FDA’s New Sentinel System to Identify Dangers from Drugs

By Anna Boyd
10:59, May 23rd 2008
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FDA’s New Sentinel System to Identify Dangers from Drugs

As the U.S. Food and Drug Administration’s drug safety monitoring has been criticized as inadequate and slow for years, the agency will begin monitoring prescription drug usage by millions of Medicare patients in an effort to identify dangers from prescription drugs and medical devices after they reach the market.

The new regulations, announced Thursday by the Health and Human Services Department, will give the FDA, states and academic researchers access to data from Medicare’s Part D prescription drug program.

Named the Sentinel System, the program will give researchers the opportunity to identify drug- and device-related problems sooner than the current system does. The new system won’t wait for patients, manufacturers or doctors to report potential side effects, but will give researchers the chance to search claims data from private health insurers, hospitals and Medicare to see if problems have occurred in patients given a particular treatment.

“We will no longer have to wait years to see a drug or medical device is affecting millions of people. The era of ‘wait and see’ is going to become the era of ‘tell me right now,’” the FDA commissioner, Andrew von Eschenbach, said, according to the Associated Press.

Information from more than 25 million patients with prescription drug coverage under Medicare will be available to the FDA in 30 days. However, “all of the data about personally identifiable information stays where it is, it doesn’t leave,” Kerry Weems, acting administrator of the Centers for Medicare and Medicaid Services, wanted to underline, meaning that the FDA won’t have access to individuals’ personal information.

The program will also cut down costs on adverse drug events, which currently reach about $900 million a year. Also, the FDA will be able to determine when a drug is inappropriately dispensed to treat certain conditions, thus leading to a curb on unnecessary prescription bills.

Officials did not reveal how long it would take to fully implement the Sentinel system, which was first proposed by the Institute of Medicine in 2006. However, the FDA set a goal for the regulators to have access to data from 100 million patients by July 2012.



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