AUSTRALIA’S first clinical practice guideline for psychedelics has been released for public consultation.

The new framework is designed to support clinicians, including pharmacists, to make informed decisions about the use of methylenedioxymethamphetamine-assisted psychotherapy (MDMA-AP) to treat post-traumatic stress disorder (PTSD).

Authorised psychiatrists have been able to prescribe MDMA to treat PTSD since 2023, when Australia became the first country to reschedule the drug from a prohibited substance to a controlled substance (PD 15 May 2023).

The draft guideline was developed at Monash University’s Centre for Medicine Use and Safety (CMUS) and Neuromedicines Discovery Centre (NDC), led by an 18-member development group that was co-chaired by a pharmacist.

While the document does not specifically identify the co-chair, Professor J Simon Bell from the Faculty of Pharmacy and Pharmaceutical Sciences at Monash is listed as a corresponding author.

The standards recommend limiting the use of MDMA-AP to adults with PTSD symptoms for at least six months post-diagnosis, and for those experiencing moderate or severe symptoms in the past month.

Use of MDMA-AP should also be confined to those who have received an adequate trial of first-line evidence-based treatments first, and are at low risk of being re-exposed to trauma during treatment.

In section seven of the guideline, pharmacists are advised to dispense or supply MDMA directly to authorised prescribers only, rather than to patients, and in accordance with the guidance from the Therapeutic Goods Administration.

Additionally, clinicians who provide MDMA-AP are directed to do so in consultation with the patient’s regular healthcare providers, and to bear in mind that the drug should be integrated into, rather than replace, a patient’s broader treatment plan.

“The guideline addresses an important need because nearly half of people with PTSD do not improve with current treatments,” said Project Manager Dr Alene Yong from CMUS.

“The Australian Institute of Health and Welfare estimates that up to 11% of Australians will experience PTSD at some point in their lives.”

Public consultation is open until 31 Aug – click here to see the guideline and submit feedback. JM

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