Annual Pharmacovigilance Report 2016 of the Danish Medicines Agency
The number of reports on suspected adverse reactions submitted to the DKMA in 2016 more or less levelled the year before. We received less ADR reports from physicians, but ADR reports involving patient compensation cases from the Patient Compensation Association accounted for a larger share than previous years.
Recent years have shown a clear trend that regions with an ADR manager role report more adverse reactions than the regions with no ADR manager role. But this trend has not been as marked in 2016, which recorded a fall in ADR reports especially from the Capital Region of Denmark compared to 2015. In the coming time, our focus will therefore be to strengthen ADR reporting in the regions.
Our focus areas in 2016 included contraceptive pills, melatonin use in children and adolescents, HPV vaccines and biological medicines and biosimilars, which we monitor routinely. We were also very active on the international scene and participated in several European collaborations.