Development of instrument to report and assess causality of adverse events related to herbal medicines
Autor(a) principal: | |
---|---|
Data de Publicação: | 2017 |
Outros Autores: | , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.17533/udea.vitae.v24n1a02 http://hdl.handle.net/11449/228312 |
Resumo: | 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. |
id |
UNSP_0273678d024bedffd0eedc8fe1b2bd6f |
---|---|
oai_identifier_str |
oai:repositorio.unesp.br:11449/228312 |
network_acronym_str |
UNSP |
network_name_str |
Repositório Institucional da UNESP |
repository_id_str |
2946 |
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)de Carvalho Mastroianni, Patrícia [UNESP]Rossi Varallo, Fabiana [UNESP]Amaral Costa, Marília [UNESP]Da Silva Sacramento, Luis Vitor [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/openAccess2024-06-24T14:51:26Zoai:repositorio.unesp.br:11449/228312Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-06-24T14:51:26Repositório 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 |
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.contributor.author.fl_str_mv |
de Carvalho Mastroianni, Patrícia [UNESP] Rossi Varallo, Fabiana [UNESP] Amaral Costa, Marília [UNESP] Da Silva Sacramento, Luis Vitor [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 |
|
_version_ |
1803649431625531392 |