Published: 2 May 2014

Consultations

Outcome of consultation on the planned changes to the prescribing restrictions for clozapine

About the consultation

In December 2013, Medsafe published a proposed change to the prescribing restrictions for clozapine on the Medsafe website, and sought feedback on the proposal by 3 March 2014.

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.

Consultation

Medsafe proposed 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 proposed that:

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

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

Consultation feedback

A total of seven submissions were received.  Overall, the submissions largely supported the proposed changes, and several suggested further amendments. Three submissions requested the wording to include all authorised prescribers including nurses, and one submission requested the incorporation of pharmacist prescribers. The submissions raised the following issues for consideration by Medsafe:

1. Further safeguarding should be required to ensure that prescribing occurs in accordance with best practice guidelines. Specifically, that initiation of patients on clozapine, after confirmation of a diagnosis of schizophrenia, should be undertaken only by medical practitioners who are certified as competent in psychiatry.
   
   Medsafe noted that as the medicines regulator, it is not responsible for ensuring prescribing occurs in accordance with best practice guidelines. Medsafe will forward the submitters concerns to the New Zealand Medical Association and the Medical Council of New Zealand.
2. Nurse practitioners should be able to prescribe clozapine as authorised prescribers.
3. The restrictions should be altered to encompass pharmacist prescribers in the near future.

Medsafe noted that the intent of the consultation was to focus on the continuation of clozapine supply under current conditions. Medsafe would welcome support for an additional consultation on authorised prescribers following the change in legislation as part of the Medicines Amendment Act later in in 2014. Interested parties should submit a proposal to Medsafe who will then progress the consultation.

Implementation

From 8 May 2014, the proposed changes will be implemented and it will be possible to prescribe clozapine 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 who 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

Enquiries

Any questions relating to this consultation should be directed via email to: askmedsafe@health.govt.nz