FDA's MedWatch program turns 20: What's new?

Patients are increasingly more interested in participating in MedWatch; a new form was designed for ease of use by the public; a Web-based learning tool provides additional resources

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.

New consumer-friendly form

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:

  • Product name (and information such as model and serial numbers for medical devices) 
  • Description of the adverse event, including confirmatory and/or relevant test or laboratory results
  • Confounding factors (such as concomitant medical products and medical history) 
  • Date of event onset and start/stop dates for use of medical product 
  • Dosage and frequency of use 
  • Whether adverse event stopped after patient reduced dose or stopped taking the product, and whether it returned if the patient began using the product again (if this information is available) 
  • Outcome 
  • Reporter  

Public health benefits of reporting

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.

“Learn” from MedWatch

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: 

  • Medical product information resources 
  • What to report to MedWatch and what is reported elsewhere 
  • How the data in MedWatch reports are evaluated by FDA 
  • How data from MedWatch reports are used  

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. 

New online look

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.   

Reports can save lives

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.

The role of pharmacists

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.