Development of a Facts Database for Evidence-Based Adverse Reaction Diagnosis

Abstract

Purpose: We have been building the CARPIS (Case Reports of Adverse Drug Reactions and Poisoning Information System) database since 1987 and have been using CARPIS primarily as a literature database. The purposes of this study were to revamp CARPIS as a fact database for adverse drug reactions (ADRs) and to develop methodology for identifying symptoms as part of evidence-based adverse reaction diagnosis. Revamp: Fact data in case reports, such as causative drugs, ADRs, and patient backgrounds, were analyzed to develop functions for the fact database and to establish different data fields. We developed our own dictionaries and data-tabulating function. Outcome: It was possible to calculate the incidence of subjective symptoms for ADRs, list causative drugs, and identify risk factors using the revamped CARPIS. The incidence of each subjective ADR symptom was compared with the incidence of objective symptoms associated with particular ADRs to identify subjective symptoms that could estimate ADRs. We succeeded in creating new information regarding the symptoms for evidence-based adverse reaction diagnosis. Conclusion: We were successful in revamping CARPIS as a novel fact database for ADRs and in developing methodology for identifying symptoms for evidence-based adverse reaction diagnosis.