The EU-ADR Alliance is an EMA (European Medicines Agency) project that follows the 2008-2012 EU-ADR project. EU-ADR has developed a computer system exploiting data from electronic healthcare records (EHR) for the early detection of adverse drug reactions. Italy will be one of the five nations enrolled in this project

Caterina Lucchini

Following the 30 million of data analyzed in 2008-2012 by the EU-ADR project on drug adverse reactions, a new project, the EU-ADR Alliance, will start. Italy, Germany, United Kingdom, Denmark and The Netherlands will be enrolled in this project, allowing the consultation of more that 45 million records from clinical databases on three principal topics: use of oral contraceptives, risk of cardiac valve disorders associated with the use of biphosphonates, and monitoring of the effectiveness of risk minimization in patients treated with pioglitazone-containing products.

The EU-ADR aim

A number of recent drug safety issues showed that adverse drug reactions (ADRs) may be detected too late, once the drug is on the market, when millions of patients have already been exposed, revealing that earlier detection is needed. The EU-ADR aim is to overcome some of the limitations of spontaneous reporting database, providing a solid basis for large-scale monitoring of drug safety. The system generates signals (drug-event pairs that may warrant further investigation) using epidemiological andcomputational, data and text mining techniques on the basis of a federated structure of data sources. Once generated, the signals are substantiated by applying causality criteria (based on biological plausibility). The purpose of this substantiation process is to place the signals in the context of the current biomedical knowledge that might explain the signal. The resulting EU-ADR platform allows to explore datasets, run specific substantiation modules and combine the evidence obtained from each of the methods, constituting an effective tool to help research work in pharmacovigilance. In the EU-ADR project, 8 Databases containing medical records of more than 30 million European citizens have been involved.