Skip to main content

Adherence to Absolute Neutrophil Count (ANC) Monitoring Recommendations Following Clozapine Use: Third 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 differed from the first and second descriptive analyses by expanding capture of ANC claims to include the laboratory results table in addition to the procedure table.

The study period includes data from January 1, 2010 to April 30, 2023. We distributed this request to six Sentinel Data Partners on October 6, 2023.

Deliverables (1)
Sentinel Modular Program Report: Adherence to Absolute Neutrophil Count (ANC) Monitoring Recommendations Following Clozapine Use: Third Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
January 1, 2010 – April 30, 2023
Analysis Type
Descriptive
Population / Cohort
Individuals 12 years of age and older
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Study: Clozapine & Adherence to Absolute Neutrophil Count (ANC) Monitoring and Neutropenia
Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Psychopharmacologic Drugs Advisory Committee Meeting