| ABSTRACT Objective:Adverse drug reaction (ADR) information bulletin was an effective means of pharmacovigilance. It had so far been 15 years since China began to implement this system in 2001. To provide guidance for the development of Chinese pharmacovigilance, this study was conducted. Methods:A total of 69 issues of the bulletin during 15 years period were analyzed statistically. Results:The numbers of issues and drug varieties continued to increase, while for the different varieties of different types of ADR, the government has adopted more flexible measures to control drug risk. In terms of western medicine submitted, the anti microbial drugs had the largest proportions. 26 kinds of traditional Chinese medicine (TCM) were submitted, of which ADR of TCM injection were of particular interest. In addition, the latest information bulletin of global drug safety provided a useful complement effect for risk control of drugs using clinically. ADR regarding the skin and its annexes prevailed most from all ADR submitted, and anaphylactic shock was the most serious kind. Conclusion:Chinese ADR information bulletin had achieved some success in guiding drug manufacturing and management area. On the basis of ADR information bulletin, if we could strengthen the active surveillance of high risk species, improve the current laws and regulations, and establish the drug risk management guidelines combining Chinese conditions, it would further promote the development of our pharmacovigilance work. |
