Knowledge of the safety profile of drugs prior to marketing is limited because of the small and selective groups of individuals included in clinical trials. A life-cycle approach to surveillance therefore needs to be adopted in order to learn the effects of drugs in ‘real-world’ practice. Safety surveillance of drugs post-marketing has traditionally been carried out by systematic manual review of reports of suspected adverse drug reactions from physicians, other healthcare professionals, consumers, and marketing authorisation holders and registered in national spontaneous reporting systems. Safety-related warnings and market withdrawals of widely used products in the first decade of the new millennium has fueled efforts to explore other data sources and develop new methodologies to offset the limitations of current surveillance systems. One of the important resources considered to have potential for active drug safety surveillance are electronic healthcare records (EHRs). Across the globe various public-private initiatives have been launched to investigate the secondary use of EHRs for this purpose. Databases containing electronic medical records as well as reimbursement claims for various healthcare services have been used for evaluation of drug safety issues in the past, but such studies were always conducted using one database at a time. This lecture will focus on the recently concluded EU-ADR Project (Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge, http://www.euadr-project.org/). EU-ADR, launched in 2008, was funded by the European Commission under its Seventh Framework Programme. A computerised integrated framework using EHR and biomedical data was developed in EU-ADR for detection and evaluation of drug safety signals. The database network originally comprised eight population-based administrative claims databases and general practitioner databases in four European countries (Denmark, Italy, the Netherlands, and the United Kingdom). EU-ADR is now expanding its network and expertise through the EU-ADR Alliance, a more stable collaboration framework for conducting drug safety studies in a federated manner especially when engagement of several EHR databases is required. This lecture will further describe the opportunities and challenges that come with heterogeneity in database structure, with differences in language and coding of both drugs and diseases, and with the diversity in the organisation of European healthcare systems.
Disclosure of Interest None Declared