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

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.

Fig. 1

Publications using EudraVigilance data up to 31 December, 2016, classified per country of author and type of publication (as per the classification stated in EMBASE). Absolute numbers. EMA European Medicines Agency

Fig. 2

Publications per year and the main classification of the publications using EudraVigilance data up to 31 December, 2016. Absolute numbers

Fig. 3

Anatomical Therapeutic Chemical (ATC) code classification of the drugs analysed in the publications using EudraVigilance data to describe safety issues up to 31 December, 2016. Absolute numbers. excl excluding

Fig. 4

MedDRA^® System Organ Class distribution for the specific safety issues described in the publications using EudraVigilance data up to 31 December, 2016. Absolute numbers. incl including

Fig. 5

Classification of the pharmacovigilance topics analysed using EudraVigilance data up to 31 December, 2016. Absolute numbers. ADRs adverse drug reactions

Fig. 6

Access to Level 1 EudraVigilance data by research organisations. ADR adverse drug reaction, ICSR individual case safety report

Fig. 7

Access to Level 2A EudraVigilance data by research organisations. EMA European Medicines Agency