The European Medicines Agency (EMA) plans to scale up its battle against harmful drug reactions in 2012 after citing figures that the problem costs thousands of lives and €79 billion a year. The agency's management board backed a program Dec. 15 that puts into action new pharmacovigilance legislation, which calls for the formation of a new committee to address issues related to drug safety in Europe.
A component of the EMA's 2012 work plan budget of €222.5 million, the Pharmacovigilance Risk Assessment Committee (PRAC) is expected to meet for the first time in July after the new legislation kicks in in June, according to the EMA's release. Part the group's work involves an overhaul of how EU countries coordinate monitoring of adverse drug reactions, and the monitoring of the effectiveness of risk management systems. Plans call for its Coordination Group to meet for the first time in September.
Bad drug reactions are a huge problem in Europe and beyond. According to an EMA presentation in June, there are an estimated 197,000 deaths from adverse drug reactions per year in EU countries. The lethal events are the fifth leading cause of death in hospitals in the EU and the reason for 5% of hospital admissions. And it turns out that patients aren't safe from such drug reactions after they get to hospitals, where 5% of patients suffer adverse drug reactions.
- here's the EMA's release