Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections

Detalhes bibliográficos
Autor(a) principal: Ferreira, Joana
Data de Publicação: 2022
Outros Autores: Placido, Ana Isabel, Afreixo, Vera, Ribeiro-Vaz, Ines, Roque, Fatima, Herdeiro, Maria Teresa
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10362/137781
Resumo: Funding: This research was funded by the project PTDC/SAU-SER/31678/2017, supported by the Operational Program on Competitiveness and Internationalization (POCI) in its FEDER/FNR component, POCI-01-0145-FEDER-031678, and by the Foundation for Science and Technology in its state budget component (OE).
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spelling Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infectionsadverse drug reactionsantibioticsupper airway infectionsEudraVigilance databaseFunding: This research was funded by the project PTDC/SAU-SER/31678/2017, supported by the Operational Program on Competitiveness and Internationalization (POCI) in its FEDER/FNR component, POCI-01-0145-FEDER-031678, and by the Foundation for Science and Technology in its state budget component (OE).Adverse drug reactions (ADR) significantly impact mortality and morbidity and lead to high healthcare costs. Reporting ADR to regulatory authorities allows for monitoring the safety and efficacy profile of medicines on the market and for assessing the benefit–risk ratio. This retrospective study aims to characterize the ADR profile of the most consumed antibiotics in Portugal that are prescribed for upper airway infections and submitted to the EudraVigilance database. The variables were analyzed in an exploratory perspective, through absolute and relative frequencies, with emphasis on serious ADR. A total of 59,022 reports were analyzed of which 64.4% were classified as suspected serious ADR. According to serious ADR, the female sex (52.2%) and 18–64 age group (47.5%) prevail. Health professionals reported 87.8% of suspected serious ADR and European Economic Area (EEA) countries represented 50.8% of the reports. “Skin and subcutaneous tissue connections” (15.9%), “general disorders and administrations site conditions” (12%), and “gastrointestinal disorders” (9.8%) are the prevalent system organ classes. In 4.5% of the reports, patients had a fatal outcome. A periodic evaluation of the safety of the antibiotic should be performed to facilitate the development of guidelines and policies to reduce the frequency of serious ADR.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)RUNFerreira, JoanaPlacido, Ana IsabelAfreixo, VeraRibeiro-Vaz, InesRoque, FatimaHerdeiro, Maria Teresa2022-05-11T22:48:25Z2022-04-022022-04-02T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10362/137781eng2079-6382PURE: 43681977https://doi.org/10.3390/antibiotics11040477info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-03-11T05:15:13Zoai:run.unl.pt:10362/137781Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:48:53.561123Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections
title Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections
spellingShingle Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections
Ferreira, Joana
adverse drug reactions
antibiotics
upper airway infections
EudraVigilance database
title_short Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections
title_full Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections
title_fullStr Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections
title_full_unstemmed Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections
title_sort Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections
author Ferreira, Joana
author_facet Ferreira, Joana
Placido, Ana Isabel
Afreixo, Vera
Ribeiro-Vaz, Ines
Roque, Fatima
Herdeiro, Maria Teresa
author_role author
author2 Placido, Ana Isabel
Afreixo, Vera
Ribeiro-Vaz, Ines
Roque, Fatima
Herdeiro, Maria Teresa
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
RUN
dc.contributor.author.fl_str_mv Ferreira, Joana
Placido, Ana Isabel
Afreixo, Vera
Ribeiro-Vaz, Ines
Roque, Fatima
Herdeiro, Maria Teresa
dc.subject.por.fl_str_mv adverse drug reactions
antibiotics
upper airway infections
EudraVigilance database
topic adverse drug reactions
antibiotics
upper airway infections
EudraVigilance database
description Funding: This research was funded by the project PTDC/SAU-SER/31678/2017, supported by the Operational Program on Competitiveness and Internationalization (POCI) in its FEDER/FNR component, POCI-01-0145-FEDER-031678, and by the Foundation for Science and Technology in its state budget component (OE).
publishDate 2022
dc.date.none.fl_str_mv 2022-05-11T22:48:25Z
2022-04-02
2022-04-02T00:00:00Z
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.uri.fl_str_mv http://hdl.handle.net/10362/137781
url http://hdl.handle.net/10362/137781
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 2079-6382
PURE: 43681977
https://doi.org/10.3390/antibiotics11040477
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
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reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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