Information Technology (IT) and specialized systems could have a prominent role towards the support of drug safety processes, both in the clinical context but also beyond that. PVClinical project aims to build an IT platform, enabling the investigation of potential Adverse Drug Reactions (ADRs). In this paper, we outline the utilization of Observational Medical Outcomes Partnership - Common Data Model (OMOP-CDM) and the openly available Observational Health Data Sciences and Informatics (OHDSI) software stack as part of PVClinical platform. OMOP-CDM offers the capacity to integrate data from Electronic Health Records (EHRs) (e.g., encounters, patients, providers, diagnoses, drugs, measurements and procedures) via an accepted data model. Furthermore, the OHDSI software stack provides valuable analytics tools which could be used to address important questions regarding drug safety quickly and efficiently, enabling the investigation of potential ADRs in the clinical environment.
Keywords: Adverse Drug Reactions; Drug Safety; Electronic Health Records; OMOP-CDM; Pharmacovigilance.