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Article

Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital

1
Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain
2
Department of Pediatrics, Hospital Universitari Germans Trias i Pujol, 08916 Badalona, Spain
3
Department of Clinical Pharmacology, Hospital Universitari Sant Pau, 08025 Barcelona, Spain
4
Department of Clinical Pharmacology, Hospital Universitari Germans Trias i Pujol, 08916 Badalona, Spain
5
Department of Pediatrics, Obstetrics and Gynecology, Preventive Medicine and Public Health, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain
*
Author to whom correspondence should be addressed.
Academic Editors: Antonio J. Carcas-Sansuán and Alberto M. Borobia Pérez
J. Clin. Med. 2021, 10(23), 5531; https://doi.org/10.3390/jcm10235531
Received: 26 October 2021 / Revised: 21 November 2021 / Accepted: 23 November 2021 / Published: 26 November 2021
(This article belongs to the Collection Practice and Research in Clinical Pharmacology)
The pediatric population is a vulnerable group for adverse drug reactions (ADRs), and data on spontaneous reporting of ADRs in the hospital setting are scarce. We conducted a retrospective analysis of ADRs in pediatric patients spontaneously reported by health care professionals to a Pharmacovigilance Program in a tertiary hospital between 2010 and 2020, and we compared characteristics of ADRs between pediatric age subgroups. From 1787 spontaneously reported ADRs in an 11-year period, 103 (5.85%) were pediatric ADRs. The median age of patients with ADRs was 8.4 years (range 1 day–17 years) and 57.3% were male. The most frequent ADRs reported were nervous system disorders (13.6%) and the most frequently involved drugs were antineoplastics and immunodulators (32.4%). A 59.2% of the ADRs were serious and 55.3% were classified as being type B reactions. Medication errors were involved in 7.8% of the ADRs and 11.9% of the suspected drugs were used off-label. Spontaneous reports of ADRs in newborns, infants, and toddlers were more serious and less often described in the product data sheet than in children and adolescents (p < 0.001 and p = 0.004 respectively). Medication errors were more frequent in patients under two years of age. These results should be interpreted with caution due to under-reporting and biases in spontaneous reporting of ADRs. View Full-Text
Keywords: adverse drug reaction; spontaneous reporting; pharmacovigilance; children; pediatrics adverse drug reaction; spontaneous reporting; pharmacovigilance; children; pediatrics
MDPI and ACS Style

López-Valverde, L.; Domènech, È.; Roguera, M.; Gich, I.; Farré, M.; Rodrigo, C.; Montané, E. Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital. J. Clin. Med. 2021, 10, 5531. https://doi.org/10.3390/jcm10235531

AMA Style

López-Valverde L, Domènech È, Roguera M, Gich I, Farré M, Rodrigo C, Montané E. Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital. Journal of Clinical Medicine. 2021; 10(23):5531. https://doi.org/10.3390/jcm10235531

Chicago/Turabian Style

López-Valverde, Laura, Èlia Domènech, Marc Roguera, Ignasi Gich, Magí Farré, Carlos Rodrigo, and Eva Montané. 2021. "Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital" Journal of Clinical Medicine 10, no. 23: 5531. https://doi.org/10.3390/jcm10235531

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