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

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 Pharmacovigilan...

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Detalhes bibliográficos
Autores: Lopez-Valverde, L, Domenech, E, Roguera, M, Gich, I, Farre, M, Rodrigo, C, Montane, E
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Recursos:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositorio:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p5855
Acesso em linha:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=5855
Access Level:acceso abierto
Palavra-chave:adverse drug reaction
spontaneous reporting
pharmacovigilance
children
pediatrics
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spelling Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary HospitalLopez-Valverde, LDomenech, ERoguera, MGich, IFarre, MRodrigo, CMontane, Eadverse drug reactionspontaneous reportingpharmacovigilancechildrenpediatricsThe 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.MDPI2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=5855Journal of Clinical MedicineISSN: 20770383reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pauinstname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)Inglésinfo:eu-repo/semantics/openAccessoai:iibsantpau.fundanetsuite.com:p58552026-06-14T12:41:47Z
dc.title.none.fl_str_mv Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital
title Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital
spellingShingle Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital
Lopez-Valverde, L
adverse drug reaction
spontaneous reporting
pharmacovigilance
children
pediatrics
title_short Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital
title_full Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital
title_fullStr Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital
title_full_unstemmed Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital
title_sort Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital
dc.creator.none.fl_str_mv Lopez-Valverde, L
Domenech, E
Roguera, M
Gich, I
Farre, M
Rodrigo, C
Montane, E
author Lopez-Valverde, L
author_facet Lopez-Valverde, L
Domenech, E
Roguera, M
Gich, I
Farre, M
Rodrigo, C
Montane, E
author_role author
author2 Domenech, E
Roguera, M
Gich, I
Farre, M
Rodrigo, C
Montane, E
author2_role author
author
author
author
author
author
dc.subject.none.fl_str_mv adverse drug reaction
spontaneous reporting
pharmacovigilance
children
pediatrics
topic adverse drug reaction
spontaneous reporting
pharmacovigilance
children
pediatrics
description 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.
publishDate 2021
dc.date.none.fl_str_mv 2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=5855
url https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=5855
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv MDPI
publisher.none.fl_str_mv MDPI
dc.source.none.fl_str_mv Journal of Clinical Medicine
ISSN: 20770383
reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
instname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
instname_str Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
reponame_str r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
collection r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
repository.name.fl_str_mv
repository.mail.fl_str_mv
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