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U.S. Department of Health and Human Services

Drugs

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FDA’s Adverse Event Reporting System Notification of Paper Backlog

[6/24/2013]

The U.S. Food and Drug Administration (FDA) is alerting the public to a backlog of paper reports submitted to FDA’s Adverse Event Reporting System (FAERS).  FAERS is a new FDA database that contains reports from the public, health professionals, and industry on drug side effects and medication errors associated with marketed drugs.  Unforeseen issues in data entry operations have slowed entry of paper reports into the database, which has resulted in a backlog of unprocessed paper reports.

Adverse event reports are submitted to FAERS in electronic and paper formats.  FDA currently receives about 900,000 adverse event reports every year.  Ninety percent of all adverse event reports are submitted to FDA in the electronic format. Ten percent are submitted in paper, which must be entered manually.  There is no backlog in data entry for the electronic reports.

To eliminate the backlog of paper reports, FDA has added additional data entry staff and is instituting other methods of entering paper adverse event reports into FAERS. Until the backlog is completely eliminated, FDA is prioritizing data entry of the most critical reports – ones that contain information on adverse events that are serious and not in the product’s current label, ones that come from consumers, and ones about which FDA has concerns about an emerging safety issue. FDA is committed to transparency and will provide more information on our progress as this backlog is resolved.

Health care professionals and consumers should continue to report adverse events and/or medication errors to the products’ manufacturers and to FDA’s MedWatch Program. Sponsors should remain vigilant in their reporting practices and are encouraged to submit adverse event reports electronically.

To report adverse events or medication errors to FDA’s MedWatch Safety Information and Adverse Event Reporting program see the options below:

  • Complete and submit the report online: www.fda.gov/MedWatch/report.htm
  • Download the form and submit by fax to 1-800-FDA-0178.
  • Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form