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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。
OBJECTIVE: To understand the status quo of ADR reporting units in Jiangsu Province and Guangdong Province, and to provide basis for the improvement of ADR monitoring. Methods: Through literature review, we got an overview of ADR monitoring at home and abroad. Cluster sampling was conducted with ADR reporting units in Jiangsu Province and Guangdong Province (pharmaceutical manufacturers, pharmaceutical companies, medical institutions), and questionnaires were distributed. Sex statistics analysis and other methods to deal with and analyze the survey results. Results: A total of 205 valid questionnaires were collected. ADR reporting units in Jiangsu Province and Guangdong Province set up 67 and 60 specialized ADR monitoring departments respectively, and 98.1% and 99.0% respectively for ADR work. The ADR monitoring work was extremely large in drug production and operation enterprises, Most of them belong to the quality control department, and most of the medical institutions belong to the pharmacy department. Most of them are equipped with basic office equipment such as computers, printers and photocopiers. However, most job responsibilities are still not clear enough. There are separate budgets devoted to ADR monitoring 27 and 15, respectively; 97.2% and 96.9% of them had communication and communication with local ADR monitoring centers respectively, but the information feedback was not satisfactory; 85.0% and 86.7% were related to staff training respectively; , The establishment of standard workflow is relatively good, other related system construction is not yet ideal; found ADR will be reported immediately after the 91.6% and 90.8%, respectively, will report the ADR backup records accounted for 92.5% and 97.9% , Mainly in the form of network reports. In the aspect of job satisfaction evaluation, the average score of Jiangsu Province was higher than that of Guangdong Province. Conclusion: According to the survey results, it is suggested to improve the ADR monitoring by improving the organization of ADR monitoring, optimizing office conditions, ensuring financial support for ADR monitoring, strengthening work exchange and strengthening system construction.