TY - JOUR
T1 - EudraVigilance Medicines Safety Database
T2 - Publicly Accessible Data for Research and Public Health Protection
AU - Postigo, Rodrigo
AU - Brosch, Sabine
AU - Slattery, Jim
AU - van Haren, Anja
AU - Dogné, Jean-Michel
AU - Kurz, Xavier
AU - Candore, Gianmario
AU - Domergue, Francois
AU - Arlett, Peter
N1 - Funding Information:
The authors gratefully acknowledge the contribution made by Luis Pinheiro. No sources of funding were received for the preparation of this review. Rodrigo Postigo, Sabine Brosch, Jim Slattery, Xavier Kurz, Gianmario Candore, Francois Domergue and Peter Arlett are employees of the European Medicines Agency. Jean-Michel Dogné is a member of the Pharmacovigilance Risk Assessment Committee, as well as an employee of the Federal Agency for Medicines and Health Products of Belgium. Anja van Haren is an employee of the Medicines Evaluation Board of the Netherlands and she acts as a co-chair of the EudraVigilance Expert Working Group.
Publisher Copyright:
© 2018, The Author(s).
PY - 2018/7/1
Y1 - 2018/7/1
N2 - 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.
AB - 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.
KW - Adverse Drug Reaction Reporting Systems/standards
KW - Databases, Factual/standards
KW - European Union
KW - Humans
KW - Pharmacovigilance
UR - http://www.scopus.com/inward/record.url?scp=85043374613&partnerID=8YFLogxK
U2 - 10.1007/s40264-018-0647-1
DO - 10.1007/s40264-018-0647-1
M3 - Article
C2 - 29520645
AN - SCOPUS:85043374613
SN - 0114-5916
VL - 41
SP - 665
EP - 675
JO - Drug Safety
JF - Drug Safety
IS - 7
ER -
