FDA MedWatch Safety and Adverse Event Reporting Program Expands Patient Resources

Earlier this month, the Food and Drug Administration (FDA) celebrated the 20th anniversary of its MedWatch program, which provides important safety information associated with FDA-regulated products, with a new form that will encourage more consumer participation. Under MedWatch, health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated products. Reporting to FDA such "adverse events" as unexpected, serious side effects, accidental exposure, and product quality issues can prompt the agency to act—and it can also bring new safety information forward and help the FDA take appropriate actions, including: Making necessary changes on the label for a medication to better describe how the product should be used; Influencing how a patient receiving the product should be monitored; and, Issuing product recalls, warnings, corrections, or safety messages which FDA issues through MedWatch. Over the years, most of the voluntary MedWatch forms have been submitted by health care professionals but recently consumers have been increasingly interested in participating in the program. Consumers had been able to report side effects, product quality problems and other issues to MedWatch since the program was founded in 1993, although the focus had always been more on encouraging reporting from health care professionals. Because the healthcare professional form was t...
Source: Policy and Medicine - Category: Health Medicine and Bioethics Commentators Authors: Source Type: blogs