利用定性访谈的方法探讨我国药品安全的涵义

目的了解药品监管人员、医务工作者和专业技术人员对于药品安全涵义的认识。方法采取定性访谈的方法围绕访谈提纲了解调查对象对药品安全的概念和核心问题的看法。结果访谈对象对我国药品安全的形势十分担忧，不过认为总体上是向好的方向发展；大部分受访者认为药品安全涵盖所有与药物相关的工作，其组成应包括：药品质量问题、药品不良反应、合理使用、政策保障、可获得性等内容；现阶段质量问题和合理用药是受访者集中反映的药品安全核心内容；访谈对象认为药品安全的薄弱环节和工作重点体现在多方面，包括研究、生产、流通、使用的各个环节，普遍认为从源头抓起是最有效的措施，包括构建和完善与药品安全相关的法律、法规和文件，明确部门职责，加强对药品研发、生产、经营和使用的监管。结论药品安全的涵义可总结为“通过对药品研发、生产、流通、使用全环节进行管理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”。

Analysis on Concept of Drug Safety According to the Result of Qualitative Interview

Objective To discuss the definition and factors in China. Methods Qualitative interview category of drug safety, and to identify the main risk methods were implemented in this study. Results Depth interviews of 15 experts showed that most experts believed that drug safety should include quality of drugs, adverse drug reactions, non-rational use of drugs, policy safeguard and accessibility, the quality issues and non-rational use of drugs were major influence factors. Conclusion Drug safety should be defined as a status that the external and internal risk was eliminated by supervising, besides necessary supply and information feedback.