title: Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration.
abstract: OBJECTIVE
  The Food and Drug Administration (FDA) conducted a quality assessment of the Adverse Drug Events Spontaneous Triggered Event Reporting (ASTER) pilot study, which represented the FDA's first experience with the receipt of electronic health record (EHR)-triggered adverse event reports. The EHR-triggered adverse event reports from ASTER were evaluated for their utility in conducting FDA's pharmacovigilance work. FDA is sharing these findings to assist others who are pursuing the use of patient EHR data for electronic adverse event identification and reporting.
  
  
  METHODS
  ASTER pilot study reports were identified from the FDA Adverse Event Reporting System database, then reviewed and assessed.
  
  
  RESULTS
  Demographic and other objective data that can be easily derived from EHRs were both present in the submitted reports and relevant to the reported adverse drug event (ADE), but other data, such as an informative description of the ADE, dates that support a temporal relationship between the product and the event, and relevant laboratory data, were often either conflicting or lacking. Most of the ADEs captured in the ASTER pilot and reported to FDA are known events (i.e. included in product labeling) for the suspect drugs.
  
  
  CONCLUSIONS
  Triggered adverse event reporting from patient EHRs is a potentially valuable source of postmarketing safety information, especially for known adverse events. Attention to quality is needed to ensure that the data generated from EHR-triggered ADE reporting systems are relevant to the reported adverse events so that the FDA and others engaged in pharmacovigilance can fully utilize these reports.
authors.affiliation: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. sonja.brajovic@fda.hhs.gov
authors.forename: Sonja
authors.initials: S
authors.lastname: Brajovic
authors.forename: Toni
authors.initials: T
authors.lastname: Piazza-Hepp
authors.forename: Lynette
authors.initials: L
authors.lastname: Swartz
authors.forename: Gerald
authors.initials: G
authors.lastname: Dal Pan
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D016208:Databases, Factual / Q000592:standards*; D010865:Pilot Projects; D011785:Quality Assurance, Health Care; D014481:United States; D014486:United States Food and Drug Administration