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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Autores: López Valverde, Laura|||0000-0003-2504-6008, Domènech Marsal, Èlia, Roguera, M., Gich, Ignasi|||0000-0003-3975-6588, Farré Albaladejo, Magí|||0000-0001-8338-7543, Rodrigo Gonzalo de Líria, Carlos|||0000-0003-1140-2585, Montané Esteva, Eva|||0000-0002-1691-7652
Tipo de recurso: artículo
Fecha de publicación:2021
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:264656
Acceso en línea:https://ddd.uab.cat/record/264656
https://dx.doi.org/urn:doi:10.3390/jcm10235531
Access Level:acceso abierto
Palabra clave: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 hospitalLópez Valverde, Laura|||0000-0003-2504-6008Domènech Marsal, ÈliaRoguera, M.Gich, Ignasi|||0000-0003-3975-6588Farré Albaladejo, Magí|||0000-0001-8338-7543Rodrigo Gonzalo de Líria, Carlos|||0000-0003-1140-2585Montané Esteva, Eva|||0000-0002-1691-7652Adverse 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. 22021-01-0120212021-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/264656https://dx.doi.org/urn:doi:10.3390/jcm10235531reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2646562026-06-06T12:50:31Z
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
López Valverde, Laura|||0000-0003-2504-6008
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 López Valverde, Laura|||0000-0003-2504-6008
Domènech Marsal, Èlia
Roguera, M.
Gich, Ignasi|||0000-0003-3975-6588
Farré Albaladejo, Magí|||0000-0001-8338-7543
Rodrigo Gonzalo de Líria, Carlos|||0000-0003-1140-2585
Montané Esteva, Eva|||0000-0002-1691-7652
author López Valverde, Laura|||0000-0003-2504-6008
author_facet López Valverde, Laura|||0000-0003-2504-6008
Domènech Marsal, Èlia
Roguera, M.
Gich, Ignasi|||0000-0003-3975-6588
Farré Albaladejo, Magí|||0000-0001-8338-7543
Rodrigo Gonzalo de Líria, Carlos|||0000-0003-1140-2585
Montané Esteva, Eva|||0000-0002-1691-7652
author_role author
author2 Domènech Marsal, Èlia
Roguera, M.
Gich, Ignasi|||0000-0003-3975-6588
Farré Albaladejo, Magí|||0000-0001-8338-7543
Rodrigo Gonzalo de Líria, Carlos|||0000-0003-1140-2585
Montané Esteva, Eva|||0000-0002-1691-7652
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 2
2021-01-01
2021
2021-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/264656
https://dx.doi.org/urn:doi:10.3390/jcm10235531
url https://ddd.uab.cat/record/264656
https://dx.doi.org/urn:doi:10.3390/jcm10235531
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
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