Boom in unapproved medicinal cannabis products worries Australian experts

Prescriptions for unapproved medicinal cannabis products in Australia have quadrupled since 2019, with half issued for adults aged 24 and under.

Most prescriptions for medicinal cannabis in Australia are for unapproved products, which means they have not been authorised by the Therapeutic Goods Administration for legal supply.

Practitioners must apply to the TGA through the Special Access Scheme for permission to prescribe the products, and show why approved products are not suitable.

Since the start of 2021 the TGA has approved more than 200,000 medicinal cannabis prescriptions through the scheme for people who are not severely ill but who have exhausted evidence-based treatments for their condition. There were 122,486 such prescriptions in 2021 alone, compared with 57,714 in 2020 and 25,516 in 2019.

Doctors treating terminally ill patients or those likely to die prematurely apply through a separate, less commonly used process.

The most common reason for prescriptions was chronic pain (60% of approvals), but almost one in four were for anxiety. This is despite low-quality and patchy evidence that medicinal cannabis products are effective for anxiety.

Hallinan said evidence was lacking that medicinal cannabis was an effective treatment for many of the conditions claimed by its manufacturers, although that did not mean clinical trials might not eventually show the products worked.

She said increased prescribing had not been accompanied by strong monitoring of efficacy, side-effects and which conditions specific age groups were using the products for. She said patients should be encouraged to use apps to track their outcomes, and this data could then be combined with deidentified patient data and prescribing data to better understand the use and impact of medicinal cannabis.

Hallinan said the launch of cannabis clinics was one reason for the sharp rise in prescriptions.

Some clinics have a strong online presence, and offer same-day appointments to a prescribing GP. Some claim medicinal cannabis can be useful in treating a wide range of conditions, including migraine, insomnia, stress and pelvic pain, without always highlighting adverse events or the limited evidence.

The RACGP said it was very concerned about the emergence of online prescription services for medicinal cannabis.

Many of the major dispensaries operating in Australia are owned by medicinal cannabis manufacturers and suppliers.

On Wednesday, the TGA issued 73 infringement notices totalling $972,360 to three medicinal cannabis companies for the alleged unlawful advertising of medicinal cannabis products on their websites and social media platforms.

The companies allegedly promoted the use of prescription-only, unapproved medicinal cannabis products, and published references to the treatment of serious diseases such as cancer and epilepsy.