Spontaneous reporting of adverse drug reactions in a pediatric population in a tertiary hospital
López Valverde, Laura (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia)
Domènech Marsal, Èlia (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Roguera, M. (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Gich, Ignasi (Institut d'Investigació Biomèdica Sant Pau)
Farre, Magi (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Rodrigo Gonzalo de Líria, Carlos (Universitat Autònoma de Barcelona. Departament de Pediatria, Obstetrícia i Ginecologia i Medicina Preventiva i Salut Pública)
Montané, E. (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)

Fecha:	2021
Resumen:	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.
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Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Adverse drug reaction ; Spontaneous reporting ; Pharmacovigilance ; Children ; Pediatrics
Publicado en:	Journal of clinical medicine, Vol. 10 Núm. 23 (12-1 2021) , p. 5531, ISSN 2077-0383

Adreça alternativa: https://www.mdpi.com/2077-0383/10/23/5531
DOI: 10.3390/jcm10235531
PMID: 34884233

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