Any Australian-registered doctor can apply to the TGA to prescribe unapproved medicinal cannabis, if they feel it is appropriate for their patient.
For most GPs, the SAS Category B pathway is the most convenient way to access medicinal cannabis for patients.
With growing awareness and interest from both patients and prescribers regarding the use of medicinal cannabis, many GPs may be looking for information about the process they need to follow to prescribe these products.
As such, the Therapeutic Goods Administration (TGA) has published a short guidance document – Medicinal cannabis: process for prescribers – to help GPs navigate the process.
What is the Special Access Scheme?
The Special Access Scheme (SAS) enables patients to have access to unapproved therapeutic goods such as medicinal cannabis on a case-by-case basis.
For most GPs, the most convenient SAS pathway is SAS Category B.
However, prescribers need to consider appropriate treatment options included in the Australian Register of Therapeutic Goods (ARTG) before accessing an unapproved good for their patients.
An approval letter from the TGA is required for access to goods via SAS Category B, as opposed to the other notification-based pathways, but these applications are generally processed by the TGA within two working days of receipt.
Any Australian registered health practitioner can apply via the SAS pathway, by registering through the SAS online system.
Clinical justification requirements
When applying to access an unapproved medicinal cannabis product on behalf of a patient under SAS Category B, prescribers must provide a short clinical justification.
The clinical justification should summarise 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.
Applicants should also provide a short 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.
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