PRM68 - Spontaneous reporting data: A global comparison using an online database resource

Abstract

Analyze SR database profiles and classify use of data fields. We identified databases profiled in B.R.I.D.G.E. collecting SR data using two search criteria: Database Type=Spontaneous reporting systems; and Database Source=Spontaneous reports. Twenty of 198 profiles matched ≥1 criteria; frequency of use of the 75 data fields were compared. Based on use frequency, fields were categorized into Group 1 (G1 - consensus in use of field among the set), Group 2 (G2 - use by ≥50% databases), or Group 3 (G3 - use by <50% databases). Of the 75 data fields, 53 (71%) were frequently used among databases with SR data: 21 (28%) were classified into G1 (e.g., Diagnosis data, Drug data), and 32 (43%) into G2 (e.g., Death recorded, Physician specialty). Fields utilized less frequently (n=22; 29%) comprised G3 (e.g., Medical Record Access, Linkage Capabilities). Analysis of G1 revealed that a majority of SR databases are funded by government agencies, capture OTC & prescription drug use in inpatient & outpatient settings; however, diagnosis data are heterogeneously coded. Of the 25 fields on the CIOMS reporting form, 17 corresponded to G1, and 8 to G2. In this analysis, B.R.I.D.G.E. served as a screening tool to categorize data fields used in SR databases and successfully identified additional fields to complement the CIOMS effort.