医院“超说明书用药”管理与应对流程初探

Researches on Management and Response Processes Concerning Off-label Uses in Hospitals

目的探讨医院超说明书用药行为的管理制度和应对流程。方法从超说明书用药行为本身出发,结合医院相关制度,设计超说明书用药行为的管理规范,并提出详细的应对流程。结果与结论临床超说明书用药难以避免,不能实行规范的管理将引发诸多问题,为此,医院应制定相应的管理制度和应对流程,使超说明书用药行为规范化。

Objective To approach an appropriate management system and response processes to deal with off-label uses in the hospital. Methods In combination of behaviors of off label uses and relevant systems in the hospital, a management system was designed and the detailed response process was proposed. Results and Conclusion Clinical off-label uses are hard to avoid, and inadequate regulation would lead to severe drug-induced risk. Therefore, the hospital should drafta corresponding management system and response processes to regulate off-label uses.