Antimicrobial package inserts for veterinary use and public health: a critical analysis and impacts from the residues perspectives

Detalhes bibliográficos
Autor(a) principal: Paula, Ramon Alves de Oliveira
Data de Publicação: 2020
Outros Autores: Souza, Scheilla Vitorino Carvalho de
Tipo de documento: Artigo
Idioma: por
Título da fonte: Research, Society and Development
Texto Completo: https://rsdjournal.org/index.php/rsd/article/view/10216
Resumo: The presence of residues in food due to the irrational use of veterinary drugs in farm animals is recognized as a global threat to consumer health, with emphasis on bacterial resistance. Here, we present a comprehensive and not yet reported approach, with the objective of establishing a detailed critical analysis of the instructions for 433 antimicrobials for poultry, cattle and pigs marketed in Brazil, in relation to the current legislation. The frequencies of conformities were compared by the global chi-square test (X2), resulting in 78 contrasts, for each group of data, which were evaluated by approximation to normal (α=0.05). The discrimination between the frequencies was performed by studying the contrasts and by approaching the normal post hoc, using the Bonferroni correlation to estimate the critical z. There was a significant discrepancy between the different requirements (p<0.05), with information on pharmacodynamics and pharmacokinetics being considered critical, as only 1.2 % of the package inserts addressed this topic, as well as warnings, precautions, side effects, contraindications, drug interactions and antidotes; legend for veterinary use; storage conditions; and sales declaration under veterinary prescription, with 100 %, 97.9 %, 72.5 % and 80.6 %, respectively, of non-conformities. These findings reinforce the urgent need for action to meet legal requirements of the package inserts, which are undoubtedly a key point for ensuring food safety and quality.
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spelling Antimicrobial package inserts for veterinary use and public health: a critical analysis and impacts from the residues perspectivesProspectos de antimicrobianos para uso veterinario y salud pública: un análisis crítico e impactos desde la perspectiva de los residuosBulas de antimicrobianos para uso veterinário e saúde pública: uma análise crítica e impactos sob a ótica dos resíduosFoods of animal originConsumer health informationAntibacterial drug resistanceFood safety and quality. Alimentos de origen animalInformación de salud al consumidorResistencia bacteriana a los antibióticosSeguridad y calidad de los alimentos.Alimentos de origem animalInformação de saúde ao consumidorResistência bacteriana a antibióticosSegurança e qualidade dos alimentos. The presence of residues in food due to the irrational use of veterinary drugs in farm animals is recognized as a global threat to consumer health, with emphasis on bacterial resistance. Here, we present a comprehensive and not yet reported approach, with the objective of establishing a detailed critical analysis of the instructions for 433 antimicrobials for poultry, cattle and pigs marketed in Brazil, in relation to the current legislation. The frequencies of conformities were compared by the global chi-square test (X2), resulting in 78 contrasts, for each group of data, which were evaluated by approximation to normal (α=0.05). The discrimination between the frequencies was performed by studying the contrasts and by approaching the normal post hoc, using the Bonferroni correlation to estimate the critical z. There was a significant discrepancy between the different requirements (p<0.05), with information on pharmacodynamics and pharmacokinetics being considered critical, as only 1.2 % of the package inserts addressed this topic, as well as warnings, precautions, side effects, contraindications, drug interactions and antidotes; legend for veterinary use; storage conditions; and sales declaration under veterinary prescription, with 100 %, 97.9 %, 72.5 % and 80.6 %, respectively, of non-conformities. These findings reinforce the urgent need for action to meet legal requirements of the package inserts, which are undoubtedly a key point for ensuring food safety and quality.La presencia de residuos en los alimentos provenientes del uso irracional de medicamentos veterinarios en animales de granja se reconoce como una amenaza global para la salud del consumidor, con énfasis en la resistencia bacteriana. A continuación, se presenta, en un enfoque integral y aún no reportado, un análisis crítico exhaustivo de las instrucciones para 433 antimicrobianos destinados a aves, bovinos y porcinos comercializados en Brasil, de acuerdo con la legislación vigente. Las frecuencias de las conformidades se compararon mediante la prueba del chi-cuadrado global (X2), resultando en 78 contrastes, para cada grupo de datos evaluados por aproximación a lo normal (α=0,05). La discriminación entre las frecuencias se realizó mediante el estudio de los contrastes y acercándose a la normal post hoc, utilizando la correlación de Bonferroni para estimar la z crítica. Hubo una diferencia significativa entre los diferentes requisitos (p<0,05), considerándose crítico: información sobre farmacodinamia y farmacocinética, ya que solo el 1,2 % de los prospectos abordaban el tema, así como advertencias, precauciones, efectos secundarios, contraindicaciones, interacciones farmacológicas y antídotos; leyenda para uso veterinario; condiciones de almacenaje; y declaración de venta bajo prescripción veterinaria, con 100 %, 97,9 %, 72,5 % y 80,6 % de no conformidades, respectivamente. Estos hallazgos refuerzan la urgente necesidad de acciones para el cumplimiento de los requisitos legales para los prospectos de los envases, ya que este instrumento es sin duda un punto clave para garantizar la seguridad y la calidad de los alimentos.A presença de resíduos em alimentos provenientes do uso irracional de medicamentos veterinários em animais de produção é reconhecida como uma ameaça global à saúde do consumidor, com destaque para a resistência bacteriana. Apresentamos aqui, uma abordagem abrangente e ainda não relatada, com o objetivo de estabelecer uma análise crítica minuciosa das bulas de 433 antimicrobianos destinados a aves, bovinos e suínos comercializados no Brasil, em relação à legislação vigente. As frequências de conformidades foram comparadas pelo teste de qui-quadrado (X2) global, resultando em 78 contrastes, para cada grupo de dados, que foram avaliados por aproximação à normal (α=0,05). A discriminação entre as frequências foi realizada pelo estudo dos contrastes e pela aproximação à normal post hoc, utilizando a correlação de Bonferroni para estimativa do z crítico. Houve diferença significativa entre os diferentes requisitos (p<0,05), sendo considerados críticos: informações sobre a farmacodinâmica e a farmacocinética, pois apenas 1,2 % das bulas abordavam o tema, bem como as advertências, precauções, efeitos colaterais, contraindicações, interações medicamentosas e antídotos; legenda uso veterinário; condições de armazenamento; e declaração de venda sob receita veterinária, com 100 %, 97,9 %, 72,5 % e 80,6 % de não conformidades, respectivamente. Essas constatações reforçam a necessidade urgente de ações para o atendimento aos requisitos legais de bulas, pois tal instrumento é, sem dúvida, ponto-chave para a garantia da segurança e qualidade de alimentos.Research, Society and Development2020-11-25info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://rsdjournal.org/index.php/rsd/article/view/1021610.33448/rsd-v9i11.10216Research, Society and Development; Vol. 9 No. 11; e53291110216Research, Society and Development; Vol. 9 Núm. 11; e53291110216Research, Society and Development; v. 9 n. 11; e532911102162525-3409reponame:Research, Society and Developmentinstname:Universidade Federal de Itajubá (UNIFEI)instacron:UNIFEIporhttps://rsdjournal.org/index.php/rsd/article/view/10216/9116Copyright (c) 2020 Ramon Alves de Oliveira Paula; Scheilla Vitorino Carvalho de Souzahttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessPaula, Ramon Alves de OliveiraSouza, Scheilla Vitorino Carvalho de 2020-12-10T23:37:57Zoai:ojs.pkp.sfu.ca:article/10216Revistahttps://rsdjournal.org/index.php/rsd/indexPUBhttps://rsdjournal.org/index.php/rsd/oairsd.articles@gmail.com2525-34092525-3409opendoar:2024-01-17T09:32:19.697679Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)false
dc.title.none.fl_str_mv Antimicrobial package inserts for veterinary use and public health: a critical analysis and impacts from the residues perspectives
Prospectos de antimicrobianos para uso veterinario y salud pública: un análisis crítico e impactos desde la perspectiva de los residuos
Bulas de antimicrobianos para uso veterinário e saúde pública: uma análise crítica e impactos sob a ótica dos resíduos
title Antimicrobial package inserts for veterinary use and public health: a critical analysis and impacts from the residues perspectives
spellingShingle Antimicrobial package inserts for veterinary use and public health: a critical analysis and impacts from the residues perspectives
Paula, Ramon Alves de Oliveira
Foods of animal origin
Consumer health information
Antibacterial drug resistance
Food safety and quality.
Alimentos de origen animal
Información de salud al consumidor
Resistencia bacteriana a los antibióticos
Seguridad y calidad de los alimentos.
Alimentos de origem animal
Informação de saúde ao consumidor
Resistência bacteriana a antibióticos
Segurança e qualidade dos alimentos.
title_short Antimicrobial package inserts for veterinary use and public health: a critical analysis and impacts from the residues perspectives
title_full Antimicrobial package inserts for veterinary use and public health: a critical analysis and impacts from the residues perspectives
title_fullStr Antimicrobial package inserts for veterinary use and public health: a critical analysis and impacts from the residues perspectives
title_full_unstemmed Antimicrobial package inserts for veterinary use and public health: a critical analysis and impacts from the residues perspectives
title_sort Antimicrobial package inserts for veterinary use and public health: a critical analysis and impacts from the residues perspectives
author Paula, Ramon Alves de Oliveira
author_facet Paula, Ramon Alves de Oliveira
Souza, Scheilla Vitorino Carvalho de
author_role author
author2 Souza, Scheilla Vitorino Carvalho de
author2_role author
dc.contributor.author.fl_str_mv Paula, Ramon Alves de Oliveira
Souza, Scheilla Vitorino Carvalho de
dc.subject.por.fl_str_mv Foods of animal origin
Consumer health information
Antibacterial drug resistance
Food safety and quality.
Alimentos de origen animal
Información de salud al consumidor
Resistencia bacteriana a los antibióticos
Seguridad y calidad de los alimentos.
Alimentos de origem animal
Informação de saúde ao consumidor
Resistência bacteriana a antibióticos
Segurança e qualidade dos alimentos.
topic Foods of animal origin
Consumer health information
Antibacterial drug resistance
Food safety and quality.
Alimentos de origen animal
Información de salud al consumidor
Resistencia bacteriana a los antibióticos
Seguridad y calidad de los alimentos.
Alimentos de origem animal
Informação de saúde ao consumidor
Resistência bacteriana a antibióticos
Segurança e qualidade dos alimentos.
description The presence of residues in food due to the irrational use of veterinary drugs in farm animals is recognized as a global threat to consumer health, with emphasis on bacterial resistance. Here, we present a comprehensive and not yet reported approach, with the objective of establishing a detailed critical analysis of the instructions for 433 antimicrobials for poultry, cattle and pigs marketed in Brazil, in relation to the current legislation. The frequencies of conformities were compared by the global chi-square test (X2), resulting in 78 contrasts, for each group of data, which were evaluated by approximation to normal (α=0.05). The discrimination between the frequencies was performed by studying the contrasts and by approaching the normal post hoc, using the Bonferroni correlation to estimate the critical z. There was a significant discrepancy between the different requirements (p<0.05), with information on pharmacodynamics and pharmacokinetics being considered critical, as only 1.2 % of the package inserts addressed this topic, as well as warnings, precautions, side effects, contraindications, drug interactions and antidotes; legend for veterinary use; storage conditions; and sales declaration under veterinary prescription, with 100 %, 97.9 %, 72.5 % and 80.6 %, respectively, of non-conformities. These findings reinforce the urgent need for action to meet legal requirements of the package inserts, which are undoubtedly a key point for ensuring food safety and quality.
publishDate 2020
dc.date.none.fl_str_mv 2020-11-25
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/10216
10.33448/rsd-v9i11.10216
url https://rsdjournal.org/index.php/rsd/article/view/10216
identifier_str_mv 10.33448/rsd-v9i11.10216
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/10216/9116
dc.rights.driver.fl_str_mv Copyright (c) 2020 Ramon Alves de Oliveira Paula; Scheilla Vitorino Carvalho de Souza
https://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2020 Ramon Alves de Oliveira Paula; Scheilla Vitorino Carvalho de Souza
https://creativecommons.org/licenses/by/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Research, Society and Development
publisher.none.fl_str_mv Research, Society and Development
dc.source.none.fl_str_mv Research, Society and Development; Vol. 9 No. 11; e53291110216
Research, Society and Development; Vol. 9 Núm. 11; e53291110216
Research, Society and Development; v. 9 n. 11; e53291110216
2525-3409
reponame:Research, Society and Development
instname:Universidade Federal de Itajubá (UNIFEI)
instacron:UNIFEI
instname_str Universidade Federal de Itajubá (UNIFEI)
instacron_str UNIFEI
institution UNIFEI
reponame_str Research, Society and Development
collection Research, Society and Development
repository.name.fl_str_mv Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)
repository.mail.fl_str_mv rsd.articles@gmail.com
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