J Korean Med Assoc.  2014 May;57(5):391-397. 10.5124/jkma.2014.57.5.391.

Use of big data for drug safety monitoring and decision making

• Jung SY
• Choi NK
• Lee J
• Park BJ

• KMID: 2194881
• DOI: http://doi.org/10.5124/jkma.2014.57.5.391

Abstract

The development of information technologies has led to the era of big data; such enormous collections of information on drugs and adverse drug reactions are stored in either a structured, a semistructured, or an unstructured form. Because of the nature of the emerging issue of drug safety, it is common for policy makers and healthcare professionals to make decisions without sufficient evidence. Big data may be used as an efficient pharmacovigilance tool, which enables us to recognize adverse drug reactions that may not have been identified in pre-marketing clinical trials, in order to capture the patterns of drug utilization and adverse events, and to predict the occurrence of adverse drug reactions. National surveillance systems using electronic health databases have been established successfully in the US and Europe. The Korea Institute of Drug Safety and Risk Management (KIDS) plans to establish a big data platform for pharmacovigilance in Korea. The big data may be effectively used for evidence-based regulatory and clinical decision making in the field of drug safety and risk management.

Keyword

Big data; Pharmacovigilance; Pharmacoepidemiology

MeSH Terms

Administrative Personnel
Decision Making*
Delivery of Health Care
Drug Utilization
Drug-Related Side Effects and Adverse Reactions
Europe
Humans
Korea
Pharmacoepidemiology
Pharmacovigilance
Risk Management

Figure

• 

  Figure 1 Big data platform model by Korea Institute of Drug Safety and Risk Management (KIDS). EMR, electronic medical record; SNS, social network service; DB, database; KAERS, Korea Adverse Event Reporting System; ADR, adverse drug reaction.

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  Figure 2 A framework of future drug safety monitoring system based on the big data. SNS, social network service; ADR, adverse drug reaction.

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