One of the last steps on the road to rescheduling cannabidiol (CBD) in Australia has been completed this past week. The proposal for down-scheduling low-dose CBD preparations from a Schedule 4 (Prescription only) to Schedule 3 (Pharmacy only) controlled substance has been closed for public comment.
The TGA advisory committee will now review submissions from industry, medical associations and lay individuals before delivering a decision on the matter. If all goes according to plan, this could be in September. In the meantime, let’s adopt a broad lens and review CBD oil, its potential benefits, concerns and what rescheduling would look like for Australian consumers.
Many countries around the world, even those with nascent medical cannabis industries, have accepted and provided guidelines for treating epilepsy with CBD oil. Experimental research shows that cannabis CBD oil may play a protective role for the brain, as well as act as an anticonvulsant.
Human research has been, and continues to be, instigated around the world. So far epilepsy subjects in clinical trials have recorded significant reductions in seizure frequency and increase in positive quality of life scores.
There is sufficient evidence for CBD oil in addressing treatment-resistant epilepsy that governments around the globe have granted special access and even modified regulations in light of positive outcomes witnessed. Professor John Skerritt, Deputy Secretary of the Commonwealth Department of Health indicated in May that there is a possibility that in a few months’ time we could have CBD medication Epidiolex both approved and subsidised.
In the example of epilepsy, we find a solid foundation for evidenced-based CBD oil prescriptions, bolstering calls for more research into other conditions where CBD shows promise.
There are three main conditions where CBD oil is showing positive research outcomes that have been listed in the TGA proposal. These are insomnia, chronic pain and anxiety.
CBD oil used in the treatment of insomnia is known to have a paradoxical effect, a phenomenon encountered in many botanical medicine treatments. At low doses, CBD oil has the capacity to be alerting, however at moderately higher doses CBD is reported to have positive effects on sleep and sleep latency.
Numerous observational studies and anecdotal examples report the success of CBD hemp oil in alleviating insomnia. However, gold-standard trials are very much needed to achieve greater confidence in these results.
Anxiety is another condition where anecdotal evidence abounds, and fortunately, the past decade has revealed numerous human and experimental trials showcasing the efficacy of CBD oil in anxiety.
With regards to chronic pain, CBD oil is thought to ameliorate pain via the same pathways as conventional non-steroidal anti-inflammatories such as ibuprofen. This may be beneficial for patients suffering painful conditions.
CBD oil has been proven safe and without significant side effects innumerable times in clinical trials, yet there is understandable still other concerns to be addressed.
Given the association with being a component of an illicit drug, many have concerns for the abuse and dependence potential. In regards to CBD specifically, through extensive review, the World Health Organisation has determined that there is no evidence of dependence or abuse when it comes to this cannabinoid: “In humans, CBD exhibits no effects indicative of any abuse or dependence potential…. To date, there is no evidence of public health related problems associated with the use of pure CBD oil.”
With any substance that alters physiology, be it a pharmaceutical or botanical-based medicine, there is always a possibility of adverse effects or interactions with other drugs. In relation to CBD, adverse effects are usually mild and include drowsiness, diarrhoea and reduced appetite.
CBD’s potential to interact with other drugs is also something to take note of. The liver enzymes by which CBD oil is metabolised are the same as those used by many other pharmaceutical drugs and alcohol. Thus those already being treated with polypharmacy or drugs specific to coagulation should be monitored when taking CBD.
While these may be points of concern, they can be addressed with responsible history-taking by the pharmacist dispensing the product and comprehensive labelling. And as always, it’s advised to check in with your doctor to monitor your treatment and condition.
The TGA advisory committee will deliberate on the rescheduling of CBD oil from Schedule 4 (Prescription only) to Schedule 3 (Pharmacy only) until September, at which time they will provide an interim decision that will once again be open for public comment.
A final decision should be announced in November and should the proposal be approved, changes will be implemented in February 2021.
Exciting stuff really! But don’t expect to be able to purchase CBD over-the-counter straight away.
Companies will have to have their low-dose CBD products registered via the Australian Registration of Therapeutic Goods (ARTG). Registration is currently a relatively unknown hurdle for CBD, and we won’t know the exact requirements until rescheduling is passed.
Generally, requirements for ARTG registration involve testing and reports that verify the toxicology, constituents and stability of products, as well as evidence of its efficacy against symptoms or diseases. The unknown in this equation is what and how much evidence will be required to approve CBD products.
There is currently limited evidence on the use of low-dose CBD, which is specifically what the proposal includes – daily doses of <60mg per day. Whether large scale gold standard trials will be required or somewhat more attainable literature reviews showcasing efficacy will be adequate is yet to be determined.
So for individuals looking for CBD oil products to ameliorate mild or temporary conditions such as those listed in the proposal, it still looks like a minimum of 8-12 months before purchasing CBD oil at a pharmacy could be a reality. And for many medical conditions, a low dose such as the kind that could be available over the counter in pharmacies, may not be effective in helping alleviate your symptoms.
Therefore, for those interested in CBD to treat a specific medical condition it’s still always best to consult with your GP or one of our specialist doctors at CA Clinics to ensure you get the right dose, and thus the most therapeutic benefit and positive health outcomes for your individual needs.
Worldwide attitudes towards CBD have undergone tectonic shifts in the past decade. Between a growing body of scientific evidence supporting cannabis CBD oil, and expanding online availability, it can be almost guaranteed CBD oil will be available more broadly soon enough.
Using a Telehealth model, our 15 minute screening appointments provide a quick and convenient way to assess the suitability of a patient’s condition for treatment prior to discussing options with their own doctor.