某院超说明书用药问题的现状与分析

目的:通过分析超说明书用药的现状及规制环境,为制定超说明书用药的管理措施提供有益的参考,减少规范超说明书用药现象。方法:通过文献研究,澄清超说明书用药的概念、分类和原因,并对超说明书用药现象进行了分析,总结出超说明书用药存在的问题、面临的主要风险和规制环境,最后分析提出超说明书用药管理的政策性建议。结果和结论:超说明书用药在临床中广泛存在有其合理性和必要性,但其也面临复杂的环境。超说明书用药的法律地位有待明确、制定切实可行的标准化诊疗规范、知情同意书是降低医疗机构超说明书用药执业风险的有效手段。

Current situation and analysis of off-label drug use in our hospital

OBJECTIVE To analyze the current situation and regulating environment of off-label drug use in our hospital, provide a useful reference for developing management measures of drugs, and reduce off-label drug use. METHODS Literatures were retrieved to clarify the concept, classification and reasons for off-label use, which was analyzed to summarize medication problems main risks and environmental regulation in our hospital. Finally, policy and recommendations would be proposed for administrating off-label drug use. RESULTS and CONCLUSION It is reasonable and necessary for off-label drug use in clinical practice, which also faces complicated conditions. Legal status of off-label drug use needs definite position, practical and feasible regulations for diagnosis and therapy. Informed consent form is an effective method to reduce the risk of off-label drug use in medical institutions.