Enhancing antidepressant safety surveillance: comparative analysis of adverse drug reaction signals in spontaneous reporting and healthcare claims databases.

ABSTRACT: Background/Objective: Spontaneous reporting systems (SRS) such as the Korea Adverse Event Reporting System (KAERS) are limited in their ability to detect adverse drug reaction (ADR) signals due to their limited data on drug use. Conversely, the national health insurance claim (NHIC) data include drug use information for all qualifying residents. This study aimed to compare ADR signal profiles for antidepressants between KAERS and NHIC, evaluating the extent to which detected signals belong to common ADRs and labeling information. Materials and Methods: ADR signal detection in KAERS and NHIC databases, spanning January to December 2017, employed disproportionality analysis. Signal classes were determined based on System Organ Class (SOC) of the Medical Dictionary for Regulator

SUBMITTER: Kim T 

PROVIDER: S-EPMC10800508 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature