No. 1 in the world, Australia has announced that it will officially recognize MDMA and psilocybin as drugs.
Australia’s Therapeutic Goods Administration (TGA), the government agency that regulates medicines, announced on February 3 that licensed psychiatrists will be able to prescribe MDMA to treat post-traumatic stress from July 1, 2023 disorder (PTSD), and psilocybin is the active ingredient in magic mushrooms used to treat treatment-resistant depression. As the TGA has not approved any actual medicines containing MDMA or psilocybin, patients will initially receive ‘unapproved’ medicines containing these substances.
The decision was unexpected. At the end of December 2021, the same regulator decided not to downgrade the drug for medical use. “When I woke up, I was completely inundated with emails from people saying: ‘Have you heard what happened?’ I was shocked by the decision,” said psychiatrist and co-author of the University of Melbourne’s Psychae Institute. Senior researcher Simon Ruffell said.
Before advocates celebrate, experts warn that many questions remain about how many people will actually be able to access the treatments on July 1, and whether Australia is rushing ahead before gathering enough evidence on how to roll them out effectively and safely. land.
“I think it will take a while for this to improve,” said Daniel Perkins, adjunct associate professor at Swinburne University’s Center for Mental Health and senior research fellow at the University of Melbourne. It’s sensible, he says: Let it open up gradually and see what works, which are invalid. “They probably did it on purpose.”
The path for psychiatrists to gain full license to dispense medication can be long and winding. First, psychiatrists need to be approved by the Australian Authorized Prescriber Scheme, which means being accredited by the Human Research Ethics Committee and then by the TGA. To do so, they need to demonstrate that they can clinically justify the treatment regimen, that they will manage the course of treatment appropriately, and that they will use appropriate measures to protect patients. The TGA has not yet detailed how these measures will work in practice.
In addition, the TGA has not provided any details on the minimum training standards required for psychiatrists to become licensed prescribers. Specific prescriptions for these treatments are ambiguous, given that the underlying evidence supporting these treatments involves patients being treated by trained professionals as well as the drugs themselves. Because of this — and because the TGA has placed the onus on psychiatrists to demonstrate that their prescribing practices are appropriate — there may be a need to offer treatment in combination with medications, says Rhys Cohen, a non-executive advisory board member of the TGA at the University of Sydney. Lambert Initiative for Cannabinoid Therapeutics and advises the medical cannabis industry.
Not any psychiatrist or psychologist can safely administer these treatments. In well-established indigenous psychedelic practices around the world, people spend at least five to 10 years training to use the substances, Ruffell noted. “I think it’s a serious mistake to think that psychiatry and psychology qualifications are transferable to psychedelic substances without additional training.”
