Development of instrument to report and assess causality of adverse events related to herbal medicines

Background: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment. Objectives: This study aimed to develop an instrument to allow detection and...

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Detalles Bibliográficos
Autores: de Carvalho Mastroianni, Patrícia [UNESP], Rossi Varallo, Fabiana [UNESP], Amaral Costa, Marília [UNESP], Da Silva Sacramento, Luis Vitor [UNESP]
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2017
País:Brasil
Institución:Universidade Estadual Paulista (UNESP)
Repositorio:Repositório Institucional da UNESP
Idioma:inglés
OAI Identifier:oai:repositorio.unesp.br:11449/228312
Acceso en línea:http://dx.doi.org/10.17533/udea.vitae.v24n1a02
http://hdl.handle.net/11449/228312
Access Level:acceso abierto
Palabra clave:Adverse drug reaction reporting systems
Herbal medicine
Pharmacovigilance
Postmarketing
Product surveillance
Risk assessment
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spelling Development of instrument to report and assess causality of adverse events related to herbal medicinesDesarrollo de un instrumento para reportar y evaluar la causalidad de los eventos adversos asociados a plantas medicinalesAdverse drug reaction reporting systemsHerbal medicinePharmacovigilancePostmarketingProduct surveillanceRisk assessmentBackground: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment. Objectives: This study aimed to develop an instrument to allow detection and evaluation of the causal likelihood of AE related to herbal medicines. Methods: A quantitative methodological development research intervention was performed with primary care health professionals. Two cases were distributed in an interval of one week in order to allow for completion of the proposal form. The within-rater reliability was calculated and classified into satisfactory, regular, and unsatisfactory, according to essential, necessary, and recommended items reported. Results: Fifty-seven professionals were enrolled. A high degree of the within-rater reliability was observed for the most essential, necessary, and recommended fields. The instrument contributed to assessment of definite causal association, once the duration of reactions including evolution, withdrawal, and reposition items showed high reliability. Most fields poor and weak filled were related to quality defects, such as popular name and appearance. Conclusions: Data suggest the instrument is adequate to report AE arising from herbal medicines. Owing to information regarding to organoleptic characteristics, the instrument is different from drug instruments. Therefore, it is intended to improve AE reports related to herbal medicines and contribute for appropriate use.Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)Department of Drugs and Medicines School of Pharmaceutical Sciences Universidade Estadual Paulista “Júlio de Mesquita Filho-AraraquaraDepartment of Natural Active Principles and Toxicology School of Pharmaceutical Sciences Universidade Estadual Paulista “Júlio de Mesquita Filho-AraraquaraDepartment of Drugs and Medicines School of Pharmaceutical Sciences Universidade Estadual Paulista “Júlio de Mesquita Filho-AraraquaraDepartment of Natural Active Principles and Toxicology School of Pharmaceutical Sciences Universidade Estadual Paulista “Júlio de Mesquita Filho-AraraquaraFAPESP: 2013/12681-2FAPESP: 99999.014301/2013-00Universidade Estadual Paulista (UNESP)2022-04-29T08:03:55Z2022-04-29T08:03:55Z2017-01-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article13-22http://dx.doi.org/10.17533/udea.vitae.v24n1a02Vitae, v. 24, n. 1, p. 13-22, 2017.2145-26600121-4004http://hdl.handle.net/11449/22831210.17533/udea.vitae.v24n1a022-s2.0-85018376409Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengVitaeinfo:eu-repo/semantics/openAccessde Carvalho Mastroianni, Patrícia [UNESP]Rossi Varallo, Fabiana [UNESP]Amaral Costa, Marília [UNESP]Da Silva Sacramento, Luis Vitor [UNESP]2025-03-29T05:21:18Zoai:repositorio.unesp.br:11449/228312Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestrepositoriounesp@unesp.bropendoar:29462025-03-29T05:21:18Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv Development of instrument to report and assess causality of adverse events related to herbal medicines
Desarrollo de un instrumento para reportar y evaluar la causalidad de los eventos adversos asociados a plantas medicinales
title Development of instrument to report and assess causality of adverse events related to herbal medicines
spellingShingle Development of instrument to report and assess causality of adverse events related to herbal medicines
de Carvalho Mastroianni, Patrícia [UNESP]
Adverse drug reaction reporting systems
Herbal medicine
Pharmacovigilance
Postmarketing
Product surveillance
Risk assessment
title_short Development of instrument to report and assess causality of adverse events related to herbal medicines
title_full Development of instrument to report and assess causality of adverse events related to herbal medicines
title_fullStr Development of instrument to report and assess causality of adverse events related to herbal medicines
title_full_unstemmed Development of instrument to report and assess causality of adverse events related to herbal medicines
title_sort Development of instrument to report and assess causality of adverse events related to herbal medicines
dc.creator.none.fl_str_mv de Carvalho Mastroianni, Patrícia [UNESP]
Rossi Varallo, Fabiana [UNESP]
Amaral Costa, Marília [UNESP]
Da Silva Sacramento, Luis Vitor [UNESP]
author de Carvalho Mastroianni, Patrícia [UNESP]
author_facet de Carvalho Mastroianni, Patrícia [UNESP]
Rossi Varallo, Fabiana [UNESP]
Amaral Costa, Marília [UNESP]
Da Silva Sacramento, Luis Vitor [UNESP]
author_role author
author2 Rossi Varallo, Fabiana [UNESP]
Amaral Costa, Marília [UNESP]
Da Silva Sacramento, Luis Vitor [UNESP]
author2_role author
author
author
dc.contributor.none.fl_str_mv Universidade Estadual Paulista (UNESP)
dc.subject.por.fl_str_mv Adverse drug reaction reporting systems
Herbal medicine
Pharmacovigilance
Postmarketing
Product surveillance
Risk assessment
topic Adverse drug reaction reporting systems
Herbal medicine
Pharmacovigilance
Postmarketing
Product surveillance
Risk assessment
description Background: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment. Objectives: This study aimed to develop an instrument to allow detection and evaluation of the causal likelihood of AE related to herbal medicines. Methods: A quantitative methodological development research intervention was performed with primary care health professionals. Two cases were distributed in an interval of one week in order to allow for completion of the proposal form. The within-rater reliability was calculated and classified into satisfactory, regular, and unsatisfactory, according to essential, necessary, and recommended items reported. Results: Fifty-seven professionals were enrolled. A high degree of the within-rater reliability was observed for the most essential, necessary, and recommended fields. The instrument contributed to assessment of definite causal association, once the duration of reactions including evolution, withdrawal, and reposition items showed high reliability. Most fields poor and weak filled were related to quality defects, such as popular name and appearance. Conclusions: Data suggest the instrument is adequate to report AE arising from herbal medicines. Owing to information regarding to organoleptic characteristics, the instrument is different from drug instruments. Therefore, it is intended to improve AE reports related to herbal medicines and contribute for appropriate use.
publishDate 2017
dc.date.none.fl_str_mv 2017-01-01
2022-04-29T08:03:55Z
2022-04-29T08:03:55Z
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://dx.doi.org/10.17533/udea.vitae.v24n1a02
Vitae, v. 24, n. 1, p. 13-22, 2017.
2145-2660
0121-4004
http://hdl.handle.net/11449/228312
10.17533/udea.vitae.v24n1a02
2-s2.0-85018376409
url http://dx.doi.org/10.17533/udea.vitae.v24n1a02
http://hdl.handle.net/11449/228312
identifier_str_mv Vitae, v. 24, n. 1, p. 13-22, 2017.
2145-2660
0121-4004
10.17533/udea.vitae.v24n1a02
2-s2.0-85018376409
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Vitae
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 13-22
dc.source.none.fl_str_mv Scopus
reponame:Repositório Institucional da UNESP
instname:Universidade Estadual Paulista (UNESP)
instacron:UNESP
instname_str Universidade Estadual Paulista (UNESP)
instacron_str UNESP
institution UNESP
reponame_str Repositório Institucional da UNESP
collection Repositório Institucional da UNESP
repository.name.fl_str_mv Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)
repository.mail.fl_str_mv repositoriounesp@unesp.br
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score 15,300719

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