HQ Team
July 4, 2023: Australia became the first country to allow authorized psychiatrists to prescribe psychedelic substances psilocybin and methylenedioxy-methamphetamine (MDMA) for the treatment of certain mental health conditions.
Starting July 1, the Therapeutic Goods Administration (TGA) will permit MDMA or ecstasy prescriptions for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression, according to a government statement.
“These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients,” according to the government.
There are currently no approved products containing psilocybin, found in psychedelic mushrooms, or MDMA that the TGA has evaluated for quality, safety, and efficacy.
However, an amendment to the country’s drug standards will allow authorized psychiatrists to access and legally supply a specified ’unapproved’ medicine containing these substances to patients under their care for PSTD and depression.
For these specific uses, psilocybin and MDMA will be listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standard. For all other uses, they will remain in Schedule 9 (Prohibited Substances) which largely restricts their supply to clinical trials.
To prescribe, psychiatrists will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee. The Authorised Prescriber Scheme allows prescribing permissions to be granted under strict controls that ensure the safety of patients.
The decision follows applications made to the TGA to reclassify the substances in the Poisons Standard, extensive public consultation, a report from an expert panel, and advice received from the Advisory Committee on Medicines Scheduling.
