ArticlePloS one2021
Analysis of the reporting of adverse drug reactions in children and adolescents in Germany in the time period from 2000 to 2019.
Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed.
- Signal Detection and Temporal Analysis of Aromatase Inhibitor-Associated Hepatotoxicity: A Pharmacovigilance Study Integrating Bayesian Belief-Propagation Network and Frequentist Metrics.The international journal of medical robotics + computer assisted surgery : MRCAS · 2026Article
- Prescribing trends and spontaneous reporting patterns of adverse drug reactions of ADHD medications in children and adolescents in germany: A retrospective analysis (2013-2022).European child & adolescent psychiatry · 2026Article
- Analysis of Reporting Trends of Serious Adverse Events Associated With Anti-Obesity Drugs.Pharmacology research & perspectives · 2025Article
- Pre-prescription review system improves prescription safety, efficiency, and cost-effectiveness in pediatric outpatients: a western China study.Frontiers in pharmacology · 2025Article
- Adverse Event Profile of First-line Drugs for Treating Patent Ductus Arteriosus in Neonates: A Disproportionality Analysis Study of USFDA Adverse Event Reporting System.Paediatric drugs · 2024Article
- Article
- Development of a checklist for the assessment of pharmacovigilance guidelines in Southern Africa: a document review.Therapeutic advances in drug safety · 2023Article
- Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy.Drug safety · 2022Review
- Analysis of pharmacovigilance databases for spontaneous reports of adverse drug reactions related to substandard and falsified medical products: A descriptive study.Frontiers in pharmacology · 2022Article
- A Survey of Prescription Errors in Paediatric Outpatients in Multi-Primary Care Settings: The Implementation of an Electronic Pre-Prescription System.Frontiers in pediatrics · 2022Article
- Descriptive analysis of adverse drug reaction reports in children and adolescents from Germany: frequently reported reactions and suspected drugs.BMC pharmacology & toxicology · 2021Article
- Assessment and analysis of outpatient medication errors related to pediatric prescriptions.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2021Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The objective of this study was to analyse reports on adverse drug reactions (ADRs) from Germany in the particularly vulnerable patient group of children and adolescents. Reporting characteristics, demographic parameters and off-label use were examined among others. The ratio of ADR reports per number of German inhabitants and the ratio of ADR reports per number of German inhabitants exposed to drugs were calculated and compared. These parameters were examined to derive trends in reporting of ADRs. 20,854 spontaneous ADR reports for the age group 0-17 years were identified in the European ADR database EudraVigilance for the time period 01.01.2000-28.02.2019 and analysed with regard to the aforementioned criteria. 86.5% (18,036/20,854) of the ADR reports originated from Healthcare Professionals and 12.2% (2,546/20,854) from non-Healthcare Professionals. 74.4% (15,522/20,854) of the ADR reports were classified as serious. The proportion of ADR reports per age group was 11.8% (0-1 month), 11.0% (2 months-1 year), 7.4% (2-3 years), 9.3% (4-6 years), 25.8% (7-12 years), and 34.8% (13-17 years) years, respectively. Male sex slightly dominated (51.2% vs. 44.8% females). Only 3.5% of the ADR reports reported off-label use. The annual number of ADR reports increased since 2000, even if set in context with the number of inhabitants and assumed drug-exposed inhabitants. The pediatric population declined in the study period which argues against its prominent role for the increase in the total number of ADR reports. Instead, among others, changes in reporting obligations may apply. The high proportion of serious ADR reports underlines the importance of pediatric drug safety.
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