Medsafe has given a New Zealand psychiatrist approval 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 approval is specific to this psychiatrist, so only they will be able to prescribe psilocybin. 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.
The psychiatrist is highly experienced in prescribing psilocybin to patients, and has already been doing this safely for some time in clinical trials.
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.
Any applications will be considered in the context of patient safety, and will take into account the prescriber's experience and skill level with managing these types of medicines.
Medsafe is aware other countries like Australia allow specified authorised prescribers to access products containing psilocybin for the treatment of treatment resistant depression.
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.
