Cost-effectiveness study of therapeutic approaches for mucosal leishmaniasis.

This study aimed to estimate the cost-effectiveness of four therapeutic approaches available for mucosal leishmaniasis in Brazil: miltefosine, meglumine antimoniate, combined with and without pentoxifylline, and liposomal amphotericin B. The perspective adopted was that of the Brazilian Unified National Health System (SUS). The outcome of interest was "cured patient", which was analyzed using a decision tree model. Estimates of direct costs and effectiveness were obtained from the scientific literature. Meglumine antimoniate alone was the base comparator strategy; liposomal amphotericin B showed an incremental cost-effectiveness ratio (ICER) of USD 7,409.13 per cured patient, and the combination of meglumine antimoniate with pentoxifylline presented an ICER of USD 85.13. Miltefosine was absolutely dominated, with higher cost and similar effectiveness when compared to meglumine antimoniate. Sensitivity analyses, varying the cost by ±25%, did not change the results. However, when the cost of miltefosine was estimated at less than USD 171.23, this strategy was dominant over meglumine antimoniate alone. The results confirm that treatment with liposomal amphotericin B remains the option with the highest ICER among the approaches analyzed. Miltefosine may be cost-effective based on the variation in the acquisition price, which deserves attention because it is the only available oral option. The non-accounting of other aspects prevent the use of these results immediately to support decision-making, but they point out the need to negotiate the prices of drugs available for mucosal leishmaniasis and indicates the need of encouraging technology transfer or other actions aimed at expanding the performance of the Brazilian national industrial complex.

Effects of respiratory muscular training in post-covid-19 patients: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Post-Covid-19 syndrome is defined as non-self-sustaining signs and/or symptoms lasting more than 12 weeks, occurring during or after a Covid-19 infection. The primary outcome was the analysis of the respiratory muscle training (RMT) result in respiratory muscle strength, (maximum inspiratory pressure (MIP) e maximum expiratory pressure (MEP)); and the secondary results were the analysis of lung function, dyspnea, quality of life (QoL), fatigue and functional performance. METHODS: The PICO description for this research was: P: patients diagnosed with post-Covid-19; I: RMT; C: Sham or simulated inspiratory or expiratory muscle training and usual care; O: MIP, MEP, Lung Function, level of dyspnea, QoL and functional performance. On January 15, 2024, the following databases were consulted: PubMed, Lilacs, Cochrane Library, PEDro and EMBASE. Randomized clinical trials were included without restrictions on year of publication or language. The data selection and extraction steps were carried out by two independent reviewers. RESULTS: The search in the databases resulted in a total of 14,216 studies, and after the eligibility process, 7 studies were included with a sample of 527 patients. The MIP results suffered a statistically significant increase, that is, the RMT was favorable to improve the MIP (MD = 29.55cmH2O IC 95%: 7.56cmH2O to 51.54cmH2O, p = 0,00001). For the MEP outcome, the results were statistically significant in favor of RMT (MD = 10.93cmH2O CI 95%: 3.65cmH2O to 18.21cmH2O, p = 0.00001). We also noticed a significant improvement for the group that received the RMT in the distance covered in the 6-Minute Walk Test (6MWT) MD = 40.70 m CI 95%: 18.23 m to 65.17 m%, p = 0.01). CONCLUSION: We noticed that RMT is being used in patients with respiratory diseases, including post-Covid-19. Our systematic review observed that this training provides an increase in inspiratory and expiratory muscle strength, a reduction in dyspnea levels, and an increase in the distance covered in the 6MWT and improved QoL in post-covid patients after intervention.

Custo Direto do Tratamento do Acidente Vascular Cerebral Isquêmico na Perspectiva de um Hospital Público Terciário (Direct Cost of Treating Ischemic Stroke From the Perspective of a Tertiary Public Hospital).

OBJECTIVES: To measure the direct cost of treating acute ischemic stroke (IS) from the perspective of a public hospital in Brazil (HCFMB) and compare it with the reimbursement by the Unified Health System (SUS), through the Procedure Table Management System, Medicines, Orthoses/Prostheses and Special Materials of the Unified Health System (SIGTAP). METHODS: We performed a micro-costing study; four scenarios were evaluated: standard (1); alteplase (2); alteplase and mechanical thrombectomy (3); mechanical thrombectomy (4). Based on the number of patients hospitalized for ischemic stroke in 2019, hospital cost, and SUS billing were calculated for each scenario. Hospital costs were adjusted for inflation using CCEMG-EPPI-Centre Cost Converter. RESULTS: In 2019, 258 patients were hospitalized due to IS, 89.5% in scenario 1, 8% in scenario 2, 1.5% in scenario 3, 1% in scenario 4. From the hospital's perspective, the cost per patient was estimated at R$7780.13, R$15 741.23, R$28 988.49, R$25 739.79, for scenarios 1, 2, 3 and 4, respectively. The reimbursement by SIGTAP was estimated at R$3079.87, R$5417.21, R$10 901.92, R$10 286.28, respectively. If thrombectomy had been included in the SIGTAP, the last two values would be R$25 393.34 and R$24 248.89. CONCLUSIONS: The hospital cost of treating acute IS in 2019 was estimated at R$2 295 209, the SUS reimbursement at R$889 391.54. With the inclusion of thrombectomy at SIGTAP, this reimbursement would be R$975 282.44, and the loss in the cost of HCFMB per patient in relation to reimbursement by the SUS is greater in scenarios without this procedure.

Treatment of Childhood Brucellosis: A Systematic Review.

BACKGROUND: Proper treatment for brucellosis is crucial to eradicate the infection and prevent complications, but there is a notable gap in evidence for pediatric treatment. This study aims to address this gap by reviewing current literature, analyzing the efficacy and safety of brucellosis treatment in children, and identifying areas that require further investigation. METHODS: A systematic review, following preferred reporting items for systematic reviews and meta-analyses and Cochrane Handbook guidelines, assessed antimicrobial regimens' efficacy and safety for treating human brucellosis in children. Original human studies with clinical outcomes after drug therapy intervention for children up to 10 years were included. Searches were conducted in Medline, Embase, Cochrane Library and LILACS databases for studies indexed until March 6, 2023. Study selection, data extraction, and bias risk assessment were performed by pairs of reviewers. The quality assessment used Joanna Briggs Institute tools and grading of recommendations assessment, development and evaluation system. Data were analyzed using R software. RESULTS: A total of 1773 records were reviewed, yielding 11 eligible studies encompassing 1156 children. All included studies presented an observational design. The most reported treatment approaches included sulfamethoxazole-trimethoprim with rifampicin or aminoglycosides, with summarized failure rates of 2% (95% confidence interval: 0.0-0.49) and 13% (95% confidence interval: 0.06-0.29), respectively (very low certainty of evidence). Adverse events and time to defervescence were not reported. CONCLUSIONS: Sulfamethoxazole-trimethoprim + rifampicin were the most prescribed antibiotics for brucellosis for pediatrics. The study highlights the need for more research with robust designs, and emphasizes uncertainty regarding the efficacy of antimicrobial regimens, emphasizing the importance of further investigations to guide specific treatment protocols for this population.

Diagnosis of human brucellosis: Systematic review and meta-analysis.

BACKGROUND: Brucellosis, a widely spread zoonotic disease, poses significant diagnostic challenges due to its non-specific symptoms and underreporting. Timely and accurate diagnosis is crucial for effective patient management and public health control. However, a comprehensive comparative review of available diagnostic tests is lacking. METHODOLOGY/PRINCIPAL FINDINGS: This systematic review addressed the following question: 'What is the accuracy of the available tests to confirm human brucellosis?' Two independent reviewers examined articles published up to January 2023. The review included original studies reporting symptomatic patients with brucellosis suspicion, through any index test, with sensitivity and/or specificity as outcomes. As exclusion criteria were considered: sample size smaller than 10 patients, studies focusing on complicated brucellosis, and those lacking essential information about index or comparator tests. Sensitivity and specificity were assessed, with consideration for the index test, and 'culture' and 'culture and standard tube agglutination test (SAT)' were used as reference standards. Bias assessment and certainty of evidence were carried out using the QUADAS-2 and GRADE tools, respectively. A total of 38 studies reporting diagnostic test performance for human brucellosis were included. However, the evidence available is limited, and significant variability was observed among studies. Regarding the reference test, culture and/or SAT are deemed more appropriate than culture alone. Rose Bengal, IgG/IgM ELISA, and PCR exhibited equally high performances, indicating superior overall diagnostic accuracy, with very low certainty of the evidence. CONCLUSIONS/SIGNIFICANCE: This systematic review underscores the potential of the Rose Bengal test, IgG/IgM ELISA, and PCR as promising diagnostic tools for brucellosis. However, the successful implementation and recommendations for their use should consider the local context and available resources. The findings highlight the pressing need for standardization, improved reporting, and ongoing advancements in test development to enhance the accuracy and accessibility of brucellosis diagnosis.

Efficacy and safety of therapeutic strategies for human brucellosis: A systematic review and network meta-analysis.

BACKGROUND: Human brucellosis is a neglected, re-emerging, and endemic zoonosis in many countries. The debilitating and disabling potential of the disease is a warning about its morbidity, generating socioeconomic impact. This review aims to update the current evidence on the efficacy and safety of therapeutic options for human brucellosis using the network meta-analysis (NMA). METHODOLOGY: A systematic search was conducted in four different databases by independent reviewers to assess overall therapy failure, adverse events, and time to defervescence associated with different therapies. Randomized clinical trials (RCTs) evaluating any therapeutic drug intervention were selected, excluding non-original studies or studies related to localized forms of the disease or with less than 10 participants. Data were analyzed by frequentist statistics through NMA by random effects model. The risk of bias and certainty of evidence was assessed, this review was registered at PROSPERO. RESULTS: Thirty-one (31) RCTs involving 4167 patients were included. Three networks of evidence were identified to evaluate the outcomes of interest. Triple therapy with doxycycline + streptomycin + hydroxychloroquine for 42 days (RR: 0.08; CI 95% 0.01-0.76) had a lower failure risk than the doxycycline + streptomycin regimen. Doxycycline + rifampicin had a higher risk of failure than doxycycline + streptomycin (RR: 1.96; CI 95% 1.27-3.01). No significant difference was observed between the regimens when analyzing the incidence of adverse events and time to defervescence. In general, most studies had a high risk of bias, and the results had a very low certainty of evidence. CONCLUSIONS: This review confirmed the superiority of drugs already indicated for treating human brucellosis, such as the combination of doxycycline and aminoglycosides. The association of hydroxychloroquine to the dual regimen was identified as a potential strategy to prevent overall therapy failure, which is subject to confirmation in future studies.

Management of pharmaceutical services in the fight against COVID-19 in universal public health systems: a rapid review.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic brought new challenges and lessons were learnt for health services. In the field of pharmaceutical care, several interventions have been proposed to optimize and expand the response capacity of services. OBJECTIVE: To identify and characterize interventions performed in the management of pharmaceutical services during the COVID-19 pandemic in universal public health systems. METHODS: A rapid literature review was conducted and registered in PROSPERO (CRD42022360902). Systematic searches in the MEDLINE (PubMed), Embase, and Virtual Health Library databases were conducted to identify interventions and practices adopted for the management of pharmaceutical care during the COVID-19 pandemic. RESULTS: Thirteen articles reporting interventions developed in six countries were included. The interventions were summarized under three major themes: actions for continuous access to medicines, logistical measures for acquisition and storage, and organizational strategies. Telepharmacy services stand out as a typical action adopted in different services, which highlights the use and consolidation of digital technologies in these services. Strategies for process management were described and focused on the reorganization of the internal service of pharmacies, flow of services, and people management. CONCLUSIONS: Many interventions were developed during the pandemic, some of which have already been incorporated into routine service delivery. Although the studies did not measure the effect of each intervention, the strategies developed are a source of information for the future delivery of care. Studies should be conducted to evaluate the potential of similar interventions in other health emergency contexts.

Implementation of health technologies in Brazil: analysis of federal guidelines for the public health system. / Implementação de tecnologias em saúde no Brasil: análise de orientações federais para o sistema público de saúde.

This study aimed to identify the regulatory framework and federal guidelines that support the process of implementing health technologies in the Unified Health System (SUS) through analysis of documents and legislation related to the National Health Technology Management Policy, published between 2009 and 2021. The search and selection of documents and subsequent data extraction were carried out. The documents were grouped into three categories: structural regulatory documents, recommendations on evaluation of technologies, and recommendations on clinical guidelines. In 38.8% of the regulatory documents, citations to implementation related mainly to SUS clinical guidelines were identified; however, no document dedicated to guiding implementation actions was identified. Recommendations related to implementations were identified in 27.1% of the reports and 66.1% of the guidelines, although without standardization and, in general, in little detail, focusing on resources and actions needed for making technology available rather than on methods and interventions for its implementation. The results evidence a gap in formal guidelines to guide the implementation process in Brazil, representing an opportunity for the development of models aligned with the reality of the SUS.

O objetivo foi identificar o arcabouço regulatório e as orientações federais que sustentam o processo de implementação de tecnologias em saúde no Sistema Único de Saúde (SUS), por meio da análise de documentos e legislações relacionados à Política Nacional de Gestão de Tecnologias de Saúde, publicados entre 2009 e 2021. Foi realizada busca e seleção dos documentos e posterior extração de dados, agrupados por três categorias: normativas estruturantes, recomendações na avaliação de tecnologias e recomendações nas diretrizes clínicas. Em 38,8% das normativas, foram identificadas citações à implementação relacionadas principalmente às diretrizes clínicas do SUS, mas nenhum documento dedicado a orientar as ações de implementação. As recomendações relacionadas às implementações foram identificadas em 27,1% dos relatórios e em 66,1% das diretrizes, mas sem padronização e, de modo geral, pouco detalhadas, com foco em recursos e ações necessárias para a disponibilização da tecnologia, ao invés de métodos e intervenções para implementação. Os resultados confirmam a existência de uma lacuna de diretrizes formais para guiar o processo de implementação no Brasil, o que se constitui em oportunidade para o desenvolvimento de modelos alinhados à realidade do SUS.

Cost-effectiveness study of therapeutic approaches for mucosal leishmaniasis / Estudo de custo-efetividade das abordagens terapêuticas para leishmaniose mucosa / Estudio de coste-efectividad de terapéuticas para la leishmaniasis mucosa

Abstract: This study aimed to estimate the cost-effectiveness of four therapeutic approaches available for mucosal leishmaniasis in Brazil: miltefosine, meglumine antimoniate, combined with and without pentoxifylline, and liposomal amphotericin B. The perspective adopted was that of the Brazilian Unified National Health System (SUS). The outcome of interest was "cured patient", which was analyzed using a decision tree model. Estimates of direct costs and effectiveness were obtained from the scientific literature. Meglumine antimoniate alone was the base comparator strategy; liposomal amphotericin B showed an incremental cost-effectiveness ratio (ICER) of USD 7,409.13 per cured patient, and the combination of meglumine antimoniate with pentoxifylline presented an ICER of USD 85.13. Miltefosine was absolutely dominated, with higher cost and similar effectiveness when compared to meglumine antimoniate. Sensitivity analyses, varying the cost by ±25%, did not change the results. However, when the cost of miltefosine was estimated at less than USD 171.23, this strategy was dominant over meglumine antimoniate alone. The results confirm that treatment with liposomal amphotericin B remains the option with the highest ICER among the approaches analyzed. Miltefosine may be cost-effective based on the variation in the acquisition price, which deserves attention because it is the only available oral option. The non-accounting of other aspects prevent the use of these results immediately to support decision-making, but they point out the need to negotiate the prices of drugs available for mucosal leishmaniasis and indicates the need of encouraging technology transfer or other actions aimed at expanding the performance of the Brazilian national industrial complex.

Resumo: O objetivo deste estudo foi estimar o custo-efetividade de quatro abordagens terapêuticas disponíveis para leishmaniose mucosa no Brasil: miltefosina, antimoniato de meglumina, com e sem associação à pentoxifilina e anfotericina B lipossomal. A perspectiva adotada foi a do Sistema Único de Saúde (SUS). O desfecho de interesse foi "paciente curado", que foi analisado por meio de um modelo de árvore de decisão. Estimativas de custos diretos e efetividade foram obtidas da literatura científica. O antimoniato de meglumina isolado foi a estratégia de comparação de base; a anfotericina B lipossomal apresentou razão de custo-efetividade incremental (RCEI) de USD 7.409,13 por paciente curado, e a combinação de antimoniato de meglumina com pentoxifilina apresentou RCEI de USD 85,13. A miltefosina foi dominada, com maior custo e efetividade semelhante quando comparada àquelas do antimoniato de meglumina. As análises de sensibilidade, variando o custo em ±25%, não alteraram os resultados. No entanto, quando o custo da miltefosina foi estimado em menos de USD 171,23, essa estratégia foi dominante sobre o antimoniato de meglumina isolado. Os resultados confirmam que o tratamento com anfotericina B lipossomal continua sendo a opção com maior RCEI entre as abordagens analisadas. Por sua vez, a miltefosina pode ser custo-efetiva com base na variação do preço de aquisição, o que merece atenção por ser a única opção oral disponível. A não consideração de outros aspectos impede o uso imediato desses resultados para subsidiar a tomada de decisão, mas apontam a necessidade de negociação dos preços dos medicamentos disponíveis para a leishmaniose mucosa e indicam a necessidade de incentivar a transferência de tecnologia ou outras ações que visem ampliar a atuação do complexo industrial nacional.

Resumen: El objetivo de este estudio fue estimar el coste-efectividad de cuatro terapéuticas disponibles para la leishmaniasis mucosa en Brasil: miltefosina, antimoniato de meglumina, asociado con y sin pentoxifilina, y anfotericina B liposomal. La perspectiva adoptada fue la del Sistema Único de Salud brasileño (SUS). El resultado de interés fue el "paciente curado", que se analizó mediante un modelo de árbol de decisión. Las estimaciones de costes directos y efectividad se obtuvieron de la literatura científica. El antimoniato de meglumina aislado fue la estrategia de comparación de referencia; el anfotericina B liposomal tuvo una razón coste-efectividad incremental (RCEI) de USD 7.409,13 por paciente curado, y la combinación de antimoniato de meglumina con pentoxifilina tuvo una RCEI de USD 85,13. Predominó la miltefosina, con un coste más elevado y una eficacia similar en comparación con la de antimoniato de meglumina. Los análisis de sensibilidad que variaron el coste en ±25% no alteraron los resultados. Sin embargo, cuando el coste de la miltefosina se estimó en menos de USD 171,23, esta estrategia resultó dominante sobre la antimoniato de meglumina aislada. Los resultados confirman que el tratamiento con anfotericina B liposomal sigue siendo la opción con el RCEI más elevado entre las terapéuticas evaluadas. A su vez, la miltefosina puede ser coste-efectiva en función de la variación del precio de compra, lo que merece atención al ser la única opción oral disponible. La falta de consideración de otros aspectos impide el uso inmediato de estos resultados para subvencionar la toma de decisiones, pero también apunta a la necesidad de negociar los precios de los fármacos disponibles para leishmaniasis mucosa y de fomentar la transferencia de tecnología u otras acciones dirigidas a ampliar el papel del sector industrial nacional.

Implementação de tecnologias em saúde no Brasil: análise de orientações federais para o sistema público de saúde / Implementation of health technologies in Brazil: analysis of federal guidelines for the public health system

Resumo O objetivo foi identificar o arcabouço regulatório e as orientações federais que sustentam o processo de implementação de tecnologias em saúde no Sistema Único de Saúde (SUS), por meio da análise de documentos e legislações relacionados à Política Nacional de Gestão de Tecnologias de Saúde, publicados entre 2009 e 2021. Foi realizada busca e seleção dos documentos e posterior extração de dados, agrupados por três categorias: normativas estruturantes, recomendações na avaliação de tecnologias e recomendações nas diretrizes clínicas. Em 38,8% das normativas, foram identificadas citações à implementação relacionadas principalmente às diretrizes clínicas do SUS, mas nenhum documento dedicado a orientar as ações de implementação. As recomendações relacionadas às implementações foram identificadas em 27,1% dos relatórios e em 66,1% das diretrizes, mas sem padronização e, de modo geral, pouco detalhadas, com foco em recursos e ações necessárias para a disponibilização da tecnologia, ao invés de métodos e intervenções para implementação. Os resultados confirmam a existência de uma lacuna de diretrizes formais para guiar o processo de implementação no Brasil, o que se constitui em oportunidade para o desenvolvimento de modelos alinhados à realidade do SUS.

Abstract This study aimed to identify the regulatory framework and federal guidelines that support the process of implementing health technologies in the Unified Health System (SUS) through analysis of documents and legislation related to the National Health Technology Management Policy, published between 2009 and 2021. The search and selection of documents and subsequent data extraction were carried out. The documents were grouped into three categories: structural regulatory documents, recommendations on evaluation of technologies, and recommendations on clinical guidelines. In 38.8% of the regulatory documents, citations to implementation related mainly to SUS clinical guidelines were identified; however, no document dedicated to guiding implementation actions was identified. Recommendations related to implementations were identified in 27.1% of the reports and 66.1% of the guidelines, although without standardization and, in general, in little detail, focusing on resources and actions needed for making technology available rather than on methods and interventions for its implementation. The results evidence a gap in formal guidelines to guide the implementation process in Brazil, representing an opportunity for the development of models aligned with the reality of the SUS.

Use of Psychotropic Drugs during the COVID-19 pandemic in Minas Gerais, Brazil.

OBJECTIVE: To describe the profile of dispensation of mental health drugs by analyzing trends in use before and during the COVID-19 pandemic within the Unified Health System (Sistema Único de Saúde [SUS]). METHODS: Pharmacoepidemiological study based on the retrospective analysis of records regarding the dispensation of psychotropic medicines in the SUS database in the state of Minas Gerais between 2018 and 2021, considering the periods before (2018-2019) and during the COVID-19 pandemic (2020-2021). A database with the records of dispensation of municipalities was created, and the consistency of releases was verified using the Analysis of Variance (ANOVA) test. Medicine consumption was measured in a defined daily dose (DDD) per 1,000 inhabitants/day for SUS, and the difference between periods was evaluated using Student's t-test. RESULTS: During the COVID-19 pandemic, there was an increase in the consumption of psychotropic drugs in SUS-MG. The most consumed medicines were fluoxetine hydrochloride, diazepam and phenobarbital sodium (DDD=5.89; 3.42; 2.49) in the Basic Pharmaceutical Services Component(CBAF), and olanzapine, risperidone and quetiapine hemifumarate (DDD=0.80; 0.47; 0.38) in the Specialized Pharmaceutical Services Component (CEAF). The highest percentage increase in consumption was attributed to clonazepam (75.37%) and lithium carbonate (35.35%), in CBAF, and levetiracetam (3,000.00%) and memantine hydrochloride (340.0%) in CEAF. CONCLUSION: The change in the psychotropic drug dispensation profile during the COVID-19 pandemic highlights the need to produce more studies to complete, confirm or rule out this profile and monitor the use of psychotropic drugs by the population in the post-pandemic context.

How to improve the dissemination of clinical practice guidelines in the Brazilian Unified Health System? Report of a pilot project.

In Brazil, there have been some initiatives to improve the development of Ministry of Health clinical protocols and therapeutic guidelines (PCDTs in Portuguese, and clinical practice guidelines-CPGs, in English) and their implementation so that best practices can be disseminated and adopted at multiple levels of health systems. One of the initiatives was to conduct a pilot project to improve the format of these CPGs. The objective of this article is to present the processes and results of the pilot project, including the development of a new standardized format for CPGs to promote national dissemination and uptake. The pilot project was designed in three phases: identification and selection of strategies to effectively implement clinical practice guidelines, definition of the ideal characteristics for the format of CPGs, and development and implementation of the new format. Initially, an overview of systematic reviews was conducted to map the global evidence on the effectiveness of dissemination and implementation strategies of CPGs. Among the most effective interventions, a low-cost strategy was selected to improve the format of CPGs, namely a full format and a short format. The two formats were evaluated for usefulness and acceptability by professionals who use or develop CPGs, and after several reiterations, the formats were finalized, considering the progression of care (from diagnosis of the disease to treatment, including specific technologies indicated in each stage of the disease). Related to the technical aspects, the visual presentation of the CPGs was improved, ensuring that key information was easily identified for decision-making by end users. The initial phase of implementation involved 33 clinical conditions, equating to approximately 20% of published CPGs. It is anticipated that disseminating the CPGs in the new formats will promote the accessibility of information and implementation of standardized CPGs by health professionals in the public health sector (servicing more than 210 million Brazilians). Further research should be considered to determine the impact of the use of the new CPGs formats, contributing to the knowledge base related to the implementation of guidelines in Brazil and internationally.

Use of Psychotropic Drugs during the COVID-19 pandemic in Minas Gerais, Brazil / Perfil de utilização de psicofármacos durante a pandemia de COVID-19 em Minas Gerais, Brasil

ABSTRACT Objective: To describe the profile of dispensation of mental health drugs by analyzing trends in use before and during the COVID-19 pandemic within the Unified Health System (Sistema Único de Saúde [SUS]). Methods: Pharmacoepidemiological study based on the retrospective analysis of records regarding the dispensation of psychotropic medicines in the SUS database in the state of Minas Gerais between 2018 and 2021, considering the periods before (2018-2019) and during the COVID-19 pandemic (2020-2021). A database with the records of dispensation of municipalities was created, and the consistency of releases was verified using the Analysis of Variance (ANOVA) test. Medicine consumption was measured in a defined daily dose (DDD) per 1,000 inhabitants/day for SUS, and the difference between periods was evaluated using Student's t-test. Results: During the COVID-19 pandemic, there was an increase in the consumption of psychotropic drugs in SUS-MG. The most consumed medicines were fluoxetine hydrochloride, diazepam and phenobarbital sodium (DDD=5.89; 3.42; 2.49) in the Basic Pharmaceutical Services Component(CBAF), and olanzapine, risperidone and quetiapine hemifumarate (DDD=0.80; 0.47; 0.38) in the Specialized Pharmaceutical Services Component (CEAF). The highest percentage increase in consumption was attributed to clonazepam (75.37%) and lithium carbonate (35.35%), in CBAF, and levetiracetam (3,000.00%) and memantine hydrochloride (340.0%) in CEAF. Conclusion: The change in the psychotropic drug dispensation profile during the COVID-19 pandemic highlights the need to produce more studies to complete, confirm or rule out this profile and monitor the use of psychotropic drugs by the population in the post-pandemic context.

RESUMO Objetivo: Descrever o perfil de dispensação de medicamentos da saúde mental analisando o uso antes e durante a pandemia de COVID-19 no âmbito do Sistema Único de Saúde (SUS). Métodos: Estudo farmacoepidemiológico a partir da análise retrospectiva dos registros de dispensação de psicofármacos na base de dados do SUS no estado de Minas Gerais (MG) nos períodos antes (2018-2019) e durante a pandemia de COVID-19 (2020-2021). Um banco de dados com os registros de dispensação dos municípios foi elaborado, sendo verificada a consistência de lançamento pelo teste de Análise de Variância (ANOVA). O consumo dos medicamentos foi mensurado em dose diária definida (DDD) por 1.000 habitantes/dia para o SUS, sendo a diferença entre os períodos avaliada pelo teste estatístico t de Student. Resultados: Durante a pandemia de COVID-19 houve aumento no consumo de psicofármacos no SUS-MG. Os medicamentos mais consumidos foram cloridrato fluoxetina, diazepam e fenobarbital sódico (DDD=5,89; 3,42; 2,49) no componente básico (CBAF), e olanzapina, risperidona e hemifumarato de quetiapina (DDD=0,80; 0,47; 0,38) no componente especializado da Assistência Farmacêutica (CEAF). Os maiores aumentos percentuais no consumo foram atribuídos ao clonazepam (75,37%) e carbonato de lítio (35,35%) no CBAF e levetiracetam (3.000,00%) e cloridrato de memantina (340,00%) no CEAF. Conclusão: A alteração do perfil de dispensação de psicotrópicos durante a pandemia de COVID-19 alerta quanto à necessidade de produção de mais estudos a fim de completar, confirmar ou afastar este perfil e monitorar o uso de psicofármacos pela população no contexto pós-pandêmico.

The cure rate after different treatments for mucosal leishmaniasis in the Americas: A systematic review.

BACKGROUND: Mucosal or mucocutaneous leishmaniasis is the most severe form of tegumentary leishmaniasis due to its destructive character and potential damage to respiratory and digestive tracts. The current treatment recommendations are based on low or very low-quality evidence, and pentavalent antimonial derivatives remain strongly recommended. The aim of this review was to update the evidence and estimate the cure rate and safety profile of the therapeutic options available for mucosal leishmaniasis (ML) in the Americas. METHODOLOGY: A systematic review was conducted in four different databases and by different reviewers, independently, to evaluate the therapeutic efficacy and toxicity associated with different treatments for ML. All original studies reporting cure rates in more than 10 patients from American regions were included, without restriction of design, language, or publication date. The risk of bias was assessed by two reviewers, using different tools according to the study design. The pooled cure rate based on the latest cure assessment reported in the original studies was calculated grouping all study arms addressing the same intervention. The protocol for this review was registered at the International Prospective Register of Systematic Reviews, PROSPERO: CRD42019130708. PRINCIPAL FINDINGS: Twenty-seven original studies from four databases fulfilled the selection criteria. A total of 1,666 patients with ML were treated predominantly with pentavalent antimonials in Brazil. Other interventions, such as pentamidine, miltefosine, imidazoles, aminosidine sulfate, deoxycholate and lipidic formulations of amphotericin B (liposomal, lipid complex, colloidal dispersion), in addition to combinations with pentoxifylline, allopurinol or sulfa were also considered. In general, at least one domain with a high risk of bias was identified in the included studies, suggesting low methodological quality. The pooled cure rate based on the latest cure assessment reported in the original studies was calculated grouping all study arms addressing the same intervention. It was confirmed that antimony is still the most used treatment for ML, with only moderate efficacy (possibly increased by combining with pentoxifylline). There is already evidence for the use of miltefosine for ML, with a cure rate similar to antimony, as observed in the only direct meta-analysis including 57 patients (OR: 1.2; 0.43-3.49, I2 = 0). It was possible to gather all descriptions available about adverse events reported during ML treatment, and the toxicity reflected the pattern informed in the manufacturers' technical information. CONCLUSIONS: This study provides an overview of the clinical experience in the Americas related to ML treatment and points out interventions and possible combinations that are eligible to be explored in future well-designed studies.

[Drug use in Psychosocial Care Centers: analysis of prescriptions and the profile of users in different modalities of the service]. / Uso de medicamentos nos Centros de Atenção Psicossocial: análise das prescrições e perfil dos usuários em diferentes modalidades do serviço.

The scope of this article was to identify the profile of users and the prescription of drugs in the Psychosocial Care Centers (CAPS) in a region of Minas Gerais, Brazil. A cross-sectional study was conducted in 11 CAPS of 5 different modalities. Sociodemographic data and information about drug use were obtained through interviews with users and analysis of prescriptions and medical records, using a semi-structured questionnaire. The mean number of drugs prescribed per user in CAPS was 3.38 (± 1.76) and the amounts were 4.08 (± 1.56), 3.54 (± 1.64) and 2.00 (± 1.66) for CAPS Alcohol and Drugs (CAPS ad), CAPS II and III and CAPS for children (CAPSi), respectively. The most prescribed therapeutic class was antipsychotics, with emphasis on haloperidol. Users in the economically active age group attended larger units (24h) or the CAPS ad modality and reported that in the past they had used drugs inappropriately and had a higher prevalence of prescriptions containing 5 drugs or more. The profile of drug use in the CAPS differed according to the modality of the service, and a greater degree of utilization was observed in the CAPS ad units. The differences revealed may subsidize discussion of the strategies for promoting the rational use of drugs.

O objetivo deste artigo foi identificar o perfil dos usuários e a prescrição de medicamentos nos Centros de Atenção Psicossocial (CAPS) em uma região de Minas Gerais, Brasil. Foi realizado um estudo transversal em 11 CAPS de 5 diferentes modalidades. Dados sociodemográficos e informações sobre o uso de medicamentos foram obtidas por meio de entrevistas com os usuários, análise de prescrições e prontuários utilizando um formulário semiestruturado. O número médio de medicamentos prescritos por usuário dos CAPS foi de 3,38 (±1,76) e os valores foram 4,08 (±1,56), 3,54 (±1,64) e 2,00 (±1,66) para as modalidades de CAPS álcool e Drogas (CAPS ad), CAPS II e III e CAPS infantil, respectivamente. A classe terapêutica mais prescrita foi de antipsicóticos. Usuários que estavam na faixa etária economicamente ativa, frequentavam serviços de maior porte (24h) ou modalidade CAPS ad e relataram que já utilizaram os medicamentos de maneira inadequada, apresentaram maior prevalência de prescrições com 5 ou mais medicamentos. O uso de medicamentos nos CAPS diferiu segundo a modalidade do serviço, tendo sido observado um maior grau de utilização nos CAPS ad. As diferenças encontradas podem subsidiar a discussão de estratégias para a promoção do uso racional de medicamentos.

Clinical practice guidelines in Brazil - developing a national programme.

In Brazil, governmental and non-governmental organisations develop practice guidelines (PGs) in order to optimise patient care. Although important improvements have been made over the past years, many of these documents still lack transparency and methodological rigour. In order to conduct a critical analysis and define future steps in PG development in Brazil, we carried out a structured assessment of strengths, weaknesses, opportunities and threats (SWOT analysis) for the development of a national guideline programme. Participants consisted of academia, methodologists, medical societies and healthcare system representatives. In summary, the PG development process has improved in Brazil and current investments in methodological research and capacity-building are ongoing. Despite the centralised processes for public PGs, standardised procedures for their development are not well established and human resources are insufficient in number and capacity to develop the amount of trustworthy documents needed. Brazil's capacity could be strengthened and initial efforts have been made such as the adoption of standards proposed by world-renowned institutions in PG development and enhancement of the involvement of key stakeholders. Further steps involve the alignment between health technology assessment and PG processes for synergy and the development of a national network to promote the interaction between groups involved in the development of PGs. The lessons learned from this paper could be used to foster debate on guideline development, especially for countries facing similar threats on this topic.

Brazilian Mental Health Services Assessment: user satisfaction and associated factors. / Avaliação de Serviços de Saúde Mental Brasileiros: satisfação dos usuários e fatores associados.

Patient satisfaction is an important criterion for assessing the quality of Brazilian mental health services at Psychosocial Care Centers (CAPS - from the Portuguese 'Centro de Atenção Psicossocial'). The aim of this study was to evaluate the satisfaction of users at the main CAPS in a region of Minas Gerais state, Brazil, as well as associated factors. This was a cross-sectional study with 11 CAPS. Patients were interviewed using the Patient Satisfaction with Mental Health Services Scale (SATIS-BR) and a semi-structured questionnaire containing sociodemographic and clinical variables. The users were satisfied with the CAPS, particularly in terms of staff competence and the welcome received and care provided. The physical facilities and comfort at the centers obtained the lowest satisfaction scores on the scale. Almost half of the users were unfamiliar with basic aspects of their drug therapy, such as the name of medicines, and one-third reported inappropriate use of medications. Users of midsize CAPS and those providing treatment for alcohol and drug addiction were more satisfied than patients at mental health or 24-hour CAPS. Although this study identified a need for improvement in physical facilities, mechanisms of participation and patient empowerment, the users were satisfied with the CAPS care model.

A satisfação dos usuários é um importante critério para avaliar a qualidade dos Centros de Atenção Psicossocial (CAPS). O objetivo foi avaliar a satisfação de usuários dos principais CAPS de uma região de Minas Gerais e seus fatores associados. Foi realizado um estudo transversal em 11 CAPS, os usuários foram entrevistados para aplicação da Escala de Avaliação da Satisfação dos Usuários com os Serviços de Saúde Mental e um formulário semi-estruturado com variáveis sociodemográficas e clínicas. Os usuários estavam satisfeitos com os CAPS, sobretudo quanto à competência dos profissionais, acolhida e ajuda recebida no serviço. Condições físicas e conforto do serviço obtiveram os menores escores na escala de avaliação de satisfação. Verificou-se que quase metade dos usuários não conhecia aspectos básicos de sua terapia medicamentosa, como o nome dos medicamentos em uso, e um terço relatou que já fez uso inadequado destes. Os usuários dos CAPS álcool e drogas ou de serviços de médio porte estavam mais satisfeitos que os dos CAPS saúde mental ou serviços com funcionamento 24h. Os usuários estão satisfeitos com o modelo de atenção praticado nos CAPS, embora detectada a necessidade de melhorias na estrutura física, mecanismos de participação e empoderamento dos usuários.

Pharmaceutical interventions in mental health: A review of the literature to support evidence-informed policymaking.

BACKGROUND: Pharmaceutical interventions may have an impact on different treatment aspects, such as therapy adherence, reducing the number of different medications in use and lowering treatment costs. OBJECTIVE: Identify pharmaceutical interventions in the mental health field and their possible application in Brazilian public mental health services, considering the evidence-based model to establish implementation options. METHODS: A structured search of the literature was performed in the Pubmed (Medline), Cochrane, PsycINFO and Lilacs databases to identify the main pharmaceutical intervention studies conducted in the mental health area. The articles selected were evaluated according to the quality of the evidence. The current laws and public database were researched to collect information on services and procedures provided by the Brazilian units, known as CAPS, and the number the pharmacists allocated to them. The proposal to synthesize the results of pharmaceutical interventions in Brazil was based on SUPPORT methodology items to prepare evidence-based policies. RESULTS: A total of 1442 studies were identified, 18 of which were included. Several interventions are reported in the literature, educational interventions being frequently cited. However, there is a need for further studies with more methodological rigor. The number of pharmacists working in the CAPS is insufficient to cover all the services, since only 26.5% of CAPS employ pharmacists, who work an average of 29 (±11.1) hours a week. Three options were formulated to implement interventions in the Brazilian context that consider including pharmacists on the basic team of CAPS professionals and educational interventions through pharmacist training. CONCLUSIONS: The present study could support the establishment of health policies, based on a synthesis of the evidence, contextualization of the current situation, given the absence of local evidence, and a discussion of the options available to implement pharmaceutical interventions in the Brazilian health system. Organizational changes in CAPS are needed to broaden pharmacist participation on the multidisciplinary team.

Avaliação de Serviços de Saúde Mental Brasileiros: satisfação dos usuários e fatores associados / Brazilian Mental Health Services Assessment: user satisfaction and associated factors

Resumo A satisfação dos usuários é um importante critério para avaliar a qualidade dos Centros de Atenção Psicossocial (CAPS). O objetivo foi avaliar a satisfação de usuários dos principais CAPS de uma região de Minas Gerais e seus fatores associados. Foi realizado um estudo transversal em 11 CAPS, os usuários foram entrevistados para aplicação da Escala de Avaliação da Satisfação dos Usuários com os Serviços de Saúde Mental e um formulário semi-estruturado com variáveis sociodemográficas e clínicas. Os usuários estavam satisfeitos com os CAPS, sobretudo quanto à competência dos profissionais, acolhida e ajuda recebida no serviço. Condições físicas e conforto do serviço obtiveram os menores escores na escala de avaliação de satisfação. Verificou-se que quase metade dos usuários não conhecia aspectos básicos de sua terapia medicamentosa, como o nome dos medicamentos em uso, e um terço relatou que já fez uso inadequado destes. Os usuários dos CAPS álcool e drogas ou de serviços de médio porte estavam mais satisfeitos que os dos CAPS saúde mental ou serviços com funcionamento 24h. Os usuários estão satisfeitos com o modelo de atenção praticado nos CAPS, embora detectada a necessidade de melhorias na estrutura física, mecanismos de participação e empoderamento dos usuários.

Abstract Patient satisfaction is an important criterion for assessing the quality of Brazilian mental health services at Psychosocial Care Centers (CAPS - from the Portuguese 'Centro de Atenção Psicossocial'). The aim of this study was to evaluate the satisfaction of users at the main CAPS in a region of Minas Gerais state, Brazil, as well as associated factors. This was a cross-sectional study with 11 CAPS. Patients were interviewed using the Patient Satisfaction with Mental Health Services Scale (SATIS-BR) and a semi-structured questionnaire containing sociodemographic and clinical variables. The users were satisfied with the CAPS, particularly in terms of staff competence and the welcome received and care provided. The physical facilities and comfort at the centers obtained the lowest satisfaction scores on the scale. Almost half of the users were unfamiliar with basic aspects of their drug therapy, such as the name of medicines, and one-third reported inappropriate use of medications. Users of midsize CAPS and those providing treatment for alcohol and drug addiction were more satisfied than patients at mental health or 24-hour CAPS. Although this study identified a need for improvement in physical facilities, mechanisms of participation and patient empowerment, the users were satisfied with the CAPS care model.

Prescrições em serviços de saúde mental: aspectos legais e indicadores do uso racional de medicamentos / Prescriptions in mental health services: legal aspects and indicators of rational drug use

OBJETIVOS: Avaliar os aspectos legais e indicadores do uso racional de medicamentos em prescrições emitidas nos serviços de saúde mental. MÉTODOS: Foram avaliadas prescrições de farmácias/unidades de dispensação dos Centros de Atenção Psicossocial eleitos como referência para o atendimento de usuários da saúde mental, localizados na região denominada Médio Paraopeba, Minas Gerais, Brasil. Foi elaborado um formulário semiestruturado para a coleta de dados, que incluiu os indicadores de prescrição da Organização Mundial da Saúde e os critérios de adequação das prescrições em relação aos requisitos exigidos pela Portaria nº 344/1998 da Secretaria de Vigilância em Saúde. RESULTADOS: Foram analisadas 390 prescrições, cujo número médio de medicamentos prescritos em cada uma foi de 2,17. Observou-se que 96,78% dos medicamentos foram prescritos pelo nome genérico e 97,13% deles estavam na lista de medicamentos essenciais dos municípios. Aspectos legais das prescrições foram atendidos para diversos critérios: 99,23% das prescrições apresentaram assinatura do prescritor, 98,97% apresentaram data e 97,69% continham informações mínimas para compreensão do usuário sobre o uso do medicamento. Em nenhum dos serviços as prescrições dispensadas apresentaram registro completo de todos os dados dos pacientes e as informações referentes aos medicamentos dispensados, conforme previsto na legislação. CONCLUSÕES: A maioria das prescrições analisadas apresentou adequação aos requisitos legais da prescrição e níveis satisfatórios nos valores dos indicadores relacionados ao uso racional de medicamentos. No entanto, informações sobre o controle e registro da dispensação dos medicamentos estavam incompletas nos serviços avaliados, apontando deficiências na identificação dos pacientes e rastreabilidade dos medicamentos dispensados.

AIMS: To evaluate the legal aspects and indicators of rational drug use in prescriptions issued by mental health services. METHODS: Prescriptions dispensed by pharmacies of reference of the Psychosocial Care Centers located in the Medio Paraopeba region, Minas Gerais, Brazil, were evaluated. A semi-structured questionnaire was developed for the collection of data, including the World Health Organization prescribing indicators and the criteria for compliance of prescriptions with the Brazilian legislation. RESULTS: A total of 390 prescriptions were analyzed, and the average number of drugs in each prescription was 2.17. It was observed that 96.78% of the drugs were prescribed by their generic names and that 97.13% were on the essential medicines list of municipalities. Legal aspects of the prescriptions were met for several criteria: 99.23% of the prescriptions had the prescriber's signature, 98.97% showed the date of issue, and 97.69% contained minimum information for the user regarding the use of the medications. None of the assessed health centers issued prescriptions with all the necessary patient data and with information about the dispensed medications, as required by law. CONCLUSIONS: The study indicated that most of the prescriptions analyzed complied with the legal requirements and that the indicators of rational medication use were satisfactory. However, information on dispensing control and records of users was incomplete, demonstrating problems with patient identification and with the traceability of dispensed medicines.