Annual pharmacovigilance report 2015

25 April 2016

The DKMA's latest pharmacovigilance report shows that the number of reported suspected adverse reactions increases year by year. Especially, the regions with ADR managers report more frequently. General practitioners have also submitted more ADR reports in the last year.

Both healthcare staff and medicine users have submitted more ADR reports in the past few years. The DKMA received altogether 7538 ADR reports, which is 16% more than the year before, so shows the Annual pharmacovigilance report 2015 just published by the DKMA.

"The DKMA encourages everyone to report it, even if they only suspect that they have experienced adverse reactions to the medicine they take. So, from this perspective, it is positive that more people submit ADR reports. In the past few years, we have made efforts to increase awareness on adverse reactions through various campaigns. But we cannot tell from the figures if we receive more ADR reports because of the campaigns – but it is likely that they have had an influence. Adverse reactions is a topic that doctors, patients, manufacturers and the media are concerned with, and it is therefore paramount that we gain as much knowledge as possible about adverse reactions. ADR reporting is the first step in the process and therefore a very important part of our work," says Helle Harder, acting Head of the Pharmacovigilance & Medical Devices Division.

Especially general practitioners have become more aware of reporting suspected adverse reactions, now accounting for 15% of the total number of ADR reports compared to last year's 8%.


Annual pharmacovigialance report 2015