ATTN: System Maintenance
The Login to Registry section and the Interactive Demo section of the Apo-Clozapine Risk Management Program website will be offline for a system upgrade from Thursday May 23 at 5 PM ET to Monday May 26th at 10 AM ET. We apologize for the inconvenience.


What is the Apo-Clozapine Risk Management Program?
Health Canada mandates that any distributor of clozapine must have a patient monitoring system to ensure the optimal safety of all patients using the drug. This monitoring system must be able to register patients and their respective physicians, pharmacists and laboratories, as well as monitor for adverse effects of the drug, including neutropenia and agranulocytosis. The Apo-Clozapine Risk Management Program was created to meet Health Canada’s requirements. It is a national patient registry for patients who are using Apo-Clozapine.

Goals of the Program
The Apo-Clozapine Risk Management Program’s job is to ensure that if a patient does develop agranulocytosis, that they are quickly identified and proper action is taken. Additionally, the program works to prevent patients, who previously had clozapine-induced agranulocytosis, from re-initiating the use of clozapine.



*Clozapine Registry Requirements

 

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Registry Forms

How It Works
When a patient is initiated on Apo-Clozapine therapy, his/her physician will complete a registration form. This form contains information about the patient, the physician, the pharmacist, and the laboratory. This form will be forwarded to the Apo-Clozapine Risk Management Program. Members of the program will then contact all suppliers of the drug to ensure that on no prior occasion, had the patient been designated with a non-rechallengable status by any other supplier. If everything is okay, the patient can begin using Apo-Clozapine therapy.

If the patient is new to the drug, he or she will begin weekly blood testing to ensure that safety is maintained. After the patient has been on the drug for a 26 week period, he/she can then move to biweekly testing. Biweekly testing must continue as long as the patient is using the drug.

Each time a blood test is completed, the physician will ensure that the results are sent to the Apo-Clozapine Risk Management Program. Once received, the monitoring program will check the results to ensure that the patient is not at risk for agranulocytosis. In the case that agranulocytosis, or risk of agranulocytosis, is detected, the patient’s physician and pharmacist will be notified within 24 hours of receipt by the monitoring program. At this point, the physician will decide if it is in the patient’s best interest to be permanently withdrawn from clozapine therapy.

If the physician, pharmacist or laboratory has any questions or concerns, they can contact the Apo-Clozapine Risk Management Program and speak to one of the program’s representatives.