For the past few months, the Therapeutic Goods Administration (TGA) has been reviewing the safety of low dose cannabidiol (CBD), given the fact there were little studies published on the subject. And in April 2020, the review was completed.
The TGA has proposed low dose CBD (1mg/kg/day – up to 60mg) be downgraded from a current Schedule 4 drug (prescription only) to either Schedule 3 or Schedule 2.
If it were to become a Schedule 3 drug it would be accessible without medical supervision. However, it would still be kept behind the pharmacy counter and require professional advice from the pharmacist to assess appropriate use. This would bring CBD on a similar level to eye drops, pseudoephedrine, and the morning after pill.
Schedule 2, and you could grab it off the shelf and pay for it without ever having to talk to anyone. Meaning low dose CBD would be classed the same as large packets of paracetamol, ibuprofen, and nasal congestion sprays.
Who Can Low Dose CBD Benefit?
Low dose CBD, as a medicine, is typically used to treat mild to medium conditions. Anxiety, insomnia, chronic pain, defects of neurological function, and pain related to skin ulcers are a few conditions which have already been treated with the lower doses.
Of course, safety was a large factor in the proposal, and you can almost guarantee if any prominent, adverse side effects were found over long periods of time, the TGA would not have made their recommend to down-schedule.
In a case study utilising approximately 40 mg of cannabidiol per day over 5 months in the treatment of paediatric anxiety and insomnia in a single patient, no side effects were observed from taking the CBD oil.
It’s important to note that these studies were only conducted on adults. Forcing the TGA to recommend the low dose of CBD treatment should “be limited to management of conditions in adults (i.e. those over 18 years of age)”.
When Will It Be Available in Pharmacies?
Hold your keys, because it’s still going to be more than 7 months before you can pop down to the pharmacy and buy some CBD medication.
Now that the safety review has been complete, and the proposal made by the TGA, public comments are being welcomed. Comments will be considered at the joint meeting of the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling.
If you’d like to comment you can do so by reading the instructions here. Public comments close on May 22nd with the initial meeting to be held sometime in June.
Following the initial meeting, the Delegate will make an interim decision, which will then be followed by another second public consultation period. Only after these stages have taken place will the Delegate make the final decision – to be handed down on November 25th.
And then, even if the re-scheduling is to go ahead, legislation (the SUSMP) containing the drug schedules will likely only happen in early 2021.
A lengthy process, but one that ensures all considerations are considered.
If CDB’s Re-Scheduled – Can Pharmacies Stock Anyone’s Product?
No. Only those registered on the ARTG can be legally sold in Australia.
That means any CBD suppliers in Australia, such as the many ASX-listed cannabis stocks, or overseas, wanting to sell their low-dosed CBD medicines in Australia, will need to prove their products meet all quality and safety standards first. Another lengthy and resource heavy process.
Thankfully, the TGA already agrees CBD is quite safe at low doses.
At low doses, CBD appears to have an acceptable safety and tolerability profile.
How Can You Help?
If you believe in the effectives of CBD and would like to see low dose CBD available for purchase in pharmacies soon, make a submission.
It doesn’t have to be a 100-page PHD-worthy submission, but rather something much simpler. You can comment on suggested improvements they could make, or how the proposed changes to the CBD scheduling could benefit you. You can even keep your submission anonymous, just mark it on the cover sheet.
To make a submission, visit the TGA website here.
You can also view the full TGA safety review here.