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欧美国家与我国利用社交媒体收集药物不良反应的应用现状对比及启示
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篇名: 欧美国家与我国利用社交媒体收集药物不良反应的应用现状对比及启示
TITLE: Situation Comparison and Enlightenment of ADR Collection by Social Media between European and American Countries and China
摘要: 目的:比较欧美国家与我国利用社交媒体收集药物不良反应(ADR)的应用现状,为我国相应工作的完善提供借鉴。方法:通过检索中国知网、WebofScience、ElsevierScienceDirect、SpringerLink等数据库的相关文献,查阅国际人用药品注册技术协调会(ICH)官网的相关资料,先容欧美国家(组织)如美国、欧盟、英国、法国等利用社交媒体(或相关移动应用程序)收集ADR的现状,并与我国相应工作进行比较,分析利用社交媒体收集ADR的优点以及可能存在的问题,同时对我国利用社交媒体收集ADR的工作提出建议。结果与结论:2013年以来,欧美许多国家陆续开始利用社交媒体(如Twitter、脸书等)收集ADR,例如美国药物研究与制造商协会(PhRMA)发布的关于社交媒体上涉及药物安全问题的草案,欧盟组织的创新药物计划(IMI)网络识别药物不良反应事件(WEB-RADR)项目等都包含了利用社交媒体收集ADR的内容。通过这一途径可以更方便患者报告ADR,有助于药物警戒部门及时收集ADR信息,并可作为传统药物安全信息报告的重要补充;另一方面,其也存在患者自发报告的健康词汇与医学专业词汇不匹配,平衡公众健康维护和患者隐私权保护的关系面临挑战,各种偏差影响了利用社交媒体收集ADR的报告率及质量等不足。我国在利用社交媒体(如微信、微博、QQ等社交媒体或工具以及应用程序、小程序等)收集ADR信息时,应确保报告ADR应用程序的易用性与安全性,完善应用程序的设计以符合ICH个例安全报告电子传输实行引导原则E2B(R3)数据要素和信息规范;同时,还要充分发挥监管部门的监督作用并考虑非监管因素,并采取隐私保护措施以使其符合伦理道德。
ABSTRACT: OBJECTIVE:To c ompare the situation of adverse drug reaction (ADR) collection by social media between European and American countries and China ,so as to provide reference for the improvement of corresponding work in China. METHODS:By retrieving relevant literatures from CNKI ,Web of Science ,Elsevier ScienceDirect ,SpringerLink and so on , referring to the official website of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH),the current situation of ADR collection by social media in European and American countries(organizations)such as the United States ,the European Union ,the United Kingdom ,France was introduced ,and compared with the corresponding work in China. The advantages and possible problems of using social media to collect ADR were analyzed so as to put forward some suggestions on how to use social media to collect ADR in China. RESULTS & CONCLUSIONS:Since 2013,many countries in Europe and the United States have started to collect ADRs using social media (such as Twitter ,脸书),such as the draft on drug safety issues on social media issued by the Pharmaceutical Research and Manufacturers of America (PhRMA),and the EU organization ’s Innovative Medicines Initiative (IMI)network to identify adverse drug reaction in web media (WEB-RADR)projects. Through this way ,it is more convenient for patients to report ADR ,and helpful for the pharmacovigilance department to collect ADR information in time ,and can be used as an important supplement to the traditional drug safety information report. However ,there are some advantages ,such as mismatch between the health vocabulary spontaneously reported by patients and medical professional vocabulary ,the challenges of balancing the relationship between public health maintenance and patient privacy protection ,and various deviations affecting the reporting rate and quality of ADR collected by social media. When using social media (such as Wechat ,microblog,QQ and other social media or tools ,as well as applications and small programs )to collect ADR information in China ,it is suggested to ensure the ease of use and security of reporting ADR applications ,and improve the design of applications to comply with E 2B (R3) data elements and information specifications of ICH guidelines for the electronic transmission of individu al security reports. At the same time ,we should give full play to the supervisory role of regulatory department ,consider non-regulatory factors ,and take privacy protection measures to make it conform to ethics.
期刊: 2021年第32卷第07期
编辑: 胡霞,顾雅婕,王峻霞
AUTHORS: HU Xia,GU Yajie,WANG Junxia
关键字: 药物不良反应;药物警戒;社交媒体;欧盟;美国
KEYWORDS: Adverse drug reaction ;Pharmacovigilance;Social media ;EU;United States
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