The world’s first Australia has announced that it will officially recognize MDMA and psilocybin as medicines.
On 3 February, Australia’s Therapeutic Goods Administration (TGA), the government agency responsible for regulating medicines, announced that from 1 July 2023, licensed psychiatrists will be able to treat post-traumatic stress disorder (PTSD). announced that it will be possible to prescribe MDMA for treatment. Psilocybin, the active ingredient in magic mushrooms, is effective in treatment-resistant depression. The TGA has not yet approved an actual drug containing MDMA or psilocybin, so patients will first receive an “unapproved” drug containing the substances.
This decision came as a big surprise. At the end of December 2021, the same regulatory body made a decision against reducing the schedule of medicines for medical use. “When I woke up, my email read, ‘Have you heard what happened? I am shocked by this decision,'” says Simon Raffel, a psychiatrist and senior fellow at the University of Melbourne’s Psych Research Institute. says.
Before advocates celebrate, experts say there are still many questions about how many people will actually have access to these treatments on July 1st, and how Australia will effectively roll out these treatments. Warn if you flew the gun before you gathered enough evidence on how to do so…and safely.
“I think it will take some time to launch,” says Daniel Perkins, an adjunct associate professor at Swinburne University Mental Health Center and a senior fellow at the University of Melbourne. This is wise, he says. “They probably did it this way on purpose.”
The road to full psychiatric authorization to administer drugs can be a long and winding one. First, the psychiatrist must be approved under the Australian Accredited Prescriber Scheme. This means that he will be approved by the human research ethics committee and then by the TGA. This requires demonstrating that the treatment regime is clinically justifiable, that the treatment process can be adequately controlled, and that appropriate measures are taken to protect patients. What these measures will look like in practice has yet to be detailed by the TGA.
Additionally, the TGA has not yet provided details on the minimum training standards required for a psychiatrist to become a licensed prescriber. This obscures exactly how these treatments are prescribed. For this reason, and because the TGA places the onus on psychiatrists to demonstrate that their prescribing practices are adequate, it becomes necessary to offer treatment in combination with drugs. Likely, says Rhys Cohen. Consultant to the Lambert Initiative for Cannabinoid Therapies at the University of Sydney and the medical cannabis industry.
And psychiatrists and psychologists aren’t the only ones who can safely administer these kinds of treatments. of training to be able to work with this kind of substance. “I think it is a grave mistake to think that psychiatric and psychological qualifications can be transferred to psychedelic substances without additional training.”
