Agreement Between Parental Self-Reported Antiseizure Medication Use and Dispensed Prescription Records From a National Prescription Database.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-04-01 DOI:10.1002/pds.70139

Emilie Willoch Olstad, Hedvig Nordeng, Marte-Helene Bjørk, Kaja Kristine Selmer, Kristina Gervin

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Abstract

Purpose: Accurate measurement of medication exposure is crucial for studying the safety of antiseizure medications (ASMs) during pregnancy. Pregnancy safety studies of ASMs frequently rely on secondary data from drug prescription registries to assess potential teratogenic effects and impact on fetal development. This study aimed to evaluate the agreement between dispensed prescriptions registered in a national database and self-reported ASM use by parents.

Methods: The Norwegian Prescription Database (NorPD) was linked to the Norwegian Mother, Father, and Child Cohort Study (MoBa) and the Medical Birth Registry of Norway (MBRN). Participants included mothers and fathers in the MoBa-study between 2004 and 2009. Agreement between dispensed ASM prescriptions and self-reported use was assessed by calculating Cohen's kappa (κ), sensitivity, and specificity, with self-reported use as the reference standard.

Results: A total of 40 632 pregnant women and 42 247 fathers were included. Maternal dispensed ASM prescriptions during pregnancy showed strong overall agreement (κ = 0.81) with self-reported use, with a sensitivity of 80.6% and specificity of 99.9%. Paternal dispensed ASM prescriptions up to 7 months prior to conception also demonstrated strong agreement (κ = 0.81) with self-reported use. Analysis of individual ASMs revealed varying reliability: levetiracetam and lamotrigine had the highest agreement among maternal (κ = 0.92) and paternal (κ = 0.92) dispensed prescriptions, respectively.

Conclusion: There is strong agreement between dispensed ASM prescriptions and self-reported medication use by parents, supporting the use of prescription data for evaluating the risks of ASM use during pregnancy.

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家长自我报告的抗癫痫药物使用和国家处方数据库中分配的处方记录之间的协议。

目的：准确测定妊娠期抗癫痫药物的用药剂量对研究妊娠期抗癫痫药物的安全性至关重要。asm的妊娠安全性研究经常依赖于药物处方登记的二手数据来评估潜在的致畸效应和对胎儿发育的影响。本研究旨在评估在国家数据库中注册的配药处方与家长自我报告的ASM使用之间的一致性。方法：挪威处方数据库（NorPD）与挪威母亲、父亲和儿童队列研究（MoBa）和挪威医学出生登记处（MBRN）相关联。在2004年至2009年的moba研究中，参与者包括母亲和父亲。通过计算Cohen's kappa （κ）、敏感性和特异性来评估分配的ASM处方与自我报告的使用情况之间的一致性，并以自我报告的使用情况作为参考标准。结果：共纳入40 632名孕妇和42 247名父亲。孕妇在怀孕期间配用的ASM处方与自我报告的使用情况总体一致（κ = 0.81），敏感性为80.6%，特异性为99.9%。父亲在怀孕前7个月分配的ASM处方也与自我报告的使用表现出强烈的一致性（κ = 0.81）。对个体的ASMs分析显示出不同的可靠性：左乙拉西坦和拉莫三嗪分别在母体配药处方（κ = 0.92）和父亲配药处方（κ = 0.92）中具有最高的一致性。结论：配发的ASM处方与父母自我报告的用药情况有很强的一致性，支持使用处方数据来评估妊娠期间使用ASM的风险。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.