江苏省和广东省药品不良反应报告单位调查研究

发布时间：2018-11-18 14:17

【摘要】：目的:了解江苏省和广东省药品不良反应(ADR)报告单位工作开展现状,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,以江苏省和广东省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205份。江苏省和广东省受访ADR报告单位专门建立ADR监测部门的分别为67家和60家,专门配备人员负责ADR工作的分别占98.1%和99.0%;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;大多数配备了计算机、打印机、复印机等基本办公设备;但大多数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27家和15家;与当地ADR监测中心有交流沟通的分别占97.2%和96.9%,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85.0%和86.7%;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占91.6%和90.8%,会对上报的ADR进行备份记录的分别占92.5%和97.9%,以网络报告形式为主;工作满意度评价方面,江苏省的平均分高于广东省。结论:针对调查结果,建议通过完善ADR监测工作组织建设、优化办公条件、保证ADR监测经费支持、加强工作交流、加强制度建设等措施,促进其ADR监测工作的开展。
[Abstract]:Objective: to understand the present situation of (ADR) reporting units of adverse drug reactions in Jiangsu Province and Guangdong Province, and to provide basis for the improvement of ADR monitoring. Methods: to find out the general situation of ADR monitoring at home and abroad by consulting the literature, taking Jiangsu Province and Guangdong Province ADR reporting units (drug production enterprises, drug trading enterprises, medical institutions) as the research objects, cluster sampling and issuing questionnaires. The method of descriptive statistical analysis is used to deal with and analyze the survey results. Results: 205 valid questionnaires were collected. In Jiangsu province and Guangdong province, 67 and 60 ADR monitoring departments were established, and 98.1% and 99.0% of them were specially staffed to take charge of ADR work, respectively. ADR monitoring work in drug production, most of the business enterprises belong to the quality management department, most of the medical institutions belong to the pharmaceutical department, most of them are equipped with computer, printer, photocopier and other basic office equipment. However, most of the job responsibilities are not clear enough; 27 and 15 special budgets are available for ADR monitoring, 97.2% and 96.9% of the local ADR monitoring centers communicate with each other, respectively, but the information feedback is not satisfactory. 85.0% and 86.7% of the staff were trained respectively. In the aspect of system construction, the establishment of standard work flow is relatively good, and the other related system construction is not ideal. 91.6% and 90.8% of ADR will be reported immediately, 92.5% and 97.9% of them will backup and record the reported ADR respectively, mainly in the form of network report. In terms of job satisfaction evaluation, the average score of Jiangsu Province is higher than that of Guangdong Province. Conclusion: in view of the investigation results, it is suggested to improve the organization and construction of ADR monitoring work, optimize office conditions, ensure the support of ADR monitoring funds, strengthen work communication and strengthen the system construction to promote the development of ADR monitoring work.
【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】：R95

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