A taxonomy of regulatory and policy matters relevant to psychedelic-assisted therapy in Australia.

OBJECTIVES: The Australian government recently rescheduled psilocybin and 3,4-methylenedioxymethamphetamine for limited clinical uses. This change has raised various regulatory concerns and challenges for the field of psychedelic-assisted therapy. To provide clarity, we aimed to comprehensively catalogue the matters relating to psychedelic-assisted therapy that are or could be regulated. METHODS: We conducted a desktop review of the literature and current regulatory sources, semi-structured interviews with professionals who had expertise in fields relating to psychedelic-assisted therapy and a framework analysis to generate a taxonomy of relevant regulatory matters. In relation to each matter, we further identified what type of regulation (if any) currently applies to that matter, any uncertainty as to how the matter should be addressed in clinical practice in the context of current regulation and whether there are conflicting views as to how the matter could or should be further regulated. RESULTS: The taxonomy is structured into six main regulatory domains, three of which have a substantial proportion of matters with uncertainty or conflicting views: Service Establishment, Practitioner, and Treatment Delivery. Key examples of such matters include the location of services and facilities required, which professionals are eligible to become psychedelic therapists, and with what qualifications and experience. Matters in the remaining three domains, Patient Evaluation, Drug Supply and Service Oversight, appear by comparison relatively settled, with regulation either well-established or thought unnecessary. CONCLUSIONS: The taxonomy provides a roadmap for health services establishing and implementing a psychedelic-assisted therapy program, or for government and other policymakers when determining areas that may require further regulation.

Implementation of a ketamine programme for treatment-resistant depression in the public health system: Lessons from the first Australian public hospital clinic.

One could argue that we are living through a period of innovation and change in psychiatry unlike that seen before, with repurposed medications emerging as novel treatments. However, despite evidence of enhanced clinical outcomes and potential medium-term savings, delivering these promising interventions is resource-intensive and perceived as difficult in the public sector. Consequently, they are generally only available in the private sector, often at great cost, effectively making them inaccessible to the 'Have Nots'. The arrival of these paradigm-shifting treatments has inadvertently highlighted a growing mental health inequity. The Royal Prince Alfred Hospital's Ketamine Treatment Clinic was the first public-sector ketamine treatment clinic for complex mood disorders in Australia. Based on 3 years' experience establishing, developing and running a public-sector ketamine treatment service, we review the progress, perils and pitfalls for clinicians and health services contemplating establishing a public-sector ketamine treatment service of their own.