FDA to develop electronic information system

EIS will be used to improve medical-product safety

The Food and Drug Administration is developing a new electronic information system to monitor how drugs and other medical products perform once they go on the market.

Called the Sentinel System, the data-mining technology will enable the agency to gather information about medical products by querying electronic health records, patient registry data, insurance claims data, and other large health care information databases. The project is in conjunction with the Centers for Medicare and Medicaid Services and is intended to improve patient safety and medical care.

'This initiative will tremendously increase the FDA's capacity to monitor the use of medical products on the market,' said Mike Leavitt, secretary of the Health and Human Services Department, which is the parent agency of the FDA. '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.'

The data will be used to identify possible postmarket adverse events nationwide. Part of the data will come from the Medicare Part D prescription drug program, subject to protections for beneficiary privacy and commercially sensitive data. The technology will link Medicare drug claims to other Medicare information on patient care, such as hospitalizations and physician visits, and be made available to other federal agencies, state Medicaid programs, researchers and beneficiaries for their personal health records. CMS will be developing guidelines and workshops to inform researchers how they can request this data.

The technology will be created through public/private partnerships and capitalize on large, existing electronic claims and medical records data sources maintained by private and government entities that agree to participate. It will allow FDA to analyze significantly more information than it can today and 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 von Eschenbach. 'By harnessing the world's most powerful information technologies and by partnering with CMS, the [Veterans Affairs and Defense departments], 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.'

The Institute of Medicine recommended creating an active surveillance system such as the Sentinel System in a 2006 report on ways to improve the safe use of drugs.

'The public health and safety benefits from this cooperative venture with the FDA will be substantial,' said Kerry Weems, CMS' acting administrator.

An FDA white paper on the project, titled 'The Sentinel Initiative ' A National Strategy for Monitoring Medical Product Safety,' is available here.

About the Author

Kathleen Hickey is a freelance writer for GCN.

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