It’s the latest ‘joint’ effort from the AMA and Pharmacy Guild on medicinal cannabis reform.
The peak body for doctors and the peak body for pharmacists have teamed up to call for medicinal cannabis reform again; this time, though, the two organisations appear to have slightly different perspectives on the best fix.
On Tuesday, the AMA and Pharmacy Guild of Australia announced they had written a joint letter to Health Minister Mark Butler raising concerns about “excessive and poorly regulated” medicinal cannabis prescribing practices.
The letter includes patient testimony about coercive practices by cannabis companies and outlines further concerns about the rapid proliferation of single-issue, vertically integrated clinics.
While there are currently just two cannabis products listed on the Australian Register of Therapeutic Goods, hundreds of products are available through the Special Access Scheme and the Authorised Provider pathways.
The SAS and AP pathways are technically meant to be a temporary, exceptional access mechanism for patients to access medicines that aren’t available in Australia.
But the AMA and the guild argue that medicinal cannabis suppliers have come to see the SAS and AP pathways as more of a permanent way to avoid jumping through the TGA’s regulatory hoops.
“We are seeing a system that is being exploited – with prescriptions issued without proper clinical oversight and patients bypassing their regular GP and pharmacist,” guild president Professor Trent Twomey said.
“What began as a special pathway for medication has now become the norm with thousands of products prescribed without safety, quality or efficacy controls.”
The letter calls for the immediate suspension of all products containing THC concentrations above 98% while the TGA completes its review of the safety and regulatory oversight of unapproved medicinal cannabis products.
It follows a similar missive penned by the NSW branches of the RACGP and guild, as well as the AMA NSW, sent to state Health Minister Ryan Park several weeks ago.
That letter focussed more on the potential dangers inherent in so-called “closed loop” models, where one parent company may own a telehealth clinic that prescribes cannabis and direct patients toward a “preferred” dispensary that they also happen to own.
Both the AMA and Pharmacy Guild of Australia also released their submissions to the TGA review, which closed for submissions last week.
Both organisations expressed concern that the SAS and AP were being exploited, that there had been an uptick in patients with cannabis-induced psychosis and that the current quality and safety requirements were not sufficient.
Both also supported more stringent labelling standards, a two-year transition period to allow medicinal cannabis sponsors to apply for ARTG listing and certain limits on prescribing and dispensing.
This last point is where the AMA and the guild diverge slightly.
Part of the guild’s proposed solution is to cap the number of prescriptions that any one prescriber can issue per month under the SAS and AP pathways. Essentially, the regulatory focus would be on the doctors prescribing.
The AMA also floated a suggestion to cap prescriptions; however, the process it argued for was a threshold for prescribing volume or supply that would trigger mandatory ARTG registration of a product.
This would be more squarely focussed on regulating drug manufacturer behaviour.
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“The AMA urges comprehensive reform of the regulatory framework for unapproved medicinal cannabis products to restore clinical governance, protect patient safety, and uphold the integrity of Australia’s therapeutic goods system,” the submission said.
“Central to this is the requirement that products used beyond exceptional access must be registered on the ARTG, ensuring rigorous pre-market assessment for safety, efficacy, and quality.
“An immediate high THC concentration product freeze and prescribing volume thresholds would promote patient safety while the regulatory arrangements for medicinal cannabis products are reviewed.
“Products that reach defined levels of use should be required to justify their registration status, with exclusion from the SAS and AP pathways if standards are not met.”
The association also argued for per-patient dispensing limits on high THC products (i.e., a weekly cap or maximum pack size and controlled repeat intervals) and a prohibition of prescribing via direct-to-consumer telehealth models for paediatric patients.
The TGA consultation closed on 7 October. It has reportedly received more than 750 submissions.
