Latest Blog Post

30 APR 2020

Cannabidiol (CBD) has surged in popularity across the globe in recent years. CBD is now sold in many countries and there is widespread belief in its medical value to treat a whole range of conditions including chronic pain.

In Australia, the Therapeutic Goods Administration is currently consulting on a proposal to create a new Schedule 3 (Pharmacist Only Medicine) entry for CBD at doses up to 60 mg/day or less. A safety review conducted by the TGA established that low doses of CBD may have possible clinical utility when used via the oral route in the management of some conditions that do not require medical practitioner oversight.

Cannabidiol (CBD) and tetrahydrocannabinol (THC) are the major cannabinoids present in cannabis. Unlike THC, CBD does not cause psychomotor or cognitive impairment or strong psychoactive effects as it has relatively weak affinity for receptors primarily located in the central nervous system (the major mediator in THC for these effects) and other receptors found in the periphery on cells with immune function and in the gastrointestinal tract.

In Australia, CBD is currently a schedule 4 substance and therefore only available with a prescription. This access is seen by many as too restrictive noting it is available as an over the counter product (if provided without medicinal claims) in some jurisdictions such as the UK and some US states; and is widely available in some countries in various forms of non-prescription products.

The experience overseas has also shown that producers of various products that are not subject to the strict regulations governing pharmaceuticals are also interested in CBD products.  Everything from skin creams, edibles and even pet products are now available with CBD which may or may not have valid medical use.

In preclinical studies, CBD has been found to demonstrate both a favourable safety profile and a wide range of pharmacological activity with potential therapeutic use. While some studies have shown CBD to have anti-inflammatory, anti-pain and anti-psychotic properties, there has been only minimal testing in human clinical trials, which are important to determine what a drug does, how much patients should take, its side effects and so on. It is also important to note that evidence continues to emerge with a recent systematic review and meta-analysis highlighting potential risks associated with the use of cannabis.

There is little evidence from randomised controlled trials or systematic reviews about suitable doses of individual cannabis products.  This makes it difficult to be able to formulate definitive statements on the effectiveness of medicinal cannabis. This lack of definitive clinical evidence is also making it difficult for practitioners to prescribe it, despite community expectations that these products will be made available to treat conditions such as chronic pain and other conditions.

The evidence from the TGA establishes that CBD has an acceptable safety and tolerability profile at the proposed dose, so we may yet see broader access to CBD in Australia.

There are several other considerations that must be assessed. The TGA’s safety report notes that the use of synthetic CBD may have psychoactive potential that would not be found in plant-derived cannabidiol. This is one consideration that needs to be made in any decision to down-schedule CBD allowing over the counter provision. Consideration of whether a Schedule 3 listing will provide an appropriate level of health professional advice is also another issue.

These and other considerations will be important in ensuring that there are no unintended adverse outcomes from the easing of access to CBD in Australia.

Painaustralia’s  submission to the Senate Inquiry on current barriers to patient access to medicinal cannabis in Australia outlines some of the broader considerations.

Painaustralia will also be providing a submission to the TGA consultation and are currently seeking views from health professionals and people living with chronic pain to inform our position.

While Painaustralia acknowledges the widespread use of cannabis products and high degree of community support for greater access to medicinal cannabis, we are conscious that at best this is a singular treatment modality that has limited benefit for treatment of chronic pain. 

There are some promising results in the role of these products in areas of distress and neuropathic pain, and that adds another treatment to a limited supply. 

It is becoming increasingly clear that providing greater access to CBD may have some benefit to a limited number of people experiencing pain.  It is also important to acknowledge that the latest research is showing that CBD is unlikely to be a ‘silver bullet’ for the millions of Australians experiencing complex and debilitating pain conditions. 

Carol Bennett,
Painaustralia CEO