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目的:调查研究陕西省药品不良反应报告主体工作开展的现状,探讨目前存在的问题和不足,从组织体系建设、制度政策等方面提供切实可行的建议。方法:以陕西省药品不良反应报告主体(药品生产企业、药品经营企业、医疗机构)为研究对象对其进行整群抽样,使用SPSS 19.0统计软件,运用描述性统计分析等方法对回收问卷进行分析处理,得出相应统计结果。结果:陕西省药品不良反应报告主体工作现状、制度建设、上报情况良好,但工作人员满意度方面有待进一步加强。结论:针对研究结果,提出以下建议:完善药品不良反应监测工作组织建设;优化办公条件;保证药品不良反应监测经费;加强工作交流;加强制度建设。
OBJECTIVE: To investigate the status quo of the main body of ADR report in Shaanxi Province, discuss the existing problems and shortcomings, and provide feasible suggestions from the aspects of organizational system, system and policies. Methods: The main body of drug adverse reactions in Shaanxi Province (drug manufacturing enterprises, pharmaceutical companies, medical institutions) as the research object of its cluster sampling, the use of SPSS 19.0 statistical software, the use of descriptive statistical analysis methods to analyze the recovery questionnaire Processing, come to the corresponding statistical results. Results: The status quo, system construction and reporting of the main body of adverse drug reaction reports in Shaanxi Province were in good condition, but the staff satisfaction needs to be further strengthened. Conclusion: According to the research results, the following suggestions are proposed: perfecting the construction of adverse drug reaction monitoring work organization; optimizing office conditions; ensuring drug adverse reaction monitoring funding; strengthening work exchange; and strengthening system construction.