FDA’s MedWatch Program Facilitates Reporting on Suspected, Identified Problems

FDA pharmacist Captain Catherine Chew recently appeared in a video that advertised the importance of being vocal about problems with medicines during clinical use. On behalf of the FDA, she asked that professionals and patients utilize MedWatch if they suspect or identify issues with medical products within a clinical setting. FDA’s MedWatch program is a tool that will be essential for reporting these serious allegations and issues.

“When you report adverse events to the FDA’s MedWatch program, you provide a vital source of information to the FDA. Today, resources are available to you, a health care professional, to make reporting to MedWatch easier than ever,” said Capt. Chew in the PSA video. “The FDA needs to know when a serious problem with a medical product is suspected or identified during clinical use. That’s why the MedWatch program makes it easy to get important information from you to us.”

Anyone can submit a MedWatch report online at FDA.gov/MedWatch. Also, the site features guidelines regarding what should and shouldn’t be reported to MedWatch. The reporting forms can be completed online, the form can also be printed out and completed by hand. There is a report form designated for health professional, and a consumer form designed specifically for patients.

The MedWatchLearn section teaches healthcare professional, students, and consumers how to complete the forms necessary to submit suspected or identified problems to the FDA. MedWatchLearn is a teaching tool that allows students, professionals and consumers to learn how to complete a MedWatch report by using a case study that’s based on an actual report. The resource also provides information to patients and providers about clinical safety. There’s an additional 24-minute tutorial available for public consumption, offering information on post-marketing safety surveillance.

Providers and patients are encouraged to call or email FDA’s Division of Drug Information or submit a report via MedWatch.