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.
- Initial consultation
- Provide clinical evidence
- Queensland Health approval
- Find a product
- TGA approval
- Import/export licence and permit
- Report patient progress
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
- Telephone: (07) 3708 5294
- Fax: (07) 3708 5431
- Email: MedicationSafety@health.qld.gov.au
Guidance and regulations
- Clinical guidance for the use of medicinal cannabis products, March 2017 (PDF 492 kB): covers the medical conditions, symptoms, and products to be used.
- Medicinal cannabis access and use in Queensland, March 2017 (PDF 470 kB): the process for medical practitioners to access, prescribe and supply medicinal cannabis in Queensland.
- 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 (PDF 593KB): describes patient-class prescribers, the class of patients to be treated, and the medicinal cannabis products to be prescribed.
1 Initial consultation
Your patient may approach you directly to see if they can access medicinal cannabis for the management of their medical condition or symptoms. Or, you may have observed that a body of knowledge is developing around medicinal cannabis for specific conditions, and this may apply for 1 or more of your patients. Either way, it is important to have an informed discussion with your patient about medicinal cannabis.
Medicinal cannabis should not be considered a first-line therapy for any condition.
You may consider prescribing when:
- the patient has tried all of the conventional treatments available and these have failed OR
- the conventional treatment causes intolerable side effects
- there is some clinical evidence that a medicinal cannabis product may be beneficial to help manage the medical condition or symptoms.
During the consultation:
- complete a comprehensive clinical assessment of the patient
- consider the risks of dependency and risks to mental health
- discuss the risks of treatment with medicinal cannabis, including effects on the central nervous system (psychological and cognition) and the cardiovascular and respiratory systems
- discuss current medications and their continued use
- if a medicinal cannabis product containing THC is proposed for use, emphasise restrictions for driving and/or operating heavy machinery
- keep a record of the discussion and a signed consent document in the patient’s clinical record.
2 Provide clinical evidence
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.
Current limited evidence suggests that a trial of 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)
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.
Patients should not:
- consider medicinal cannabis as an alternative treatment for cancer
- defer their standard treatment in favour of using medicinal cannabis.
3 Queensland Health approval
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 162 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.
4 Find a product
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, however needs to be imported from overseas. Sativex is a Schedule 8 medicine and is a plant-derived product.
- 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.
5 TGA approval
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.
6 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.
7 Report patient progress
As a condition of the Queensland medicinal cannabis approval, you must:
- provide a written report to Queensland Health every 3 months 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
- comply with any requests mandated by the TGA on their approval.