超说明书用药 理与法的考量

Off-label Drug Use,Pros and Cons from the View of Regulation and Science?

若要列出2010年的＂医药大事记＂,恐怕阿瓦斯汀的＂眼药门＂事件必定榜上有名。2010年9月10日,上海市卫生局披露,上海市第一人民医院对116名眼部出现＂黄斑变性＂的患者注射阿瓦斯汀治疗,其中61人出现眼部红肿、视力模糊等局部反应症状。

Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication;off-label use may include irrational use and evidence-based treatments required by the patients' conditions.The former one is due to the irresponsibility of physicians,and the latter one is needed by the patients' conditions.Although the latter condition may be supported by clinical evidence,off-label use implicates that both the physicians and patients will face more extra risks.The phenomenon of off-label will continue to exist,how to regulate and avoid the possible risk should be considered the most importantly.