Open Access Pharmacovigilance Databases: Analysis of 11 Databases

Background Public access to human drug safety or pharmacovigilance (PV) data is a matter of interest to patients as well as to researchers and prescribers. Objective The objective of the present study was to identify databases with open access and to analyse the accessibility of relevant data in the existing databases. Methods To identify which drug safety databases offer public access, the 31 health authority websites that enable patients to directly report adverse events to their National Competent Authority (NCA) were reviewed between September 2014 and December 2015. For each identified open-access PV database, the type of safety data that can be retrieved was examined based on E2B fields and the level of access. For each PV database, a score was attributed based on three points: the open access items/adverse drug reactions (ADR) reporting form items ratio, the ability to access ADR details, and the processability of the data. Public access to PV databases was thus classified as high (three points), medium (two points) or low (zero or one point). Results A total of 11 PV databases providing open access were identified: nine national and two regional. Six databases grant case-level access, the others only provide aggregated data. In terms of general case information, the USA and Canada come first by sharing case ID, the type of report, the reporter and their qualification, whereas the World Health Organization (WHO) does not provide any general information. The other databases mostly provide only one of these three items: source, case ID, or type of report. At the case level, the US database offers the greatest amount of information followed by Canadian and German databases; data are available in a workable format for the US, Canadian and EudraVigilance databases. Overall, the databases from Denmark, Japan, the Netherlands, UK and VigiBase were classified as providing a low level of access to available safety information; those from Australia, EudraVigilance, Germany and New Zealand as providing a medium level of access; and those from the USA and Canada, as providing a high level of access. Conclusion The 11 PV databases analysed, except for those in North America, provide limited information. This may be acceptable for patient use but not for research purposes.