[medinformatics] McClellan Suggests Medicare-based Drug Monitoring System

[Medical Informatics News]

According to the Los Angeles Times, CMS Administrator Mark McClellan, a doctor and an economist who once ran the FDA, has proposed a Medicare-based system to track the safety and effectiveness of medications. McClellan has proposed using billing data and health care information collected from Medicare beneficiaries to serve as a post-market surveillance system for prescription drugs. He suggested collecting adverse-event information from Medicare beneficiaries who enroll in the new prescription drug benefit, which begins January 1, 2006.Reportedly, the FDA's*system of voluntary reporting picks up no more than 10% of serious drug reactions--think Vioxx and the recent infromation about Viagra and blindness. Currently the FDA approves drugs for market on the basis of trials involving a few thousand patients, and sometimes serious side effects don't show up until the medication is widely used on the open market.*ReadPermalink*|*Email this*|*Linking*Blogs*|*Comments









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