The Pharmaceutical Society of Australia (PSA) has welcomed the Therapeutic Goods Administration’s (TGA) consultation to address growing safety concerns surrounding unapproved medicinal cannabis products.
“PSA commends the TGA for taking action to address the growing safety concerns of both healthcare professionals and our community,” says PSA National President Associate Professor Fei Sim FPS.
Ensuring medicinal cannabis used safely
Associate Professor Sim is calling for reform around the use of medicinal cannabis that ensures these products are 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.
“These gaps increase the risk of harm and demand greater care in prescribing.”
Using the Scheme’s as potential loopholes
There are reportedly more than 1000 medicinal products products currently accessed through the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme, and the concern is that these initiatives may be used as loopholes to help get around regulations.
“The SAS and AP scheme were designed for unique clinical situations, not as a loophole for hundreds of products to bypass regulatory scrutiny,” says Associate Professor Sim.
Use supported when clinically appropriate
Associate Professor Sim notes that PSA supports the use of medicinal cannabis when clinically appropriate and overseen by qualified health professionals.
“However, the current system leaves pharmacists and prescribers without the tools they need to ensure safe and informed use,” she says.
Promoting an effective regulatory environment
The PSA says it 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.
The professional pharmacy body says that while the TGA has acknowledged that product-specific telehealth and digital services fall outside its scope, it is calling on other regulators to step up scrutiny of vertically integrated, direct-to-consumer business models.
“More needs to be done to curtail aggressive telehealth services that, in many cases, appear to lack robust clinical governance,” says Associate Professor Sim.
“There is a place for medicinal cannabis products, but we need to prioritise the tools and regulatory environment that promote their safe and appropriate use.”
