Serious adverse drug reactions and safety signals in children: a nationwide database study

Detalhes bibliográficos
Autor(a) principal: Vieira, Jean Mendes de Lucena
Data de Publicação: 2020
Outros Autores: Matos, Guacira Corrêa de, Silva, Fabricio Alves Barbosa da, Bracken, Louise E., Peak, Matthew, Lima, Elisangela da Costa
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/42661
Resumo: Link para o artigo publicado: https://www.frontiersin.org/articles/10.3389/fphar.2020.00964/full
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spelling Vieira, Jean Mendes de LucenaMatos, Guacira Corrêa deSilva, Fabricio Alves Barbosa daBracken, Louise E.Peak, MatthewLima, Elisangela da Costa2020-08-11T15:21:08Z2020-08-11T15:21:08Z2020VIEIRA, Jean Mendes de Lucena et al. Serious adverse drug reactions and safety signals in children: a nationwide database study. Front. Pharmacol., v. 11, n. 964, p. 1-9, 6 Aug. 2020.1663-9812https://www.arca.fiocruz.br/handle/icict/4266110.3389/fphar.2020.00964Link para o artigo publicado: https://www.frontiersin.org/articles/10.3389/fphar.2020.00964/fullCNPqUniversidade Federal do Rio de Janeiro. Centro de Ciências da Saúde. Faculdade de Farmácia. Rio de Janeiro, RJ, Brasil.Universidade Federal do Rio de Janeiro. Centro de Ciências da Saúde. Faculdade de Farmácia. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Presidência. Programa de Computação Científica. Rio de Janeiro, RJ, Brasil.Alder Hey Children's NHS Foundation Trust. Paediatric Medicines Research Unit. Liverpool, England.Alder Hey Children's NHS Foundation Trust. Paediatric Medicines Research Unit. Liverpool, England.Universidade Federal do Rio de Janeiro. Centro de Ciências da Saúde. Faculdade de Farmácia. Rio de Janeiro, RJ, Brasil.Children are more exposed to inappropriate medicine use and its consequent harms. Spontaneous reporting of suspected Serious Adverse Drug Reactions (SADR) increases knowledge and prevention of pharmacotherapy risk. Disproportionality measures are useful to quantify unexpected safety issues associated with a given drug event pair (signals of disproportionality). This cross-sectional study aimed to assess SADR reporting and safety signals for Brazilian children from 0-12 years old, notified between January 2008 and December 2013 from the Brazilian Surveillance Agency (Notivisa). Information from serious reports (gender and age of the patient, event description, suspected drug) was included. Disproportionality analysis based on Reporting Odds Ratios with a confidence interval of 95% was conducted to identify possible signals of disproportionate reporting (SDR). Almost 30% of 1,977 suspected SADR was related to babies (0-1-year-old). 69% of reports happened with intravenous dosage forms, and 35% of suspected SADR involved off label use according to age. Laronidase, miglustat, imipenem/cilastatin, and clofarabine were involved in six or more suspected deaths among 75 deaths reported. There were 107 SDRs, of which 16 events (15%) were not described in the product labels. There was a relatively higher number of SADRs in Brazilian children compared with studies from other countries. SDRs found, (especially drug-event pairs ‘imipenen/cilastatin–pneumonia’ and ‘laronidase–respiratory insufficiency’) should be investigated more. The reports of SADR with IV dosage forms and OL drug use suggest the need for drug research and the use of better dosage forms for children in Brazil.engFrontiers in PharmacologySerious adverse drug reactions and safety signals in children: a nationwide database studyinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleSerious adverse drug reactionsChildrenSpontaneous reportsOff label drug useSafety signalsinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; 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dc.title.en.fl_str_mv Serious adverse drug reactions and safety signals in children: a nationwide database study
title Serious adverse drug reactions and safety signals in children: a nationwide database study
spellingShingle Serious adverse drug reactions and safety signals in children: a nationwide database study
Vieira, Jean Mendes de Lucena
Serious adverse drug reactions
Children
Spontaneous reports
Off label drug use
Safety signals
title_short Serious adverse drug reactions and safety signals in children: a nationwide database study
title_full Serious adverse drug reactions and safety signals in children: a nationwide database study
title_fullStr Serious adverse drug reactions and safety signals in children: a nationwide database study
title_full_unstemmed Serious adverse drug reactions and safety signals in children: a nationwide database study
title_sort Serious adverse drug reactions and safety signals in children: a nationwide database study
author Vieira, Jean Mendes de Lucena
author_facet Vieira, Jean Mendes de Lucena
Matos, Guacira Corrêa de
Silva, Fabricio Alves Barbosa da
Bracken, Louise E.
Peak, Matthew
Lima, Elisangela da Costa
author_role author
author2 Matos, Guacira Corrêa de
Silva, Fabricio Alves Barbosa da
Bracken, Louise E.
Peak, Matthew
Lima, Elisangela da Costa
author2_role author
author
author
author
author
dc.contributor.author.fl_str_mv Vieira, Jean Mendes de Lucena
Matos, Guacira Corrêa de
Silva, Fabricio Alves Barbosa da
Bracken, Louise E.
Peak, Matthew
Lima, Elisangela da Costa
dc.subject.en.en.fl_str_mv Serious adverse drug reactions
Children
Spontaneous reports
Off label drug use
Safety signals
topic Serious adverse drug reactions
Children
Spontaneous reports
Off label drug use
Safety signals
description Link para o artigo publicado: https://www.frontiersin.org/articles/10.3389/fphar.2020.00964/full
publishDate 2020
dc.date.accessioned.fl_str_mv 2020-08-11T15:21:08Z
dc.date.available.fl_str_mv 2020-08-11T15:21:08Z
dc.date.issued.fl_str_mv 2020
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv VIEIRA, Jean Mendes de Lucena et al. Serious adverse drug reactions and safety signals in children: a nationwide database study. Front. Pharmacol., v. 11, n. 964, p. 1-9, 6 Aug. 2020.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/42661
dc.identifier.issn.pt_BR.fl_str_mv 1663-9812
dc.identifier.doi.pt_BR.fl_str_mv 10.3389/fphar.2020.00964
identifier_str_mv VIEIRA, Jean Mendes de Lucena et al. Serious adverse drug reactions and safety signals in children: a nationwide database study. Front. Pharmacol., v. 11, n. 964, p. 1-9, 6 Aug. 2020.
1663-9812
10.3389/fphar.2020.00964
url https://www.arca.fiocruz.br/handle/icict/42661
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Frontiers in Pharmacology
publisher.none.fl_str_mv Frontiers in Pharmacology
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/42661/1/license.txt
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