Sentinel Initiative to Streamline Medical Product Surveillance

U.S. Department of Health and Human Services Secretary Mike Leavitt recently announced efforts underway at the U.S. Food and Drug Administration (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," 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."

FDA published a CMS final regulation on May 22 that the agency said 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.

In addition, a white paper was released by FDA that same day that 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. That Sentinel System, FDA said, 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.

The 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. FDA says the system would enable it 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," said FDA Commissioner Andrew C. von Eschenbach, M.D. "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, FDA says the system will fulfill some requirements of FDAAA while also meeting some additional needs.

"We look forward to working with the FDA on the Sentinel Initiative," said Kerry Weems, CMS acting administrator. "There's a clear nexus between the data collected through Medicare's prescription drug program and the FDA's role in protecting the public from adverse events. The public health and safety benefits from this cooperative venture with the FDA will be substantial."

Weems noted that CMS's most recent survey of beneficiaries indicates that people with Medicare use more than twice as many medications in a year as do other Americans. Medicare beneficiaries use an average of 28 prescriptions in a year, while those who consider themselves in poor health have about 45 prescriptions in a year (source: Medicare current beneficiary survey, 2004). In contrast, other Americans use about 13 prescriptions a year, according to a 2007 study by the Agency for Healthcare Research and Quality (www.ahrq.gov/news/nn/nn051607.htm). Medicare beneficiaries' high usage of medications, coupled with numerous chronic health conditions, puts this population segment at higher risk of adverse drug events than other Americans and makes them the group most likely to see benefits from the new initiative, FDA said.

The Medicare Prescription Drug Benefit data, linked to Medicare inpatient and outpatient claims data, will allow the creation of a highly robust HHS database as the prototype for the Sentinel System. Publication of the Medicare Part D Claims Data Rule enables the FDA to use Part D claims data as the FDA explores drug safety questions related to particular products. With approximately 1 billion claims per year, the Medicare Part D database is unprecedented in size and scope and will be a valuable resource for patient safety analyses that will benefit not only Medicare beneficiaries but the entire nation, FDA said.

CMS will be developing guidelines and workshops to inform researchers on how they can request these data. The CMS final rule and a related fact sheet may be viewed at www.cms.hhs.gov/PrescriptionDrugCovGenIn/08_PartDData.asp

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