Australian patients will be allowed purchase CBD products over the counter without the need for a prescription from February 1, 2021.

The Therapeutic Goods Administration has announced a final decision to down-schedule certain low-dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine).

The decision will allow TGA approved low-dose CBD containing products, up to a maximum of 150 mg/day, for use in adults, to be supplied over-the-counter by a pharmacist, without a prescription.

The decision was made following an earlier TGA safety review of low dose CBD which indicated that the known adverse events of CBD at low doses were not serious.

Chair of Painaustralia’s Consumer Advisory Group, Sr Mary-Lynne Cochrane, said that low-dose CBD provides another option for the pain toolkit: “When it comes to chronic pain, there is a need to expand availability of safe and effective treatments as current treatments are not adequate. It won’t be a silver bullet or suitable for all people experiencing chronic pain but it does expand the range of options that might work for some people.” 

There are currently no TGA approved products on the Australian Register of Therapeutic Goods (ARTG) that meet the Schedule 3 criteria. However, companies that have CBD preparations currently in development can now lodge an application to the TGA for the inclusion of their CBD preparations on the ARTG.

More pain management education needed

Painaustralia CEO Carol Bennett said changes that provide more accessible and affordable pain management options are necessary but will not provide people with chronic pain good access to the most effective treatments for their conditions.

“While the number of people living with pain in Australia rises, there will still be significant gaps in access to, and understanding of, best practice holistic pain management,” she said.

“The evidence available for pain management demonstrates that pharmacological treatments on their own are not successful for long-term pain management. A holistic approach that incorporates medical, physical and psychological treatments is recommended.”

Painaustralia is advocating for a National Action Plan for pain management to ensure a national and holistic policy framework that supports consumers, health professionals and the wider community.

“Additional steps need to be taken to promote quality use of CBD and all cannabis-derived products given the potential for increased use and greater accessibility,” Bennett concluded.


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