Trønnes Johanne N, Lupattelli Angela, Nordeng Hedvig
PharmacoEpidemiology and Drug Safety Research Group, School of Pharmacy, PharmaTox Strategic Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway.
Department of Child Health, Norwegian Institute of Public Health, Oslo, Norway.
Pharmacoepidemiol Drug Saf. 2017 Jul;26(7):802-811. doi: 10.1002/pds.4213. Epub 2017 Apr 27.
The present study describes the safety profile of medications used during pregnancy across European countries and examines maternal factors associated with the use of risky medications during pregnancy.
This study is based on a multinational, web-based study conducted in 15 European countries from October 2011 to February 2012. Information about maternal demographics, illnesses, and medication use during pregnancy was collected via an electronic questionnaire. Pregnant women and new mothers with a child less than 1-year-old could participate. The Swedish, Australian, and U.S. risk classification systems were used to evaluate medication safety. Descriptive statistics and generalized estimating equation models were used.
A total of 587 medications were reported by the study sample (n = 6657). Sixty-nine percent of the women used medications classified as safe, 28% used medications classified as risky, and 3% used medications with no classification available. Both socio-demographic and medical factors were associated with the use of risky medications during pregnancy. Having a chronic disorder was the factor with the strongest association with the use of risky medications during pregnancy (adjusted odds ratio = 3.99, 95% confidence interval 3.54-4.49).
The majority of women used medications classified as safe to use during pregnancy. However, a considerable proportion of women still used medications classified as risky. Having a chronic disorder was an important driver for using risky medications. Such use may still be appropriate when considering the woman's underlying condition. Pre-pregnancy counselling is important to ensure safe medication use for both mother and child. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.
本研究描述了欧洲各国孕期用药的安全性概况，并探讨了与孕期使用高风险药物相关的母体因素。
本研究基于2011年10月至2012年2月在15个欧洲国家开展的一项跨国网络研究。通过电子问卷收集有关孕产妇人口统计学、疾病及孕期用药情况的信息。怀孕妇女及子女未满1岁的新妈妈均可参与。采用瑞典、澳大利亚和美国的风险分类系统评估药物安全性。运用描述性统计和广义估计方程模型。
研究样本（n = 6657）共报告了587种药物。69%的女性使用了分类为安全的药物，28%使用了分类为高风险的药物，3%使用了无分类信息的药物。社会人口统计学因素和医学因素均与孕期使用高风险药物有关。患有慢性疾病是与孕期使用高风险药物关联最强的因素（调整比值比 = 3.99，95%置信区间3.54 - 4.49）。
大多数女性使用了分类为孕期可安全使用的药物。然而，仍有相当比例的女性使用了分类为高风险的药物。患有慢性疾病是使用高风险药物的一个重要驱动因素。考虑到女性的基础疾病，这种用药情况可能仍然是合适的。孕前咨询对于确保母婴安全用药非常重要。© 2017作者。药物流行病学与药物安全。由John Wiley & Sons Ltd出版。
