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EudraVigilance 药物安全数据库:用于研究和公共卫生保护的公开可获取数据。

EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection.

机构信息

European Medicines Agency, 30 Churchill Place, Canary Wharf, London, E14 5EU, UK.

Medicines Evaluation Board, Utrecht, The Netherlands.

出版信息

Drug Saf. 2018 Jul;41(7):665-675. doi: 10.1007/s40264-018-0647-1.

Abstract

The analysis of safety data from spontaneous reporting systems has a proven value for the detection and analysis of the risks of medicines following their placement on the market and use in medical practice. EudraVigilance is the pharmacovigilance database to manage the collection and analysis of suspected adverse reactions to medicines authorised in the European Economic Area. EudraVigilance first operated in December 2001, with access to the database being governed by the EudraVigilance access policy. We performed a literature search including data up to December 2016 to demonstrate how the data from EudraVigilance has been used in scientific publications. We describe the results, including by type of publication, research topics and drugs involved. In 50% of the publications, the data are used to describe safety issues, in 44% to analyse methodologies used in pharmacovigilance activities and in 6% to support clinical perspectives. We also outline a description of the use of the database by the European Union regulatory network. Driven by the full implementation of the 2010 pharmacovigilance legislation, EudraVigilance has undergone further enhancements together with a major revision of its access policy, taking into account the use of the new individual case safety report standard developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and the International Organization for Standardization. The aim of the broadened access is to facilitate more effective safety monitoring of authorised medicines, to make more data available for research and to provide better access to information on suspected adverse reactions for healthcare professionals and patients. In November 2017, the new full functionalities of EudraVigilance were launched, including the extensive web access to data on suspected adverse drug reactions and the possibilities for academic research institutions to request a more extensive dataset for the purposes of health research. The main objective of this article is to describe the new access to the database together with the opportunities that this new access can bring for research. It is intended to promote an appropriate use of the data to support the safe and effective use of medicines.

摘要

自发报告系统的安全性数据分析对于在药品上市后和在医疗实践中使用时监测和分析其风险具有重要价值。EudraVigilance 是一个药物警戒数据库,用于管理疑似药品不良反应报告的收集和分析,这些药品在欧洲经济区获得了授权。EudraVigilance 于 2001 年 12 月首次投入运行,数据库的访问受 EudraVigilance 访问政策的管理。我们进行了一项文献检索,包括截至 2016 年 12 月的数据,以展示 EudraVigilance 中的数据如何在科学出版物中得到应用。我们按出版物类型、研究主题和涉及的药物描述了结果。在 50%的出版物中,数据用于描述安全性问题,在 44%的出版物中用于分析药物警戒活动中使用的方法,在 6%的出版物中用于支持临床观点。我们还概述了欧盟监管网络对数据库的使用情况。在 2010 年药物警戒法规全面实施的推动下,EudraVigilance 进行了进一步的增强,并对其访问政策进行了重大修订,考虑到采用了国际人用药品注册技术协调会和国际标准化组织制定的新的个例安全性报告标准。扩大访问范围的目的是促进更有效地监测已授权药品的安全性,为研究提供更多数据,并为医疗保健专业人员和患者提供更好地获取疑似不良反应信息的途径。2017 年 11 月,推出了 EudraVigilance 的全新功能,包括广泛的网络访问疑似药物不良反应数据的功能,以及学术研究机构为健康研究目的请求更广泛数据集的可能性。本文的主要目的是描述对数据库的新访问以及这种新访问可以为研究带来的机会。其目的是促进对数据的适当使用,以支持药品的安全有效使用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8af/5990579/3f0abd11c614/40264_2018_647_Fig1_HTML.jpg

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