药物临床应用风险因果模型的构建与探讨

中国药物警戒 ›› 2013, Vol. 10 ›› Issue (9): 549-552.

药物临床应用风险因果模型的构建与探讨

李春潇,武志昂^1*,胡欣²

1.沈阳药科大学工商管理学院,辽宁沈阳1100162；
2.卫生部北京医院,北京100730

收稿日期:2013-05-03 修回日期:2016-03-09 出版日期:2013-09-08 发布日期:2016-03-09
通讯作者: 武志昂,男,教授,药品上市评价、药物风险管理。 E-mail：wuerla501@126.com
作者简介:李春潇,男,在读硕士研究生,药品风险管理。

Establishment and Discussion of the Drug Utility Related Risk Causal Model

LI Chun-xiao¹, WU Zhi-ang^1* ,HU Xin²

1.The Pharmaceutical Administration School of Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;
2.Department of Clinical Pharmacology of Beijing Hospital, Beijing 100730, China

Received:2013-05-03 Revised:2016-03-09 Online:2013-09-08 Published:2016-03-09

摘要/Abstract

摘要： 目的构建和探讨适用于药物临床应用风险事件的风险因果模型。方法对本文立论相关风险理论、药物治疗学论著进行了归纳、分析。结果和结论 风险因素、风险事件和风险损害是风险发生的三大要素,复杂系统中风险促发因素和风险拦截因素也十分重要,上述要素共同组成风险发生因果模型。风险因果模型移植药物应用过程可见：药物固有特性对应风险因素,是大多用药的风险事件和损害的本因；医务工作者药物诊疗计划的制定和执行、患者生理心理状态均是风险促发因素；正式的规章制度、操作规程和散在的感知和沟通构成药物应用中风险拦截因素。药物临床应用风险发生因果模型可以帮助正确认识用药风险来源、正视风险事件和发生过程,对于药物应用管理措施设计具有促进作用。

关键词: 药物, 临床应用, 风险

Abstract: Objective To establish and discuss the drug utility related risk causal model. Methods The works concerning the foundation of this article, namely risk theory and pharmacotherapeutics, were summarized and analyzed. Results & Conclusion Hazard, loss, peril were the three key elements of risk, they constituted the causal model together with contributory and intercept factors, which took important role in complex system. In the view of causal model, the drug characters were the hazard, which contributed most drug related peril and loss. The contributory factors included the healthcare staff's clinical decision and related implementation, as well as the condition of the patients. The regulation, SOPs and individual experience, perception and communication were acted as intercept factors. The casual model would give rise to the acknowledgement of the drug related risk source, process, which would enhance drug utility management.

Key words: drug, clinical use, risk

中图分类号:

R954

李春潇,武志昂,胡欣 . 药物临床应用风险因果模型的构建与探讨[J]. 中国药物警戒, 2013, 10(9): 549-552.

LI Chun-xiao, WU Zhi-ang ,HU Xin. Establishment and Discussion of the Drug Utility Related Risk Causal Model [J]. Chinese Journal of Pharmacovigilance, 2013, 10(9): 549-552.

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