New Sentinel Initiative to Improve Safety of Medical Products

The U.S. Food and Drug Administration is working with the Centers for Medicare & Medicaid Services to improve the safety of Prescription drugs, as well as other medical products.

The new initiative will make Medicare prescription drug data available in order to assist researchers and government agencies in ensuring and improving safety, quality, and care.  It will incorporate a new electronic system – the “Sentinel System” - that will allow the Food and Drug Administration to look at a wide variety of information in order to see potential concerns.  The system will utilize substantial databases – including information provided by Medicare – to carefully monitor effects of medical products and to provide prompt information about the performance of a drug or other medical product.

The use of Medicare claims information, like diagnoses, treatments, and hospitalizations is particularly helpful, since it is such a large database.  The Centers for Medicare & Medicaid Services has published a final rule which will allow them to use Medicare Part D claims data to aid research, care coordination, program oversight, and quality improvement and performance measurement initiatives. 

The Sentinel System will be good, in particular, for Medicare Part D beneficiaries.  A survey done by the Center for Medicare & Medicaid Services shows that Medicare beneficiaries use over twice the medications as other Americans.  Because this means that Medicare beneficiaries would therefore be at greater risk of negative medication effects, a system designed to protect people from these risks is of particular use to people enrolled in Medicare Plan D.

With the new Sentinel Initiative underway, we can look forward to both an improvement in safety and an increase of relevant, timely information.