Introdução: A resistência microbiana representa um importante problema de saúde pública, impulsionando a busca por novas alternativas terapêuticas. A nanoencapsulação do óleo essencial de Cymbopogon winterianus surge como estratégia promissora para potencializar sua estabilidade e atividade frente a microrganismos de relevância clínica. Objetivo: Avaliar a atividade antimicrobiana do óleo essencial de Cymbopogon winterianus livre e em nanoemulsão pelo método de disco-difusão e determinar a concentração inibitória mínima frente a Escherichia coli e Staphylococcus aureus. Método: Para determinação da menor concentração capaz de inibir o crescimento microbiano, utilizou-se a microdiluição. O teste de suscetibilidade antibacteriana foi realizado pelo método de disco-difusão, utilizando concentrações múltiplas da concentração inibitória mínima. Resultados: O óleo essencial, tanto livre como em nanoemulsão de citronela, apresentou uma fraca atividade antibacteriana frente a S. aureus, com uma concentração inibitória mínima de 2.048 μg/mL para o óleo livre e de 62.500 μg/mL para a nanoemulsão, e uma atividade moderada frente a E. coli, com uma concentração inibitória mínima de 512 μg/mL e 31.250 μg/mL para a nanoemulsão. Já no teste de suscetibilidade, o óleo não apresentou halo de inibição em nenhuma das concentrações testadas. Conclusões: O óleo essencial de citronela apresentou atividade antibacteriana in vitro limitada frente às cepas avaliadas, sendo observada uma eficácia melhor na forma livre em comparação à nanoemulsão. A nanoemulsão não demonstrou ganho de atividade, sugerindo que fatores relacionados à formulação e às condições experimentais podem ter influenciado seu desempenho. Esses achados indicam que, nas condições testadas, a incorporação em nanoemulsão não potencializou o efeito antimicrobiano do óleo essencial.
Introdução: O polimetilmetacrilato (PMMA) é um biomaterial amplamente utilizado em cranioplastias devido ao baixo custo, facilidade de moldagem intraoperatória e adequada estabilidade estrutural. Entretanto, a ocorrência de complicações infecciosas e outras intercorrências clínicas torna necessária a análise sistemática de seu perfil de segurança em reconstruções cranianas. Objetivo: Analisar o perfil de segurança e os efeitos adversos associados ao uso do PMMA em técnicas reparadoras de cranioplastia. Método: Foi realizado um overview de revisões sistemáticas, conduzido de acordo com as recomendações da Cochrane e reportado conforme o PRISMA. A busca foi realizada em 04/03/2026 em seis bases de dados eletrônicas: Medline via PubMed, Embase via Elsevier, Cochrane Library, Portal Regional BVS, Web of Science e Scopus, com busca complementar no Google Acadêmico. Foram incluídas revisões sistemáticas com ou sem metanálise que avaliaram o uso de PMMA em cranioplastia e reportaram desfechos de segurança. Resultados: Foram identificadas 108 revisões sistemáticas, das quais dez foram incluídas. Os eventos adversos associados ao PMMA em cranioplastia concentraramse principalmente em complicações locais e infecciosas. Entre os eventos locais leves destacaram-se eritema, edema local, prurido e equimose, descritos como comuns (10%–50%). Entre os eventos locais moderados, observaram-se infecção superficial em 10,47% e infecção do implante superficial ou profunda com frequências de 14,90%, 7,80% e 8,00%. Entre os eventos locais graves foram descritos granuloma intracraniano por corpo estranho e migração ou deslocamento do implante, com frequências de 3,72%, 2,30% e 2,00%. Entre os eventos sistêmicos destacaram-se convulsões e eventos neurológicos pós-operatórios, com frequência de até 15,6%. Conclusões: O perfil de segurança do PMMA demonstrou risco relevante de infecção e ocorrência de eventos adversos graves, ainda que raros. A escolha do material deve ser individualizada, considerando o perfil de risco do paciente, a complexidade do defeito craniano e a disponibilidade de alternativas terapêuticas. A predominância de estudos retrospectivos e a heterogeneidade metodológica reforçam a necessidade de ensaios clínicos randomizados para fortalecer as evidências sobre a segurança e a eficácia de longo prazo do PMMA.
Introduction: This study addresses the evaluation of blood glucose monitoring systems using strip-based glucometers by regulatory agencies, comparing Brazil with Canada, the United States of America (USA), Japan, Australia, and countries in the European continent. It was developed to provide technical support to the Brazilian Health Regulatory Agency (ANVISA). Objective: To identify evidence on complaints or adverse events related to the use of glucometers with strips by patients with type 1 or type 2 diabetes mellitus, with regard to the nature and form of monitoring these occurrences. Method: An integrative review was conducted to investigate how regulatory agencies evaluate technical complaints associated with blood glucose monitoring systems using glucometers and reagent strips. Searches were performed in MEDLINE (via PubMed), Embase, and SCOPUS databases, as well as in secondary sources, civil society documents, and through manual reference checks. Results: A total of 1,220 citations were retrieved. Eight studies were selected, with data on device accuracy, human factors involved in use, and user experiences. The findings indicate frequent failures in the use of devices, low reporting of adverse events by users and a lack of public information on regulatory flows, except in Australia, which adopts a structured risk-based model. The results point to the need for greater regulatory transparency and educational actionsfor the safe use of these devices. Conclusions: Information from regulatory agencies focuses on standards, regulations and guidelines for medical devices, with emphasis on the Australian agency’s approach to managing adverse events. There are no details on how other agencies deal with user complaints about the routine use of these devices.
Introduction: The use of combined oral contraceptives (COCs) has raised concerns about the risk of venous thromboembolism (VTE) in women of childbearing age, which generally contain two components: estrogen and a variety of progestogens. Objective: To evaluate the safety of combined oral contraceptives for VTE in women of childbearing age. Method: Critical review of systematic reviews to respond to the research objective. Results: Five systematic reviews (SRs) were included. Brabaharan et al. (2022) found an increased risk of VTE associated with the use of COCs containing low-dose desogestrel, with an effect size of 2.05 (95% CI 1.59–2.64). Wan-Lin Zhang et al. (2021) evaluated COCs with drospirenone (DRSP) compared with those not containing DRSP (excluding levonorgestrel), reducing the risk of VTE, with an adjusted HR of 0.76 (95% CI 0.59–0.98). De Bastos et al. (2014) showed an increased risk of VTE when comparing COC users with non-users: 1st generation: RR 3.2 (95% CI 1.6–6.4); 2nd generation: RR 2.6 (95% CI 1.5–4.7); 3rd generation: RR 3.5 (95% CI 2.0–6.1); Stegeman et al., 2013) with a study identical to De Bastos showed a relative risk of 3.5 (95% CI 2.9–4.3). The review by Peragallo Urrutia et al. (2013) showed an odds ratio of 2.97 (95% CI 2.46–3.59) when comparing users with non-users. Conclusions: The evidence gathered in the systematic reviews analyzed indicates that the absolute risk of VTE is low in young, healthy women; however, the relative risk is present especially with the use of COCs containing estrogen in higher doses or third- and fourth-generation progestogens. The influence of confounding factors such as age, body mass index, and individual characteristics should be carefully considered when interpreting the data.
Introduction: In Brazil, a drug must be registered with the Brazilian Health Surveillance Agency (ANVISA) before it can be marketed. The registration application process requires the submission of safety, efficacy, and quality data. Compliance with all requirements is essential for registration review and approval. Objective: To analyze the requirements and reasons forrejection of the safety and efficacy analysis of new and innovative drugs in 2023. Method: Observational, descriptive, and qualitative-quantitative study of new and innovative drugs in 2023. Data collection was carried out from primary sources through technical rejection reports and requirement item reports contained in DATAVISA. Results: Sixty-eight publicationsrelated to new and innovative drug registrations were found in the Official Government Gazette. Of these, four (5.88%) drugs were rejected by Anvisa: three rejections related to new drugs and one rejection of an innovative drug. Two registrations were rejected due to safety and efficacy concerns. Furthermore, 1,374 technical requirements for registration and 358 technical requirements related to post-registration petitions were issued. Conclusion: The frequency of drugs rejected for safety and efficacy reasons was low. Furthermore, most of the requirements were for medium and low risk. This may be related to the continuous improvement of the Brazilian regulatory process in recent years.
Introduction: Nutrition in the first months of life is crucial for child development, and breastfeeding is widely recommended by institutions such as the World Health Organization (WHO) and the Brazilian Ministry of Health. However, in situations where breastfeeding is not possible, infant formulas have emerged as an essential alternative. In this context, understanding the Brazilian regulatory framework for these formulas is fundamental to ensuring food safety and product quality. Objective: To describe how Brazilian legislation regulates the formulation, commercialization, microbiological quality, and use of infant formulas (IF) for infants, as well as to analyze the implications of this regulation for public health and the infant food market. Method: This is a narrative review study of the literature and national legislation regarding IF. Resolutions from the National Health Surveillance Agency (Anvisa), federal laws, and technical standards were consulted, in addition to scientific articles published between 2014 and 2024 in databases such as SciELO, LILACS, PubMed, and Google Scholar. The descriptors used were “infant formulas,” “nutritional composition,” and “Brazilian legislation.” Results: The analysis showed that Brazil has a robust set of regulatory instruments, including Law No. 11,265/2006 (NBCAL) and Resolutions RDC No. 43, 44, and 45/2011, which regulate the composition, labeling, and commercialization of IF, as well as RDC No. 429/2020, which defines rules for nutritional labeling. RDC No. 724/2022 is also noteworthy, as it establishes strict microbiological standards. Reviewed studies indicated that, although most IF partially comply with current legislation, nonconformities were mainly related to labeling and nutritional composition. Conclusion: The analyzed studies revealed at least one nonconformity with current legislation, highlighting the need for infant formula manufacturers to adapt their products to the relevant regulations and for health authorities to intensify inspections to ensure greater effectiveness in law enforcement, thus guaranteeing product quality and protecting infant health.
Introduction: The pharmaceutical sector is highly regulated to ensure the quality, safety, and efficacy of medicines throughout their entire lifecycle. Quality-oriented Research, Development & Innovation (R&D&I) is crucial for achieving valid, traceable, and reproducible results. Analytical methods play a fundamental role in the control strategy that drives the technological maturity of these products. Organizational Knowledge is an essential resource for achieving institutional objectives. Objective: To demonstrate how a process-based approach, integrated with Knowledge Management practices, can contribute to the development of a sustainable Quality Management System (QMS). Method: Descriptive and exploratory in nature, this study reports the experience of the technological platform of the Department of Analytical Methods (DMA) at Farmanguinhos, the pharmaceutical laboratory of the Brazilian Ministry of Health and a technicalscientific unit of the Oswaldo Cruz Foundation (Fiocruz). Critical processes were identified and prioritized according to their impact on deliverables, costs, and regulatory compliance. These processes were then consolidated into a SIPOC matrix and modeled using the Bizagi Process Modeler®. Bottlenecks were identified and improvement proposals developed through brainstorming sessions. Results: Five processes were implemented, one of them being a core process, and twelve supporting documents were established, including standard operating procedures, recording forms, and control spreadsheets. Cloud-based platforms were incorporated to support team collaboration and Electronic Document Management (EDM). This systematization established a foundation of Explicit Knowledge and processes capable of promoting operational efficiency, strengthening the QMS, and driving continuous improvement. Conclusions: The DMA’s model is knowledge-centered for process restructuring. Its flexibility supports application across other platforms within the Fiocruz and research laboratories, with potential contributions to future studies.
The thematic series "Evidence Synthesis for Health Regulation" is an initiative of the Evidence for Health Policies and Technologies Program (PEPTS), which, through technical cooperation established with the National Health Surveillance Agency (ANVISA), developed a set of evidence syntheses that resulted in the articles presented here. This initiative is made possible with the essential support of the Visa in Debate Journal, which, in synergy with the institutional mission of those involved, aims to publicize and disseminate the knowledge produced, so that it reaches professionals working in the field of health surveillance and regulation, as well as others interested in the subject. The publication addresses essential topics to broaden the debate on emerging and re-emerging issues that are on the daily agenda of management in health surveillance and regulation. With this, it intends to foster reflections on the use of the best available evidence, whether from the literature or from national and international experiences, whose potential applies to guiding regulatory decisions in Brazil. The thematic series includes three diverse sections: Post-marketing Surveillance; Regulatory Impact; and Technological Innovation, and publishes original articles and scoping reviews, in Portuguese and English, and is distributed digitally. The Editors wish you a great reading experience!
Introduction: The definition of research priorities is essential to align scientific efforts with the real needs of health systems. In this scenario, the National Health Surveillance Agency and Fiocruz Brasilia implemented the "Priority Cycle" as a strategy to identify and select research topics relevant to sanitary regulation. Objective: To present the research topic prioritization process, called the Priority Cycle, to produce strategic studies that support regulatory policies in the field of health surveillance. Method: Experience report on the Priority Cycle based on the Combined Approach Matrix and topic selection approaches, structured in four phases: theme identification, data collection systematization, topic selection workshops, and agenda with a portfolio of prioritized studies. Results: 73 themes were received, of which 38 were ranked and evaluated for operational, technical, and scientific feasibility. The process resulted in the prioritization of 46 studies: 33 evidence syntheses, nine technical-scientific opinions, and four technical reports. The prioritized themes covered different areas of health surveillance, such as pharmacovigilance, cosmetovigilance, and food regulation. Conclusions: The Priority Cycle constitutes an effective, participatory, and transparent methodology for defining regulatory research agendas, promoting the use of health technology assessment in evidence-based decision-making within Anvisa.
Introduction: Cosmetics formulated with nanotechnology (1.0 x 10(-9) m) have great market potential due to their effectiveness and consumer satisfaction. Objective: To conduct a documentary review of international regulatory requirements related to the safety of cosmetics containing nanomaterials. Method: A systematic documentary analysis was performed using official websites of eight regulatory agencies: the United States, European Union, Canada, Japan, Australia, China, India, and South Korea. The research was structured using the PICOT acronym. Documents were screened based on inclusion and exclusion criteria and evaluated by peer reviewers. Data extraction was conducted using REDCap (R) software and organized into thematic frameworks. Results: Nine documents were included, with emphasis on those issued by the SCCS (EU), FDA (USA), ICCR, and MHLW (Japan). Regulatory convergence was observed in aspects such as the physicochemical characterization of nanomaterials (including size, morphology, purity, and stability) and the requirement for specific testing related to dermal irritation, inhalation toxicity, genotoxicity, and skin absorption. The analyzed documents highlight that nanomaterials may exhibit physicochemical properties, biological interactions, and toxicological effects distinct from the same ingredients on a conventional scale - with magnetic, optical, structural, electrical, and chemical differences that may impact product performance, safety, and efficacy. Conclusions: There is no international regulatory consensus on mandatory criteria for the use of nanomaterials in cosmetics. Agencies recommend multiple validated tests, applied to different product batches, and emphasize the importance of detailed physicochemical characterization as well as dose-response assessment as essential requirements. The experience of more established jurisdictions can support the advancement of the Brazilian regulatory framework in this emerging field.
Introduction: Lisdexamfetamine (LDX) is a medication indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Binge Eating Disorder (BED). After oral administration, the medication is rapidly absorbed by the gastrointestinal tract and converted into D-amphetamine covalently bound to the natural amino acid L-lysine, responsible for the drug's activity. Objective: To evaluate the long-term effectiveness of Lisdexamfetamine for treating Attention Deficit Hyperactivity Disorder and Binge Eating Disorder. Method: A search was conducted in PubMed, Embase, Web of Science, and Cochrane using descriptors and their respective synonyms to identify the long-term efficacy and safety of LDX in individuals with ADHD and BED. Interventional and controlled group studies with a follow-up period of more than 5 weeks were included. Results: 30 studies were included. Regarding the population, the effects of LDX were investigated in individuals aged 5-55 years, with the longest follow-up being 108 weeks. Overall, the literature indicates a significant reduction in symptoms within the first 5-6 weeks of treatment, stabilizing in the following weeks. For ADHD, studies up to 108 weeks reported mean reductions of-25.8 points on the ADHD-RS-IV (95% CI-27.0 to-24.5), improvement in CGI-I ratings from 42.3% to 89.1%, and maintenance-of-response rates above 75% in adults after 12 months. For BED, studies with up to 52 weeks of follow-up showed that 89.8% of participants experienced clinical improvement on the CGI-I, with significant reductions in weekly binge-eating days (least-squares mean differences up to-1.66; p < 0.001) and a mean improvement of-1.95 points on the EDE-Q. Conclusions: The findings suggest that LDX shows promising long-term results for both health conditions. However, healthcare professional follow-up is necessary due to the drug's adverse events.
Introduction: Benzodiazepines (BZD) and Z-drugs have been increasingly prescribed and used. In addition to well-recognized adverse events, these classes may trigger paradoxical reactions, which are rarely explored in the literature and are characterized by effects opposite to those expected. Objective: To evaluate the profile of reports of paradoxical reactions to BZD and Z-drugs in the Brazilian electronic spontaneous reporting system (VigiMed). Method: Cross-sectional analytical study based on reports of potential adverse drug events (ADEs) indicative of paradoxical reactions, classified according to MedDRA terminology and recorded in VigiMed between January 2018 and April 2023. The analysis included anxiolytics (N05BA), hypnotics and sedatives (N05CF, N05CD), and benzodiazepine-derived antiepileptics (N03AE). Disproportionality analysis was performed using the Reporting Odds Ratio (ROR). Results: A total of 466 reports of potential paradoxical reactions were identified. Most reports were submitted by consumers (65.9%) and pharmacists (26.6%) and involved women (54.5%) and older adults (34.9%). The majority were classified as non-serious (59.4%), with outcomes unknown (36%) or resolved (28.5%). The most frequently reported reactions were insomnia (29.8%), anxiety (18.9%), agitation (18.2%), and hallucination (13.7%). Disproportionality analysis showed significant associations for both BZD and Z-drugs. Agitation, insomnia, and anxiety stood out as paradoxical reactions associated with all drugs. Zolpidem and clonazepam were the medications with the highest number of significant associations. Conclusions: The signals of potential paradoxical reactions in widely prescribed drugs, especially zolpidem and clonazepam, highlight the need to reassess routine use. The findings reinforce the importance of pharmacovigilance and critical prescribing, particularly in older adults and women.
Introduction: The regulation of assisted human reproduction (AHR) involves ethical and technical guidelines that vary between countries and institutions, especially regarding Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) disposal and donor remuneration. Harmonization of these criteria is essential to ensure safety in reproductive processes. Objective: To identify requirements in assisted human reproduction regarding disposal and remuneration adopted by the international regulatory agencies Food and Drug Administration (FDA) and European Commission (EC) and by the recommending societies/institutions American Society for Reproductive Medicine (ASRM), European Society of Human Reproduction and Embryology (ESHRE), and Human Fertilization Embryology Authority (HFEA). Method: Documentary, descriptive, and exploratory review complemented by a scoping review. The documents were analyzed using normative and technical criteria related to tissue and cell disposal and donor compensation. Results: The EC (Directive 2006/86/EC) and the FDA (CFR 21 Part 1271) have regulations on disposal, emphasizing health safety and traceability. The HFEA limits compensation to fixed amounts to cover reasonable financial losses, prohibiting any gain. The ESHRE reinforces safe disposal practices and, together with the ASRM, allows limited compensation for time and expenses, discouraging financial motivations as the main reason for donation. European guidelines tend to favor altruistic models with controlled reimbursements, whereas in the USA, there is greater flexibility, although with ethical requirements. Conclusion: Although the European model prioritizes altruism and limits compensation, this rigidity can restrict donor availability and affect equity in access. In contrast, North American flexibility favors a greater supply but requires constant ethical oversight. Sanitary safety and traceability should remain universal principles in any regulatory donation system. The analysis demonstrates convergences and divergences in regulatory requirements, reflecting different sociocultural and ethical contexts. The findings may contribute to the development of more equitable and safe policies in assisted reproduction, especially in countries seeking to update their regulations according to international practices.
Introduction: The COVID-19 pandemic highlighted the vulnerability of countries due to their high dependence on imports of APIs (Active Pharmaceutical Ingredients) from Asian countries. Despite the country having consolidated pharmaceutical manufacturing, lack of access to APIs will inevitably lead to drug shortages. Objective: To identify the pharmaceutical companies operating in Brazil, characterize the type and scale of production, verify the structure for the development and production of Active Pharmaceuticals Ingredients (APIs, and encourage discussions, proposals, and actions that help overcome the challenges of the sector. Method: This field research study is quantitative and descriptive in nature. Thirty-seven national companies producing APIs were identified using synthetic, biotechnological, and animal and plant extraction routes. Thirty-two visits were conducted, where the main indicators were evaluated in situ, in addition to discussions about the sector and proposals for its strengthening. The visits were preceded by the completion of a questionnaire. Results: National production of APIs represents approximately 6% of national demand; of the 32 companies that participated in the census, 95% have national capital; the sector's annual revenue was approximately R$ 18 billion; 98% of the companies have national/international certification; annual production was 1,760 tons; 199 patents or patent applications were counted in Brazil and abroad; 70% of the companies have their own research and development structure; and 40% participate in Partnerships for Productive Development. Conclusions: Due to the technical qualifications of the companies and the already installed manufacturing structure, there is a possibility of increasing national API production. The analysis of the data systematized by the Census points to the need to stimulate the development of production chains through sectoral policies.
Introdução: Este artigo analisa a estratégia de priorização da análise de registro de medicamentos implementada pela Agência Nacional de Vigilância Sanitária (Anvisa) por meio das RDC nº 204/2017 e nº 205/2017, com foco na estratégia regulatória e na gestão do passivo de petições. Objetivo: Avaliar a estratégia de priorização da análise de registro de medicamentos na Anvisa quanto aos seus efeitos sobre a celeridade na análise dos pedidos e a redução do passivo regulatório, entendido como o estoque de petições. Método: Estudo descritivo, quantitativo e longitudinal, baseado no indicador “evolução trimestral das petições de registro priorizadas”, composto por entradas, saídas e passivo acumulado. Utilizaram-se dados da AIR, da base de Business Intelligence da Gerência-Geral de Medicamentos e da fila de petições. O período analisado compreendeu de janeiro de 2018 a dezembro de 2024. Os dados foram organizados em séries temporais e analisados por estatística descritiva. Resultados: O indicador proposto evidenciou aumento das entradas de petições priorizadas a partir de 2019 e esforços institucionais para ampliar a capacidade de análise a partir de 2021. Entretanto, o passivo acumulado apresentou tendência de crescimento ao longo do período, com pico em 2024, indicando limitações da estratégia na redução do tempo de espera, apesar dos mecanismos de priorização. Conclusões: Conclui-se que a estratégia é relevante, porém insuficiente, isoladamente, para reduzir o passivo e ampliar a celeridade na Anvisa. Os resultados indicam a necessidade de articulá-la a uma estratégia mais ampla, baseada em gestão de risco, uso de dados e mecanismos como reliance e regulação ágil, para melhorar o desempenho e a previsibilidade do processo regulatório.
Introdução: As quedas em ambientes hospitalares são um problema de saúde pública, especialmente entre idosos, devido às suas graves consequências clínicas e econômicas. O uso de medicamentos que afetam a cognição e o equilíbrio é um fator de risco relevante. Objetivo: Identificar ações e estratégias na literatura que possam ser aplicadas para diminuir o risco ou a incidência de quedas em pacientes hospitalizados em uso de medicamentos que potencializam esse risco. Método: Foi realizada uma revisão integrativa da literatura, nas bases de dados PubMed e Biblioteca Virtual em Saúde (BVS), considerando estudos publicados entre 2019 e 2024, que abordassem intervenções para minimização de quedas. Resultados: A busca nas bases de dados resultou na seleção final de 11 estudos. As estratégias identificadas incluíram ajuste de aprazamento, cálculo do Drug Burden Index (DBI), comparação entre medicamentos ou classes medicamentosas, comparação entre diferentes doses utilizadas, sugestão para desprescrição e substituição de medicamentos. Algumas intervenções farmacológicas foram associadas à redução do risco de quedas, como o ajuste de doses e a substituição de determinados medicamentos por opções potencialmente mais seguras. No entanto, outros estudos não identificaram impacto significativo das intervenções, e certas classes medicamentosas foram associadas a um aumento no risco de quedas. Conclusões: A prevenção de quedas em ambiente hospitalar requer uma abordagem multidisciplinar e individualizada, considerando fatores clínicos e farmacológicos. Embora algumas estratégias tenham demonstrado potencial na redução do risco, ainda há necessidade de mais estudos para consolidar diretrizes específicas baseadas em evidências científicas.
Introdução: Diversos tipos de dispositivos intrauterinos (DIU) estão disponíveis no mercado nacional, mas o disponibilizado pelo Sistema Único de Saúde (SUS) é o contendo cobre (Cu). Devido à necessidade de controlar a qualidade do dispositivo, a Agência Nacional de Vigilância Sanitária (Anvisa) publicou a RDC nº 552/2021 que determina que a pureza do Cu deve ser maior ou igual a 99,9% e a concentração de sulfato de bário deve ser entre 15% e 25%. O teor mínimo permitido de prata (Ag) em DIU comercializados no Brasil não é definido. Objetivos: Avaliar a qualidade dos dispositivos médicos (DM) que solicitaram registro para serem disponibilizados pelo SUS quanto à concentração de Cu, Ag e bário (Ba). Método: Para a determinação de Cu e Ag foram selecionadas nove amostras de três marcas distintas. Já para o ensaio de determinação de Ba foram analisadas sete amostras de três marcas diferentes. Resultados: Os resultados indicam a importância do monitoramento dos DM, uma vez que obtivemos resultados satisfatórios e insatisfatórios. Conclusões: Com o presente trabalho, reforça-se a importância da elaboração de uma legislação sanitária que determine parâmetros de qualidade para o DIU que contenha Cu e Ag em sua composição.
Introdução: O ambiente hospitalar exige atenção ao uso seguro de medicamentos devido à complexidade terapêutica e ao perfil clínico dos pacientes, sendo a farmacovigilância essencial para a detecção e prevenção de eventos adversos. A notificação espontânea é uma das principais ferramentas utilizadas, sendo operacionalizada em hospitais da rede Ebserh por meio do Vigihosp, sistema interno de registro e monitoramento de eventos adversos. Objetivo: Analisar o perfil das notificações de farmacovigilância de um hospital universitário em Alagoas, integrante da Rede Sentinela, entre 2021 e 2024. Método: Estudo retrospectivo, descritivo e quantitativo, realizado no Serviço de Farmacovigilância do Hospital Universitário Professor Alberto Antunes. Foram avaliadas variáveis como tipo e assunto da notificação, erro de administração, reação adversa e classificação Anatômica Terapêutica Química (ATC) dos medicamentos. Resultados: Foram registradas 288 notificações, sendo 213 analisadas após exclusões. As notificações foram mais frequentes em 2023 (n = 80; 37,5%) e 2024 (n = 50; 23,4%), com destaque para a equipe de farmacêuticos (n = 84; 39,4%) como principal notificador. Medicamentos das classes ATC B (n = 79; 41,3%), J (n = 22; 11,5%) e L (n = 22; 11,5%) foram os mais notificados. Queixas técnicas predominaram (n = 110; 57,6%), especialmente no grupo B (n = 67; 84,8%). As RAMs foram mais frequentes no grupo J (n = 9; 40,9%). Conclusões: Os achados evidenciam fragilidades no processo de notificação, com predomínio de eventos relacionados à qualidade de produtos. Esses resultados reforçam a necessidade de qualificar o sistema de farmacovigilância, ampliar o envolvimento multiprofissional e aprimorar a utilização dos dados para a tomada de decisão.
Introdução: A rotulagem nutricional frontal (RNF) é recomendada pela Organização Mundial da Saúde como uma estratégia para combater as doenças crônicas não transmissíveis. Seu intuito é simplificar as informações nutricionais dos produtos alimentícios, auxiliando consumidores em escolhas mais conscientes. Nesse contexto, diversos países da América Latina têm adotado sistemas de RNF diferentes. Objetivo: Apresentar o histórico da RNF no Brasil, relatar os modelos adotados na América Latina, analisar o desempenho da lupa como design de RNF e avaliar o seu potencial impacto como política pública. Método: Esta revisão seguiu cinco etapas: 1) Definição dos conceitos de RNF/perfil nutricional; 2) Análise dos sistemas de RNF na América Latina; 3) Avaliação do processo regulatório no Brasil (2014-2024); 4) Estudo do desempenho da lupa em experimentos, no qual foram utilizados termos “rotulagem nutricional frontal” e “lupa”, de forma isolada ou combinada, na busca por estudos na base PubMed; 5) Análise do potencial impacto da RNF. Resultados: O processo regulatório brasileiro iniciou-se há mais de 10 anos. Em 2020, foram promulgadas as legislações que implementaram a RNF, com o modelo de lupa e perfil nutricional próprio. A maioria dos países latino-americanos optou pelo octógono, e alguns seguiram o perfil nutricional proposto pela Organização Pan-Americana da Saúde (OPAS). Estudos indicam que a lupa apresenta bom desempenho frente ao controle (sem RNF), embora inferior ao octógono em alguns casos. Ambos os modelos de RNF mostram potencial para estimular a reformulação de produtos e contribuir para a desaceleração do crescimento da obesidade. Conclusões: A análise do processo histórico da RNF brasileira evidencia a relevância da participação multissetorial na formulação de políticas públicas. A implementação da RNF no país configura um avanço regulatório, e o modelo de lupa, embora apresente desempenho inferior ao octógono, mostra potencial para favorecer escolhas alimentares mais saudáveis. Contudo, a norma ainda demanda aprimoramentos, especialmente quanto ao ajuste do perfil nutricional adotado.
Introdução: Nos últimos anos, têm aumentado os relatos de incidentes em exames de ressonância magnética (RM), como atração de objetos ferromagnéticos e riscos biológicos, incluindo aquecimento de tecidos. Para regulamentar esses serviços, a Anvisa publicou a RDC nº 611/22 e a IN nº 97/21, que estabelecem normas de segurança e garantia da qualidade. Objetivo: Este estudo teve como objetivo mapear o parque tecnológico dos serviços de RM em Porto Alegre e caracterizar os serviços quanto ao atendimento dos requisitos sanitários vigentes. Método: Os dados de 29 instituições com equipamentos de RM foram obtidos a partir dos documentos de renovação de alvará sanitário, os quais incluem o Programa de Segurança em RM (PSRM), o Programa de Educação Permanente (PEP) e o Programa de Garantia da Qualidade (PGQ) e das respostas da Notificação Coletiva no 01/2024. Resultados: Identificaram-se 49 equipamentos em funcionamento, predominantemente em instituições privadas. Quanto às práticas de segurança, observaram-se resultados positivos na sinalização dos ambientes (86,2%) e na aplicação do questionário de segurança (79,3%). Entretanto, persistem fragilidades na descrição de riscos (55,2%) e na verificação de compatibilidade de materiais (58,6%). Das 26 instituições que responderam à Notificação Coletiva, 61,5% afirmaram utilizar o sistema Notivisa para notificação de eventos adversos. Conclusões: Conclui-se que, embora existam avanços, ainda há lacunas importantes. Reforçar os Comitês de Gerenciamento de Riscos, ampliar o uso de detectores de metais e investir em educação permanente são medidas essenciais para consolidar a cultura de segurança em RM e proteger pacientes e profissionais.
