PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Chantelle Bailey; David Peddie; Maeve E Wickham; Katherin Badke; Serena S Small; Mary M Doyle-Waters; Ellen Balka; Corinne M Hohl Journal: Br J Clin Pharmacol Date: 2016-05-09 Impact factor: 4.335