Controle judicial da política de assistência farmacêutica: direito, ciência e técnica

Para identificar mecanismos de compatibilização entre a lei e as normas técnicas, foram considerados o conceito de saúde e as características do Estado Democrático de Direito. Tomando-se o exemplo brasileiro das normas da política de assistência farmacêutica, concluiu-se que racionalidade jurídica impõe verificar se sua elaboração obedeceu ao requisito constitucional que exige a "participação da comunidade", instaurando um controle democrático e judicial.

Atenção farmacêutica em farmácias e drogarias: existe um processo de mudança?

Para se conhecer a prática profissional de farmacêuticos que atuam em farmácias e drogarias, seus conhecimentos e percepções acerca da Atenção Farmacêutica (AF), realizou-se estudo descritivo com 91 farmacêuticos do município de Jundiaí-SP. A maioria era jovem (62,6% entre 20 e 29 anos), do sexo feminino (63,7%), graduada em instituições privadas (90,1%) e não proprietária do estabelecimento (87,9%). Desenvolviam atividades administrativas, técnicas e de atenção ao usuário, principalmente dispensação de medicamentos e orientação; 67,0% acompanhavam o tratamento farmacoterapêutico dos usuários, mas sem registrar informações. Para 62,7%, AF relacionava-se apenas à orientação e atendimento dispensados, mas tais atividades não eram realizadas de forma sistemática e organizada, como preconizado. Muitos (91,2%) consideravam necessário realizar trabalho mais intenso com os usuários, porém apontaram dificuldades como falta de tempo e de apoio dos proprietários e desinteresse dos usuários. Várias dessas dificuldades têm sido verificadas também em outros países, sugerindo que a prática da AF: (a) requer uma mudança estrutural e rearranjo de funções, uma vez que, atualmente, a estrutura e as atividades são adequadas à atividade comercial; (b) reflete uma crise de identidade profissional e, em consequência, falta de reconhecimento social e pouca inserção na equipe multiprofissional de saúde. O conhecimento sobre AF mostrou-se limitado, mas a situação pode vir a alterar-se à medida que as mudanças curriculares em curso surtam efeito na formação dos novos farmacêuticos.

Polímeros sintéticos biodegradáveis: matérias-primas e métodos de produção de micropartículas para uso em drug delivery e liberação controlada

Micropartículas produzidas a partir de polímeros sintéticos têm sido amplamente utilizadas na área farmacêutica para encapsulação de princípios ativos. Essas micropartículas apresentam as vantagens de proteção do princípio ativo, mucoadesão e gastrorresistência, melhor biodisponibilidade e maior adesão do paciente ao tratamento. Além disso, utiliza menores quantidade de princípio ativo para obtenção do efeito terapêutico proporcionando diminuição dos efeitos adversos locais, sistêmicos e menor toxidade. Os polímeros sintéticos empregados na produção das micropartículas são classificados biodegradáveis ou não biodegradáveis, sendo os biodegradáveis mais utilizados por não necessitam ser removidos cirurgicamente após o término de sua ação. A produção das micropartículas poliméricas sintéticas para encapsulação tanto de ativos hidrofílicos quanto hidrofóbicos pode ser emulsificação por extração e/ou evaporação do solvente; coacervação; métodos mecânicos e estão revisados neste artigo evidenciando as vantagens, desvantagens e viabilidade de cada metodologia. A escolha da metodologia e do polímero sintético a serem empregados na produção desse sistema dependem da aplicação terapêutica requerida, bem como a simplicidade, reprodutibilidade e factibilidade do aumento de escala da produção.

The use of a graphite-silicone rubber composite electrode in the determination of rutin in pharmaceutical formulation

The possibility of using a graphite silicone-rubber composite electrode (GSR) in a differential pulse voltammetric(DPV) procedure for rutin (vitamin P) determination is described. Cyclic voltammograms of rutin presented a reversible pair of oxidation/reduction peaks respectively at 0.411 and 0.390 V (vs. SCE) at the GSR surface in Britton-Robinson(B-R) buffer solution pH 4.0. In DPV after optimization of conditions, an oxidation peak at 0.370 V (vs. SCE) was used to quantitative determination of rutin in B-R buffer solution pH 4.0. In this case a linear dynamic range of 5.0×10-8 to 50.0×10-8 mol L-1 was observed with a detection limit of 1.8×10-8 mol L-1 for the analyte. Recoveries from 94 to 113% were observed. The electrode surface was renewed by polishing after each determination, with a repeatability of 1.09 ± 0.06 µA (n = 10) peak current. Rutin was determined in a pharmaceutical formulation using the proposed electrode and the results agreed with those from an official method within 95% confidence level.

Brazilian scientific production on pharmaceutical care from 1990 to 2009

Brazilian scientific production on pharmaceutical care was identified based on articles indexed on the Medline, Embase, Lilacs, Web of Science and International Pharmaceutical Abstracts databases. Sixty-three articles published in both national and international journals were retrieved. With regard to authors, 72.3% were from the Southeast and South Regions, and 60.8% were affiliated to public universities. In relation to the type of studies, 85.7% were descriptive, and the most frequently researched fields were community pharmacies, hospitals and primary health care units. Articles were original in 65.1% of cases, updates in 20.6%, and reviews in 7.9%. An increase in publications commenced in 2006. In 31.7% of cases, authors had adopted a bibliographical study design, 28.6% qualitative study, 23.8% intervention, and 15.9% observational study design. The most researched subjects were elderly with chronic diseases. The importance of stimulating the conducting of experimental and qualitative studies, as well as amplifying authorship affiliated with the service area, foreign authors and with research in a wide variety of practice settings were highlighted. Despite the limited quantity of articles, an increase in their number as well as in their scope and quality is expected, so as to create further knowledge that contributes to the recognition of pharmacists' actions by patient healthcare teams.

Um enfoque sanitário sobre a demanda judicial de medicamentos

No Brasil, apesar dos avanços da assistência farmacêutica, permanecem falhas na garantia do acesso dos cidadãos aos medicamentos pelo Estado. Nos últimos anos, vem crescendo a reivindicação de medicamentos por parte do cidadão via sistema judiciário. Os objetos dessas solicitações são tanto os medicamentos em falta na rede pública como aqueles ainda não incorporados pelo Sistema Único de Saúde. Este fenômeno pode ser analisado sob diferentes perspectivas, inclusive a sanitária, entendida aqui como os desfechos sobre a saúde dos indivíduos que demandam estes medicamentos. O presente texto busca discutir as principais características das demandas judiciais frente aos seguintes aspectos: o uso racional de medicamentos, o uso de evidências científicas para a indicação terapêutica proposta e o quanto as demandas se justificam diante do conceito de acesso adotado pelo campo da assistência farmacêutica. Ponderações podem ser feitas no sentido de minimizar os riscos à saúde dos demandantes de medicamentos por via judicial, sobretudo quando o objeto da ação são medicamentos não pertencentes às listas de fornecimento público, ou com uso off label, ou desprovidos de registro no país. Considera-se que o Judiciário, a partir do fornecimento de medicamentos, busca garantir a saúde dos demandantes, e assim a dignidade da pessoa humana. Cabe ressaltar que este objetivo só será atingido quando a garantia da saúde estiver associada aos aspectos que certificam a segurança do paciente, inclusive no uso de medicamentos.

Os investimentos das indústrias farmacêuticas brasileiras em programas sociais: uma análise dos indicadores sociais de 2006

O objetivo deste artigo é analisar a evolução dos investimentos sociais praticados pelo setor industrial farmacêutico brasileiro. A importância do estudo das políticas sociais criadas por esse importante segmento produtivo deve-se à sua forte influência nas mais variadas definições sobre políticas de saúde, entre elas o conflituoso campo de disputa entre a defesa das patentes por parte das empresas e as tentativas de licenciamento compulsório de medicamentos, por parte do governo. Tomamos como fonte de pesquisa os indicadores sociais de 62 indústrias farmacêuticas, relativos ao ano de 2006, publicados pela Federação Brasileira da Indústria Farmacêutica (Febrafarma), em maio de 2007, sob o título Painel Social, apresentados de três formas: dados gerais sobre o número de programas, valores investidos e o número de pessoas beneficiadas; dados gerais classificados segundo um modelo pré-definido e composto de categorias fixas (saúde, educação, comunidade, valorização da vida, cultura, meio ambiente, voluntariado e outros); e dados individualizados por empresa, com a indicação das ementas de cada programa criado. Buscamos com a reflexão sobre esses indicadores averiguar se eles possibilitam realizar um acompanhamento longitudinal das diretrizes e das proposições relacionadas às ações socialmente responsáveis praticadas pelas indústrias farmacêuticas.

Cross-national epidemiology of DSM-IV major depressive episode

Background: Major depression is one of the leading causes of disability worldwide, yet epidemiologic data are not available for many countries, particularly low- to middle-income countries. In this paper, we present data on the prevalence, impairment and demographic correlates of depression from 18 high and low-to middle-income countries in the World Mental Health Survey Initiative. Methods: Major depressive episodes (MDE) as defined by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DMS-IV) were evaluated in face-to-face interviews using the World Health Organization Composite International Diagnostic Interview (CIDI). Data from 18 countries were analyzed in this report (n = 89,037). All countries surveyed representative, population-based samples of adults. Results: The average lifetime and 12-month prevalence estimates of DSM-IV MDE were 14.6% and 5.5% in the ten high-income and 11.1% and 5.9% in the eight low- to middle-income countries. The average age of onset ascertained retrospectively was 25.7 in the high-income and 24.0 in low- to middle-income countries. Functional impairment was associated with recency of MDE. The female: male ratio was about 2: 1. In high-income countries, younger age was associated with higher 12-month prevalence; by contrast, in several low-to middle-income countries, older age was associated with greater likelihood of MDE. The strongest demographic correlate in high-income countries was being separated from a partner, and in low- to middle-income countries, was being divorced or widowed. Conclusions: MDE is a significant public-health concern across all regions of the world and is strongly linked to social conditions. Future research is needed to investigate the combination of demographic risk factors that are most strongly associated with MDE in the specific countries included in the WMH.

Cross-National Analysis of the Associations between Traumatic Events and Suicidal Behavior: Findings from the WHO World Mental Health Surveys

Background: Community and clinical data have suggested there is an association between trauma exposure and suicidal behavior (i.e., suicide ideation, plans and attempts). However, few studies have assessed which traumas are uniquely predictive of: the first onset of suicidal behavior, the progression from suicide ideation to plans and attempts, or the persistence of each form of suicidal behavior over time. Moreover, few data are available on such associations in developing countries. The current study addresses each of these issues. Methodology/Principal Findings: Data on trauma exposure and subsequent first onset of suicidal behavior were collected via structured interviews conducted in the households of 102,245 (age 18+) respondents from 21 countries participating in the WHO World Mental Health Surveys. Bivariate and multivariate survival models tested the relationship between the type and number of traumatic events and subsequent suicidal behavior. A range of traumatic events are associated with suicidal behavior, with sexual and interpersonal violence consistently showing the strongest effects. There is a dose-response relationship between the number of traumatic events and suicide ideation/attempt; however, there is decay in the strength of the association with more events. Although a range of traumatic events are associated with the onset of suicide ideation, fewer events predict which people with suicide ideation progress to suicide plan and attempt, or the persistence of suicidal behavior over time. Associations generally are consistent across high-, middle-, and low-income countries. Conclusions/Significance: This study provides more detailed information than previously available on the relationship between traumatic events and suicidal behavior and indicates that this association is fairly consistent across developed and developing countries. These data reinforce the importance of psychological trauma as a major public health problem, and highlight the significance of screening for the presence and accumulation of traumatic exposures as a risk factor for suicide ideation and attempt.

Pharmacokinetics of tetracycline in plasma, synovial fluid and milk using single intravenous and single intravenous regional doses in dairy cattle with papillomatous digital dermatitis

The purpose of this study was to compare the pharmacokinetics of tetracycline in plasma, synovial fluid, and milk following either a single systemic intravenous (i.v.) injection or a single i.v. regional antibiosis (IVRA) administration of tetracycline hydrochloride to dairy cattle with papillomatous digital dermatitis (PDD). To this end, plasma and synovial fluid tetracycline concentrations were compared with the minimal inhibitory concentration (MIC) values of the major bacteria, which are known to cause digital diseases and thus assess its efficacy in PDD. Residual tetracycline concentrations in milk from cows treated by both methods were also determined. Twelve Holstein cows with various stages of PDD were randomly assigned to two groups of six animals. Group 1 received a single systemic i.v. injection of 10 mg/kg of tetracycline hydrochloride. Group 2 received 1000 mg of tetracycline hydrochloride by IVRA of the affected limb. Blood, synovial fluid and milk samples were taken prior to tetracycline administration (time 0 control), and then at 22, 45 and 82 min, and 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h following drug administration. Tetracycline concentrations were determined by high-performance liquid chromatography. Mean tetracycline plasma and milk concentrations in Group 1 were higher than Group 2. The opposite was observed for synovial fluid concentrations. Group 2 synovial fluid concentrations were higher than the MIC value over 24 h for the bacteria most frequently responsible for claw disease. Compared with i.v. administration, IVRA administration of tetracycline produced very high synovial fluid and low plasma and milk concentrations.

Rosuvastatin and Cardiovascular Events in Patients Undergoing Hemodialysis

Background Statins reduce the incidence of cardiovascular events in patients at high cardiovascular risk. However, a benefit of statins in such patients who are undergoing hemodialysis has not been proved. Methods We conducted an international, multicenter, randomized, double-blind, prospective trial involving 2776 patients, 50 to 80 years of age, who were undergoing maintenance hemodialysis. We randomly assigned patients to receive rosuvastatin, 10 mg daily, or placebo. The combined primary end point was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Secondary end points included death from all causes and individual cardiac and vascular events. Results After 3 months, the mean reduction in low-density lipoprotein (LDL) cholesterol levels was 43% in patients receiving rosuvastatin, from a mean baseline level of 100 mg per deciliter (2.6 mmol per liter). During a median follow-up period of 3.8 years, 396 patients in the rosuvastatin group and 408 patients in the placebo group reached the primary end point (9.2 and 9.5 events per 100 patient-years, respectively; hazard ratio for the combined end point in the rosuvastatin group vs. the placebo group, 0.96; 95% confidence interval [CI], 0.84 to 1.11; P = 0.59). Rosuvastatin had no effect on individual components of the primary end point. There was also no significant effect on all-cause mortality (13.5 vs. 14.0 events per 100 patient-years; hazard ratio, 0.96; 95% CI, 0.86 to 1.07; P = 0.51). Conclusions In patients undergoing hemodialysis, the initiation of treatment with rosuvastatin lowered the LDL cholesterol level but had no significant effect on the composite primary end point of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. (ClinicalTrials.gov number, NCT00240331.)

Prevalence of diabetic peripheral neuropathy and relation to glycemic control therapies at baseline in the BARI 2D cohort

We evaluated the associations between glycemic therapies and prevalence of diabetic peripheral neuropathy (DPN) at baseline among participants in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial on medical and revascularization therapies for coronary artery disease (CAD) and on insulin-sensitizing vs. insulin-providing treatments for diabetes. A total of 2,368 patients with type 2 diabetes and CAD was evaluated. DPN was defined as clinical examination score > 2 using the Michigan Neuropathy Screening Instrument (MNSI). DPN odds ratios across different groups of glycemic therapy were evaluated by multiple logistic regression adjusted for multiple covariates including age, sex, hemoglobin A1c (HbA1c), and diabetes duration. Fifty-one percent of BARI 2D subjects with valid baseline characteristics and MNSI scores had DPN. After adjusting for all variables, use of insulin was significantly associated with DPN (OR = 1.57, 95% CI: 1.15-2.13). Patients on sulfonylurea (SU) or combination of SU/metformin (Met)/thiazolidinediones (TZD) had marginally higher rates of DPN than the Met/TZD group. This cross-sectional study in a cohort of patients with type 2 diabetes and CAD showed association of insulin use with higher DPN prevalence, independent of disease duration, glycemic control, and other characteristics. The causality between a glycemic control strategy and DPN cannot be evaluated in this cross-sectional study, but continued assessment of DPN and randomized therapies in BARI 2D trial may provide further explanations on the development of DPN.

Lipid goals among patients with diabetes or metabolic syndrome: Lipid Treatment Assessment Project (L-TAP) 2

Objective: This analysis of the Lipid Treatment Assessment Project 2 population compared lipid goal attainment by diabetes and metabolic syndrome status. Research design and methods: Dyslipidaemic patients aged >= 20 years on stable lipid lowering therapy had their lipid levels determined once during enrolment at investigation sites in nine countries between September 2006 and April 2007. Achievement of low-density lipoprotein (LDL) cholesterol success, triglycerides < 150 mg/dl (1.7 mmol/l), and high-density lipoprotein (HDL) cholesterol success (> 40 mg/dl [1.0 mmol/l] in men or > 50 mg/dl [1.3 mmol/l] in women) was compared using logistic regression. Results: A total of 9955 patients were evaluated. Patients with diabetes, compared with those without diabetes, had lower achievement of LDL cholesterol goals (according to National Cholesterol Education Program Adult Treatment Panel [NCEP ATP] III guidelines; 67% vs. 75%), triglycerides < 150 mg/dl (55% vs. 64%), and HDL cholesterol success (61% vs. 74%; p < 0.0001 for all comparisons). The significantly lower lipid goal attainment in patients with diabetes was consistent across participating world regions. Patients with metabolic syndrome, compared with those without metabolic syndrome, had lower achievement of NCEP ATP III LDL cholesterol goals (69% vs. 76%), triglycerides < 150 mg/dl (36% vs. 83%), and HDL cholesterol success (49% vs. 89%; p < 0.0001 for all comparisons). As the number of metabolic syndrome components increased, lipid success rates progressively decreased (p < 0.0001 for LDL cholesterol success, triglycerides < 150 mg/dl, and HDL cholesterol success). Conclusions: This analysis indicates that despite their increased cardiovascular risk, patients with diabetes or metabolic syndrome remain undertreated.

Sensitization to foods in gastroesophageal reflux disease and its relation to eosinophils in the esophagus: is it of clinical importance?

Background: Refractory gastroesophageal reflux disease (GERD) can be related to greater sensitization to foods. Objective: To evaluate sensitization to foods in patients with refractory GERD. Methods: Patients with refractory GERD after using at least 40 mg of a proton pump inhibitor were given a restriction diet based on the results of skin prick testing and atopy patch testing with foods. The characteristics of sensitized patients were compared with those of nonsensitized patients in relation to atopy and number of eosinophils in the esophageal mucosa. Results: The prevalence of sensitization to foods was 27.7%. Asthmatic patients showed higher sensitization to foods (P = .008). Eosinophils were determined to be present in the esophageal mucosa in 15.8% of patients, and this correlated with greater sensitization to foods (P = .01). One case of eosinophilic esophagitis was confirmed. A diet excluding identified sensitizing foods led to clinical improvement regarding GERD symptoms (P = .004). Conclusion: The presence of eosinophils in esophageal mucosa associated with greater sensitization to foods and the response to a restriction diet in patients with positive test results suggest that refractory GERD can represent an initial stage of eosinophilic esophagitis. Ann Allergy Asthma Immunol. 2010;105:359-363.