Aquisição de medicamentos genéricos em município de médio porte

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.

Drug use in college students: a 13-year trend

OBJECTIVE: To analyze drug use trends among college students in 1996, 2001 and 2009. METHODS: A cross-sectional epidemiological study with a multistage stratified cluster sample with 9,974 college students was conducted in the city of São Paulo, southeastern Brazil. An anonymous self-administered questionnaire was used to collect information on drug use assessed in lifetime, the preceding 12 months and the preceding 30 days. The Bonferroni correction was used for multiple comparisons of drug use rates between surveys. RESULTS: There were changes in the lifetime use of tobacco and some other drugs (hallucinogens [6.1% to 8.8%], amphetamines [4.6% to 8.7%], and tranquilizers [5.7% to 8.2%]) from 1996 to 2009. Differences in the use of other drugs over the 12 months preceding the survey were also seen: reduced use of inhalants [9.0% to 4.8%] and increased use of amphetamines [2.4% to 4.8%]. There was a reduction in alcohol [72.9% to 62.1%], tobacco [21.3% to 17.2%] and marijuana [15.0% to 11.5%] use and an increase in amphetamine use [1.9% to 3.3%] in the preceeding 30 days. CONCLUSIONS: Over the 13-year study period, there was an increase in lifetime use of tobacco, hallucinogens, amphetamines, and tranquilizers. There was an increase in amphetamine use and a reduction in alcohol use during the preceding 12 months. There was an increase in amphetamine use during the preceding 30 days.

Adaptação e validação de conteúdo da versão brasileira do Posttraumatic Cognitions Inventory

OBJETIVO: Realizar a tradução, adaptação e validação de conteúdo da versão brasileira do Posttraumatic Cognitions Inventory . MÉTODOS: O processo de tradução e adaptação das instruções iniciais e dos itens do PTCI envolveu cinco etapas: (1) tradução; (2) retradução; (3) correção e adaptação semântica; (4) validação do conteúdo por profissionais da área (juízes); e (5) teste da versão final, por meio de uma escala verbal-numérica. Como indicadores de desempenho para a compreensão, foram computados os escores de tendência central (média) e dispersão (desvio padrão) para cada item na etapa 5. Definiu-se escore médio ≥ 3 para compreensão satisfatória. RESULTADOS: As 36 questões e as instruções iniciais foram traduzidas e adaptadas para compor a versão brasileira do Posttraumatic Cognitions Inventory . Quarenta e cinco adultos responderam aos itens do Posttraumatic Cognitions Inventory na etapa teste da versão final, mostrando compreensão adequada do instrumento na escala verbal-numérica (M = 4,13; dp = 0,11). CONCLUSÕES: O Posttraumatic Cognitions Inventory é um instrumento de fácil compreensão e semanticamente válido. Estudos posteriores são necessários para a verificação e adequação da avaliação de suas propriedades psicométricas na população brasileira.

Gender and racial inequalities in trends of oral cancer mortality in Sao Paulo, Brazil

OBJECTIVE:To analyse recent trends in oral cancer mortality, focusing specifically on differences concerning gender and race.METHODS:Official information on deaths and population in the city of Sao Paulo, 2003 to 2009, were used to estimate mortality rates from oral cancer (C00 to C10, International Classification of Diseases, 10th Revision), adjusted for age and stratified by gender (females and males) and race (blacks and whites). The Prais-Winsten auto-regression procedure was used to analyse the time series.RESULTS:During the study period, 8,505 individuals living in the city of Sao Paulo died of oral cancer. Rates increased for females (rate of yearly increase = 4.4%, 95%CI 1.4;7.5), and levelled off for men, which represents an inversion of previous trends among genders in the city. Increases were identified for blacks, with a high rate of yearly increase of 9.1% (95%CI 5.5;12.9), and levelled off for whites. Oral cancer mortality in blacks almost doubled during the study period, and surpassed mortality in whites for almost all categories.CONCLUSIONS:Mortality presented a higher increase among women than in men, and it doubled among backs. The surveillance of trends of oral cancer mortality across gender and racial groups may contribute to implementing socially appropriate health policies, which concurrently reduce the burden of disease and the attenuation of unfair, avoidable and unnecessary inequalities in health.

Adaptação cultural da versão brasileira do Godin-Shephard Leisure-Time Physical Activity Questionnaire

OBJETIVO: Realizar adaptação cultural para versão brasileira do questionário de atividade física no tempo de lazer e avaliar a validade de conteúdo, praticabilidade, aceitabilidade e confiabilidade.MÉTODOS: Foram realizadas as etapas de tradução, síntese, retrotradução, avaliação por comitê de especialistas e pré-teste, seguidos pela avaliação da praticabilidade, aceitabilidade e confiabilidade (teste-reteste). Os juízes avaliaram as equivalências semântico-idiomática, conceitual, cultural e metabólica. A versão adaptada foi submetida ao pré-teste (n = 20) e teste-reteste (n = 80) em indivíduos saudáveis e pacientes com doenças cardiovasculares, em Limeira, SP, entre 2010 e 2011. A proporção de concordância do comitê de juízes foi quantificada por meio do Índice de Validade de Conteúdo. A confiabilidade foi avaliada segundo critério de estabilidade, com intervalo de 15 dias entre as aplicações, a praticabilidade pelo tempo gasto na entrevista e a aceitabilidade pelo percentual de itens não respondidos e proporção de pacientes que responderam a todos os itens.RESULTADOS: A versão traduzida do questionário apresentou equivalências semântico-idiomática, conceitual, cultural e metabólica adequadas, com substituição de algumas atividades físicas mais adequadas para a população brasileira. A análise da praticabilidade evidenciou curto tempo de aplicação do instrumento (média de 3,0 min). Quanto à aceitabilidade, todos os pacientes responderam a 100% dos itens. A análise do teste-reteste sugeriu estabilidade temporal do instrumento (Índice de Correlação Intraclasse = 0,84).CONCLUSÕES: A versão brasileira do questionário apresentou propriedades de medida satisfatórias. Recomenda-se sua aplicação a populações diversas em estudos futuros, a fim de disponibilizar propriedades de medida robustas.

Experiência de importação de equipamentos para pesquisa no ELSA-Brasil

OBJETIVO: Políticas de fomento à pesquisa em saúde foram estabelecidas na última década, avançando a produção científica nacional. Tal movimento não foi acompanhado do aperfeiçoamento do arcabouço legal-institucional, dificultando o desenvolvimento dos projetos de pesquisa. Isso inclusive no que tange às atividades de importação de equipamentos. O objetivo deste artigo foi analisar o processo de importação de equipamentos para o Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil).MÉTODOS: Trata-se de estudo de caso, com dados coletados em documentos internos do ELSA-Brasil em cinco Centros de Investigação e respectivas fundações de apoio. Foram analisados documentos de importação de: velocidade de onda de pulso, bioimagem e retinografia. Adicionalmente, foram realizadas entrevistas não estruturadas com pesquisadores e informantes chave nas fundações. Os dados foram tratados e organizados em três etapas: administrativa-operacional, cambial e fiscal. Foram calculados os intervalos de duração dessas etapas de modo comparativo entre os centros.RESULTADOS: A necessidade de padronização dos equipamentos em estudo multicêntrico exigiu atuação conjunta de instituições executoras e fundações. Dos equipamentos analisados, a primeira etapa, a administrativa-operacional, teve duração variada (mínimo 8 e máximo de 101, com média de 55 dias), sendo mais demorada quando incluía pareceres jurídicos. A segunda etapa, a cambial, mais longa que a primeira, não apresentou entraves ao processo (mínimo 11 e máximo 381, média de 196 dias). A terceira etapa, a fiscal, foi a mais longa (mínimo 43 e máximo 388 dias, média de 215,5 dias), devido à liberação dos equipamentos sem registro no País. Outros fatores que representaram entraves: inexperiência dos centros de investigação e das instituições em trabalhar em rede; inadequação da legislação nacional às especificidades da pesquisa científica; e falta de profissionais especializados em gestão de projeto científico.CONCLUSÕES: Os resultados mostram morosidade no processo de importação de equipamentos para pesquisa no Brasil, devido, especialmente, a entraves de ordem legal, burocrática e gerencial.

Determinants of using pacifier and bottle feeding

OBJECTIVE To analyze the factors associated with the use of pacifiers and/or bottle feeding in infants aged under one year.METHODS This is a cross-sectional study with 34,366 children and using data from the database of the 2nd Nationwide Survey of Breastfeeding Prevalence performed in the Brazilian capitals and Federal District in 2008. Cluster sampling was used. The questionnaire included questions about the use of artificial nipples in the last 24 hours. The analysis considered three outcomes: exclusive use of pacifier, exclusive use of bottle feeding, and use of artificial nipples (pacifier and bottle feeding). Prevalence ratios were obtained using Poisson regression with robust variance following a hierarchical model.RESULTS The following factors were associated with exclusive use of the pacifier: mother working outside the home, primiparity, child was not breastfed within the first hour, and child had consumed tea on the first day at home. The following factors were associated with exclusive use of bottle feeding: mother working outside the home, primiparity, low birth weight, child not breastfed within the first hour, and child had consumed milk formula and tea on the first day at home. The following factors were associated with use of artificial nipples (pacifier and bottle feeding): mother working outside the home, primiparity, cesarean delivery, the male gender, low birth weight, born in a hospital not accredited as “baby friendly”, required health baby monitoring in the Primary Health Care Unit (PR = 0.91), and child had consumed milk formula, water, or tea on the first day at home.CONCLUSIONS This study identified profiles of exclusive users of pacifiers, bottle feeding, and both. The provided information can guide preventive practices for child health.

Validity and reliability of a health care service evaluation instrument for tuberculosis

OBJECTIVE To evaluate the validity and reliability of an instrument that evaluates the structure of primary health care units for the treatment of tuberculosis.METHODS This cross-sectional study used simple random sampling and evaluated 1,037 health care professionals from five Brazilian municipalities (Natal, state of Rio Grande do Norte; Cabedelo, state of Paraíba; Foz do Iguaçu, state of Parana; Sao José do Rio Preto, state of Sao Paulo, and Uberaba, state of Minas Gerais) in 2011. Structural indicators were identified and validated, considering different methods of organization of the health care system in the municipalities of different population sizes. Each structure represented the organization of health care services and contained the resources available for the execution of health care services: physical resources (equipment, consumables, and facilities); human resources (number and qualification); and resources for maintenance of the existing infrastructure and technology (deemed as the organization of health care services). The statistical analyses used in the validation process included reliability analysis, exploratory factor analysis, and confirmatory factor analysis.RESULTS The validation process indicated the retention of five factors, with 85.9% of the total variance explained, internal consistency between 0.6460 and 0.7802, and quality of fit of the confirmatory factor analysis of 0.995 using the goodness-of-fit index. The retained factors comprised five structural indicators: professionals involved in the care of tuberculosis patients, training, access to recording instruments, availability of supplies, and coordination of health care services with other levels of care. Availability of supplies had the best performance and the lowest coefficient of variation among the services evaluated. The indicators of assessment of human resources and coordination with other levels of care had satisfactory performance, but the latter showed the highest coefficient of variation. The performance of the indicators “training” and “access to recording instruments” was inferior to that of other indicators.CONCLUSIONS The instrument showed feasibility of application and potential to assess the structure of primary health care units for the treatment of tuberculosis.

Strategies for price reduction of HIV medicines under a monopoly situation in Brazil

ABSTRACT OBJECTIVE To analyze Government strategies for reducing prices of antiretroviral medicines for HIV in Brazil. METHODS Analysis of Ministry of Health purchases of antiretroviral medicines, from 2005 to 2013. Expenditures and costs of the treatment per year were analyzed and compared to international prices of atazanavir. Price reductions were estimated based on the terms of a voluntary license of patent rights and technology transfer in the Partnership for Productive Development Agreement for atazanavir. RESULTS Atazanavir, a patented medicine, represented a significant share of the expenditures on antiretrovirals purchased from the private sector. Prices in Brazil were higher than international references, and no evidence was found of a relationship between purchase volume and price paid by the Ministry of Health. Concerning the latest strategy to reduce prices, involving local production of the 200 mg capsule, the price reduction was greater than the estimated reduction. As for the 300 mg capsule, the amounts paid in the first two years after the Partnership for Productive Development Agreement were close to the estimated values. Prices in nominal values for both dosage forms remained virtually constant between 2011 (the signature of the Partnership for Productive Development Agreement), 2012 and 2013 (after the establishment of the Partnership). CONCLUSIONS Price reduction of medicines is complex in limited-competition environments. The use of a Partnership for Productive Development Agreement as a strategy to increase the capacity of local production and to reduce prices raises issues regarding its effectiveness in reducing prices and to overcome patent barriers. Investments in research and development that can stimulate technological accumulation should be considered by the Government to strengthen its bargaining power to negotiate medicines prices under a monopoly situation.

Treatment of depression in older adults beyond fluoxetine

This review aimed to discuss the importance of the comprehensive treatment of depression among older adults in Brazil. The abuse of selective serotonin reuptake inhibitors, including fluoxetine hydrochloride, as antidepressants has been considered a serious public health problem, particularly among older adults. Despite the consensus on the need for a comprehensive treatment of depression in this population, Brazil is still unprepared. The interface between pharmacotherapy and psychotherapy is limited due to the lack of healthcare services, specialized professionals, and effective healthcare planning. Fluoxetine has been used among older adults as an all-purpose drug for the treatment of depressive disorders because of psychosocial adversities, lack of social support, and limited access to adequate healthcare services for the treatment of this disorder. Preparing health professionals is a sine qua non for the reversal of the age pyramid, but this is not happening yet.

Methylphenidate use in children with attention deficit hyperactivity disorder

A Brazilian Health Technology Assessment Bulletin (BRATS) article regarding scientific evidence of the efficacy and safety of methylphenidate for treating attention deficit hyperactivity disorder (ADHD) has caused much controversy about its methods. Considering the relevance of BRATS for public health in Brazil, we critically reviewed this article by remaking the BRATS search and discussing its methods and results. Two questions were answered: did BRATS include all references available in the literature? Do the conclusions reflect the reviewed articles? The results indicate that BRATS did not include all the references from the literature on this subject and also that the proposed conclusions are different from the results of the articles chosen by the BRATS authors themselves. The articles selected by the BRATS authors showed that using methylphenidate is safe and effective. However, the BRATS final conclusion does not reflect the aforementioned and should not be used to support decisions on the use of methylphenidate.

ERICA: prevalence of healthy eating habits among Brazilian adolescents

ABSTRACT OBJECTIVE To describe the prevalence of eating habits considered healthy in adolescents according to sex, age, education level of the mother, school type, session of study, and geographic region. METHODS The assessed data come from the Study of Cardiovascular Risks in Adolescents (ERICA), a cross-sectional, national and school-based study. Adolescents of 1,247 schools of 124 Brazilian municipalities were evaluated using a self-administered questionnaire with a section on aspects related to eating behaviors. The following eating behaviors were considered healthy: consuming breakfast, drinking water, and having meals accompanied by parents or legal guardians. All prevalence estimates were presented proportionally, with their respective 95% confidence intervals. The Chi-square test was used to evaluate the differences in healthy eating habits prevalences according to other variables. The module survey of the Stata program version 13.0 was used to analyze complex data. RESULTS We evaluated 74,589 adolescents (72.9% of the eligible students). Of these, 55.2% were female, average age being 14.6 years (SD = 1.6). Among Brazilian adolescents, approximately half of them showed healthy eating habits when consuming breakfast, drinking five or more glasses of water a day, and having meals with parents or legal guardians. All analyzed healthy eating habits showed statistically significant differences by sex, age, type of school, session of study, or geographic region. CONCLUSIONS We suggest that specific actions of intersectoral approach are implemented for the dissemination of the benefits of healthy eating habits. Older female adolescents (15 to 17 years old) who studied in public schools, resided in the Southeast region, and whose mothers had lower education levels, should be the focus of these actions since they present lower frequencies concerning the evaluated healthy habits.

ERICA: use of screens and consumption of meals and snacks by Brazilian adolescents

ABSTRACT OBJECTIVE To describe the length of exposure to screens and the prevalence of consumption of meals and snacks by Brazilian adolescents in front of screens. METHODS We evaluated 74,589 12 to 17-year old adolescents from 1,247 schools in 124 Brazilian municipalities. A self-administered questionnaire was used. Its segment regarding nutrition contained questions about using TV, computers, and video game systems, having meals while watching TV, and consuming snacks in front of screens. Consumption of meals and snacks in front of screens was analyzed according to the following variables: geographical region, gender, age range, type of school (public or private), and school shift. The prevalences and their respective 95% confidence intervals were estimated under a complex sampling design. RESULTS A great deal of the adolescents (73.5%, 95%CI 72.3-74.7) reported spending two or more hours a day in front of screens. That habit was more frequent among male adolescents, private school students, morning shift students, and students from Brazil’s South region. More than half of the adolescents (56.6%, 95%CI 55.4-57.8) reported almost always or always having meals in front of TV, and 39.6% (95%CI 38.8-40.5) of them said they consumed snacks in front of screens exactly as often. Both situations were the most prevalent ones among the girls, who attended public schools and were from Brazil’s Midwest region. CONCLUSIONS Length of exposure to screens and consumption of meals and snacks almost always or always in front of screens are high among Brazilian adolescents. It is necessary to develop strategies aiming to reduce the length of screen use, considering the media reality that children and adolescents have been experiencing from earlier and earlier ages. That context must therefore be analyzed in an indissociable way.

ERICA: prevalences of hypertension and obesity in Brazilian adolescents

ABSTRACT OBJECTIVE To estimate the prevalence of arterial hypertension and obesity and the population attributable fraction of hypertension that is due to obesity in Brazilian adolescents. METHODS Data from participants in the Brazilian Study of Cardiovascular Risks in Adolescents (ERICA), which was the first national school-based, cross-section study performed in Brazil were evaluated. The sample was divided into 32 geographical strata and clusters from 32 schools and classes, with regional and national representation. Obesity was classified using the body mass index according to age and sex. Arterial hypertension was defined when the average systolic or diastolic blood pressure was greater than or equal to the 95th percentile of the reference curve. Prevalences and 95% confidence intervals (95%CI) of arterial hypertension and obesity, both on a national basis and in the macro-regions of Brazil, were estimated by sex and age group, as were the fractions of hypertension attributable to obesity in the population. RESULTS We evaluated 73,399 students, 55.4% female, with an average age of 14.7 years (SD = 1.6). The prevalence of hypertension was 9.6% (95%CI 9.0-10.3); with the lowest being in the North, 8.4% (95%CI 7.7-9.2) and Northeast regions, 8.4% (95%CI 7.6-9.2), and the highest being in the South, 12.5% (95%CI 11.0-14.2). The prevalence of obesity was 8.4% (95%CI 7.9-8.9), which was lower in the North region and higher in the South region. The prevalences of arterial hypertension and obesity were higher in males. Obese adolescents presented a higher prevalence of hypertension, 28.4% (95%CI 25.5-31.2), than overweight adolescents, 15.4% (95%CI 17.0-13.8), or eutrophic adolescents, 6.3% (95%CI 5.6-7.0). The fraction of hypertension attributable to obesity was 17.8%. CONCLUSIONS ERICA was the first nationally representative Brazilian study providing prevalence estimates of hypertension in adolescents. Regional and sex differences were observed. The study indicates that the control of obesity would lower the prevalence of hypertension among Brazilian adolescents by 1/5.

ERICA: prevalence of common mental disorders in Brazilian adolescents

ABSTRACT OBJECTIVE To describe the prevalence of common mental disorders in Brazilian adolescent students, according to geographical macro-regions, school type, sex, and age. METHODS We evaluated 74,589 adolescents who participated in the Cardiovascular Risk Study in Adolescents (ERICA), a cross-sectional, national, school-based study conducted in 2013-2014 in cities with more than 100,000 inhabitants. A self-administered questionnaire and an electronic data collector were employed. The presence of common mental disorders was assessed using the General Health Questionnaire (GHQ-12). We estimated prevalence and 95% confidence intervals of common mental disorders by sex, age, and school type, in Brazil and in the macro-regions, considering the sample design. RESULTS The prevalence of common mental disorders was of 30.0% (95%CI 29.2-30.8), being higher among girls (38.4%; 95%CI 37.1-39.7) when compared to boys (21.6%; 95%CI 20.5-22.8), and among adolescents who were from 15 to 17 years old (33.6%; 95%CI 32.2-35.0) compared to those aged between 12 and 14 years (26.7%; 95%CI 25.8-27.6). The prevalence of common mental disorders increased with age for both sexes, always higher in girls (ranging from 28.1% at 12 years to 44.1% at 17 years) than in boys (ranging from 18.5% at 12 years to 27.7% at 17 years). We did not observe any significant difference by macro-region or school type. Stratified analyses showed higher prevalence of common mental disorders among girls aged from 15 to 17 years of private schools in the North region (53.1; 95%CI 46.8-59.4). CONCLUSIONS The high prevalence of common mental disorders among adolescents and the fact that the symptoms are often vague mean these disorders are not so easily identified by school administrators or even by health services. The results of this study can help the proposition of more specific prevention and control measures, focused on highest risk subgroups.