江苏省药品不良反应和药品安全性问题认知度调查

Investigation of the Recognition Degree and Influence Factors of Adverse Drug Realtion and Drug Safety in Jiangsu Province

目的:了解江苏省涉药人员对药品不良反应(ADR)和药物安全性问题的认知情况,为药品安全监管提供参考。方法:采用多级分层随机抽样的方法,按单位集中被调查人员统一填写问卷。EpiData3.1建立录入系统,用SPSS13.0和SAS9.1软件进行统计分析。结果:回收问卷5 482份,纳入统计5 474份,回收率81.69%。江苏省涉药人员对于ADR基本知识、ADR的监管知识、合理用药等知识认知程度较高,对于药物警戒认知程度较低。不司地区、不同单位之间、单位内不同岗位之间人员的认知程度有一定差距。单因素分析显示,单位类型、地区、工龄、本岗工作年限、文化程度和职称与认知程度有关,性别与年龄则与认知程度高低无关。多因素回归分析显示,单位类型、地区、文化程度和职称与认知程度的高低有高度的统计学关联,而工龄和本岗工作年限与认知度无关。结论:江苏省涉药人员对于ADR的相关知识认知程度较高,而对于药物警戒认知度低,不同单位不同地区之间存在差异。需加大对药品生产企业,以及经济欠发达地区的宣传培训力度,在不同的单位中,应加大对直接面对患者的人员的培训教育,提高ADR报告意识,促进ADR监测工作平稳、高速发展。

Objective： To investigate the recognition degree and influence factors of adverse drug reactions and drug safety. Method： By means of multiphase random sampling, the interviewees filled in the questionnaires on the spot. The data were input with EpiData 3.1 and analyzed with software SAS 9.1. Result： 5474 eligible questionnaires were obtained and the recovery rate was 81.69%. The interviewees had a good recognition of basic ADR knowledge, administration knowledge and rational drug use, but a poor recognition of pharmacovigilance. There were some differences in recognition between different regions, units and positions. The mono-factor analysis suggested that the recognition degree was related with regions, unit types, and length of service, culture degrees and professional titles. The multi-factor analysis suggested that the recognition degree was highly related with regions, unit types, culture degrees and professional titles. Conclusion： The interviewees have a better recognition of basic ADR knowledge than pharmacovigilance knowledge. There are differences in the recognition between different regions and units. It is imperative to provide special training courses for healthcare professionals according to different regions and units, so as to improve their consciousness of ADR reporting and promote the development of ADR monitoring.