Uncovering the Hidden Hurdles: Exploring Challenges in Pediatric Pharmacovigilance in the Netherlands.

IF 3.8 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Anne T M Dittrich, Yvet Kroeze, Michel A A P Willemsen, Jos M Th Draaisma, Eugène P van Puijenbroek, D Maroeska W M Te Loo
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Abstract

Introduction: The use of drugs carries risks, as adverse drug reactions (ADRs) can occur. In the Netherlands, a voluntary pharmacovigilance system is in place, allowing healthcare professionals and patients to report (suspected) ADRs. Previous research has highlighted underreporting as a significant problem; however, barriers for ADR reporting are not clear.

Objectives: The aim was to assess perceptions of ADR reporting among pediatricians (in training), to identify barriers hindering reporting, and to study differences between our hospital and other Dutch hospitals.

Methods: A cross-sectional survey was conducted among pediatricians (in training) in the Netherlands. The study questionnaire was based on a validated questionnaire and adjusted for the Dutch context, addressing aspects related to ADR reporting, attitudes toward ADRs in work environment, personal vision, reasons for nonreporting, and future perspectives.

Results: A dataset of 127 respondents was included. Of these, 93% reported knowing how to report an ADR. Overall, 95% believed that reporting ADRs has the potential to enhance knowledge and improve drug safety, and 93% acknowledged the overall importance of ADR reporting. However, 19% of respondents indicated that they had never reported an ADR. The most commonly cited reason (61%) for not reporting was prior knowledge of the ADR. Other barriers included uncertainty about whether a symptom constituted an ADR, the perception that the ADR was not severe, and time constraints.

Conclusions: This study highlights the importance of addressing barriers to ADR reporting in pediatric healthcare. While healthcare professionals recognize the significance of ADR reporting, several impediments hinder their reporting efforts.

揭示隐藏的障碍:探索荷兰儿科药物警戒的挑战。
药物的使用存在风险,可能会发生药物不良反应(adr)。荷兰建立了自愿药物警戒系统,允许卫生保健专业人员和患者报告(疑似)不良反应。先前的研究强调了漏报是一个重大问题;然而,不良反应报告的障碍尚不清楚。目的:目的是评估儿科医生(在培训中)对不良反应报告的看法,确定阻碍报告的障碍,并研究我院与其他荷兰医院之间的差异。方法:在荷兰儿科医生(在培训)中进行横断面调查。研究问卷基于一份经过验证的问卷,并根据荷兰的情况进行了调整,涉及与ADR报告相关的方面,对工作环境中ADR的态度,个人愿景,不报告的原因和未来前景。结果:纳入了127名受访者的数据集。其中,93%的人表示知道如何报告不良反应。总体而言,95%的人认为报告不良反应有可能增强知识和提高药物安全性,93%的人承认报告不良反应的总体重要性。然而,19%的受访者表示他们从未报告过药品不良反应。不报告的最常见原因(61%)是事先知道不良反应。其他障碍包括不确定症状是否构成不良反应,认为不良反应不严重,以及时间限制。结论:本研究强调了在儿科医疗保健中解决不良反应报告障碍的重要性。虽然医疗保健专业人员认识到不良反应报告的重要性,但有几个障碍阻碍了他们的报告工作。
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
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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