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| 陕西省药品不良反应报告主体工作现状的实证研究 |
| Empirical Research on the Work Status of Adverse Drug Reaction Reporting Entities in Shanxi Province |
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| DOI： |
| 中文关键词: 药品不良反应 陕西省 报告主体 |
| 英文关键词:Adverse drug reaction Shanxi Province Report entity |
| 基金项目:国家社科基金资助项目（编号：13BGL132） |
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| 中文摘要: |
| 摘 要 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。 |
| 英文摘要: |
| ABSTRACT Objective: To investigate the present situation of adverse drug reaction reporting entities in Shanxi province, identify gaps and priorities of monitoring activities. And provide practical recommendations for the construction of organization system. Methods: The questionnaire was administered to Shanxi province reporting entities, selecting the subject by cluster sampling. The statistical analysis was performed with SPSS 19.0.Results:After analyze information of the returned questionnaires, information of the present situation of Shanxi province reporting entities, status of adverse drug reactions reporting were conclude . Conclusion:The present study has identified some challenges of drug safety monitoring in Shanxi province. We argue that a comprehensive pharmacovigilance system should involve the following elements including structures, specific systems, sufficient staffs and facilities and state of the art tools. Improving the quality and quantity of the adverse drug reactions report is also a key point in the process of drug safety monitoring. |
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