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BACKGROUND: Emicizumab is a monoclonal antibody approved for prophylaxis against bleeds for people with hemophilia A (PwHA). A systematic review was conducted evaluating the efficacy/effectiveness and the safety of emicizumab as prophylaxis for PwHA compared to prophylaxis with factor VIII (FVIII) or bypassing agents (BPA), respectively in patients without and with inhibitors. RESEARCH DESIGN AND METHODS: Database-directed search strategies were performed in Aug/26/2022 and updated in Mar/16/2023. Studies evaluating the prophylaxis with emicizumab versus prophylaxis with FVIII or BPA in PwHA without or with inhibitors, respectively, were selected by two independent reviewers. Data were extracted by two independent reviewers. Annualized bleeding rates for total treated bleeding events (ABR-all) were evaluated by meta-analysis. The quality of studies and certainty of evidence were assessed. RESULTS: A total of 11 studies were included. The standard mean differences for ABR-all were -0.6 (95%CI -1.0 to -0.2, p-value = 0.0002), among PwHA without inhibitors, and -1.7 (95%CI -2.4 to -0.9, p-value <0.00001), among PwHA with inhibitors. However, there was moderate heterogeneity in both meta-analyses. The most frequent adverse event was injection site reaction. CONCLUSIONS: Emicizumab prophylaxis was superior in reducing the ABR-all when compared with prophylaxis with FVIII or BPA.

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Costs of hemophilia A treatment are increasing. Waste of clotting products should be avoided. To estimate the first-year waste of emicizumab prophylaxis for people with hemophilia A and inhibitors (PwHAi) who failed immune tolerance induction (ITI), in Brazil. We evaluated the manufacturer and the Brazilian Ministry of Health (MoH) protocol-recommended regimens in a budget impact model. The loading dose consisted of 3.0 mg/kg/Q1W for 4 weeks, for both recommendations. The manufacturer maintenance regimens comprised 1.5 mg/kg/Q1W, 3.0 mg/kg/Q2W, and 6.0 mg/kg/Q4W. The MoH protocol maintenance regimen encompassed a hybrid Q1W/Q2W administration, depending on the body weight. The Q4W regimen was not recommended by the MoH protocol. Analyses were performed to estimate waste given its expense based on the World Health Organization body weight range (percentiles [P] 15, 50, and 85). The first-year emicizumab waste was estimated individually and for the disclosed PwHAi who failed ITI (n = 114). The highest emicizumab waste was estimated for the lowest body weights and the Q1W regimen. The Q4W regimen resulted in the lowest emicizumab waste, followed by the MoH protocol regimen. The total reconstituted costs estimated for the PwHAi who failed ITI according to the hybrid MoH protocol ranged from US$32,858,777 (P15) to US$47,186,858 (P85), with emicizumab waste ranging from 7.9 % (US$2,594,515) to 3.7 % (US$1,738,750), respectively. Lost resources due to current protocols for emicizumab prophylaxis for PwHAi who failed ITI in Brazil are considerable. Waste was more pronounced due to lower body weight and shorter administration intervals.

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Comprehensive medication management (CMM) is the service offered within the clinical practice of pharmaceutical care, which has the objective to optimize pharmacotherapeutic outcomes. Patient satisfaction is a multidimensional construct that points to the quality of the health services offered and the degree to which the patients' expectations and needs are met. The evaluation of the level of patient satisfaction is a key indicator to support decisions and to improve the quality of the service provided. This study aims to describe the protocol for a scoping review to map the instruments to measure patient satisfaction with CMM services and compare them according to their development characteristics and the applicability of patient-reported outcome measures. The literature search will be conducted using the scoping review methodology, proposed by the Joanna Briggs Institute and the PRISMA Extension for Scoping Reviews (PRISMA-ScR) method. The results will be presented in two sessions: (1) description of the search strategy; and (2) the characteristics of the satisfaction instruments, number of items and questions related to the conceptual model, content validity, construct validity, reliability, score/interpretation, and respondent burden. This review will shed light on the available satisfaction measurement instruments, allowing existing gaps to be identified for future research.

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INTRODUCTION: Inappropriate use and increase of health care spending reinforce the need to extend our knowledge about the quality of medication use. OBJECTIVES: To describe and evaluate the profile of medication use in a representative sample of adult users of primary care services in the Unified Health System (SUS) of Minas Gerais. METHOD: Cross-sectional study, with 1,159 interviewees in 104 municipalities and 253 health care services. Data on sociodemographic characteristics, health conditions and use of medicines were collected, and these variables were stratified by age group. Univariate and multivariate analyses, using logistic regression, were conducted to identify predictors of self-medication. We set a significance level of 5% for all tests. RESULTS: The prevalence of medication use was 81.8%, with an average of 2.67 medicines per user, which increased with age. The most used drugs were losartan, hydrochlorothiazide and simvastatin, which differed between age groups. Significant self-medication was observed not only in young adults but also in the elderly. The predictors of self-medication were: being a young adult, having a higher level of education, not having chronic diseases, having worse self-perception of health and not adhering to prescription drugs. Young and elderly adults showed characteristics that made them more vulnerable in relation to the rational use of medicines. CONCLUSION: This study can contribute to improving primary care, where it identified problems related to the extent of medication use, especially among young adults and the elderly in Minas Gerais.

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RESUMO: Introdução: O uso inadequado e o crescimento dos gastos em saúde reforçam a necessidade de ampliar o conhecimento sobre a qualidade de uso de medicamentos. Objetivos: Descrever e avaliar o perfil de utilização de medicamentos em uma amostra representativa de usuários adultos da atenção primária do Sistema Único de Saúde (SUS) de Minas Gerais. Método: Estudo transversal, com 1.159 entrevistados em 104 municípios e 253 serviços de saúde. Foram coletados dados sobre características sociodemográficas, condições de saúde e uso de medicamentos, sendo essas características estratificadas por faixas etárias. Análises univariada e multivariada, por meio de regressão logística, foram conduzidas para identificar preditores de automedicação. Para todos os testes, foi adotado o nível de significância de 5%. Resultados: A prevalência de uso de medicamentos foi de 81,8%, com média de 2,67 medicamentos por usuário, que aumenta com a faixa etária. Os medicamentos mais utilizados foram losartana, hidroclorotiazida e sinvastatina, com diferenças entre as faixas etárias. Observou-se automedicação significativa não só em adultos jovens, mas também entre idosos. Os preditores de automedicação foram: ser adulto jovem, ter maior nível de escolaridade, não apresentar doenças crônicas, ter pior autopercepção de saúde e não aderir a medicamentos prescritos. Adultos jovens e idosos apresentaram características que os tornaram mais vulneráveis em relação ao uso racional de medicamentos. Conclusão: O estudo pode contribuir para melhorar o cuidado na atenção primária, pois identificou problemas relevantes relacionados à qualidade do uso de medicamentos, especialmente entre adultos jovens e idosos em Minas Gerais.

ABSTRACT: Introduction: Inappropriate use and increase of health care spending reinforce the need to extend our knowledge about the quality of medication use. Objectives: To describe and evaluate the profile of medication use in a representative sample of adult users of primary care services in the Unified Health System (SUS) of Minas Gerais. Method: Cross-sectional study, with 1,159 interviewees in 104 municipalities and 253 health care services. Data on sociodemographic characteristics, health conditions and use of medicines were collected, and these variables were stratified by age group. Univariate and multivariate analyses, using logistic regression, were conducted to identify predictors of self-medication. We set a significance level of 5% for all tests. Results: The prevalence of medication use was 81.8%, with an average of 2.67 medicines per user, which increased with age. The most used drugs were losartan, hydrochlorothiazide and simvastatin, which differed between age groups. Significant self-medication was observed not only in young adults but also in the elderly. The predictors of self-medication were: being a young adult, having a higher level of education, not having chronic diseases, having worse self-perception of health and not adhering to prescription drugs. Young and elderly adults showed characteristics that made them more vulnerable in relation to the rational use of medicines. Conclusion: This study can contribute to improving primary care, where it identified problems related to the extent of medication use, especially among young adults and the elderly in Minas Gerais.

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OBJECTIVES: To characterize the infrastructure of public pharmacies in Minas Gerais, comparing municipalities that have received the RFM program to the ones that haven't, in order to verify if the State's Economic Incentives implied in improvement of local Pharmaceutical Services (PS). METHODS: A cross-sectional, exploratory, evaluative study in a representative sample of the municipalities of Minas Gerais. Face-to-face interviews were conducted with users, physicians, and drug dispensers, as well as observation of pharmacy facilities and telephone interviews with municipal officials from the PS. 104 municipalities were selected, of which 41.3% had adopted the RFM. Data were collected from July 2014 to May 2015. RESULTS: Municipalities adept to the RFM presented significantly higher rates of legal documentation, more comfort for users and staff, better storage conditions of medicine and competence to conduct clinical activities. CONCLUSION: The higher state investment in the PS organization for municipalities adept to the RFM developed better infrastructure that have been approved by health professionals and the users of the National Health System.

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Resumo Em 2008, o estado de Minas Gerais criou o Programa Rede Farmácia de Minas (RFM), uma estratégia para garantir infraestrutura adequada das farmácias. O objetivo deste artigo é caracterizar a infraestrutura da Assistência Farmacêutica (AF) de Minas Gerais, comparando municípios contemplados ou não pela RFM, no intuito de verificar se os gastos estaduais implicaram em melhoria das AF municipais. Estudo transversal de avaliação da AF de Minas Gerais. Foram realizadas entrevistas presenciais e telefônicas com usuários, médicos, responsáveis pela AF e dispensadores de medicamentos, além de observação das instalações. Foram selecionados 104 municípios, dos quais 41,3% haviam adotado a RFM. Os dados foram coletados de julho de 2014 a maio de 2015. Municípios com RFM apresentaram taxas significativamente maiores de regularização da documentação legal, maior conforto para os usuários e funcionários, melhores condições de armazenamento de medicamento e realização de atividades clínicas. O maior volume de investimentos estadual na AF dos municípios com RFM gerou melhores condições de infraestrutura que foram avaliadas positivamente tanto por profissionais de saúde como pelos usuários do SUS.

Abstract In 2008 the state of Minas Gerais created the "Program Rede Farmácia de Minas" (RFM), a strategy to ensure adequate infrastructure of local public pharmacies, in order to improve the quality of medications use. Objectives To characterize the infrastructure of public pharmacies in Minas Gerais, comparing municipalities that have received the RFM program to the ones that haven't, in order to verify if the State's Economic Incentives implied in improvement of local Pharmaceutical Services (PS). Methods A cross-sectional, exploratory, evaluative study in a representative sample of the municipalities of Minas Gerais. Face-to-face interviews were conducted with users, physicians, and drug dispensers, as well as observation of pharmacy facilities and telephone interviews with municipal officials from the PS. 104 municipalities were selected, of which 41.3% had adopted the RFM. Data were collected from July 2014 to May 2015. Results Municipalities adept to the RFM presented significantly higher rates of legal documentation, more comfort for users and staff, better storage conditions of medicine and competence to conduct clinical activities. Conclusion The higher state investment in the PS organization for municipalities adept to the RFM developed better infrastructure that have been approved by health professionals and the users of the National Health System.

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INTRODUCTION: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by systemic joint inflammation that often leads to significant disability. Several effective anti-TNF agents have been used, but some patients have shown an inadequate response. Rituximab is a therapeutic monoclonal antibody indicated in such cases. METHODS: We conducted a systematic review to access efficacy and safety of rituximab in patients with active RA which have or have not been treated with anti-TNF agents before, and to relate outcome with RF and anti-CCP serology. We searched major electronics databases, grey literature and searched for references manually. We used Review Manager(r)5.1 for meta-analysis. RESULTS: We included six RCTs comparing rituximab 1000 mg with placebo. Methotrexate was used by both groups. Treatment with rituximab was more effective in naïve and in anti-TNF treatment failure patients - ACR20/50/70 and EULAR response. We observed lower changes in Total Genant-modified Sharp score, erosion score and joint narrowing scores in the rituximab group, and SF-36, FACIT-T and HAQ-DI scores were also better in this group. There were no differences between groups regarding safety outcomes, with exception of acute injection reactions, which were more common on rituximab group. More RF/anti-CCP seropositive patients achieved ACR20 than RF/anti-CP negative patients in rituximab group. CONCLUSION: Available data support the use of rituximab for the treatment of RA, as it is an effective and safe option for naïve and anti-TNF treatment failure patients. RF and anti-CCP seam to influence treatment results, but this inference needs further research.

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Introdução: A artrite reumatoide (AR) é uma doença autoimune crônica caracterizada por inflamação articular sistêmica que, com frequência, leva a significativa incapacitação. Vários agentes anti-TNF têm sido usados efetivamente, mas alguns pacientes demonstraram resposta inadequada. Rituximabe é um anticorpo monoclonal terapêutico indicado em tais casos. Métodos: Realizou-se uma revisão sistemática para avaliar a eficácia e a segurança de rituximabe em pacientes com AR ativa previamente tratados ou não com agentes anti-TNF e para relacionar o desfecho com a sorologia para FR e anti-CCP. Pesquisaram-se importantes bancos de dados eletrônicos e a literatura não convencional, além de se fazer uma busca manual de referências. Para a meta-análise, utilizou-se o programa Review Manager® 5.1. Resultados: Consideramos seis ERCs comparando rituximabe 1000 mg com placebo. Em ambos os grupos usou-se Metotrexato. O tratamento com rituximabe foi mais efetivo em pacientes jamais tratados e nos que não obtiveram sucesso com a terapia anti-TNF - critérios ACR 20/50/70 e EULAR. No grupo de rituximabe, observaram-se mudanças menos expressivas nos escores de Sharp/Genant, de erosão e de estreitamento do espaço articular; nesse grupo, os escores SF-36, FACIT-T e HAQ-DI também foram melhores. Não foram notadas diferenças entre grupos com relação aos desfechos de segurança, com exceção das reações agudas à infusão, que foram mais comuns no grupo de rituximabe. Ainda no grupo de rituximabe, um número maior de pacientes soropositivos para FR/anti-CCP alcançou ACR20, em comparação com pacientes negativos para RF/anti-CCP. Conclusão: Os dados disponíveis falam em favor do uso de rituximabe para o tratamento ...

Introduction: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by systemic joint inflammation that often leads to significant disability. Several effective anti-TNF agents have been used, but some patients have shown an inadequate response. Rituximab is a therapeutic monoclonal antibody indicated in such cases. Methods: We conducted a systematic review to access efficacy and safety of rituximab in patients with active RA which have or have not been treated with anti-TNF agents before, and to relate outcome with RF and anti-CCP serology. We searched major electronics databases, grey literature and searched for references manually. We used Review Manager(r)5.1 for meta-analysis. Results: We included six RCTs comparing rituximab 1000 mg with placebo. Methotrexate was used by both groups. Treatment with rituximab was more effective in naïve and in anti-TNF treatment failure patients - ACR20/50/70 and EULAR response. We observed lower changes in Total Genant-modified Sharp score, erosion score and joint narrowing scores in the rituximab group, and SF-36, FACIT-T and HAQ-DI scores were also better in this group. There were no differences between groups regarding safety outcomes, with exception of acute injection reactions, which were more common on rituximab group. More RF/anti-CCP seropositive patients achieved ACR20 than RF/anti-CP negative patients in rituximab group. Conclusion: Available data support the use of rituximab for the treatment of RA, as it is an effective and safe option for naïve and anti-TNF treatment failure patients. RF and anti-CCP seam to influence treatment results, but this inference needs further research. .

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O presente trabalho teve como objetivo determinar a prevalência e os fatores associados a interações medicamentosas potencialmente prejudiciais (IMPPs) entre idosos (60 + anos de idade) residentes na cidade de Bambuí, bem como identificar os princípios ativos mais frequentemente envolvidos nesses eventos e caracterizar essas interações quanto à gravidade. Participaram do estudo 1.132 idosos que utilizaram dois ou mais medicamentos simultaneamente. Esses participantes eram predominantemente do sexo feminino (68,6%), com idade entre 60-69 anos (54,8%),e 84,2% apresentavam pelo menos uma das doenças crônicas pesquisadas. Foram consumidos em média 4,2 medicamentos por participantes, e a prevalência do uso de cinco ou mais fármacos foi de 36,1%. A prevalência de IMPPs foi de 11,9%, das quais 13,2% foram classificadas como maiores e 66,5% moderadas...

Os medicamentos mais frequentemente envolvidos em IMPPs foram diclofenaco(10,2%) e efedrina (9,8%) e a associação mais comum foi a de teofilina + efedrina(18,2%). As classes terapêuticas com atuação sobre o aparelho cardiovascular(36,8%) e sistema músculo esquelético (27,8%) foram as mais frequentes. A ocorrência de IMPPs foi mais frequente entre os usuários de polifarmácia, entre aqueles submetidos à hospitalização e a um maior número de consultas médicas,mas somente a polifarmácia permaneceu independentemente associada ao evento(OR= 4,49; IC 95% 2,93- 6,87). Na análise multivariada, as chances de exposição ao risco de IMPPs foram menores entre aqueles que apresentavam uma ou duas das condições crônicas investigadas, em comparação àqueles livres delas. O estudo constitui uma importante contribuição para a melhoria da qualidade de prescrição,integrando os esforços despendidos para reforçar as ações de farmacovigilância,especialmente na população idosa, em que os riscos no uso de medicamentos são agravados pela própria fisiologia do envelhecimento. Além disso, vem ajudar a preencher a carência de produção científica sobre o tema em populações idosas residentes em comunidade, em um cenário distinto do serviço de saúde,especialmente o hospitalar...

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O presente trabalho teve como objetivo determinar a prevalência e os fatores associados a interações medicamentosas potencialmente prejudiciais (IMPPs) entre idosos (60 + anos de idade) residentes na cidade de Bambuí, bem como identificar os princípios ativos mais frequentemente envolvidos nesses eventos e caracterizar essas interações quanto à gravidade. Participaram do estudo 1.132 idosos que utilizaram dois ou mais medicamentos simultaneamente. Esses participantes eram predominantemente do sexo feminino (68,6%), com idade entre 60-69 anos (54,8%),e 84,2% apresentavam pelo menos uma das doenças crônicas pesquisadas. Foram consumidos em média 4,2 medicamentos por participantes, e a prevalência do uso de cinco ou mais fármacos foi de 36,1%. A prevalência de IMPPs foi de 11,9%, das quais 13,2% foram classificadas como maiores e 66,5% moderadas.

Os medicamentos mais frequentemente envolvidos em IMPPs foram diclofenaco(10,2%) e efedrina (9,8%) e a associação mais comum foi a de teofilina + efedrina(18,2%). As classes terapêuticas com atuação sobre o aparelho cardiovascular(36,8%) e sistema músculo esquelético (27,8%) foram as mais frequentes. A ocorrência de IMPPs foi mais frequente entre os usuários de polifarmácia, entre aqueles submetidos à hospitalização e a um maior número de consultas médicas,mas somente a polifarmácia permaneceu independentemente associada ao evento(OR= 4,49; IC 95% 2,93- 6,87). Na análise multivariada, as chances de exposição ao risco de IMPPs foram menores entre aqueles que apresentavam uma ou duas das condições crônicas investigadas, em comparação àqueles livres delas. O estudo constitui uma importante contribuição para a melhoria da qualidade de prescrição,integrando os esforços despendidos para reforçar as ações de farmacovigilância,especialmente na população idosa, em que os riscos no uso de medicamentos são agravados pela própria fisiologia do envelhecimento. Além disso, vem ajudar a preencher a carência de produção científica sobre o tema em populações idosas residentes em comunidade, em um cenário distinto do serviço de saúde,especialmente o hospitalar.

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Biological agents directed against tumor necrosis factor (TNF) represent therapeutic options for patients with ankylosing spondylitis with high disease activity despite use of non-steroidal anti-inflammatory drugs. To evaluate the efficacy and safety of the anti-TNF agents infliximab, etanercept, adalimumab, golimumab, and certolizumab for the treatment of ankylosing spondylitis, we performed a systematic review of randomized clinical trials on adult patients with ankylosing spondylitis using articles culled from the EMBASE, MEDLINE, Cochrane Controlled Trials Register and LILACS databases (September/2012), manual literature search, and the gray literature. Study selections and data collection were performed by two independent reviewers, with disagreements solved by a third reviewer. The following outcomes were evaluated: ASAS 20 response, disease activity, physical function, vertebral mobility, adverse events, and withdraws. The meta-analysis was performed using the Review Manager(®) 5.1 software by applying the random effects model. Eighteen studies were included in this review. No study of certolizumab was included. Patients treated with anti-TNF agents were more likely to display an ASAS 20 response after 12/14 weeks (RR 2.21; 95 % CI 1.91; 2.56) and 24 weeks (RR 2.68; 95 % CI 2.06; 3.48) compared with controls, which was also true for several other efficacy outcomes. Meta-analysis of safety outcomes and withdraws did not indicate statistically significant differences between treatment and control groups after 12 or 30 weeks. Adalimumab, infliximab, etanercept, and golimumab can effectively reduce the signs and symptoms of the axial component of ankylosing spondylitis. Safety outcomes deserve further study, especially with respect to long-term follow-ups.

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