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Downloaded from by 195.169.219.220 on 14-Jul-2021 for Gastroesophageal Reflux Disease and Nervous System Medications PDF hosted at the Radboud Repository of the Radboud University Nijmegen The following full text is a publisher's version. For additional information about this publication click this link. https://repository.ubn.ru.nl/handle/2066/231924 Please be advised that this information was generated on 2021-09-30 and may be subject to change. Clinical Epidemiology Dovepress open access to scientific and medical research Open Access Full Text Article ORIGINAL RESEARCH Antiemetic Prescription Fills in Pregnancy: A Drug Utilization Study Among 762,437 Pregnancies in Norway This article was published in the following Dove Press journal: Clinical Epidemiology Marleen MHJ van Gelder 1,2 Objective: To determine antiemetic prescription fill patterns during pregnancy in Norway, Hedvig Nordeng 3,4 with special focus on the use of ondansetron and recurrent use in subsequent pregnancies. Methods: We conducted a population-based registry study based on data from the Medical 1Department for Health Evidence, Radboud Institute for Health Sciences, Birth Registry of Norway linked to the Norwegian Prescription Database for 762,437 Radboud University Medical Center, pregnancies >12 gestational weeks ending in live or non-live births between 2005 and 2 Nijmegen, the Netherlands; Radboud 2017. Prescription fills of medications used for nausea and vomiting of pregnancy were REshape Innovation Center, Radboud University Medical Center, Nijmegen, the summarized in treatment pathways to determine drug utilization patterns. Logistic regression Netherlands; 3PharmacoEpidemiology analyses were used to estimate associations between maternal and pregnancy characteristics and Drug Safety Research Group, and antiemetic prescription fills. Department of Pharmacy, and PharmaTox For personal use only. Strategic Research Initiative, Faculty of Results: The prescription fill rate for antiemetic medication during pregnancy was 7.6%. Mathematics and Natural Sciences, However, prescription fill rates were 35.5% in the second pregnancy after filling an antie­ University of Oslo, Oslo, Norway; 4Department of Child Health and metic prescription in the first pregnancy and 53.5% for women who filled antiemetic Development, Norwegian Institute of prescriptions in the previous 2 pregnancies. Among pregnancies with antiemetic prescription Public Health, Oslo, Norway fills, 62.2% were dispensed metoclopramide, 28.2% meclizine, and 17.2% promethazine. First-line treatment started with monotherapy in 97.4% of these pregnancies, which was the only treatment received in 78.7%. Prescriptions for ondansetron were filled in 0.3% of pregnancies, with 76.9% being initially filled in the first trimester. Ondansetron as first-line prescription medication and/or use in the first trimester was associated with proxies for more severe nausea and vomiting of pregnancy, including a diagnosis of hyperemesis gravidarum, multiple gestations, a higher obstetric comorbidity index, and concomitant use of medication Clinical Epidemiology downloaded from https://www.dovepress.com/ by 195.169.219.220 on 14-Jul-2021 for gastroesophageal reflux disease and nervous system medications. Women who filled an antiemetic prescription in their first pregnancy were less likely to have subsequent pregnan­ cies than women who did not fill an antiemetic prescription in their first pregnancy (OR 0.93, 95% CI 0.90–0.96). Conclusion: Complex patterns of antiemetic prescription fills in pregnancy may mirror the challenge of optimal management of nausea and vomiting of pregnancy in clinical practice, especially for women with severe symptoms. Keywords: hyperemesis gravidarum, MBRN, metoclopramide, nausea and vomiting of pregnancy, NorPD, ondansetron Correspondence: Marleen MHJ van Gelder Introduction Department for Health Evidence Nausea and vomiting is the most common pregnancy-related condition, affecting up (HP133), Radboudumc, P.O. Box 9101, 1 Nijmegen, 6500 HB, the Netherlands to 70% of pregnant women. The symptoms typically occur during the first Tel +31 24 3666126 trimester, varying in severity from mild to life-threatening. Hyperemesis gravi­ Fax +31 24 3613505 1 Email [email protected] darum is among the latter, affecting 1% of the pregnant population. It is submit your manuscript | www.dovepress.com Clinical Epidemiology 2021:13 161–174 161 DovePress © 2021 van Gelder and Nordeng. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress. http://doi.org/10.2147/CLEP.S287892 com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Powered by TCPDF (www.tcpdf.org) van Gelder and Nordeng Dovepress characterized by persistent nausea and vomiting, dehydra­ Materials and Methods tion, electrolyte and nutritional imbalances, and excessive We used individual-level data from the Medical Birth weight loss, and the most common reason for hospitaliza­ Registry of Norway (MBRN) and the Norwegian tion during the first part of pregnancy.2 Nausea and vomit­ Prescription Database (NorPD). These registries were ing is generally not associated with adverse pregnancy linked using an encrypted version of the unique personal outcomes,3 although hyperemesis gravidarum has been identification number assigned to every citizen of Norway. associated with an increased risk of preterm birth, This study was approved by the Regional Committee for low birth weight, and small-for-gestational age.4 Research Ethics in South Eastern Norway (approval num­ Nevertheless, treatment of nausea and vomiting during ber 2018/140/REK SørØst) and by the Data Protection pregnancy is recommended because of its detrimental Officer at the University of Oslo (approval number impact on daily life functioning and quality of life,5,6 and 58033). to prevent progression to hyperemesis gravidarum. No uniform international guideline for the treatment of 7 Data Sources nausea and vomiting of pregnancy currently exists. The The MBRN is a nationwide population-based registry majority of national clinical treatment guidelines recom­ established in 1967, containing information on >2.3 mil­ mend to first consider non-pharmacologic options, such as lion births. It is based on mandatory notifications of all 3,8,9 lifestyle and dietary changes. If symptoms are severe pregnancies ending after gestational week 12, including or persist, pharmacologic therapy is recommended, but elective terminations and late miscarriages. The MBRN treatment algorithms vary between guidelines reflecting includes information on maternal demographics, maternal differences in marketed products and prescribing tradi­ health before and during pregnancy, pregnancy complica­ tions. As a result, antiemetic drug utilization patterns differ tions, labor interventions, gestational age at birth, as well considerably between countries. For example, in the as information on the infant, including vital status, birth For personal use only. United Kingdom antihistamines (ie, promethazine and weight, congenital malformations, and other perinatal cyclizine) and prochlorperazine are the most commonly outcomes.25 used antiemetics, followed by metoclopramide as second- All Norwegian pharmacies have been obliged to send line therapy,10 whereas in the United States ondansetron electronic data to the NorPD on all prescribed medications was used in nearly one in four pregnancies in 2014.11 Most dispensed to individuals in outpatient care since January clinical guidelines recommend reserving use of ondanse­ 2004.26 Medications in the NorPD are classified according tron if other treatments have failed and delaying use until to the Anatomical Therapeutic Chemical (ATC) classifica­ after 10 weeks’ gestation.3,9,12–17 tion system.27 In addition, information on the dates of In 2019, the European Medicines Agency (EMA) dispensing and the number of Defined Daily Doses recommended to avoid the use of ondansetron in the first (DDDs) dispensed is included. As we did not have infor­ Clinical Epidemiology downloaded from https://www.dovepress.com/ by 195.169.219.220 on 14-Jul-2021 trimester,18 after publication of several epidemiological mation on the actual dosage prescribed, we assumed that studies showing associations with small increased risks all women used 1 DDD of the medication per day. The of oral clefts (three additional cases per 10,000 exposed NorPD does not contain information on in-hospital treat­ to ondansetron in the first trimester) and inconclusive ment and over-the-counter medications, except when these results on the risk of cardiac malformations.19–22 Insight were prescribed. into how nausea and vomiting of pregnancy is pharmaco­ logically managed in the real world is especially warranted Study Population in light of these recommendations, especially since the For the present study, we included all women with a 23,24 EMA recommendation is not undisputed. Therefore, pregnancy recorded in the MBRN in 2005–2017 who we conducted a population-based register study to deter­ could be linked to the NorPD. We excluded pregnancies mine antiemetic prescription fill patterns during preg­ with missing information
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