By Jessica Kindynis
It is hard to pinpoint when cannabidiol (CBD) went from being a vaguely known cannabinoid, in the shadows of THC, to the preeminent therapeutic compound it is recognised as today.
CBD is probably best known for its cases of success in ameliorating symptoms of treatment-resistant epilepsy. Yet the scope of its potential application is proving to be vast.
Positive research outcomes have been seen in conditions such as anxiety, depression, inflammatory bowel diseases, neurodegenerative and autoimmune disorders.
Under international law, CBD is classified as a cannabis extract, and is lumped into the same category as drugs of abuse such as opium, cocaine and fentanyl.
In recent years the World Health Organization (WHO) has commissioned a review on cannabis and its derivatives, to determine if cannabis should remain at its current scheduling under international conventions.
In June 2018, a separate critical review was released specific to CBD, recommending it should be removed from scheduling under the 1961 UN Convention on Narcotic Drugs. This de-scheduling is yet to occur however still represents a huge milestone in changing attitudes towards cannabis, particularly the non-psychoactive CBD.
Currently, CBD is a Schedule 4 drug under Australian regulations. THC-containing cannabis products are classified as Schedule 8 (controlled substances), and while CBD has fewer restrictions, both still require a doctor’s prescription and can currently only be accessed via the Special Access Scheme (SAS).
In a similar time frame as the international reviews on cannabis, the Australian Therapeutics Goods Administration (TGA) initiated a safety review on CBD and is processing an update to the current clinical guidance documents for the use of medical cannabis.
In regards to CBD, the official comments on its reclassification make it very clear that its potential for over-the-counter (OTC) access is indefinite and a “possible… relaxation could be considered in 2020”.
Considering the number of local CBD companies and those international ones importing for Australian consumers, it’s clear there is a strong public appetite for the compound.
Currently, data suggests approximately 1/3 of medical cannabis prescriptions in Australia are CBD-only or CBD-dominant products. This suggests the conditions patients are presenting with are relevant to CBD’s actions and that there is a public desire for non-psychoactive cannabis medicines.
In submissions to the Senate made in January 2020, cannabis industry and medical professionals encouraged changes to be made to the local scheduling of CBD. Recommendations included moving CBD from a Schedule 4 (prescription only) to a Schedule 3 (pharmacist only ) or Schedule 2 (pharmacy medicine).
This would mean CBD would be available without a doctor’s prescription, negating the need to navigate the SAS pathways and relieving doctors of the burden of prescribing a medicine generally regarded as safe.
Pharmacists would be able to dispense CBD medications under Schedule 3, removing barriers to access for patients such as pricey and time-consuming consultations, or the prospect of encountering reluctant medical professionals.
If CBD was to be rescheduled to a Schedule 2, patients would be able to access formulations OTC in the same fashion they purchased cold and flu tablets.
Considering the thousands of Australians self-medicating with illicit cannabis, having legal CBD access has the potential to decrease illicit consumption, guiding individuals to quality assured products, instead of untested illegal products.
Around the globe, several countries already allow OTC access to CBD. The UK has a thriving CBD market with approximately 8-11% of the population consuming a CBD product in the past year, with 1/3 of frequent users over the age of 55.
This last point indicates CBD isn’t only appealing to those “young folk” up to date with the cannabis lingo, but also individuals with a few more birthdays up their sleeve – perhaps seeking treatment for conditions without the adverse effects associated with pharmaceutical drugs.
Switzerland also has a regulatory framework allowing for CBD products to be accessed under a number of categories including medicinal products, ingestible items and tobacco substitutes. Within Canada and certain US states, CBD is available via the legalization of medical and/or recreational cannabis.
There is a hearty appetite for CBD in the aforementioned countries and indications from the Australian market show the general public and those seeking medical CBD treatments could be just as enthused by the possibility of legal access to low-dose CBD over-the-counter here. However, Dr Mark Hardy, Addiction Specialist and CA Clinics medical advisory board member says that, “Patients who are seeking treatment for chronic conditions that may benefit from medicinal cannabis may require higher dosages or other cannabinoids such as THC and should therefore consult their GP before taking these products, even in small amounts”.
Rhys Cohen, Principal Consultant of FreshLeaf Analytics added that: “If the only thing making the TGA hesitate about allowing low-dose (15-100mg/day by their definition) CBD products to be made available OTC is safety, it doesn’t seem like they’ll have much of a problem. The effects of low-dose CBD may be negligible for many patients, but it’s a pretty benign drug and is already widely available online and in retail outlets across North America and Europe”.
Bottomline, while regulatory changes may result in pharmacy-dispensed low-dose CBD, for patients needing effective and safe long-term management and monitoring of chronic conditions, with the trust that the product they’re taking contains what it says it contains, they should always consult their doctor.