Two decades ago, MedWatch, FDA’s Safety Information and Adverse Event Reporting Program, was launched by then–FDA Commissioner David Kessler, MD, to grow the voluntary reporting system beyond physicians to include other health professionals such as nurses, pharmacists, and risk managers.
Individual health professionals are not required by federal law or regulation to submit adverse event reports on any medical product, except for vaccines. Therefore, adverse event reporting is voluntary. Product manufacturers, however, are required to report certain adverse events to FDA. In a journal article announcing the launch of MedWatch, Kessler said he hoped the new MedWatch system would encourage health professionals to regard reporting “as a fundamental professional and public health responsibility.”
Over the years, MedWatch has broadened its reach with expanded Web-based tools and processes for disseminating new safety information. The MedWatch program provides new safety alerts for human medical products on the MedWatch website (www.fda.gov/MedWatch). On the same site, it also posts a chart of Monthly Safety Labeling Changes for drug products. In addition, the public can subscribe to free e-mail alerts, Twitter posts, and an RSS feed.
As FDA’s MedWatch program marks its 20th anniversary, we wanted to highlight some recent MedWatch activities and enhancements.
This year MedWatch launched a new, consumer-friendly reporting form. FDA worked in close collaboration with consumer groups to develop the new form, responding to concerns that FDA Form 3500, originally designed for health professionals, was too hard to understand.
Over the years, most of the voluntary MedWatch forms were submitted by health professionals. However, consumers are increasingly more interested in participating in the program. Self-reported patient information captures a valuable perspective not captured by other means.
The new form—MedWatch Form 3500B—is designed to be easier to understand and complete. For example, “Adverse Event” was changed to “Were hurt or had a bad side effect (including new or worsening symptoms).” “Product Use Error” was changed to “Used a product incorrectly, which could have led to a problem.” Other organizational layout changes to help patients include separate sections for drugs and other medical products, as well as “go to” instructions so patients can clearly see what section they need to fill out, depending on the type of product involved.
A complete MedWatch adverse event report should include the following information:
FDA relies on reports of serious problems with medical devices and other products as one important way to help identify and better understand the risks associated with these products. Receiving higher quality reports helps FDA identify and respond to safety signals and public health emergencies more efficiently and effectively. These reports, along with data from other sources, can provide critical information that can lead to improved patient safety.
MedWatch also launched MedWatchLearn, a Web-based learning tool designed to educate students, health professionals, and consumers on MedWatch reporting in a way that provides the best information for reviewers to further investigate a problem. Additional resources are located within MedWatchLearn and are available at www.accessdata.fda.gov/scripts/MedWatchLearn/HP-addnl-resources.htm. These resources focus on the following topics:
MedWatchLearn was developed as a result of a Science of Safety study that included recommendations encouraging interprofessional education and training in patient safety and related topics at schools of medicine, nursing, pharmacy, and other health professions.
The MedWatch Online Voluntary Reporting form has a new look and feel. It also includes two paths, one for health professionals and the other for patients/consumers.
In addition, the MedWatch online voluntary reporting form is FDA’s first Web page to include responsive design. Responsive design optimizes the way the screen appears based on the device that accesses it. Mobile phones, tablets, and desktop and laptop computers were included in the testing phase of this project.
MedWatch reports sometimes provide the first indication that an issue needs investigation and possible action. Reporting serious adverse events and product quality issues to FDA can result in a variety of FDA actions. FDA can issue a safety alert advising the public and health professionals to monitor a product’s use, adjust the way it is used, or stop using it altogether. For some products, FDA can also require updates to the product label to reflect new warnings about the product’s potential adverse effects. FDA may also issue product recalls or other warnings through MedWatch.
Since pharmacists are easily accessible health professionals, they are in a key position to learn about adverse events from patients and to educate patients and caregivers about MedWatch.
Pharmacists are encouraged to report and help patients report adverse events to FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Complete the voluntary form FDA 3500 online at www.fda.gov/MedWatch/report.htm, or download a reporting form—Form FDA 3500 or Form 3500B (the new, consumer-oriented form)—and either fax the form to 800-FDA-0178 or mail it. Or call 800-332-1088 to request a reporting form, complete and return it to the address on the preaddressed form, or fax it to 800-FDA-0178.