加强医药企业药品不良反应报告的管理

目的探讨加强医药企业药品不良反应报告的管理方法。方法描述我国药品不良反应报告制度现状,分析存在的问题,对如何加强医药企业的工作提出相关建议。结果与结论我国应从完善法律体系、建立激励机制与补偿机制等方面入手,建立完善的药品不良反应报告制度,保护患者和医药企业的利益。     

美国制药企业不良反应报告和监测工作对我国的启示

通过介绍美国药品生产企业开展不良反应监测工作的情况并与我国医药企业进行比较,分析我国药品生产企业存在的问题与原因,并针对性地提出建议。对此,我国应该借鉴美国药品生产企业开展不良反应监测工作的经验,通过细化法规要求、扩展不良反应信息收集来源、优化内部信息传递途径、引进专业人员及完善反馈机制等举措,提高我国制药企业不良反应报告的自觉性和监测水平。     

国家药品不良反应监测中心通报硫普罗宁注射剂和胸腺肽注射剂不良反应情况

国家药品不良反应监测中心日前发布第12期药品不良反应信息通报。通报提醒医生、患者和医药企业:硫普罗宁注射剂和胸腺肽注射剂可能会引起患者过敏性休克。通     

不同人群药品不良反应认知度调查

目的调查不同人群对药品不良反应相关知识的认知程度,为完善和促进药品不良反应监测工作提供依据。方法对社会公众、药品生产与经营单位的涉药人员、医疗机构医务人员进行药品不良反应认知度问卷调查,并对回收的有效调查表进行统计分析。结果本次调查共发放问卷3100份,回收有效问卷3026份。被调查人群中,了解药品不良反应的占95．3％,对药品不良反应的发生原因了解不确切的占64．7％,发生药品不良反应不知道应报告的占19．5％,不知道如何报告药品不良反应的占25．8％。另有近50％的被调查者认为需要提高药品不良反应相关知识,认为有必要进行药品不良反应的相关知识培训的占86．1％。结论应加强宣传教育,提高广大市民特别是医药企业和医疗机构专业人员的药品不良反应报告意识。同时,应强化药品监管部门职能,并与卫生行政部门共同推进药品不良反应监测相关法规的修订与完善,保障公众用药安全。     

药品不良反应自发报告系统信息采集内容和方式的分析

药品不良反应自发报告系统所采集药品不良反应监测信息的内容和方式都决定了自发报告系统能否快速有效的收集药品不良反应的相关信息,这些信息在药品不良反应/事件报告表及其填写说明中能够体现,报告表的填写说明通常包括对报告内容、报告原则、报告范围、报告方式以及保密原则等方面的说明.本文通过介绍英国、美国、澳大利亚以及加拿大的药品不良反应/事件报告表及其填写说明中的主要内容,并与我国药品不良反应/事件报告表进行对比分析,希望能为进一步优化我国的药品不良反应信息采集的内容和方式提供参考.     

药剂师在药品不良反应报告与监测中的作用

目的探究药剂师在药品不良反应报告与监测中的作用。方法探讨药品不良反应的概念,明晰药剂师在药品不良反应报告与监测工作中的任务,分析其作用。结果药剂师是药品不良反应报告与监测的主力军,可以全面了解药品的使用信息及发展趋势,及时与医师、护士、患者进行沟通,宣传药品不良反应的相关知识,对药品不良反应事件作出判断和评价,收集相关信息,监测新引进药物的应用情况,能够有效减少药源性损害,促进临床合理用药,同时为广大人民群众提供合理用药咨询服务。结论明晰药剂师在药品不良反应报告与监测中的主体责任,能够有效降低临床用药风险,保障患者的生命安全。     

论公平责任原则在我国药品不良反应救济中的适用

运用公平责任原则审理药品不良反应案件能够有效维护患者的权益,督促医药企业、医疗机构加强药品安全管理。运用公平责任原则审理药品不良反应案件还没有得到推广,司法机关有必要加强这方面的工作。该文阐述运用公平责任原则审理药品不良反应案件的必要性与合理性。     

边振甲副局长强调：医药企业要时刻绷紧药品质量安全弦

据国家食品药品监督管理局网站信息。日前在江苏省无锡市举办的中国医药质量年会暨协会成立20周年大会上，国家食品药品监督管理局副局长边振甲强调，保证药品质量安全是医药企业的生存之本．医药企业在任何时候都要绷紧药品质量安全弦。     

如何发挥执业药师在药品不良反应监测中的地位和作用

药品不良反应是危害人们生命安全的重要因素之一,发挥执业药师在药品不良反应报告和监测中的作用尤为重要。执业药师要加强学习,增强责任心;保证药品和药学服务质量,保障大众用药安全、有效、经济、合理;在药品不良反应报告及监测中发挥应有的作用。     

新旧《药品不良反应报告和监测管理办法》对比分析

目的探讨新《药品不良反应报告和监测管理办法》的先进性。方法从监管部门职责、不良反应报告和监测过程各个环节,对比分析《药品不良反应报告和监测管理办法》修订前后的差异,阐述其实施的重要意义。结果与原法规比较,新法规明确了省以下监管部门和监测机构的职责,细化、规范了不良反应报告要求,完善、强化了评价与控制措施,引入重点监测,使不良反应被动监测变为主动、被动相结合。结论新法规为及时、全面获取药品不良反应相关信息、科学评价药品安全性问题、有效控制药品风险提供了有力保障。     

Quality check of spontaneous adverse drug reaction reporting forms of different countries

Adverse drug reactions (ADRs) are considered as one of the leading causes of death among hospitalized patients. Thus reporting of adverse drug reactions become an important phenomenon. Spontaneous adverse drug reaction reporting form is an essential component and a major tool of the pharmacovigilance system of any country. This form is a tool to collect information of ADRs which helps in establishing the causal relationship between the suspected drug and the reaction. As different countries have different forms, our aim was to study, analyze the suspected adverse drug reaction reporting form of different countries, and assess if these forms can capture all the data regarding the adverse drug reaction. For this analysis we identified 18 points which are essential to make a good adverse drug reaction report, enabling proper causality assessment of adverse reaction to generate a safety signal. Adverse drug reaction reporting forms of 10 different countries were collected from the internet and compared for 18 points like patient information, information about dechallenge–rechallenge, adequacy of space and columns to capture necessary information required for its causality assessment, etc. Of the ADR forms that we analyzed, Malaysia was the highest scorer with 16 out of 18 points. This study reveals that there is a need to harmonize the ADR reporting forms of all the countries because there is a lot of discrepancy in data captured by the existing ADR reporting forms as the design of these forms is different for different countries. These incomplete data obtained result in inappropriate causality assessment. Copyright © 2010 John Wiley & Sons, Ltd.     

Program coordinated by a drug information service to improve adverse drug reaction reporting in a hospital

A program coordinated by a drug information service to improve adverse drug reaction (ADR) reporting in a hospital is described. At a 520-bed teaching hospital, the drug information service was asked to design a new adverse drug reaction reporting system that would encourage clinicians to report ADRs. A new system was implemented on a general medical unit: A physician, pharmacist, or nurse telephoned the drug information service when an adverse drug reaction was suspected, and drug information personnel followed up on the report, completing all subsequent investigation and documentation. A standard algorithm was used to evaluate causality of the reported reactions. Pertinent data were entered on a form and retained in the drug information service. The primary physician's approval was obtained before a reaction could be reported on an FDA drug-experience form. Drug information service personnel reviewed the ADR data monthly to detect any trends that clinicians should be aware of and to prepare a report for the pharmacy and therapeutics committee. Nurses, physicians, and pharmacy personnel were oriented to the new system before its implementation and were subsequently informed about reported ADRs and use of the system through newsletters and meetings. In the initial three-month period, 23 ADRs involving 19 drugs were reported from the medical unit; in a six-month period before development of the new system, no ADRs had been reported. This ADR reporting system developed and implemented by the drug information service was effective in improving reporting of adverse drug reactions.     

Reporting of adverse drug reactions by poison control centres in the US.

BACKGROUND: Although US poison control centres manage approximately 30,000 adverse drug reactions each year, the extent of voluntary reporting of these events to the US Food and Drug Administration (FDA) MedWatch spontaneous surveillance programme is unknown. METHODS: A survey was mailed to directors of all 72 US poison control centres during April 1999 to determine their practices and opinions on reporting adverse drug reactions. The survey requested information on the poison control centre staff's practices in reporting adverse drug reactions to the FDA MedWatch programme during 1998. RESULTS: A total of 56 fully completed surveys were returned. Of the respondents, 30 had not directly submitted adverse drug reaction reports to the FDA, 22 had submitted 10 or less, and 4 had submitted a total of 47 during 1998. Reasons given for not routinely reporting adverse drug reactions included adverse drug reactions reporting is not part of the regular routine (20%), lack of time to complete forms (15%), inability to determine causality (13%), most reactions are already reported and not unique (10%), reporting to the FDA is too much work (9%), and responsibility rests with the attending physician (7%). Direct reporting to MedWatch of any cases of adverse drug reactions was more likely when the poison control centre was certified by the American Association of Poison Control Centers (p < 0.05; odds ratio = 5.1; 95% confidence interval 1.1 to 23.5); however, this practice was not associated with documenting deaths associated with adverse drug reactions, having more than 75% of the staff of the Poison Information Specialists composed of pharmacists or nurses, or managing greater than 20,000 or 34,000 human exposure cases during 1998. Approximately half of the poison control centres directly or indirectly reported some adverse drug reactions to the FDA by virtue of contacting the manufacturer or cooperating with postmarketing surveillance. CONCLUSION: Poison control centres represent an underutilised source of reporting to MedWatch, but several internal and external obstacles limit the direct reporting of adverse drug reactions routinely.     

加强药品不良反应报告和监测工作保证合理用药

目的强化人们对药品不良反应的认识,积极做好药品不良反应报告和监测工作,防止药品不良反应的重复发生。方法回顾分析我院2007年～2011年上报的药品不良反应报告的情况,介绍药品不良反应的相关知识,及我院报告和监测的应对措施,明确药品不良反应报告的关联性评价原则和要点。结果通过对我院药品不良反应报告的统计分析,明确药品不良反应报告和监测的重要性。结论通过加强对药品不良反应知识的学习,明确药品不良反应发生的原因,加强药品不良反应报告和监测,防止药品不良反应的重复发生,保证临床合理用药。     

药品不良反应数据挖掘技术在药物警戒的应用

随着信息技术的发展,医药电子数据海量增长,药品不良事件报告大幅增加,给药物警戒研究带来了巨大的挑战。而数据挖掘技术可以自动从真实世界数据中撷取药品不良反应风险信号。因此,对海量不良事件报告数据进行高效数据挖掘是实现药品不良反应自动检测的必要措施。本研究通过介绍当前主要的大型药品不良事件报告数据库和相关数据挖掘方法,对药品不良反应数据挖掘技术在药物警戒中的应用及其局限性进行综述,为药物警戒相关机构和科研人员提供参考。     

Review of national spontaneous reporting schemes. Strengths and weaknesses

OBJECTIVE: To investigate and compare the operation of different national spontaneous reporting schemes for adverse drug reactions. DESIGN: Drug safety agencies in 18 countries were contacted by letter to request information about their spontaneous reporting scheme for adverse drug reactions. This information related to the background of the scheme, operational aspects of the scheme and numbers of reports received. RESULTS: Replies were received from 12 countries. Many differences were found between the schemes operating in different countries. Some schemes had been in operation for over 30 years, while others were more recently established. While most schemes rely on voluntary reports, in two countries (France and Spain), reporting is a legal requirement for healthcare professionals. Reports are accepted from doctors, dentists and pharmacists in all of the countries surveyed; however the role of other health professionals and the general public was found to vary. There were also differences in the types of reactions for which reports are requested, and the products covered by the schemes. In some countries (e.g. Denmark) reports of all reactions are sought, while other countries focus on only serious reactions or reactions to newly marketed products. In Australia, there is a separate scheme for drug-induced congenital malformations and Canada, South Africa and the US run separate schemes for reactions to vaccines. However, other countries include these reactions in the general spontaneous reporting schemes. The numbers of reports received by the countries also varies considerably--from a few hundred each year in South Africa to over 20,000 in the US. CONCLUSION: While the schemes all operate on the basic principle of collecting reports of adverse reactions to identify potential hazards, they showed many different approaches to the spontaneous reporting of adverse drug reactions. Features of one scheme may serve to improve reporting rates for another. In addition, all 12 countries participate in the World Health Organization International Drug Monitoring Programme, thus helping to inform the whole international community of drug safety problems.     

Control charts to monitor rates of adverse drug reactions

We describe the use of control charts in monitoring rates of adverse drug reactions. Adverse drug reactions are recognized as important outcomes of patient care and are specifically associated with the process of medication use. The systematic monitoring of adverse drug reactions may allow one to identify opportunities to improve this process. Reported adverse drug reactions from 36 consecutive months at a university hospital were analyzed. The mean rate of adverse drug reaction reporting was 1.65% (denominator of patient admissions) and the 3 sigma upper and lower control limits were 3.22% and 0.08%, respectively. The mean rate of preventable adverse drug reactions was 21.25% (denominator of total reported adverse drug reactions) and the 3 sigma upper and lower control limits were 73.54% and < 0%, respectively. The experience described in this report suggests that monitoring adverse drug reactions using control charts, facilitates identification of trends in reporting and the actual incidence of adverse drug reactions, and allows identification of opportunities to improve the systems and processes of medication use.     

论药品不良反应强制报告法律制度

我国目前在药品不良反应报告制度方面存在着药品不良反应报告的数量少、质量不高、有的单位不重视药品不良反应和监测工作以及严重药品不良反应事件频发等突出问题,危害人民群众的用药安全。其中重要的原因是我国未建立起药品不良反应强制报告法律制度。药品不良反应强制报告法律制度是指境内的药品生产企业、药品经营企业、医疗卫生机构及医务人员,必须向国家(食品)药品监督管理部门报告其所发现、发生的药品不良反应及事件,否则应负法律责任,国家支持和鼓励相关单位和个人报告药品不良反应。我国应当尽快建立药品不良反应强制报告法律制度,并改革和完善相应的法律规定和奖惩措施。