Efforts are under way at FDA and the Centers for Medicare & Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care.

"This initiative will tremendously increase the FDA's capacity to monitor the use of medical products on the market," Secretary Leavitt says. "We are moving from reactive dependence on voluntary reporting of safety concerns to proactive surveillance of medical products on the market. In addition, Medicare data on prescription drug use will be available to help government agencies and academic researchers improve the safety, quality and efficiency of healthcare services."

In a white paper, FDA 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. That Sentinel System will be created through public-private partnerships and will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort.
A CMS final regulation will make it possible for federal agencies, states, and academic researchers to use claims data from the Medicare prescription drug program (Part D)-subject to protections for beneficiary privacy and commercially sensitive data-for public health and safety research, quality initiatives, care coordination and other research and analysis.

The Sentinel System is an important example of how electronic health records and other electronic health information, such as the Medicare data, can help move the nation toward a system that delivers safer and better quality health care. President Bush has set the goal of most Americans having access to an interoperable electronic health record by 2014.

The new FDA white paper, titled "The Sentinel Initiative-A National Strategy for Monitoring Medical Product Safety," describes the proposed Sentinel System and calls for a public-private collaboration to develop and implement it. The report is available at: www.fda.gov/oc/initiatives/advance/reports/report0508.html. The system would enable FDA to analyze significantly more information than it can today by tapping into vast databases of health information to detect early signs of emerging safety problems.

"With the Sentinel System we will no longer have to wait years to see how a drug or medical device is affecting millions of people," says FDA Commissioner Andrew C. von Eschenbach, MD. "The era of 'wait and see' is going to become the era of 'tell me right now.' By harnessing the world's most powerful information technologies, and by partnering with CMS, the VA and DoD, and an array of private health care organizations, we will have the ability to monitor a product's performance in millions of patients in real time. The Sentinel System will give us an unprecedented ability to detect problems as they first begin to surface."

Creating an active surveillance system such as the Sentinel System was one of the recommendations made by the Institute of Medicine in a 2006 report on ways to improve the safe use of drugs. The recently passed Food and Drug Administration Amendments Act of 2007 (FDAAA) includes provisions that call for the development of such a system. As planned, the Sentinel System will fulfill some requirements of FDAAA while also meeting additional FDA needs.

The CMS final rule and a related fact sheet can be viewed at www.cms.hhs.gov/PrescriptionDrugCovGenIn/08_PartDData.asp

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