摘要
目的:构建超说明书用药风险评估体系,实现超说明书用药风险分级管理,为医疗实践提供操作指导。方法:利用德尔菲法、问卷调查法和进行小组研讨会等方法,考察超说明书用药过程中可能发生的风险条目,调查各超说明书用药风险条目的可能性并完成严重性量化评估。根据评估结果,利用风险矩阵分析及Borda序值法进行风险分级。结果:超说明书用药的风险维度为法律政策风险、患者人身损伤风险、经济相关风险和医院经营风险,4个风险维度下包含12项高危风险条目。平均风险程度排序第一的是法律政策风险。结论:超说明书用药风险评估体系实现了风险条目的评估和量化,为临床超说明书用药的风险评判提供参考,达到保障患者权益且降低医生执业风险的目的。
OBJECTIVE To establish the risk assessment system on off-label drug use and achieve the graded management of off-label drug use, so as to provide operation guidance for medical practice.METHODS Delphi, questionnair and group seminar, etc were applied to the study. Possible risks and possibility of risk occurrence in the process of using the off-label drugs were investigated as well as the severity quantitative evaluation was completed. According to the results of the evaluation, risk stratification was conducted with risk matrix and Borda.RESULTS The risk dimensions of off-label drug use were legal and policy risk, patients’ damage risk, economic risk and hospital operation risk. Among the four risk dimensions, there were 12 high-risk items included. At the average risk level, the risks of legal and policy ranked first.CONCLUSION The risk assessment system on off-label drug use realizes the assessment and quantification of risk items, provides reference for the risk evaluation of clinical off-label drug use, and also achieves the purpose of protecting the rights and interests of patients and reducing the practice risks of doctors.
作者
刘巾玮
梁明杰
孙章皓
张静雯
张天明
王旭梅
LIU Jin-wei;LIANG Ming-jie;SUN Zhang-hao;ZHANG Jing-wen;ZHANG Tian-ming;WANG Xu-mei(Department of Pharmacy,Chifeng Municipal Hospital,Inner Mongolia Chifeng 024000,China)
出处
《中国医院药学杂志》
CAS
北大核心
2022年第7期754-757,共4页
Chinese Journal of Hospital Pharmacy
基金
赤峰市自然科学科研课题(编号:SZR21191)。
