Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks.

ABSTRACT:

Introduction

The basis of pharmacovigilance is provided by the exchange of Individual Case Safety Reports (ICSRs) between the recipient of the original report and other interested parties, which include Marketing Authorization Holders (MAHs) and Health Authorities (HAs). Different regulators have different reporting requirements for report transmission. This results in replication of each ICSR that will exist in multiple locations. Adding in the fact that each case will go through multiple versions, different recipients may receive different case versions at different times, potentially influencing patient safety decisions and potentially amplifying or obscuring safety signals inappropriately.

Objective

The present study aimed to investigate the magnitude of replication, the

SUBMITTER: van Stekelenborg J 

PROVIDER: S-EPMC9870831 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature