FDA and Medicare Work Together to Keep Beneficiaries Safer    E-Mail This Post/Page   Print This Post/Page

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There are numerous complaints about government agencies not communicating with one another and not working together.  Some of these complaints make it clear that because of this lack of communication people have been hurt or killed, lost money or property and have often ended up in crisis.

There is some good news for Medicare recipients.  The Food and Drug Administration (FDA) and Medicare will be working together to help keep recipients safer.  Both the FDA and Medicare have huge databases.  Medicare’s databases contain a tremendous amount of information regarding claims, which include medication.  The agencies have determined how they can use the databases to explore and address problems with medications and medical devices and equipment that are discovered while they are new on the market. This computerized early-warning system is being designed to keep people healthy and save lives.  In addition, the system will save money by recognizing negative reactions quickly, look at patterns that lead to hospitalizations and work to isolate medications that are causing or increasing health problems.  With all this at work together, this should eliminate some hospitalizations and other medical expenses, saving money for recipients, for Medicare and for all involved in the system that tries to keep people well.

This new system will keep individual records private.  Only information regarding medical issues will be shared, but the identity of the individual will be kept private.  The FDA has a current early warning system, but it relies on self-reporting by patients and doctors, which is not accurate, and which also does not capture a high percentage of information, since many people don’t report for many reasons.

This system has taken years to devise, and is important because it could shorten the time it takes to detect drug safety issues and bring it don from years to months.  This is good news, not only for Medicare recipients, but for all of us.

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