Many patients may be unaware of FDA’s MedWatch Adverse Reporting Program and the role they can play in helping the agency identify potential safety issues with products in the marketplace. Educating patients about the program, the importance of reporting, and how to submit a report to FDA will aid in safeguarding future patients from potentially serious adverse events.
Explain to patients that MedWatch is FDA’s adverse event reporting program that detects safety hazard signals for medical products. MedWatch reports can be voluntarily submitted by both patients and health care providers for a variety of products. Serious adverse events associated with use of FDA-regulated prescription and OTC drugs, biologics, medical devices, dietary supplements, and cosmetics can all be submitted to the program.
FDA specifically looks for reports of serious adverse events, product quality problems, product use errors, or therapeutic inequivalence or failure associated with the use of these products. In terms of serious adverse events, the agency looks for events that are fatal, life-threatening, or permanently or significantly disabling or those that require or prolong hospitalization, cause a birth defect, or require an intervention to prevent permanent impairment or damage.
Tell patients inquiring about product use errors about the potential for two drugs with similar names to cause numerous medication errors because of name confusion. Past MedWatch alerts for therapeutic inequivalence or failure have been generated after patients have reported select products not being effective.
Patients should not report common, less serious adverse events cited in the prescribing information, such as nausea or constipation, to MedWatch. In addition, patients should not report problems associated with vaccines, investigational drugs or biologics, or websites selling illegal products.
MedWatch reports can be generated using FDA’s Form 3500 and submitted online at www.fda.gov/medwatch or mailed or faxed to FDA. The agency also has a dedicated toll-free number for those who want to submit a report by phone (800-332-1088).
Explain to patients that clinical trials cannot identify all potential problems. Controlled clinical trials test a relatively small number of patients; therefore, it is harder for these trials to detect rarer adverse events. Because these trials are also limited in duration, they may also miss adverse events that develop with longer-term therapy.
Once a report is submitted, FDA reviews it, looks for similar reports, and determines if additional studies or a change is needed. These changes may include an update to the product labeling; a change to its design, process, packaging, or distribution; or a product recall. When FDA generates safety alerts from MedWatch reports, the agency sends them to thousands of practitioners via email announcements, RSS feeds, and Twitter so that clinicians can be instantly informed of safety issues and they can protect patients from potential problems.
FDA has a number of online resources to help patients understand MedWatch, including FDA 101: How to Use the Consumer Complaint System and MedWatch (www.fda.gov/ForConsumers/ConsumerUpdates/ucm049087.htm) and Your Guide to Reporting Problems to FDA (www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm). Patients can use the National Council on Patient Information and Education’s Make Notes & Take Notes document (www.talkaboutrx.org/assocdocs/TASK/269/make_notes.pdf) to determine what to watch for and expect from their medications.
Encourage all patients to report serious problems to FDA’s MedWatch. It takes only one person to make a difference.