Avaliação do polimorfismo de fármacos utilizados para produção de medicamentos genéricos no Brasil

O polimorfismo é definido como a tendência de uma substância em se cristalizar em diferentes estados cristalinos. A presença de diversas formas cristalinas diferentes para um mesmo fármaco pode alterar algumas das propriedades físico-químicas da substância, dentre as quais a sua solubilidade, o que pode afetar diretamente o seu perfil de dissolução. O objetivo do trabalho foi revisar a literatura sobre os métodos de detecção de polimorfismo dos fármacos e avaliar diferentes amostras de carbamazepina disponíveis no Brasil visando identificar a presença de diferente polimorfos. A carbamazepina apresentou indícios de polimorfismo no DSC para algumas das cinco amostras, o que não foi confirmado pelos demais métodos empregados (IV e raio-X). Após os testes de dissolução, os perfis foram comparados com a amostra de referência e apenas uma das amostras apresentou perfil de dissolução semelhante quando comparado ao padrão através do cálculo de f1 e f2. Os resultados observados na etapa prática sinalizam que se faz necessário o desenvolvimento e aprofundamento do assunto junto à Anvisa com vistas à preservação da segurança dos medicamentos dos medicamentos genéricos comercializados no País.

Riscos e benefícios para o feto e recém-nascido de medicamentos utilizados na gestação : misoprostol e antianêmicos

Foi investigada a associação entre a utilização pré-natal de medicamentos com finalidade profilática, terapêutica e não-terapêutica e desfechos adversos da gravidez. Foram analisadas as evidências sobre o potencial teratogênico do misoprostol, por meio de revisão sistemática e metanálise de estudos de caso-controle. A partir da base de dados do Estudo Brasileiro de Diabetes Gestacional (EBDG), uma coorte multicêntrica de gestantes atendidas pelo Sistema Único de Saúde em seis capitais brasileiras, foi analisada a associação entre o uso referido de medicamentos para induzir a menstruação e desfechos adversos perinatais, incluindo anomalias congênitas, morte intra-uterina e nascimento pré-termo. O uso referido e prescrito de sais de ferro, isolado ou associado a vitaminas, foi analisado quanto aos riscos e benefícios da utilização profilática ou terapêutica em relação a nascimento pré-termo e baixo peso ao nascer. Quatro estudos envolvendo 4899 casos de anomalias congênitas e 5742 controles foram incluídos na revisão sistemática de acordo com os critérios de seleção. Nenhum estudo analisou outros efeitos adversos do misoprostol no resultado da gestação. Foi estimado um risco aumentado de anomalia congênita associada ao uso de misoprostol para qualquer defeito congênito (RC= 3,56; IC 95% 0,98 – 12,98), seqüência de Moebius (RC= 25,31; IC 95%11,11 – 57,66) e redução transversa de membros (RC=11,86; IC 95% 4,86 – 28,90). Entre as 4856 gestantes estudadas a partir da base de dados do EBDG, 707 (14,6%) relataram o uso de substâncias para induzir a menstruação, das quais as mais citadas foram chás, hormônios sexuais e misoprostol. Foi verificada associação positiva entre misoprostol e anomalias congênitas ajustado para centro de realização da pesquisa (RC 2,64: IC 95% 1,03 – 6,75). Foi detectada associação positiva entre o uso de hormônios sexuais e anomalias congênitas (RC 2,24; IC 95% 1,06 – 4,74), independente do centro de realização da pesquisa. Para os desfechos morte intra-uterina e nascimento pré-termo, não foi verificada qualquer associação com o uso de misoprostol, hormônios sexuais ou chás. Entre as 3865 gestantes estudadas quanto ao uso de sais de ferro durante a gestação, 805 (20,8%) referiram o uso de sais de ferro isolado e 1136 (29,4%) ferro associado a vitaminas. O uso prescrito de sais de ferro isolado foi verificado para 1973 gestantes (51,0%) e de ferro vi associado a vitaminas prescrito para 890 (23%). A prevalência de anemia foi de 31,3%. Entre as gestantes anêmicas, 70,9% utilizavam sais de ferro e entre as não-anêmicas, o percentual foi de 51,5%. Após ajustamento para potenciais confundidores, o uso prescrito de sais de ferro isolado apresentou associação negativa para nascimento pré-termo em gestantes anêmicas (RC 0,57 IC 95% 0,40 – 0,80) mas não em gestantes não-anêmicas. Para as demais exposições analisadas, não foi verificado qualquer associação. Não foi detectada associação entre o uso de sais de ferro e/ou vitaminas e baixo peso ao nascer. Os resultados apresentados indicam que o uso de misoprostol em gestações que não se perdem está associado a um maior risco de anomalias congênitas, em geral, e de Seqüência de Moebius e redução transversa de membros, em particular. O uso terapêutico de sais de ferro em gestantes anêmicas mostrou associação negativa para nascimento pré-termo. Entretanto, o uso de sais de ferro em gestantes não anêmicas não mostrou relação com os desfechos analisados.

Concorrência e acesso a medicamentos: evergreening em perspectiva comparada

Este trabalho estuda o fenômeno do evergreening, definido como o uso de patenteamento secundário para a obtenção de extensão indevida na proteção patentária sobre uma criação, sob a perspectiva do direito da concorrência no Brasil, União Europeia, Estados Unidos e Índia. Baseia-se em suas experiências com esta prática para determinar a aplicabilidade do direito da concorrência brasileiro e mais alternativas institucionais para abordar o problema.

Centro de Informação sobre Medicamentos - CIM: avaliação da informação prestada

Providing information about medication, an essential function of pharmaceutical practice to ensure rational drug use, is an important activity of hospital pharmacy services. The Drug Information Center of Onofre Lopes University Hospital (DIC-HUOL) initiated its activities in 1979 with the first Clinical Pharmacy Service in Brazil. The aim of this study was to assess information provided by DIC-HUOL, describing the profile of passive information offered by the center. A retrospective cross-sectional study was conducted to identify the profile of information requests (IR). One hundred percent of the IR received by the DIC between January 2008 and December 2009 were used. The results were divided by year to determine the influence of the restructuring process that occurred in 2008 and 2009. The study at DIC-HUOL showed a mean of 5.5 IR/month in 2008 and 20.3 IR/month in 2009; the mean of the last year is comparable to that of other Brazilian DIC. Most of the IR were made by medical residents (22.7%) in 2008 and by pharmacists (32.5%) in 2009. The significant use of the DIC by medical residents may be due to its location in a university hospital. The most recurrent types of IR concerned issues related to pathway/mode of administration (16.8%) and drug stability (13.1%) in 2008 and 2009, respectively. Requests were made verbally in 100% of the cases in 2008 and 78.8% in 2009, owing to the fact that most of the DIC users were professionals from the hospital itself. Time elapsed between request and response was not reported in 83.3% and 21.3% of the cases in 2008 and 2009, respectively. The most widely used bibliographic source during the two years was MICROMEDEX®, with 41.9% and 39.2%, respectively. The restructuring process had a positive influence on the DIC-HUOL, exhibiting similar parameters to those of other Brazilian DIC, but some of these parameters must be improved to achieve international standards

Avaliação da publicidade de medicamentos veiculada nas principais emissoras de rádio de Natal-RN

Drugs advertising is one of the most important marketing resources used by the pharmaceutical industry to induce people to buy these products although they do not have the real necessity to use them. The purpose of this article is to evaluate drugs advertisings transmitted on radio stations in Natal/RN, from October 2007 to September 2008. Were collected 228 advertising pieces, where, 21 were different among themselves and corresponded to 15 drugs. The results showed that 73,3% of the drugs ads were announced on AM station and 26,7% on FM station. The majority of the drugs were constituted of analgesics (26%), following by antiacids, vitamins, phitotherapics (13% each). The legal analysis showed that each advertising had some kind of infraction. The omission of the registration number happened in each advertising, following by the totally lack of contraindications (95,2%) and contraindications DCB/DCI (76,2%). In 42,9% advertisements were observed the relation between drugs use and physique/intellectual/emotional/sexual performance and/or beauty and 33% of them had abusive exploration of illnesses. The obligatory warning was omitted in 28,6% and the offer of financial bonus happened in 9,5% cases. The content analysis demonstrated that the most persuasion and convincing elements observed were indicatives of consumption appeal (34,2%). The study indicates the necessity of the topic drugs advertisements to be treated in a wide context, that is, to be discussed as a public health concern. Although the advertising regulation and inspection is the State responsibility , this should be shared with the advertising agency, pharmaceutical industry and media. Furthermore, it is indispensable to inform and to conscience the population of their rights in such mistaken situation

Micropartículas de poli (ácido lático-co-ácido glicólico) obtidas por spray drying para a liberação prolongada de metotrexato

Methotrexate (MTX) is a drug used in the chemotherapy of some kind of cancers, autoimmune diseases and non inflammatory resistant to corticosteroids uveits. However, the rapid plasmatic elimination limits its therapeutic success, which leads to administration of high doses to maintain the therapeutic levels in the target tissues, occurring potential side effects. The aim of this study was to obtain spray dried biodegradable poly-lactic acid co-glycolic acid (PLGA) microparticles containing MTX. Thus, suitable amounts of MTX and PLGA were dissolved in appropriate solvent system to obtain solutions at different ratios drug/polymer (10, 20, 30 and 50% m/m). The physicochemical characterizing included the quantitative analysis of the drug using a validate UV-VIS spectrophotometry method, scanning electron microscopy (SEM), infrared spectrophotometry (IR), thermal analyses and X-ray diffraction analysis. The in vitro release studies were carried out in a thermostatized phosphate buffer pH 7.4 (0.05 M KH2PO4) medium at 37°C ± 0.2 °C. The in vitro release date was subjected to different kinetics release models. The MTX-loaded PLGA microparticles showed a spherical shape with smooth surface and high level of entrapped drug. The encapsulation efficiency was greater then 80%. IR spectroscopy showed that there was no chemical bond between the compounds, suggesting just the possible occurrence of hydrogen bound interactions. The thermal analyses and X-ray diffraction analysis shown that MTX is homogeneously dispersed inside polymeric matrix, with a prevalent amorphous state or in a stable molecular dispersion. The in vitro release studies confirmed the sustained release for distinct MTX-loaded PLGA microparticles. The involved drug release mechanism was non Fickian diffusion, which was confirmed by Kornmeyer-Peppas kinetic model. The experimental results demonstrated that the MTX-loaded PLGA microparticles were successfully obtained by spray drying and its potential as prolonged drug release system.

A propaganda de medicamentos voltados à clínica obstétrica e/ou ginecológica e sua influência sobre a prescrição

INTRODUCTION: Drug advertisement stimulates self-medication and irrational use of medicines, especially when it starts to interfere in the prescription. Monitoring advertisements, as well as the observation of its influence on health professionals, prescriptions become necessary because of this public health problem. OBJECTIVE: The aim of this work was to analyze drug advertisements directed to gynecologists and/or obstetricians doctors relating them to the current legislation as well as its influence on prescription. METHODOLOGY: The sample was composed of drug advertisements divulged to the gynecologists and / or obstetricians doctors and was analyzed according to RDC96/2008. To evaluate the influence of advertisement on prescription, a questionnaire was administered to gynecologists / obstetricians doctors and prescriptions of a public maternity were also evaluated. RESULTS AND CONCLUSION: Concerning the advertisements analyzed, 48% complied fully with current legislation and 52% of the advertisements analyzed were in accordance to the RDC No. 96/2008 in most of the items evaluated. The doctors interviewed are used to receive the visits of propagandists, even in the public service, receiving gifts offered by the industry and believe that medicine advertisement tries to influence prescribing. Many of them use the material provided by the propagandist as a source for their prescription, although they present a critical view about them information. The use of trade name / mark on the prescription is a common practice among the doctors interviewed, even in the public service, suggesting there is an influence of medicine advertisement on the prescription

O direito à saúde: a medida do dever do estado de fornecer Medicamentos de dispensação excepcional à sociedade sob a ótica do desenvolvimento

It is a fact that the fundamental rights of citizens are being recognized and guaranteed by the state over time, regardless of the belief that if these rights has always been part of the heritage of subjective individuals, or whether they will be aggregated during the course of human history. In that, emerged the rights of freedom of men and, subsequently, the rights to create a situation of equality between the humans, the so-called social rights. In turn, as these rights known as social, to be implemented, need a positive action by the state, more precisely by the state power whose function is to manage public money and create policies for implementation of fundamental rights. Given this, pay attention to the right to health, was created the Programa de Medicamentos de Dispensação Excepcional, which aims to provide high-cost medicines to citizens Brazilian carriers of serious diseases, such as Alzheimer's and Mal Hepatitis C. Also on the program, it provides a way which will be mandatory that the drugs will be offered in such situations, and does not include a means of updating the list predicted able to monitor the progress of medicine that have been in the interest of the program. Given that, at present it is necessary to mention the recognition of another fundamental right: the right to development, which is the right of access to positive actions being implemented by the State, which are nothing more than public policy, gender which the Programa de Medicamentos de Dispensação Excepcional is kind. Thus, through the search in legislation and doctrine in relation to the theme, this work has the aim to examine the extent of the state to provide exceptional dispensing of medicines. Specifically, if the State in attention to the right to development and the implementation of the right to health, can really list exhaustively the drugs to be provided by the State, and what are the elements guiding this choice and how to control the same

O direito à saúde e a política nacional de atenção oncológica: uma análise a partir da crescente judicialização dos medicamentos antineoplásicos

The 1988 Federal Constitution of Brazil by presenting the catalog of fundamental rights and guarantees (Title II) provides expressly that such rights reach the social, economic and cultural rights (art. 6 of CF/88) as a means not only to ratify the civil and political rights, but also to make them effective and practical in the life of the Brazilian people, particularly in the prediction of immediate application of those rights and guarantees. In this sense, health goes through condition of universal right and duty of the State, which should be guaranteed by social and economic policies aimed at reducing the risk of disease and other hazards, in addition to ensuring universal and equal access to actions and services for its promotion, protection and recovery (Article 196 by CF/88). Achieving the purposes aimed by the constituent to the area of health is the great challenge that requires the Health System and its managers. To this end, several policies have been structured in an attempt to establish actions and services for the promotion, protection and rehabilitation of diseases and disorders to health. In the mid-90s, in order to meet the guidelines and principles established by the SUS, it was established the Política Nacional de Atenção Oncológica PNAO, in an attempt to sketch out a public policy that sought to achieve maximum efficiency and to be able to give answers integral to effective care for patients with cancer, with emphasis on prevention, early detection, diagnosis, treatment, rehabilitation and palliative care. However, many lawsuits have been proposed with applications for anticancer drugs. These actions have become very complex, both in the procedural aspects and in all material ones, especially due to the highcost drugs more requested these demands, as well as need to be buoyed by the scientific evidence of these drugs in relation to proposed treatments. The jurisprudence in this area, although the orientations as outlined by the Parliament of Supreme Court is still in the process of construction, this study is thus placed in the perspective of contributing to the effective and efficient adjudication in these actions, with focus on achieving the fundamental social rights. Given this scenario and using research explanatory literature and documents were examined 108 lawsuits pending in the Federal Court in Rio Grande do Norte, trying to identify the organs of the Judiciary behave in the face of lawsuits that seeking oncology drugs (or antineoplastic), seeking to reconcile the principles and constitutional laws and infra constitutional involving the theme in an attempt to contribute to a rationalization of this judicial practice. Finally, considering the Rational Use of health demands and the idea of belonging to the Brazilian people SUS, it is concluded that the judicial power requires ballast parameters of their decisions on evidence-based medicine, aligning these decisions housing constitutional principles that the right to health and the scientific conclusions of efficacy, effectiveness and efficiency in oncology drugs, when compared to the treatments offered by SUS