Regulators have agreed to open up the passage of information to forge a ‘joined-up’ approach to the ever-changing landscape.
The number of patients using unregistered medicinal cannabis products now exceeds one million, says AHPRA, meaning regulators must band together to keep pace.
Last Friday, AHPRA met with a number of National Boards to touch base on all things regulatory.
Regulation of medicinal cannabis was identified as a “key priority”, “amid a growing number of prescriptions and the emergence of telehealth, online prescribing and direct-to-consumer health services”, said AHPRA in a communique.
TGA head Professor Tony Lawler said it was up to the regulatory system to keep pace with the changing landscape.
“Only two medicinal cannabis products have been evaluated for safety, quality and efficacy by the TGA and included in the Australian Register of Therapeutic Goods (ARTG),” said Professor Lawler.
“While patients are accessing around 500 unregistered products under the TGA’s special access pathways, the TGA would welcome more products included in the ARTG to ensure Australian patients have access to products that have been subject to evaluation for safety, quality, and effectiveness by the TGA.”
According to AHPRA, the number of patients using unregistered medicinal cannabis products has “spiralled” from 18,000 in 2019 to over one million in January 2024.
“The number of prescribers accessing the Authorised Prescriber and the Special Access Scheme has also risen sharply to more than 5,700 medical and nurse practitioners using these schemes to prescribe and dispense medicinal cannabis products that have not been evaluated by the TGA for safety, quality, or efficacy,” added the regulator.
Last week’s forum was labelled the “first step” in working towards a sustainable balance between access and safety.
The forum agreed to monitor and identify issues in the following areas:
- Improving data and information sharing among Australia’s regulatory agencies
- Gaining a better understanding of the drivers of the recent rapid rise in access to these products
- Enhancing communication to prescribers, including clinical guidance, on the safe and effective use of medical cannabis products
- Examining ways of better educating consumers about medicinal cannabis medications
- Encouraging more research to drive the production of clinical guidelines for medicinal cannabis
According to Pharmacy Board of Australia chair Brett Simmonds, the forum helped forge a “joined-up” approach to medicinal cannabis regulation among the attendees and provide a clear direction.
“It’s important that regulators come together to share knowledge, information and approaches in order to ensure the best outcomes for the public,” Mr Simmonds said.
“This is particularly important with newly available medicines such as medicinal cannabis and in areas of healthcare that are rapidly evolving and changing, such as telehealth and online prescribing.”
The TGA’s Professor Lawler concurred, noting the complexity of the space.
“The regulation of medicinal cannabis products and providers is a complex space with interplay across regulators, jurisdictions, industry, and peak bodies,” he said.
“Collaboration between all of these bodies is critical to ensuring safe products are being properly prescribed and dispensed to patients.”
In good news, while medicinal cannabis use has skyrocketed, complaints to AHPRA about prescribing practitioners has remained low.
“Since 1 July 2019, AHPRA and its co-regulator in Queensland have received 267 notifications about 199 practitioners relating to the prescribing or dispensing of medicinal cannabis,” said AHPRA.
“This accounts for around 0.5% of all notifications received by AHPRA.
“Most concerns raised by patients relate to access to medication, fees and costs, and being prescribed lower doses than they have requested.
“After investigation, a small number of notifications have required regulatory action, with cautions or conditions being imposed on practitioners in 12 cases.”
Mr Fletcher said that sharing of information between regulatory agencies should help keep pace and strike the balance between public safety and access to services.