Pharmacovigilance in China: issues of concern identified through an analysis of the Chinese Adverse Drug Reaction Information Bulletin 2001 to 2014.

Abstract

The Adverse Drug Reaction Information Bulletin (ADRIB), issued by China Food and Drug Administration (CFDA), is a major source of information on drugs causing safety concerns in China. As the publication is only published in Chinese, we undertook an analysis of the reports in the ADRIB since its first publication in 2001 to give international readers a better appreciation of the pharmacovigilance issues addressed. Every issue of the ADRIB was scrutinized, and the issues addressed as well as the drugs involved are summarized and discussed. From 2001 to 2014, 109 items of ADR information have been reported. The antimicrobial agents were most often the subject of discussion. There were 28 traditional Chinese medicines (TCMs) discussed. Among the ADRs addressed, the adverse reactions of the skin and its appendages were most frequent. About two-fifths of the ADRs arose from the inherent properties of the active substance, and a majority of the ADRs were caused by off-label use, irrational drug combinations and misuse in special populations. Many of the pharmacovigilance issues addressed were similar to those considered by Western Drug Regulatory Agencies. The pharmacovigilance issues relating to Chinese traditional medicines are less well addressed internationally, and these would be of particular value as the use of such medicines increases in the West.