欧盟药物警戒额外监测制度简介与启示

2013年随着欧盟《良好药物警戒管理规范X》的生效,药品额外监测制度得到进一步完善。药品额外监测制度是一种通过建立监测目录、公开目录药品信息、采用特定标识等措施,鼓励医务人员和患者自发报告可疑不良反应,以便顺利开展上市后安全性评价,确保任何新的用药安全隐患能够被及时发现和有效避免的制度。通过介绍欧盟药物警戒额外监测制度,阐述我国药品不良反应（ADR）监测的现状,指出该制度是一种积极主动发现用药风险的尝试;学习和借鉴该制度,有助于我国弥补原有药品ADR报告系统低报、漏报等缺陷,主动开展用药安全监测,从而获得更加全面科学的结果。     

欧盟药物警戒额外监测制度简介与启示

2013年随着欧盟《良好药物警戒管理规范x》的生效,药品额外监测制度得到进一步完善。药品额外监测制度是一种通过建立监测目录、公开目录药品信息、采用特定标识等措施,鼓励医务人员和患者自发报告可疑不良反应,以便顺利开展上市后安全性评价,确保任何新的用药安全隐患能够被及时发现和有效避免的制度。通过介绍欧盟药物警戒额外监测制度,阐述我国药品不良反应（ADR）监测的现状,指出该制度是一种积极主动发现用药风险的尝试;学习和借鉴该制度,有助于我国弥补原有药品ADR报告系统低报、漏报等缺陷,主动开展用药安全监测,从而获得更加全面科学的结果。     

英国药物警戒检查简介及启示

为促进药品安全第一责任人即药品生产企业上市后监测责任的落实,英国于2003年启动了药物警戒检查项目,目前已经形成了一套完整的检查体系。通过对英国药物警戒检查类型、检查流程、检查结果等内容介绍,提出了对我国生产企业药品不良反应报告和监测的检查分工、检查指南、自我检查指标体系以及信息沟通方面的思考和建议。     

欧盟新法规下的药物警戒制度简介

通过对于欧盟药物警戒法规修订情况的介绍,进一步了解欧盟药物警戒制度框架的组成,并且清晰了欧盟药物警戒系统和质量体系、药物警戒系统主文件、药物警戒检查、风险管理系统等制度形式的具体内容,为完善和发展我国药品不良反应报告和监测体系提供借鉴和参考。     

国内外药物警戒制度的比较研究

药物警戒是药品安全监管的重要组成内容,涵盖药品整个生命周期全方位的安全监管,全面保障用药安全性.药物警戒体系的建立是我国当前药品安全性监测的必然选择,也是提升药品安全性监测水平的迫切需要.通过从组织机构设置和管理机制等方面分析欧盟、美国药物警戒制度的现状,采用文献阅读、资料查询的方法对比分析我国药物警戒制度的现状,为我...     

澳大利亚药物警戒指南简介

澳大利亚药物警戒指南是澳大利亚于2003年7月颁布的药品安全与评价部门对已注册申请者的药物警戒职责的管理要求,是针对报告已经注册的医药产品的不良反应(ADR)而制定的.文件中有关"产品"和"已注册的医药产品"是指由澳大利亚药品管理局(TGA)的药品安全与评价部门(DSEB)负责管理的注册医药产品.     

欧盟新的药物警戒法规简介与启示

目的对欧盟新药物警戒法进行介绍,为完善我国药品不良反应报告和监测体系提供参考。方法通过查阅国内外文献,应用文献研究的方法进行分析。结果欧盟药物警戒当前所关注的焦点问题主要集中在收集药品安全性信息,分析和挖掘药品数据信息,开展围绕公众健康监管活动以及与利益相关者进行有效沟通。结论我国应借鉴欧盟新药物警戒法,提高我国药品不良反应报告和监测能力。     

欧盟药物警戒体系建立运行与实施进展

目的 对欧盟药物警戒体系及其实施进展进行介绍,为完善我国药物警戒体系提供参考。方法 通过查阅国内外文献,运用文献研究法进行分析。结果 在欧盟药物警戒体系内,其法律法规文件完整规范,各相关方职责明确,程序简化合理,信息公开透明,可合理有效的保障药品整个生命周期的安全。结论 我国应借鉴欧盟药物警戒体系,提高我国药品安全监测能力。     

欧盟药物警戒信息监管体系的分析与借鉴

欧盟的药物警戒信息监管体系对欧洲的药物监管和不良反应监测方面发挥了重要的作用.本文介绍了欧盟药物警戒体系的主要机构,欧盟药物警戒信息体系的组成,包括不良反应报告体系、上市后研究、风险管理策略等.目的是为我国的不良反应监测体系和药物警戒的发展提供借鉴和启示.     

《药物警戒质量管理规范》对持有人实施药物警戒制度的启示

该文以《药物警戒质量管理规范》(GVP)出台为背景,探究持有人实施药物警戒制度的重要意义,总结GVP对持有人提出的新制度要求,分析持有人实施药物警戒面临的挑战.实施药物警戒制度,最大限度地降低药品安全风险,保护和促进公众健康,是现代药企必须牢固树立的观念,也是其立业之根本.     

欧盟药品不良反应管理和上报指南简介

通过对于欧盟药品不良反应管理和上报指南的介绍,进一步了解欧盟对药品不良反应定义、报告收集、报告确认、报告随访、数据管理、质量管理等不良反应管理流程,为完善和发展我国药品不良反应报告和监测工作提供借鉴和参考。     

欧盟药品上市后额外监测制度及现状分析

欧盟为加强对特定药品不良反应的监测力度,及时收集用药信息,引入了药品上市后额外监测制度。该制度鼓励医务人员和患者自发报告可疑的不良反应,以便对药品进行安全性评估。介绍了欧盟额外监测制度的管理程序、监测方式以及实施现状,并结合中国不良反应监测制度实践情况,借鉴欧盟积累的经验,从完善法律体系和上报系统、制定额外监测药品纳入原则与目录、加强宣传等方面构建额外监测制度框架,为丰富我国药品上市后监测模式,完善药物警戒体系提供参考。     

Nurses are increasingly involved in pharmacovigilance in Sweden

INTRODUCTION: In Sweden, voluntary adverse drug reaction (ADR) reporting started over 40 years ago to detect rare, serious, unexpected adverse, mainly type B, reactions. During the period 1965-2004, 92,000 reports were assessed. Since certain nurses are licensed to prescribe a limited number of drugs, nurses also form part of the reporting team. AIM: To analyse the ADR reporting by nurses in Sweden. METHODS: All reports by nurses and other health-care personnel entered into the Swedish ADRs database SWEDIS (Swedish Drug Information System) were retrieved for the 10-year period 1995-2004 (Swedish population: 9 million). The intention was to analyse the nurses' reports from a quantitative and qualitative point of view. RESULTS: The total number of ADR reports has gradually increased during the past 10 years from 3000 to over 4000 in 2004 (465 per million inhabitants), an increase by 28%. All ADR reports originate from health care personnel. The nurses' contribution to the ADR reporting increased from 2-3% in the mid-90s to 12% in 2004. The most common drugs involved in the nurses' reporting were various kinds of vaccines. Skin reactions dominated among the nurses' ADR reports. The ADRs reported by nurses were, as a consequence of many vaccine reports, compared to all reports, not so often classified as serious, but were on the other hand more often assessed with a causal relationship. CONCLUSIONS: Nurses, in their position as drug administrators who record signs and symptoms of the patients, play an increasingly important role for detection of suspected ADRs and are now contributing to a significant amount of the ADR reporting in Sweden.     

The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France

INTRODUCTION: Because of design, objectives and number of included subjects, clinical studies are insufficient to assess the safety of new drugs. Sometimes, serious adverse drug reactions (ADRs) led to withdrawal of the drug from the market after their approval. The objective of our study was to determine the scientific evidences leading to drug withdrawal for pharmacovigilance reasons in France. METHODS: Data coming from French Health Products Safety Agency, literature and Toulouse Pharmacovigilance Center allowed to identify all drugs withdrawn from the French market for pharmacovigilance reasons from 1998 to 2004. We classified data according to their study design (Randomized Clinical Trial [RCT], case serie or case report, case-control study, cohort study, observational study, animal study), the organ/system affected and the type of ADR. RESULTS: A total of 21 drugs were withdrawn for safety reasons between 1998 and 2004 in France. The most frequent ADRs were hepatic (n = 7), cardiovascular (n = 4) or neurological (n = 3) ones. Eleven withdrawals were due to type-B ('unexpected') reactions (52%). For 19 out of 21 drugs, scientific evidence leading to drug withdrawal came from spontaneous case reports (or case series). Among these, case reports were the sole evidence in 12 cases. Withdrawals were based on evidence from case reports in combination with case-control or cohort study in four cases, in combination with observational study in two cases or in combination with animal study in two other cases. In only one case, a RCT supported the decision. CONCLUSIONS: This study underlines the importance of spontaneous case reports in detecting signals and supporting withdrawal of drug for pharmacovigilance reasons in France. Health authorities suffer from lack of comparative data resource. In this perspective, a pharmaco-epidemiological population-based database could represent a helpful tool to both generate and test safety hypotheses.     

Current state of biologic pharmacovigilance in the European Union: improvements are needed

Introduction: Pharmacovigilance is essential to monitoring the safety profiles of authorized medicines. Compared with small-molecule drugs, biological drugs are more complex, more susceptible to structural variability due to manufacturing processes, and have the potential to induce immune-related reactions, underscoring the importance of safety monitoring for these products. Although highly similar to reference products, biosimilars are not expected to be structurally identical. For these reasons, proper reporting of potential adverse drug reactions (ADRs) using distinguishable names and batch numbers is essential for accurate tracing of all biological drugs. To address the need for robust pharmacovigilance, the European Parliament and Council of the European Union provided legislation regarding pharmacovigilance of biologics in 2010.

Areas covered: This narrative review examines the current state of pharmacovigilance for biologics in the European Union (EU) and discusses relevant information on pharmacovigilance of biosimilars, the current EU pharmacovigilance system, and areas that could be improved.

Expert opinion: Although steps have been taken to improve pharmacovigilance of biologics in the EU, several enhancements can still be made, including additional training for healthcare professionals on ADR reporting, the use of 2D barcodes that enhance traceability, and an open discussion of potentially missed opportunities in the pharmacovigilance of biosimilars.     

Impact of knowledge,attitude and preceptor behaviour in pharmacovigilance education

This study aimed to determine the level of pharmacovigilance (PV) education in pharmacy programmes and to evaluate the predictive factors for the intent to report adverse drug reactions (ADRs) by pharmacy students in South Korea. Self‐administered questionnaires were collected from a regionally stratified nationwide convenience sample of pharmacy students in September 2017. The association between students' intent to report ADRs and their knowledge and attitude was evaluated by using multivariate logistic regression analysis. In total, 303 pharmacy students participated in the survey; the average age of students was 26.7 (standard deviation 2.9) years and 40.6% were males. Eighty‐eight students (29%) marked the degree of their intent as “strongly high.” Increased knowledge of ADR reporting methods and positive attitude towards the need for ADR reporting were significant predictors of the intent to report ADRs. Further, witnessing reporting by the preceptor (adjusted odds ratio, 2.37; 95% confidence interval, 1.26‐4.46; P < 0.01) was significantly correlated with the knowledge on and attitude towards ADR reporting of pharmacy students. The findings of our study indicated the need for improvements in PV curriculum, such as educational content focused on ADR reporting methods and demonstration of a preceptor's reporting in pharmacy practice experiential rotation, within Korean college of pharmacy curriculum.     

Evaluation of a training course on pharmacovigilance in Sub‐Saharan Africa

Purpose — To evaluate the impact of a sub‐regional training course in pharmacovigilance on participants' attitudes to ADR reporting, and self‐reported application of knowledge gained. Method — The study involved a cross‐sectional survey during a sub‐regional pharmacovigilance training course in Zimbabwe. Eighteen participants from 10 African countries attended and were asked to complete self‐administered pre‐course and post‐course questionnaires. A follow‐up questionnaire was also posted to each participant 2 months after the workshop. Results — After the course, there was a marked difference in the perceived factors discouraging a participant from reporting an ADR with only a few respondents unsure how to report ADRs or worried about confidentiality and legal issues. Only 5.4% of responses were inappropriate after the training when asked what should be reported to a voluntary ADR reporting scheme compared to 19.8% before the course. Half of the respondents to the follow‐up questionnaire expected a pharmacovigilance centre to be established in their countries as a result of the training. Conclusion — The training course had a positive effect on attitudes and knowledge of pharmacovigilance and may lead to establishment of pharmacovigilance centres in some of the participating countries. There would be value in holding more of these workshops within the region. Copyright © 2000 John Wiley & Sons, Ltd.