中国药房2012,Vol.23Issue(33):3078-3080,3.DOI:10.6039/j.issn.1001-0408.2012.33.03
我国药品安全信息的管理与交流探讨
Investigation on Administration and Communication of Domestic Drug Safety Information
摘要
Abstract
OBJECTIVE: To provide references for the promotion of effective use of drug safety information in China. METHODS : The administration status and main communication form of drug safety information in China were analyzed. Suggestions on improving the communication of drug safety information in China were put forward by learning the guidance of drug safety information communication in America. RESULTS & CONCLUSIONS: At present, ADR report system, principle of drug safety information openness have been carried out in China, and the revision of package insert must be informed to users and safety risk of recalled drug shall be made public in society. Main communication patterns of drug safety information include the establishment of ADR reporting system, Pharmacovigilance Briefing issued by center of ADR monitoring, announcements and documents issued by SFDA, drug quality announcement issued by drug administration department. It is suggested to prefect drug safety information public issue mechanism, standardize drug safety information dissemination process, content and form, ensure the timeliness and authority of information and enhance information utilization to play an active role on guiding clinical rational use of drug.关键词
药品安全信息/管理/交流Key words
Drug safety information/ Administration/ Communication分类
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赵怀全..我国药品安全信息的管理与交流探讨[J].中国药房,2012,23(33):3078-3080,3.