Improving Adverse Event Report Processing at the FDA

Authors

Hannah S. Miller, Mark S. Panetta, Shira N. Shartiag

Sponsor

Food and Drug Administration

Advisors

James Hanlan, Stephen McCauley

Term

October – December 2016

Project Outcomes

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Abstract

Adverse drug events, or unintended and dangerous drug effects, impact millions of people in the United States each year. Our goal was to increase the efficiency of adverse event case report processing at the United States Food and Drug Administration using business process improvement methods. Information was collected from shadowing and surveying staff, conducting interviews, and participating in meetings and presentations.  Our recommendations focused on improving consumer education resources, enhancing the data entry user interface, utilizing new and existing metrics, and ultimately decreasing total report processing time and cost while considering the needs of the system’s stakeholders.

Executive Summary

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