The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy of marketed medical products, such as drugs and medical devices (including OTC and dietary supplements). In order to perform ongoing safety surveillance of medical products, the FDA relies on the voluntary reporting of serious adverse events, product quality problems and product use errors. Health care professionals and consumers may report adverse events and product problems to Med watch by calling 1800 –FDA-1088, by submitting the Med Watch 3500 form by mail or fax, or by going online to the FDA web page. CMS encourages Part D sponsors to educate prescribers and pharmacies providers about the importance of reporting adverse events, product problems and product use errors, as well as how to utilize the FDA Medwatch reporting mechanisms. A broader discussion on Med Watch reporting, including downloadable Med watch forms, is available at the FDA Med Watch Web page (see appendix A) FDA Med Watch program enables healthcare professionals and consumers to report these issues by the following:
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