Analysis in Spontaneous Reporting Databases

Spontaneous reporting systems have been established to gather reports of suspected adverse drug reactions (ADRs). Reports may be submitted by clinicians, pharmacists, other healthcare professionals, patients and the general public. Their function is to identify potential safety issues as soon as possible in the early post-marketing period. This offers an important safety net since not all issues are detectable in premarketing clinical studies. These systems generate large databases of ADR reports which are administered by national and international regulatory bodies, drug manufacturers and drug monitoring programmes. Policies for access to the data for research purposes vary by database.

The DSRU has collaborated in a number of projects that involve analysis of data from spontaneous reporting systems.

1. SAFEGUARD Project

SAFEGUARD is a multicentre collaborative project funded by the Seventh Framework Programme (FP7) of the European Commission.
The FDA-AERS database in the United States receives adverse drug reaction reports from healthcare professionals, patients and drug manufacturers worldwide. A public, anonymised version of the FDA-AERs database, with selected fields, is readily accessible to researchers by downloading data files from the FDA website. In the EU, EudraVigilance was set up in 2001 to collect adverse drug reaction reports from national regulatory agencies of the European Union and drug manufacturers. Access to this data for research purposes is considered on a case-by-case basis under the framework of the Eudravigilance Access Policy. The DSRU is currently using both the public version of the FDA database and an extract from the Eudravigilance database in the SAFEGUARD project. This project aims to evaluate the potential for these data sources to identify signals of disproportionate reporting of specific cardiovascular and pancreatic outcomes in association with drugs used in Type II diabetes mellitus.

2. Yellow Card Project (Patient Reporting)

The DSRU collaborated in a NIHR funded research project that evaluated the specific impact of patient reporting in the UK spontaneous reporting database. In this project, access was granted to a limited subset of the Yellow Card Scheme which is administered by the Medicines and Healthcare products Regulatory Agency (MHRA). Along with colleagues at the Universities of Aberdeen, Nottingham and Liverpool John Moores, we compared ADR reporting between patients and healthcare professionals in terms of the types of suspected reaction, the seriousness of the reported events, types of suspect drug involved and the time taken to report the reaction. In addition, we evaluated the relative contribution of patient reporting to detection of new ADR signals. Analysis of the verbatim reaction description also permitted a qualitative evaluation of the ‘richness’ of the information contributed by patients.

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