Pub Date : 2024-07-23DOI: 10.22239/2317-269x.02292
Cáren Caroline Andrade Travassos, Karla Frida Flister Torres
Introduction: Electronic cigarettes were introduced to the market for assisting in smoking cessation. However, this alternative is related to the development of Lung Injury Associated with the Use of Electronic Cigarettes and Vaporizers (EVALI), especially in the young population. In this context, it is necessary to understand the mechanisms of lung injury produced by the use of electronic cigarettes in order to establish the true risks of long-term exposure to these vapors. Objective: To elucidate the pathophysiological mechanisms of EVALI. Method: Integrative literature review based on the PRISMA method and search in the LILACs, PubMed, and EMBASE databases, from 2003 to 2023 and free access experimental and epidemiological research in full, with an approach to the pathogenesis of EVALI, were selected. Results: The different constituents present in electronic cigarettes are involved in the development of EVALI as they age through different mechanisms, such as: changes in the structure and functions of the lung surfactant; accumulation of oil droplets in mucus, and alteration of the structure, function, and chemotaxis of cells that make up innate immunity, such as neutrophils and macrophages. Conclusions: Electronic cigarettes induce EVALI through different mechanisms due to the complexity of the composition of substances present in vapors. Clarifying the mechanisms of lung injury is pertinent for regulatory agencies to apply more stringent measures to electronic cigarettes in order to reduce the impact of exposure and cases of morbidity and mortality among young people and adults.
{"title":"Lesão pulmonar induzida pelo uso excessivo de cigarros eletrônicos: toxicantes envolvidos e mecanismos fisiopatológicos","authors":"Cáren Caroline Andrade Travassos, Karla Frida Flister Torres","doi":"10.22239/2317-269x.02292","DOIUrl":"https://doi.org/10.22239/2317-269x.02292","url":null,"abstract":"Introduction: Electronic cigarettes were introduced to the market for assisting in smoking cessation. However, this alternative is related to the development of Lung Injury Associated with the Use of Electronic Cigarettes and Vaporizers (EVALI), especially in the young population. In this context, it is necessary to understand the mechanisms of lung injury produced by the use of electronic cigarettes in order to establish the true risks of long-term exposure to these vapors. Objective: To elucidate the pathophysiological mechanisms of EVALI. Method: Integrative literature review based on the PRISMA method and search in the LILACs, PubMed, and EMBASE databases, from 2003 to 2023 and free access experimental and epidemiological research in full, with an approach to the pathogenesis of EVALI, were selected. Results: The different constituents present in electronic cigarettes are involved in the development of EVALI as they age through different mechanisms, such as: changes in the structure and functions of the lung surfactant; accumulation of oil droplets in mucus, and alteration of the structure, function, and chemotaxis of cells that make up innate immunity, such as neutrophils and macrophages. Conclusions: Electronic cigarettes induce EVALI through different mechanisms due to the complexity of the composition of substances present in vapors. Clarifying the mechanisms of lung injury is pertinent for regulatory agencies to apply more stringent measures to electronic cigarettes in order to reduce the impact of exposure and cases of morbidity and mortality among young people and adults.","PeriodicalId":515818,"journal":{"name":"Vigilância Sanitária em Debate","volume":"15 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141813613","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-17DOI: 10.22239/2317-269x.02266
Elias Matias Laurentino, Ana Cláudia de Brito Passos, Rochely Florenço de Castro Ferreira, Mirian Parente Monteiro, Paulo Sérgio Dourado Arrais
Introduction: Assessing quality in healthcare environments favors decision making with the lowest possible risk and the identification of strengths and weaknesses, leading to the structuring of reliable services. Objective: To synthesize current knowledge and existing literature on assessing the quality of community pharmacies (CF). Methods: This is a scoping review (SR) aligned with the methodology proposed by the JBI Manual for Evidence Synthesis, carried out in four databases, covering the period from 2012 to 2022. Basic qualitative content analysis and descriptive statistics were used. Results: Of the 1,103 documents retrieved, 64 were selected. Quality assessment has been carried out, most of the time, from the patient’s perspective (54.7%), through quantitative studies (62.5%), cross-sectional (59.4%), and using questionnaires developed or adapted by the researchers themselves (51.6%). From the analysis, seven thematic categories and 36 subcategories were identified, highlighting, respectively, “pharmaceutical services” (81.25%) and “dispensing” processes (73.44%); “infrastructure and ambience” (70.3%) and “ambience and accessibility” (54.7%); “user experience and satisfaction” (67.2%) and “evaluation of community pharmacy services” (35.9%). It was observed that the categories of “people management”, “patient safety”, and “storage and disposal of medicines” were less evaluated and not all instruments used addressed all categories. Conclusions: This SR mapped scientific production regarding quality assessment in CF. This study shows the need to develop a standardized instrument encompassing the various evaluative aspects, which were listed based on the categories and subcategories identified in this review, in order to provide a complete overview of CF.
{"title":"Avaliação da qualidade das farmácias comunitárias: uma revisão de escopo","authors":"Elias Matias Laurentino, Ana Cláudia de Brito Passos, Rochely Florenço de Castro Ferreira, Mirian Parente Monteiro, Paulo Sérgio Dourado Arrais","doi":"10.22239/2317-269x.02266","DOIUrl":"https://doi.org/10.22239/2317-269x.02266","url":null,"abstract":"Introduction: Assessing quality in healthcare environments favors decision making with the lowest possible risk and the identification of strengths and weaknesses, leading to the structuring of reliable services. Objective: To synthesize current knowledge and existing literature on assessing the quality of community pharmacies (CF). Methods: This is a scoping review (SR) aligned with the methodology proposed by the JBI Manual for Evidence Synthesis, carried out in four databases, covering the period from 2012 to 2022. Basic qualitative content analysis and descriptive statistics were used. Results: Of the 1,103 documents retrieved, 64 were selected. Quality assessment has been carried out, most of the time, from the patient’s perspective (54.7%), through quantitative studies (62.5%), cross-sectional (59.4%), and using questionnaires developed or adapted by the researchers themselves (51.6%). From the analysis, seven thematic categories and 36 subcategories were identified, highlighting, respectively, “pharmaceutical services” (81.25%) and “dispensing” processes (73.44%); “infrastructure and ambience” (70.3%) and “ambience and accessibility” (54.7%); “user experience and satisfaction” (67.2%) and “evaluation of community pharmacy services” (35.9%). It was observed that the categories of “people management”, “patient safety”, and “storage and disposal of medicines” were less evaluated and not all instruments used addressed all categories. Conclusions: This SR mapped scientific production regarding quality assessment in CF. This study shows the need to develop a standardized instrument encompassing the various evaluative aspects, which were listed based on the categories and subcategories identified in this review, in order to provide a complete overview of CF.","PeriodicalId":515818,"journal":{"name":"Vigilância Sanitária em Debate","volume":" 47","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141829420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-17DOI: 10.22239/2317-269x.02156
Renata Lippi Oakim Costa, Maria Nalbaline Sampaio dos Santos
Introduction: Since antiquity, humans have used plants for various purposes, including improving physical performance. However, in recent years, the search for herbal medicines aimed at mimicking the anabolic effect, with lower health risks and without being detected in doping control, has sparked the interest of athletes and gym users. Objective: To evaluate which herbal drugs with possible androgenic activity are prescribed as magistral formulations in the city of Rio de Janeiro. Method: Data from 10,276 prescriptions recorded in the database of a network of compounding pharmacies located in the city of Rio de Janeiro between January and December 2020 were collected and analyzed. The prescribed and dispensed formulations contained Ajuga turkestanica, Cyanotis vaga, Eurycoma longifolia, Lepidium meyenii, Mucuna pruriens, Tribulus terrestris, Trigonella foenum-graecum, and Withania somnifera. Results: Most prescriptions (57.0%) were for women, prescribed by specialists in orthomolecular medicine (38.0%), and only 4.0% of prescriptions were prescribed by nutritionists. Regarding the types of medications, 8,116 prescriptions (79.0%) were formulations of combinations of one or more anabolic herbal drugs with pharmaceuticals. M. pruriens was the most prescribed herbal drug (29.0%), with or without combination. Conclusions: Most of the prescribed plants still do not have proven efficacy and safety regarding anabolic action; therefore more clinical studies are necessary to determine the possible drug interactions and adverse effects of these herbal drugs.
{"title":"Perfil das prescrições de fitoterápicos anabolizantes comercializados por uma farmácia magistral no Rio de Janeiro","authors":"Renata Lippi Oakim Costa, Maria Nalbaline Sampaio dos Santos","doi":"10.22239/2317-269x.02156","DOIUrl":"https://doi.org/10.22239/2317-269x.02156","url":null,"abstract":"Introduction: Since antiquity, humans have used plants for various purposes, including improving physical performance. However, in recent years, the search for herbal medicines aimed at mimicking the anabolic effect, with lower health risks and without being detected in doping control, has sparked the interest of athletes and gym users. Objective: To evaluate which herbal drugs with possible androgenic activity are prescribed as magistral formulations in the city of Rio de Janeiro. Method: Data from 10,276 prescriptions recorded in the database of a network of compounding pharmacies located in the city of Rio de Janeiro between January and December 2020 were collected and analyzed. The prescribed and dispensed formulations contained Ajuga turkestanica, Cyanotis vaga, Eurycoma longifolia, Lepidium meyenii, Mucuna pruriens, Tribulus terrestris, Trigonella foenum-graecum, and Withania somnifera. Results: Most prescriptions (57.0%) were for women, prescribed by specialists in orthomolecular medicine (38.0%), and only 4.0% of prescriptions were prescribed by nutritionists. Regarding the types of medications, 8,116 prescriptions (79.0%) were formulations of combinations of one or more anabolic herbal drugs with pharmaceuticals. M. pruriens was the most prescribed herbal drug (29.0%), with or without combination. Conclusions: Most of the prescribed plants still do not have proven efficacy and safety regarding anabolic action; therefore more clinical studies are necessary to determine the possible drug interactions and adverse effects of these herbal drugs.","PeriodicalId":515818,"journal":{"name":"Vigilância Sanitária em Debate","volume":" 13","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141830154","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-15DOI: 10.22239/2317-269x.02154
Lara Bueno Coelho, Graciella Corcioli, Fabiana Thomé da Cruz
Introduction: The State of Goiás has significant food production from family rural agro-industries. Objective: Considering this scenario and the recent publication of legislation on the crafting of foods of animal origin, the objective of this article was to broaden the debate on the topic through a historical-critical analysis of the federal and state regulations in Goiás, as well as to characterize the enterprises that were granted Selo Arte in the state. Method: Documentary research was carried out in order to identify the current legislation, and field research was conducted using a questionnaire that was applied to all five producers who acquired Selo Arte in Goiás. Results: As a result, it was observed that there are many gaps and bottlenecks in the legislation related to artisanal products, which hinder the formal commercialization of artisanal products and the regularization of rural agro-industries. As for the Goiás enterprises that have the Selo Arte, despite having some similarities, it was not possible to identify a characteristic pattern, most likely because the legislation is recent and few establishments have obtained the concession, which does not generate a significant quantity for comparisons. Conclusions: In conclusion, it was observed that it is essential to improve legislation at the federal, state, and municipal levels with a view to encouraging the legalization of food processing from rural agro-industries, especially family-owned ones.
引言戈亚斯州的家庭式农村农业产业生产了大量粮食。目的考虑到这一情况以及最近公布的关于动物源性食品加工的法律，本文旨在通过对戈亚斯州的联邦和州法规进行历史批判性分析，扩大对这一主题的讨论，并描述该州获得 Selo Arte 的企业的特点。研究方法：为了确定现行法规，进行了文献研究，并对戈亚斯州获得 Selo Arte 的所有五家生产商进行了问卷调查。研究结果结果发现，与手工产品有关的立法存在许多空白和瓶颈，阻碍了手工产品的正式商业化和农村农产工业的正规化。至于拥有 Selo Arte 的戈亚斯州企业，尽管有一些相似之处，但却无法确定一种特有的模式，这很可能是因为立法时间不长，获得特许权的企业很少，无法进行大量比较。结论总之，有必要完善联邦、州和市一级的立法，以鼓励农村农产工业，特别是家庭所有的农产工业的食品加工合法化。
{"title":"Produção artesanal de alimentos lácteos em Goiás: análise de normativas e cenário do Selo Arte","authors":"Lara Bueno Coelho, Graciella Corcioli, Fabiana Thomé da Cruz","doi":"10.22239/2317-269x.02154","DOIUrl":"https://doi.org/10.22239/2317-269x.02154","url":null,"abstract":"Introduction: The State of Goiás has significant food production from family rural agro-industries. Objective: Considering this scenario and the recent publication of legislation on the crafting of foods of animal origin, the objective of this article was to broaden the debate on the topic through a historical-critical analysis of the federal and state regulations in Goiás, as well as to characterize the enterprises that were granted Selo Arte in the state. Method: Documentary research was carried out in order to identify the current legislation, and field research was conducted using a questionnaire that was applied to all five producers who acquired Selo Arte in Goiás. Results: As a result, it was observed that there are many gaps and bottlenecks in the legislation related to artisanal products, which hinder the formal commercialization of artisanal products and the regularization of rural agro-industries. As for the Goiás enterprises that have the Selo Arte, despite having some similarities, it was not possible to identify a characteristic pattern, most likely because the legislation is recent and few establishments have obtained the concession, which does not generate a significant quantity for comparisons. Conclusions: In conclusion, it was observed that it is essential to improve legislation at the federal, state, and municipal levels with a view to encouraging the legalization of food processing from rural agro-industries, especially family-owned ones.","PeriodicalId":515818,"journal":{"name":"Vigilância Sanitária em Debate","volume":"43 45","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141645231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-15DOI: 10.22239/2317-269x.02054
Mariana Saraiva dos Santos, Luana Santana Bacelar, Soane Da Silva Félix, Patrícia Lima de Araújo, Regina Maria da Hora dos Santos Azevedo, M. T. Bendicho, R. Xavier
Introduction: The increase in the costs of cancer treatments is configured as a relevant problem for health services linked to the constant incorporation of new drugs for cancer treatment. This growth in expenses reflects the challenge of managing resources to meet the needs of the oncologic area. It is necessary to optimize resources in view of the growing demand and associated costs. In the scenario where patients receive personalized treatments, changes in therapy are possible, causing some returns of antineoplastic drugsand increasing costs in health services. Objective: To analyze the profile of returns of chemotherapy drugs handled by the Pharmacy sector and the relationship with costs in a philanthropic hospital in Salvador. Method: This was a cross-sectional, retrospective, and analytical study conducted between August 2019 and August 2020. Data were collected through forms obtained after the return of chemotherapy. Information such as the drug name, dose, reuse status, and reason for return were evaluated. Data were tabulated using SPSS software. Results: 171 chemotherapy bags were returned involving 19 active ingredients. The clinical factor accounted for 59.1% of the returns. Cisplatin accounted for 14.6% of the returns. Carboplatin was the most discarded drug, representing 16.9% of the lost bags, whereas Cisplatin had the highest rate of reuse. In pharmacoeconomics, the returns represented the value of R$ 13,887.87. The hospital lost R$ 7,475.61 with the discarded products but saved R$ 6,412.21 through reuse. Conclusions: Oncology needs to be linked to pharmacoeconomics and to minimize discards, strategies should be adopted.
{"title":"Análise do perfil de devoluções de quimioterapias endovenosas em um hospital filantrópico de Salvador-BA","authors":"Mariana Saraiva dos Santos, Luana Santana Bacelar, Soane Da Silva Félix, Patrícia Lima de Araújo, Regina Maria da Hora dos Santos Azevedo, M. T. Bendicho, R. Xavier","doi":"10.22239/2317-269x.02054","DOIUrl":"https://doi.org/10.22239/2317-269x.02054","url":null,"abstract":"Introduction: The increase in the costs of cancer treatments is configured as a relevant problem for health services linked to the constant incorporation of new drugs for cancer treatment. This growth in expenses reflects the challenge of managing resources to meet the needs of the oncologic area. It is necessary to optimize resources in view of the growing demand and associated costs. In the scenario where patients receive personalized treatments, changes in therapy are possible, causing some returns of antineoplastic drugsand increasing costs in health services. Objective: To analyze the profile of returns of chemotherapy drugs handled by the Pharmacy sector and the relationship with costs in a philanthropic hospital in Salvador. Method: This was a cross-sectional, retrospective, and analytical study conducted between August 2019 and August 2020. Data were collected through forms obtained after the return of chemotherapy. Information such as the drug name, dose, reuse status, and reason for return were evaluated. Data were tabulated using SPSS software. Results: 171 chemotherapy bags were returned involving 19 active ingredients. The clinical factor accounted for 59.1% of the returns. Cisplatin accounted for 14.6% of the returns. Carboplatin was the most discarded drug, representing 16.9% of the lost bags, whereas Cisplatin had the highest rate of reuse. In pharmacoeconomics, the returns represented the value of R$ 13,887.87. The hospital lost R$ 7,475.61 with the discarded products but saved R$ 6,412.21 through reuse. Conclusions: Oncology needs to be linked to pharmacoeconomics and to minimize discards, strategies should be adopted.","PeriodicalId":515818,"journal":{"name":"Vigilância Sanitária em Debate","volume":"28 14","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141648000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-13DOI: 10.22239/2317-269x.02209
Frederico Felipe Costa Tebas de Freitas, Livia Rosas Ferreira, Paola Karolyne Jandrey, Gabriela Pôrto Marques
Introduction: Health Plans are management instruments that guide the definition and implementation of health activities. As an integral part of the Unified Health System, Health Surveillance actions must be included in Health Plans. Objective: To analyze the inclusion of health surveillance in municipal health plans in the state of Espírito Santo, aiming to understand how this area was expressed in the management of these instruments. Method: A documentary analysis of municipal health plans for the four-year periods 2018–2021 and 2022–2025 was carried out, framing health surveillance actions into categories and subcategories. It was found that health surveillance actions are mostly of an authorization and health control nature, as well as related to the process of decentralization of activities between the state and municipality. Results: There was a strong presence of actions related to the physical structuring of health surveillance bodies, denoting a possible weakness in meeting the population’s health needs. Conclusions: The lack of consolidated national indicators and information systems in health surveillance ends up distancing this area from planning bodies, thus generating discrepancies between the population’s health needs and health surveillance actions.
{"title":"Health Plans in municipalities in the state of Espírito Santo:an analysis focusing on Health Surveillance","authors":"Frederico Felipe Costa Tebas de Freitas, Livia Rosas Ferreira, Paola Karolyne Jandrey, Gabriela Pôrto Marques","doi":"10.22239/2317-269x.02209","DOIUrl":"https://doi.org/10.22239/2317-269x.02209","url":null,"abstract":"Introduction: Health Plans are management instruments that guide the definition and implementation of health activities. As an integral part of the Unified Health System, Health Surveillance actions must be included in Health Plans. Objective: To analyze the inclusion of health surveillance in municipal health plans in the state of Espírito Santo, aiming to understand how this area was expressed in the management of these instruments. Method: A documentary analysis of municipal health plans for the four-year periods 2018–2021 and 2022–2025 was carried out, framing health surveillance actions into categories and subcategories. It was found that health surveillance actions are mostly of an authorization and health control nature, as well as related to the process of decentralization of activities between the state and municipality. Results: There was a strong presence of actions related to the physical structuring of health surveillance bodies, denoting a possible weakness in meeting the population’s health needs. Conclusions: The lack of consolidated national indicators and information systems in health surveillance ends up distancing this area from planning bodies, thus generating discrepancies between the population’s health needs and health surveillance actions.","PeriodicalId":515818,"journal":{"name":"Vigilância Sanitária em Debate","volume":"67 48","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141346403","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-13DOI: 10.22239/2317-269x.02203
Maria Cristina Ferreira Pessoa, J. Granjeiro
Introduction: Specific Prostate Antigen (PSA) is crucial for monitoring prostate cancer, which is one of the leading causes of male mortality in Brazil and the USA. The reliability of PSA results provides an efficient diagnosis to direct to therapy, treatment response evaluation, and epidemiology. However, known discrepancies exist in the results obtained from different laboratories. Metrological traceability emerges as a key factor for the comparability and precision of these results and is a subject of little knowledge in the laboratory community. Objective: This study aimed to identify the metrological traceability of Total PSA kits registered in Brazil. Method: A search was conducted on the ANVISA product registration page, where the origin and instructions for use of the kits provided by in vitro diagnostic (IVD) manufacturers were analyzed. Results: The ANVISA data showed that 75.0% of IVD producers use the WHO 96/670 product, and 25.0% do not mention metrological traceability. Foreign products prevail (87.5%), with only two national kits registered, which do not provide information on traceability. Conclusions: the Brazilian market for Total PSA diagnostic kits (excluding rapid tests and free PSA) is predominantly dominated by foreign products that use the WHO 96/670 reference material. The lack of information on traceability in a significant number of IVD products highlights the need for regulatory and educational actions to promote awareness and compliance with metrological traceability principles of, thereby improving the quality and reliability of laboratory tests for public health protection.
{"title":"Overview of metrological traceability of total PSA diagnostic kits inbrazilian clinical laboratories","authors":"Maria Cristina Ferreira Pessoa, J. Granjeiro","doi":"10.22239/2317-269x.02203","DOIUrl":"https://doi.org/10.22239/2317-269x.02203","url":null,"abstract":"Introduction: Specific Prostate Antigen (PSA) is crucial for monitoring prostate cancer, which is one of the leading causes of male mortality in Brazil and the USA. The reliability of PSA results provides an efficient diagnosis to direct to therapy, treatment response evaluation, and epidemiology. However, known discrepancies exist in the results obtained from different laboratories. Metrological traceability emerges as a key factor for the comparability and precision of these results and is a subject of little knowledge in the laboratory community. Objective: This study aimed to identify the metrological traceability of Total PSA kits registered in Brazil. Method: A search was conducted on the ANVISA product registration page, where the origin and instructions for use of the kits provided by in vitro diagnostic (IVD) manufacturers were analyzed. Results: The ANVISA data showed that 75.0% of IVD producers use the WHO 96/670 product, and 25.0% do not mention metrological traceability. Foreign products prevail (87.5%), with only two national kits registered, which do not provide information on traceability. Conclusions: the Brazilian market for Total PSA diagnostic kits (excluding rapid tests and free PSA) is predominantly dominated by foreign products that use the WHO 96/670 reference material. The lack of information on traceability in a significant number of IVD products highlights the need for regulatory and educational actions to promote awareness and compliance with metrological traceability principles of, thereby improving the quality and reliability of laboratory tests for public health protection.","PeriodicalId":515818,"journal":{"name":"Vigilância Sanitária em Debate","volume":"6 17","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140982561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-19DOI: 10.22239/2317-269x.02236
Meire Nikaido Suzuki, Guilherme Sgobbi Zagui, Carolina Sampaio Machado, Sabrina Alves dos Reis, Gabriel Pinheiro Machado, Marina Smidt Celere Meschede, Danilo Vitorino Santos, Carlos Henrique Gomes Martins, Leonardo Neves Andrade, S. Segura-Muñoz
{"title":"Avaliação da metodologia analítica para determinação de arsênio, cádmio e chumbo em amostras de café, segundo os critérios de aceitação do Codex Alimentarius","authors":"Meire Nikaido Suzuki, Guilherme Sgobbi Zagui, Carolina Sampaio Machado, Sabrina Alves dos Reis, Gabriel Pinheiro Machado, Marina Smidt Celere Meschede, Danilo Vitorino Santos, Carlos Henrique Gomes Martins, Leonardo Neves Andrade, S. Segura-Muñoz","doi":"10.22239/2317-269x.02236","DOIUrl":"https://doi.org/10.22239/2317-269x.02236","url":null,"abstract":"","PeriodicalId":515818,"journal":{"name":"Vigilância Sanitária em Debate","volume":" 648","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140682208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-15DOI: 10.22239/2317-269x.02192
Cristiane Barata-Silva, Carolina Duque Magalhães, Renata Aparecida Pereira, Santos Alves Vicentini Neto, Silvana Couto Jacob, Lisia Maria Gobbo dos Santos
{"title":"Avaliação da metodologia analítica para determinação de arsênio, cádmio e chumbo em amostras de café, segundo os critérios de aceitação do Codex Alimentarius","authors":"Cristiane Barata-Silva, Carolina Duque Magalhães, Renata Aparecida Pereira, Santos Alves Vicentini Neto, Silvana Couto Jacob, Lisia Maria Gobbo dos Santos","doi":"10.22239/2317-269x.02192","DOIUrl":"https://doi.org/10.22239/2317-269x.02192","url":null,"abstract":"","PeriodicalId":515818,"journal":{"name":"Vigilância Sanitária em Debate","volume":"17 14","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140240477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-20DOI: 10.22239/2317-269x.02260
P. Binsfeld, José Mauro Granjeiro
que os benefícios sejam aproveitados de maneira
确保效益得到利用
{"title":"Nanotecnologias: regulação baseada em evidências","authors":"P. Binsfeld, José Mauro Granjeiro","doi":"10.22239/2317-269x.02260","DOIUrl":"https://doi.org/10.22239/2317-269x.02260","url":null,"abstract":"que os benefícios sejam aproveitados de maneira","PeriodicalId":515818,"journal":{"name":"Vigilância Sanitária em Debate","volume":"37 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140449123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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