods Administration (TGA) consultation, the college said the current system – which allows authorised medical practitioners to prescribe unapproved products – is not working as it should.
 
‘It is the view of the RACGP that the absence of ARTG processes leave Australians vulnerable to unsafe products and devices,’ the submission states.
 
It called for all medicinal cannabis products to go through ARTG processes with a suggested transition period of 18–24 months, which would include the same evidence of good manufacturing practice principles expected of all pharmaceuticals.
 
‘This multi-billion-dollar industry must invest in proper clinical trials to meet ARTG approval processes,’ the RACGP stated.
 
It said the move ‘may contribute to the development of a stronger evidence base as sponsors must be accountable for providing evidence of efficacy and safety’.
 
Currently only two medicinal cannabis products are fully approved on the ARTG, but the prescribing of cannabis has skyrocketed in recent years, triggering widespread concern.
 
While noting that consultation does not cover the role of telehealth providers, the college stressed the need for reform, saying ‘an area of major concern is the circumventing of TGA regulations when prescribing unapproved medicinal cannabis products’.
 
‘There is clearly a lack of ethical guidance and professionalism among some prescribers,’ the submission states.
 
‘This is critical to address as potentially harmful or costly treatments should only be recommended when benefits outweigh risks and in the context of shared decision-making, free from bias.
 
‘Prescribers should have a broad complement of treatment options available to address patient needs so that the most suitable option can be selected.
 
‘This is not the case for cannabis-only prescribing services.’
 
The RACGP’s submission was among almost 800 contributions to the consultation, which the TGA launched last year in response to ‘increasing public and professional concern’ over safety risks, in particular for high-strength products containing tetrahydrocannabinol (THC).
 
Last week, the regulator published a summary of the viewpoints received, noting widespread backing for stronger oversight.
 
‘There was agreement across stakeholder groups that the current access framework, used for exceptional clinical circumstances, is not fit-for-purpose and not proportionate to the potential safety and quality risks associated with unapproved medicinal cannabis products,’ the TGA stated.
 
‘While reform was generally supported, there was a strong desire to carefully consider any impact to patient access.’
 
According to the TGA, the most prominent concerns surrounded dried herb products, as well as concentrated extracts used for vaping.
 
The RACGP’s submission was among them, noting the very high rate of prescribing of THC-dominant products, which now account for the highest number of permits, according to the TGA.
 
These are mostly dispensed to the 18–44-year-old age group, purportedly to treat chronic pain and anxiety.
 
‘This is a potential major public health risk, eg increased risk of anxiety and psychotic events, and may contribute to physical and psychological dependency, leading to cannabis use disorder,’ the RACGP warns.
 
‘Whilst medicinal cannabis has a role in patient care, the RACGP supports the most conservative approach to prescribing THC-containing products, emphasising these are used only as a last resort treatment and at the lowest possible therapeutic dose.’
 
Melbourne GP Associate Professor Vicki Kotsirilos, who was among the first authorised prescribers of medicinal cannabis in Australia and contributed to the RACGP submission, said she would welcome changes limiting the prescription of THC products.
 
‘The majority of GPs prescribe appropriately, I don’t think it’s coming from your grassroots GPs,’ she told newsGP.
 
‘I’m confident that the telehealth companies that are driven by the sponsors are responsible for these inappropriate prescriptions.
 
‘What’s come through that consultation clearly is that the risk and harm to our community, which not only includes increased cases of psychosis but also cannabis use disorder, has been the main concern.’
 
In its summary of all the feedback, the TGA said risks in all dosage forms had been identified, with many contributors, like the RACGP, pushing for bolstered product quality controls. 
 
Many also endorsed stronger packaging and labelling rules, which included calls for plain packaging, warning statements, transparent registration status, product information documents and child-resistant packaging.
 
The risk of medicinal cannabis in the form of pastilles and gummies was among the concerns raised in many submissions, according to the TGA.
 
It also highlighted gaps in patients’ knowledge about the unapproved status of medicinal cannabis products and committed to taking action to support healthcare practitioners and consumers to understand the risks.
 
The publication of the responses to the consultation comes in the same month as the Department of Veterans’ Affairs announced dosing caps and stricter prescriber requirements for its funding of medicinal cannabis prescriptions.
 
Log in below to join the conversation.
 

medicinal cannabis TGA Therapeutic Goods Administration