Legal and health variations in drug litigation injunctions granted in Minas Gerais

OBJECTIVE To investigate the factors related to the granting of preliminary court orders [injunctions] in drug litigations. METHODS A retrospective descriptive study of drug lawsuits in the State of Minas Gerais, Southeastern Brazil, was conducted from October 1999 to 2009. The database consists of 6,112 lawsuits, out of which 6,044 had motions for injunctions and 5,167 included the requisition of drugs. Those with more than one beneficiary were excluded, which totaled 5,072 examined suits. The variables for complete, partial, and suppressed motions were treated as dependent and assessed in relation to those that were independent – lawsuits (year, type, legal representation, defendant, court in which it was filed, adjudication time), drugs (level five of the anatomical therapeutic chemical classification), and diseases (chapter of the International Classification of Diseases). Statistical analyses were performed using the Chi-square test. RESULTS Out of the 5,072 lawsuits with injunctions, 4,184 (82.5%) had the injunctions granted. Granting varied from 95.8% of the total lawsuits in 2004 to 76.9% in 2008. Where there was legal representation, granting exceeded 80.0% and in lawsuits without representation, it did not exceed 66.9%. In public civil actions (89.1%), granting was higher relative to ordinary lawsuits (82.8%) and injunctions (80.1%). Federal courts granted only 68.6% of the injunctions, while the state courts granted 84.8%. Diseases of the digestive system and neoplasms received up to 87.0% in granting, while diseases of the nervous system, mental and behavioral disorders, and diseases of the skin and subcutaneous tissue received granting below 78.6% and showed a high proportion of suspended injunctions (10.9%). Injunctions involving paroxetine, somatropin, and ferrous sulfate drugs were all granted, while less than 54.0% of those involving escitalopram, sodium diclofenac, and nortriptyline were granted. CONCLUSIONS There are significant differences in the granting of injunctions, depending on the procedural and clinical variances. Important trends in the pattern of judicial action were observed, particularly, in the reduced granting [of injunctions] over the period.

What can and should be legalized in ecological restoration?

After listing the five key elements of ecological restoration, ecology, economics, social values, cultural values, and politics, I celebrate the fact that in Brazil there is legislation on how to perform ecological restoration of degraded tropical forests, as well as an ongoing dialogue among legislators and scientists about this legislation, and also a lively debate among scientists as the best way forward, referring to articles by Brancalion et al. (2010) and Durigan et al. (2010) in this issue of Revista Árvore. Legislators elsewhere, especially megadiversity countries, should take note. I do not take sides in the debate; I think both groups of authors make very good points. Instead I call on the scientists and legislators concerned with restoration to ponder five strategic tools: A. Start with clear concepts. B. Decide where you want to go and why. C. Negotiate who should benefit & how, and who should pay, how, & why. D. Work out how an honest cost-benefit analysis of restoration would look, regardless of the biome in which you are working. Finally, figure out how to make the restoration immediately attractive for private landowners. Otherwise, they will not cooperate as fully as they could or should, and restoration efforts will not achieve its full potential.

Climate paradox of the G-8: legal obligations, policy declarations and implementation gap

This article analyzes the climate policy performance of the G-8 from 1992 to 2012 based on their legal commitments (Annex-1 and Annex-B countries) under the UNFCCC (1992) and the Kyoto Protocol (1997) and their policy declarations on their GHG reduction goals until 2050. A climate paradox has emerged due to a growing implementation gap in Canada, USA and Japan, while Russia, Germany, UK, France and Italy fulfilled their GHG reduction obligation.

Cross-cultural differences in children's concepts of health and illness

INTRODUCTION: In spite of general agreement that cross-cultural research is needed in the health area, most existing investigations of children's development of health and illness-related concepts have involved samples from developed countries. The study examined the development of the concepts of health and illness as a function of subject's age, socio-economic status (SES), gender and grade level in a Brazilian sample of 96 elementary and junior high school students. METHODS: Subjects were interviewed individually and their ideas of health and illness were assessed through open-ended questions. Participants' answers were transcribed verbatim and subjected to content analysis. RESULTS: Chi-square analyses revealed significant age, school grade and SES-related differences in participants' concepts of health and illness. DISCUSSION AND CONCLUSION: The themes employed by subjects to define both health and illness were broadly consistent with those found by previous research. The study showed a predictable relationship between subject's age and school grade level and increasingly more highly differentiated and multidimensional concepts of health and illness. This investigation suggests that, for the most part, cross-cultural similarities in children's concepts of health and illness may be more striking than the differences.

The development of a scale to measure concepts of schizophrenia: experience among Brazilian psychiatrists

INTRODUCTION: Among psychiatric disorders schizophrenia is often said to be the condition with the most disputed definition.The Bleulerian and Schneiderian approaches have given rise to diagnostic formulations that have varied with time and place. Controversies over the concept of schizophrenia were examined within European/North American settings in the early 1970s but little has since been reported on the views of psychiatrists in developing countries. In Brazil both concepts are referred to in the literature. A scale was developed to measure adherence to Bleulerian and Schneiderian concepts among psychiatrists working in S. Paulo. METHODOLOGY: A self-reported questionnaire comprising seventeen visual analogue-scale statements related to Bleulerian and Schneiderian definitions of Shizophrenia, plus sociodemographic and training characteristics, was distributed to a non-randomised sample of 150 psychiatrists. The two sub-scales were assessed by psychometric methods for internal consistency, sub-scale structure and test-retest reliability. Items selected according to internal consistency were examined by a two-factor model exploratory factor analysis. Intraclass correlation coefficients described the stability of the scale. RESULTS: Replies were received from 117 psychiatrists (mean age 36 (SD 7.9)), 74% of whom were made and 26% female. The Schneiderian scale showed better overall internal consistency than the Bleulerian scale. Intra-class correlation coefficients for test-retest comparisons were between 0.5 and 0.7 for Schneiderian items and 0.2 and 0.7 for Bleulerian items. There was no negative association between Bleulerian and Schneiderian scale scores, suggesting that respondents may hold both concepts. Place of training was significantly associated with the respondent's opinion; disagreement with a Bleulerian standpoint predominated for those trained at the University of S. Paulo. CONCLUSIONS: The less satisfactory reliability for the Bleulerian sub-scale limits confidence in the whole scale but on the other hand this questionnaire contributes to the understanding of the controversy over Bleulerian and Schneiderian models for conceptualisation of schizophrenia, the former requiring more inference and therefore being prone to unreliability.

Biological drugs for the treatment of psoriasis in a public health system

OBJECTIVE To analyze the access and utilization profile of biological medications for psoriasis provided by the judicial system in Brazil.METHODSThis is a cross-sectional study. We interviewed a total of 203 patients with psoriasis who were on biological medications obtained by the judicial system of the State of Sao Paulo, from 2004 to 2010. Sociodemographics, medical, and political-administrative characteristics were complemented with data obtained from dispensation orders that included biological medications to treat psoriasis and the legal actions involved. The data was analyzed using an electronic data base and shown as simple variable frequencies. The prescriptions contained in the lawsuits were analyzed according to legal provisions.RESULTS A total of 190 lawsuits requesting several biological drugs (adalimumab, efalizumab, etanercept, and infliximab) were analyzed. Patients obtained these medications as a result of injunctions (59.5%) or without having ever demanded biological medication from any health institution (86.2%), i.e., public or private health services. They used the prerogative of free legal aid (72.6%), even though they were represented by private lawyers (91.1%) and treated in private facilities (69.5%). Most of the patients used a biological medication for more than 13 months (66.0%), and some patients were undergoing treatment with this medication when interviewed (44.9%). Approximately one third of the patients discontinued treatment due to worsening of their illness (26.6%), adverse drug reactions (20.5%), lack of efficacy, or because the doctor discontinued this medication (13.8%). None of the analyzed medical prescriptions matched the legal prescribing requirements. Clinical monitoring results showed that 70.3% of the patients had not undergone laboratory examinations (blood work, liver and kidney function tests) for treatment control purposes.CONCLUSIONS The plaintiffs resorted to legal action to get access to biological medications because they were either unaware or had difficulty in accessing them through institutional public health system procedures. Access by means of legal action facilitated long-term use of this type of medication through irregular prescriptions and led to a high rate of adverse drug reactions as well as inappropriate clinical monitoring.

Prescription, dispensation and marketing patterns of methylphenidate

OBJECTIVE To analyze the patterns and legal requirements of methylphenidate consumption. METHODS We conducted a cross-sectional study of the data from prescription notification forms and balance lists of drugs sales – psychoactive and others – subject to special control in the fifth largest city of Brazil, in 2006. We determined the defined and prescribed daily doses, the average prescription and dispensation periods, and the regional sales distribution in the municipality. In addition, we estimated the costs of drug acquisition and analyzed the individual drug consumption profile using the Lorenz curve. RESULTS The balance lists data covered all notified sales of the drug while data from prescription notification forms covered 50.6% of the pharmacies that sold it, including those with the highest sales volumes. Total methylphenidate consumption was 0.37 DDD/1,000 inhabitants/day. Sales were concentrated in more developed areas, and regular-release tablets were the most commonly prescribed pharmaceutical formulation. In some regions of the city, approximately 20.0% of the prescriptions and dispensation exceeded 30 mg/day and 30 days of treatment. CONCLUSIONS Methylphenidate was widely consumed in the municipality and mainly in the most developed areas. Of note, the consumption of formulations with the higher abuse risk was the most predominant. Both its prescription and dispensation contrasted with current pharmacotherapeutic recommendations and legal requirements. Therefore, the commercialization of methylphenidate should be monitored more closely, and its use in the treatment of behavioral changes of psychological disorders needs to be discussed in detail, in line with the concepts of the quality use of medicines.

Chagas disease cardiomyopathy: current concepts of an old disease

Chagas disease continues to be a significant public health problem, as ca. 10 million people are still infected with T. cruzi in Latin America. Decades after primary infection, 30% of individuals can develop a form of chronic inflammatory cardiomyopathy known as Chagas disease cardiomyopathy (CCC). Data from both murine models and human studies support the view that an autoimmune response as well as a parasite-driven immune response involving inflammatory cytokines and chemokines may both play a role in generating the heart lesions leading to CCC. This review aims to summarize recent advances in the understanding of the immunopathogenesis of Chagas disease cardiomyopathy.

Estimativa de área de vegetação secundária na Amazônia Legal Brasileira

A vegetação secundária tem funções relevantes para os ecossistemas, tais como a fixação de carbono atmosférico, a manutenção da biodiversidade, o estabelecimento da conectividade entre remanescentes florestais, manutenção dos regime hidrológico e a recuperação da fertilidade do solo. O objetivo deste trabalho é, através de uma abordagem amostral, estimar a área ocupada por vegetação secundária na Amazônia Legal Brasileira (AML) em 2006. A amostragem se baseia em uma abordagem estratificada pelo grau de desflorestamento das cenas LANDSAT-TM que recobrem a AML. Foram selecionadas 26 cenas para o ano de 2006, distribuídas em sete estratos conforme o percentual de desflorestamento, nas quais foram mapeadas as áreas de vegetação secundária a partir de técnicas de classificação de imagens. Foi desenvolvido um modelo multivariado de regressão para estimar a área de vegetação secundária utilizando como variáveis independentes a área de desflorestamento, a área de hidrografia, a estrutura agrária, e área das unidades de conservação. A análise de regressão encontrou um R2 ajustado de 0,84 , e coeficientes positivos para a proporção de hidrografia na imagem (2,055) e para a estrutura agrária (0,197), e coeficientes negativos para o grau de desflorestamento na imagem (-0,232) e para a proporção de Unidades de Conservação na imagem (-0,262). O modelo de regressão estimou uma área de 131.873 km² de vegetação secundária para o ano de 2006. Aplicando uma simulação Monte Carlo foi estimada uma incerteza de aproximadamente 12.445 km² para a área.

Impact of health legislation on the sale of anorectics in a city in the Amazon region

OBJECTIVES: The International Narcotics Control Board released its 2005 annual report, highlighting the Brazil population as one of the largest consumers of anorectics. In Brazil, the National Health Surveillance Agency issued the resolution RDC 58/2007 in order to control the prescription and sale of such drugs. In Belém, the biggest city in the Brazilian Amazon region, this resolution came into force in 2008, leading to inspections of drugstores and magistral pharmacies. The aim of this work was to evaluate the consumption of psychotropic anorectic drugs and the impact of RDC 58/2007 on the prescription and dispensing of anorectics in drugstores and magistral pharmacies in Belém. METHODOLOGY: A retrospective quantitative and descriptive study was conducted of records from the Municipal Department of Health Surveillance of Belém, for 2005 to 2008. The differences in findings were regarded significant when p < 0.05. RESULTS: A total of 1,641 balance sheets of drugstores and magistral pharmacies were analyzed. Amfepramone was the most dispensed medication, followed by fenproporex and mazindol. The highest consumption of anorectics occurred in magistral pharmacies. In 2008, there was a significant reduction in dispensing of anorectics, in drugstores as well as in magistral pharmacies. CONCLUSIONS: This study showed that there was a decrease in the dispensing of anorectics after RDC 58/2007 came into force, and that the magistral pharmacies dispensed more of these drugs. This resolution is a remarkable tool in health control, where it is of great benefit to public health and contributes substantially to the rational use of medicines in Brazil.

Racial inequalities in the socioeconomic, demographic and health conditions of elderly from Maranhão State, Legal Amazon, Brazil: a population-based study

Aging with quality of life does not occur equally among the racial groups of Brazilian elderly, and few studies have analyzed this issue in the states of the Brazilian Legal Amazon. The objective of this study was to investigate racial inequalities in the socioeconomic, demographic and health conditions of elderly residents of Maranhão state, Brazil. The present work is a cross-sectional study of 450 elders aged 60 years or older included in the 2008 National Household Sample Survey. The prevalence of socioeconomic, demographic, health and habit indicators and of risk factors were estimated in white, brown and black racial categories that were self-reported by the survey participants. The chi-square test was used for comparisons (a=5%). The majority of the elderly respondents identified themselves as brown (66.4%) or white (23.3%). There were significant socioeconomic, demographic, habit and lifestyle differences among the racial groups. Most of the black and brown elderly lived alone, reported lower educational levels and were in the lowest quintile for income. These respondents were also highly dependent on the Unified Health System (Sistema Único de Saúde - SUS), exhibited low rates of screening mammograms and lower physical activity levels and had a greater proportion of smokers. However, there was no difference in the prevalence of health indicators or in the proportion of elderly by gender, age, social role in the family or the urban-rural location of the household. These results indicate the presence of racial inequalities in the socioeconomic and demographic status and in the practice of healthy habits and lifestyles among elderly from Maranhão, but suggest equity in health status. The results also suggest the complexity and challenges of interlinking race with socioeconomic aspects, and the findings reinforce the need for the implementation of public policies for these population groups.