March 30, 2023


Regulators in Australia this week announced that qualified psychiatrists will be able to prescribe “medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) … for the treatment of certain mental health conditions” later this year.

Under newly permitted uses, those substances “will be listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standard,” but they will “remain in Schedule 9 (Prohibited Substances) which largely restricts their supply to clinical trials” for all other uses.

The Therapeutic Goods Administration, the Australian regulatory arm overseeing medicine and therapy in the country, said on Friday that the reclassification of the substances will take effect on July 1.

“Prescribing will be limited to psychiatrists, given their specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions, with therapies that are not yet well established. 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 announcement said.

The administration said that it will “permit the prescribing of MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression,” which it regards as “the only conditions where there is currently sufficient evidence for potential benefits in certain patients.”

“The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses. 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,” the administration said in the announcement on Friday. 

“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,” the regulatory agency continued. “There are currently no approved products containing psilocybin or MDMA that the TGA has evaluated for quality, safety and efficacy. However, this amendment will allow authorised psychiatrists to access and legally supply a specified ’unapproved’ medicine containing these substances to patients under their care for these specific uses.”

The administration said that the changes in classification for the substances “were made by a senior medical officer at the TGA who has been delegated by the Secretary of the Department of Health and Aged Care to exercise their authority to make decisions about the scheduling of medicines in the Poisons Standard.”

“The decision maker recognised there is a need for access to new therapies for treatment-resistant conditions such as treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). Psychotherapy involving psilocybin and MDMA has shown to be potentially beneficial in the treatment of these conditions,” the administration explained. “However, as with all medicines, there are risks with psilocybin and MDMA. Although these substances are themselves relatively safe when administered in the doses used in conjunction with psychotherapy and in a medically controlled environment, patients are in an altered state of consciousness when undergoing psychedelic-assisted psychotherapy. It was decided that by limiting prescribing to authorised psychiatrists and for TRD or PTSD the benefits for patients and public health will be greater than the risks.”

The announced policy change comes at a time when lawmakers in Australia are readying a push to legalize cannabis in the country.

The Australia Parliamentary Budget Office released a report detailing a pair of potential cannabis legalization plans and laying the groundwork for a regulated retail marijuana market.



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