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.

Prescrição de exercício físico para mulheres com síndrome dos ovários policísticos: impacto sobre a aptidão cardiorrespiratória e resposta afetiva

analisar o efeito do treinamento aeróbio periodizado sobre a aptidão cardiorrespiratória e respostas afetivas em mulheres com síndrome dos ovários policísticos (SOP) e II) investigar se o exercício aeróbio realizado na zona de prazer para essa população atende a recomendação do American College of Sports Medicine (ACSM) no que se refere à intensidade para melhoria da saúde. Metodologia: foram incluídas mulheres na faixa etária entre 18 e 34 anos, com diagnóstico de SOP de acordo com o Consenso de Rotterdam. Para o subestudo I, oito pacientes sedentárias participaram de 16 semanas de treinamento aeróbio com incrementos mensais de intensidade: fase 1 = 60-70% da frequência cardíaca máxima (FCmax); fase 2 = 70-75% da FCmax; fase 3 = 75-80% da FCmax; fase 4 = 80-85% da FCmax. A intervenção foi realizada três vezes por semana, 40 minutos por sessão. Em todas as sessões foram registradas as respostas afetivas (Feeling Scale -5/+5) e a percepção subjetiva do esforço (escala de Borg CR 6-20). Antes e após a intervenção, as voluntárias realizaram teste ergoespirométrico. Para o subestudo II, 11 pacientes realizaram duas sessões de exercício aeróbio na zona de prazer, sendo registrados parâmetros relativos à demanda física através de receptor de GPS (Global Positioning System) de pulso com cardiofrequencímetro acoplado. As pacientes foram instruídas a realizar 40 minutos de exercício guiadas pelas âncoras verbais bom e muito bom (+3 e +5 na Feeling Scale). Resultados: no subestudo I, após 16 semanas de treinamento, houve aumento da aptidão cardiorrespiratória máxima (17,3%) e submáxima (21,5%). As respostas afetivas variaram entre bom (+3,1 ± 0,8) e razoavelmente bom xi (1,0 ± 0,9) e a percepção subjetiva do esforço entre muito leve a leve (10,2 ± 0,7) e um pouco difícil (12,7 ± 0,6) durante a intervenção. No subestudo II, as pacientes exercitaram-se a ~72,5 ± 6% da FC máxima, ~78,5 ± 6% da FC no limiar anaeróbio e passaram > 95% do tempo em intensidade moderada (~82%) e vigorosa (~16%) durante as sessões experimentais. Em média, as voluntárias reportaram as sessões como fácil (percepção subjetiva do esforço da sessão ~2,2 ± 0,7). Conclusões: o programa de treinamento aeróbio periodizado aumentou a aptidão cardiorrespiratória das pacientes analisadas e foi percebido como uma intervenção prazerosa. Adicionalmente, exercício aeróbio realizado de forma prazerosa atende a recomendação do ACSM no que se refere à intensidade para melhoria da saúde

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

Investigação farmacoepidemiológica do uso do clonazepam no distrito sanitário leste em Natal-RN

Prescription errors are the most serious type of medication errors found in the health system. The main purpose of this study was to evaluate the quality of clonazepam prescriptions. A descriptive and observational study with retrospective data collection was conducted at 30 community pharmacies in Natal/RN, Brazil, after informed consent was obtained from the pharmacists. A sample of 313 prescription notifications was randomly collected in October 2009. They were analyzed for legible handwriting and completeness. During the study, one researcher, two pharmacists, and one pharmacy undergraduate student evaluated patient and purchaser identification, pharmaceutical form, dosing regimen, administration route, and prescription by generic name. This research was approved by the institutional Ethics Committee. Among the 313 collected notifications, only 44.1% were legible. A total of 55.91% (175/313) had at least one illegible item, 100% contained incomplete information, and 97.12% (304/313) contained one or more abbreviations. The proportion of illegible handwriting related to the patient s identification (p=0.0001) was statistically significantly greater than that related to the drug purchaser s identification (p=0.0004). Contrary to legal requirements, prescriptions with the generic name accounted for 13.42% (42/313) of the total. All the examined notifications were handwritten. Prescription errors, which potentially can have serious consequences, have been evaluated worldwide, although little is known about this subject as it relates to community pharmacies. This study showed high percentages of prescribing problems, which justifies the development of future research about medication errors in community pharmacies and education activities for prescribers

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

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

A mediação como instrumento concretizador do direito fundamental à saúde: uma alternativa à judicialização de conflitos Natal 2013

In Brazil, the 1946 Constitution enshrined the right to health, having it defined as the possession of the best state of health that the individual can achieve. Already the Federal Constitution of 1988 lifted that right to the status of fundamental social right, which transcends the effectiveness and cure of the disease is based on the joint liability of public entities for the provision of a quality service, efficient and prioritize human dignity and comprehensive evaluation of patients. According to the World Health Organization, the definition of health, first characterized as the mere absence of disease, has become recognized as the need to search for preventive mechanisms to ensure the welfare and dignity of the population. Garantista this context, the growing seem lawsuits that deal with the implementation of public policies, especially in the area of the right to health, the omission of which the Government can result in the risk of death. Hence the concern of law professionals about whether or not the intervention of the judiciary in cases that deal with providing material benefits of health care. It claims to break the principle of separation of powers, disobedience to the principle of equality and the impossibility of judicial intervention in the formulation of public policy to try and exclude the liability of public entities. In contrast, the judiciary has repeatedly guardianships granted injunctions or merit determining the supply of materials indicated by the medical benefits that accompany the treatment of patients who resort to a remedy. In this context, mediation, object of study and resolution presented in this work, is presented as an instrument conciliator between the reserve clause and the right to financially possible existential minimum, as it seeks to serve all through rationalization of health services , avoidance of negativistic influence of the pharmaceutical industry, with prioritizing the welfare of the individual and the quality of relationships. This is alternative way to judicialization that in addition to encouraging and developing active citizen participation in public policy formulation also allows the manager to public knowledge of community needs. It is in this sense that affirms and defends the right to health is no longer the mere provision of medical care and prescription drugs, but a dialogue conscious existential minimum to guarantee a dignified life