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The Food and Drug Administration now has access to another major ingredient of its Sentinel project, one intended to detect adverse drug effects by mining medical data. The Centers for Medicare and Medicaid Services will make claims data from its Medicare Part D prescription drug program available to the FDA, researchers and others. Although the data will be anonymized, it can be linked to Medicare inpatient and outpatient claims records, enabling researchers to associate drugs and medical devices with their effects on health.

At a Washington press conference, Health and Human Services Secretary Mike Leavitt lauded the surveillance project. “This initiative will tremendously increase the FDA’s capacity to monitor the use of medical products on the market,” Leavitt said.

The Medicare data will be only part of the data the FDA plans to scan. In a white paper released today, it outlined plans for a public-private partnership in which other medical data sources, such as insurers and integrated health care delivery systems, would participate voluntarily.

The agency has been working to develop Sentinel at least since 2006. It has a number of pilot projects and data-sharing agreements in place, including an agreement with the Department of Defense to use information from DOD’s e-medical records system.

“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,” FDA Commissioner Andrew C. von Eschenbach said in a statement. “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.”

Congress called for the creation of such a system when it passed a major FDA bill last year. Nonetheless, the agency is proceeding cautiously. The white paper states that Sentinel “is a long-term effort that must proceed in stages. FDA looks forward to initiating a series of discussions on the scientific and policy issues that must be addressed as the partnership is established.”

As an immediate next step, the paper calls for a public meeting to discuss plans for the project.

In one of the pilot projects, two regional organizations with e-health records have tested the use of EHR data, other clinical data and claims data in detecting possible liver side effects related to the use of cholesterol-lowering drugs, bleeding episodes related to warfarin, and a small set of adverse patient events commonly associated with medications, or “designated medical events.”

That project, organized by the eHealth Initiative Foundation, also involved the FDA, Partners Health Care System in Boston, the Regenstrief Institute in Indianapolis and three drug makers.

A second round of testing is now under way, eHealth Initiative officials said, and more partners are likely to be added over the summer.

Eventually, the Sentinel system could not only be used to spot patterns of medical problems associated with certain drugs or combinations of drugs, but in time it could reveal which drugs are more effective in certain groups of patients or certain forms of a disease.

 

Get the full article here http://www.govhealthit.com/online/news/350379-1.html

 

 

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