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Consultation Documents

Outcome of the consultation on the proposal to widen prescriber access to clozapine

7 May 2010

Executive summary

A total of 37 submissions were received regarding the consultation on the proposal to widen prescriber access to clozapine:

• 49% of the submitters supported the proposed prescribing conditions
• 40% of the submitters supported the proposed prescribing conditions in principle and recommended further work before the proposal was taken forward
• 11% of the submitters opposed the proposal.

As a result of the consultation Medsafe will revise the prescribing conditions for clozapine to:

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
• 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 who is considered stable in collaboration, or following consultation, with a Community Mental Health Team.

2. Persons prescribing the medicine must comply with appropriate local treatment guidelines.

Further detail on the outcome of the consultation is available in the following report on the analysis of submissions.

Submissions

A total of 34 submissions were received by the deadline of Friday 26 March 2010. Three submissions were received after the deadline but were taken into account in the analysis. The submitters included general practitioners, representatives from the medical profession, the organisation representing general practitioners in New Zealand, representatives of community mental health services, representatives and groups within the field of psychiatry, pharmacists and their representative organisations in New Zealand.

Overall, eighteen (49%) of the submitters supported the proposed prescribing conditions. Fifteen (40%) of the submitters supported the proposed prescribing conditions in principle and recommended further work before the proposal was taken forward. Four (11%) of the submitters opposed the proposal.

Analysis of the submissions received

The most common themes from the submitters who supported the proposed prescribing conditions were:

• The proposed change was supported and long overdue.
   
• A general practitioner continuing the prescribing of clozapine was more appropriate.
   
• It will benefit patients by removing the barrier to discharge and allowing them to resume life within the community.

The most common themes from the submitters who supported the proposed prescribing conditions in principle were:

• The revised conditions should refer to vocationally registered general practitioners.

Medsafe comment - Medsafe will include 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 within the revised conditions.

• General practitioners would have to set up effective monitoring of patients.

Medsafe comment - All prescribers of clozapine should follow the datasheet recommendations with regard to the monitoring requirements for clozapine.

• General practitioners should only continue the prescribing of clozapine for patients who are considered stable.

Medsafe comment - Medsafe supports the submissions that general practitioners should continue the prescribing of clozapine only for patients who are considered stable and will include this within the revised conditions.

• General practitioners would need to be educated about clozapine and receive training.

Medsafe comment - Medsafe strongly agrees with the importance of training and education. Education and training are implicit within good medical practice and are promoted by the Medical Council and medical colleges.

• Good communication channels need to be set up between general practitioners and the Community Mental Health Team.

Medsafe comment - Medsafe supports the suggestions within the submissions that good communication channels need to be set up between general practitioners and the Community Mental Health Team. As stated within the proposed conditions, the general practitioner must be continuing the prescribing of clozapine for a specific patient in collaboration, or following consultation, with a Community Mental Health Team.

• A clear protocol for referral back to the community Mental Health Team from the general practitioner should be established

Medsafe comment -Medsafe supports the suggestions within the submissions of a clear protocol for referral back to the Community Mental Health Team. As stated within the proposed conditions, the general practitioner must be continuing the prescribing of clozapine for a specific patient in collaboration, or following consultation, with a Community Mental Health Team.

• General practitioner prescribing needs to be free for all clozapine patients.

Medsafe comment - The cost of general practitioner appointments and prescribing fees are outside of Medsafe's remit.

The most common themes from the submitters who opposed the proposed prescribing conditions in principle were:

• A significant burden would be placed on pharmacists, the patient group and the prescriber in primary care.
   
• The general practitioner systems are not robust enough.

Medsafe comment - Medsafe acknowledges that some submitters feel that a significant burden would be placed on others with the change of prescribing conditions, and those that believe the general practitioner systems are not robust enough. However, Medsafe believes that general practitioners are best placed to make the decision regarding the robustness of their prescribing and monitoring systems and whether it is appropriate for them to prescribe clozapine for a patient who is stable on the medication.

Conclusion and Recommendations

Medsafe will progress the proposal to revise the prescribing conditions for clozapine.

The following condition in the proposal:

• General practitioners continuing the prescribing of clozapine for a specific patient in collaboration or following consultation with a Community Mental Health Team.

Will be revised to:

• Registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are registered with the New Zealand Medical Council within the vocational scope of practice of general practice. The general practitioner must be continuing the prescribing of clozapine for a specific patient who is considered stable in collaboration, or following consultation, with a Community Mental Health Team.