陕西省和四川省药品不良反应报告单位调查研究

发布时间：2018-04-24 10:50

本文选题：陕西省 + 四川省　；参考：《中国药房》2015年30期

【摘要】：目的:了解陕西和四川两省药品不良反应(ADR)报告单位的工作开展现状,为ADR监测工作的完善提供依据。方法:通过查阅文献了解国内外关于ADR监测工作的概况,以陕西省和四川省ADR报告单位(药品生产企业、药品经营企业、医疗机构)为研究对象进行整群抽样,发放调查问卷,运用描述性统计分析等方法对调查结果进行处理和分析。结果:共回收有效问卷198份,陕西省100份,四川省98份。陕西和四川受访ADR报告单位专门建立ADR监测部门的分别为61家和63家,专门配备人员负责ADR工作的分别为98.0%和100%;ADR监测工作在药品生产、经营企业绝大多数隶属于质量管理部门,在医疗机构大多隶属于药剂科;大多数都配备了计算机、打印机等基本办公设备;但大多数工作职责不够明确;有专门用于ADR监测工作的预算的分别为13家和23家;与当地ADR监测中心有交流沟通的分别为87家和89家,但信息反馈情况不理想;对工作人员有进行了相关培训的分别为80.0%和83.0%;制度建设方面,建立标准工作流程的情况相对较好,其他相关制度建设尚不够理想;发现ADR后会立即上报的分别为89.0%和96.9%,会对上报的ADR进行备份记录的分别为88.0%和96.9%,上报形式以网络报告形式为主;工作满意度评价方面陕西省的平均分高于四川省。结论:针对调查结果,建议通过调整人员构成、购买相关软件资源、完善工作职责、加强资金支持等措施促进其ADR监测工作的开展。
[Abstract]:Objective: to investigate the status quo of ADR reporting units in Shaanxi and Sichuan provinces, and to provide evidence for the improvement of ADR monitoring. Methods: the general situation of ADR monitoring at home and abroad was investigated by consulting the literature. The ADR reporting units of Shaanxi Province and Sichuan Province (drug manufacturing enterprises, drug trading enterprises, medical institutions) were selected for cluster sampling, and questionnaires were distributed. The method of descriptive statistical analysis is used to deal with and analyze the survey results. Results: 198 valid questionnaires were collected, 100 in Shaanxi Province and 98 in Sichuan Province. In Shaanxi and Sichuan provinces, 61 and 63 ADR monitoring departments were specially established. 98.0% and 100% of ADR monitoring departments were specially staffed respectively in drug production, and the vast majority of trading enterprises were subordinate to quality management departments. Most of the medical institutions are attached to the Pharmacy Department; most are equipped with basic office equipment, such as computers, printers, etc., but most of the duties are not clear enough, and the budgets dedicated to ADR monitoring are 13 and 23, respectively; There were 87 and 89 local ADR monitoring centers, respectively, but the information feedback was not satisfactory; 80.0% and 83.0% of the staff were trained, respectively; and the establishment of the standard work flow was relatively good in the area of system construction. The other related system construction is not good enough: after finding ADR, 89.0% and 96.9% will be reported immediately, 88.0% and 96.9% will backup and record the reported ADR respectively, and the form of report is mainly in the form of network report. The average score of job satisfaction evaluation in Shaanxi Province is higher than that in Sichuan Province. Conclusion: according to the investigation results, it is suggested that the ADR monitoring should be promoted by adjusting the personnel composition, purchasing related software resources, perfecting the work responsibility and strengthening the financial support.
【作者单位】：西安交通大学药学院药事管理与临床药学系;西安交通大学药品安全与政策研究中心;
【基金】：国家社会科学基金资助项目(No.13BGL132)
【分类号】：R95

【参考文献】