Use of big data for drug safety monitoring and decision making.
10.5124/jkma.2014.57.5.391
- Author:
Sun Young JUNG
1
;
Nam Kyong CHOI
;
Joongyub LEE
;
Byung Joo PARK
Author Information
1. Korea Institute of Drug Safety and Risk Management, Seoul, Korea. bjpark@snu.ac.kr
- Publication Type:Original Article
- Keywords:
Big data;
Pharmacovigilance;
Pharmacoepidemiology
- MeSH:
Administrative Personnel;
Decision Making*;
Delivery of Health Care;
Drug Utilization;
Drug-Related Side Effects and Adverse Reactions;
Europe;
Humans;
Korea;
Pharmacoepidemiology;
Pharmacovigilance;
Risk Management
- From:Journal of the Korean Medical Association
2014;57(5):391-397
- CountryRepublic of Korea
- Language:Korean
-
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.
