Health Surveillance actions in pharmaceutical products and services in a large municipality in Northeastern Brazil: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02130 | Published on: 19/04/2023

Detalhes bibliográficos
Autor(a) principal: Lúcio Mendes, Geraldo
Data de Publicação: 2023
Outros Autores: Sérgio Dourado Arrais, Paulo
Tipo de documento: Artigo
Idioma: por
eng
Título da fonte: Vigilância Sanitária em Debate
Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2130
Resumo: Introduction: Health Surveillance acts through inspection to prevent people, establishments, or processes from producing situations of risk to individual and collective health. Objective: To present a situational diagnosis of the sanitary actions of the area of pharmaceutical products and services in the city of Fortaleza – Ceará, registered in the Fiscalize system, from January 2018 to December 2019. Method: Access to the tax system, search by registration group and registration date, with the visualization and copy of the content, individually, of each inspection. The data were stratified into notified and fined, categorized by type of establishment, neighborhood and date of occurrence, noncompliance found, and legislation used in the reasoning. The results were expressed in absolute and relative frequencies. Results: A total of 614 establishments were inspected, 948 inspections were carried out and 2,830 were found to be sanitary inadequacies, of which 385 (23.60%) were registered and 2,445 (86.40%) were reported. The irregularities found varied according to those inspected. Drugstore was the most frequent group among establishments (420/614; n = 68.40%) and the lack of mandatory sanitary documentation was the prevalent non-conformity (491/2,830; n = 17.30%). The legislation most used to substantiate irregularities was RDC Anvisa No. 44/2009, used in 45.20% (1,279/2.830) of inadequacies. In the distribution by neighborhoods, the city center concentrated the largest number of inspected (44/614; n = 7.20%). Conclusions: The results showed that most of the inspected establishments followed the legally provided sanitary standards, because only a minority of the sanitary non-conformities found were grounds for action, while the vast majority were only notified to present improvements.  
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spelling Health Surveillance actions in pharmaceutical products and services in a large municipality in Northeastern Brazil: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02130 | Published on: 19/04/2023Ações de Vigilância Sanitária na área de produtos e serviços farmacêuticos em município de grande porte do Nordeste do Brasil: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02130 | Publicado em: 19/04/2023Vigilância SanitáriaSistema de Vigilância SanitáriaInspeção SanitáriaFarmácia com ManipulaçãoHealth SurveillanceHealth Surveillance SystemSanitary InspectionPharmacyIntroduction: Health Surveillance acts through inspection to prevent people, establishments, or processes from producing situations of risk to individual and collective health. Objective: To present a situational diagnosis of the sanitary actions of the area of pharmaceutical products and services in the city of Fortaleza – Ceará, registered in the Fiscalize system, from January 2018 to December 2019. Method: Access to the tax system, search by registration group and registration date, with the visualization and copy of the content, individually, of each inspection. The data were stratified into notified and fined, categorized by type of establishment, neighborhood and date of occurrence, noncompliance found, and legislation used in the reasoning. The results were expressed in absolute and relative frequencies. Results: A total of 614 establishments were inspected, 948 inspections were carried out and 2,830 were found to be sanitary inadequacies, of which 385 (23.60%) were registered and 2,445 (86.40%) were reported. The irregularities found varied according to those inspected. Drugstore was the most frequent group among establishments (420/614; n = 68.40%) and the lack of mandatory sanitary documentation was the prevalent non-conformity (491/2,830; n = 17.30%). The legislation most used to substantiate irregularities was RDC Anvisa No. 44/2009, used in 45.20% (1,279/2.830) of inadequacies. In the distribution by neighborhoods, the city center concentrated the largest number of inspected (44/614; n = 7.20%). Conclusions: The results showed that most of the inspected establishments followed the legally provided sanitary standards, because only a minority of the sanitary non-conformities found were grounds for action, while the vast majority were only notified to present improvements.  Introdução: A Vigilância Sanitária atua por meio da fiscalização e inspeção para evitar que pessoas, estabelecimentos ou processos produzam situações de risco à saúde individual e coletiva. Objetivo: Apresentar um diagnóstico situacional das ações sanitárias na área de produtos e serviços farmacêuticos no município de  Fortaleza, Ceará, registradas no sistema Fiscalize, no período de janeiro de 2018 a dezembro de 2019. Método: Trata-se de estudo descritivo, com acesso ao sistema Fiscalize, com busca por grupo de cadastro e data de registro, com visualização e cópia do conteúdo, individualmente, de cada inspeção. Os dados foram estratificados em notificados e autuados, categorizados por tipo de estabelecimento, bairro e data de ocorrência, não conformidade constatada e a legislação utilizada na fundamentação. Os resultados foram expressos em frequências absolutas e relativas. Resultados: Nos 614 estabelecimentos fiscalizados, foram realizadas 948 inspeções e foram constatadas 2.830 inadequações sanitárias, das quais 385 (23,60%) foram autuadas e 2.445 (86,40%), notificadas. As irregularidades constatadas variaram de acordo com os inspecionados. Drogaria foi o grupo mais frequente dentre os estabelecimentos (420/614; n = 68,40%) e a inexistência de documentação sanitária obrigatória foi a não conformidade prevalente (491/2.830; n= 17,30%). A legislação mais utilizada para fundamentar as irregularidades foi a RDC Anvisa nº 44, de 17 de agosto de 2009, usada em 45,19% (1.279/2.830) das inadequações. Na distribuição por bairros, o centro da cidade concentrou o maior número de fiscalizados (44/614; n = 7,20%). Conclusões: Os resultados demonstraram que a maioria dos estabelecimentos inspecionados seguiu os padrões sanitários legalmente previstos, pois apenas uma minoria das não conformidades sanitárias constatadas foi motivo de autuação, enquanto a maioria foi apenas notificada para apresentar melhorias.    Instituto Nacional de Controle de Qualidade em Saúde2023-04-19info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/213010.22239/2317-269x.02130Health Surveillance under Debate: Society, Science & Technology ; v. 11 (2023) | Continuous publication; 1-12Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; v. 11 (2023) | Publicación continua; 1-12Vigil Sanit Debate, Rio de Janeiro; v. 11 (2023) | Publicação contínua; 1-122317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2130/1492https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2130/1587https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2130/1547https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2130/1548https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2130/1549Copyright (c) 2023 Geraldo Lúcio Mendes, Paulo Sérgio Dourado Arrais (Autor)https://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessLúcio Mendes, GeraldoSérgio Dourado Arrais, Paulo2024-02-21T17:48:20Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/2130Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2024-02-21T17:48:20Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Health Surveillance actions in pharmaceutical products and services in a large municipality in Northeastern Brazil: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02130 | Published on: 19/04/2023
Ações de Vigilância Sanitária na área de produtos e serviços farmacêuticos em município de grande porte do Nordeste do Brasil: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02130 | Publicado em: 19/04/2023
title Health Surveillance actions in pharmaceutical products and services in a large municipality in Northeastern Brazil: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02130 | Published on: 19/04/2023
spellingShingle Health Surveillance actions in pharmaceutical products and services in a large municipality in Northeastern Brazil: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02130 | Published on: 19/04/2023
Lúcio Mendes, Geraldo
Vigilância Sanitária
Sistema de Vigilância Sanitária
Inspeção Sanitária
Farmácia com Manipulação
Health Surveillance
Health Surveillance System
Sanitary Inspection
Pharmacy
title_short Health Surveillance actions in pharmaceutical products and services in a large municipality in Northeastern Brazil: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02130 | Published on: 19/04/2023
title_full Health Surveillance actions in pharmaceutical products and services in a large municipality in Northeastern Brazil: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02130 | Published on: 19/04/2023
title_fullStr Health Surveillance actions in pharmaceutical products and services in a large municipality in Northeastern Brazil: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02130 | Published on: 19/04/2023
title_full_unstemmed Health Surveillance actions in pharmaceutical products and services in a large municipality in Northeastern Brazil: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02130 | Published on: 19/04/2023
title_sort Health Surveillance actions in pharmaceutical products and services in a large municipality in Northeastern Brazil: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02130 | Published on: 19/04/2023
author Lúcio Mendes, Geraldo
author_facet Lúcio Mendes, Geraldo
Sérgio Dourado Arrais, Paulo
author_role author
author2 Sérgio Dourado Arrais, Paulo
author2_role author
dc.contributor.author.fl_str_mv Lúcio Mendes, Geraldo
Sérgio Dourado Arrais, Paulo
dc.subject.por.fl_str_mv Vigilância Sanitária
Sistema de Vigilância Sanitária
Inspeção Sanitária
Farmácia com Manipulação
Health Surveillance
Health Surveillance System
Sanitary Inspection
Pharmacy
topic Vigilância Sanitária
Sistema de Vigilância Sanitária
Inspeção Sanitária
Farmácia com Manipulação
Health Surveillance
Health Surveillance System
Sanitary Inspection
Pharmacy
description Introduction: Health Surveillance acts through inspection to prevent people, establishments, or processes from producing situations of risk to individual and collective health. Objective: To present a situational diagnosis of the sanitary actions of the area of pharmaceutical products and services in the city of Fortaleza – Ceará, registered in the Fiscalize system, from January 2018 to December 2019. Method: Access to the tax system, search by registration group and registration date, with the visualization and copy of the content, individually, of each inspection. The data were stratified into notified and fined, categorized by type of establishment, neighborhood and date of occurrence, noncompliance found, and legislation used in the reasoning. The results were expressed in absolute and relative frequencies. Results: A total of 614 establishments were inspected, 948 inspections were carried out and 2,830 were found to be sanitary inadequacies, of which 385 (23.60%) were registered and 2,445 (86.40%) were reported. The irregularities found varied according to those inspected. Drugstore was the most frequent group among establishments (420/614; n = 68.40%) and the lack of mandatory sanitary documentation was the prevalent non-conformity (491/2,830; n = 17.30%). The legislation most used to substantiate irregularities was RDC Anvisa No. 44/2009, used in 45.20% (1,279/2.830) of inadequacies. In the distribution by neighborhoods, the city center concentrated the largest number of inspected (44/614; n = 7.20%). Conclusions: The results showed that most of the inspected establishments followed the legally provided sanitary standards, because only a minority of the sanitary non-conformities found were grounds for action, while the vast majority were only notified to present improvements.  
publishDate 2023
dc.date.none.fl_str_mv 2023-04-19
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
"Peer-reviewed article"
"Artículo revisado por pares"
"Artigo avaliado pelos pares"
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2130
10.22239/2317-269x.02130
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2130
identifier_str_mv 10.22239/2317-269x.02130
dc.language.iso.fl_str_mv por
eng
language por
eng
dc.relation.none.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2130/1492
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2130/1587
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2130/1547
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2130/1548
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2130/1549
dc.rights.driver.fl_str_mv Copyright (c) 2023 Geraldo Lúcio Mendes, Paulo Sérgio Dourado Arrais (Autor)
https://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2023 Geraldo Lúcio Mendes, Paulo Sérgio Dourado Arrais (Autor)
https://creativecommons.org/licenses/by/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
dc.source.none.fl_str_mv Health Surveillance under Debate: Society, Science & Technology ; v. 11 (2023) | Continuous publication; 1-12
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; v. 11 (2023) | Publicación continua; 1-12
Vigil Sanit Debate, Rio de Janeiro; v. 11 (2023) | Publicação contínua; 1-12
2317-269X
reponame:Vigilância Sanitária em Debate
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Vigilância Sanitária em Debate
collection Vigilância Sanitária em Debate
repository.name.fl_str_mv Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br
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