The following Clozapine REMS Program and Website Changes will be effective beginning 02/28/2019. Program Requirement Changes: Prescriber and Pharmacy Certification Requirements Only prescribers certified in the Clozapine REMS Program will be able to prescribe clozapine to patients for outpatient use. Prescribing clozapine for patients receiving inpatient care does not require prescriber certification in the Clozapine REMS Program if the patient is already enrolled in the program. If the patient is to be initiated on clozapine while admitted to an inpatient setting, a certified prescriber must enroll the patient in the Clozapine REMS Program prior to receiving the first dose of clozapine. Only pharmacies certified in the Clozapine REMS Program will be able to receive and dispense clozapine. For more information on the 02/2019 Clozapine REMS Program changes, please click on the links below. Program Document Changes: The following Clozapine REMS Program Materials have been updated and can be found on the program website: The Frequently Asked Questions (FAQs) include new content regarding program changes effective 02/28/2019. New Clozapine REMS Program Fact Sheets have been posted in the Program Materials section. These Fact Sheets include: Predispense Authorization (PDA) Fact Sheet for Outpatient Pharmacies Eligibility Check Fact Sheet for Inpatient Pharmacies How to Start Clozapine and Monitor Patients for Prescribers The Clozapine REMS Program web demos have been updated to reflect program changes. Thirteen (13) total web demos have been posted in the Program Materials section within the Fact Sheets and Demos tab that will provide stakeholders with information on the Clozapine REMS Program. Recent communications to Prescribers and Pharmacies regarding the 02/28/2019 launch have been posted in the Program Materials section. These materials can be found at the following links: Letter to Outpatient Pharmacies using the Pharmacy Network (Switch) for PDA Letter to Outpatient Pharmacies that use Web-based PDA Letter to Inpatient Pharmacies Letter to Prescribers The Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers has been updated with program changes. Program Requirements that are NOT Changing Patient Requirements Patients who meet the following requirements can receive clozapine. Patients must: Be enrolled in the Clozapine REMS Program; Have an Absolute Neutrophil Count (ANC) lab on file with the Clozapine REMS Program; and The ANC lab must be within the acceptable range or a "Treatment Rationale" must be provided by the prescriber for a patient to receive clozapine. Patients that do not meet the requirements cannot receive clozapine. ANC Current Lab Requirements Absolute Neutrophil Count not current (i.e., within 7, 15, or 31 days of the lab draw date) based on the patient's monitoring frequency (MF) will not prevent a patient from receiving clozapine from the pharmacy. Although 'ANC not current' will not prevent a patient from receiving clozapine from the pharmacy, pharmacies are encouraged to submit the ANC to the Clozapine REMS Program when the pharmacist is made aware of a more current ANC than the most recent lab value reported in the PDA response. Pharmacies may submit ANCs to the Clozapine REMS Program at www.clozapinerems.com, by calling the Clozapine REMS Program Contact Center at 844-267-8678 or faxing a completed Clozapine REMS ANC Lab Reporting Form (available from the website) to the Clozapine REMS Program at 844-404-8876. If the most recent ANC indicates moderate or severe neutropenia the prescriber must provide a Treatment Rationale to the Clozapine REMS Program to allow the pharmacy to receive a PDA and dispense clozapine to the patient. The pharmacy may contact the prescriber to remind them of the need for a Treatment Rationale. If the last ANC result on file with the Clozapine REMS Program is not current according to the patient's MF (within 7 days of the PDA/Eligibility Check transaction date for weekly monitoring, 15 days for every two weeks monitoring, and 31 days for monthly monitoring), a PDA/Eligibility Check will still be issued, but the pharmacist will receive a warning message regarding the need to ensure that the ANC is current. In the future, patients who do not have a current ANC on file may not be allowed to receive clozapine.