Resumo Neste trabalho, é analisada a situação dos processos judiciais contra a Secretaria de Esta

ObjectivesThe Brazilian constitution guarantees the right to health, including access to medicines. In May 2004, Brazil’s government announced the “Farmácia Popular” Program (FPP) as a new mechanism to improve the Brazilian population’s access to medicines. Under FPP, a selected list of medicines is subsidized by the government and provided in public and private pharmacies.The aim of this study is to describe the historical stages of the FPP and to identify associated changes in the geographical accessibility of medicines through the FPP over time.MethodsIt was performed documentary review and an ecological study assessing program coverage in terms of number of facilities and a FPP Pharmacy Facilities Density (PFD) index at national and regional levels from 2004 to 2013, using the FPP database. We used geographic information system mapping to depict a pharmaceutical facilities density (PFD) index at the municipality level on thematic maps.ResultsA growth of the PFD index coincident with the phases of the FPP was noticed. In the public sector, the program started in 2004; by 2006, there was a sharp increase in the numbers of participating pharmacies, stabilizing in 2009. In the private sector, the program started in 2006; by 2009 the PFD ratio had increased substantially and it continued to grow through 2011. There was an increase in FPP coverage in most regions between 2006, when the private pharmacy component started, and 2013, but participating pharmacies remain unequally distributed across geographical regions. Specifically, the wealthy areas in the South and Southeast have higher coverage, with lower coverage mostly in the North and Northeast, relatively poorer areas with greater need for access to medicines, health care, and other basic services such as potable water and sanitization.ConclusionsThere has been a substantial increase in the number of pharmacies participating in the FPP over time. This has led to greater program coverage and has potentially improved access to FPP medicines in the country. Nevertheless, disparities in pharmacy coverage remain among the regions.Electronic supplementary materialThe online version of this article (doi:10.1186/s40545-015-0030-x) contains supplementary material, which is available to authorized users.

O estudo objetivou analisar as solicitações de medicamentos por usuários individuais, de 2003 a 2006, no município de Florianópolis. Foram analisadas 2.426 autorizações para fornecimento de 5.645 medicamentos e 5.283 produtos correlatos na Secretaria de Saúde e na Secretaria da Criança, Adolescente, Idoso, Família e Desenvolvimento Social (SMDS) e na Associação Florianopolitana de Voluntários, considerando os tipos de medicamentos solicitados, valores empregados e características dos solicitantes. A Secretaria de Saúde recebeu, em comparação à SMDS e à Associação Florianopolitana de Voluntários, o maior número de solicitações em todos os anos e as autorizações de compra não apresentavam todos os dados sobre as so

RESUMOOBJETIVO: Analisar resultados do Sistema Hórus, comparando elementos desse Sistema com algumas experiências internacionais. MÉTODOS:Hórus é uma inovação tecnológica introduzida em 2009 no sistema de informações para a Assistência Farmacêutica do Sistema Único de Saúde. Em 2011, gestores locais e profi ssionais de saúde de 1.247 municípios (16 estados) que aderiram ao Hórus responderam a questionários sobre a assistência farmacêutica na atenção básica e sobre o Sistema Hórus. Estudo descritivo e exploratório, desenvolvido com emprego de método qualiquantitativo de pesquisa. Foram utilizados instrumentos multivariados de coleta de dados e suporte interpretativo da inferência estatística e da análise temática. RESULTADOS:As principais mudanças identifi cadas após a implantação desse Sistema foram: melhoria do controle técnico e científi co da qualidade da assistência farmacêutica, da dispensação dos medicamentos e da atenção à saúde; capacitação dos recursos humanos e gestão do conhecimento; melhoria da relação gestores de saúde/usuários de medicamentos; da gestão administrativa e maior gestão interfederativa; e melhoria da infraestrutura tecnológica. Em termos de sistemas de informação em saúde, essas categorias são condizentes com avanços e obstáculos observados em experiências internacionais. A maior lacuna identifi cada foi a falta de inserção do Hórus a uma política nacional de sistemas de informação em saúde, em processo de consolidação no País. A base nacional de dados das ações e serviços da Assistência Farmacêutica no Sistema Único de Saúde possibilitará coletar, analisar e disseminar informações relativas à gestão integrada da Assistência Farmacêutica no contexto da saúde no Brasil. CONCLUSÕES:O Sistema Hórus é uma inovação tecnológica viabilizadora da gestão da Assistência Farmacêutica. A base nacional possibilitará a defi nição e pactuação de indicadores nacionais de Assistência Farmacêutica, a fi m de propiciar melhores condições de saúde aos usuários e produzir evidências sobre a situação da Política Nacional de Assistência Farmacêutica e suas tendências.

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OBJECTIVES:The use of intravitreal injection of vascular endothelial growth factor inhibitors is an effective treatment for AMD and trials have showed similar clinical effects of bevacizumab and ranibizumab. The aim of this study was to estimate the budget impact for Brazilian Ministry of Health (MoH) recommending ranibizumab instead of bevacizumab for AMD. METHODS: We did a deterministic budget impact analysis, with the MoH perspective, comparing the use of ranibizumab and bevacizumab for wet AMD. The target population was estimated by extrapolating epidemiologic data to the Brazilian population. Data about dosage, administration and fractioning were extracted from literature. Prices were obtained with the Brazilian regulatory agency, applying potential discounting benefits. This analysis did not consider the cost of the fractioning process because it will be assumed by the states and not by the MoH. RESULTS: The considered price of the ranibizumab vial was US$ 962.86 (fractioning is not an option). In contrast, a 4 mL vial of bevacizumab would cost US$ 410.86 (US$ 5.14 each 0.05 mL dose, resulting in 80 doses/vial). Therefore, the expenses of one year on ranibizumab would be about US$ 11,554.37 and about US$ 61.63 for bevacizumab (12 injections for both). Thus, the use of ranibizumab instead of bevacizumab for treating 467,600 people would be related with a US$ 5,374,007,960.48 budget impact. The sensitivity analyses also demonstrated a budget impact of US$ 3,097,416,007.65 and US$ 5,287,555,101.51 (1 dose/ vial and 20 doses/vial, respectively). CONCLUSIONS: Although not a label indication, bevacizumab has been widely adopted in clinical practice. As presented above, even with inefficient fractioning methods, the use of bevacizumab would bring substantial savings to MoH resources. Even the need of preserving the sterility of the solution being a real-world worry, stability studies have showed the maintenance of the solution characteristics through adequate handling and storage.

A31 Objectives: Many initiatives (e.g., PROTECT, EFSPI) are exploring quantitative methodologies to conduct benefit/risk assessments of medicines. Objectives of this study were to combine quantitative methodologies that can capture expert knowledge and decisionmakers insights to genuinely support real-world decisions. MethOds: Using the case study of efalizumab, approved by the EMA in 2004 for the treatment of plaque psoriasis and withdrawn in 2009, a pragmatic methodology was developed that combines advanced pharmacoepidemiology and MCDA for quantitative benefit/ risk assessment. Development involved application of: MCDA principles to ensure applicability to any therapeutic area, comparability across medicines, and portability over product cycle (re-evaluation); and advanced pharmacoepidemiology and Bayesian modeling to identify/generate most useful data. Overarching design was guided by ethical implications of criteria and data selection as well as applicability in real life settings including face validity, time constraints, complexity and transparency. Results: The hierarchical multicriteria model consists of two major domains: Benefits (favourable effects, covering the criteria Clinical efficacy/effectiveness and Patient Reported outcomes); and Risks (unfavourable effects-criterion Safety). The safety criterion is subdivided into three generic subcriteria (Adverse events, Serious AEs and Fatal AEs). The benefit criteria are subdivided into specific subcriteria that correspond to the most relevant outcomes for a treatment for plaque psoriasis. All performance are assigned relative to existing alternatives or placebo. Each subcriterion contributes to the output of the model, the Benefit/Risk Estimate, which is the sum of normalized weights for each subcriterion multiplied by the respective performance score. Pharmacoepidemiology data is provided in a standardized format for each subcriterion and includes meta-analytic comparative statistics based on clinical trials, observational data and Bayesian models. Uncertainty is explored in sensitivity analyses. cOnclusiOns: Integration of pragmatic MCDA modeling with advanced pharmacoepidemiology allows quantitative benefit/risk assessment that can be applicable and meaningful in real life regulatory settings.

A65problems with cognitive functions and problems with emotional dysregulation. ADHD was seen to impact everyday activities, social interactions and emotional functioning. These impacts had implications for the achievements at school; self-esteem and indulgence in risky behavior. Variables that moderate these impacts were also identified. The interrelationships among variables will be presented. The model was used to inform a strategy to evaluate outcomes of pharmacological treatments in adolescents with ADHD. The plausibility of the model was confirmed based on discussions with clinicians and drug development experts. CONCLUSIONS: An ADHD disease conceptual model was developed based on information from literature and stakeholders interviews, to describe ADHD in adolescents. It will be used to develop a strategy for PRO development in adolescent ADHD and identify new outcomes.