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Using The Registry - Frequently Asked Questions The National Non-Rechallenge Masterfile - Frequently Asked Questions How does a medical group practice or pharmacy enroll? If a health care practitioner is a part of a group practice, the lead health care practitioner may enroll for the entire group. All communications with the FazaClo® Patient Registry should include the identifiers for the lead health care practitioner as well as the health care practitioner who is responsible for the patient. If a pharmacist is part of a larger group with multiple pharmacists the lead pharmacist may enroll for the entire group. In such cases all communications with the FazaClo® Patient Registry should include the identifiers for the lead pharmacist as well as the pharmacist who is responsible for the contact. If the lead health care practitioner leaves the group or is replaced or if the lead pharmacist leaves the pharmacy or is replaced, the group or pharmacy must re-enroll with the FazaClo® Patient Registry. Health care practitioners and pharmacists/pharmacies need only enroll once with the FazaClo® Patient Registry in order to qualify to provide treatment for multiple registry patients. What are the data submission timelines? Patients on an Every Four Weeks Monitoring
Schedule
Patients on Every Other Week Monitoring Schedule
Patients on Weekly Monitoring Schedule
Patients on Daily Monitoring Schedule
What happens when patients transfer healthcare providers? Patients who are currently receiving treatment with another formulation of clozapine may be switched to FazaClo® treatment by an enrolled pharmacist in the FazaClo® Patient Registry if provided with 1) a current prescription from a health care practitioner and, 2) a WBC test result that is within normal limits according to product labeling. This information must be received within 7 days of blood draw if the patient is currently on weekly monitoring, within 14 days if currently on every other week monitoring, or within 28 days if currently on every 4 week monitoring. The pharmacist must contact the registry Coordinating Center immediately at 1-877-FAZACLO (329-2256) to facilitate patient registration. How do I update my contact information? You can update your contact information by calling the FazaClo® Patient Registry Coordinating Center at 1-877-FAZACLO (329-2256). What are the hours of operation of the FazaClo® Patient Registry Call Center? The call center is staffed 24 hours/day every day of the year. How do I request registry materials? Registry health care practitioners and pharmacists may request registry materials directly through the call center or download them from the website. What happens if my patient goes on vacation or out-of town? Support will be provided for traveling patients to insure uninterrupted therapy. An extra supply (defined according to current patient monitoring schedule) of FazaClo® treatment may be dispensed at the discretion of the affiliated treatment pair only if acceptable WBC counts (≥3500/mm3) and ANCs (>2000/mm3) over the prior 30 days can be verified and if there have been no treatment interruptions during the same time period. A temporary affiliated treatment pair (enrolled health care practitioner and pharmacist) may be established where necessary and possible in the area of the extended travel and in collaboration with the patient and original/permanent affiliated treatment pair. Patients, health care practitioners and pharmacists may contact the Coordinating Center at 1-877-FAZACLO (329-2256) for more information. What is the FazaClo® Patient Registry security policy? While security of a computer system can never be guaranteed, the Registry is designed to be accessible only to registered users with a user ID and password obtained from the FazaClo® Patient Registry Coordinating Center. The Registry is designed to provide health care practitioners and pharmacists access to information concerning only those patients registered to them. Data security is accomplished using 128-bit data encryption standards. All data communications are encrypted and require 128-bit Secure Sockets Layer browser support.
The Clozapine National Non-Rechallenge Masterfile contains the identities of all patients who have developed clozapine-induced agranulocytocis (WBC counts below 2000/mm3 or ANC below 1000/mm3) and must never be rechallenged with any clozapine formulation. The masterfile was originally developed and is maintained by Novartis Pharmaceuticals Corporation. The United States Food and Drug Administration mandated agranulocytosis post-marketing surveillance for all clozapine formulations (brand and generic) and requires all products to interact with and update the National Non-Rechallenge Masterfile. This consolidates the list of all patients with a “non-rechallenge” status into a single database. The FazaClo® Patient Registry maintains bi-directional linkage and communication with the Clozapine National Non-Rechallenge Masterfile. The registry will be responsible for verifying non-rechallenge status for all patients registered and monitored in the FazaClo® Patient Registry and notifying the affiliated treatment pairs of this status. The registry will immediately provide the Clozapine National Non-Rechallenge Masterfile with identifying information on patients treated with FazaClo® treatment who experience a confirmed inappropriate blood test result and meet non-rechallenge criteria (WBC below 2000/mm3 or ANC below 1000/mm3).
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