Cannabidiol should remain under the guidance of doctors but exempt from the Special Access Scheme, a leading GP has said, as calls grow for a re-think on the down scheduling of low-dose CBD.
An interim decision to allow low doses to be sold without a prescription as a schedule 3 medicine was made in September, with a final ruling by the Therapeutics Goods Administration expected later this month.
Among the key industry concerns is that the current maximum dose set by the TGA – 60mg per day – is simply too low and will restrict the ability to bring products to market.
In making its interim ruling, the TGA spelt out the need for solid data, emphasising that “only products that have been approved for a specific indication appropriate under a schedule 3 listing will be available without a prescription”.
With a paucity of clinical data for low doses, it is felt manufacturers will struggle to demonstrate efficacy and therefore be unable to list a product on the Australian Register of Therapeutic Goods (ARTG).
In its final submission to the TGA, the Medicinal Cannabis Industry Australia (MCIA) called on the TGA to raise the maximum dose from 60mg per day to 300mg, a level it insists is still safe but at which higher quality evidence exists to demonstrate efficacy.
But Dr Vicki Kotsirilos, associate professor at La Trobe and Western Sydney Universities and Australia’s first authorised prescriber of medicinal cannabis, said CBD, whatever the dose, should remain a prescription-only medicine.
However, she said GPs should be free to prescribe it without having to justify their decision.
“CBD is relatively safe and has very few side effects, so being required to fill out a clinical justification is onerous and unnecessary,” she said. “I can understand it for THC products but not for CBD.
“CBD should still come under the care of the GP with an S4 prescription, but we should be able to prescribe without the SAS-B form. That would remove a huge barrier for GPs and we’d probably find more doctors would prescribe it.
“As GPs, we really should be in a position where we know when it’s safe to prescribe a medicine, particularly a product like CBD which is relatively safe compared to other medications. We should be able to prescribe it as we do other pharmaceuticals.”
As an advocate of medicinal cannabis, Kotsirilos said she would prefer to have oversight of her patients’ health and medication. She raised the prospect of consumers visiting several chemists to accumulate more than the maximum permitted dose.
“Unless there is a register, which exists for drugs of addiction as S8 products, patients may go from one chemist to another to source more CBD products to achieve higher doses. Currently there is an element of control with knowing when a patient is prescribed, where it is being dispensed, how many bottles they obtained and over what period of time. If CBD goes over-the-counter this monitoring may disappear.
“The other issue is which products are going to be on the ARTG? If I have a patient using a particular brand of CBD that does not become available, will they get the same clinical response if they start using a different brand that is available over the counter? They might not respond as well, so it adds a lot of complexity to the situation which is why I think GPs need to have oversight.
“We know our patients well, we know their clinical history, we can monitor them and look for side effects.”
Kotsirilos also questioned how thorough a pharmacist could be in determining whether CBD was the right medication. Pain and anxiety can be complex and personal issues that should not be discussed in the open setting of a chemist, she said.
“It’s very different discussing issues with a GP behind closed doors where you can talk openly about your anxiety, your pain, your sleep problems.
“There is a lack of sensitivity and confidentiality if left to a pharmacist to ask extensive questions, over the counter, about someone’s health. I don’t find that appropriate or ethical.”
MCIA report
MCIA said a report it commissioned confirmed already widely held fears that the proposed dose will make it difficult for products to achieve registration.
In calling for a higher maximum dose, MCIA claimed a 300mg oral dose is the threshold at which “higher quality evidence accumulates around CBD efficacy in the absence of significant safety concerns”.
The proposed level has “limitations in terms of delivering the desired patient access”.
“In proposing a higher dose, it is recognised that this is within the S3 framework where the product would only apply to conditions that do not require medical diagnosis or only requires initial medical diagnosis, and the consumer does not require close medical management,” the association said. “It will provide the opportunity for products to be able to meet registration requirements for efficacy, thereby delivering real outcomes for patients”.
MCIA chairman Peter Crock added: “Down scheduling of CBD will benefit patients by allowing them to move from the illicit market and providing easier and more affordable access to high-quality products.
“Our submission proposes an approach that balances benefits and risk. We strongly encourage review of the daily dose cap. This regulatory clarity will deliver better safety, quality and efficacy outcomes for patients and the community.”