An Overview of the Design and Implementation of FDA’s Prospective Routine Observational Monitoring Program Tools for Safety Surveillance

On September 16, 2013, the Engelberg Center for Health Care Reform at Brookings hosted a webinar entitled “An Overview of the Design and Implementation of FDA’s Prospective Routine Observational Monitoring Program Tools for Safety Surveillance.” This webinar provided an overview of the objectives, design, and process of a new program within the Mini-Sentinel system named the Prospective Routine Observational Monitoring Program Tools (PROMPT). The goal of the PROMPT system is to develop a relatively standardized, semi-automated, routine prospective surveillance program that can examine a number of products simultaneously by monitoring the occurrence of health outcomes of interest in association with use of newly approved medical products. This prospective monitoring mechanism will identify potential excess risk for subsequent follow-up and play an important role in U.S. Food and Drug Administration’s ongoing safety surveillance efforts.

For more information about Mini-Sentinel and Brookings events on this topic, please visit Brookings’ Sentinel Project Page and the Mini-Sentinel Organization website.