CANBERRA: Australia has announced it will officially recognize MDMA for the treatment of post-traumatic stress disorder (PTSD), and psilocybin, the active ingredient in magic mushrooms, for treatment-resistant depression.
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On February 3, Australia’s Therapeutic Goods Administration (TGA)—the government authority responsible for regulating medicines—announced that starting July 1, 2023, authorized psychiatrists will be able to prescribe MDMA for the treatment of post-traumatic stress disorder (PTSD), and psilocybin, the active ingredient in magic mushrooms, for treatment-resistant depression. Because the TGA has yet to approve any actual medicines that contain MDMA or psilocybin, patients will initially be receiving “unapproved” medicines containing the substances.
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The decision came as a big surprise because at the end of December 2021, the same regulatory body decided against down-scheduling the drugs for use in a medical context.
However, the path for a psychiatrist to get the all-clear to dole out the drugs could be lengthy and twisted. First, psychiatrists will need to be approved under Australia’s Authorised Prescriber Scheme, which means being endorsed by a human research ethics committee and then the TGA. For this, they’ll need to prove that they can clinically justify the treatment regime, that they will have proper governance over the treatment process, and that they will be using suitable measures to protect patients. What exactly these measures look like in practice have yet to be laid out in detail by the TGA.
