Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection.

ABSTRACT:

Background and objective

Spontaneous reporting systems (SRSs) remain the cornerstone of post-marketing drug safety surveillance despite their well-known limitations. Judicious use of other available data sources is essential to enable better detection, strengthening and validation of signals. In this study, we investigated the potential of electronic healthcare records (EHRs) to be used alongside an SRS as an independent system, with the aim of improving signal detection.

Methods

A signal detection strategy, focused on a limited set of adverse events deemed important in pharmacovigilance, was performed retrospectively in two data sources-(1) the Exploring and Understanding Adverse Drug Reactions (EU-ADR) database network and (2) the EudraVigilance database-using data between

SUBMITTER: Pacurariu AC 

PROVIDER: S-EPMC4659852 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature