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Practitioners call out ‘unworkable’ psychedelic regulations


A group of medical and health practitioners who support the use of PAT in clinical practice in Australia, are now urgently calling for a comprehensive review of the current rules, regulations and guidelines for the use of psychedelic medicines which they say are not fit for purpose and are causing more problems than they solve.

On 1 July 2023, the TGA made changes to the classification of psilocybin and MDMA to enable prescribing by authorised psychiatrists for the treatment of certain mental health conditions including treatment resistant depression and PTSD. To prescribe, psychiatrists must be approved under the Authorised Prescriber Scheme by the TGA following approval by a Human Research Ethics Committee.

AMAPP is a registered multidisciplinary organisation of qualified healthcare practitioners including doctors, psychiatrists, psychologists, nurses, paramedics and social workers, who are keen to encourage and promote the safe and judicious introduction of PAT as a recognised, well-regulated and effective treatment in the Australian mental health field.

“To this end, our members many of whom have extensive experience understanding and working with psychedelic medicines for the treatment of psychiatric disorders, have come together to develop safe, efficient and practical guidelines for the use of PAT as well educational resources for general practitioners and the public,” said the AMAPP Chairman Dr Anthony Bloch.

‘We feel that the current regulations and recommendations made this year by the TGA and the RANZCP leave a lot to be desired,” said Dr Bloch. “We understand that the TGA decision made earlier this year was both unexpected and perhaps premature, considering the lack of adequate research up until now into psychedelic medicines, but nevertheless the decision was made and under certain prescribed circumstances PAT can now be legally utilized by suitably qualified and trained psychiatrists.”

But according to Dr Bloch: “The current regulatory system is virtually unworkable, overly cautious and cumbersome and needs to evolve with the help and input from those practitioners who have appropriate knowledge and experience working in the psychedelic field.”

AMAPP is proposing an urgent meeting of “minds and regulators” so that all those interested and invested in this work can come together and develop fairer and more progressive guidelines and regulations. According to the group what is most important is equitable and reasonable patient access to these treatments, as well as more flexibility and sharing of the treatment roles and responsibilities by the psychiatrists and the therapists involved.

“The current TGA requirement for a psychiatrist to be physically present at every therapy session and personally administer medication to clients, regardless of their role within the therapy team, is an impractical and cumbersome practice,” said Dr Bloch. “Most Psychiatrists would not be able to do this in their current model of practice. In some cases, it would be inadvisable and may contribute to worse outcomes in clients that have had to have prolonged and careful preparatory sessions with therapists they have come to trust.”

AMAPP argues that a number of other issues also need to be sorted out and agreed upon such as appropriate advertising, clinic locations and types, the need for uniform national standards, as well as the future collection of accurate treatment and research data.

“We are proposing that everyone invested in PAT, the TGA, State Health Departments, HREC’s, Academic institutions, the RANZCP, and all the professional organisations representing our members, get together and formulate ways of significantly improving the current inadequate state of play. Failure to address these issues may push desperate vulnerable patients to unregulated therapists where real harm is more likely.”

“We at AMAPP feel that PAT is a very promising treatment modality in this era of increasing mental health morbidity. Like everyone else we want PAT to be introduced safely and carefully but the current situation in Australia is not meeting the potential treatment needs of many of our patients. The current regulations are counterproductive and limited by obfuscation and too much bureaucracy. We demand change.”

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Ritchelle is a Content Producer for Healthcare Channel, Australia’s premier resource of information for healthcare.


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