U.S. Health officials announced plans for a new computer tracking system, called the Sentinel System, that will help identify adverse events associated with U.S. Food and Drug Administration approved prescription medication and medical devices.
Sentinel System would allow the FDA to search through multiple databases, including the government's Medicare health insurance plan, for signs of possible adverse events.
"We're moving from a reactive dependence on voluntary reporting of product safety concerns to a proactive surveillance of medical products that are currently on the market," said Health and Human Services Secretary Mike Leavitt.
At the moment the FDA relies on data from manufacturers, doctors and consumers to establish side effects associated with drugs and medical devices. The new system would allow the FDA to search claim data from private health insurers, hospitals and Medicare for problems associated to a specific treatment. Data searched will not include any patient personal information and will be made available to states and academic researchers.
The Pharmaceutical Research and Manufacturers of America, an industry group, said the effort "should improve the efficiency of post-market surveillance" and benefit patients.
PhRMA statement on the Sentinel System
[Source: YahooNews]
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