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KMID : 1011320120050030137
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Journal of Pharmacoepidemiology and Risk Management
2012 Volume.5 No. 3 p.137 ~ p.142
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Pharmacovigilance System Based on EHR for Surveillance of Adverse Drug Reactions
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Rho Mi-Jung
Kim Si-Ra
Choi In-Young
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Abstract
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Objective: Drug safety surveillance have been done based on spontaneous reporting system in South Korea. However, it have been reported about disadvantages of spontaneous reporting system. As a result, surveillance of adverse drug reactions based on Electronic Health Record (EHR) system is proposed as complementary method. However, little research has been conducted on surveillance of adverse drug reactions based on EHR system.
Methods: This study reviewed three previously conducted project for surveillance systems including Europe- Adverse Drug Reaction, Mini-Sentinel and Observational Medical Outcomes Partnership. Three project were compared from the different categories such as project periods, funding resource, database structure and developed software.
Results: The proposed project were begun in 2008 and each project developed different Common Data Model (CDM) to standardize different data structure and to get unified analysis results from the distributed system. In addition, software was developed to analyze safety signal and provide results. Finally, standard vocabulary like ICD-9-CM, ATC, and SNOMED-CT were proposed.
Conclusion: Even though Electronic Medical Record (EMR) system is more popular in South Korea, we believe the lessons learned from three projects will be the principal reference to develope the Korean adverse drug even monitoring system in near future.
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KEYWORD
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Adverse Drug Reactions, Common Data Model, Europe-Adverse Drug Reaction (EU-ADR), Mini Sentinel, Observational Medical Outcomes Partnership (OMOP)
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