Prescribing medicinal cannabis
From Monday 30 July 2018, Queensland doctors seeking approval to prescribe medicinal cannabis will do so via the Therapeutic Goods Administration (TGA) online system.
The online system has been introduced to enable the electronic submission of special access scheme (SAS) applications and notifications to the TGA. Use of this online system will streamline the application process and allow users to manage the SAS applications and nofications they submit to the TGA. Submission via the TGA's online system will fulfil the requirements for both the TGA and Queensland Health (which were previously 2 separate processes).
Visit the Special Access Scheme Online System page to find out more.
Doctors can legally prescribe medicinal cannabis products through 2 pathways:
- single-patient prescriber: both general practitioners and medical specialists
- patient class prescriber pathway: specialists medical practitioners, including specialist general practitioners.
Changes to patient class prescribing
From 30 August 2018, the Public Health (Medicinal Cannabis) Regulation 2017 has been amended to expand access to medicinal cannabis by streamlining the requirements for a Queensland approval and removing some of the administrative and reporting requirements. Commonwealth approvals are required for all medical practitioners looking to prescribe.
- The amendments expand the prescribed class of specialist medical practitioners to all specialist medical practitioners without the need for approval from the chief executive of the Department of Health for some conditions.
- The amendments also expand the types of patients to whom a patient-class prescriber may prescribe medicinal cannabis to include persons suffering chronic non-cancer pain.
- A reduction in treatment reporting requirements for patient-class prescribers
You must have obtained the mandatory Therapeutic Goods Administration (TGA) and Queensland Health approvals.
If you have any questions, contact Queensland Health:
Healthcare Approvals and Regulation Unit (HARU):
- Telephone: (07) 3708 5264
- 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 564 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 via TGA's online portal,
- clinical evidence
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.
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.
Your legal obligations
As a condition of the Queensland medicinal cannabis approval, you must:
- 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 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 nabiximols.
Products currently used in Australia:
- Imported medicinal cannabis products are currently in use in Australia, a list of providers is available from the Office of Drug Control.
- 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).