Adverse drug reaction reports in Iceland from 2013 to 2016. A comparison with other Nordic countries

Information regarding adverse drug reactions (ADRs) of new medications is based on clinical studies of selected populations. The reporting of ADRs from real-life use following the marketing of new active substances is instrumental for the continuous evaluation of their benefit-risk balance. The aim of this study was to determine the number and nature of ADR reports in Iceland and compare with other Nordic countries. Reports of ADRs from 2013 to 2016 were examined using the Icelandic Medicines Agency´s database. The total number and seriousness of ADRs by ATC-classification of drugs were compared with data published in the 2013 to 2015 annual reports from the Swedish, Danish and Norwegian Medicines Agencies. Comparison of sales between countries was examined. The number of ADR reports in Iceland was between 36 to 104 per 100 thousand inhabitants/year, with less than 10% defined as serious. This compares to 58 to 133 ADR reports per 100 thousand inhabitants in the other Nordic countries, with 38% to 64% of ADRs classified as serious. In Iceland, ADR reports were more common for medications in ATC-class A and less common for classes B, J and L compared to the other Nordic countries. Sales of medications were comparable between these nations. There is great variability in the number of ADRs reported annually in Iceland. The drugs reported are within different ATC-classes and the proportion of serious ADRs is low compared to the other Nordic countries. This is not explained by different sales volumes. Key words: adverse drug reaction, pharmacovigilance, ADR reporting, side effects. Correspondence: Hrefna Guðmundsdóttir, Hrefna.Gudmundsdottir@lyfjastofnun.is.