The Irony of MedWatch and the FAERS Database: An Assessment of Data Input Errors and Potential Consequences

Abstract

Health care delivery revolves around accurate documentation, with data management free from error. A seemingly insignificant typographical error can cause short- and long-term problems that may lead to inaccurate records and misinformation. This report presents an overview of input errors in the US Food and Drug Administration Adverse Event Reporting System (FAERS). The focus is on errors and inconsistencies in reporting of drug names in the FAERS database, initiated through input of the MedWatch reporting system. The consequences from erroneous data input—in this case, drug names—can have an impact on data integrity, research, and patient safety.