Real-Time Data on Medical Products' Effects Seen from Sentinel System

HHS Secretary Mike Leavitt announced a Sentinel Initiative has been launched by the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services with the goal of improving 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," Leavitt said. "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 health care services."

An FDA white paper describes the initiative, which will include the development of a new electronic system that will let 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. A CMS regulation, meanwhile, will allow 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 and quality initiatives.

The white paper, "The Sentinel Initiative -- A National Strategy for Monitoring Medical Product Safety," calls for a public-private collaboration to develop and implement it. "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," said FDA Commissioner Dr. Andrew C. von Eschenbach. "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."

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