THE Therapeutic Goods Administration (TGA) is today launching a public consultation to explore the possibility of expanding the regulation of unapproved medicinal cannabis products, a move welcomed by the Pharmaceutical Society of Australia.

The initiative has been prompted by increasing public and professional concern about the safety risks associated with unapproved medicinal cannabis products, particularly those containing higher levels of tetrahydrocannabinol (THC).

The TGA noted that the concern “appears to correlate with the rapid growth in the number and type of these products being used and accessed in Australia by patients”.

With more than 1,000 products currently accessed through the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme, PSA National President Assoc Prof Fei Sim is calling for reform that ensures medicinal cannabis is prescribed and dispensed safely, with appropriate oversight.

“Unregistered medicinal cannabis products pose serious challenges, including inconsistent dosing, limited safety data, and minimal post-market surveillance,” she said.

“These gaps increase the risk of harm and demand greater care in prescribing.”

Assoc Prof Sim pointed out that the SAS and AP schemes were “designed for unique clinical situations, not as a loophole for hundreds of products to bypass regulatory scrutiny”.

The PSA will engage with subject matter experts and the broader profession to inform its submission to the TGA, and is “committed to partnering with government to reduce harm from unapproved medicinal cannabis products”.

“PSA commends the TGA for taking action to address the growing safety concerns of both healthcare professionals and our community,” Assoc Prof Sim said. KB

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