EMA Database Aids Safety Monitoring

June 3, 2010
Stephanie Sutton

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

ePT--the Electronic Newsletter of Pharmaceutical Technology

A study conducted by the European Medicines Agency (EMA) has shown that statistical methods using EMA's EudraVigilance database of adverse drug reaction reports can be used to detect drug safety issues "significantly earlier" compared with routine pharmacovigilance.

A study conducted by the European Medicines Agency (EMA) showed that statistical methods using EMA’s EudraVigilance database of adverse drug reaction reports can be used to detect drug safety issues “significantly earlier” compared with routine pharmacovigilance.

The study was published in Drug Safety, the journal of the International Society of Pharmacovigilance, and was conducted on data from centrally authorized medicines. The EMA used a statistical signal-detection method in the EudraVigilance database and found that safety issues could be detected earlier in about 54% of cases where a clinically important adverse drug-reaction report was found (compared with routine pharmacovigilance).

According to a press statement from EMA, the study “provides direct evidence for a strong additive role of Eudravigilance signal-detection methods.” The agency also claims that the study underlines the importance of well-established pharmacovigilance systems such as active surveillance or the periodic safety-update reporting and concludes that “a combination of routine pharmacovigilance and statistical signal detection provides the optimal safety monitoring with earlier detection and better management of safety issues.”

Although the study examined statistical signal detection retrospectively, EMA now uses the method to strengthen signal detection for centrally authorized medicines with the aim of detecting new or changing safety issues with medicines earlier than before.