The Teva Clozapine Patient Registry is the national patient registry for patients taking Teva Clozapine. The Registry is a systematic active post-marketing surveillance program mandated by the Food and Drug Administration ("FDA"). Under this mandate, Teva is required to register patients, physicians and pharmacies, collect and monitor WBC counts and ANC values(lab reports) and process adverse events.
The primary goals of the Teva Clozapine Patient Registry are to:
- prevent clozapine rechallenge in patients with a history of clozapine induced agranulocytosis.
- detect leukopenia or granulocytopenia based on WBC counts and ANC values.
Patients must be registered with the Teva Clozapine Patient Registry prior to dispensing Teva Clozapine. Patients must also be assigned to a dispensing pharmacy and a treating physician.
The Teva Clozapine Patient Registry will conduct a rechallenge status check with the National Non-Rechallenge Masterfile on all patients new to clozapine, restarting clozapine, or if clozapine experience is unknown at the time of registration and prior to issuing treatment authorization.
Once a patient initiates therapy, health care professionals are required to submit lab reports to the Registry. Lab reports should be submitted to the Teva Clozapine Patient Registry within 7 days of the blood draw date.
The Registry will provide courtesy reminders if lab data are not submitted in a timely manner.
If a significant leukopenic event is identified, the Registry may contact members of a patients treatment team to confirm the health care provider is aware of the event.
Registry Services
- Provide 24/7 support for patient registrations.
- Maintain communication with Novartis Clozaril® National Non-Rechallenge Masterfile to verify rechallenge status and to post patients who become non-rechallegnable.
- Monitor lab reports and notify relevant health care providers if low counts are detected.
- Provide special monitoring procedures for patients with difficult clinical circumstances such as patients who develop leukopenia from oncology therapy or in hospice care where continued venipuncture may be contraindicated.
- Send courtesy reminders to assure timely submission of lab reports.
- Support for traveling or relocating patients to assure uninterrupted therapy and monitoring.
- Provide an interactive website, customized electronic data import utilities, and live user support.
- Provide lab report forms available in single and multiple patient format, prefilled with patient information or blank. To download blank forms,Click here.
- Offer a Patient Assistance Program to provide product for indigent patients.To submit an application, Click here .
Interactive Website
The Teva Clozapine Patient Registry website has a public access component and a secure access component.
The public access component provides general information about clozapine and the patient registry to any web browser. The secure access component allows electronic management of patient lab data.
The secure access component requires a User ID and Password to view patient data. The User ID must be associated to a valid pharmacy or physicans DEA number. Once access is granted, the user has access only to his or her own set of patients based on the DEA association.
Website Features and Benefits
- Password Protection
- Secure and Confidential
- Fewer phone calls
- Eliminate the need to mail or fax lab reports
- Real-time visibility of lab history after data entry
- View lab histories and graph results
- Enter lab reports on a single patient or multiple patients
- Enter and view Patient Notes
- Allow for user designation of relevant monitoring frequency
- Electronic Registration of Patients, Physicians and Pharmacies
- Easy access to patient information grouped by physician, pharmacy or user specified group names
- Change Patient Names and Group Information
- Change Pharmacy and Physician Information with an auto-fill feature
- Master user feature that allows an approved central user the ability to manage lab submissions from multiple facilities
- Helpdesk and registry staff available for assistance
- Demo available
- Secure internet connection with a minimum of 128 bit encryption
- Confirmed USER ID and Password associated to a registered pharmacy or physician