摘要
药品质量风险管理,药品使用的整个过程中,均发挥着十分重要的作用,药品质量管理可以对药品质量中存在的风险进行评估,从而为其相关控制对策的制定提供依据,促进审核过程的不断加强。在药品质量风险管理中,其主要的风险管理为药品生产的相关风险管理、药品储存中的风险管理、在运输药品时的风险管理、使用药品中的风险管理以及药物疗效和安全保障的风险管理。药品疗效风险的管理,其是对药品管理的最基础的要求,可以对患者经药物治疗的效果进行保证。在流通药品的过程中,包括多个环节,即运输药品、储存药品等多个环节,在此些环节中,加强风险管理,同样具有十分重要的价值。药品均具有疾病防治以及毒副反应的特点,其中药品安全控制可以将药品所致的毒副反应几率降低,保证临床治疗的安全性。
Medicine quality risk management plays important role during whole process of medicine application, which can evaluate quality risk of medicine, and provide evidence for formulation of related control countermeasures, and promote strengthening of audit process. During medicine quality risk management, main risks include production related risk management, storage risk management, transportation risk management, application risk management, and medicine effect and safety guarantee risk management. Risk management of medicine effect is the most basic requirement of medicine management, which can guarantee curative effect of medicine for patients. During circulation course of medicine, there are many links, including transportion, storage and etc, it is of great value to strengthen risk management for the links. Medicine has characteristics of disease prevention, treatment and toxic and side effects, and safety control can reduce risks of toxic and side effects of medicine and ensure safety of clinical treatment.
作者
张炜
ZHANG Wei(Henan Runhong Pharmaceutical Co Ltd,Zhengzhou,Henan,451100)
出处
《智慧健康》
2018年第9期9-10,共2页
Smart Healthcare
关键词
药品
生产
质量
风险
对策
Medicine
Production
Quality
Risk
Countermeasures
