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Resources, clinical trials and clinical evidence

20 January 2022

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:

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

Videos

Medicinal cannabis access for health professionals

This video provides an overview of access pathways for medicinal cannabis.

Transcript

As a medical practitioner, 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.

One option is to use the Special Access Scheme (or SAS).

Using the SAS online system, 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 in most cases can also be done in the SAS online system.

Another option is to apply to the TGA to become an Authorised Prescriber.

This allows you to access a medicinal cannabis product for patients with a particular condition...

without requiring a separate approval for each patient.

Your Authorised Prescriber application will need to be approved by a human research ethics committee or specialist college.

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.

Transcript

As a prescriber, there may be times when you determine that an unapproved medicinal cannabis product is the most appropriate treatment for your patient.

In most cases you must apply to the Therapeutic Goods Administration or TGA for access to the unapproved product under the Special Access Scheme, or SAS.

The SAS online system makes it easy to apply, and applications are reviewed within two working days.

Be aware that 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.

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.

You can visit the ODC website for a list of Australian manufacturers and suppliers of medicinal cannabis products.

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 are Controlled Drugs.

For these products, you may also need state or territory approval.

If you apply through the SAS online system, in most cases you can apply to the TGA and your state or territory Health Department at the same time.

Be aware that Category B approval is for a specific product, patient and prescriber.

This means that you will have to apply for access for each patient and product.

The SAS online system streamlines new applications with a cloning feature that lets you copy and edit previous applications.

For example, if there is a product shortage, you can apply for access to an additional product for the same patient by copying your previous application and editing the product details.

The SAS 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 SAS online system.

If you often prescribe medicinal cannabis, consider applying to become an Authorised Prescriber.

An Authorised Prescriber may access a medicinal cannabis product for patients with a particular condition without requiring a separate approval for each patient.

For more information and guidance, visit the TGA website.