In a white paper released May 22 by the Food and Drug Administration (FDA), the agency describes plans for the Sentinel Initiative, which will include the development of a new electronic system that will enable FDA to query a broad array of information to identify possible post-market adverse events. The white paper, titled The Sentinel Initiative: A National Strategy for Monitoring Medical Product Safety, describes the proposed system and calls for a public-private collaboration to develop and implement it. The system will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in the nationwide effort.
The system would enable FDA to analyze significantly more information than it can currently by tapping into vast databases of health information to detect early signs of emerging safety problems. Creating an active surveillance system such as the Sentinel Initiative was one of the recommendations made by the Institute of Medicine in a 2006 report on ways to improve the safe use of drugs. Read the white paper.
