FDA readies new data systems for drug safety

MedWatchPlus, FAERS will expand adverse event reporting

The Food and Drug Administration will use two new data systems for tracking prescription drug safety in 2010 and is developing a third drug safety tracking system, known as Sentinel, according to a new report today from the Government Accountability Office.

The new systems are MedWatchPlus, which is designed to improve the collection and processing of reports filed with the FDA on adverse effects from drugs, and the FDA Adverse Event Reporting System (FAERS), which will receive the reports and stores them in a single location, the report states.

MedWatchPlus is scheduled to be implemented by the summer of 2010. It will replace MedWatch, which collects data on a Web site as well as paper data. The paper reports currently take between two days and two months to be converted into digital documents and made accessible to FDA staff, the GAO report stated. With MedWatchPlus, the FDA expects more data to be filed electronically and to be available to its staff members in less than two days.

The FAERS system will be an upgrade of the existing FDA storage system and will allow for creating a more integrated and comprehensive database and for greater opportunities to analyze, data mine and perform research from the adverse event report database, GAO said. It will be partially deployed by the end of 2010.

The Sentinel system, now in the early development stages, will use drug safety data from a network of external data providers and will offer more information than is available from the adverse event reports filed in the FAERS and other current databases, GAO said.

However, in a separate report in June, GAO said Sentinel needs more work to make sure information in the system is kept private and secure.

The FDA also has increased by five-fold its purchases of commercial data on prescription drug safety. The agency spent $28 million on external data for drug safety surveillance in fiscal 2008, up from $5 million in fiscal 2007, GAO noted.

The agency also is in the early stages of putting in place an agreement with the Veterans Affairs and Defense departments and with the Centers for Medicare and Medicaid Services to access their databases for drug safety research. In a related agreement, FDA is to get direct access to Medicare and Medicaid prescription drug data to create a database that can be used for research.

About the Author

Alice Lipowicz is a staff writer covering government 2.0, homeland security and other IT policies for Federal Computer Week.

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