Video Title: (Reporting Adverse Events To Medwatch)
Video Duration: 2:17
From: USFoodandDrugAdmin
Category: Education
an important fda program called "medwatch" allows health care professionals and consumers to report serious problems that they believe may be ociated with the medical products they prescribe, dispense, or use. these reports, along with follow-up investigations, can help to identify important safety concerns. medwatch reports alone rarely confirm a causal relationship between an adverse event and a medical product. it may take a formal epidemiologic study or a controlled clinical trial to do that. still, medwatch reports are vital in helping to make sure that medical products are safe, because they provide a rapid signal to fda that problems may be occurring. fda depends on reports from healthcare professionals and consumers to keep the medwatch system working. here are the kinds of problems to report: • any serious adverse event that might be ociated with a drug, biologic, medical device, dietary supplement or cosmetic product. fda is particularly interested in serious adverse events that are not listed in the product labeling. "serious" means fatalities, hospitalizations, and medically significant events. • theobsutic failures where the drug or device failed to work as it should eg, if a patient has to switch from one brand of a drug to another because the original one was ineffective. • use errors with medications or devices, including situations where the error may have been due to poor communication, or to ambiguities in product names, directions for use, or ltbgt...lt bgt
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