TABLE 1

Data Sources, Case Definitions, and Case Identification/Acquisition Processes

Data SourceCase DefinitionCase Identification/Acquisition Process
National Poison Data System of the American Association of Poison Control CentersCases that reported a medical outcome of moderate effect, major effect, or death.Real-time surveillance software algorithms identified eligible cases by age, index drug, and medical outcome. Standardized data collection sheet included patient information, products involved, dose, duration of use, drug administration technique, clinical course, clinical effects, and outcomes. Deidentified case records were received.
FAERSFatal and nonfatal AEs based on the International Conference on Harmonization definition.The FAERS database was searched quarterly to identify eligible cases by age and index drug. The deidentified records were obtained from the FDA as MedWatch forms with standardized fields for patient demographics, exposure information, suspect drugs, concomitant medications, AEs, and case narrative.
Medical literatureCases that met minimum eligibility criteria.English-language medical literature was systematically searched weekly to identify eligible cases. Search results were reviewed and the full text of publications that potentially included eligible cases were obtained.
News/media reportsCases that met minimum eligibility criteria.A weekly search using software algorithms was conducted to identify eligible cases in regional or national news and media reports. All reports were publicly available. The full article was retrieved for reports that potentially contained an eligible case.
Manufacturer postmarketing safety databasesFatal and nonfatal serious AEs based on the International Conference on Harmonization definition.Participating manufacturers searched their safety databases quarterly by age and index drug to identify eligible cases. The deidentified record was delivered as either a FDA MedWatch form or World Health Organization’s Council for International Organizations of Medical Sciences form with standardized fields for patient demographics, exposure information, suspect drugs, concomitant medications, AEs, and case narrative.