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Medsafe, New Zealand's regulator of medicines and medical devices, has given approval for psychiatrists to prescribe medicinal psilocybin for treating treatment-resistant depression.
This is the first time psilocybin will be prescribed outside of a research setting in New Zealand, and will give people with this severe condition more options.
The psychiatrist can prescribe, supply and administer medicinal psilocybin to any patient they have assessed and diagnosed with treatment-resistant depression.
There are a number of safeguards in place to ensure psilocybin is prescribed appropriately. The psychiatrist will need to follow a defined process, which includes carrying out detailed clinical assessments and considering any potential history of medicine misuse.
There will also be requirements around recording-keeping and reporting to Medsafe. This ensures Medsafe can take action quickly if the need arises.
There are no approved products containing psilocybin in New Zealand, so it has not been assessed for its safety and effectiveness by Medsafe. This also means that no other clinician can prescribe psilocybin, at this stage.
Other clinicians who want to manage this work will need to request approval from Medsafe separately. There is work underway to make it easier for more healthcare practitioners to take on this work. Medsafe is currently developing guidance to assist with the application process.
Psilocybin is a Class A controlled drug in New Zealand, meaning its supply and use is restricted. Sometimes, pharmaceutical grade versions of Class A drugs are used in medical settings, but there are significantly higher controls around their use.
