Standardizing Drug Adverse Event Reporting Data

Stud Health Technol Inform. 2013;192:1101.

Abstract

Normalizing data in the Adverse Event Reporting System (AERS), an FDA database, would improve the mining capacity of AERS for drug safety signal detection. In this study, we aim to normalize AERS and build a publicly available normalized Adverse drug events (ADE) data source.he drug information in AERS is normalized to RxNorm, a standard terminology source for medication. Drug class information is then obtained from the National Drug File - Reference Terminology (NDF-RT). Adverse drug events (ADE) are aggregated through mapping with the PT (Preferred Term) and SOC (System Organ Class) codes of MedDRA. Our study yields an aggregated knowledge-enhanced AERS data mining set (AERS-DM). The AERS-DM could provide more perspectives to mine AERS database for drug safety signal detection and could be used by research community in the data mining field.

MeSH terms

  • Adverse Drug Reaction Reporting Systems / standards*
  • Data Mining / standards*
  • Databases, Pharmaceutical / standards*
  • Documentation / standards*
  • Medical Record Linkage
  • Practice Guidelines as Topic*
  • RxNorm*
  • United States
  • United States Food and Drug Administration
  • Vocabulary, Controlled*