Pharmacovigilance systems and databases in Korea, Japan, and Taiwan
Article first published online: 21 SEP 2011
Copyright © 2011 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 20, Issue 12, pages 1237–1245, December 2011
How to Cite
Kimura, T., Matsushita, Y., Yang, Y.-H. K., Choi, N.-K. and Park, B.-J. (2011), Pharmacovigilance systems and databases in Korea, Japan, and Taiwan. Pharmacoepidem. Drug Safe., 20: 1237–1245. doi: 10.1002/pds.2244
- Issue published online: 22 NOV 2011
- Article first published online: 21 SEP 2011
- Manuscript Accepted: 1 AUG 2011
- Manuscript Revised: 3 JUL 2011
- Manuscript Received: 17 MAR 2011
- signal detection;
The aim of this article is to qualitatively describe the characteristics of spontaneous reporting systems, signal detection methods, and observational databases in Korea, Japan, and Taiwan.
National statistics and published literature were reviewed to determine the annual number of spontaneous reports and the main source (reporters) for each country. The data items collected for spontaneous reports, mode of transmission, availability of reports, and quantitative methods for signal detection were compared across the countries. The characteristics of the national insurance claims databases also were summarized.
The number of annual domestic spontaneous reports in 2007 from Korea, Japan, and Taiwan were 3751, 32 391, and 6971, respectively, which increased to 26 827, 34 649, and 10 320, respectively, over the next 2 years. If adjusted by total population, the latter would be 5.59, 2.71, and 4.49 per 10 000 persons, respectively. The reports were directly submitted mainly by physicians (51%) in Korea and hospital pharmacists (65%) in Taiwan, whereas 89% of the reports in Japan were submitted by manufacturers. Routine data mining of the national spontaneous report database has been implemented in Japan and will be in Korea and Taiwan.
Differences in quantity and submission practice of spontaneous reports should be noted for potential comparison among these countries/regions, as well as with those from Western countries, even after the full implementation of national data mining system. Nationwide claims databases with nearly 100% coverage are great assets for pharmacovigilance and pharmacoepidemiology and can be major contributors to global pharmacovigilance. Copyright © 2011 John Wiley & Sons, Ltd.