Clozapine: Proposed changes to blood monitoring and prescribing requirements - consultation questions for healthcare professionals

Overview

This Medsafe consultation seeks your feedback on proposed changes to the blood monitoring and prescribing requirements for clozapine. We are running this consultation on behalf of the companies that distribute clozapine-containing medicines in New Zealand.

Clozapine is an antipsychotic medicine used in treatment-resistant schizophrenia. To increase the safety of people taking clozapine, there are restrictions on use of the medicine in New Zealand. In some people, clozapine can cause neutropenia (a reduction in neutrophils, a type of white blood cell), increasing the risk of severe infections. Currently, patients taking clozapine must have regular blood tests throughout treatment to check for neutropenia.

Medsafe has been reviewing the clozapine blood monitoring requirements and we have identified several opportunities to optimise them.

With the expanded roles of some healthcare professions, we are also seeking your feedback on who should initiate clozapine treatment and which prescribers can continue clozapine treatment.

We have sought initial expert advice on these proposals from representatives from the Ministry of Health, Te Whatu Ora, The Royal Australian & New Zealand College of Psychiatrists and the pharmaceutical companies marketing these medicines.

We propose four major changes to the clozapine blood monitoring requirements:

1. Duration of blood monitoring
2. Monitoring thresholds
3. Management of low blood count results (‘red’ results)
4. Who can prescribe clozapine.

We are also seeking feedback about Point-of-Care testing and educational needs for healthcare professionals.

The Related section below contains background information for this consultation. The Evidence review summarises the evidence we used to inform the proposed changes to clozapine blood monitoring requirements. The paper we presented to the Medicines Adverse Reactions Committee (MARC) is more in-depth analysis of the evidence.

Who can take part?

We are seeking feedback from New Zealand-based healthcare professionals for this consultation. There is a separate consultation for consumers here.

To assist in the analysis of submissions, Medsafe will only accept submissions made through this consultation website. However, we have attached the consultation document below as a PDF, and you can view it online, download it and/or print it.

Other information

If you have any questions or requests about your response, please contact us at medsafeadrquery@health.govt.nz