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目的分析适合我国的药品不良反应公众报告途径、报告内容及反馈方式,为我国建立药品不良反应公众报告模式提供参考。方法选择全国省级不良反应监测机构和部分市县级监测机构人员,并采取配额抽样的方法选择山东省的公众进行问卷调查,调查对我国建立药品不良反应公众报告途径、报告内容及反馈方式等的需求。结果公众优先选择电话(74.2%)、微信公众号(68.7%)和互联网网站(66.0%)为报告途径,54.6%的监测机构认为应选择互联网网站报告。在报告内容方面,愿提供除身份证号码外个人基本信息的公众占42.6%;47.6%的监测机构认为身份证号不是必报内容,97.9%的监测机构认为应提供报告人或联系人电话号码。公众能提供伤害表现的比例为80.2%,而能提供产品名称、生产批号、批准文号、规格型号和生产厂家等产品信息(占34.2%)和伤害表现、伤害过程或事件描述、伤害部位、照片等伤害信息(占24.3%)的比例较低。需要信息反馈的公众占30.5%。结论开展药品不良反应公众报告工作时,应建立电话、微信公众号、互联网等多种报告途径;报告内容应该根据公众特点设计易于获取且是分析评价必需的参数;应向报告人做好信息反馈工作。
Objective To analyze the public reporting methods, contents and feedback methods of adverse drug reactions suitable for our country and provide reference for our country to establish the public reporting mode of adverse drug reactions. Methods Select the national ADR monitoring institutions and some city-level monitoring agencies, and take the quota sampling method to select the public in Shandong Province to conduct questionnaire survey to investigate the public reporting ways, content and feedback of adverse drug reactions in China The demand. Results Public preference telephone (74.2%), WeChat public account (68.7%) and Internet website (66.0%) were the reporting channels, while 54.6% of the monitoring agencies believed that they should choose Internet website report. In terms of the contents of the report, 42.6% of the general public is willing to provide personal basic information except for the ID number. 47.6% of the monitoring agencies consider that the ID number is not essential and 97.9% of the monitoring agencies consider that the reporter or contact number should be provided . The public can provide 80.2% of the damage performance, but can provide product information such as product name, production lot number, approval number, model number and manufacturer (34.2%) and injury performance, injury process or event description, injury site, Photos and other injury information (24.3%) is lower. The public, who need feedback, accounts for 30.5%. Conclusion When conducting public reporting of adverse drug reactions, we should establish a variety of reporting channels such as telephone, WeChat public account, internet and so on. The content of the report should be designed according to public characteristics and be easy to obtain and necessary for analysis and evaluation. Information should be provided to the reporter jobs.