Plea for psychedelic rules reform

Vulnerable patients will seek out psychedelic drugs from ‘underground sources’ if restrictive prescribing rules are not changed, according to a new group pleading for intervention.
 
The Australian Multidisciplinary Association for Psychedelic Practitioners (AMAPP) has launched an urgent appeal for a comprehensive review of the current rules, regulations, and guidelines for the use of psychedelic medicines, saying they are not fit for purpose.
 
Consisting of doctors, psychiatrists, psychologists, nurses, paramedics and social workers, the group says the current regulatory system is ‘unworkable’.
 
But GPs are urging caution moving forward, saying ‘we need to get it right’ when it comes to safe and effective treatments.
 
On 1 July this year the Therapeutic Goods Administration (TGA) unexpectedly permitted psilocybin and methylenedioxy-methamphetamine (MDMA) to be made available for prescription by authorised psychiatrists.
 
Under the new regulations, MDMA can be prescribed for the treatment of post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression.
 
Under the Authorised Prescriber Scheme, approved psychiatrists are allowed to prescribe the medications under strict controls to ensure the safety of patients.
 
While the decision was welcomed by some, caution was advised from several healthcare professions due to a lack of evidence on the drugs’ efficacy and safety.
 
AMAPP Chair Dr Anthony Bloch told newsGP the current regulations are ‘counterproductive’ and limited by too much bureaucracy, at the same time as a ‘mental health epidemic’ is taking over Australia and its healthcare systems.
 
‘Some of the guidelines … were fear-based and ignorance-based guidelines,’ he said.
 
‘It’s very easy to fall back onto the stigma of these drugs and to put in guidelines that are overly restrictive and have actually almost completely prevented this from rolling out in a reasonable way.
 
‘The psychological harm is mitigated fairly easily by selecting the right patients, having proper preparation and intake assessments, and by having properly trained therapists, so we don’t feel that there’s inherent danger.’
 
The AMAPP wants increased flexibility and sharing of treatment roles and responsibilities by psychiatrists and therapists.
 
It also wants to see changes to a current TGA requirement for a psychiatrist to be physically present at every therapy session and personally administering medication to clients, regardless of their role within the therapy team, saying this is not practical.
 
AMAPP is also calling for changes to advertising, clinic locations and types, uniform national standards, and the collection of accurate treatment and research data.
 
Dr Bloch said if the guidelines are not changed, patients will begin seeking out the drugs from alternative, and often dangerous, sources.
 
‘People are going to go underground, they’re going to get frustrated … there’s a lot of danger in not allowing sensible, equitable, safe access,’ he said.
 
‘And if everyone goes underground, all of these highly trained psychedelic therapists will be left with skills that they can’t use.
 
‘It’s not giving someone a pill and helping them through the trip until they come out the other side, these are profound transformative changes in the way people view the world and they cure mental illness as a side effect of that.’
 
But with the therapy expected to set patients back up to $10,000, Dr Bloch said the treatment will be seen as ‘drugs for rich people’ until it becomes more affordable.
 
Dr Cathy Andronis, Chair of RACGP Specific Interests Psychological Medicine, told newsGP any new and effective therapy is welcome if it is safe, effective and evidence based.
 
‘There are some promising [psychedelic] studies but many more are needed to establish safety and efficacy, so we need to hasten slowly and carefully,’ she said.
 
‘It’s an important opportunity to get it right this time – previous rushed and poorly monitored psychedelic use in the 60s and 70s ended badly.
 
‘The experience with medicinal cannabis is a timely warning of how quickly prescribing and treating can get out of control, and the risks of misuse, addiction and poor monitoring are high, especially when safety is such a critical component of good psychedelic-assisted therapy management.’
 
Australia’s adoption of psychedelic treatments made headlines worldwide when it was announced in February this year, becoming the first country to do so.
 
Moving forward, AMAPP is pleading for an urgent meeting of stakeholders to develop ‘fairer and more progressive’ guidelines and regulations.
 
Dr Andronis said a strong, evidence-based approach that closely monitors and tailors treatments to individual patient’s needs is vital.
 
‘Only under these conditions will governments consider subsidising or providing affordable and/or public services to those who would benefit, but not have the capacity to pay,’ she said. 

‘[As a GP I] talk about the considerable risks as well as the potential, but still uncertain, benefits of treatment.
 
‘Point people towards reliable online sources of information that are evidence based – the potential is there but we need to get it right this time.’
 
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