Published: 16 December 2013

Consultations

Changes to the prescribing restrictions for clozapine

To:
Healthcare Practitioners

Background

Clozapine is an atypical antipsychotic used in the treatment of schizophrenia in patients intolerant of or unresponsive to ≥ two classic antipsychotics.

Clozapine is a prescription medicine approved under section 23 of the Medicines Act 1981. The following conditions regarding prescriber access to this medicine apply. Please note that other conditions exist regarding the dispensing and sale of clozapine which are unaffected by this proposal.

Medsafe received an enquiry from a Consultant Psychiatrist pointing out that the current prescribing restrictions do not allow house surgeons to prescribe clozapine to patients on discharge. Medsafe understands that this change is necessary to ensure patients are prescribed correct medication when discharged from hospital care, and that this change also supports the transition between hospital and primary care.

Current prescribing restrictions

Clozapine can currently be prescribed subject to the following restrictions:

1. The medicine may only be prescribed by:
   • registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry
   • medical practitioners employed as registrars in the branch of psychiatry who are under the supervision of the persons referred to above
   • Medical officers of special scale who work solely in the field of psychiatry, are in the employment of a district health board, and are under the supervision of persons who are registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry.
   • registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are registered with the Medical Council of New Zealand within the vocational scope of practice of general practice. The general practitioner must be continuing the prescribing of clozapine for a specific patient whose illness is well-controlled in collaboration, or following consultation, with a Community Mental Health Team.
2. Persons prescribing the medicine must comply with appropriate local treatment guidelines.
3. The medicine must be dispensed in accordance with appropriate local dispensing guidelines.
4. Sale or marketing of this medicine may only occur if:
   • the sponsor has an appropriate blood monitoring and patient record database in place
   • the sponsor creates or participates in a central "red flag" database identifying patients who have previously been prescribed clozapine and who developed adverse drug reactions, which mean further use is contraindicated.

Proposed change to prescribing restrictions

Medsafe proposes that the restrictions be amended to allow all registered doctors employed by district health boards to prescribe clozapine, if under the supervision of a psychiatrist.

Medsafe proposes that:

• the statement "Medical officers of special scale" be changed to "Medical officers"
• the statement "work solely in the field of psychiatry" be removed.

Benefits

This proposed amendment will allow house surgeons to prescribe clozapine to patients upon discharge.

Next steps

The target implementation date for the changes described above is 3 March 2014.

Medsafe welcomes feedback on the proposed prescribing conditions of clozapine. Queries about, or comments on, the proposed changes described above should be sent to:
Laurence Holding
Medsafe
PO Box 5013
WELLINGTON

Email: askmedsafe@health.govt.nz

by Monday 3 March 2014.

Comment on the feedback received and any resulting adjustments to the new requirements will be provided through the Medsafe website (www.medsafe.govt.nz).

Yours sincerely,
Sarah Reader
Manager Product Regulation