Uncovering Pregnancy Exposures in Pharmacovigilance Case Report Databases: A Comprehensive Evaluation of the VigiBase Pregnancy Algorithm.

ABSTRACT:

Background

Information on the safety of medicine use during pregnancy is limited at the time of marketing, making post-marketing surveillance essential. However, the lack of a specific indicator for pregnancy-related case reports within the international standard for transmission of individual case safety reports complicates the retrieval of such reports in pharmacovigilance databases. To address this, an algorithm to identify reports of exposures during pregnancy was developed in VigiBase, the World Health Organization global database of adverse event reports.

Objective

We aimed to evaluate and characterise the VigiBase pregnancy algorithm.

Methods

The rule-based algorithm uses multiple structured data elements in the International Council of Harmonisation (ICH) E2B

SUBMITTER: Sandberg L 

PROVIDER: S-EPMC12423168 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature