摘要
目的提高药品生产企业应对聚集信号的能力。方法辨析药品不良事件聚集性信号内涵,结合日常工作分析探讨药品生产应对药品不良事件聚集性信号的主要问题及原因。结果药品生产企业主动收集信息能力有限,难以及时发现药品不良事件聚集性信号;调查时以自查为主,难以从临床收集到药品不良事件聚集性信号的病例资料;分析评价能力较弱,难以评估药品不良事件聚集性信号提示的风险因此缺少针对性防控措施。结论药品生产企业应从组织管理与制度设计入手,为药品不良事件聚集性信号应对工作奠定基础;从规定信息收集渠道和传递要求入手,借助信息化手段及时发现药品不良事件聚集性信号;从知识更新和专家咨询入手,全面提升分析评价和风险防控能力。
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.
出处
《中国药物警戒》
2017年第11期671-673,共3页
Chinese Journal of Pharmacovigilance
