美国药品标签和说明书修改的程序与方法

The procedures and methods of amending the US drug label

目的:探讨美国修改药品标签的方法,并对我国药品标签和说明书的管理提出建议。方法:选取美国FDA官网上修改药品标签的案例进行统计,并对典型案例进行分析,分析其标签修改的具体措施、程序及原因。结果:美国修改标签的具体措施包括增加黑框警示语、增加标签警示语、注明预防措施、增加禁忌证、增注不良反应、患者说明书改变/增加药物指南等形式。修改标签的原因包括FDA监测过程中发现不良反应、收到上报的不良反应报告、出现严重不良反应事件等。结论:我国药品标签管理应借鉴美国的成熟经验,完善相关法律法规,并鼓励患者主动上报相关问题。

OBJECTIVE To explore the methods for amending the drug label and instructions in the United States, and to make recommendations on the management of drug labels and instructions in China.METHODS The cases of drug label modification on FDA website were selected for statistics, and the typical cases were analyzed to analyze the specific measures, procedures and reasons for label modification.RESULTS Specific measures for label modification l in the United States include adding black box warnings, adding label warnings, indicating preventive measures, adding contraindications, increasing notes to adverse reactions, and modifying/adding drug guides to patient instructions. The reasons for the modification of the label include adverse reactions identified during FDA monitoring, reports of adverse reactions and serious adverse events.CONCLUSION China’s drug label management should learn from the mature experience of the United States, improve relevant laws and regulations, and encourage patients to actively report relevant issues.