Prescribing medicinal cannabis
Any registered medical practitioner in Queensland can prescribe medicinal cannabis for any patient with any condition, if they believe it is clinically appropriate and have obtained the required Commonwealth and/or state approvals.
Medicinal cannabis products are classified as either Schedule 8 or Schedule 4 controlled substances, most products are not listed on the Australian Register of Therapeutic Goods (ARTG). In circumstances where patients need access to therapeutic goods that are not included in the ARTG, a Therapeutic Goods Administration approval is required in order for the medicine to be prescribed. The Commonwealth Department of Health manages the Special Access Scheme (SAS) and Authorised Prescriber Scheme (AP). These are the schemes that enable this access.
In Queensland, the Health (Drugs and Poisons) Regulation 1996 describes the requirements for prescribing and dispensing restricted drugs (S4) and controlled drugs (S8).
Depending on the product being prescribed, a doctor may also need a state approval in addition to the required Commonwealth approval.
Queensland doctors can prescribe Schedule 4 - cannabidiol (CBD) only products without a Queensland approval.
Doctors who hold a specialist registration (including specialist general practitioners) can also prescribe Schedule 8 - products containing tetrahydrocannabinol (THC) without a Queensland approval.
When a Queensland approval is required
Schedule 8 Medicinal cannabis not registered on the ARTG
In Queensland, doctors who do not hold a specialist registration need approval from Queensland Health if prescribing a Schedule 8 medicinal cannabis product that is not registered on the ARTG. Both the Commonwealth and state applications are made via the Online portal.
Schedule 8 medicinal cannabis registered on the ARTG
To prescribe the registered medicine nabiximols (Sativex), all non-specialist medical practitioners need to apply to the Director-General Queensland Health for a Section 18 approval under the Health Drugs and Poisons Regulation 1996 (HDPR). Complete the Request for Chief Executive Approval form (PDF 398 kB).
Treating a drug-dependant person with a schedule 8 medicinal cannabis product
A Queensland approval is also required for those special cases where the patient is considered a drug dependent person and is seeking access to schedule 8 medicinal cannabis. Complete the Request for Chief Executive Approval form (PDF 398 kB).
For further information on requirements for prescribing to a drug dependant person, visit Drugs of Dependence on the Queensland Health website or phone 13 78 46.
Guidance and regulations
- Guidances for the use of medicinal cannabis in Australia, December 2017 are a suite of national guidance documents that cover a range of medical conditions, symptoms, and products to be used. The individual documents can be viewed on the TGA's website.
- Standard for security of medicinal cannabis stock – June 2019: how to secure and store medicinal cannabis products, under the regulation.
When making an application, you will 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 next clinical 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)
- some forms 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.
NSW Cannabis Medicines Advisory Service – (The Service is for NSW health practitioners only). However, the Service is also available if:
- You are a medical practitioner in a state or territory outside of NSW but are treating a patient residing in NSW, or
- You are a NSW medical practitioner treating a patient in cross-border areas of NSW.
Commonwealth Department of Health
The Commonwealth Department of Health regulates medicinal cannabis products through the Therapeutic Goods Administration (TGA) and the Office of Drug Control (ODC).
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 mechanisms available for access to medicines that are not registered on the ARTG.
As most medicinal cannabis products are currently unregistered medicines, access to these products is through the Commonwealth Special Access or Authorised Prescriber Schemes or through a Clinical Trial.
Your legal obligations
The prescriber must:
- adhere to all conditions as detailed in any TGA import licence or permit, if they are the importing party
- comply with any conditions imposed on a TGA approval relating to the medicinal cannabis product(s) being used, including obtaining informed consent in writing from the patient (or the person with the legal authority to consent to the treatment on behalf of the patient) in relation to the proposed use of the specified medicine
- comply with any conditions imposed on a Queensland Health approval
- if requested by the Chief Executive, 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
- report any adverse events, adverse reactions, serious adverse reactions and unexpected reactions to the TGA.
Find a product
Doctors can apply to prescribe both plant-based products and synthetic products. When used for a therapeutic purpose, including:
- tinctures: plant material infused in oil or alcohol
- vapour: dried plant material or concentrated cannabis extract is heated in a vaporiser
- capsules or sprays: generally, oil-based capsules taken orally
- pharmaceutical products such as nabiximols.
Smoking in general is harmful, smoking of cannabis products will not be approved in Queensland.
The Therapeutic Goods Administration website provides information regarding registered medical devices (vaporisers) in Australia. Search the ARTG for available registered medical devices (vaporisers) in Australia. If vaporised cannabis is to be used it is recommended that those which have been studied in a research setting and found to be safe and feasible are chosen for use.
Products currently used in Australia:
- Imported and locally produced medicinal cannabis products are currently in use in Australia, a list of manufacturers and suppliers is available from the Office of Drug Control.
- Nabiximols (Sativex), Nabilone (Cesamet) and Dronabinol are listed as approved medicines on the Australian Register of Therapeutic Goods. Sativex is a Schedule 8 medicine and is a plant-derived product. In Queensland specialist medical practitioners can prescribe Sativex without requiring an approval from the state or the TGA.