@article{ref1,
title="Adverse drug reaction reports in Iceland from 2013 to 2016. A comparison with other Nordic countries",
journal="Laeknabladid",
year="2017",
author="Jonsdottir, Sara Skulina and Olafsdottir, Sigridur Maria and Gudmundsdottir, Hrefna",
volume="103",
number="7",
pages="319-323",
abstract="INTRODUCTION: 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. <br><br>MATERIALS AND METHODS: 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. <br><br>RESULTS: 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. <br><br>CONCLUSION: 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.<p /> <p>Language: is</p>",
language="is",
issn="0023-7213",
doi="",
url="http://dx.doi.org/"
}