Adverse drug reactions in children: a ten-year review of reporting to the Portuguese Pharmacovigilance System
Rattachement africain : pt, is. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
OBJECTIVE: Adverse drug reactions (ADR) are a public health problem. They cause significant morbidity, mortality and health costs. Less is known about pediatric ADR. Our goal was to characterize a pediatric case series of ADR reported to the Portuguese Pharmacovigilance System (PPS) during the past 10 years. RESEARCH DESIGN AND METHODS: Retrospective analysis of ADR reports concerning patients till 17 years old received by the PPS between 2003 and 2012. We evaluated patients' demographic data and involved drugs, as well as characteristics and seriousness of reactions, stratified by age groups. RESULTS: We found 1742 reports (50% females) corresponding to 9.7% of the total received. The age of the patients varied from 0 to 17 years (median: 5 years, interquartile range: 10.6), with 566 cases (32%) occurring in patients younger than 2y. Among the 1195 serious cases, 31% (370) episodes led to hospitalization. In 32 cases (2%) there was a fatal outcome. Most of the ADR reported referred to general disorders and administration site conditions, followed by skin and subcutaneous tissue reactions. Vaccines were the most represented group (42%) followed by antibacterials for systemic use (17%). CONCLUSIONS: Pediatric ADR represents about 10% of the reports received by the PPS. Most ADR were considered serious. Major findings varied according to age groups.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Adverse drug reactions in children: a ten-year review of reporting to the Portuguese Pharmacovigilance System
- Date Crossref
- 07/11/2015
- Éditeur
- Informa Healthcare
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Ordem dos Médicos pays non établi dans la noticeOrganisme public
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Infarmed pays non établi dans la noticeOrganisme public
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Cooperativa de Ensino Superior Politécnico e Universitário pays non établi dans la noticeUniversité ou école supérieure
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Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da Saúde pays non établi dans la noticeStructure de recherche
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Universidade do Porto pays non établi dans la noticeUniversité ou école supérieure
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Instituto do Emprego e Formação Profissional pays non établi dans la noticeOrganisme public
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Directorate of Health pays non établi dans la noticeOrganisme public
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Centro Hospitalar do Porto g Allergy Department pays non établi dans la noticeÉtablissement de santé
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a Direção de Gestão do Risco de Medicamentos pays non établi dans la noticeInstitution
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b Institute for Research in Biomedicine - iBiMED & Health Sciences Department pays non établi dans la noticeStructure de recherche
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Institute for Research in Biomedicine – iBiMED & Health Sciences Department pays non établi dans la noticeStructure de recherche
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e Department of Quality in Health pays non établi dans la noticeInstitution
Ordem dos Médicos, Infarmed et Cooperativa de Ensino Superior Politécnico e Universitário, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.