陕西省和四川省药品不良反应报告单位调查研究  

Investigation on the ADR Reporting Entities in Shaanxi and Sichuan Province

作　　者：张雪梅[1,2] 郭佳栋[1,2] 冯变玲[1,2] 杨世民[1,2] 

机构地区：[1]西安交通大学药学院药事管理与临床药学系,西安710061 [2]西安交通大学药品安全与政策研究中心,西安710061

出　　处：《中国药房》2015年第30期4185-4187,共3页China Pharmacy

基　　金：国家社会科学基金资助项目(No.13BGL132)

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。OBJECTIVE： To understand the present situation of ADR reporting entities in Shaanxi and Sichuan province, and provide evidence for the improvement of ADR monitoring. METHODS： Getting the overview of ADR monitoring at home and abroad by reading a lot of literature, the ADR monitoring entities （drug manufacturers, drug distributors and medical institutions） in Shaanxi and Sichuan province were selected as subject for cluster sampling, questionnaires were sent out and descriptive statis- tics analysis was adopted to processing and analyze the results. RESULTS： Totally 198 questionnaires were received, 100 for Shaanxi province and 98 for Sichuan province. In Shaanxi and Sichuan province, there are 61 and 63 investigated subjects had es- tablished ADR monitoring departments, 98.0% and 100% had had personnel for the ADR work; ADR monitoring work mostly be- longed to the quality control department in drug manufacturers and drug distributors, and belonged to pharmacy department in medi- cal institutions; most of them were equipped with computer, printer and other basic office equipment; however, the major duty of most was not clearly; 13 and 23 subjects had special budget for ADR monitoring; 87 and 89 subjects had communication with lo- cal ADR monitoring center, however, the information feedback was not very ideal; training the workers accounted for 80.0% and 83.0%, respectively; in terms of system construction, the standard operation procedure was relatively good, and the other related was not ideal; reporting quickly when finding ADR was 89.0% and 96.9%, 88.0% and 96.9% of which had backup records for ADR reporting, it was mainly network report; Shaanxi province was better than Sichuan province about the satisfaction evaluation of ADR work. CONCLUSIONS： According to the results, it is suggested to adjust the structure of workers, buy related software re- source, improve the responsibilities and strengthen the financial support to promote the implementation of ADR monitoring.

关 键 词：陕西省 四川省 药品不良反应 报告单位 调查 

分 类 号：R195[医药卫生—卫生统计学]