Practical Considerations in Developing an Automated Signaling Program within a Pharmacovigilance Department

Abstract

In recent years, there has been increasing regulatory and industry interest in the use of automated systems for the detection and assessment of drug safety signals from postmarketing adverse drug reaction databases. Several factors have contributed to this development, including: the constant growth in adverse event report volume; the availability of more sophisticated data systems, which allow data exploration; and advances in signaling methodologies.

This article discussed the process by which a global pharmacovigilance department has planned, designed, and implemented an automated signaling program. Our experience indicated that a good understanding of signaling methodologies, an awareness of the strengths and limitations of the available data source, and the development of a transparent signaling process are crucial to the design and implementation of any program. The algorithm and processes developed here may be applicable to others who are considering the implementation of an automated signaling program. As both regulatory authorities and manufacturers gain more experience and familiarity with automated signaling systems, further process improvements and novel approaches to this type of safety data evaluation are needed.