Development Common Data Model for Adverse Drug Signal Detection Based on Multi-Center EMR Systems

The drug safety monitoring based on EMR system is able to collect more objective pharmacovigilance data and analyze adverse drug reaction (ADR) earlier than spontaneous ADR reporting. This study developed the Korea ADR common data model (K-ADR CDM) for early detection of adverse drug reaction which is feasible for Korean EMR systems. To do that, we analyzed previously studied data model from two prominent drug safety surveillance researches: Mini-Sentinel data model and Observational Medical Outcomes Partnership (OMOP) data model. The K-ADR CDM of eight tables which contain demographic table, drug table, visit table, procedure table, diagnosis table, death table, laboratory table and organization table. Each table consists of 5~12 fields. In addition, controlled terminology will be applied to integrate different EMR systems. To validate the data model of K-ADR, EMR data of S hospital was exported and mapped with the K-ADR. Further efforts for the standardization of procedure code and laboratory code will be needed for multi-institutional pharmacovigilance database system. The pharmacovigilance activity based EMR system will be cost-effective method to detect ADR signals.