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Adherence to Absolute Neutrophil Count (ANC) Monitoring Recommendations Following Clozapine Use: Second Descriptive Analysis

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    clozapine
    Health Outcome(s)
    adherence to absolute neutrophil count (ANC) monitoring
    Description

    This analysis examined adherence to FDA's Risk Evaluation and Mitigation Strategy (REMS) absolute neutrophil count (ANC) monitoring recommendations among clozapine users in the Sentinel Distributed Database (SDD). This analysis differs from the first descriptive analysis by updating some definitions of adherence. 

    We distributed this request to seven Sentinel Data Partners on August 15, 2022. This analysis contains three reports.

    • Report 1 contains all data returned by Data Partners. The study period includes data from January 1, 2010 to October 31, 2021.
    • Reports 2 contains data from members with Medicaid/Children's Health Insurance Program (CHIP). The study period includes data from October 1, 2015 to December 31, 2019.
    • Report 3 contains data from members with Medicare Fee-For-Service (FFS). The study period includes data from October 1, 2015 to December 31, 2019.
    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2010 – October 31, 2021; October 1, 2015 – December 31, 2019
    Analysis Type
    Descriptive
    Population / Cohort
    Individuals 12 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)