江苏省和广东省药品不良反应报告单位调查研究

Study on the Adverse Drug Reaction Reporting Entities in Jiangsu Province and Guangdong Province

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 investigate the present situation of adverse drug reaction（ADR）reporting entities in Jiangsu province and Guangdong province,and provide reference for the improvement of ADR monitoring. METHODS：With the overview of ADR monitoring at home and abroad by reading literatures,the ADR reporting entities（drug manufacturers,drug distributors and medical institutions）in Jiangsu province and Guangdong province were selected as objects for cluster sampling by questionnaires,and descriptive statistical analysis and other methods were adopted to process and analyze the results. RESULTS：There were totally205 effective questionnaires. In Jiangsu province and Guangdong province,67 and 60 of the surveyed ADR reporting entities had specialized ADR monitoring departments,98.1% and 99.0% had equipped with specialized personnel for ADR work;ADR monitoring mostly belonged to quality management department in drug manufacturers and distributors,and pharmacy department in medical institutions;most entities were equipped with computers,printers,copiers and other basic office equipments;but most entities＇ responsibilities were not clear enough;27 and 15 entities had specialized budget for ADR monitoring;97.2% and 96.9% had communication with ADR,monitoring center,but the feedback information was unsatisfactory;85.0% and 86.7% had related training for personnel;establishing standard operating procedures of the system construction was relatively good,the other related system construction was still not ideal;91.6% and 90.8% would report ADR immediately after discovery,92.5% and 97.9% would backup recording the ADR,mainly by internet reporting;the average scores in terms of job satisfaction in Jiangsu province were higher than Guangdong province. CONCLUSIONS：According to the results,it is suggested to improve the system construction of ADR monitoring,optimize working conditions,ensure financial support of ADR monitoring,and strengthen work communication and system construction and other measures to promote conduct of ADR monitoring.