By ALLISON HORE
Following a decision passed down by the TGA, a prescription will no longer be required to access some low-dose medical cannabis products in Australia.
In December, the Therapeutic Goods Administration (TGA) announced a final decision to “down-schedule” low-dose CBD products to a Schedule 3 substance.
The decision will allow TGA approved low-dose CBD products to be supplied over-the-counter by a pharmacist, without a prescription.
CBD (or cannabidiol) is a non-intoxicating component of the hemp plant which is currently listed as a Schedule 4 “prescription-only medicine”. Some research suggests the substance can be useful in treating conditions such as epilepsy, anxiety, pain and insomnia while carrying few, if any, risks of major side effects or addiction.
For a cannabis product to be deemed legal in Australia, the CBD component of the oil must be more than 98 percent concentration. This means only 2 percent of the product can contain other cannabinoids such as tetrahydrocannabinol (THC), the substance that gives users a high.
Previously, CBD was only available with a prescription, and that prescription had to be approved by the TGA through their Special Access Scheme.
When the interim decision was handed down earlier this year, it had set a maximum dosage of 60 milligrams per day. Sharon Bentley, Managing Director of Medical Cannabis Australia, told City Hub at the time while she thought the interim decision was “a step in the right direction” it was “not as great as it appears”.
“The problem with this is there is currently little to no evidence to suggest that CBD at a low dose of 60mg per day is effective for the most common disorders, such as anxiety, insomnia and pain,” she explained.
However, following further consideration of safety information, the public submissions on the interim decision and advice given during a committee meeting on the matter, the maximum dosage was increased to 150 milligrams per day.
Analysis by the University of Sydney’s Lambert Initiative show benefits of CBD products are usually seen at higher doses of between 300 and 1500 milligrams a day.
Side effects considered
The decision followed a safety review of CBD products conducted by the TGA in April of 2020.
The safety review identified a number of possible side effects of CBD products but concluded that low-dose CBD products had “an acceptable safety and tolerability profile.”
The most commonly reported side effects were tiredness, diarrhoea, changes in appetite and weight, sleep disturbances, infection and anaemia. The TGA say the risks related to symptoms such as drowsiness and fatigue could be managed as it is for other Schedule 3 substances, with labelling advising against its use if driving or operating heavy machinery.
Lead researcher at the Lambert Initiative, Professor Iain McGregor, said making CBD products easier to access in Australia is a smart decision for the TGA.
“The signs are promising for CBD having efficacy treating a multitude of conditions,” he said.
“Simplifying access to reasonable doses of CBD for consumers seems like a wise option for regulators, given the inherent safety of the drug.”
While the TGA’s decision is welcome news to those who rely on CBD products, there are currently no TGA approved CBD products which meet the criteria to be available over the counter.
To be sold as a Schedule 3 substance products will need to be listed on the Australian Register of Therapeutic Goods (ARTG). This hurdle will likely limit the range of products initially available and be reflected in higher pricing. On the flip-side, this means that consumers can be certain the products they are buying in pharmacies are safe and quality.
Unapproved products will still have to be accessed through the Special Access Scheme or Authorised Prescriber scheme under prescription only. In 2019, the TGA granted 25,182 applications from doctors to prescribe the drug.
It is estimated that more than 600,000 patients have been prescribed CBD since its legalisation.