Online Signal Management: A Systems-Based Approach That Delivers New Analytical Capabilities and Operational Efficiency to the Practice of Pharmacovigilance

Abstract

Traditional approaches to postmarketing pharmacovigilance have been primarily qualitative and paper based. We describe the development and implementation of online signal management (OSM), a new systems-based platform for pharmacovigilance that supports prioritization of safety issues, in-stream review and data retrieval, aggregate-level analysis of data patterns, and knowledge management.

By providing an integrated view of the information needed to detect and evaluate safety signals, OSM enhances the efficiency of the pharmacovigilance process. The system enables pharmacovigilance professionals to triage incoming data using statistical, visualization, and alerting tools. Safety issues can be flagged and tracked, providing a streamlined approach to the retention and sharing of knowledge. We have deployed OSM to more than 100 users. User surveys and operational metrics demonstrate that OSM increases the efficiency of pharmacovigilance and that users are highly satisfied with OSM and the processes implemented for its use.

In summary, this integration of state-of-the-art statistical and visualization tools with traditional, case-evaluation tools and a novel knowledge management system represents a significant advance in pharmacovigilance.

Keywords

Pharmacovigilance Drug safety Signal detection Signal management Safety signal

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