Resources, clinical trials and clinical evidence
This page provides useful resources and information for health professionals considering prescribing or supplying 'unapproved' medicinal cannabis products.
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 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
- Medicinal cannabis reforms: Frequently asked questions
Medicinal cannabis access for health professionals
This video provides an overview of access pathways for medicinal cannabis.
As a prescriber, you might be wondering if medicinal cannabis products are suitable for your patients.
Most medicinal cannabis products are not approved medicines, which means the Therapeutic Goods Administration (or TGA) has not assessed them for safety, quality and efficacy.
You may need to start by doing some research… and you should consider all relevant, approved treatments before seeking access to an unapproved treatment.
If you determine that an unapproved medicinal cannabis product… is clinically suitable for your patient… there are pathways you can use. The most convenient option for medical practitioners may be to apply to the TGA to become an Authorised Prescriber.
This allows medical practitioners to access a medicinal cannabis product for patients with a particular condition... without requiring a separate approval for each patient.
Instead, Authorised Prescribers must report the number of patients treated every six months.
Reports can be submitted using the SAS and Authorised Prescriber Online system.
You may not need approval from a human research ethics committee or specialist college if the product you are prescribing is included in the TGA's list of medicines with an established history of use for your patient's condition.
If the product you wish to prescribe is not included in the list of medicines with established history of use, or if you wish to prescribe for a different condition, you can still apply to become an Authorised Prescriber, but you will need approval from a human research ethics committee or specialist college.
Another option is to use the Special Access Scheme (or SAS).
You can apply to the TGA for access to a medicinal cannabis product for an individual patient.
You may also need approval from your state or territory government, which can be done in the SAS and Authorised Prescriber online system.
To learn more about medicinal cannabis and access pathways, visit the TGA website.
Medicinal cannabis: The SAS Pathway
This video provides an overview of accessing medicinal cannabis for a patient using the SAS.
As a prescriber, there may be times when you determine that an unapproved medicinal cannabis product is the most appropriate treatment for your patient.
The usual process is to apply to the Therapeutic Goods Administration (or TGA) for access to the unapproved product under either the Special Access Scheme, known as SAS, or the Authorised Prescriber scheme.
Be aware that the TGA has not assessed unapproved medicines for safety, quality or efficacy.
This means the prescriber of an unapproved medicine has important responsibilities.
For example, you must research the unapproved product and obtain informed consent from your patient.
You will accept all medical and legal responsibility for the treatment outcome. You will also need to report adverse events to the TGA and the medicine sponsor.
The SAS and Authorised Prescriber Online System makes it easy to apply.
Completed applications submitted via the online system are reviewed within 2 working days under the SAS, and typically within 7 working days under the Authorised Prescriber scheme.
SAS and Authorised Prescriber applications for medicinal cannabis products are submitted by category of active ingredient.
There are five categories of active ingredient for you to consider based on your patients condition and once approved you can issue prescriptions for any product that falls under that category.
A list of medicinal cannabis products and their corresponding categories is available on the TGA website.
Becoming an Authorised Prescriber allows medical practitioners to access a medicinal cannabis product for patients with a particular condition without requiring a separate approval for each patient.
Instead, Authorised Prescribers must provide reports to the TGA every 6 months of the number of patients treated.
You don't need approval from a human research ethics committee if the condition has been included in the list of medicines with an established history of use in Australia, which is determined by the TGA.
If the product you wish to prescribe is not included in the TGA list of medicines with established history of use, or if you wish to prescribe for a different condition, you can still apply to become an Authorised Prescriber, but you will need approval from a human research ethics committee or specialist college.
If you decide to apply for access to medicinal cannabis under the SAS, you'll need to know which category to use.
Under SAS Category A, you can notify the TGA of using an unapproved product for patients who are seriously ill and likely to die.
Under SAS Category B, you can apply to the TGA for access to an unapproved product for patients where approved products are unsuitable.
If both Category A and Category B are relevant to your patient, Category B is likely to provide faster access.
Category A requires you to import a product for your patient via the Office of Drug Control (or ODC).
Under Category B you can usually access stocks of domestic or imported products that the ODC has already allowed into Australia.
If you apply for access to an unapproved medicinal cannabis product under SAS Category B, you must provide a clinical justification.
You will need to outline your patient's condition and their treatment history, including whether you have considered relevant approved products.
The clinical benefit must be balanced against the potential risks.
Some medicinal cannabis products may also need state or territory approval. If you apply for SAS Category B approval through the online system you can apply to the TGA and your state or territory Health Department at the same time.
Be aware that SAS Category B approval is for a specific patient and prescriber. This means that you will have to apply for access for each patient.
The SAS and Authorised Prescriber online system streamlines new applications with a cloning feature that lets you copy and edit previous applications.
For example, you can apply for access to an additional category for the same patient by copying your previous application and editing the category details.
The online system also allows users at the same hospital or pharmacy to share application documents. This makes it easier to work together when arranging patient access to a product.
You can view the status of your application... and download decision letters directly from the online system.
Authorised Prescribers can submit six monthly patient data reports easily using the online system.
To learn more about the SAS Pathway, visit the TGA website.