MDMA and psilocybin: What GPs need to know

In early February the Therapeutic Goods Administration (TGA) made one of its most talked recent decisions.
 
The medicines regulator announced that medicines containing psychedelic substances psilocybin and MDMA could be prescribed by specifically authorised psychiatrists to treat certain mental health conditions from 1 July this year.
 
From that date, authorised prescribers who are Fellows of the Royal Australian and New Zealand College of Psychiatrists will be able to prescribe MDMA to treat post-traumatic stress disorder, while psilocybin will be on option for treatment-resistant depression.
 
It means psilocybin and MDMA will be listed as Schedule 8 medicines in the Poisons Standard for those uses, but otherwise will remain in Schedule 9, which largely restricts supply to clinical trials.
 
‘These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients,’ the TGA said.
 
The organisation says the decision ‘acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses’.
 
The decision made headlines and has generated a significant amount of public interest, as well as controversy – and inevitably has led to more queries in general practice settings.
 
Here, Dr Hester Wilson, the Chair of RACGP Specific Interests Addiction Medicine, gives her take on the move and what GPs should be aware of when patients raise the topic.
 
There is some emerging evidence that psychedelics, including MDMA and psilocybin, may be of benefit for some patients. However, their role remains unclear.
 
I am keen for my GP colleagues to have an understanding of the complexities of the current situation, so if someone comes in asking for a referral that they can have an informed conversation with their patient.
 
As previously reported in newsGP, many clinicians have found the TGA decision is surprising – myself included.
 
From my point of view, it seems the TGA may have bowed to pressure from one external, and no doubt well-meaning, private organisation/lobby group, combined with the evidence of one overseas expert, Professor David Nutt.  
 
We have considerable local expertise and their advice was not specifically sought for the TGA approval.
 
Even though the Head of the TGA Professor John Skerritt told the ABC the decision was based on medical, scientific and regulatory criteria, I am still concerned about undue influence, as well as the lack of consideration of diverse voices and expert points of view.
 
There is no doubt that this is a major shift, and the treatment modality is very different to other mental health treatments.
 
The drug is taken once and the person is supported through their ‘trip’ over the next 6–8 hours, then undertakes counselling over the next few months to integrate the insights they gained over the day session.  
 
If there is a benefit from the first session and follow-up counselling, additional treatment sessions followed by counselling may be appropriate. 
 
This is very different to starting a medication and taking it daily for months, or years.
 
The best and most appropriate psychological interventions to support the person through the ‘trip’ and subsequent treatment are still being established.
 
The risks involved in this approach are acknowledged by the TGA in its explanation of their decision.
 
‘It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting,’ the medicines regulator states.
 
‘However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients.’
 
The TGA has limited prescribing only to psychiatrists who have undertaken specific training and are authorised.
 
However, there is currently no authorised training. It appears the sole organisation that lobbied for the change is planning to run these.
 
We know a private service is being planned for Sydney and is expected to charge many thousands of dollars for people to undertake this treatment.  
 
This seems a conflict of interest and will limit the treatment to a select group of people.
 
At the same time, information on treatment efficacy and safety, as well as evidence-based practice, governance and oversight, is lacking.
 
This could put back the progress of ensuring treatment is made available to those who could benefit from it in the future.
 
Given the current unknowns there is also a risk that these treatments could go horribly wrong.
 
I strongly suggest that the Government works with local experts to set up safe, evidence-based principles of care, as well as to oversee training and review programs designed to ensure safety.
 
My recommendation is also that these programs should be independently assessed and evaluated.
 
Evidence-based treatments with thorough principles of care are obviously welcome – but in this case, there is still a way to go.
 
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depression MDMA mental health psilocybin psychedelics TGA