Prescribing medicinal cannabis
Doctors can legally prescribe medicinal cannabis products through 2 pathways:
- single-patient prescriber: both general practitioners and medical specialists
- patient class prescriber pathway: medical specialists only.
You must have obtained the mandatory Therapeutic Goods Administration (TGA) and Queensland Health approvals.
If you have any questions, contact Queensland Health:
Medicinal Cannabis Unit (MCU):
- Telephone: (07) 3708 5283
- Email: MCTeam@health.qld.gov.au
- Fax: (07) 3708 5431
Guidance and regulations
- Guidance for the use of medicinal cannabis in Australia, December 2017 is a national guidance document that covers the medical conditions, symptoms, and products to be used. The individual documents can be viewed on the TGA's website.
- Clinical guidance for the use of medicinal cannabis products, March 2018 (PDF 524 kB): covers the medical conditions, symptoms, and products to be used.
- Standard for security of medicinal cannabis stock, January 2017 (PDF 326 kB): how to secure and store medicinal cannabis products, under Part 8 of the regulation.
- Public Health (Medicinal Cannabis) Regulation 2017: describes patient-class prescribers, the class of patients to be treated, and the medicinal cannabis products to be prescribed.
When making an application, you need to reference clinical evidence that supports using the specific type of medicinal cannabis product proposed (e.g. THC, CBD, or THC and CBD in combination) for your patient's medical condition or symptoms.
Clearly articulate the clinical outcomes you are looking for when using medicinal cannabis. At the 3 month review, this will help determine whether it is worth continuing this treatment approach, i.e. if the outcome is a reduction in spasms from multiple sclerosis, has this occurred and what measures evidence this?
More research is being done on the uses of medicinal cannabis. The scientific evidence base is limited but suggests that medicinal cannabis may be suitable for:
- severe muscular spasms and other symptoms of multiple sclerosis
- chemotherapy-induced nausea and vomiting
- some types of epilepsy with severe seizures
- palliative care (cachexia, nausea and vomiting, pain)
- treatment of chronic non-cancer pain
You may apply for other conditions; however you will need to supply clinical evidence with your application for this to be considered. There is no evidence that medicinal cannabis is an effective treatment for cancer.
Clinicians should not:
- consider medicinal cannabis as an alternative treatment for cancer
- defer their standard treatment in favour of using medicinal cannabis.
Therapeutic Goods Administration (TGA)
The Commonwealth Department of Health regulates medicinal cannabis products through the Therapeutic Goods Administration (TGA) and the Office of Drug Control (ODC).
Medicinal cannabis products are regulated as medicines in Australia. Generally medicines imported into, supplied in, and exported from Australia must be entered in the Australian Register of Therapeutic Goods (ARTG), which is administered by the TGA. However, there are other mechanisms for access to medicines that are not registered on the ARTG. Medicinal cannabis products supplied in Australia use these alternative pathways (Special Access Schemes).
Queensland Health approval
If you are using the single-patient pathway, apply for approval to prescribe the medicinal cannabis product to your patient if:
- you and your patient both determine a trial of medicinal cannabis would be worthwhile based on the evidence available
- the patient has tried all other available treatment or has significant side-effects that make the standard treatment intolerable.
Submit your application, including:
- completed application form (PDF 344 kB) and signed informed consent form
- clinical evidence
- a letter supporting the course of treatment using a named product from the relevant medical specialist (if you are a GP).
The chief executive will consider the application, and may request:
- advice from an expert advisory panel
- further information from you, as the patient's medical practitioner and prescriber
- further information from previous medical practitioners.
Commonwealth approvals, licences and permits
As all medicinal cannabis products are unregistered medicines (except for Sativex), approval is also needed from the TGA through the Special Access Scheme, Category B to obtain a supply of the product for an individual patient.
Import/export licence and permit
Once you have the TGA and Queensland Health approvals, either you or the nominated pharmacist apply to the TGA for an import licence and permit for the product.
The company that intends to supply the product will require an export permit from their home country. Currently export permits from Canada take about 30 days to be approved.
Your legal obligations
As a condition of the Queensland medicinal cannabis approval, you must:
- provide a written report to Queensland Health which may include your opinion on patient response, frequency of patients' use, and if discontinued any reasons for doing so. This will allow Queensland Health to build up a body of evidence related to the use of medicinal cannabis and assist with ongoing research proposals into the future, report any adverse events, adverse reactions, serious adverse reactions and unexpected reactions to Queensland Health AND to the TGA.
Find a product
Doctors can apply to prescribe both plant-based products and synthetic products. When used for a therapeutic purpose, these forms would be considered:
- tinctures: plant material infused in oil or alcohol
- vapour: dried plan material or concentrated cannabis extract is heated in a vaporiser
- capsules or sprays: generally oil-based capsules taken orally
- pharmaceutical products such as nabilone and nabiximols.
You will need to source an appropriate product. Australia's approved medicinal cannabis cultivation and manufacturing industries are not established. The Netherlands and Canada are currently the only countries that are able to export medicinal cannabis products. It is recommended that you seek a product from either of these countries until the Australian industry is established.
These products need to be manufactured by a company that:
- meets the required TGA standards
- can provide a "Certificate of Analysis" confirming what is in the product.
Products currently used in Australia:
- Sativex is listed as an approved medicine on the Australian Register of Therapeutic Goods. Sativex is a Schedule 8 medicine and is a plant-derived product. In Queensland specialists eligible to be patient class prescribers under the Public Health (Medicinal Cannabis) Act 2016 and Rehabilitation Specialists are able to prescribe Sativex without requiring an approval from the state or the TGA. All other specialists and general practitioners need to apply to the Director-General Queensland Health for a Section 18 approval under the Health Drugs and Poisons Regulation 1996 (HDPR).
- NSW trials for chemotherapy induced nausea and vomiting are using a THC:CBD combination medicinal cannabis product imported from Tilray in Canada.
- NSW trials for palliative care patients are using a THC:CBD combination called Bedrodiol imported from the Netherlands, a THC:CBD combination product imported from Tilray in Canada, and Nabilone a synthetic cannabinoid available overseas. These products are all Schedule 8.
- Epidiolex® from GW Pharmaceuticals has ethical approval for use in current Queensland clinical trials for childhood epilepsy, but is not yet registered as an approved medicine so is not generally available. Epidiolex is a Schedule 4 medicine and is a plant-derived product.