Changes to medicinal cannabis prescribing pathways
The changes will improve patient access and reduce the administrative burden on prescribers, according to the TGA.
GPs prescribing medicinal cannabis products now have the flexibility to substitute an equivalent product without having to apply for a new permit.
GPs will now have a more streamlined process for prescribing medicinal cannabis following changes introduced on 22 November by the Therapeutic Goods Administration (TGA). Special Access Scheme (SAS) and Authorised Prescriber applications for ‘unapproved’ medicinal cannabis products can now be made by active ingredient, under one of five categories based on cannabinoid content, rather than by trade name. ‘This approach allows flexibility in brand substitution when needed, ie in the event of product shortage or discontinuation,’ the TGA website states. Prior to the change, prescribers who wished to change the product being prescribed had to obtain a separate permit each time. GP and integrative medicine practitioner Associate Professor Vicki Kotsirilos became Australia’s first authorised GP prescriber of medicinal cannabis in 2018. She told newsGP the changes, which came into effect on Monday, are a ‘fantastic result’ for prescribers and patients. ‘This means that as prescribers we will be able to freely switch from one product to another similar product, with equivalent cannabinoid content, without the need to apply for a new SAS approval,’ Associate Professor Kotsirilos said. ‘This is good news for the doctor as it saves time. ‘We don’t have to make a new application for a permit for … the patient who would like to switch to another equivalent product that might, for example, be cheaper or when their product is not available.’ The Melbourne GP also noted that being able to prescribe based on active ingredients rather than by a particular brand is more ethical. ‘It reduces any conflict of interest, so we don’t align ourselves with just one sponsor and their products,’ Associate Professor Kotsirilos said. Medical cannabis products will now be categorised by cannabinoid content:
Category 1 CBD medicinal cannabis product (CBD ≥98%)
Category 2 CBD dominant medicinal cannabis product (CBD ≥60% and <98%)
Category 3 Balanced medicinal cannabis product (CBD <60% and ≥40%)
Category 4 THC dominant medicinal cannabis product (THC 60-98%)
Category 5 THC medicinal cannabis product (THC >98%)
For products that contain THC, which is classified as a Schedule 8 drug under the Australian Poisons Standard, prescribers are still required to apply for authorisation following the relevant state or territory jurisdiction. In Queensland, however, this is only required if the patient is known to have drug dependency issues.
As part of the change, the TGA has also simplified its requirements around becoming an authorised prescriber.
As products listed under categories 1–3 have been included in the Authorised Prescriber ‘Established history of use’ pathway, to become an authorised prescriber, approval from a Human Research Ethics Committee (HREC) or specialist medical college endorsement will no longer be required before applying to the TGA.
Associate Professor Kotsirilos says this change helps to recognise the experience of doctors who have an established history of prescribing medicinal cannabis for chronic refractory pain and chronic refractory anxiety in adults.
‘This is also positive as it reduces administrative burden and makes it easier to prescribe, as well eliminating the cost for obtaining Authorised Prescribing through the HREC or an institution,’ she said.
Associate Professor Vicki Kotsirilos became Australia’s first authorised GP prescriber of medicinal cannabis in 2018.
However, GPs who want to become an Authorised Prescriber for conditions other than chronic refractory pain and chronic refractory anxiety in adults will require approval from an HREC or a medical specialist college endorsement.
An October newsGP poll found 24% of respondents cited the difficult prescribing process as the main barrier GPs face when prescribing medicinal cannabis, while 26% said a lack of knowledge was also a barrier.
While Associate Professor Kotsirilos says the latest streamlined process is largely good news, addressing any knowledge gaps remains an issue.
Where the former requirement for prospective authorised prescribers to go through an ethics committee or institution required GPs to demonstrate their understanding, that is no longer the case.
‘While this is a really exciting space for GPs – it broadens our ability to provide patients with choices of treatments – we still need to educate,’ she said.
‘While it can help in some cases, it does need to be prescribed cautiously as a last resort treatment when all other Australian-registered products have already been trialled, based on the principle of “start low, go slow” to ensure we do not cause any harm.
‘GPs need to be aware of how to prescribe it safely, how to monitor patients, what side effects to look for, to report any side effects, and also when to stop if it’s not effective for the patient.
‘So education is the key here.’ Originally published here: https://www1.racgp.org.au/newsgp/clinical/changes-to-medicinal-cannabis-prescribing-pathways?