New system records rise in reported adverse events

EMA Highlights – by Gary Finnegan – A new system designed to increase the safety of medicines in Europe has seen a significant increase in the number of suspected adverse drug reactions reported to the European Medicines Agency (EMA).

Nearly 25,000 patients reported suspected adverse reactions – an increase of more than 60% compared to the previous 12 months – under a revamped method of data collection which facilitates greater reporting by doctors and patients.

The figures are contained in the first report by the EMA to the European Commission on implementation of the EU’s new pharmacovigilance laws

The EMA said the legislation had led to better collection of key information on medicines, improved analysis and understanding of data, and greater transparency.

The watchdog said better information exchange had led to changes in product information following the assessment of signals of emerging safety issues. For example, the agency said it was able to respond to reports of hearing disorders associated with medicines containing roxithromycin.

Over the 12-month period in question, which ran from mid-2012 to the middle of 2013, several major public health reviews were initiated. In addition, thousands of people were trained in pharmacovigilance and a catalogue with training material was published to raise awareness of the new legislation.