欧盟药品上市许可持有人的药物警戒责任研究

目的：简要介绍欧盟对药品上市许可持有人的药物警戒责任,为建立和完善我国药品上市许可持有人直接报告不良反应制度提供借鉴与参考。方法：通过查阅国内文献,欧盟药品管理局官方网站,欧盟药物警戒体系及药品上市许可持有人承担的药物警戒责任,并进行分析。结果：欧盟针对药品上市许可持有人的药物警戒责任做出了详细规定,包括药品不良反应报告责任、对药物警戒合格人员管理责任、负责实施质量体系、对分包的药物警戒任务的质量体系管理责任。结论：应进一步建立与完善我国药品上市许可持有人直接报告不良反应制度,提高药品不良反应监测水平。     

浅析国外药物警戒受权人制度对我国药品不良反应监测工作的启示

目的简要介绍国外药品药物警戒受权人相关制度,为建立和完善我国药品不良反应监测联系人制度提供借鉴和参考。方法通过查阅国内外文献,应用文献研究的方法调研欧盟和澳大利亚的药物警戒受权人(QPPV)的相关制度,并进行分析。结果欧盟、澳大利亚均建立了严谨的药物警戒受权人制度,可为我国建立药品不良反应监测联系人制度提供宝贵的实践经验。结论吸收借鉴国际经验,结合我国的药品安全监管特点,应进一步建立和完善我国的药品不良反应监测联系人制度,提高药品不良反应监测水平。     

《药品管理法》中药物警戒制度实施的思考

目的：新修订的《中华人民共和国药品管理法》首次引入建立药物警戒制度,原有的不良反应监测和报告制度已不能满足我国药品监管的要求,需要从法规层面和实际操作层面整体设计。方法：通过查阅国内外文献,WHO、FDA和EMA网站等,比较分析WHO、美国和欧盟的药物警戒制度。结果与结论：对比WHO、美国和欧盟的药物警戒制度发现,我国的药物警戒制度处在刚刚起步阶段,本文从法律法规框架、科学监管体系、建立专业数据库以及加强药品上市许可持有人报告等方面提出了建议和意见。     

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...     

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.     

欧盟、美国和日本的药物警戒信号管理体系比较研究

目的:比较欧盟、美国和日本的药物警戒信号管理体系,为建立和完善我国药物警戒信号管理体系提供参考.方法:采用文献研究分析法,系统对比欧盟、美国和日本的相关监管机构在药物警戒信号定义、来源、检测方法和管理流程等方面的异同,并对我国药物警戒管理工作提出建议.结果与结论:欧盟、美国和日本的监管机构对于信号的定义并不统一,欧盟药...     

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。     

国外药物警戒体系建设现状探究及启示

目的：探讨欧盟、美国、韩国、日本和中国的药物警戒体系建设现状,为我国医疗机构药物警戒体系建设提供建议与参考。方法：对欧盟、美国、韩国和日本药物警戒体系建设现状进行分析,并与我国医疗机构药物警戒体系建设进行对比,提出我国的医疗机构药物警戒建设建议。结果与结论：药物警戒是药品安全监管的重要内容,贯穿药品全生命周期,我国应充分利用医疗机构报告主渠道优势,建立具有我国特色的医疗机构药物警戒体系,并强化风险监测和预警,促进临床安全用药。     

国际药物警戒开展现状对我国药品风险管理的启示

本文就世界卫生组织药物警戒合作项目和欧盟、美国药物风险管理现状进行分析。以期对我国药物警戒系统的建立和药品风险管理提出一些建议。国际药物警戒已将药品风险管理从单纯的不良反应监测扩大到与疾病预防治疗相关的领域．变被动监测为主动警戒,以防患于未然。我国建立药物警戒体系需要在组织体系、交流沟通．人员培训及制药企业主动进行药品上市后风险管理等方面多加完善与改进。     

浅谈发展中国家的药物警戒系统:成就与挑战

根据世界卫生组织的定义,药物警戒是＂发现、评价、理解和预防不良反应或其他任何可能与药物有关问题的科学研究与活动[1]＂。药物警戒系统作为一种安全工具在公众药物使用和公众健康有关方面发挥着十分重要的作用。对大多数发展中国家而言,公共领域内的药物安全问题不仅是政府的职责,而且是衡量社会进步的重要指标。因此,建立起一个良好的药物警戒系统不仅是社会发展过程中的必然追求,同时也是一个挑战。发展中国家（如阿尔及利亚）现存的问题是,如何将重心从正在进行的基础性工作（如药物不良反应监测）转移到构建出一个完善的药物警戒系统上来。药物警戒的工作内容主要包括：培训执业医师使用最有效的药物达到更安全的目的;根据不同患者的病理状态,选择适当的给药剂量和给药间隔进行治疗;观察治疗的花费以保证其维持在个人和社会都可承受的范围内。     

Issues with regulatory pharmacovigilance in East European countries: the industry perspective

The new European Union pharmaceutical legislation emphasizes the importance of ensuring the continued safety of medicinal products in use with the main purpose to protect the public health. To fulfil this task the Member States are obliged to establish pharmacovigilance systems, which could be continually adapted to take account of scientific and technical progress. The non-EU East European countries are oriented towards the same goal on their way to the community. They are changing their legal frameworks for pharmacovigilance to harmonize it with the European requirements. As the EU accession country, Croatia is also in a phase of harmonization of the national legislation on medicines with the latest European requirements. It has established the pharmacovigilance system in which the Croatian Agency for Medicines and Medical Devices has very important role, and it involves all stakeholders-pharmaceutical industry, Healthcare Professionals and patient organizations. Belupo Inc. is faced with changes in the field of pharmacovigilance on all its markets: in Croatia, in EU as well as in the East European countries outside the EU, which are traditionally Belupo's target markets. The structure and functioning of the pharmacovigilance system in Croatia and other non-EU East European countries based on Belupo's experience gathered through the activities of its Pharmacovigilance Department and activities of its Qualified Persons for Pharmacovigilance (QP) are presented.     

Electronic transmission of rapid alerts in pharmacovigilance: A pilot EC experiment

Though electronic communication and transfer of data is becoming commonplace, it is still rare between administrations. This is why CEC DGXIII started the European Nervous System (ENS) programme, to promote the use of telematics to facilitate the work of administrations. Pharmacovigilance is one of the pilots of CARE, an ENS project in health care. This pilot involves Instituto de Salud Carlos III (Spain), Medicines Control Agency (UK), and the French Pharmacovigilance System (France) along with Norsistemas Consultores (Spain). Its objective is to explore the possibilities of telematic transmission of Pharmacovigilance data between national administrations. The technical approach has tested the transmission of urgent drug alerts, information equivalent to that of the existing Rapid Alert scheme, up to now transmitted by fax. The network using international standards (Unix, X400, and EDI, based on X25 networks) has been set up between the three participating countries. The data structure for the drug alerts has been described and submitted to future European users. The message structure itself has been entered into the registration and validation process for EDIFACT certification. The application for message transmission has been written and is being tested and re-evaluated. The information contained in these messages will be initially entered manually, but could be generated from national databases. Though this network at the present only concerns three countries, it is expected that most EC countries will be linked in the near future.     

A description of medicines-related safety issues evaluated through a referral procedure at the EU level after 2012

ABSTRACT

Introduction

Important drug safety issues are evaluated through a referral procedure in the EU by the Pharmacovigilance Risk Assessment Committee (PRAC) within the European Medicines Agency. We aim to describe all safety-related referrals assessed by the PRAC by June 2019.     

Changes to protocol in the regulation of adverse drug reactions – historical and current European view

Adverse drug reactions (ADRs) are an inevitable part of medication use. During clinical trials, limited information was gained on drug safety. After marketing authorization (MA), more safety data is available as more patients use the drug. Major changes in drug regulation came after drug disasters, like with sulphanilamide elixir or thalidomide use. In recent history, withdrawal of rofecoxib has demonstrated the importance of post-marketing safety monitoring. Subsequently, legislation on drug safety changed both in the United States (US) and in the European Union (EU), becoming simplified and more comprehensive. New EU legislation was implemented in 2012 and has broadened ADR definition to medication errors and overdoses. In the EU, the Pharmacovigilance Risk Assessment Committee (PRAC) has been formed within the European Medicines Agency (EMA), regulating all aspects of drug safety. Referral procedures enable a thorough scientific analysis on all issues of medication safety. In both the US and the EU, ADRs can be reported directly by patients. All reports of suspected ADRs are kept on electronic databases and are analyzed regularly using new technologies. New safety signals are subsequently discovered and evaluated. This author expects that the new regulations will effectively safeguard healthcare consumers from major drug risks.     

欧美制药企业临床试验药物安全报告体系研究和启示

文中研究了欧美临床试验药物安全报告体系,以为我国制药企业提供启示和借鉴。对欧美制药企业临床试验药物安全报告体系进行信息检索、梳理、汇总、分析和归纳。研究发现制药企业申办者作为欧美临床试验安全监督系统不良事件安全报告的主体,发挥了巨大的作用;而作为制药企业发挥作用的基础,其不良事件分类方法和报告方式、快速报告制度和汇总报告体系都具有重大的学习借鉴价值。     

Herbal medicines: challenges in the modern world. Part 2. European Union and Russia

Introduction: Herbal medicines (HMs) have been well known to people of the European Union (EU) and Russia for centuries. Currently, Western HMs can be classified into two categories, plant-derived conventional medicines and dietary supplements. Interest to HMs has grown rapidly in all countries during the past two decades.

Areas covered: The main goal of this review article is to present the history of HMs in the EU and Russia, forms of modern HMs, including Oriental Medicines that are popular among consumers of both countries. Additional discussion points comprise safety and adulteration issues associated with HMs, including regulatory changes and new legislative measures undertaken by the authorities. Materials available from legislative and governmental websites, PubMed and news media were used.

Expert commentary: Due to cultural diversities in the EU and Russia, traditional HMs of other regions, particularly Chinese Traditional and Ayurvedic medicines, are also popular. Recently, dietary supplements containing multiple herbal and other natural products have flooded the EU and Russian markets. Pharmacovigilance in these markets is challenging in terms of establishing quality and safety of ingredients, determining efficacy, and defining risks of herb-herb and herb-drug interactions. Both the EU and Russia have introduced new legislation aimed to overcome these deficiencies.     

Paediatric adverse drug reactions reported to the Spanish Pharmacovigilance System from 2004 to 2009

Purpose

This study was conducted to evaluate relevant new information about ADRs reported in the Spanish paediatric population over a 6-year period.

Methods

Adverse drug reactions (ADRs) for individuals aged 0–17?years reported to the Spanish Pharmacovigilance System from 2004 to 2009 were analysed with respect to time, age and sex, category of ADR [System Organ Class (SOC)], seriousness, suspected medicines [level 2 of the Anatomical Therapeutic Chemical (ATC) Classification System] and type of reporter.

Results

In total, 4,279 ADR reports corresponding to 8,196 ADRs were analysed, approximately two ADRs per report. The rate of paediatric ADR reports in 2009 was 165 per million, of which nearly half (46?%) were for children (age group 2–11?years). Similar total numbers of ADRs were reported for boys and girls. The most frequent ADRs reported were from the following SOCs: general disorders and administration site conditions (34?%); skin and subcutaneous tissue disorders (15?%); nervous system disorders (14?%). Reports encompassed medicines from various ATC groups: vaccines and anti-infectives for systemic use (67?%); nervous system (9?%); respiratory system (9?%). On average, 37?% of ADRs were classified as serious. There were 33 fatal ADRs, and 35?% of the paediatric population associated with the ADR notifications required hospitalization or extended hospital stay.

Conclusions

In Spain, ADR reporting rate in the paediatric population has increased since 2004. The proportion of suspected ADR reports related to vaccines was predominant, which highlights the important role played by nurses. ADR notification of congenital malformations in newborn infants highlights the need for joint action between the Spanish System of Pharmacovigilance of Medicines for Human Use (SEFV-H) and paediatricians, obstetricians and gynaecologists. The publication of safety reports by regulatory agencies is determinant for the increased number of ADR notifications.     

新药临床试验期间药物警戒和风险控制研究一:欧美新药临床试验期间药物警戒体系要求对我国申办者的启示

目的：通过对欧美药物警戒和风险管理体系的研究分析,结合目前我国新药临床试验药物警戒发展现状,为临床试验期间药物警戒科学监管及申办者药物警戒体系建设提供参考,以切实保护临床试验受试者的安全和权益。方法：对欧美及我国临床试验期间药物警戒监管进行了研究,为提高我国临床试验期间药物警戒的监管要求和申办者建立药物警戒体系提供参考建议。结果与结论：欧美药物警戒起步较早,发展已相对成熟。我国近两年通过逐步完善法规,不断推动我国临床试验期间药物警戒科学监管发展及申办者药物警戒体系的建立健全,以保护临床试验受试者的安全和权益。     

An overview of the pharmacovigilance system in India

Pharmacovigilance (PV) has witnessed several advancements throughout the world over the past few decades. This review provides an overview of the PV system in India, focusing on the current scenario, its development, the challenges faced, and the interventions suggested for its improvement. The Pharmacovigilance Program of India (PvPI) is playing a major role in gathering drug safety related data and adding it to the WHO database. PvPI fulfills the minimum requirements given by the WHO for any functional national Pharmacovigilance system. The Indian Pharmacopoeia Commission (IPC) is the national coordinating center under PvPI. PV in India relies mainly upon the spontaneous reporting of adverse drug events. The major challenge for PV in India is under-reporting. However, there is an improvement in the number of submitted reports after regular training and awareness programmes, which have been conducted by the IPC. The regular and periodic circulation of the ‘PvPI Newsletter’ by the IPC has also been instrumental in increasing awareness about PV amongst healthcare professionals and patients. The intensification of PV activities in India demands particular attention in health science curricula. Indeed, a change in mindset is necessary for prescribers, patients, regulatory agencies, and pharmaceutical companies.