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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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