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Reporting Drug Quality Problems

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Report through MedWatch. FDA receives drug quality reports through its MedWatch Program. MedWatch FDA Form 3500 is used for product quality reports. This form is also used to report adverse events (unexpected side effects) that occur while using FDA-regulated products such as prescription and over-the counter drugs, medical devices, and special nutritional products such as dietary supplements.

Be assured that reporting is confidential and secure. Your information is confidential. Health care professionals are sometimes afraid to make the reports, according to Johnson. “If an adverse event is possibly associated with product quality, health care professionals sometimes worry that they will be singled out," Johnson says.  "But if a reporter chooses not to have his or her identity disclosed, the reporter will remain anonymous; their name and contact information will not be released to anyone outside of FDA without their permission.” 

Fill out forms completely. It's important to fill the MedWatch form out completely as possible with regard to suspect product information and contact information. In 2008, the DQRS staff received 6,263 reports, but was not able to conduct adequate follow-up on one-third of those reports due to a lack of information. In many of those cases, the manufacturer’s name or the National Drug Code (NDC) number listed on the product label was missing.

Drug products are identified and reported using the NDC number. It is a unique 11-digit, 3-segment number assigned to each medication.  The number identifies the labeler or vendor, product, and trade package size. In other cases, contact information such as the phone number or email address was listed incorrectly or was not provided.

How to Report

Consumers or health care professionals can use any of these methods to report problems:

 

For more information about topics for your health, visit the FDA Consumer Information Center (http://www.fda.gov/ForConsumers/default.htm).