Maintaining a balance between access and the safety of medicinal cannabis is a key priority for health regulators across Australia amid a growing number of prescriptions and the emergence of telehealth, online prescribing and direct-to-consumer health services.

Ahpra and a number of National Boards convened a forum in Melbourne late February that brought together health regulators to share information and regulatory intelligence, discuss any current risks to the public, and determine how all regulators can best work together.

Australia’s medicine regulation system is complex, with different agencies responsible for overseeing the medicines themselves, the health professionals who prescribe and provide them, and the premises where they are stored and dispensed.

The use of unregistered medicinal cannabis products has spiralled in recent years, from around 18,000 Australian patients using products in 2019 to more than one million patients using medicinal cannabis up to 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.

The forum, hosted by Ahpra, is the first step to ensuring our current regulatory systems are adequate and flexible enough to deal with the challenge of protecting the public from harm and inappropriate prescribing while still allowing for legitimate access to medications.

The forum attendees agreed to continue discussions with the aim to monitor issues and identify any gaps in the regulatory and wider health response to this rapidly growing industry. In particular:

  • 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

Pharmacy Board of Australia Chair Brett Simmonds said the forum provided a clearer picture of the current and future medicinal cannabis landscape, strengthening a `joined-up’ regulatory approach to emerging issues and engagement with consumers and industry bodies.

‘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.’

TGA head Professor Tony Lawler said the recent large rise in the number of patients accessing unapproved medicinal cannabis medicines and the changing way in which these products are prescribed and dispensed through telehealth consultations and medicinal cannabis clinics means the regulatory system has to keep pace, to ensure patients are not being harmed.

“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),’ Prof Lawler said.

‘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.

‘The regulation of medicinal cannabis products and providers is a complex space with interplay across regulators, jurisdictions, industry, and peak bodies. Collaboration between all of these bodies is critical to ensuring safe products are being properly prescribed and dispensed to patients.’

While medicinal cannabis use has grown rapidly, the number of complaints to Ahpra about the health, performance and conduct of practitioners’ prescribing, dispensing, and compounding the products is relatively low to date.

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. 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.

Ahpra CEO Martin Fletcher said sharing information between all regulators was vital in striking a balance between public safety concerns and allowing access to health services as the medical cannabis sector evolves.

‘Ahpra called this forum together to examine how all the responsible regulatory agencies can work well in a rapidly growing field to ensure clarity of roles, clear information flows and use of all of our regulatory tools to best reduce potential harms to the public,’ he said.

‘We are keen to hear from consumers to better understand their perspective on medicinal cannabis prescriptions, and how practitioners and the health system can best meet their needs safely,’ Mr Fletcher said.

Attendees:

  • Australian Health Practitioner Regulation Agency
  • Medical Board of Australia
  • Nursing and Midwifery Board of Australia
  • Pharmacy Board of Australia
  • Australian Government Department of Health
  • Therapeutic Goods Administration
  • Australian Consumer and Competition Commission
  • State and Territory Health Departments – ACT, NSW, Tasmania, Queensland, Victoria and Western Australia
  • Office of the National Health Practitioner Ombudsman
  • Pharmacy premises authorities – South Australia, Tasmania and Victoria
  • Health Care Complaints Commissions – NSW, South Australia and Victoria
  • Office of the Health Ombudsman (Queensland)
  • Health Professional Councils Authority
  • ACT Human Rights Commission