Renata Cristina Rezende Macedo do Nascimento

Authors’ Reply to Dr. Malerbi: “Insulin Glargine in a Brazilian State: Should the Government Disinvest?”

Dear Editor, We thank Dr. Malerbi for his comments regarding the systematic review [1]: “Insulin Glargine in the Brazilian State: Should the Government Disinvest? An Assessment Based on a Systematic Review” [2]. In particular, we thank Dr. Malerbi for pointing out the recently published ORIGIN study [3] clarifying the situation regarding insulin glargine and its neutral effects on the development of cancer following the previous observations of Hemkens et al. and Jonasson et al. [4, 5]. This will be welcomed by patients. However, we were concerned by his comments that we “seem to have prepared their review with the primary motivation of justifying—both on administrative and juridical grounds—the denial from the government to dispense insulin analogues to those diabetic patients who need them”.

Statin use in Brazil: findings and implications

Abstract Introduction and objectives: Statins have become an integral part of treatment to reduce cardiac events in patients with cardiovascular disease. However, their use within the public healthcare system in Brazil is unknown. Consequently, we sought to determine and characterize statin use in primary healthcare delivered by the public health system (SUS) in Brazil and evaluate associated patient factors to improve future use. Methods: Cross-sectional study with a national representative sample from five Brazilian regions, derived from the National Survey on Access, Use and Promotion of Rational Use of Medicines using a multi-stage complex sampling plan. Patients over 18 years old were interviewed from July 2014 to May 2015. The prevalences of statin use and self-reported statin adherence were determined amongst medicine users. The associations between statin use and sociodemographic/health condition variables were assessed using logistic regression. Results: A total of 8803 patients were interviewed, of whom 6511 were medicine users. The prevalence of statin use was 9.4% with simvastatin (90.3%), atorvastatin (4.7%) and rosuvastatin (1.9%) being the most used statins. Poor adherence was described by 6.5% of patients. Statin use was significantly associated with age ≥65 years old, higher educational level, residence in the South, metabolic and heart diseases, alcohol consumption and polypharmacy. Conclusions: This is the first population based study in Brazil to assess statin use in SUS primary healthcare patients. Addressing inequalities in access and use of medicines including statins is an important step in achieving the full benefit of statins in Brazil, with the findings guiding future research and policies.

Evaluating statin utilisation in clinical practice in Scotland: impact of statin intensity on adherence and persistence to therapy

Background: Non-inferiority trials are associated with methodological challenges. The European Medicines Agency (EMA) does not have a guideline on designing non-inferiority trials and recommend to define the non-inferiority margin based on clinical and statistical considerations. However, they do not recommend a specific method to determine the margin. Objectives: To assess the challenges in designing non-inferiority trials for drugs intended to be marketed in Europe. Methods: Using the database of the Dutch Medicines Evaluation Board (MEB), a search in recent (2014 and 2015) final EMA scientific advice letters was conducted to identify design proposals that were sent by pharmaceutical companies to the EMA about non-inferiority trials. Each scientific letter is for one drug, and it includes proposals for different aspects of the trial with a response from the EMA to each proposal. The proportion of the accepted proposals by the EMA was assessed taking into account the therapeutic class and the type of the drug application (orphan vs other drugs) using generalized estimating equations with an exchangeable correlation matrix to account for clustering of proposals within letters. Results: The EMA accepted 142 of 232 (61%) of the total proposals. Almost 65% of the proposals were for three therapeutic classes: anti-infectives (most common), drugs for endocrine disorders (mainly anti-diabetics), and oncology drugs. The EMA acceptance did not differ between proposals for endocrine drugs vs anti-infectives (OR: 1.30, 95%CI 0.52 to 3.24) and between oncology drugs vs anti-infectives (OR: 0.54, 95%CI 0.12 to 2.47). The EMA acceptance also did not differ between orphan vs other drug applications (OR: 0.47 95%CI 0.19 to 1.14). The non-inferiority margin was the main challenge, only 25 of 61 (41%) proposals for the choice of the margin were accepted. There was no common approach proposed by pharmaceutical companies to define the margin (the recommended approach by the EMA was proposed for only 18 of 61 margins) nor a common method of the recommended approach. Conclusions: There are many questions about the design of non-inferiority trials with the choice of the inferiority margin as the main challenge. We did not find that the challenge was related to one of the three most common therapeutic classes or to a type of drug applications. This study shows that more explicit guidance from the EMA on the rationale for choosing different approaches to define the margin is needed.against myocardial infarction in UK adults aged at least 65y Background A recent investigation using routinely collected health records found the influenza vaccine to be effective against heart failure. However, treatment of overt myocardial infarction (MI) events is important in preventing progression to heart failure, especially in older adults, yet evidence for the association between respiratory disease and subsequent MI is from observational data and subject to confounding bias.Background: Cough and angioedema are well-known adverse effects of angiotensin-converting enzyme (ACE) inhibitors. Some observational studies in patients using ACE inhibitors have observed that women have a higher incidence of cough and angioedema than men. Objectives: To evaluate based on randomized controlled trials (RCTs), whether the risks of developing cough and angioedema with ACE inhibitors are modified by sex. Methods: We searched PubMed and Cochrane databases for all years to August 2016. We included RCTs that contain information about the incidence of cough and angioedema in users of ACE inhibitors and controls (active/placebo) in men and women. We performed meta-analyses using the random effects model. Pooled risk ratios (RRs) for cough and angioedema associated with ACE inhibitors in women and men were estimated and tested for interaction. Results: We included four RCTs in our analysis (three studies for cough and two studies for angioedema). We found that there was no difference in the RR to develop cough or angioedema for ACE inhibitors versus controls between women and men. For cough in women, the RR was 3.70; 95% CI (2.55-5.35) and for men, 2.61; 95% CI (1.30-5.27) (P value for interaction 0.39). For angioedema, these RRs were 5.56; 95% CI (2.45-12.62) and 6.35; 95% CI (1.81-22.36), respectively (P-value for interaction 0.86). Conclusions: Our meta-analyses show that the risks of developing cough and angioedema associated with ACE inhibitors are not modified by sex. However, these findings should be interpreted cautiously due to limited number of studies involved.

Use of medicines by patients of the primary health care of the Brazilian Unified Health System

OBJETIVO Caracterizar o perfil de utilizacao de medicamentos pelos usuarios da Atencao Primaria do Sistema Unico de Saude no Brasil. METODOS Estudo transversal, exploratorio, de natureza descritiva, integrante da Pesquisa Nacional Sobre Acesso, Utilizacao e Promocao do Uso Racional de Medicamentos – Servicos, 2015. Foram realizadas entrevistas com usuarios presentes nos servicos por meio de […]

Availability of essential medicines in primary health care of the Brazilian Unified Health System

OBJETIVO Caracterizar a disponibilidade fisica de medicamentos tracadores nos servicos de assistencia farmaceutica na atencao primaria do Sistema Unico de Saude. METODOS Estudo transversal de natureza avaliativa, integrante da Pesquisa Nacional Sobre Acesso, Utilizacao e Promocao do Uso Racional de Medicamentos – Servicos, 2015. Para a analise da disponibilidade fisica, foram verificados 50 itens selecionados […]

Financing of Pharmaceutical Services in the municipal management of the Brazilian Unified Health System

ABSTRACT OBJECTIVE To discuss factors related to the financing of the Basic Component of Pharmaceutical Services within the municipal management of the Brazilian Unified Health System. METHODS The Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil – Serviços (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services) is a cross-sectional, exploratory, and evaluative study that performed an information survey in a representative sample, stratified by Brazilian regions It considered different study populations in the sampling plan, which represent primary health care services in the cities. Data were collected in 2015 by two methods: in person, by applying direct observation scripts and interviews with users, physicians, and professionals responsible for the dispensing of medicines in primary care services; by telephone interviews with municipal health managers and municipal professionals responsible for Pharmaceutical Services. The results were extracted from the questionnaires applied by telephone. RESULTS Of the sample of 600 eligible cities, we collected 369 interviews (61.5%) with secretaries and 507 (84.5%) with pharmaceutical services managers. 70.8% of the cities have a computerized management system; and 11.9% have qualification/training of professionals. More than half (51.3%) of the cities received funds for the structuring of pharmaceutical services, and almost 60% of these cities performed this type of spending. In 35.4% of cases, municipal secretaries of health said that they use resources of medicines from the Componente Básico da Assistência Farmacêutica (CBAF – Basic Component of Pharmaceutical Services) to cover demands of other medicines, but only 9.7% believed that these funds were sufficient to cover the demands. The existence of a permanent bidding committee exclusively for acquiring medicines was reported in 40.0% of the cities. CONCLUSIONS We found serious deficiencies in the public financing of medicines, as well as little concern about the formality in the use of public resources, expenses that meet individual demands to the detriment of the community, insufficient resources allocated to the Basic Component of Pharmaceutical Services, and exhaustion of the financing model.

Avaliação da infraestrutura da Assistência Farmacêutica no Sistema Único de Saúde em Minas Gerais

Resumo Em 2008, o estado de Minas Gerais criou o Programa Rede Farmacia de Minas (RFM), uma estrategia para garantir infraestrutura adequada das farmacias. O objetivo deste artigo e caracterizar a infraestrutura da Assistencia Farmaceutica (AF) de Minas Gerais, comparando municipios contemplados ou nao pela RFM, no intuito de verificar se os gastos estaduais implicaram em melhoria das AF municipais. Estudo transversal de avaliacao da AF de Minas Gerais. Foram realizadas entrevistas presenciais e telefonicas com usuarios, medicos, responsaveis pela AF e dispensadores de medicamentos, alem de observacao das instalacoes. Foram selecionados 104 municipios, dos quais 41,3% haviam adotado a RFM. Os dados foram coletados de julho de 2014 a maio de 2015. Municipios com RFM apresentaram taxas significativamente maiores de regularizacao da documentacao legal, maior conforto para os usuarios e funcionarios, melhores condicoes de armazenamento de medicamento e realizacao de atividades clinicas. O maior volume de investimentos estadual na AF dos municipios com RFM gerou melhores condicoes de infraestrutura que foram avaliadas positivamente tanto por profissionais de saude como pelos usuarios do SUS.