Prescribing medicinal cannabis
Medicinal cannabis products are classified as either Schedule 3, Schedule 4 or Schedule 8 medicines, however 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 (TGA) approval is required in order for the medicine to be prescribed.
The TGA manages and enables access to:
In Queensland, any medical practitioner or nurse practitioner can prescribe medicinal cannabis for any patient with any condition if they believe it is clinically appropriate and, for unapproved medicinal cannabis products, they have obtained the required TGA approval.
The Medicines and Poisons (Medicines) Regulation 2021 describes the requirements for prescribing and dispensing S4 and S8 medicines.
Queensland medical practitioners and nurse practitioners can prescribe Schedule 4 - cannabidiol (CBD) and Schedule 8 - tetrahydrocannabinol (THC) or tetrahydrocannabinol: cannabidiol (THC:CBD) products without a Queensland approval.
Guidance and regulations
- In conjunction with the Commonwealth Department of Health and Aged Care, state and territory health departments and universities, guidance documents have been prepared on the use of medicinal cannabis in Australia. This suite of national guidance documents cover a range of medical conditions, symptoms, and products to be used. The individual documents can be viewed on the TGA's website.
- The Medicines and Poisons Act 2019 and Medicines and Poisons (Medicines) Regulation 2021 outline specific requirements for dealing with regulated substances, including medicinal cannabis, review the legislation for more information.
When making an application to the TGA, prescribers 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 the patient's medical condition or symptoms.
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.
Prescribers may apply for other conditions; however, clinical evidence will need to be supplied with an application for this to be considered. There is no evidence that medicinal cannabis is an effective treatment for cancer.
Prescribers 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 – (for NSW health practitioners only). However, the Service is also available if:
- You are a prescriber in a state or territory outside of NSW but are treating a patient residing in NSW, or
- You are a NSW 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
As a prescriber, you must:
- adhere to all conditions as detailed in any TGA import licence or permit, if you 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 the Departmental standard – monitored medicines (PDF 320 kB) when prescribing S8 medicinal cannabis products for dispensing or giving a treatment dose
- comply with the requirement to check QScript prior to prescribing or giving a treatment dose of a monitored medicine, including S8 medicinal cannabis
- report any adverse events, adverse reactions, serious adverse reactions and unexpected reactions to the TGA.
Find a product
Prescribers 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 is not supported.
To assist prescribers who are prescribing medicinal cannabis products, the TGA has published a list of products by ingredients, dosage form, quantity per dosage unit, and sponsor. These lists should be used where TGA approval has been obtained and the prescriber requires assistance in choosing a product from the correct category.
- TGA’s list of medicinal cannabis products by active ingredient
- medicinal cannabis products by active ingredients
Approved (registered) products currently used in Australia:
- Nabiximols (Sativex), is listed as an approved medicines on the Australian Register of Therapeutic Goods.
- Sativex is a Schedule 8 medicine and is a plant-derived product. As an approved product, prescribers can prescribe Sativex without requiring an approval from the Queensland Health or the TGA.
- Epidyolex is a Schedule 4 medicine used as an adjunct therapy in the treatment of severe forms of epilepsy.