我国药品安全定义和范畴的系统综述和定性访谈

目的：深入探讨药品安全的定义和范畴，为药品安全监管工作提供政策性建议。方法：采用系统综述方法，对近10年来相关中、英文数据库及网站中提及药品安全概念、范畴，或对保障药品安全策略和措施的文章分析、整理和综合，总结出药品安全所包含的主要内容；利用定性访谈了解药品监管人员、医务工作者和专业技术人员对于药品安全概念和范畴的认识，以及当前影响药品安全的重要问题。结果：系统综述纳入290篇文献，其中6篇给出了药品安全的定义，纳入文献对于药品安全的定义侧重于药品不良反应／事件监测、避免用药错误、风险管理以及可及性方面。药品安全的范畴主要包括药品监管、药品不良反应／事件、药品保障、药品研发、药品生产、药品流通、药品使用和药品信息获取；定性访谈结果显示，大部分受访者认为药品安全涵盖所有与药物相关的工作，现阶段质量问题和不合理用药是受访者集中反映的药品安全的主要问题。结论：通过综合分析，我们将药品安全定义为通过对药品研发、生产、流通、使用全环节进行监管所表现出来的消除或控制了外在威胁和内在隐患的综合状态，以及为达到这种状态所必要的供应保障和信息反馈。其范畴可以界定为质量符合标准、不良反应在可接受的范围内、临床无用药差错和可及性四个部分。

A systematic review and qualitative analysis of the definition and scope of drug safety in China

Objectives: This article discusses the definition and scope of drug safety, and is to identify the main risk factors in China. Methods: A systematic review was conducted through searching English database such as PubMed and some web sources to analyze, scope, and synthesize the definition and scope of drug safety, as well as the strategies and implementations of securing drug safety by using literatures within recent ten years. In addition, a quanlitative reviews was undertaken to describe the understanding of the definition and scope of drug safety through reviewing drug safety administrators, health personnel, and specialists. The review was also included their attitudes of the importance of drug safety. Results: 290 literatures were included and six of them gave the definition of drug safety. Those included literatures focused on adverse drug reactions/events to monitor, prevent medication errors, risk management, as well as drug accessibility. The scope of drug safety mainly included drug monitoring, adverse drug reactions/events, drug security, drug research and development, pharmaceutical production, the flow of drugs, using and information of drugs. Depth interviews showed that the quality issues and inappropriate use of drugs were major influence factors. Conclusion: This article concluded that drug safety should be defined as a status that the external and internal risk be eliminated by supervising, besides necessary supply and information feedback. In addition, the scope of drug safety was defined as appropriate quality, acceptable adverse reaction risk, none of medical error and accessibility.