试论药品风险的根本来源

The Elementary Resources on Drug Risk

从分析典型的药品不良反应/事件出发,全面分析了形成药品风险的性质及其根本原因;同时,分析了药品与两个要素—风险/效益比和药品质量的均一性的关系;论证了药品风险的根本来源乃是:其一,对于药品风险/效益比认识的局限性,而且这种局限性是客观的;其二,对于质量均一性或已经形成的风险/效益比认识的各种挑战因素,并且这些挑战因素并非仅仅纯粹的技术问题。文章强调,循着药品风险之两个根本来源,从药品风险管理的角度,药品监管和药品企业,无论是在高质量地捍卫药品质量均一性方面,还是在维护药品风险/效益比可以接受方面,都会增强前瞻性和系统性,进而取得良好收益。

On the basis of specific and typical happened adverse drug reactions and events, this article explores and discusses the fundamental natures and reasons that forms the drug risk. At the same time, it analyzes the relations between drug consistency of quality and balance on risk/benefit, which are the main elements. Two aspects are the elementary resources. One is the recognizing limit on risk and balance, which exists objectively nature. Another is on all kinds of challenges to the recognizing con- ceming of drug consistency of quality or the balance on risk/benefit, which are not of the pure technical problems. The article emphasizes, on the basis of above two resources, the regulators and manufacturers will all enhance the prospecnve and systematic to get the good benefit further on both of defending the consistency of drugs in high quality degree and maintaining the acceptance on drug risk/ benefit from the drug risk management.