Resources, clinical trials and clinical evidence

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.

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.