Stakeholders have welcomed an interim TGA decision to downschedule low-dose cannabidiol to S3 – but the peak pharmacist body warns that evidence and therapeutic purpose are key
The TGA has released a notice of an interim decision to amend the Poisons Standard for CBD, proposing to downschedule certain products from S4 to S3 (Pharmacist Only Medicine).
This would apply to CBD products with a maximum recommended daily dose of 60mg in packs containing supply for 30 days or less, where CBD comprises at least 98% of the total cannabinoid content in the product.
Other CBD medicines will remain Prescription Only.
A number of stakeholders have welcomed the move, which will mean that patients will be able to access low-dose CBD products after consulting a pharmacist.
Consumer Healthcare Products CEO Dr Deon Schoombie called it an “exciting and welcome development” which would ensure relevant patients got appropriate advice and guidance from their pharmacist.
“Greater access to medicines and the capacity to self-treat, where safe and appropriate, empowers individuals to take greater ownership of their health choices and care, and is fundamental to enabling greater self-care,” he said.
But Pharmaceutical Society of Australia national president Dr Chris Freeman told the AJP that it was important to consider a range of factors when responding to the interim decision, including therapeutic benefit.
“It’s important to note that this was a delegate initiated submission, the pharmacy profession did not ask for this downscheduling of cannabidiol,” he noted.
“At this stage there is limited clinical data about the effectiveness (not the safety) of low dose cannabidiol.
“Should the TGA decide to downschedule low dose cannabidiol pharmacists will need to be supported with the right information to ensure that patients are accessing these medicines appropriately.
“Whilst low dose cannabidiol may be relatively safe at low doses, it is important that it has a therapeutic purpose, and evidence behind the claims,” Dr Freeman said.
“We would not want the pharmacy profession being set up to fail, by allowing the availability of products through the Schedule 3 appendix M category that has little or no therapeutic benefit.”
Companies in the cannabis space applauded the interim decision, with Altea’s CEO Josh Fegan saying that it “reflects the significant shift in community and government attitudes towards medicinal cannabis since it was legalised in Australia in late 2016, which has seen it move from a fringe alternative towards an accepted mainstream option”.
Meanwhile Little Green Pharma Managing Director Fleta Solomon said, “The downscheduling demonstrates the TGA’s commitment to patient safety and product quality, while acknowledging the continuing shift in public, medical, and government perception towards CBD and medicinal cannabis as a treatment option”.
Stockhead reported on Thursday that “ASX pot stocks are getting high” after the decision.
“Shares in Althea Group (ASX:AGH), THC Global (ASX:THC), Elixinol Global (ASX:EXL), Cann Group (ASX:CAN, Creso Pharma (ASX:CPH) and ECS Botanics (ASX:ECS) all closed up between 7 and 11 per cent, while Cannpal Animal Therapeutics (ASX:CP1) rocketed 20 per cent and Bod Australia (ASX:BDA) soared 24 per cent,” wrote Derek Rose.