关键词: 药品生产企业, 药品不良事件, 聚集性信号

Abstract: Objective To improve the ability of drug manufacturers to deal with the adverse drug event clustering signal. Methods Analyze the connotation of adverse drug event clustering signal, discuss the main problems and causes of drug manufacturers in response to the adverse drug event clustering signal. Results The drug manufacturers are limited in their ability to collect information, so they are difficult to find the clustering signal in time. The investigation is based on self-examination, so it's hard to collect the case data of clustering signal. The ability to analysis and evaluation is weak, so it is difficult to assess the risk of adverse drug event clustering signal and therefor lack of prevention and control measures. Conclusion The drug manufacturers should lay the foundation for response to the adverse drug event clustering signal from organization management and system design. Starting with the channels and delivery requirements of the information collection, the adverse drug event clustering signals can be detected by information means. Starting with knowledge update and expert consultation, to improve the ability of evaluation and risk control.

Key words: drug manufacturers, drug adverse event, clustering signal