我国药品安全风险管理研究
摘要
众所周知,药品是特殊商品,它在帮助人们防病治病、调节生理功能、提高健康水平的同时,也可能因其毒副作用而对人体造成伤害,甚至是死亡。对于医疗卫生保健而言,安全和有效是药品在使用过程中最基本的原则。几个世纪以来人类一直在药品的安全和有效之间不懈努力,力求找到一个最佳的平衡点,使药品在防病治病的同时,能够获得最大的安全,以期不断提高人类健康水平和生命质量。随着药品安全关注度的提升,人们对建立药品风险管理体系重要性的认识越来越深刻,药品生产、流通和使用过程中的风险管理受到越来越多人的关注。许多发达国家都开始将风险管理概念引入药品监督管理机制中,建立并完善风险管理体系,增强利益相关群体对安全隐患的认识,促进监督机构和行业资源得到更有效的运用,从而确保药品安全有效,保障和促进公众健康。
药品安全风险管理是一项非常复杂的社会系统工程,从药品自身角度考虑,风险管理贯穿于药品的整个生命周期;从药品的外部环境考虑,风险管理需要众多学科和相关组织、单位和个人的支持和配合,它涉及诸多监管环节,需要有效的监管和充足的资源支持。虽然药品安全问题可能是由很多种因素造成的,但是当出现药品损害事件的时候,人们通常习惯向政府寻求解决的途径。当公众陷入高度风险的重重包围之下,对风险的了解以及规避和防范风险的能力低下的时候,药品监督管理部门必须履行确保药品安全有效的义务,可见,政府部门的政策制定和监督管理是非常重要的。本文将主要针对药品安全风险标准体系和药品监督管理部门的药品安全风险管理作用和政策制定进行研究,旨在帮助药品监督管理部门系统地收集、分析、评价和利用药品安全风险信息,更好地采取措施防范和控制安全风险,同时将安全风险的信息向公众反馈,在保证药品疗效的同时,尽可能地减少安全风险或者将安全风险降到最低,保障人民群众用药安全。
首先,本文在回顾一般风险管理理论的基础上,针对药品的特殊属性,提出了药品安全风险标准体系。该标准体系首次系统提出了药品安全风险定义、产生原因、风险识别、风险评价、风险控制、风险交流等系统理论概念,为实施药品安全风险管理提供了理论支撑和依据。
其次,本文利用文献研究和调查研究方法,对我国药品监督管理体制中已存在的涉及安全风险管理的方面进行了客观的分析,系统总结了我国药品监督管理体系在药品安全风险管理政策方面所做的工作,分析了国内药品安全风险管理面临的问题。结果表明,我国引进风险管理理论时间比较短,实践经验比较少,在实践工作中,仍以定性分析为主,对风险管理更深层次的内容进行研究和总结明显不足。出于对人们生命健康的高度重视,社会呼吁尽快建立药品安全风险管理体系,以保证广大患者的人身安全,并能使已发生损害的事件得到妥善处理。
最后,在标准研究和实际情况分析的基础上,结合借鉴国际药品风险管理经验,根据我国国情,本文提出我国药品安全风险管理政策框架,并基于该框架展开安全风险防范和控制政策研究,为我国今后实施药品风险管理战略或计划提供重要参考。
As everyone knows, drugs belong to special kind of products. Though drugs can help people to prevent and treat diseases, adjust physiological functions, improve health level, they can cause injury even death to people because of their noxious and side effects. For healthcare field, the basic principle for drug use is safety and efficacy. People have searched for a best balance between safety and efficacy for several centuries in order to obtain maximum safety for improving health level and life quality continuously. With increasing attention of drug safety, people begin to attach importance to building the system of drug risk management, especially during drug production, circulation and use. Many developed countries began to introduce the concept of risk management to drug surveillance and management mechanism and build the system of risk management in order to enhance safety understanding of all the involved parties and promote efficiency of surveillance departments and trade resources. The goal of risk management is to make sure that drugs are safety and efficacy, and to guarantee public health.
Drug safety risk management is a very complicated social project. Considering drug itself, we will apply risk management through the whole drug life circle. Considering external environment, when we apply risk management, we need supports and cooperation from many professionals, related enterprises, other organizations and people. Because risk management involves many surveillance processes, so we also need effective surveillance and enough resource supports. Though drug safety problems will be made by many factors, people will ask the governments for solving approaches when drug adverse reaction events happen. When people face danger, maybe they can't get the whole understanding of danger and know how to evade and keep away danger, so surveillance and management departments must carry out the responsibility of assuring drug safety and efficacy. It is very important for governments to make policies and implement surveillance. Whereas drug surveillance and management departments play a very important role in the whole system of drug management, this article will make research of drug safety risk standard system and the role and policies of drug surveillance and management departments in drug safety risk management. The results of this research will be helpful for these departments to collect, analyze, assess and utilize safety risk information, adopt measures to evade and control safety risk, give feedback of risk information to public, so departments can make the best of reducing risks or minimize risks at the same time of assuring efficacy to guarantee public health.
First of all, on the base of common risk management theory, this article puts forward drug safety risk standard system. This standard system puts forward the definition, reasons of drug safety risk, and risk identification, evaluation, control and communication for the first time. This system will provides theorical support for drug safety risk management.
Secondly, this article analyzed the existed aspects of drug safety risk management policy of our current drug surveillance and management departments through literature research and investigation. These analyses summarized the work that we have done in drug safety risk management and showed the problems that we are facing in drug safety risk management. The results show that there is very little time since our country introduced the theory of risk management and there aren't many practicing experiences for reference. During practical work, we still give priority to qualitative analysis and lack in in-depth research and summarization in risk management. Our society thinks public health as a very important thing and asks to build drug safety risk management system which can guarantee public health and deal with drug adverse events properly.
Finally, combined with foreign experiences of drug risk management, this article provided a series steps of drug safety risk management and a policy framework of drug safety risk management according to the situation of our country. On the base of this framework, this article developed risk intervention policy research in order to provide references for future drug risk management strategy or plan for our country.
药品安全风险管理是一项非常复杂的社会系统工程,从药品自身角度考虑,风险管理贯穿于药品的整个生命周期;从药品的外部环境考虑,风险管理需要众多学科和相关组织、单位和个人的支持和配合,它涉及诸多监管环节,需要有效的监管和充足的资源支持。虽然药品安全问题可能是由很多种因素造成的,但是当出现药品损害事件的时候,人们通常习惯向政府寻求解决的途径。当公众陷入高度风险的重重包围之下,对风险的了解以及规避和防范风险的能力低下的时候,药品监督管理部门必须履行确保药品安全有效的义务,可见,政府部门的政策制定和监督管理是非常重要的。本文将主要针对药品安全风险标准体系和药品监督管理部门的药品安全风险管理作用和政策制定进行研究,旨在帮助药品监督管理部门系统地收集、分析、评价和利用药品安全风险信息,更好地采取措施防范和控制安全风险,同时将安全风险的信息向公众反馈,在保证药品疗效的同时,尽可能地减少安全风险或者将安全风险降到最低,保障人民群众用药安全。
首先,本文在回顾一般风险管理理论的基础上,针对药品的特殊属性,提出了药品安全风险标准体系。该标准体系首次系统提出了药品安全风险定义、产生原因、风险识别、风险评价、风险控制、风险交流等系统理论概念,为实施药品安全风险管理提供了理论支撑和依据。
其次,本文利用文献研究和调查研究方法,对我国药品监督管理体制中已存在的涉及安全风险管理的方面进行了客观的分析,系统总结了我国药品监督管理体系在药品安全风险管理政策方面所做的工作,分析了国内药品安全风险管理面临的问题。结果表明,我国引进风险管理理论时间比较短,实践经验比较少,在实践工作中,仍以定性分析为主,对风险管理更深层次的内容进行研究和总结明显不足。出于对人们生命健康的高度重视,社会呼吁尽快建立药品安全风险管理体系,以保证广大患者的人身安全,并能使已发生损害的事件得到妥善处理。
最后,在标准研究和实际情况分析的基础上,结合借鉴国际药品风险管理经验,根据我国国情,本文提出我国药品安全风险管理政策框架,并基于该框架展开安全风险防范和控制政策研究,为我国今后实施药品风险管理战略或计划提供重要参考。
As everyone knows, drugs belong to special kind of products. Though drugs can help people to prevent and treat diseases, adjust physiological functions, improve health level, they can cause injury even death to people because of their noxious and side effects. For healthcare field, the basic principle for drug use is safety and efficacy. People have searched for a best balance between safety and efficacy for several centuries in order to obtain maximum safety for improving health level and life quality continuously. With increasing attention of drug safety, people begin to attach importance to building the system of drug risk management, especially during drug production, circulation and use. Many developed countries began to introduce the concept of risk management to drug surveillance and management mechanism and build the system of risk management in order to enhance safety understanding of all the involved parties and promote efficiency of surveillance departments and trade resources. The goal of risk management is to make sure that drugs are safety and efficacy, and to guarantee public health.
Drug safety risk management is a very complicated social project. Considering drug itself, we will apply risk management through the whole drug life circle. Considering external environment, when we apply risk management, we need supports and cooperation from many professionals, related enterprises, other organizations and people. Because risk management involves many surveillance processes, so we also need effective surveillance and enough resource supports. Though drug safety problems will be made by many factors, people will ask the governments for solving approaches when drug adverse reaction events happen. When people face danger, maybe they can't get the whole understanding of danger and know how to evade and keep away danger, so surveillance and management departments must carry out the responsibility of assuring drug safety and efficacy. It is very important for governments to make policies and implement surveillance. Whereas drug surveillance and management departments play a very important role in the whole system of drug management, this article will make research of drug safety risk standard system and the role and policies of drug surveillance and management departments in drug safety risk management. The results of this research will be helpful for these departments to collect, analyze, assess and utilize safety risk information, adopt measures to evade and control safety risk, give feedback of risk information to public, so departments can make the best of reducing risks or minimize risks at the same time of assuring efficacy to guarantee public health.
First of all, on the base of common risk management theory, this article puts forward drug safety risk standard system. This standard system puts forward the definition, reasons of drug safety risk, and risk identification, evaluation, control and communication for the first time. This system will provides theorical support for drug safety risk management.
Secondly, this article analyzed the existed aspects of drug safety risk management policy of our current drug surveillance and management departments through literature research and investigation. These analyses summarized the work that we have done in drug safety risk management and showed the problems that we are facing in drug safety risk management. The results show that there is very little time since our country introduced the theory of risk management and there aren't many practicing experiences for reference. During practical work, we still give priority to qualitative analysis and lack in in-depth research and summarization in risk management. Our society thinks public health as a very important thing and asks to build drug safety risk management system which can guarantee public health and deal with drug adverse events properly.
Finally, combined with foreign experiences of drug risk management, this article provided a series steps of drug safety risk management and a policy framework of drug safety risk management according to the situation of our country. On the base of this framework, this article developed risk intervention policy research in order to provide references for future drug risk management strategy or plan for our country.
引文
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