规避超说明书用药风险的管理决策

Management strategies on avoiding the risk of off-label use of drugs

目的:国内当前超说明书用药现象广泛存在但管理不统一,为超说明书用药规范化管理提出相关建议。方法:通过分析超说明书用药存在的安全隐患及原因,对规避超说明书用药风险提出管理对策。结果:超说明书用药有其合理性,但其应用的风险无可避免。结论:完善超说明书用药立法体系,完善保险体系,确立风险预警机制,减少不合理超说明书用药并规避超说明书用药风险。

Objectives：To provide references on off-label drug use management under the status quo of widespread off-label drug use in clinical treatment currently.Methods：By analyzing the hidden risks and causes of off-label drug use,countermeasures on off-label drug use were presented.Results：Off-label drug use was rational in healthcare sometimes but the risk wad hard to avoid.Conclusions：It is considered to reduce the incidence of irrational off-label drug use and the risk of the off-label use by strengthening off-label drug use legal system and security system,and set up risk early warning mechanism.