Daniel Marques Mota

Perfil da mortalidade por intoxicação com medicamentos no Brasil, 1996-2005: retrato de uma década

The occurrence of deaths caused by intoxication with medication have been considered a worsening public health problem. The study describes the epidemiological profile of medication-related intoxication in the general Brazilian population from 1996 to 2005. A descriptive study was conducted with mortality data obtained from the Mortality Information System of the Brazilian Ministry of Health. Deaths were selected according to the codes of the International Classification of Diseases (ICD-10). A total of 4,403 deaths were found inn males (53.9%), bachelors (53.7%) and the 20 to 39 year-old age bracket (44%). The majority of deaths were caused by intentional self-intoxication using anticonvulsants, sedatives, antiparkinsonians and psychotropics. The standardized mortality rate was higher in the Midwest region and Potential Life-Years Lost increased by 15.5%. The study showed the characteristics and variations in mortality by intoxication with medication in Brazil, which can be a reflex of the medication consumption patterns of the country, indicating the need for enhancement of sanitary vigilance policies.

Uso racional de medicamentos: uma abordagem econômica para tomada de decisões

O artigo aborda o uso racional de medicamentos (URM) sob um ponto de vista da economia. O URM, para ser implementado, implica custos e envolve a apropriacao de conhecimentos e mudancas de conduta de diversos agentes. A dificuldade na adocao da pratica do URM pode estar relacionada a problemas de escassez, assimetria de informacao, informacao incompleta, incertezas nas decisoes clinicas, externalidades, preco-tempo, incentivos para prescritores e dispensadores, preferencias dos prescritores e utilidade marginal. Assim, cabe as autoridades sanitarias, entre outras entidades, regular, reduzir e controlar essas falhas que poderao introduzir ineficiencias na assistencia farmaceutica, bem como produzir riscos a vida humana.

Uso abusivo de benzidamina no Brasil: uma abordagem em farmacovigilância

The abusive drug use has been object of increasing concern in public health and is commonly issued in the Brazilian press. Amongst medicines, those that are abuse substances and cause physical and/or psychic dependence, barbiturates, benzodiazepines, opioid analgesics and amphetamines are included. Analgesics, antipyretics and non-steroidal anti-inflammatory drugs, even not making part of this list, are generally associated with recreational use or non therapeutical purpose. The objective of this essay is to present information on the abusive use of benzydamine in Brazil. The present study is an exploratory essay in which different methodological strategies adopted in the regulatory practice of pharmacovigilance have been used. The abusive use of this drug was evidenced in scientific literature, press releases and on the internet. Considering the facility of purchasing drugs under medical prescription, among other factors, it must be demanded ways to assess the marketing and use of medicines, and assure its safe and rational use, including the strengthening of pharmacovigilance in Brazil.

Investigação em farmacoepidemiologia de campo: uma proposta para as ações de farmacovigilância no Brasil

O presente artigo tem como objetivos propor e descrever a investigacao em farmacoepidemiologia de campo como funcao primordial de farmacovigilância a ser conduzida pelas vigilâncias sanitarias municipais, estaduais e/ou federal frente a notificacao, comunicacao e ou rumores nos meios de comunicacao social de casos de eventos adversos relacionados com medicamentos. Inicialmente fazemos uma contextualizacao da farmacovigilância, incluindo definicao, eventos de interesse e principais funcoes. Na sequencia, descrevemos a investigacao em farmacoepidemiologia de campo orientada para a execucao dos doze passos da investigacao. Logo a seguir, apresentamos uma caracterizacao geral de investigacoes em farmacoepidemiologia de campo realizadas no Brasil. Finalmente, argumentamos que a investigacao em farmacoepidemiologia de campo constitui importante instrumento para o aperfeicoamento das acoes de farmacovigilância visando a melhoria da seguranca de pacientes no pais.

Avaliação do Sistema de Vigilância Sanitária do Sangue em âmbito federal, Brasil, 2007

Este estudo consistiu em avaliar o Sistema de Vigilância Sanitaria do Sangue em âmbito federal (Vigisan). Trata-se de um estudo de avaliacao em saude que contemplou os seguintes componentes selecionados do Vigisan: sistema gerencial de cadastro de servicos hemoterapicos, programa de avaliacao externa da qualidade de servicos de hemoterapia, sistema de hemovigilância, normatizacao e inspecao dos servicos de sangue e seus componentes. Alem da descricao e do calculo da eficiencia (razao custo-efetividade) do Vigisan, a avaliacao foi composta de duas fases com base em tres metodos. O Vigisan apresentou uma estrutura mal definida, funcionamento regular e utilidade aceitavel para a saude publica. De um total de quatro indicadores definidos para a avaliacao de desempenho, um obteve resultado satisfatorio. Dos sete atributos estudados, tres alcancaram uma avaliacao positiva. A razao custo-efetividade foi de R

Há irracionalidades no consumo de inibidores de apetite no Brasil? Uma análise farmacoeconométrica de dados em painel

80.865,80 por atividade executada, o que resultou em perda de eficiencia para o Sistema. Este estudo demonstra a importância da realizacao de avaliacoes de Sistemas de Vigilância em Saude Publica, as quais devem ser realizadas periodicamente com a finalidade de contribuir no aperfeicoamento do Sistema e, consequentemente, melhorar a saude publica do pais.

Recomendação de códigos da CID-10 para vigilância de reações adversas e intoxicações a medicamentos

The scope of this study is to analyze the determinants of the use of appetite suppressants (amfepramone, femproporex, mazindol and sibutramine) through the estimation of a dynamic panel dataset model for the Brazilian state capitals and the Federal District (DF) in the period from 2009 to 2011. The results show that consumption of appetite suppressants did not follow the geographic distribution of overweight and obese individuals across the capitals and DF. There is a recurrent consumption of appetite inhibitors, in which 79% of the current consumption of these drugs is explained by past consumption. Among the variables that explain the use of inhibitors, the percentage of obese adults, the percentage of adults who habitually consume fruit and vegetables, and the coverage rate of health plans stand out. The pharmaco-econometric analysis suggests that there are problems in the rational use of appetite suppressants in the Brazilian state capitals and the Federal District with respect to both the combined consumption of these drugs with other medicines - deemed illegal by the Federal Council of Medicine and ANVISA - and in the therapeutic prescription of these products.

Causalidade em farmacoepidemiologia e farmacovigilância: uma incursão teórica

ICD-10 is the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD), a medical classification list by the World Health Organization. It contains codes for diseases, signs and symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or diseases. Associations between variables were evaluated using Pearsons chi-squared test and multiple correspondence analysis. Six hundred and ninety-one (691) codes were identified related to adverse drug reactions (52.1%) and drug poisoning (47.9%). A total of 687 (99.4%) and 511 (73.9%) codes were validated in 1st and 2nd validation, respectively. There were statistically significant differences (p <0.05) between adverse reactions and drug poisoning in the variables used to characterize the reference list. The association between drug and hospital admission and death was statistically significant when stratified by type of adverse event (p <0.001). Three groupings of codes were identified in multiple correspondence analysis where there are associations between categories of response assessed. The reference list can be a useful tool in pharmacovigilance actions in Brazil.Resumo Propor uma lista-referencia de codigos da Classificacao Internacional de Doencas e Problemas Relacionados a Saude (CID-10) para a vigilância de reacoes adversas e intoxicacoes a medicamentos, denominados de eventos adversos. A elaboracao da lista-referencia percorreu quatro fases: definicao dos codigos, validacao e duas de caracterizacao da lista. As associacoes entre variaveis foram avaliadas por qui-quadrado de Pearson e analise de correspondencia multipla. Foram identificados 691 codigos relacionados com reacao adversa a medicamentos (52,1%) e intoxicacao medicamentosa (47,9%). Um total de 687 (99,4%) e 511 (73,9%) codigos foram validados na 1a e 2a validacao, respectivamente. Ha diferencas estatisticamente significativas (p < 0,05) entre reacoes adversas e intoxicacao medicamentosa nas variaveis utilizadas para a caracterizacao da lista-referencia. A associacao entre medicamento e admissao hospitalar e obito foi estatisticamente significativa quando estratificada por tipo de evento adverso (p < 0,001). Na analise de correspondencia multipla identificou-se tres agrupamentos de codigos em que ha associacoes entre as categorias de resposta das variaveis estudadas. A lista-referencia pode ser uma ferramenta util nas acoes de farmacovigilância no Brasil.

Miracle drug: Brazil approves never-tested cancer medicine:

The article presents some considerations about causality in Pharmacoepidemiology and Pharmacovigilance. To begin, we provide a brief introduction about the importance of the issue, noting that the understanding of causal relationships is considered one of sciences greatest achievements and has been, over time, a continuous and central concern of philosophers and epidemiologists. Next, we describe definitions and types of causes, demonstrating their influences on pharmacoepidemiological thought. After that, we present Rothmans multi-causal model as one of the founding explanations of multiple causality and the issue of causality assessment. We conclude with some comments and reflections on causality from the perspective of health surveillance, particularly with regard to regulations on pharmacovigilance.

Medicamentos de risco para a gravidez e lactacao comercializados no Brasil: uma nalise de bulas

Background Brazil recently approved synthetic phosphoetanolamine, a popularly dubbed ‘cancer pill’, a substance that has been shown to kill cancer cells in lab animal models but was not yet formally accessed in humans, and thus despite the existence of any evidence of its efficacy and safety. Methods The authors describe the recent decision of Brazil to aprove phosphoetanolamine in the context of growing ‘judicialization’ to promote access to medicines and thus reinforcing a growing sense of legal uncertainty. Results The approval of phosphoetanolamine despite the existence of any evidence of its efficacy and safety represents to the authors one of the saddest and surrealistic episodes in Brazil’s recent public health history. Brazil’s current economic crisis is fueling the ‘judicialization’ to promote access to medicines and thus reinforcing a growing sense of legal uncertainty in the context of rising economic constrains and a progressive failing state. The authors state that the Phosphoetanolamine’s approval bill violates current legal prohibition of commercialisation of drugs without the Brazilian national drug regulatory agency’s approval and thus may represent a potential menace to Brazil’s pharmacogovernance and the country’s governance to health technology assessment at the Brazilian national health systems. Conclusion Phosphoetanolamine’s approval illustrates that the combination of flawed decision making, economic crisis and political interference may threaten weak governance mechanisms for drug regulation and health technology assessment and thus representing an extra burden in the sustainability of universal access-based national health systems.