河南省和河北省药品不良反应报告单位调查研究

发布时间：2018-10-20 13:35

【摘要】：目的:了解河南省和河北省药品不良反应(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,以河南省和河北省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186份。河南省和河北省受访ADR报告单位专门建立ADR监测部门的分别有58家和62家,且全部专门配备了人员负责ADR工作;ADR监测工作在药品生产、经营企业中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;大多数配备了计算机、打印机、电话等基本办公设备;大多数受访ADR报告单位工作职责仍不够明确;有专门用于ADR监测工作的预算的分别为24家和2家;与当地ADR监测中心有交流沟通的分别占95.7%和96.8%,但信息反馈情况不理想;对工作人员进行了相关培训的分别占86.7%和98.9%;建立标准工作流程的情况河北省较好;发现ADR后会立即上报的分别占96.7%和98.9%,会对上报的ADR进行备份记录的分别占92.3%和97.8%;上报形式均以网络报告形式为主;工作满意度评价方面,河南省的平均分高于河北省。结论:针对调查结果,建议通过明确ADR监测工作职责,优化工作条件,保证工作经费,加强工作反馈等措施促进其ADR监测工作的开展。
[Abstract]:Objective: to understand the status quo of (ADR) reporting units of adverse drug reactions in Henan and Hebei provinces, and to provide basis for the improvement of ADR monitoring. Methods: the general situation of ADR monitoring at home and abroad was investigated by consulting the literature. Cluster sampling was conducted with ADR reporting units (drug manufacturing enterprises, drug trading enterprises, medical institutions) in Henan Province and Hebei Province, and questionnaires were distributed. The method of descriptive statistical analysis is used to deal with and analyze the survey results. Results: 186 valid questionnaires were collected. In Henan Province and Hebei Province, 58 and 62 ADR monitoring departments were established by ADR reporting units interviewed in Henan Province and Hebei Province respectively, and all of them were specially staffed to take charge of ADR work. Most of the enterprises belong to the quality management department, most of the medical institutions belong to the pharmacy department; most of them are equipped with basic office equipment such as computer, printer, telephone, etc. There were 24 and 2 special budgets for ADR monitoring, 95.7% and 96.8% of them had communication with local ADR monitoring center, but the information feedback was not satisfactory. 86.7% and 98.9% of the staff were trained respectively. It was found that 96.7% and 98.9% of the ADR would be reported immediately, 92.3% and 97.8% of the reported ADR would be backed up and recorded, respectively. The main form of the report was in the form of network report, and the average score of Henan Province was higher than that of Hebei Province in terms of job satisfaction evaluation. Conclusion: in view of the investigation results, it is suggested that the work of ADR monitoring should be promoted by clarifying the duties of ADR monitoring, optimizing the working conditions, ensuring the work expenses and strengthening the work feedback and so on.
【作者单位】：西安交通大学医学部药学院;
【基金】：国家社会科学基金资助项目(No.13BGL132)
【分类号】：R951

【参考文献】