云南省生产企业药品安全性监测认知度调查及分析

目的 通过对云南省药品生产企业相关负责人以及药品不良反应(ADR)监测员药品安全性监测认知度的调查,剖析目前我省药品生产企业药品不良反应监测工作中存在的问题,为提高药品生产企业药品安全性监测水平提供依据和参考.方法 通过向药品生产企业负责人及ADR监测员分别发放问卷,并对问卷结果进行统计分析.结果与结论 药品生产企业对ADR监测工作重视程度不一,人员水平参差不齐,部分企业相关工作人员缺乏ADR的社会意识和责任意识等.应积极开展药品不良反应监测的宣传、加强对企业相关人员的ADR知识的培训显得尤为重要,加强药品监管力度,在监测报告制度的基础上,明确监测责任以及奖惩机制,确保ADR监测的实效.

Yunnan Production Enterprise Drug Safety Monitoring Awareness Survey and Analysis

Objective With the purpose to provide evidences and references for the ADR monitoring enhancement of the pharmaceutical production enterprises, this thesis analyses the current problems of ADR monitoring in such enterprises of Yunnan province through a survey on drug safety monitoring cognition of the related principals and ADR monitoring staff. Methods The research method of this thesis is statistical analysis according to the results of the questionaires distributed to the related principals and ADR monitoring staff of the pharmaceutical production enterprises. Results and Conclusion Not all the enterprises have attached great importance to ADR monitoring; big differences exist among the ADR monitoring staff; the related staff of some enterprises are lacking in social consciousness and a sense of responsibility. Active propagations of ADR monitoring should be carried on; great importance should be attached in the ADR training for the related staff; drug supervision should be strengthened and in order to ensure the actual effect of ADR monitoring, the monitoring responsibility and a reward and punishment system should be made clear based on the monitoring report system.