| 摘要: |
| 目前超说明书用药存在一定必要性与合理性，但从患者安全和医生执业角度都存在一定风险。通过对常见规避超说明书用药风险方法的法律属性及效力进行分析，区分超说明书用药的不同情况，提出超说明书用药法律评价标准，以期对司法审判及医疗机构的临床应用提供帮助。 |
| 关键词: 超明书用药 法律评价 合理用药 |
| DOI： |
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| Discussion on Legal Standard of Off-label Drug Use |
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| Abstract: |
| Nowadays Off-label drug use has its necessity and rationality in clinical medication, but there are risks from both the patient safety and medical workers occupation angles. Through the analysis of the legal attribute and effectiveness of the methods of avoiding the common risk of off-label drug use , the article distinguishes the instruction on the off-label drug use from different situations，and finally puts forward the standard on classification of off-label drug use to provide guiding significance for justice and the clinical application of medical institutions. |
| Key words: off-label drug use,legal evaluation,rational drug use |
