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Abstract In Brazil, medicine dispensing is a pharmacy service provided within the national health system that allows the pharmacist to interact directly with the patient in order to prevent, detect and solve problems related to pharmacotherapy and health needs. However, it is known that most dispensing services provided in the country are still limited to supplying medications and, at their finest, offering advice on medication utilization. Attempts to change this scenario present new challenges the area of pharmacy, which involve the need for a patient-centered pharmaceutical service model. This paper describes the patient-centered pharmaceutical service of high-cost medicine dispensing performed at a pharmacy linked to the Brazilian Unified Health System. In the model described here, the medicine-dispensing activity is the pharmacist’s main field of practice, which consists of identifying patient needs related to health care itself and medication utilization. It also aims to introduce the instrument developed (a Pharmaceutical Care Protocol) that contributed to implementing this clinical service provided by the pharmacist. The protocols guide and qualify the service by providing information that helps in evaluating the effectiveness and safety of treatments and in the preparation of the care plan and can be used as a basis for other services that intend to adopt clinical pharmacy practices.

Introduction: The combination of Inhibitors of protease boceprevir (BOC) or telaprevir (TLV) concomitantly with peginterferon (PEG) and ribavirin (RBV) constitute the triple therapy (TT) for Hepatitis C treatment. Objective: To describe the experience of the TT treatment of chronic hepatitis C patients, besides discussing safety issues, in real life. Methods: Observational and retrospective study with 180 patients attended in a specialized center, between July 2014 and December 2015. Were evaluated variables as gender, age, access to drugs, pattern of alcohol consumption, pathway of contamination reported by the patient, previous treatment, degree of fibrosis, treatment regimen, treatment interruption and reason and Sustained Viral Response (SVR). Adverse Drug Reactions (ADRs) were collect through monthly self-report by the patient to the pharmacist. Results: 65 patients used BOC and 115 TLV, and the mean age was 54.20 (BOC) and 53.92 (TLV) years. End of treatment rate was 52.3% (BOC) and 53.3% (TLV). ADRs occurred in 18.5% of the patients (BOC) and 13.9% (TLV), being more frequent the severe anemia. Erythropoietin (EPO) used in 45.4% (BOC) and 58.2% (TLV). SVR rate calculated by intention to treat was 38.5% (BOC) e 50.4% (TLV). Conclusion: This study has shown that the effectiveness of TT is not significantly higher than double therapy and is lower than the reported in clinical trials. High dropout rates due to ADRs have been demonstrated, as well as a lower SVR found in clinical trials.

Objetivos: conhecer o perfil e compreender o contexto descrito nas publicações sobre a judicialização do acesso às tecnologias em saúde no Brasil. Metodologia: foi utilizada a metodologia de revisão sistemática de métodos mistos, estabelecida pelo Instituto Joanna Briggs (JBI), que permite sintetizar diferentes desenhos/tipos de estudo e auxilia os gestores na tomada de decisão em saúde. Foram consultadas cinco bases de dados e incluídos artigos que apresentassem dados de processos judiciais demandando tecnologias em saúde do SUS no Brasil, ou que analisassem esse fenômeno, publicados em português, inglês e espanhol, até 2019. A qualidade metodológica foi avaliada com a abordagem convergente segregada. A caracterização dos dados dos estudos e a análise e integração das evidências qualitativos-quantitativas foram realizadas por meio da síntese realista. Resultados: 27 estudos foram incluídos na revisão. Foram identificados 76.666 processos judiciais em que foi solicitada alguma tecnologia em saúde, principalmente medicamentos (65%); a maioria dos processos apresentou representação legal privada (68%) e a maioria das ações foi contra os estados (65%). As abordagens de análise de judicialização mais frequentes foram Social Positiva (32%) e Normativa Negativa (32%), seguidas de 29% para a abordagem Normativa Positiva. A abordagem Social Negativa (7%) foi a menos frequente. Conclusões: identificou-se que há evidências quantitativas que sustentam as evidências qualitativas. Estes demonstram que o desconhecimento do Judiciário sobre as políticas de saúde leva ao aumento das desigualdades em saúde; à promoção do paternalismo estatal, bem como o fato de que o aumento das ações judiciais explica a necessidade de buscar alternativas de acesso às tecnologias em saúde.

ABSTRACT OBJECTIVE To evaluate the utilization of benzodiazepines (BZD) in Brazilian older adults, based on the Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM - National Survey of Access, Use and Promotion of Rational Use of Medicines). METHODS The PNAUM is a cross-sectional study conducted between 2013 and 2014, representing the Brazilian urban population. In the present study, we included 60 years or older (n = 9,019) individuals. We calculated the prevalence of BZD utilization in the 15 days prior to survey data collection according to independent variables, using a hierarchical Poisson regression model. A semistructured interview performed empirical data collection (household interview). RESULTS The prevalence of BZD utilization in the older adults was 9.3% (95%CI: 8.3–10.4). After adjustments, BZD utilization was associated with female sex (PR = 1.88; 95%CI: 1.52–2.32), depression (PR = 5.31; 95%CI: 4.41–6, 38), multimorbidity (PR = 1.44; 95%CI: 1.20–1.73), emergency room visit or hospitalization in the last 12 months (PR = 1.42; 95%CI: 1.18–1.70 ), polypharmacy (PR = 1.26; 95%CI: 1.01–1.57) and poor or very poor self-rated health (PR = 4.16; 95%CI: 2.10–8.22). Utilization was lower in the North region (PR = 0.18; 95%CI: 0.13–0.27) and in individuals who reported abusive alcohol consumption in the last month (PR = 0.42; 95%CI: 0.19–0.94). CONCLUSION Despite contraindications, results showed a high prevalence of BZD utilization in older adults, particularly in those with depression, and wide regional and sex differences.

Introduction: Acute decompensation (AD) of cirrhosis is associated with systemic inflammation and increased circulating cytokines. The use of inflammatory markers, such as calprotectin, could provide information on the role of the immune response in the prognosis of cirrhosis. Aims: To evaluate serum calprotectin levels in patients hospitalized complications of cirrhosis. Methods: This prospective cohort study included 200 adult subjects hospitalized for complications of cirrhosis who were followed for up to 30 days after admission. Twenty healthy subjects and 20 patients with stable cirrhosis were evaluated as controls. Serum calprotectin was measured by the ELISA. Results: Serum calprotectin levels were higher among the two groups of cirrhosis patients when compared to healthy controls. Greater median values of calprotectin were observed among patients with Child-Pugh C, ACLF, infection, ascites and hepatic encephalopathy. Concentrations of calprotectin were not related to the presence of ACLF, infection or to 30-days survival. However, when considered only patients with AD without ACLF (n = 144), higher values of calprotectin and CLIF-C ADs were associated with the lower survival in the univariate and multivariate Cox analyzes. The Kaplan-Meier survival probability was 98.7% in subjects with none of the factors (CLIF-C ADs

Abstract Background The valuation of medicines as health needs vary depending on the stakeholders involved (users, prescribers, managers, etc.) and their expectations. These factors modulate the role of medicines as a health need and influence access to medicines, and could be useful to explain the rising of Judicialization of access to medicines. Aim To conduct a comparative analysis of the causes and consequences of judicialization of access to medicines in Argentina, Brazil, Colombia and Chile from the perspective of medicines as health needs. Methods A qualitative, cross-country study was carried out in these 4 countries. Semi-structured interviews were conducted with 50 representatives of the different stakeholders involved in the judicialization of access to medicines, including Executive branch, Judiciary, health system managers, patient organizations. The interviews were audio-recorded and transcribed verbatim. Thematic analysis used a framework approach based on the theoretical model for medicines as health needs. Findings Representatives from Argentina, Brazil and Colombia considered judicialization of access to medicines as a widespread phenomenon in their respective countries. Meanwhile in Chile, the respondents highlighted that most lawsuits related to the right to health were filed against private insurers because of unjustified increases in the insurance premiums. The comparative analysis showed that judicialization of access to medicines emerged in the four countries regardless of the constitutional protection or the health system population coverage. Among the causes were mentioned difficulties in guaranteeing access to covered medicines and the influence of pharmaceutical marketing on needs assessment and prescription behaviours. The interviewees highlighted the pressure to health system managers to fulfil their responsibilities as a positive impact of litigation. In contrast, the funding of medicines without evidence of efficacy or safety was considered a negative impact. Only in Brazil, judicialization has had impact on R&D policies. In Colombia, litigation also encouraged the recognition of the right to health as a fundamental right and the development of policies for controlling medicines prices. Conclusion The results suggest that applying the adopted theoretical model creates the possibility of identifying critical points to guide policy makers to improve the health systems performances and to control lawsuits for access to medicines.

Introduction: To train pharmacists working in the public health system, the Brazilian Ministry of Health developed a specialization course called Pharmaceutical Service and Access to Medicine Management (PSAMM) between 2010 and 2016. The course was free of charge and used e-learning as its main approach. In the end, 2,500 pharmacists were trained. The purpose of this study was to identify and analyze the strengths, weaknesses, opportunities, and threats of an in-service and e-learning course for pharmacists working in a public health system.Materials and Methods: Three workshops involving 67 participants were conducted at the conclusion of the course to analyze the perspective of the PSAMM course's faculty (tutors, regional coordinators, professors, and management committee) and students (pharmacists). Strengths, weaknesses, opportunities, and threats analysis and qualitative analysis methods were used.Results and Discussion: The strength dimension had the greatest number of items. The qualitative analysis resulted in six categories: the category “E-learning in continuing education” had the most cited items. Internal elements such as in-service hands-on activities directly related to the professionals' roles, course contents, faculty, and the methods to offer the course (the mixed methods and materials) were positively assessed. Nonetheless, external elements were considered critical for the course's outcomes such as investments in the infrastructure of pharmaceutical services, access to the internet, local managers' support for continuing education and innovation implementation, practice of interprofessional collaboration, and political stability. The continuing education course in the public health system was affected by internal elements such as its project and structure as well as external elements such as the sociopolitical scenario. Continuing education investment must be accompanied by infrastructure investment and coordination of services.

Resumo: O objetivo foi estimar a prevalência do uso de adoçantes pela população adulta brasileira e características dos usuários. Análise de dados da Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM, 2014), um inquérito nacional de base populacional. O desfecho de interesse foi o uso autorreferido de adoçantes entre brasileiros com 20 anos ou mais. As variáveis analisadas foram sexo, idade em anos completos, região do Brasil, escolaridade em anos completos e classificação econômica segundo o Critério Classificação Econômica Brasil da Associação Brasileira de Empresas de Pesquisa (ABEP). Os indicadores das condições de saúde foram: relato de doença crônica não transmissíveis (DCNT), número de DCNT e índice de massa corporal (IMC). A prevalência do uso de adoçantes na população adulta brasileira foi de 13,4% (IC95%: 12,5-14,3), sendo maior entre as pessoas do sexo feminino e no grupo com 60 anos ou mais, nas regiões Nordeste e Sudeste, entre pessoas da classe econômica A/B e entre indivíduos obesos. As pessoas com doenças crônicas (em especial diabetes) foram as que mostraram maior prevalência de uso de adoçantes, sendo o uso maior quanto maior o número de comorbidades relatadas. A prevalência de uso de adoçantes foi de 13,4% e mostrou-se associada a características sociodemográficas e de saúde.

ABSTRACT: Introduction: The written information on medicines has been acknowledged as an important tool for health education. Objective: To analyze the use and understanding of medicine package inserts by users and assess sociodemographic and medical factors associated with their comprehension. Method: Data in this analysis are part of the PNAUM National Survey - a cross-sectional population-based study conducted in Brazil. Descriptive statistics and the Pearson χ2 tests were performed to compare proportions between sociodemographic and medical characteristics, as well as use and understanding of medicine package inserts. Results: A total of 28.427 individuals responded to questions related to medicine package inserts. From these, 59.6% (95%CI 57.7 - 61.5) said they usually read the inserts, and 98.4% (95%CI 98.0 - 98.8) considered them necessary. Among people who read the medicine package inserts, more than half indicated difficulties with legibility (57.4%; 95%CI 55,2 - 59,6) and readability (54.1%; 95%CI 52.1 - 56.1). People from a lower education level reported greater difficulty in understanding them. Conclusion: The larger portion of the population usually read medicine package inserts. Nevertheless, people have difficulty in reading and understanding them.

Management and public health are important domains of competency for pharmacists. In about 90% of Brazilian health departments, pharmacists manage the selection and purchase of medicines. The Pharmaceutical Services and Access to Medicines Management Course (PSAMM) was offered to pharmacists working in the public health system. The aim of this study is to analyze the impacts of the course as perceived by the students (pharmacists). Two thousand five hundred pharmacists completed the course. It is a mixed-methods study, including subscribing forms (n = 2500), evaluation questionnaire (n = 1500), focus groups (n = 10), and semi-structured interviews (n = 31). Participants reported a high level of satisfaction with the course; they considered to have developed competencies related to leadership and management, competencies needed to enhance and sustain their practices in health services. Data analyses showed important barriers to complete the course: high course workload, poor quality of Internet access, lack of support from the health services. Participants highlighted crucial features of the course that helped them develop key competencies: practical in-service activities, useful and realistic contents, tutoring. These features helped participants overcome some important constraints described by them. The educational model described in this study was perceived as having a long-term impact on their behaviors and management practices in health services.

Objetivo: Explorar las percepciones sobre el acceso a los medicamentos del Componente Especializado de la Asistencia Farmacéutica (CEAF) del Sistema Único de Salud brasileño (que incluye los medicamentos de alto costo), por parte de los actores involucrados en el ámbito asistencial del CEAF. Métodos: Estudio cualitativo descriptivo. Para la recolección de los datos se realizaron un grupo focal con siete usuarios/as y 11 entrevistas semiestructuradas a profesionales de la salud (medicina y farmacia) del estado de Santa Catarina. Resultados: Según los/las participantes, el acceso a medicamentos del CEAF ha mejorado. Se encontraron también dos percepciones sobre los Protocolos Clínicos y Directrices de Tratamiento del CEAF: las exigencias son burocracia que limita el acceso y los requisitos aumentan la demanda de exámenes y especialistas, superando la capacidad de la red de servicios de salud. A partir de estas percepciones se generan vías alternativas de acceso que evidencian una concepción frágil del derecho a la salud, desinformación y dependencia por parte de los usuarios, las cuales pueden tener consecuencias en la salud de las personas y en el sistema de salud. Según los/las participantes, debido a las dificultades en el acceso de los servicios de salud en general, el pleno acceso a los medicamentos aún es un objetivo por alcanzar. Conclusión: De acuerdo con las percepciones encontradas, aunque el acceso a los medicamentos del CEAF ha mejorado, persisten dificultades para garantizar su oportunidad y su integralidad.

O Componente Especializado da Assistência Farmacêutica (CEAF) tem como objetivo a garantia da integralidade do tratamento medicamentoso em nível ambulatorial. Dada sua recente implementação, é necessário analisar se os estados possuem condições de executar as ações, atingir e sustentar os resultados esperados. Com este objetivo, é necessária uma avaliação da capacidade de gestão do CEAF no âmbito estadual. Uma das fases da avaliação é o desenvolvimento de um modelo teórico e um modelo lógico, apresentados neste artigo. Com os modelos apresentados, fica clara a complexidade e os diversos fatores que influenciam a capacidade de gestão do CEAF. Observou-se que há forte dependência do CEAF em relação à outras ações estruturantes na própria política de saúde, nas políticas econômicas, em relação à indústria farmacêutica, entre outros. Somado a isso, os conceitos de gestão e de capacidade de gestão adotados refletem a necessidade de superar a fragmentação e a redução tecnicista imposta à área. Por fim, a construção dos modelos de forma contextualizada auxilia de forma singular no processo de avaliação e auxiliará na análise das condições de estruturação do Componente nos estados, assim como das condições para execução e o alcance dos resultados. Palavras-chaves: Avaliação em Saúde; Gestão em Saúde; Modelos Lógicos; Assistência Farmacêutica; Componente Especializado da Assistência Farmacêutica.

ABSTRACT In 2012, the first-generation protease inhibitors telaprevir (TVR) and boceprevir (BOC) were introduced in the Brazilian health system for treatment of chronic hepatitis C, after their approval by the National Committee for Health Technology Incorporation (CONITEC). However, these medicines were discontinued in 2015. The short period of use in therapy and their high cost require a discussion about the consequences for patients and for the health system of the early incorporation of new therapies. The article presents a qualitative analysis of the incorporation process of both medications in Brazil and the results of a multicenter study that included patients treated with BOC or TVR between January 2011 and December 2015 in five Brazilian cities. The study included 855 patients (BOC: n=247) and (TVR: n=608). The document analysis showed that CONITEC’s decision to incorporate BOC and TVR was based on results of phase III clinical trials that compared sustained virologic response (SVR) rates of patients treated with BOC and TVR with rates of those that received placebo. However, these studies included a low percentage of cirrhotic patients. The SVR rates observed in this multicenter study were worse than clinical trials pointed out (BOC: 45.6%; TVR: 51.8%), but similar to those achieved with previously adopted therapies. The discontinuation rate due to adverse events was (BOC: 15.4%; TVR: 12.7%). Based on these unsatisfactory results, the study brings a discussion that goes beyond the therapy outcomes, exploring the incorporation of these high-cost medicines and the related decision-making process, contributing to future decisions in medicine policies and in the treatment of chronic hepatitis C.

Introduction: Parkinson’s disease is a neurodegenerative disorder manifested by motor and non-motor symptoms that compromise patients’ quality of life. The instrument used to assess Parkinson’s disease patients’ quality of life is the Parkinson’s Disease Questionnaire (pdq-39). This study aims to identify issues related to quality of life from the patients’ perspective, compare the results obtained with the aspects included in the pdq-39, and describe some strategies that patients have adopted to overcome difficulties. Materials and methods: This is a qualitative and descriptive study based on a focus group consisting of six patients. Data were analyzed using the content analysis method. Results: Aspects related to all pdq-39 domains were mentioned by the patients, highlighting those related to limitations on their mobility and daily activities, as well as aspects related to their emotional wellbeing. The patients did not mention some aspects of mobility that are included in the pdq-39, but limitations in the domain of emotional well-being that are included in the pdq-39 were detected. In order to overcome difficulties, patients devise various strategies that require social support. Conclusion: Understanding and reflecting on Parkinson’s disease patients’ perceptions of their quality of life contributes to our understanding of the disease and stimulates proposals for adequate clinical interventions to provide comprehensive care. It is suggested that the pdq-39 be reviewed and adapted to the current context, taking into account the most recent knowledge and technological advances related to Parkinson’s disease.

Resumo: O presente trabalho tem como objetivo descrever a prevalência e fatores associados a eventos adversos a medicamentos (EAM) referidos por usuários de medicamentos no Brasil. Trata-se de um estudo transversal de base populacional, realizado no período de setembro de 2013 a fevereiro de 2014, com dados coletados na Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM). Foram consideradas todas as pessoas que referiram o uso de medicamentos; entre elas, foram identificadas as que referiram pelo menos um problema com o uso do medicamento. Realizou-se uma análise descritiva para estimar a prevalência e os intervalos de 95% de confiança (IC95%) de EAM entre as variáveis estudadas, e foram calculadas as razões de prevalência bruta e ajustada, pela regressão de Poisson, na investigação dos fatores associados aos EAM. A prevalência de EAM no Brasil foi de 6,6% (IC95%: 5,89-7,41), sendo maior e estatisticamente significante após a realização da análise multivariada, entre pessoas do sexo feminino; residentes nas regiões Centro-oeste e Nordeste; que consumiam maior número de medicamentos; que percebiam seu estado de saúde como “ruim”; e que se automedicavam. Os EAM foram mais relatados para os medicamentos fluoxetina, diclofenaco e amitriptilina. Os EAM mais referidos pelos entrevistados foram sonolência, dor epigástrica e náuseas. Os EAM mais referidos pelos entrevistados foram de natureza leve, considerados evitáveis e estiveram associados a medicamentos de uso frequente pela população. Em razão desse estudo, foi possível conhecer a dimensão do problema ocasionado pelo uso de medicamentos no Brasil.

A gestão da assistência farmacêutica enfrenta desafios para sua construção como uma área ligada ao sistema de saúde brasileiro, que garanta acesso e uso racional dos medicamentos, tendo o usuário como centro das atividades. Entendendo gestão com um processo técnico, político e social capaz de produzir resultados, sendo pautado, também, em princípios orientadores do Sistema Único de Saúde (SUS): descentralização, flexibilidade, transparência, participação e autonomia decisória, o objetivo desse trabalho é avaliar a gestão da assistência farmacêutica em um município catarinense, sob as dimensões organizacional, operacional e da sustentabilidade. Para a avaliação a matriz utilizada tem 44 indicadores, divididos nas três dimensões, possibilitou um levantamento das fragilidades e potencialidades do município, sendo emitido juízo de valor, fator que influência tanto na tomada de decisão, quanto no avanço da gestão. Os resultados da avaliação proposta geram subsídios para a melhoria da gestão da assistência farmacêutica, já que os profissionais que atuam na área, ao se apropriarem desses resultados, terão mais instrumentos e argumentos para a negociação com os gestores, visando o desenvolvimento da área.

ABSTRACT OBJECTIVE To characterize the infrastructure of the primary health care pharmacies of the Brazilian Unified Health System, aiming at humanizing the offered services. METHODS This is a cross-sectional study, of quantitative approach, from data obtained in the Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services, 2015). Information on 1,175 pharmacies/dispensing units were gathered from direct observation and assessment of dispensing units installations conducted by trained researchers who used a standardized form. The analyzed variables refer to the physical structure of pharmacies or medicine dispensing units of the health units under research. RESULTS The pharmacy area was greater than 14 m2 in 40.3% of the sampled units, highlighting those from Midwest (56.9%) and Southeast (56.2%) regions and those of Northeast, with only 23.3%. About 80.2% units had waiting rooms with chairs for patients, 31.8% of them had dispensing areas inferior to 5m2, while in 46.2% these areas were superior to 10m2. Bars were found in service counters in 23.8% of health units, thus separating the patient from the professional; 44.1% had internet access. In most units, the area of medicine storage had no refrigerator or freezer for their exclusive storage and 13.7% had a specific room for pharmaceutical consultation. CONCLUSION Aiming at achieving care humanization and improving working conditions for professionals, the structuring of the environment of pharmacy services is necessary. This would contribute to the better qualification of pharmacy services, comprising more than medicine delivery. Data on the Northeast region indicated less favorable conditions to the development of adequate dispensing services. Based on the panorama pointed out, we suggest the expansion of stimulus concerning the physical structure of pharmaceutical services, considering regional specificities.

The objective of this study was to investigate the scientific output on health promotion within the pharmaceutical field and its relation with the development of pharmaceutical services within health systems. A comprehensive review of published scientific articles from the Medline and Lilacs databases was carried out. The review comprised articles published until December 2011, and used combinations of the terms 'health promotion' or 'health education' and 'pharmacy', 'pharmacist' or 'pharmaceutical'. The articles were selected according to inclusion and exclusion criteria. A total of 170 full texts and 87 indexed abstracts were analyzed, evidencing that most described actions of health promotion in community pharmacies and other services. Following the Ottawa Charter, most of the studies dealt with new guidance of the service and the supply of pharmaceutical information and services. It was concluded that there is a lack of theoretical background on health promotion in the pharmaceutical field to sustain the professional education and practice required by the health system and the population.

Brazilian Guidelines to HCV treatment (2007) recommended that the first choice treatment for patients with chronic hepatitis C (CHC) and genotype 2 or 3 is interferon alpha (IFN) plus ribavirin (RBV) for 24 weeks. The aim of this study is compare the cost and effectiveness to Hepatitis C treatment in patients with genotype 2 or 3 of peginterferon alpha (PEG) as the first choice of treatment within PEG for those that do not respond to IFN. The target population is CHC patients with genotype 2 or 3 in Brazil. The interventions are: PEG-SEC (first IFN plus RBV for 24 weeks, after, for non-responders and relapsers subsequently PEG plus RBV for 48 weeks); PEG-FIRST24 (PEG+RBV for 24 weeks). The type of the study is cost-effectiveness analysis. The data sources are: Effectiveness data from meta-analysis conducted on the Brazilian population. Treatment cost from Brazilian micro costing study is converted into USD (2010). The perspective is the Public Health System. The outcome measurements are Sustained Viral Response (SVR) and costs. PEG-FIRST24 (SVR: 87.8%, costs: USD 8,338.27) was more effective and more costly than PEG-SEC (SVR: 79.2%, costs: USD 5,852.99). The sensitivity analyses are: When SVR rates with IFN was less than 30% PEG-FIRST is dominant. On the other hand, when SVR with IFN was more then 75% PEG-SEC is dominant (SVR=88.2% and costs USD $ 3,753.00). PEG-SEC is also dominant when SVR to PEG24 weeks was less than 54%. In the Brazilian context, PEG-FIRST is more effective and more expensive than PEG-SEC. PEG-SEC could be dominant when rates of IFN therapy are higher than 75% or rates of PEG24 therapy are lower than 54%.

Access to medication emphasizes the availability of the product at the expense of providing a service. The goal of this paper is to propose a theoretical model for a drug dispensing service, beginning with a reflection on the current realities of the Unified Health System and drug dispensation in Brazil. A conceptual analytical research made by a methodological course called disciplined imagination was mainly the approach applied to develop the model. The drug dispensing service is part of the care process, which considers access as an attribute; reception, connection and accountability, management, and clinical pharmaceutical aspects as components; and the rational use of drugs as the purpose. The proposed model addresses access to the dispensing service and demands a reorientation of routines, instruments, and practices.O acesso a medicamentos enfatiza a disponibilidade do produto em detrimento da provisão de um serviço. O objetivo deste trabalho é propor um modelo teórico para um serviço de dispensação de medicamentos, iniciando com uma reflexão sobre a realidade atual do Sistema Único de Saúde e a dispensação de medicamentos no Brasil. Uma pesquisa analítica conceitual realizada por meio de um percurso metodológico chamado de imaginação disciplinada constituiu a estratégia principal para o desenvolvimento do modelo. O serviço de dispensação é parte do processo de cuidado, o qual considera o acesso como um atributo; os aspectos acolhimento, vínculo e responsabilização, gestão e clínica farmacêutica como componentes e o uso racional de medicamentos como o propósito. O modelo proposto direciona o acesso para o serviço de dispensação e demanda a reorientação de rotinas, instrumentos e práticas.

This study aimed to evaluate the rate of sustained virological response (SVR) and the clinical and treatment characteristics of patients with chronic hepatitis C (CHC). A retrospective uncontrolled cohort study was conducted among patients who received treatment for CHC between 2005 and 2008 attended at the Center for the Application and Monitoring of Injectable Medications, in Florianopolis, SC, Brazil. The inclusion criteria were: patients over 18 years of age, with a confirmed diagnosis of chronic hepatitis C according to Brazilian guidelines, treated with PEG-IFN alfa-2a or 2b associated with RBV. A total of 188 patients were included in the study: 70% men, 59% genotype 1, 27% coinfected with HIV, 31% with cirrhosis. The SVR rate, calculated by probability theory, was determined as 26% (max=57.4% and min=12.8%) and the intention to treat was 12.8%. Associations between Sustained Virological Response (SVR) and the variables sex (p=0.017), age (p=0.003), genotype (p=0.648) and cirrhosis (p=0.275), were determined in the bivariate analysis and only sex and age were significantly associated with SVR. The SVR rate was considered low, which can be partially explained by patients' unfavorable pretreatment characteristics.O objetivo do estudo foi avaliar a taxa de resposta viral sustentada (RVS) e as características clínicas e do tratamento dos pacientes portadores de hepatite C crônica. Realizou-se uma coorte retrospectiva não controlada com recorte temporal dos anos de 2005 a 2008, dos pacientes atendidos no Polo de Aplicação e Monitoramento de Medicamentos Injetáveis, em Florianópolis, SC. Os critérios de inclusão foram: pacientes maiores de 18 anos, com diagnóstico confirmado de hepatite C crônica de acordo com o protocolo brasileiro, tratados com PEG-IFN alfa-2a ou 2b associado a ribavirina. Total de 188 pacientes foi incluído no estudo, 70% homens, 59% genótipo 1, 27% co-infectados com o HIV e 31% apresentando cirrose. A taxa de RVS calculada através da teoria das probabilidades foi de 26% (max=57,4% and min=12,8%) e por intenção de tratamento de 12,8%. Verificou-se a associação da RVS com as variáveis: sexo (p=0,017), idade (p=0,003), genótipo (p=0,648) e presença de cirrose (p=0,275). Somente sexo e idade foram associados significativamente com a RVS. A taxa de RVS foi considerada baixa e, em parte, pode ser explicada pelas características desfavoráveis dos pacientes para a obtenção de RVS.

OBJETIVO: Analisar o impacto financeiro da aquisição de medicamentos com a exigência da apresentação de testes de biodisponibilidade e/ou bioequivalência para o componente da Assistência Farmacêutica Básica. MÉTODOS: Estudo retrospectivo, documental, em atas dos processos licitatórios para aquisição de medicamentos em município de médio porte de Santa Catarina. Foram analisadas licitações sem (2007) e com (2008) a exigência de testes de bioequivalência e/ou de biodisponibilidade. Avaliaram-se o número de recursos apresentados pelos fornecedores, o número de processos licitatórios anuais necessários para a aquisição de todos os medicamentos padronizados, o tempo para a finalização do processo licitatório, o número de itens fracassados, o custo unitário dos medicamentos e o valor total da aquisição. RESULTADOS: Foram observados 2,6% de itens fracassados em 2007 e 56,9% em 2008. Entre os medicamentos, 60,0% tiveram acréscimo e 29,3,0% decréscimo em 2008 em relação a 2007. Os custos totais de aquisição para 150 medicamentos, considerando valores unitários praticados e o consumo médio anual, foram de R$ 2.288.120,00 para 2007 e de R$ 4.270.425,00 para 2008. CONCLUSÕES: A exigência dos testes de bioequivalência e/ou de biodisponibilidade elevou em mais de 100% os custos com o financiamento do Componente da Assistência Farmacêutica Básica, indicando necessidade de discussão de uma Política de Medicamento Genérico em consonância com a Política de Assistência Farmacêutica e com a Relação Nacional de Medicamentos Essenciais.OBJETIVO: Analizar el impacto financiero de la adquisición de medicamentos con la exigencia de la presentación de pruebas de biodisponibilidad y o bioequivalencia para el componente de la Asistencia Farmacéutica Básica. MÉTODOS: Estudio retrospectivo, documental, en actas de los procesos licitatorios para adquisición de medicamentos en municipio de medio porte de Santa Catarina, Sur de Brasil. Se analizaron licitaciones sin (2007) y con la exigencia de pruebas de bioequivalencia y/o biodisponibilidad (2008). Se evaluaron el número de recursos presentados por los proveedores, el número de procesos licitatorios anuales necesarios para la adquisición de todos los medicamentos estandarizados, el tiempo para la finalización del proceso licitatorio, el número de ítems fracasados, el costo unitario de los medicamentos y el valor total de la adquisición. RESULTADOS: Se observaron 2,6% de ítems fracasados en 2007 y 56,9% en 2008. Entre los medicamentos, 60,0% tuvieron incremento y 29,3%, disminución en 2008 con relación a 2007. Los costos totales de adquisición para 150 medicamentos, considerando valores unitarios practicados y el consumo promedio anual, fueron de R$ 2.288.120,00 para 2007 y de R$ 4.270.425,00 para 2008. CONCLUSIONES: La exigencia de las pruebas de bioequivalencia y/o biodisponibilidad elevó en más de 100% los costos con el financiamiento de la Asistencia Farmacéutica Básica, indicando necesidad de discusión de una Política de Medicamento Genérico en consonancia con la Política de Asistencia Farmacéutica y con la Relación Nacional de Medicamentos Esenciales.OBJECTIVE: To analyze the financial impact of medicine procurement with the required bioavailability and or bioequivalence tests for the basic pharmaceutical services component. METHODS: A retrospective study, based on document research of competitive bidding for medicine procurement in a medium size municipality of Santa Catarina state, Southern Brazil. Bids that occurred with (2007) and without (2008) the requirement of bioequivalence and/or bioavailability tests were analyzed. The number of resources presented by providers, the number of annual bidding processes necessary to acquire all the standard medicines, the time to finalize the bidding process, the number of failing items, the per unit cost of medicines and the total value of procurement were evaluated. RESULTS: In 2007 and 2008 respectively, 2.6% and 56.9% of items failed. Among medicine purchases, 60.0% were increased and 29.3% decreased from 2008 to 2007.The total procurement costs for 150 medicines, considering per unit costs and average annual consumption was R$ 2,288,120.00 (2007) and R$ 4,270,425.00 (2008). CONCLUSIONS: The requirement for bioequivalence and/or bioavailability tests increased costs by more than 100% for the basic pharmaceutical services component. There is a need to discuss Generic Medicine Policies to agree with Pharmaceutical Assistance Policies and the National Essential Medicines Report.

INTRODUÇÃO: O termo polifarmácia, ou seja, a utilização concomitante de múltiplos fármacos pelo mesmo indivíduo vem sendo amplamente associado a pacientes institucionalizados e idosos, no entanto pode ocorrer em grupos de pacientes portadores de doenças crônicas como artrite reumatoide (AR). OBJETIVO: Quantificar a polifarmácia em um grupo de pacientes com AR e realizar um levantamento sobre o risco de potenciais interações indesejáveis entre os medicamentos utilizados no manejo dessa doença e os fármacos utilizados em enfermidades não crônicas. MÉTODOS: Realizou-se um estudo de coorte com 103 pacientes portadores de AR, atendidos no Componente Especializado da Assistência Farmacêutica/MS, Florianópolis/SC. Os pacientes foram acompanhados mensalmente, por meio de fichas. As interações medicamentosas foram identificadas pelo Drugdex System - Thomson Micromedex® - Interactions. RESULTADOS: Observou-se a presença de polifarmácia em 95,1% dos pacientes e de 19 potenciais interações indesejáveis entre os medicamentos utilizados por 74 pacientes, em média 3,0 ± 1,2 interações/paciente. Todas as potenciais interações estavam relacionadas a metotrexato. Omeprazol foi o principal representante, correspondendo a 29,3% delas, seguido por diclofenaco sódico (17,6%) e dipirona sódica (13,2%). CONCLUSÃO: Considerando que este estudo confirma que a polifarmácia é uma prática comum na terapêutica dos pacientes portadores de AR, deve haver maior vigilância acerca de efeitos adversos ou de redução da efetividade de determinados fármacos devido às suas interações farmacológicasINTRODUCTION: The term polypharmacy, meaning the concomitant use of multiple medications by one individual, has been widely reported in institutionalized or elderly patients. It can, however, occur in patients with chronic diseases, such as rheumatoid arthritis (RA). OBJECTIVE: To quantify polypharmacy in a group of RA patients and to assess the risk of potential undesirable interactions between medications used for managing RA and those used for non-chronic diseases. METHODS: A cohort study was carried out with 103 RA patients registered at the Strategy of Access to Medications from the Brazilian Health Ministry, at the School of Pharmacy of the city of Florianópolis, state of Santa Catarina. Patients were monthly followed up by use of form completion. Drug interactions were identified by use of the Drugdex System - Thomson Micromedex® - Interactions database. RESULTS: Polypharmacy was found in 95.1% of the patients, and 19 potential undesirable interactions were observed between the drugs used by 74 patients (mean of 3.0 ± 1.2 interactions/patient). All potential interactions were related to methotrexate. Omeprazole was the major representative, accounting for 29.3% of the interactions, followed by diclofenac sodium (17.6%), and metamizole sodium (13.2%). CONCLUSION: Considering that this study confirms that polypharmacy is a common therapeutic practice in RA patients, it is worth emphasizing the need for greater surveillance regarding the adverse effects or effectiveness reduction of certain drugs due to drug interaction

OBJETIVO: Avaliar as relações de custo-utilidade entre medicamentos antipsicóticos de primeira e segunda gerações no tratamento da esquizofrenia. MÉTODOS: Foi construído um modelo de Markov de cinco anos, a partir de um levantamento em prontuários de pacientes atendidos em um centro de atenção psicossocial em Florianópolis (SC), 2006. Os custos foram avaliados sob a perspectiva o Sistema Único de Saúde. As utilidades foram medidas em anos de vida ajustados pela qualidade obtidas na literatura. RESULTADOS: No modelo de Markov, a alternativa mais custo-efetiva foi a utilização de risperidona e haloperidol antes de olanzapina. CONCLUSÕES: Os antipsicóticos haloperidol e risperidona apresentaram melhor relação de custo-efetividade quando comparados à olanzapina. Estratégias que priorizem a utilização de antipsicóticos com melhor relação de custo-efetividade podem otimizar recursos, sem necessariamente implicar prejuízos à saúde dos pacientes atendidos no Sistema Único de Saúde.OBJETIVO: Evaluar las relaciones de costo-utilidad entre medicamentos antipsicóticos de primera y segunda generaciones en el tratamiento de la esquizofrenia. MÉTODOS: Fue construido un modelo de Harkov de cinco años, a partir de un levantamiento en prontuarios de pacientes atendidos en un centro de atención psicosocial en Florianópolis (Sur de Brasil), en 2006. Los costos fueron evaluados bajo la perspectiva del Sistema Único de Salud. Las utilidades fueron medidas en años de vida ajustados por la calidad obtenida en la literatura. RESULTADOS: En el modelo de Harkov, la alternativa más costo-efectiva fue la utilización de risperidona y haloperidol antes de olanzapina. CONCLUSIONES: Los antipsicóticos haloperidol y risperidona presentaron mejor relación de costo-efectividad cuando se compararon con olanzapina. Estrategias que prioricen la utilización de antipsicóticos con mejor relación de costo-efectividad pueden optimizar recursos, sin necesariamente implicar prejuicios a la salud de los pacientes atendidos en el Sistema Único de Salud.OBJECTIVE: To assess the cost-utility of first and second-generation antipsychotics for treatment of schizophrenia. METHODS: A five-year Markov model was constructed based on a survey of the records of patients seen in 2006 at a psychosocial care center in the municipality of Florianopolis, Southern Brazil. Costs were evaluated from the perspective of the Sistema Único de Saúde (SUS - Unified Healthcare System). Utility was measured in quality-adjusted life years obtained in the literature. RESULTS: The Markov model indicated risperidone and haloperidol utilization before olanzapine as the most cost-effective alternatives. CONCLUSIONS: Antipsychotic agents haloperidol and risperidone are more cost-effective than olanzapine. Strategies prioritizing the use of antipsychotics with better cost-effectiveness could optimize resource allocation without necessarily compromising the health of patients treated through the Sistema Único de Saúde.

O tratamento da artrite reumatoide envolve a utilização de medicamentos, terapias não farmacológicas, consultas médicas, exames complementares, entre outros procedimentos. O artigo apresenta, conforme as fontes pagadoras, os custos diretos médicos relacionados ao tratamento da artrite reumatoide. Trata-se de um estudo de custo-análise envolvendo 103 pacientes com artrite reumatoide grave atendidos por meio do Componente Especializado da Assistência Farmacêutica em Florianópolis, Santa Catarina, Brasil. O custo direto médico total foi R$ 2.045.596,55/ano, correspondendo a R$ 19.860,16 por paciente/ano. Do custo total, 90,8% foram para despesas com medicamentos, 2,5% às hospitalizações, 2,2% aos exames complementares, 2,1% às consultas médicas e 2,4% à soma dos demais componentes. O setor público foi responsável por 73,6% do custo direto médico total e por 79,3% do custo com a aquisição de medicamentos. A análise dos custos permitiu traçar um perfil de como uma população portadora de doença crônico-degenerativa altamente demandante de recursos transita pela composição público-privada que caracteriza o sistema de saúde brasileiro.