Applications of International Spontaneous Reporting System Databases

doi:10.19803/j.1672-8629.2021.12.09

Abstract

Abstract: Objective To outline the current applications of main international spontaneous reporting systems of ADR, including Vigibase, FAERS and EudraVigilance.Methods The websites of major foreign spontaneous reporting systems were searched and articles about the use of spontaneous reporting systems were retrieved. The data format of these databases, accessibility to them, data quality control and the applications of the databases were illustrated with examples. Results The databases of foreign spontaneous reporting systems can be downloaded publicly or obtained under certain conditions. A number of research programs have been conducted based on spontaneous reporting systems.Conclusion The spontaneous reporting system is of great value for post-marketing safety monitoring and China's spontaneous reporting system database can learn from foreign practices in data sharing.

Key words: adverse drug reaction, spontaneous reporting system, database, international

CLC Number:

R971.1

CHI Lijie, CHEN Chenxin, ZHENG Yi, WEI Lianhui, CHEN Xiao, GUO Zhijian, GUO Xiaojing, HE Jia, YE Xiaofei. Applications of International Spontaneous Reporting System Databases[J]. Chinese Journal of Pharmacovigilance, 2021, 18(12): 1144-1147.

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