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Medicinal cannabis: Information for health professionals
This page provides health professionals with information and resources related to access pathways to medicinal cannabis.
Accessing medicinal cannabis for a patient
Australian registered medical practitioners who would like to access unapproved medicinal cannabis products for the treatment of appropriate patients outside of clinical trials may choose to do so through the Special Access Scheme (SAS) or the Authorised Prescriber Scheme.
The video below, Medicinal cannabis access for health professionals, provides an overview of access pathways for medicinal cannabis.
For further information regarding these processes, including a step-by-step resource for medical practitioners and information as to what to include in an application to the TGA please see our 'Access to medicinal cannabis products: using access schemes' web page.
The video below, Medicinal cannabis: The SAS Pathway, provides an overview of accessing medicinal cannabis for a patient using the SAS.
The Office of Drug Control website has published a list of manufacturers and suppliers of medicinal cannabis products. This may assist prescribers with medicinal cannabis product selection. Note that the Australian Government cannot guarantee availability or supply by any manufacturer or importer listed on the website.
Clinical justification requirements for SAS Category B applications
When applying to access an unapproved medicinal cannabis product on behalf of a patient under the SAS Category B pathway, prescribers must provide a clinical justification. The justification should include the seriousness of the patient's condition, consideration for the use of medicines that are included in the ARTG and the potential risks and benefits of using the proposed unapproved medicine.
The clinical justification may be succinct and should summarise:
- an outline of the patient's symptoms and/or diagnosis
- details of relevant past treatments and procedures trialled or considered, including reasons why therapeutic goods currently included in the ARTG may not be the most appropriate treatment for the individual patient in the particular circumstance
- an appraisal of the expected clinical benefits versus the potential risks of the proposed treatment.
There are no restrictions on the medical conditions for which a prescriber may apply via the SAS to access an unapproved medicinal cannabis product for their patient, provided the prescriber has the appropriate knowledge on the condition being treated and on the medicinal cannabis product they wish to prescribe.
Supporting evidence may be requested by the TGA for some novel indications.
In some instances, evidence of specialist support from a practitioner with appropriate expertise may also be requested.
Clinical evidence, guidelines and resources for health professionals
The Commonwealth Department of Health, together with the NSW, Victorian and Queensland State Governments commissioned a multi-centre team of clinicians, experimental pharmacologists and other scientists at the University of New South Wales, University of Queensland and University of Sydney to review the current clinical evidence for medicinal cannabis in a range of conditions.
Further information and the guidance documents themselves are available on the medicinal cannabis - guidance documents web page.
Other available resources include:
- The NSW Cannabis Medicines Prescribing Guidance published by the Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE). This guidance provides interim information to assist medical practitioners in their decision-making around prescribing and managing the use of cannabis medicines. Guidance has been developed for anorexia/cachexia in advanced cancer, chemotherapy-induced nausea and vomiting, nausea in palliative care, dementia, non-cancer pain and spasticity.
- The United Kingdom National Institute for Health and Care Excellence (NICE) guideline on Cannabis-based medicinal products. This guideline covers prescribing of medicinal cannabis for patients with intractable nausea and vomiting, chronic pain, spasticity and severe treatment-resistant epilepsy. The guideline also includes an evidence review and tools and resources to help put the guidance into practice.
- The Royal Australian College of General Practitioners (RACGP) medicinal cannabis webinars. These webinars look at the use and prescribing of medicinal cannabis in general practice.
- NPS MedicineWise has developed a series of medicinal cannabis resources for prescribers and pharmacists.
Clinical trials on medicinal cannabis substances, extracts and products
The following Excel files provide information from the Australian New Zealand Clinical Trials Registry (ANZCTR) for relevant trials notified between 1 January 2015 and 30 November 2019 using the search terms THC, CBD and cannabinoid/s. Only trials that explore potential therapeutic uses of medicinal cannabis substances or products are shown in the files.
- THC clinical trials (xlsx,144kb)
- CBD clinical trials (xlsx,177kb)
- cannabinoid clinical trials (xlsx,178kb)
The ANZCTR is an online register of clinical trials being undertaken in Australia, New Zealand and elsewhere. Note that some trials undertaken in Australia may be registered with registries other than the ANZCTR. Trials from all Primary Registries of the World Health Organization International Clinical Trials Registry Platform can be searched at: International Clinical Trials Registry Platform.
All details of trials registered on the ANZCTR are made publicly available. Registration is voluntary, but if a registrant chooses to register a trial, certain fields are mandatory. Responsibility for registration lies with the sponsor defined as 'an individual, company or institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial'. It is the sponsor's responsibility to ensure that the information submitted is accurate and up-to-date.
The registry records a trial's objectives, main design features, sample size and recruitment status, treatments under investigation, outcomes being assessed, principal investigator and contact person.
Additional information and resources
- Import and export of controlled substances
- Access to medicinal cannabis: Frequently asked questions
- Medicinal cannabis: Importation and the traveller’s exemption