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
{"title":"揭示隐藏的障碍：探索荷兰儿科药物警戒的挑战。","authors":"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","doi":"10.1007/s40264-025-01593-y","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8000,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Uncovering the Hidden Hurdles: Exploring Challenges in Pediatric Pharmacovigilance in the Netherlands.\",\"authors\":\"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\",\"doi\":\"10.1007/s40264-025-01593-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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.</p><p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>This study highlights the importance of addressing barriers to ADR reporting in pediatric healthcare. 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Uncovering the Hidden Hurdles: Exploring Challenges in Pediatric Pharmacovigilance in the Netherlands.
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.
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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