Considering the progress made in both legislation and availability of medicinal cannabis and its derived products over the last year, we would like to provide some guidance to anyone affected by MS to help in navigating this sticky subject.
Firstly, some background: Medicinal cannabis products, which cover a range of cannabis preparations for therapeutic use including oils, tinctures and extracts are now regulated by the TGA (Therapeutic Goods Administration.) However, these products are not yet on the Australian Register of Therapeutic Goods (the Register), which is administered by the TGA, as they are awaiting further evidence in relation to safe and effective use across a range of conditions, including MS.
THC (the active ingredient in cannabis) is usually, though not always, extracted from the product.
Changes in legislation: The Australian Government wanted to facilitate access to medicinal cannabis products for patients with conditions where there is evidence to support its use (Australian Government, Department of Health.)
In late 2016 the Federal Government passed legislation that achieved two things that would enable medicinal cannabis to be used in Australia. This legislation downgraded medicinal cannabis from Schedule 9 (Prohibited substances) to Schedule 8 (Controlled Drug) meaning it could legally be prescribed. Additionally, the law now allowed for the cultivation, production and manufacture of medicinal cannabis products in Australia, overseen by the Office of Drug Control.
Cannabis remains a highly regulated drug and the use and supply for non-medicinal (or recreational) purposes remains illegal in Australia. Additionally, people who use non-prescribed cannabis, even for symptom management, are likely to experience issues with lack of quality control, inability to control dosage, and of course, if it is smoked, health concerns regarding smoking.
So Australia can now grow it legally (under very tight controls) and turn it into something that can be used as a therapy that is no longer prohibited. But, if you have one of the conditions where medicinal cannabis can be used, like MS, how can you get it?
At this stage, in Australia, medicinal cannabis products are supplied via these alternate pathways while more evidence as to safety and efficacy is gathered.
- Authorised prescriber scheme
- Special Access Scheme
- Access as part of a clinical trial (essential in developing the evidence base)
Access to medicinal cannabis products via the first two options can only be arranged through an Australian Medical Practitioner who must apply to the TGA to be an authorised prescriber, meeting a range of conditions.
Use of Medicinal Cannabis in MS: Medicinal cannabis is used in symptom management in MS, mainly for neuropathic pain and spasticity. But it has also been looked at to ease bladder spasm, sleep, ataxia and tremor, and to improve quality of life. There is evidence that it may be effective at reducing pain associated with multiple sclerosis, and also some evidence that it may reduce muscle spasticity and improve patient quality of life.
Sativex is currently the only product approved for use in symptom management in people with MS, but it is not listed on PBS. At this stage Sativex is recommended for treatment only when all other treatments have failed, and is not appropriate for people with conditions such as mood or psychotic disorders.
What are the issues?
- Low numbers of use: currently approximately 200 people nationwide are being prescribed medicinal cannabis, and approximately half are children with epilepsy
- Driving / workplace: Even though THC is usually extracted from the product, if it is detected under drug testing, the person could still be considered “under the influence.”
MS Australia believe that people with MS should have access to all safe and legal treatment options and that they be empowered to work collaboratively with their healthcare team to make informed choices as to their care.
If you are interested in this treatment and would like to discuss the matter with your neurologist or GP, there are guidance documents produced by the Commonwealth Department of Health that may assist: https://www.tga.gov.au/publication/guidance-use-medicinal-cannabis-treatment-multiple-sclerosis-australia