Generic Prescription for Cannabinoid Medications
TGA Changes Allow for Streamlined Prescription Processes for Medical Cannabis
The changes announced by the TGA will make it easier for patients to switch brands of the same medical products without having to apply for a new permit.
The TGA has announced new changes to the medicinal cannabis prescription process, making it easier for GP’s to prescribe ‘unapproved’ medicinal cannabis products based on the active ingredient instead of the trade name or brand. These changes allow patients to easily switch between different medical cannabis brands as long as they use the same cannabinoid.
The changes allow GP’s to give out Specialised Access Schemes (SAS) and Authorised Prescriber applications by active ingredient or cannabinoid instead of the trade name. The TGA has announced five different cannabinoid categories that GP’s can prescribe to patients.
The TGA’s new streamlined medical cannabis application process allows for more flexibility and brand substitution for their patients, says their website.
Before the changes, GP’s were required to give out SAS applications based on the trade name. This made it very difficult for patients to switch to a different brand if needed. In the past, to switch brands, patients had to apply for new SAS applications.
Switching between different brands was hard because GP’s could only prescribe medical cannabis, CBD, and other “unapproved” products based on the brand name. However, GP’s can now prescribe based on the active cannabinoid in the product.
The TGA has announced five categories for medical cannabis products which are:
- Category 1 CBD Medical Cannabis Products: Products with more than 98% CBD.
- Category 2 CBD Dominant Medical Cannabis Products: Products with less than 98% CBD and more than 60%.
- Category 3 Balanced Medical Cannabis Products: Products with less than 60% CBD and more than 40%.
- Category 4 THC Dominant Medical Cannabis Product: Products with 60%-98% THC.
- Category 5 THC Medical Cannabis Product: Products with more than 98% THC.
When prescribed medical cannabis under any of these categories, patients can switch between different brands as long as they have the same active ingredient or are under the same category.
One of Australia’s first GP’s to prescribe medical cannabis, Associate Professor Vicki Kostirilos, has said the changes could have "fantastic results" for both patients and GPs.The changes will save both doctors and patients time as they won’t need to apply or approve new prescriptions when patients need to change brands. This applies especially to patients who want to switch products because the original product isn’t available or is too expensive.
The changes can also reduce potential conflicts of interest. Prescribing products based on the active ingredient instead of the brand name is also more ethical, as it gives patients the freedom to choose the brand of their cannabis products, as long as they fall under the same category.
While there is a category for THC products, the compound is still classified as a Schedule 8 Drug, which means it’s a controlled substance. For this reason, prescribers of cannabis products are required to apply for authorisation from their state or territory jurisdiction.
For Queensland GPs and patients, however, this authorisation is only required when the patient has known drug dependence issues.
Another aspect of the TGA changes is the simplified requirements for being an authorised prescriber.
Cannabis products under categories 1-3 are now included in the Authorised Prescriber “Established History of use” pathway. This means that prescribers no longer need Human Rights and Ethics Committee (HREC) and specialist medical college endorsements when applying to the TGA.
Kotsirilos has said that these changes “recognise the experience of doctors who have a history of prescribing medical cannabis to adults with chronic pain or anxiety”.
These changes make it much easier to prescribe medical cannabis products such as CBD to patients who will benefit from the treatment. With that said, prescribers who wish to prescribe medical cannabis products for ailments other than chronic pain or anxiety will still need an HREC or specialist medical endorsement when applying to the TGA.
Kotsirilos has said that all these changes are pointing towards the right direction, however, some knowledge gaps present much more challenging issues.
While the changes make for a more streamlined prescription process, Kotsiliros states that “education is key” in creating an ideal system for prescribing medical cannabis.
She stated that there is still proper caution GPs need to take when prescribing medical cannabis, citing the “start low, go slow” process to ensure that the doctors are not causing any harm.
When prescribing cannabis, the Associate Professor has advised GPs to exercise caution. She has said that it’s very important to know, “how to prescribe it safely, how to monitor patients, potential side effects, and when to stop treatments when it’s ineffective to the patient”.
There is still a lot unknown about medical cannabis, so these changes will make it easier to research the effects of medical cannabis, as well as allow patients more freedom when it comes to selecting the right product for their needs and means.