Systematic assessment of the drugs cold chain in Brazil by pharmaceutical professionals

Detalhes bibliográficos
Autor(a) principal: Silva, Thiago Douberin da
Data de Publicação: 2021
Outros Autores: Macêdo , Daniel Charles dos Santos, Lucena, Joyce Nunes dos Santos, Silva , Rosali Maria Ferreira da, Soares, Luís Alberto de Lira, Pereira, Michelly Cristiny, Paulino, Symon Jonatan Santiago, Silva, Bruna Pereira da, Lucena, Maria Luiza Cavalcanti
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Research, Society and Development
Texto Completo: https://rsdjournal.org/index.php/rsd/article/view/16144
Resumo: One of the challenges in pharmaceutical logistics is to ensure that thermolabile drugs reach the patient with quality. This prospective cross-sectional study aimed to analyze the current cold chain scenario in Brazil. A semi-structured electronic questionnaire was applied for data collection. The total sample was 1793 pharmacists (CI: 99.998%; ME: 5%; p: 0.00002). 74.1% of the pharmacists reported that transportation is the most critical stage; 97.2% stated that the chosen mode influences the quality of the products; 52.5% reported only having partial parameters (tools) for the assessment of quality and that thermolabile medications possibly arrive altered to the final consumer due to the cold chain (59.8%); 66.9% do not have specific training on thermolabile medicines and 50.9% did not receive the technical data sheets of the products through the registration holders; 20.7% reported not being able to analyze or perform any activity related to qualification and validation. The absence of markings in the manual records (50.6%), the non-validation of the equipment used for conservation (30.6%) and the incorrect storage of medicines at domestic refrigerators (45.5%), near food (35.8%), were also noted. The non-measurement of the temperature of the products received was affirmed by 56.7%, as well as the use of thermometers to measure parameters (45.3%); 58.7% of the establishments do not have thermal mapping and 55.3% of the professionals are unaware of the thermal durability of the packaging. Due potentially inadequate situation, there is urgency to implement tools that guarantee the quality of thermolabile drugs in all its logistical stages.
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spelling Systematic assessment of the drugs cold chain in Brazil by pharmaceutical professionalsEvaluación sistemática de la cadena de frío de medicamentos en Brasil por profesionales farmacêuticosAvaliação sistemática da cadeia fria de medicamentos no Brasil por profissionais farmacêuticosCold chainGood manufacturing practicesPharmacovigilanceSupply chain management.Cadena de fríoBuenas prácticas de fabricaciónFarmacovigilanciaGestión de la cadena de suministro.Cadeia friaBoas práticas de fabricaçãoFarmacovigilânciaGerenciamento da cadeia de suprimentos. One of the challenges in pharmaceutical logistics is to ensure that thermolabile drugs reach the patient with quality. This prospective cross-sectional study aimed to analyze the current cold chain scenario in Brazil. A semi-structured electronic questionnaire was applied for data collection. The total sample was 1793 pharmacists (CI: 99.998%; ME: 5%; p: 0.00002). 74.1% of the pharmacists reported that transportation is the most critical stage; 97.2% stated that the chosen mode influences the quality of the products; 52.5% reported only having partial parameters (tools) for the assessment of quality and that thermolabile medications possibly arrive altered to the final consumer due to the cold chain (59.8%); 66.9% do not have specific training on thermolabile medicines and 50.9% did not receive the technical data sheets of the products through the registration holders; 20.7% reported not being able to analyze or perform any activity related to qualification and validation. The absence of markings in the manual records (50.6%), the non-validation of the equipment used for conservation (30.6%) and the incorrect storage of medicines at domestic refrigerators (45.5%), near food (35.8%), were also noted. The non-measurement of the temperature of the products received was affirmed by 56.7%, as well as the use of thermometers to measure parameters (45.3%); 58.7% of the establishments do not have thermal mapping and 55.3% of the professionals are unaware of the thermal durability of the packaging. Due potentially inadequate situation, there is urgency to implement tools that guarantee the quality of thermolabile drugs in all its logistical stages.Uno de los retos de la logística farmacéutica es conseguir que los fármacos termolábiles lleguen al paciente con calidad. Este estudio prospectivo transversal tuvo como objetivo analizar el escenario actual de la cadena fría en Brasil. Se aplicó un cuestionario electrónico semiestructurado para la recolección de datos. La muestra total fue de 1.793 farmacéuticos (IC: 99,998%; ME: 5%; p: 0,00002). El 74,1% de los farmacéuticos informó que el transporte es la etapa más crítica; El 97,2% afirmó que la modalidad elegida influye en la calidad de los productos; 52,5% refirió tener solo parámetros (instrumentos) parciales para la evaluación de la calidad y que posiblemente los medicamentos termolábiles lleguen alterados al consumidor final debido a la cadena fría (59,8%); El 66,9% no tenía formación específica en medicamentos termolábiles y el 50,9% no recibió las fichas técnicas de los productos a través de los registrantes; El 20,7% informó no poder analizar ni realizar ninguna actividad relacionada con la calificación y validación. La ausencia de marcado en los registros manuales (50,6%), la no validación de los equipos utilizados para la conservación (30,6%) y el almacenamiento incorrecto de medicamentos en refrigeradores domésticos (45,5%), cerca de alimentos (35,8%) , también se observó. La no medición de la temperatura de los productos recibidos fue afirmada por 56,7%, así como el uso de termómetros para evaluar este parámetro (45,3%); El 58,7% de los establecimientos no dispone de cartografía térmica y el 55,3% de los profesionales desconoce la durabilidad térmica de los envases. Debido a la situación potencialmente inadecuada, es urgente implementar herramientas que garanticen la calidad de los medicamentos termolábiles en todas sus etapas logísticas.Um dos desafios da logística farmacêutica é garantir que os medicamentos termolábeis cheguem ao paciente com qualidade. Este estudo transversal prospectivo teve como objetivo analisar o cenário atual da cadeia fria no Brasil. Um questionário eletrônico semiestruturado foi aplicado para a coleta de dados. A amostra total foi de 1.793 farmacêuticos (IC: 99,998%; ME: 5%; p: 0,00002). 74,1% dos farmacêuticos relataram que o transporte é a etapa mais crítica; 97,2% afirmaram que a modalidade escolhida influencia na qualidade dos produtos; 52,5% relataram possuir apenas parâmetros parciais (instrumentos) para avaliação da qualidade e que os medicamentos termolábeis possivelmente chegam alterados ao consumidor final devido à cadeia fria (59,8%); 66,9% não possuem treinamento específico sobre medicamentos termolábeis e 50,9% não receberam as fichas técnicas dos produtos por meio dos titulares dos registros; 20,7% relataram não serem capazes de analisar ou realizar qualquer atividade relacionada à qualificação e validação. A ausência de marcação nos registros manuais (50,6%), a não validação dos equipamentos utilizados para conservação (30,6%) e o armazenamento incorreto de medicamentos em geladeiras domésticas (45,5%), próximo a alimentos (35,8%), também foi observado. A não medição da temperatura dos produtos recebidos foi afirmada por 56,7%, assim como o uso de termômetros para avaliação desse parâmetro (45,3%); 58,7% dos estabelecimentos não possuem mapeamento térmico e 55,3% dos profissionais desconhecem a durabilidade térmica das embalagens. Devido à situação potencialmente inadequada, é urgente implementar ferramentas que garantam a qualidade dos medicamentos termolábeis em todas as suas etapas logísticas.Research, Society and Development2021-06-13info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://rsdjournal.org/index.php/rsd/article/view/1614410.33448/rsd-v10i7.16144Research, Society and Development; Vol. 10 No. 7; e5010716144Research, Society and Development; Vol. 10 Núm. 7; e5010716144Research, Society and Development; v. 10 n. 7; e50107161442525-3409reponame:Research, Society and Developmentinstname:Universidade Federal de Itajubá (UNIFEI)instacron:UNIFEIenghttps://rsdjournal.org/index.php/rsd/article/view/16144/14524Copyright (c) 2021 Thiago Douberin da Silva; Daniel Charles dos Santos Macêdo ; Joyce Nunes dos Santos Lucena; Rosali Maria Ferreira da Silva ; Luís Alberto de Lira Soares; Michelly Cristiny Pereira; Symon Jonatan Santiago Paulino; Bruna Pereira da Silva; Maria Luiza Cavalcanti Lucenahttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessSilva, Thiago Douberin daMacêdo , Daniel Charles dos Santos Lucena, Joyce Nunes dos Santos Silva , Rosali Maria Ferreira da Soares, Luís Alberto de Lira Pereira, Michelly Cristiny Paulino, Symon Jonatan SantiagoSilva, Bruna Pereira da Lucena, Maria Luiza Cavalcanti 2021-07-18T21:07:03Zoai:ojs.pkp.sfu.ca:article/16144Revistahttps://rsdjournal.org/index.php/rsd/indexPUBhttps://rsdjournal.org/index.php/rsd/oairsd.articles@gmail.com2525-34092525-3409opendoar:2024-01-17T09:36:46.798998Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)false
dc.title.none.fl_str_mv Systematic assessment of the drugs cold chain in Brazil by pharmaceutical professionals
Evaluación sistemática de la cadena de frío de medicamentos en Brasil por profesionales farmacêuticos
Avaliação sistemática da cadeia fria de medicamentos no Brasil por profissionais farmacêuticos
title Systematic assessment of the drugs cold chain in Brazil by pharmaceutical professionals
spellingShingle Systematic assessment of the drugs cold chain in Brazil by pharmaceutical professionals
Silva, Thiago Douberin da
Cold chain
Good manufacturing practices
Pharmacovigilance
Supply chain management.
Cadena de frío
Buenas prácticas de fabricación
Farmacovigilancia
Gestión de la cadena de suministro.
Cadeia fria
Boas práticas de fabricação
Farmacovigilância
Gerenciamento da cadeia de suprimentos.
title_short Systematic assessment of the drugs cold chain in Brazil by pharmaceutical professionals
title_full Systematic assessment of the drugs cold chain in Brazil by pharmaceutical professionals
title_fullStr Systematic assessment of the drugs cold chain in Brazil by pharmaceutical professionals
title_full_unstemmed Systematic assessment of the drugs cold chain in Brazil by pharmaceutical professionals
title_sort Systematic assessment of the drugs cold chain in Brazil by pharmaceutical professionals
author Silva, Thiago Douberin da
author_facet Silva, Thiago Douberin da
Macêdo , Daniel Charles dos Santos
Lucena, Joyce Nunes dos Santos
Silva , Rosali Maria Ferreira da
Soares, Luís Alberto de Lira
Pereira, Michelly Cristiny
Paulino, Symon Jonatan Santiago
Silva, Bruna Pereira da
Lucena, Maria Luiza Cavalcanti
author_role author
author2 Macêdo , Daniel Charles dos Santos
Lucena, Joyce Nunes dos Santos
Silva , Rosali Maria Ferreira da
Soares, Luís Alberto de Lira
Pereira, Michelly Cristiny
Paulino, Symon Jonatan Santiago
Silva, Bruna Pereira da
Lucena, Maria Luiza Cavalcanti
author2_role author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Silva, Thiago Douberin da
Macêdo , Daniel Charles dos Santos
Lucena, Joyce Nunes dos Santos
Silva , Rosali Maria Ferreira da
Soares, Luís Alberto de Lira
Pereira, Michelly Cristiny
Paulino, Symon Jonatan Santiago
Silva, Bruna Pereira da
Lucena, Maria Luiza Cavalcanti
dc.subject.por.fl_str_mv Cold chain
Good manufacturing practices
Pharmacovigilance
Supply chain management.
Cadena de frío
Buenas prácticas de fabricación
Farmacovigilancia
Gestión de la cadena de suministro.
Cadeia fria
Boas práticas de fabricação
Farmacovigilância
Gerenciamento da cadeia de suprimentos.
topic Cold chain
Good manufacturing practices
Pharmacovigilance
Supply chain management.
Cadena de frío
Buenas prácticas de fabricación
Farmacovigilancia
Gestión de la cadena de suministro.
Cadeia fria
Boas práticas de fabricação
Farmacovigilância
Gerenciamento da cadeia de suprimentos.
description One of the challenges in pharmaceutical logistics is to ensure that thermolabile drugs reach the patient with quality. This prospective cross-sectional study aimed to analyze the current cold chain scenario in Brazil. A semi-structured electronic questionnaire was applied for data collection. The total sample was 1793 pharmacists (CI: 99.998%; ME: 5%; p: 0.00002). 74.1% of the pharmacists reported that transportation is the most critical stage; 97.2% stated that the chosen mode influences the quality of the products; 52.5% reported only having partial parameters (tools) for the assessment of quality and that thermolabile medications possibly arrive altered to the final consumer due to the cold chain (59.8%); 66.9% do not have specific training on thermolabile medicines and 50.9% did not receive the technical data sheets of the products through the registration holders; 20.7% reported not being able to analyze or perform any activity related to qualification and validation. The absence of markings in the manual records (50.6%), the non-validation of the equipment used for conservation (30.6%) and the incorrect storage of medicines at domestic refrigerators (45.5%), near food (35.8%), were also noted. The non-measurement of the temperature of the products received was affirmed by 56.7%, as well as the use of thermometers to measure parameters (45.3%); 58.7% of the establishments do not have thermal mapping and 55.3% of the professionals are unaware of the thermal durability of the packaging. Due potentially inadequate situation, there is urgency to implement tools that guarantee the quality of thermolabile drugs in all its logistical stages.
publishDate 2021
dc.date.none.fl_str_mv 2021-06-13
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/16144
10.33448/rsd-v10i7.16144
url https://rsdjournal.org/index.php/rsd/article/view/16144
identifier_str_mv 10.33448/rsd-v10i7.16144
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/16144/14524
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv 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. 10 No. 7; e5010716144
Research, Society and Development; Vol. 10 Núm. 7; e5010716144
Research, Society and Development; v. 10 n. 7; e5010716144
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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