FDA proposes drug effects monitoring system.

Federal health officials have announced plans for a new monitoring system known as the Sentinel Initiative, which is intended to allow Food and Drug Administration (FDA) officials to monitor the effects of drugs currently on the market. The computer tracking system would work by enabling the FDA to search claims data from private insurers, hospitals, and the database for Medicare's health insurance plan for the elderly and disabled. In fact, the FDA plans to look at information from more than 25 million patients with prescription drug coverage under Medicare. Some healthcare analysts and consumer groups welcome the change from the current monitoring system and have expectations of finding useful information for Medicare patients within a year. Federal health officials made assurances that the FDA and other researchers would not have access to the personal information of Medicare beneficiaries. The current process of reporting is voluntary where physicians, patients and manufacturers report problems with drugs and medical devices that they deem are necessary. To assess the accuracy of the Sentinel system the FDA will conduct studies on well-known drug side effects.