People suffering serious mental health conditions will be able to be prescribed psychedelic drugs MDMA and psilocybin within six months.
The Therapeutic Good Administration made the decision following calls to reclassify the substances, but only specifically authorised psychiatrists will be able to prescribe them.
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MDMA, a synthetic substance also known as ecstasy, will only be prescribed for the treatment of post-traumatic stress disorder.
Psilocybin, a substance naturally occurring in magic mushrooms, will only be prescribed for patients with treatment-resistant depression.
“These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients,” the TGA said.
The decision will amend the Poisons Standard, reclassifying the drugs – for these specific uses – as “controlled drugs”.
This will allow authorised psychiatrists to access and supply a specified “unapproved” medicine containing these substances to their patients, and for these substances to be used “therapeutically in a controlled medical setting”.
“There are currently no approved products containing psilocybin or MDMA that the TGA has evaluated for quality, safety and efficacy,” the TGA said.
The medicines containing the substances will be authorised for prescription from July 1, 2023.
The drugs will remain classified as “prohibited substances” for all other uses, which will still restrict their supply to clinical trials.
“The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses,” the TGA said on Friday.
“It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting. However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients.”
MDMA and psilocybin-prescribing psychiatrists will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee.
A GP can advise patients and refer them to a suitable psychiatrist if they consider that psilocybin or MDMA is an appropriate treatment option, or patients may be eligible to participate in a clinical trial of psilocybin or MDMA.
For more information on how to become an authorised prescriber, click here.
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