Guide VII-085

New Zealand psilocybin prescriber approval

Cameron Lacey2025New Zealand
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[source: …] where a claim comes from[uncertain] not confirmed in a primary source[synthesis] the writer's reconstruction

1. Introduction

Version followed: Medsafe, Guidelines for applications for approval to prescribe psychedelics, Version 1.0 (24 July 2025), issued under regulation 22 of the Misuse of Drugs Regulations 1977. For the clinical frame, this guide uses what has been published about the first approved prescriber's service (Professor Cameron Lacey, Christchurch) and his University of Otago feasibility trial of psilocybin with interpersonal and social rhythm psychotherapy (NCT05581797). That trial is the most detailed published New Zealand protocol. Status is given as of October 2026.

What it is. This is a regulated-access pathway, not a psychotherapy model. In June 2025 Medsafe approved a single psychiatrist to prescribe, supply and administer psilocybin outside a research setting to patients he had personally assessed and diagnosed with treatment-resistant depression (TRD). Associate Health Minister David Seymour announced the decision on 18 June 2025. It was the first time New Zealand had allowed medicinal psilocybin prescribing outside clinical trials. Seymour said: "If a doctor believes psilocybin can help, they should have the tools to try." On 24 July 2025 Medsafe published guidance and an application form so that other medical practitioners could apply. [source: 1News 18 Jun 2025; Drug Science 27 Jun 2025; Medsafe psychedelics page; Medsafe guideline v1.0]

  • Who approves. Media reports describe Medsafe as the approver. Drug Science calls the approval a Ministry of Health "licence". A secondary legal explainer says applications go to the Minister of Health, in practice through Medsafe. The phrase "ministerial approval" fits that last description, but the primary page that announced the approval is not drawn on here. [uncertain]
  • Exact date. 1News reported the approval on 18 June 2025. The secondary explainer dates it 19 June 2025. [uncertain]
  • Legal status (as of Oct 2026). Psilocybin is a Class A controlled drug in New Zealand. No psychedelic medicine has an approved product there, so the medicine remains unapproved. Supply and use outside an approval remain illegal. [source: Medsafe guideline v1.0; Mind Medicine Law explainer]
    • Each approval is personal to one practitioner. Every other clinician needs their own Medsafe approval. [source: Ministry of Health MDMA release, 4 Sep 2026]
    • By September 2026 New Zealand had two clinicians approved for psilocybin (TRD) and two for MDMA (PTSD). [source: Ministry of Health, 4 Sep 2026; 1News 30 Jun 2026]
    • Compared with Australia: since July 2023 Australia has let authorised psychiatrists prescribe psilocybin for TRD and MDMA for PTSD. [source: Drug Science 27 Jun 2025]

Core idea of how change happens, as the New Zealand team describes it. The drug experience is not treated as the therapy on its own. Psychotherapy prepares the person, gives them a framework for making sense of the experience, and helps them integrate it afterwards. The Otago team chose interpersonal psychotherapy (IPT), which looks at how relationships affect mood and how mood affects relationships. They added work to strengthen daily and circadian rhythms (the social-rhythm element), so that insights are turned into steadier mood, relationships and sleep-wake patterns. The team itself noted that the best psychotherapy to pair with psilocybin has not been established. [source: Newsroom (Otago team); Otago study page]

2. Framework

The pathway has two layers: what Medsafe requires of an approved prescriber, and the clinical course that patients go through.

What a prescriber must have before treating anyone [source: Medsafe guideline v1.0]

  • The practitioner. A medical practitioner registered with the Medical Council of New Zealand. They need a current practising certificate with an appropriate vocational scope and no conditions that affect the application. They must understand both the medicine and the psychotherapeutic process, with relevant training and experience. Medsafe expects, for example, prior prescribing in a research setting or collegial work in a relevant practice. So far every approval has gone to a psychiatrist. [source: Mind Medicine Law explainer; Ministry of Health 4 Sep 2026]
  • The product. Pharmaceutical grade only. Mushrooms and non-pharmaceutical extracts are excluded. The prescriber is responsible for sourcing the product and its quality, and every entity involved in import or manufacture must hold the licences it needs.
  • The treatment protocol. A defined protocol, maintained by the applicant, supported by clinical research and by independent scientific peer review. Treatment must be given and monitored in an appropriate supervised environment. The protocol must cover:
    • the indication
    • participant selection: screening, inclusion and exclusion criteria, and how a person is withdrawn
    • the consent process
    • concomitant medicines
    • the dosing-session structure and rescue medicines (a medical responsibility; not described here)
    • how efficacy will be judged, with outcome measures and follow-up
    • the supporting clinical therapists
  • Peer review and support. The prescriber must obtain peer review and have access to an appropriate support network.
  • Not covered in Medsafe's guideline. It does not set reporting, adverse-event, record-keeping or approval-duration rules. Media say prescriptions carry "strict reporting and record-keeping requirements" [source: 1News 18 Jun 2025], and the secondary explainer refers to ongoing reporting to Medsafe, including adverse events. The application form, which may contain more detail, is not drawn on here. [uncertain]

The clinical course: phases, goals and format

This course follows the Otago trial and press reports of the Christchurch service. Private-service details beyond these sources are not published. [uncertain]

  1. Referral.
    • Goal: identify people with depression that has not responded to standard treatment.
    • The Otago trial required referral by a GP or a specialist mental health service. [source: Newsroom] The secondary explainer says the private pathway also starts with a GP or psychiatrist referral and does not accept self-referral. [uncertain]
  2. Screening and psychiatric assessment.
    • Goal: confirm TRD and exclude people at high risk.
    • A consultant psychiatrist assesses each person. In the first months of the service about 40 people were referred, 15 were found suitable after strict screening, and 7 went ahead. [source: 1News 29 Oct 2025; Otago study page]
  3. Consent and medical preparation.
    • Goal: an informed decision, and medical readiness that the psychiatrist oversees.
    • In the Otago trial, participants agreed to stop psychotropic medicines before treatment under psychiatric oversight, and the psychiatrist liaised with their existing health providers. [source: Otago study page; Blossom NCT05581797]
  4. Preparation psychotherapy.
    • Goal: build the therapeutic relationship, set focus and expectations, and prepare the person for difficult material.
    • The Christchurch service gives "several weeks" of psychotherapy before the session day. [source: 1News 29 Oct 2025] The Otago trial used three IPT preparation sessions. [source: Blossom NCT05581797]
  5. Supervised session day.
    • Goal: a safe, supported experience.
    • The session takes place in a clinic. The patient is accompanied there and spends about five hours in a comfortable chair with a warm throw, an eye mask and headphones playing music. Two clinicians guide the session. [source: 1News 29 Oct 2025; Newsroom (two monitors throughout)] Each session day in the Otago trial was followed by a debriefing session. [source: Otago study page]
  6. Integration psychotherapy.
    • Goal: carry insights into daily life, especially mood management, social rhythms and a stable sleep-wake cycle.
    • The Christchurch service gives "several weeks" of integration psychotherapy. [source: 1News 29 Oct 2025; Newsroom] The Otago trial used five integration sessions. [source: Blossom NCT05581797]
  7. Follow-up and outcome review.
    • Goal: measure the effect and catch delayed problems.
    • Medsafe requires outcome measures and follow-up in the protocol. The Otago trial ran for ten weeks of active treatment with a follow-up at week 18. [source: Medsafe guideline v1.0; Otago study page] A patient of the private service was checked on about two weeks after treatment. [source: 1News 29 Oct 2025]

Format and cost. Treatment is individual, in a clinic, with a prescribing psychiatrist leading a team that includes therapists. Patients pay privately. 1News reported about NZ$20,000 per course in October 2025, mostly for clinician time in therapy. In June 2026 it reported "at least $9,000". [source: 1News 29 Oct 2025; 1News 30 Jun 2026] The two figures may describe different providers or packages. [uncertain]

Criteria for moving between phases. The sources publish eligibility criteria but no explicit progression rules. The following are inferred from the protocol elements. [synthesis]

  • From referral to assessment: the referral documents an adequate trial of standard treatments.
  • From assessment to preparation: inclusion criteria are met, no exclusion applies, and consent has been given.
  • From preparation to the session day:
    • the psychiatrist confirms medical and medication readiness
    • the person is stable after any medication changes, with no current high suicide risk
    • the person understands what may happen and has a safety and aftercare plan
    • the person and therapists agree that the person is ready
  • From the session day to integration: the debrief is complete, the person is psychologically settled and has someone to accompany them.
  • From integration to discharge: outcome measures are completed, the relapse and early-warning plan has been agreed, and care has been handed back to the referrer.

3. Guiding principles

  • Work only within the approval. An approval belongs to one named practitioner, is not transferable and covers a defined clinical purpose. Practical meaning: only an approved prescriber's team can provide this treatment. Anyone else can refer or support, but cannot provide it. [source: Medsafe psychedelics page; Ministry of Health 4 Sep 2026]
  • Pharmaceutical-grade medicine in a supervised clinical setting. Practical meaning: home use, take-home supply, mushrooms and retreats all fall outside the pathway. [source: Medsafe guideline v1.0; Ministry of Health 4 Sep 2026 (no take-home supply, MDMA programme)]
  • Careful selection. Only a limited number of people are expected to be suitable. Practical meaning: expect most referrals to be declined and prepare clients for that outcome. [source: 1News 29 Oct 2025; Ministry of Health 4 Sep 2026]
  • Set and setting are central to safety. Practical meaning: invest in psychological preparation and a calm, supportive environment. The Otago team says these reduce the likelihood of a "bad trip". [source: Newsroom]
  • Psychotherapy does three jobs. It prepares the person, gives a framework for interpretation, and supports integration. Practical meaning: the hours before and after the session day are the core clinical work. [source: Newsroom]
  • Expect difficult material. Lacey says the experience can raise "a whole range of challenging thoughts, emotions and memories". Practical meaning: rehearse responses to distress before the day and plan aftercare. [source: 1News 29 Oct 2025]
  • Two clinicians are present throughout. Practical meaning: nobody is left alone during the session, and the clinicians can share observation and support. [source: Newsroom; 1News 29 Oct 2025]
  • Psychiatric oversight and liaison. Practical meaning: a consultant psychiatrist oversees medicines and safety and keeps the client's other providers informed. Non-medical therapists never advise on medicines. [source: Otago study page]
  • The relational and rhythm focus (Otago model). Practical meaning: frame preparation and integration around relationships, mood, daily routine and sleep-wake stability, not only around the content of the experience. [source: Newsroom; Otago study page]
  • Peer review and a support network. Practical meaning: arrange external clinical and scientific review and colleague support, not solo practice. [source: Medsafe guideline v1.0]
  • Measure outcomes and follow up. Practical meaning: use standard depression measures before and after treatment and agree a follow-up point in advance. [source: Medsafe guideline v1.0]
  • Informed consent that covers uncertainty. Practical meaning: explain that the evidence is still emerging, that this is an unapproved medicine, that the cost is private, and what the alternatives are. [source: Ministry of Health 4 Sep 2026; 1News 30 Jun 2026] [synthesis for the specific content]
  • Cultural safety. At least one New Zealand clinician has raised concerns about commercialisation and about psilocybin as a medicine "taken away from Māori", arguing it should come back with sovereignty and care. Practical meaning: ask about cultural identity and meaning, offer whānau involvement and Māori health input, and do not appropriate tikanga. [source: 1News 30 Jun 2026] [synthesis for the practice points]
  • Outside the pathway the role is harm reduction, not facilitation. Practical meaning: a therapist outside the programme assesses, educates in general terms, plans for safety, refers and supports integration. They never help a client obtain or use an illegal substance. [synthesis, in line with legal status]

4. Intervention inventory

This section has two parts. Part A covers the components delivered inside an approved prescriber's service. Part B covers what a psychotherapist outside the programme does.

The New Zealand sources name these components but publish almost no in-session procedure. Steps marked [synthesis] are my own operational guidance, consistent with the published frame. Where IPT or social-rhythm techniques are described, the primary IPT and IPSRT manuals are not drawn on, so the techniques are given as general practice and are not attributed to their originators. [uncertain]

All medical tasks belong to the prescribing psychiatrist and medical staff and are not described technically here. These include medicine decisions, physiological monitoring, the dosing itself and rescue medicines. This guide contains no dosing or administration information.

Part A. Inside an approved service

A1. Referral intake and pre-screening

  • Purpose / when. At first contact, to check whether a referral could meet the protocol before using psychiatrist time. In the first months, most referrals were screened out: about 40 referred, 15 suitable. [source: 1News 29 Oct 2025]
  • Steps.
    1. Confirm the referral source. The Otago trial required a GP or specialist mental health service. [source: Newsroom]
    2. Collect the treatment history: antidepressant trials, their adequacy, and psychotherapy received. The Otago criterion was no improvement after two adequate antidepressant trials of different classes. [source: Blossom NCT05581797]
    3. Run a brief pre-screen against the exclusion list in A2, then explain the remaining steps, the private cost and the likelihood of not being accepted. [synthesis]
  • Example language (illustrative). "Before anything else, I need to check whether this treatment could be safe and suitable for you. Many people who are referred turn out not to be eligible, and that says nothing about how serious their depression is."
  • Watch for.
    • Referrals that underestimate the client's psychosis, bipolar or substance history.
    • Clients who learned about the treatment from the media and treat acceptance as their last hope. Assess suicide risk at intake. [synthesis]

A2. Psychiatric eligibility and medical screening

  • Purpose / when. Before acceptance, to confirm the diagnosis and exclude higher-risk people. A consultant psychiatrist carries this out. [source: Otago study page]
  • Published Otago trial criteria, paraphrased [source: Blossom NCT05581797]
    • Inclusion:
      • adults aged 21 to 75, able to give written consent
      • a current major depressive episode that has not responded to two adequate antidepressant trials
      • a baseline depression score above a moderate threshold on a standard clinician-rated scale
      • assessed as low suicide risk and medically stable
      • willing to stop psychoactive medicines and to follow substance-avoidance rules
      • limited previous hallucinogen use
      • pregnancy testing and contraception where relevant
    • Exclusion:
      • pregnancy or breastfeeding
      • significant cardiovascular disease or an ECG abnormality (prolonged QTc)
      • epilepsy and some cases of diabetes
      • regular use of centrally acting serotonergic drugs
      • a personal history of psychotic disorder or bipolar I or II disorder, or one in a first- or second-degree relative
      • moderate or severe substance use disorder in the past year
      • a medically significant suicide attempt
      • no response to ECT in the current episode
      • not fluent in English
    • Medical checks included ECG, laboratory tests, and urine drug and pregnancy tests.
    • Media and the secondary explainer also cite personal or family history of psychosis as a contraindication for the private service. [source: 1News 30 Jun 2026; Mind Medicine Law explainer]
    • The private service's full criteria are not published. [uncertain]
  • Steps for the therapist on the team [synthesis]
    1. Take a structured history of psychosis, mania or hypomania (including family history), trauma, dissociation, substance use and suicidal behaviour.
    2. Note psychosocial readiness: a stable home, a support person, the ability to take time off.
    3. Pass everything to the psychiatrist, who makes the eligibility decision.
  • Example language (illustrative). "I'll ask about your family's mental health too, including any relatives who had psychosis or bipolar disorder. That affects whether this treatment is safe for you."
  • Watch for.
    • Family history the client does not know or plays down.
    • Undisclosed cannabis or other substance use.
    • Pressure to bend the criteria. [synthesis]

A3. Informed consent

  • Purpose / when. After eligibility is confirmed and before preparation begins. Medsafe requires a defined consent process. [source: Medsafe guideline v1.0]
  • Steps [synthesis for the content, beyond the Medsafe requirement]
    1. Explain that the medicine is unapproved and that this is not a funded or standard treatment. [source: 1News 18 Jun 2025; Ministry of Health 4 Sep 2026]
    2. Describe the whole course: preparation, the supervised session day, debrief, integration and follow-up.
    3. Describe what the session day may involve: intense emotion and challenging memories, about five hours in clinic, two clinicians present, an eye mask and music. [source: 1News 29 Oct 2025]
    4. Explain what medicine changes are needed (the psychiatrist leads this), the substance-avoidance rules, the need to be accompanied, and the right to withdraw at any point.
    5. Explain the service's policy on physical contact. None is published, so the service must define its own. [uncertain]
    6. Give the cost, and ask the client to explain the plan back in their own words.
  • Example language (illustrative). "You can stop at any stage, including on the day. Can you tell me in your own words what you expect the day to be like and what might be hard?"
  • Watch for.
    • Consent driven by desperation.
    • Unrealistic expectations of a cure.
    • Agreement without understanding. Revisit consent before the session day. [synthesis]

A4. Medication transition and liaison (therapist's supporting role)

  • Purpose / when. During preparation. The Otago protocol required psychotropic medicines to be stopped under psychiatric oversight, with liaison with the client's existing providers. [source: Otago study page]
  • Steps [synthesis]
    1. The therapist does not advise on medicines.
    2. Agree with the psychiatrist how often mood and risk will be checked during the transition.
    3. Teach the client and their support person the early-warning signs of relapse and the plan to contact the psychiatrist.
  • Example language (illustrative). "Any changes to your medicines are between you and the psychiatrist. My job is to keep an eye on how you're coping while that happens."
  • Watch for.
    • Low mood, insomnia, agitation or suicidal thinking getting worse. Escalate to the psychiatrist the same day. [synthesis]

A5. Preparation psychotherapy: interpersonal focus

  • Purpose / when. The preparation sessions. The Christchurch service gives several weeks; the Otago trial used three IPT sessions. The work builds the relationship, gives a framework for interpreting the experience, and sets a relational focus for integration. [source: Newsroom; Blossom NCT05581797; 1News 29 Oct 2025]
  • Steps [synthesis; follows general IPT practice]
    1. Draw a timeline linking the onset and course of the depression to relationship events: losses, conflicts, role changes, isolation.
    2. Agree one or two interpersonal focus areas.
    3. Map the client's important relationships and their support people.
    4. Explore the client's hopes and fears about the session day, and normalise difficult emotions arising.
    5. Agree a simple stance for difficult moments, such as staying with and moving towards the experience. This is general psychedelic-therapy practice, not a published New Zealand instruction.
    6. Practise grounding with the client: breathing, and noticing the support of the chair.
    7. Agree signals the client can use with the therapists during the session.
  • Example language (illustrative). "Your low periods seem to follow changes in your closest relationships. Let's keep that thread in mind, so we have somewhere to bring whatever comes up on the day."
  • Watch for.
    • A therapeutic alliance that is not strong enough by the end of preparation. Do not proceed until it is.
    • High anticipatory anxiety or rigid expectations. Address these before the session day. [synthesis]

A6. Social-rhythm and sleep-wake stabilisation

  • Purpose / when. In preparation and integration. The Otago model adds work to strengthen circadian rhythms, and its integration work aims to manage mood and social rhythms and stabilise sleep and waking. [source: Otago study page; Newsroom]
  • Steps [synthesis; specific techniques not described in the sources]
    1. Ask the client to track the daily timing of waking, first contact with another person, meals, activity and going to bed.
    2. Link irregular days to mood.
    3. Choose one or two anchors to make regular, such as a fixed waking time.
    4. Plan a protected and predictable routine for the days around the session day.
  • Example language (illustrative). "Keeping your days steady helps your mood stay steady. Let's choose one anchor, perhaps your waking time, and hold it through treatment."
  • Watch for.
    • Rhythms that get worse after the session day, or reduced need for sleep. Reduced sleep need can signal emerging hypomania and should go to the psychiatrist. [synthesis]

A7. Session-day orientation and set-and-setting planning

  • Purpose / when. At the last preparation session and on arrival. The Otago team calls set and setting key to safety. [source: Newsroom]
  • Setting as published. A clinical room, a comfortable chair, a warm throw, an eye mask, headphones with music, and two clinicians. The patient is accompanied to and from the clinic. [source: 1News 29 Oct 2025]
  • Steps [synthesis]
    1. Show the client the room in advance if possible.
    2. Confirm their support person, their transport and the plan for the evening.
    3. Revisit the intention set in preparation, the agreed signals and the right to remove the eye mask or talk at any time.
    4. Confirm the client agrees to the agreed policy on physical contact.
  • Example language (illustrative). "We'll both be here the whole time. You can lift the eye mask or talk to us whenever you want to."
  • Watch for.
    • Last-minute fear or ambivalence. The client can postpone, and this should be offered without pressure. [synthesis]

A8. In-session support by the two-clinician team

  • Purpose / when. Throughout the session, which lasts about five hours. Two clinicians guide or monitor and are present the whole time. [source: 1News 29 Oct 2025; Newsroom] Physiological monitoring and any medical intervention belong to the medical staff. [source: Medsafe guideline v1.0 (supervised environment)]
  • What is published. Music is a key element, and a change in the music shifted one patient's experience towards sorrow and anger. [source: 1News 29 Oct 2025]
  • Steps [synthesis]
    1. Keep the presence calm and mostly non-directive, and keep talk to a minimum unless the client starts a conversation.
    2. Check in briefly at intervals.
    3. One clinician should always be attending to the client, including during breaks.
    4. Record observations of the client's state and anything they say.
    5. Any touch follows the policy agreed in advance and the client's consent at the time. The New Zealand touch policy is not published. [uncertain]
  • Example language (illustrative). "We're right here. Whatever is happening, let it come, and breathe with it."
  • Watch for.
    • Escalating panic.
    • Confusion about where they are.
    • Attempts to leave.
    • Physical distress. Bring in the medical staff.
    • Disclosures that need follow-up in the debrief. [synthesis]

A9. Responding to distress during the session

  • Purpose / when. When the client shows fear, grief, anger or bodily distress. Lacey describes challenging thoughts, emotions and memories as an expected part of the experience. [source: 1News 29 Oct 2025]
  • Steps [synthesis]
    1. Name the distress and normalise it.
    2. Remind the client of the stance agreed in preparation.
    3. Offer grounding: the breath, the feet, the chair, the clinician's voice.
    4. Offer to remove the eye mask or pause the music.
    5. Do not interpret the content.
    6. If distress keeps escalating or there are medical concerns, the medical staff assess the client under the protocol's rescue provisions. [source: Medsafe guideline v1.0 (rescue medications element)]
  • Example language (illustrative). "This is hard, and you're safe. You don't have to work it out right now. Just feel your back against the chair."
  • Watch for.
    • Distress settling into emotional release, a sign the approach is working. Contrast this with growing confusion or agitation, which calls for medical review. [synthesis]

A10. Post-session debrief

  • Purpose / when. After each session day. The Otago trial included debriefing sessions. [source: Otago study page]
  • Steps [synthesis]
    1. Before discharge, check the client is oriented and settled, and hand them over to their support person.
    2. At the debrief, invite an open account of the experience, then note the main emotions, images and relational themes.
    3. Check sleep, mood and risk.
    4. Agree contact arrangements for the next few days.
  • Example language (illustrative). "Tell me about it in whatever order it comes. We don't need to make sense of it yet."
  • Watch for.
    • Confusion that persists, fear, perceptual changes or suicidal thinking. Escalate to the psychiatrist. [synthesis]

A11. Integration psychotherapy

  • Purpose / when. Over the weeks after the session day. The Christchurch service gives several weeks; the Otago trial used five sessions. The aim is to apply insights to daily life, especially mood and social rhythms. [source: 1News 29 Oct 2025; Newsroom; Blossom NCT05581797]
  • Steps [synthesis; IPT-informed]
    1. Link material from the experience to the interpersonal focus areas.
    2. Turn insights into concrete relational actions, such as a conversation that has been avoided or a reconnection.
    3. Review the social-rhythm anchors (A6).
    4. Track mood each session.
    5. Towards the end, build a relapse-prevention and early-warning plan with the client, and share it with the referrer.
  • Example language (illustrative). "You said you felt your father's absence very strongly. What, if anything, do you want to do differently in your relationships now?"
  • Watch for.
    • Improvement that shows up in behaviour, not only in insight.
    • Taking on grand new meanings, or a fall in mood after an initial lift. Assess and liaise with the psychiatrist. [synthesis]

A12. Outcome measurement and follow-up

  • Purpose / when. At baseline, during treatment and at follow-up. Medsafe requires efficacy assessment, outcome measures and follow-up. The Otago trial followed up at week 18. [source: Medsafe guideline v1.0; Otago study page]
  • Steps [synthesis]
    1. Use a validated clinician-rated and a self-rated depression measure, plus risk screening, at fixed points.
    2. Give results to the prescriber for regulatory records and peer review.
    3. Schedule follow-up before discharge.
  • Example language (illustrative). "We'll repeat these questionnaires in a few months, so we can both see whether the change is holding."
  • Watch for.
    • Clients who drop out of follow-up. Gather data actively; Seymour has said private-provider data could inform funding decisions. [source: 1News 30 Jun 2026]

A13. Adverse-event recognition, escalation and reporting

  • Purpose / when. At every phase. Media report strict reporting and record-keeping duties attached to prescriptions. [source: 1News 18 Jun 2025] The secondary explainer says prescribers report adverse events to Medsafe. [source: Mind Medicine Law explainer] The detailed rules were not found in a primary source. [uncertain]
  • Steps [synthesis]
    1. Define in advance what the team will record as an adverse event, including psychological events: prolonged anxiety, perceptual disturbance, mood elevation, suicidality and deterioration.
    2. Escalate any event to the prescriber at once.
    3. Document each event, and support the prescriber in reporting it to Medsafe as the approval requires.
  • Example language (illustrative). "If anything feels wrong in the days after, even something small, please tell us. We'd rather hear about it than not."
  • Watch for.
    • Delayed effects that appear days or weeks later. Keep contact open throughout follow-up. [synthesis]

Part B. Psychotherapists outside the programme

B1. Discussing and making a referral

  • Purpose / when. A client with long-standing depression asks about psilocybin therapy.
  • Steps [synthesis, based on the published pathway]
    1. Explain the legal position and how the pathway works:
      • Only individually approved prescribers can provide the treatment. As of September 2026 there were two in New Zealand. [source: Ministry of Health 4 Sep 2026]
      • Treatment is private and costly. [source: 1News 29 Oct 2025; 1News 30 Jun 2026]
      • Most people referred are not accepted. [source: 1News 29 Oct 2025]
    2. Pre-screen roughly against the published exclusions (A2): psychosis or bipolar disorder in the client or their family, serious heart disease, epilepsy, pregnancy, a recent substance use disorder, a serious suicide attempt.
    3. Send the request through the client's GP or psychiatrist, with a summary of the treatment history and your psychotherapy formulation. Do not encourage self-referral. [source: Newsroom (GP or specialist referral, Otago trial)]
  • Example language (illustrative). "It's legal now, but only through a very small number of approved psychiatrists, and they accept only some of the people referred. If you want to try, I can write to your GP with a summary."
  • Watch for. If the client is turned down, frame it as a decision about safety and suitability, not about them as a person. Have alternative evidence-based options ready. [synthesis]

B2. Ongoing therapy while a client goes through the programme

  • Purpose / when. A current client is accepted. The Otago model has the psychiatrist liaise with the client's existing providers. [source: Otago study page]
  • Steps [synthesis]
    1. With the client's consent, agree roles with the treating team. Usually the outside therapist pauses or eases off trauma-focused work during the programme, so there are not two competing frames.
    2. Share relevant risk history.
    3. Leave all medication matters to the psychiatrist.
    4. Agree who is the first point of contact during and after the session day.
    5. After the programme, take over integration and relapse-prevention work with the team's handover.
  • Example language (illustrative). "While you're with the psilocybin team, they'll lead the preparation and integration. I'll stay in the background, and we'll pick our work back up once they hand you back."
  • Watch for. Splitting between providers, and the client not telling one provider what the other has said. [synthesis]

B3. Harm-reduction assessment for psilocybin use outside the legal pathway

  • Purpose / when. A client says they intend to use psilocybin, or have used it, outside an approval: mushrooms, overseas retreats or unregulated "therapists". This remains illegal in New Zealand outside an approval. [source: Mind Medicine Law explainer; Medsafe guideline v1.0 (mushrooms excluded)] Your role is assessment, safety planning, general education, referral and integration. You must never help the client obtain or use the substance. [synthesis]
  • Steps [synthesis]
    1. Take a non-judgemental history: what the client intends, why, and in what setting.
    2. Screen for the risk factors the regulated programmes exclude: personal or family history of psychosis or bipolar disorder, current suicidality, cardiovascular problems, pregnancy, substance use disorder.
    3. Explain in general terms why these matter. A psychiatrist on the New Zealand training course reported seeing complex psychosis linked to psilocybin use. [source: 1News 30 Jun 2026]
    4. Tell the client that psilocybin can interact with psychiatric and other medicines, and that they must not change or stop any medicine without speaking to their prescriber. Do not give advice on combinations or timing.
    5. Note that unregulated settings usually lack medical screening, a two-person team and aftercare.
    6. Make a safety plan: who to contact, crisis services, and when to seek emergency care.
    7. Record the conversation, and consider your duty to share information if the risk becomes serious.
  • Example language (illustrative). "I'm not going to help you get hold of it or tell you how to use it, but I do want to keep you safe. Can we go through what would make this risky for you in particular?"
  • Watch for.
    • High-risk features. Strongly advise against use and involve their GP or psychiatrist.
    • Coercive or exploitative group settings. [synthesis]

B4. Integration support after an experience outside the pathway

  • Purpose / when. A client brings material from a past psychedelic experience, legal or otherwise.
  • Steps [synthesis]
    1. Assess the current mental state: perceptual changes, persistent anxiety, depersonalisation, mood elevation, suicidality. Refer to a psychiatrist for anything psychotic-like.
    2. Help the client tell the story of the experience without judgement.
    3. Separate felt meaning from factual claims.
    4. Link themes to current relationships and routine, using the same interpersonal and social-rhythm frame as A11.
    5. Do not encourage repeat use.
  • Example language (illustrative). "Let's take what felt important in it and see what it might mean for how you're living now."
  • Watch for. Symptoms that persist or get worse after the experience. Arrange psychiatric assessment. [synthesis]

5. Handling problems

New Zealand sources say almost nothing about problems during treatment. The responses below are my own synthesis unless a source is given. [synthesis]

  • Client not accepted, or excluded after assessment.
    • Expect grief, anger and higher risk at the moment hope is lost.
    • Do a risk review, offer a debrief, return to the referrer with alternatives, and make clear the decision was about safety. [synthesis; high screen-out rate per 1News 29 Oct 2025]
  • Mood falls or risk rises during the medication transition.
    • Increase contact and escalate to the psychiatrist the same day.
    • Postponing treatment is a legitimate outcome.
    • Never suggest changes to medicines yourself. [synthesis; psychiatric oversight per Otago study page]
  • Suicidal ideation at any phase.
    • Use standard structured risk assessment and safety planning, including lethal-means counselling (safe storage and removal of means). Inform the prescriber.
    • The Otago trial excluded high suicide risk and medically significant attempts, so new high risk means the session day is postponed until the psychiatrist reviews. [source: Blossom NCT05581797; synthesis for the response]
  • Anticipatory anxiety or ambivalence before the session day.
    • Spend more time on preparation, rehearse grounding, and visit the room.
    • Allow postponement with no penalty, and re-confirm consent. [synthesis]
  • Overwhelm during the session. Follow A9. If agitation, confusion or physical distress continue, the medical staff assess under the protocol's rescue provisions; the therapist does not act medically. [source: Medsafe guideline v1.0 (rescue medications in protocol); synthesis]
  • Resistance or "nothing happened".
    • Validate the disappointment.
    • Explore subtle shifts and any defensive control during the session.
    • Keep the integration focus on interpersonal and rhythm goals, which do not depend on how dramatic the experience was.
    • The prescriber decides on any further session days under the protocol. [synthesis]
  • Destabilisation after the session.
    • Look for persistent anxiety, perceptual changes, mood elevation, reduced need for sleep, paranoia or new suicidality.
    • Assess urgently, involve the psychiatrist, record it as an adverse event and support reporting to Medsafe. [synthesis; reporting duties per 1News 18 Jun 2025 and Mind Medicine Law explainer, uncertain]
  • Non-adherence.
    • This includes substance use or psychotropic medicine use against the protocol, missed preparation sessions, or turning up unaccompanied.
    • Explore the reason without blame. The safety rules are protocol conditions (Otago inclusion criteria), so the psychiatrist decides whether to postpone or withdraw the client. [source: Blossom NCT05581797; synthesis]
  • Ruptures with the team.
    • Common triggers are a sense of being controlled by the rules, disappointment with the experience, or feeling exposed after strong emotion in front of two clinicians.
    • Name the rupture, repair it openly, and offer a different team member for debrief where possible. [synthesis]
  • Disclosures in session.
    • Trauma memories or abuse disclosures can surface during the session.
    • Note them without interpreting. Follow up in the debrief with safeguarding duties in mind, and avoid suggestive questioning that could shape memory. [synthesis]
  • Boundary and touch issues.
    • No New Zealand touch policy is published. [uncertain]
    • Adopt a written policy agreed before the session day, two clinicians in the room at all times, documentation, and no touch without prior and in-the-moment consent. [synthesis]
  • Inflated expectations and media hype. Use consent and preparation to correct beliefs about cures. Note that evidence is still emerging, the medicine is unapproved, and attitudes among clinicians are "slowly changing". [source: 1News 30 Jun 2026; Ministry of Health 4 Sep 2026]
  • Cost barriers and inequity.
    • Treatment is privately funded at several thousand to around NZ$20,000. [source: 1News 29 Oct 2025; 1News 30 Jun 2026]
    • Discuss the financial strain openly.
    • Watch for clients turning to illegal routes because of cost, and respond as in B3. [synthesis]
  • A client plans to use an illegal or overseas retreat route. Respond as in B3: harm-reduction assessment, general risk education, a safety plan and integration support. Never facilitate. [synthesis]
  • Cultural safety for Māori clients.
    • Concerns have been raised about commercialisation and Māori sovereignty. [source: 1News 30 Jun 2026]
    • Offer whānau involvement and access to Māori health practitioners, ask what the experience means within the client's own worldview, and do not take on or perform tikanga or ceremony. Those decisions rest with the relevant iwi and Māori practitioners. [synthesis]
  • Language barrier. The Otago trial excluded people who were not fluent in English. Services should decide in advance whether they will use interpreters and how. [source: Blossom NCT05581797; synthesis]
  • Practitioner isolation.
    • Medsafe requires peer review and a support network.
    • Use regular supervision and case review, especially after difficult sessions. [source: Medsafe guideline v1.0; synthesis]

Sources

Sources

Further reading (not drawn on) [uncertain]

  • Medsafe application form for approval to prescribe psychedelics.
  • Ministry of Health release "New Zealand psychiatrist granted approval to prescribe psilocybin".
  • ClinicalTrials.gov record NCT05581797 (the Blossom mirror is cited instead).
  • The primary IPT and IPSRT treatment manuals are not drawn on, so the IPT and social-rhythm steps above are marked [synthesis].

Legislation referred to

  • Misuse of Drugs Act 1975 (NZ); Misuse of Drugs Regulations 1977, regulation 22. These are cited through Medsafe and the explainer; the legislation text itself is not drawn on here.