Regulamentação e criminalização das drogas no Brasil / Drug regulation and criminalization in Brazil

O presente estudo visa avaliar, através de uma revisão narrativa da literatura, como o controle do Estado exerceu ao longo da história do Brasil a regulamentação do uso de drogas. Método Foram consultados livros, artigos de periódicos acadêmicos indexados, trabalhos completos apresentados em congressos e documentos históricos disponíveis na internet relativos ao tema. Resultados A primeira legislação penal em relação ao uso de drogas surge apenas no Brasil império. Nesse período começam a surgir também os primeiros problemas devido ao uso de drogas. A criação de cursos superiores nas áreas de saúde e de ciências naturais veio a formar profissionais capacitados na manipulação e fiscalização de produtos químicos e farmacêuticos. Com o tempo, observando-se os efeitos, algumas substâncias passam a ser proscritas. Conclusão Por toda história do país, o uso e a regulação das drogas, permearam todas as épocas influenciando na cultura, educação e no modo de vida da população. Atualmente há um grande debate acerca das políticas sobre drogas no Brasil, principalmente sobre a maconha e seus usos terapêuticos, mostrando novamente a influência do Estado sobre a saúde e a segurança da população.

The present study aims to evaluate, through a narrative review of the literature, how State's control has exercised regulation of drug use throughout the history of Brazil. Method Books, articles from indexed academic journals, complete works presented at conferences and historical documents available on the internet relating to the topic were consulted. Results The first criminal legislation related to drug use only appeared in Imperial Brazil. During this period, the first problems due to drug use also begin to appear. The creation of higher education courses in the areas of health and natural sciences resulted in the training of professionals capable of handling and supervising chemical and pharmaceutical products. Over time, observing the effects, some substances become proscribed. Conclusion Throughout the country's history, the use and regulation of drugs has permeated all eras, influencing culture, education and the population's way of life. There is currently a great debate about drug policies in Brazil, mainly regarding marijuana and its therapeutic uses, once again showing the influence of the State on the health and safety of the population.

Detección de drogas en saliva: aspectos metodológicos y legales / Detection of drugs in saliva: methodological and legal aspects

El análisis de drogas en saliva es una alternativa no invasiva para evidenciar su presencia en el organismo. La finalidad es amplia, pero se ha utilizado en medicina legal y forense, en especial para drogas ilícitas. La recolección de saliva no implica riesgo, ni personal especializado. El objetivo fue valorar diversos aspectos metodológicos y de validez del test de drogas en saliva para el diagnóstico de su consumo. Asimismo, se analizaron algunos aspectos relativos a la legislación de drogas. Las sustancias psicoactivas a evaluar fueron marihuana, cocaína, anfetaminas y opiáceos. Se realizó una búsqueda en las bases de Pubmed/MEDLINE, Embase, LILACS, Scopus, SciELO y de literatura gris. La identificación de drogas en fluidos biológicos incluye técnicas inmunoquímicas, cromatográficas y procedimientos espectrométricos. Resultados positivos obtenidos mediante una técnica deberían confirmarse con un segundo análisis basado en distintos principios químicos o físicos. Se han detectado en saliva marihuana, cocaína, opiáceos y anfetaminas, entre otras, mediante métodos analíticos, como inmunoensayo y cromatografía de gases / espectrometría de masas en tándem. En el fluido oral, se pueden detectar drogas de abuso durante 5-48 horas posteriores al consumo, a un nivel bajo de nanogramos por mililitro. Se concluyó que la detección de drogas en saliva es una opción indicada ante sospecha de su consumo, por signos o síntomas que sugieren abuso de drogas o para la vigilancia del usuario en un centro de tratamiento por dependencia. En el aspecto legal el uso de test de drogas en saliva es una posibilidad para determinadas circunstancias.

The analysis of drugs in saliva is a non-invasive alternative to demonstrate their presence in the body. The purpose is broad, but it has been used in forensic and legal medicine, especially for illicit drugs. The collection of saliva is not risky and does not require specialized personnel. The objective was to assess various methodological and validity aspects of the saliva drug test for the diagnosis of drug use. Likewise, some aspects related to drug legislation were analyzed. The psychoactive substances to be evaluated were marijuana, cocaine, amphetamines and opiates. A search was carried out in the Pubmed / MEDLINE, Embase, LILACS, Scopus, SciELO and gray literature databases. Identification of drugs in biological fluids was found to include immunochemical, chromatographic and spectrometric procedures. Positive results obtained by one technique must be confirmed with a second analysis based on different chemical or physical principles. Marijuana, cocaine, opiates and amphetamines, among other drugs, have been detected in saliva by various analytical methods, like immunoassay and gas chromatography / tandem mass spectrometry. In oral fluid, drugs of abuse can be detected for 5-48 hours post-consumption, at a low level of nanograms per milliliter. It was concluded that the detection of drugs in saliva is an option that is indicated in the event of suspected drug use, for signs or symptoms that suggest drug abuse, or for monitoring the user in a dependency treatment center. In the legal aspect, the use of drug tests in saliva is a possibility for certain circumstances.

Lung cancer mortality trends in Mexico, 1998-2018: the impact of the General Law on Tobacco Control / Tendências de mortalidade por câncer de pulmão no México, 1998-2018: o impacto da Lei Geral de Controle do Tabaco

ABSTRACT: Objective: The aim of this study was to describe trends in lung cancer (LC) mortality and trends in tobacco use. Methods: This is an ecological time-series study to determine mortality trends due to lung cancer resulting from tobacco consumption, based on secondary open-access sources, such as the National Surveys. Smoking prevalence, tobacco use trends, mortality rates, and percentage were determined by LC. The mortality trend from LC was calculated, and a linear regression analysis was performed to evaluate the impact of the General Law for Tobacco Control. Results: The prevalence of tobacco use decreased steadily between 1988 and 2015, particularly in men. Mortality rates and percentage decreased between 1998 and 2018. During this period, the mortality rate decreased from 6.3 to 5.4 per 100,000 population (−0.032/100,000 each year, p<0.001), with a net decrease of 0.9 per 100,000. We observe increases in mortality in women in the central and southeastern regions. Of 32 states, 18 showed a tendency to loss (p<0.005). The rate of change for men was −0.24, with a total reduction of 2.17 before the introduction of the laws and −0.32 after their introduction, a total reduction of 3.24 (p<0.005). Women showed no reduction. Conclusions: Mortality rates showed a limited decrease. Strategies need to be strengthened, mainly in the central and southeastern regions, and to focus on the control of tobacco use by women.

RESUMO: Objetivos: Descrever tendências na mortalidade por câncer de pulmão e no uso do tabaco. Métodos: Realizamos um estudo ecológico de séries temporais para determinar a tendência de mortalidade por câncer de pulmão de acordo com o consumo de tabaco, com base em fontes secundárias de acesso aberto, como as Pesquisas Nacionais. Prevalência de tabagismo, tendências de uso de tabaco, porcentagem e taxas de mortalidade foram determinadas pelo câncer de pulmão. A tendência de mortalidade por câncer de pulmão foi calculada e uma análise de regressão linear foi realizada para avaliar o impacto da lei geral para o controle do tabagismo. Resultados: A prevalência do uso de tabaco diminuiu continuamente entre 1988 e 2015, principalmente em homens. As taxas e percentuais de mortalidade diminuíram entre 1998 e 2018. Durante esse período, a taxa de mortalidade diminuiu de 6,3 para 5,4 por 100 mil habitantes (-0,032 por 100 mil a cada ano, p<0,001), com redução líquida de 0,9 por 100 mil. Observamos aumentos na mortalidade de mulheres nas regiões Centro e Sudeste. Dos 32 estados, 18 apresentaram tendência à perda (p<0,005). A taxa de mudança para os homens foi de -0,24, com redução total de 2,17 antes da introdução das leis e -0,32 após a sua introdução — redução total de 3,24 (p<0,005). As mulheres não apresentaram redução. Conclusões: As taxas de mortalidade mostraram redução limitada. Estratégias precisam ser fortalecidas, principalmente nas regiões Centro e Sudeste, e deve-se enfocar o controle do uso do tabaco pelas mulheres.

Forced degradation studies to identify organic impurities in pharmaceuticals: a Brazilian perspective

Objective: The aim of this study was to highlight and sediment the necessary steps to be followed while conducting forced degradation studies to identify degradation products and to describe the Brazilian and international regulations associated with degradation studies of drugs and drug products. Methods: This review was conducted based on the Brazilian guidance tools as RDC 53/2015, Guide 4 and Question and Answer resource; references used as international guides; and articles in the field of degradation product analyses. Results: Characterization of the impurity profile for a substance, and development of indicative stability methods are essential criteria for compliance with current legislation, and address a legitimate health concern. As this matter falls under the purview of recently published regulation, many doubts remain regarding methods of conducting studies of forced degradation, and development of methods indicative of stability. Analytical conditions predict degradation after exposing them to thermal, humid, acidic, basic, oxidation, photolytic, and metal ion conditions. Conclusions: Although RDC 53/2015 outlines the parameters of degradation, the analytical conditions are not specified, as well as in other international standards. A well-designed forced degradation study is key to obtaining a good stability indicating method with peak purity and mass balance.

Regulación del uso de marihuana en colombia con fines medicinales / Regulation of the use of marijuana in colombia with medicinal purposes / Regulação do uso de maconha em colômbia com fins medicinais

OBJETIVO: Interpretar el proceso de regulación del uso de marihuana con fines medicinales. MATERIALES Y MÉTODOS: Cualitativo con enfoque hermenéutico, utiliza la técnica de entrevista, se aplicó a 15 expertos en octubre de 2015. Se hizo triangulación: expertos, artículos científicos e investigadores. Se realizó interpretación a partir de sistema categorial y de apoyo de programa Atlas. Ti. RESULTADOS: El debate sobre la regulación de la marihuana con fines terapéuticos se continúa dando en el mundo, en especial en relación a los beneficios para la salud. Con el uso de algunos cannabinoides ya existen evidencias, pero expertos consultados reconocen que no son suficientes; en estos casos se recomienda más investigación. Los expertos de diversas disciplinas entrevistados respaldan el argumento que con la prohibición poco se ha conseguido y que los enfoques de salud pública traen una apertura científica no represiva a la situación, situando el debate en los posibles beneficios que puede traer para el tratamiento de algunas enfermedades. Estos procesos regulatorios deben considerar un control sobre la producción, fabricación, exportación, distribución, comercio y uso del cannabis con fines médicos e investigativos; proceso distinto al de la legalización del consumo con fines recreativos. CONCLUSIÓN: Para el caso colombiano, la regulación del cannabis con fines medicinales hasta hace unos meses era solo una discusión con posiciones radicalizadas a favor y en contra. Hoy es una realidad en términos de legislación pues fue aprobada por decreto, pero con escaso debate y acción pedagógica de lo que implica la ley para población.

OBJECTIVE: To understand the process of regulating the use of marijuana for medicinal purposes.MATERIALS AND METHODS: Hermeneutical method with qualitative approach, using the interview technique, applied to fifteen experts in October 2015. Interpretation was performed from categorical system and support of Atlas.ti bar program. RESULTS: The debate on the regulation of marijuana for therapeutic purposes continuous sweeping the globe, particularly in relation to health benefits. With the use of some cannabinoids there is some evidence, but experts consulted recognize that they are not sufficient in these cases: further investigation is recommended. The interviewed experts from different disciplines support the arguments that the ban imposed over marijuana little has achieved and that public health approaches bring a non-repressive scientific openness to the situation, placing the debate on the potential benefits it can bring for the treatment of some diseases. These regulatory processes must consider control over the production, manufacture, export, distribution, sale and use of cannabis for medical and research purposes, other than the legalization of recreational use process. CONCLUSION: For the Colombian case, the regulation of cannabis for medicinal purposes, until a few months ago was just an argument with radicalized positions for and against. Today it is reality as it was approved by decree on which progress in terms of legislation is being done, but with little debate, research and information to the population.

OBJETIVO: Interpretar o processo de regulação do uso de maconha com fins medicinais. MATERIAIS E MÉTODOS: Qualitativo com enfoque hermenêutico utiliza a técnica de entrevista, se aplicou a 15 expertos em outubro de 2015. Fez-se triangulação: expertos, artigos científicos e investigadores. Realizou-se interpretação a partir de sistema categorial e de apoio de programa Atlas. Ti. RESULTADOS: O debate sobre a regulação da maconha com fins terapêuticos se continua dando no mundo, em especial em relação aos benefícios para a saúde. Com o uso de alguns canabinoides já existem evidencias, mas expertos consultados reconhecem que não são suficientes; nestes casos se recomenda mais pesquisa. Os expertos de diversas disciplinas entrevistados sustentam o argumento que com a proibição pouco se tem conseguido e que os enfoques de saúde pública trazem uma apertura científica não repressiva à situação, situando o debate nos possíveis benefícios que pode trazer para o tratamento de algumas doenças. Estes processos regulatórios devem considerar um controle sobre a produção, fabricação, exportação, distribuição, comercialização e uso do cannabis com fins médicos de pesquisa; processo distinto ao da legalização do consumo com fins recreativos. CONCLUSÃO: Para o caso colombiano, a regulação do cannabis com fins medicinais até faz uns meses era só uma discutição com posições radicalizadas a favor e em contra. Hoje é uma realidade em termos de legislação, pois foi aprovada por decreto, mas com escasso debate e ação pedagógica do que implica a lei para povoação.

Centro regulador de medicamentos de la Alianza Bolivariana de Nuestros Pueblos de América (ALBAMED): nueva iniciativa de integración reguladora / Regulatory Center for Medicines of the Bolivarian Alliance for the Peoples of the Americas (ALBAMED): a new initiative for regulatory integration

RESUMEN Objetivo Revisar, organizar y compartir la experiencia de las autoridades reguladoras de los países incorporados a un proyecto de la Alianza Bolivariana de Nuestros Pueblos de América (ALBA) para crear un centro regulador (ALBAMED) y un registro único dirigido a facilitar el acceso a medicamentos esenciales con calidad, seguridad y eficacia, así como para caracterizar los beneficios que ha aportado la construcción de este foro regional de cooperación a estas auto-ridades y a sus respectivos sistemas reguladores. Métodos Estudio descriptivo, longitudinal y retrospectivo de las actividades de ALBAMED entre 2009 y 2014 con materiales publicados y de archivo. Se diagnosticó el nivel de convergencia mediante encuestas y se evaluó la construcción conjunta de estándares, la transferencia de conocimientos y la identificación de mejores prácticas. Resultados Participaron en el proyecto las autoridades de Bolivia, Cuba, Ecuador, Nicaragua y Venezuela. Se realizaron 25 diagnósticos comparativos de la situación reguladora sobre nueve temas clave. Se realizaron seis reuniones de coordinación y cuatro talleres especializados. Se aprobaron más de 130 disposiciones y procedimientos, desarrollados específicamente para el Centro Regulador de ALBAMED o adoptados de lineamientos emitidos por la Organización Mundial de la Salud y la Organización Panamericana de la Salud. Conclusiones El ejercicio de proyección de un centro regulador y un registro supranacional para los países del ALBA ha repercutido en beneficio del desempeño de las autoridades participantes y el fortalecimiento de los respectivos sistemas de regulación de medicamentos mediante la elaboración y selección de los estándares que serán aplicados, la transferencia de conocimientos y la promoción de las mejores prácticas.

ABSTRACT Objective To review, organize, and share the experience of the regulatory authorities of countries involved in a project headed by the Bolivarian Alliance for the Peoples of Americas (ALBA) for the establishment of a regulatory center (ALBAMED) and a single registry to facilitate access to essential medicines while ensuring quality, safety, and effectiveness, as well as to demonstrate how the construction of this forum for regional cooperation has benefited these authorities and their respective regulatory systems. Methods A descriptive, longitudinal, and retrospective study of ALBAMED’s activities between 2009 and 2014 using published and archived materials. The level of agreement was determined by means of surveys; and joint development of standards, knowledge transfer, and the identification of best practices were assessed. Results The regulatory authorities of Bolivia, Cuba, Ecuador, Nicaragua, and Venezuela participated in the project. Twenty-five comparative assessments of the status of regulation in nine key areas were carried out. Six coordination meetings and four specialized workshops were held. More than 130 provisions and procedures were approved, having been developed specifically for the ALBAMED Regulatory Center or adopted from guidelines issued by the World Health Organization and the Pan American Health Organization. Conclusions The mapping exercise for a regulatory center and supranational registry for ALBA countries has enhanced the performance of participating authorities and strengthened drug regulatory systems through the development and selection of the standards to be applied, knowledge transfer, and the promotion of best practices.

Relevance of variation in use of terminology to define generic pharmaceutical products / Relevancia de la variación en el uso de la terminología para definir los medicamentos genéricos

The World Health Organization (WHO) promotes the use of generic drug policies to foster competition in the pharmaceutical sector, reduce drug prices, and increase access to therapeutic drugs. However, little is known about how countries implement these policies. This article describes different terminology adopted by national regulatory authorities to define generic versus proprietary drug products in developing countries, including those in Latin America, and challenges that arise in their application of WHO guidelines, such as labeling issues. The author concludes that variation in generics terminology in these countries is a result of institutional context (i.e., the public sector setting as well as the body of laws and regulations that exists in the country) and policy legacies, such as intellectual property regimes, and highlights the need for further analysis of pharmaceutical regulations to improve understanding of the barriers and political implications of generic drug policies.

La Organización Mundial de la Salud (OMS) promueve el uso de políticas de medicamentos genéricos para estimular la competencia en el sector farmacéutico, reducir los precios y aumentar el acceso a los medicamentos. Sin embargo, hay poca información sobre la aplicación de dichas políticas por parte de los países. Este artículo describe la terminología empleada por los organismos regulatorios nacionales para definir los medicamentos genéricos frente a las especialidades farmacéuticas de marca en los países en desarrollo, incluidos los de América Latina, así como las dificultades que se encuentran en la aplicación de las directrices de la OMS, como por ejemplo en el etiquetado. El autor llega a la conclusión de que la variación en la terminología de los medicamentos genéricos en estos países es resultado del contexto institucional (es decir, el sector público y el ordenamiento jurídico-administrativo del país) y de los legados de las políticas, como los regímenes de propiedad intelectual, y destaca la necesidad de analizar más a fondo los reglamentos farmacéuticos a fin de conocer mejor los obstáculos y las implicaciones de las políticas en materia de medicamentos genéricos.

Autoridades reguladoras de medicamentos sul-americanas: uma análise a partir de regras organizacionais / Drug regulatory authorities in South America: an analysis based on organizational rules

OBJETIVO: Descrever a organização das autoridades reguladoras nacionais (ARN) de medicamentos da Argentina, Brasil, Chile e Peru pela análise de categorias representativas de regras organizacionais. MÉTODOS: As ARN estudadas foram selecionadas utilizando-se os seguintes critérios: estar em país da América do Sul, ter sido identificada como ARN nos Encuentros de Autoridades Competentes en Medicamentos de los Países Iberoamericanos e apresentar boa disponibilidade de dados eletrônicos sobre estrutura e processo da regulação de medicamentos. Como principal fonte de dados, foram consultadas páginas eletrônicas entre maio de 2010 e março de 2011. As categorias analíticas foram: estrutura da organização, competências, direcionalidade e formas de responsabilidade e prestação de contas. RESULTADOS: As ARN da Argentina e do Brasil funcionavam como agências autônomas, enquanto que as do Chile e do Peru se subordinavam diretamente aos respectivos ministérios da saúde. À exceção da ARN brasileira, evidenciou-se a dependência das demais em relação ao ministério para emitir normas sanitárias. O escopo de ação de cada autoridade se diferenciou pelos bens e serviços a ela sujeitos, sendo a do Peru a única dedicada exclusivamente à regulação de medicamentos. As quatro ARN realizam todos os processos apontadas pela Organização Mundial da Saúde como essenciais para uma regulação efetiva. CONCLUSÕES: Os resultados apontam para um esforço dos países estudados em melhorar sua estrutura regulatória. Não obstante, em diversos aspectos, as quatro ARN ainda precisam aprimorar mecanismos para garantir, ao final da cadeia regulatória, a qualidade e a segurança dos medicamentos por elas regulados, com mais transparência nos processos decisórios e prestação de contas à sociedade.

OBJECTIVE: To describe the organization of national drug regulatory authorities (DRAs) in Argentina, Brazil, Chile, and Peru through the analysis of categories representing organizational rules. METHODS: The DRAs were selected using the following criteria: being in a South American country, having been identified as DRAs at Encuentros de Autoridades Competentes en Medicamentos de los Países Iberoamericanos (Conferences of Ibero-American Drug Regulatory Authorities), and having good availability of electronic data regarding organizational structure and the process of drug regulation. The main source of data were websites, which were reviewed between May 2010 and March 2011. The analytical categories were: organizational structure, competencies, directionality (mission and vision statements), and forms of accountability. RESULTS: The DRAs of Argentina and Brazil functioned as autonomous agencies, while those of Chile and Peru were directly subordinated to the ministries of health. Except for the Brazilian DRA, the agencies in the other three countries were dependent on their health ministries to issue sanitary regulations. The scope of action of each DRA differed in terms of the goods and services covered, with the Peruvian DRA being the only one exclusively dedicated to the regulation of drugs. The four DRAs performed all the processes identified by the World Health Organization as essential for effective drug regulation. CONCLUSIONS: The results show an effort by the studied countries to improve their regulatory structure. Nevertheless, all four DRAs need to improve some mechanisms to ensure that, at the end of the regulatory chain, the drugs they regulate have the desired quality and safety, with more transparency in decision-making processes and social accountability.

Litigios por derecho a la salud en tres países de América Latina: revisión sistemática de la literatura / Right-to-health litigation in three Latin American countries: a systematic literature review

OBJETIVO: Identificar y evaluar estudios que analizaron las características de los litigios por derecho a la salud en Brasil, Colombia y Costa Rica. MÉTODOS: Se evaluaron estudios que analizaron las características de los litigios por derecho a la salud identificados mediante una búsqueda en PubMed, LILACS, Biblioteca Cochrane, Scirus (Abril, 2012). Dos revisores evaluaron los estudios. Las variables recabadas fueron, entre otras: causales de litigio, proporción de demandas por beneficios cubiertos por el sistema de salud y demandas por tecnologías de alto costo. RESULTADOS: Se identificaron 30 estudios (Brasil 19, Colombia 10 y Costa Rica 1). La decisión judicial fue frecuentemente favorable para los demandantes: Colombia (75%-87%), Costa Rica (89,7%) y Brasil (70%-100%). En Colombia las demandas se efectuaron por beneficios incluidos en el Plan Obligatorio de Salud (rango 41%-69,9%). En Brasil se presentó una variación importante de demandas entre el Programa de Medicamentos de Dispensación Excepcional (13%-31%) y los medicamentos básicos del Sistema Único de Salud (aproximadamente 50%). En relación al total de demandas, las de medicamentos fueron variables (Colombia 11,9%-35,6%, Costa Rica 30,2% y Brasil 49,6%). Un estudio de Brasil encontró una diferencia estadísticamente significativa al comparar las demandas por medicamentos excepcionales versus los demás, según el estrato social; y en otro estudio según las demandas de municipios con mejores indicadores socioeconómicos. Se reportó una concentración de las demandas en la prescripción de medicamentos por un grupo acotado de médicos. La prescripción no fue siempre sustentada por evidencia científica. Otro estudio halló que en la mitad de los casos el costo del proceso judicial resultó ser superior al costo de los servicios demandados. CONCLUSIONES: Existen similitudes en las causales, naturaleza y repercusiones de la judicialización en el contexto de los países estudiados. Los estudios incluidos muestran las debilidades de los sistemas de salud para garantizar el acceso a los distintos servicios así como para la incorporación de las nuevas tecnologías sanitarias.

OBJECTIVE: Identify and evaluate studies that analyzed characteristics of right-to-health litigation in Brazil, Colombia, and Costa Rica. METHODS: Studies were evaluated that analyzed characteristics of right-to-health litigation identified through a search of PubMed, LILACS, Cochrane Library, and Scirus (April 2012). Two reviewers evaluated the studies. Variables collected were, among others, grounds for litigation, proportion of lawsuits for benefits covered by the health system, and lawsuits on high-cost technologies. RESULTS: Thirty studies were identified (Brazil 19, Colombia 10, and Costa Rica 1). Judgments were frequently in favor of plaintiffs: Colombia (75%-87%), Costa Rica (89.7%), and Brazil (70%-100%). In Colombia, lawsuits were filed for benefits included in the Compulsory Health Plan (range: 41%-69.9%). In Brazil there was considerable variation in the amount of lawsuits between the Exceptional Circumstance Drug Dispensing Program (13%-31%) and basic medicines in the Unified Health System (approximately 50%). Lawsuits on drugs varied as a percentage of all lawsuits (Colombia 11.9%-35.6%, Costa Rica 30.2%, and Brazil 49.6%). A study in Brazil found a statistically significant difference when comparing lawsuits on exceptional drugs versus all other drugs, by social class; and in another study, according to lawsuits from municipalities with better socioeconomic indicators. A concentration of lawsuits on drug prescribing by a limited group of physicians was reported. Prescribing was not always supported by scientific evidence. Another study found that in half of the cases, the cost of legal proceedings was higher than the cost of the services being claimed. CONCLUSIONS: There are similarities in the grounds, nature, and impact of litigation in the context of the countries studied. The studies included show weaknesses of health systems to ensure access to different services as well as in the introduction of new health technologies.

Eficacia y seguridad en la nueva regulación de productos farmacéuticos en el Perú / Efficacy and safety in the new regulation of pharmaceutical products in Peru

A nivel internacional los productos farmacéuticos son autorizados luego de evaluar el balance riesgo-beneficio, teniendo en cuenta parámetros de eficacia, seguridad y calidad. A partir del 2009, en el Perú se ha establecido que todo PF por comercializar deberá contar con evidencia de eficacia y seguridad. Según la nueva reglamentación de la ley, vigente a partir del 2012, las especialidades farmacéuticas (EF) se han agrupado en tres categorías: categoría 1 si se encuentran en el Petitorio Nacional de Medicamentos Esenciales, categoría 2 si están autorizados en países de alta vigilancia sanitaria y categoría 3 si no se incluyen en las categorías 1 o 2. La documentación científica a presentar al momento de su inscripción o reinscripción en la entidad reguladora dependerá de la categoría de la EF.

Internationally, pharmaceutical products (FP) are authorized after their risk-benefit profile has been assessed, taking into account efficacy, safety and quality parameters. In 2009, it was established in Peru that all pharmaceutical products to be commercialized should show proof of their efficacy and safety. According to the new regulation, in effect as of 2012, the pharmaceutical specialties (FS) have been grouped into three categories: category 1, if included in the National List of Essential Medicines; category 2, if authorized in countries with high health surveillance; and category 3, if not included in categories 1 or 2. The scientific documentation to be submitted for the registration or re-registration of the product in the regulatory entity will depend on its FS category.

Motivos de la prescripción inadecuada de antibióticos en un hospital pediátrico de alta complejidad / Reasons for inappropriate prescribing of antibiotics in a high-complexity pediatric hospital

Objetivo. Describir el estado de la aplicación de la norma relacionada con la prohibición de la venta de antibióticos sin prescripción médica en farmacias de Bogotá, Colombia. Métodos. Estudio descriptivo transversal, en el cual se utilizó la técnica de simulación de compra en farmacias (droguerías) de Bogotá. La muestra de 263 farmacias se calculó con una precisión de 5% y un factor de corrección de 2% mediante estratificación (farmacias de cadena e independientes) y asignación aleatoria simple en cada estrato. Resultados. Del total de farmacias estudiadas, 80,3% no cumplen la norma que establece la venta de antibióticos con receta. En 20,1% de los casos, el expendedor indagó la edad del paciente o sus síntomas o ambos, con el fin de ofrecer otros medicamentos o para cambiar el antibiótico. En ninguna oportunidad se preguntó por antecedentes personales de alergia a los antibióticos. En los casos en los cuales hubo intención de venta del antibiótico, la presentación genérica fue la más comúnmente ofrecida (81,2%). Algunos expendedores de medicamentos hicieron recomendaciones inapropiadas. Las localidades con mayor incumplimiento de la norma coinciden con aquellas que tienen altas tasas de necesidades básicas insatisfechas. Conclusiones. A cinco años de adopción de la norma orientada a contrarrestar la venta libre de antibióticos, su cumplimiento es mínimo y la entrega no se realiza de acuerdo a los parámetros establecidos. El personal de farmacia no suministra la información requerida de acuerdo con sus competencias.

Objective. Describe the implementation status of a regulation prohibiting antibiotic sales without a medical prescription in pharmacies of Bogotá, Colombia. Methods. A cross-sectional descriptive study was conducted using the simulated purchase technique in Bogotá pharmacies (drugstores). The sample of 263 pharmacies was calculated by stratification (chain pharmacies and independent pharmacies) with 5% accuracy and a 2% correction factor. Simple randomization was assigned in each stratum. Results. Out of the total pharmacies studied, 80.3% did not comply with the regulation established for prescription sales of antibiotics. In 20.1% of the cases, the dispenser asked about the patient’s age, symptoms, or both age and symptoms in order to offer other drugs or change the antibiotic. There were no inquiries about a medical history of allergy to antibiotics. In cases in which there was the intention to sell antibiotics, the generic format was most commonly offered (81.2%). Some drug dispensers made inappropriate recommendations. The locations with the highest levels of noncompliance with the regulation were also those with high rates of unmet basic needs. Conclusions. Five years after passage of a regulation to halt the unrestricted sales of antibiotics, there is minimal compliance, and dispensing does not conform to the established parameters. Pharmacy personnel do not provide the required information according to their responsibilities.

Restricción de la venta de antibióticos en farmacias de Bogotá, Colombia: estudio descriptivo / Restriction of antibiotic sales in pharmacies in Bogotá, Colombia: a descriptive study

Objetivo. Describir el estado de la aplicación de la norma relacionada con la prohibición dela venta de antibióticos sin prescripción médica en farmacias de Bogotá, Colombia. Métodos. Estudio descriptivo transversal, en el cual se utilizó la técnica de simulación de compra en farmacias (droguerías) de Bogotá. La muestra de 263 farmacias se calculó con una precisión de 5% y un factor de corrección de 2% mediante estratificación (farmacias de cadenae independientes) y asignación aleatoria simple en cada estrato. Resultados. Del total de farmacias estudiadas, 80,3% no cumplen la norma que establecela venta de antibióticos con receta. En 20,1% de los casos, el expendedor indagó la edad del paciente o sus síntomas o ambos, con el fin de ofrecer otros medicamentos o para cambiar elantibiótico. En ninguna oportunidad se preguntó por antecedentes personales de alergia a los antibióticos. En los casos en los cuales hubo intención de venta del antibiótico, la presentación genérica fue la más comúnmente ofrecida (81,2%). Algunos expendedores de medicamentos hicieronrecomendaciones inapropiadas. Las localidades con mayor incumplimiento de la norma coinciden con aquellas que tienen altas tasas de necesidades básicas insatisfechas. Conclusiones. A cinco años de adopción de la norma orientada a contrarrestar la ventalibre de antibióticos, su cumplimiento es mínimo y la entrega no se realiza de acuerdo a los parámetros establecidos. El personal de farmacia no suministra la información requerida de acuerdo con sus competencias.

Objective. Describe the implementation status of a regulation prohibiting antibiotic sales without a medical prescription in pharmacies of Bogotá, Colombia. Methods. A cross-sectional descriptive study was conducted using the simulated purchase technique in Bogotá pharmacies (drugstores). The sample of 263 pharmacies was calculated by stratification (chain pharmacies and independent pharmacies) with 5% accuracy and a 2% correction factor. Simple randomization was assigned in eachstratum. Results. Out of the total pharmacies studied, 80.3% did not comply with the regulation established for prescription sales of antibiotics. In 20.1% of the cases, the dispenser asked about the patient’s age, symptoms, or both age and symptoms in order to offer other drugs or change the antibiotic. There were no inquiries about amedical history of allergy to antibiotics. In cases in which there was the intention to sell antibiotics, the generic format was most commonly offered (81.2%). Some drug dispensers made inappropriate recommendations. The locations with the highest levels of noncompliance with the regulation were also those with high rates of unmetbasic needs. Conclusions. Five years after passage of a regulation to halt the unrestricted sales of antibiotics, there is minimal compliance, and dispensing does not conform to the established parameters. Pharmacy personnel do not provide the required information according to their responsibilities.

Regulación de la dispensación de medicamentos y su efecto en el consumo de antibióticos en Venezuela / Regulations governing the dispensing of medications and their effect on antibiotic consumption in Venezuela

Objetivo. Determinar las variaciones en la tendencia de consumo de los antibióticos regulados y no regulados en Venezuela, entre el período antes (2005) y después (2006–2008) de introducir la regulación de su venta por receta. Métodos. Se obtuvo información sobre consumo de antibióticos en Venezuela de los datos aportados por International Marketing Services. El consumo se expresó en dosis diarias definidas por 1 000 habitantes por día. Se realizaron análisis de varianzas (ANOVA) con un intervalo de confianza de 95% para conocer las diferencias entre los períodos estudiados. Resultados. Los antibióticos regulados de mayor consumo fueron ciprofloxacina y azitromicina. Las clases de antibióticos no regulados de mayor consumo fueron penicilinas y cefalosporinas de primera generación, aminoglucósidos, diaminopiridinas-sulfamidas y tetraciclinas. El consumo total de las categorías de antibióticos de libre dispensación fue el doble del de las categorías de venta regulada, tanto antes como después de haberse aplicado la regulación. Conclusiones. No se encontraron diferencias estadísticamente significativas en el consumo de antibióticos, ya fueran regulados o de libre dispensación, ni antes ni después de aplicarse la medida regulatoria de dispensación de antibióticos.

Objective. Determine the variations in consumption trends for regulated and unregulated antibiotics in Venezuela in the period before (2005) and after (2006–2008) the regulation of prescription sales was introduced. Methods. Information on antibiotic consumption in Venezuela was obtained from the data provided by International Marketing Services. Consumption was expressed in daily doses per 1 000 inhabitants. Analyses of variance (ANOVA) were performed, with a 95% confidence interval, to identify the differences between the periods studied. Results. The regulated antibiotics with the highest consumption were ciprofloxacin and azithromycin. The classes of unregulated antibiotics with the highest consumption were penicillins and first-generation cephalosporins, aminoglycosides, diaminopyridine- sulfonamides, and tetracyclines. Total consumption in the categories of antibiotics with unregulated dispensing was twice as high as in the categories with regulated sales, both before and after introduction of the regulation. Conclusions. There were no statistically significant differences in antibiotic consumption with regulated or unregulated dispensing, either before or after the introduction of measures regulating the dispensing of antibiotics.

Avaliação do conhecimento e das condutas dos farmacêuticos, responsáveis técnicos por drogarias / Assessment of knowledge and behavior of pharmacists with technical responsibility for drugstores

Através deste estudo, avaliou-se o nível de conhecimento e conduta dos farmacêuticos, responsáveis técnicos (RT) em drogarias, quanto a alguns aspectos da legislação farmacêutica e sanitária. Foram entrevistados 45 RT em 2007, sendo que 19 desconheciam a definição dos medicamentos de referência, 21 do genérico e 25 dosimilar. Todos sabiam da permissão de aplicação de medicamentos injetáveis. Porém, apenas dois sabiam da permissão da aplicação de penicilínicos, metade desconhecia que é permitido fracionar medicamentos fracionáveis em drogaria, 18 não sabiam dispensar corretamente uma prescrição pelo princípio ativo e 37 acreditavam que o farmacêutico pode intercambiar qualquer medicamento de marca pelo genérico. A maioria dos RT apresentou nível regular e insatisfatório de conduta e de conhecimento sobre a legislação profissional e sanitária, o que sinaliza um problema na formação acadêmica e de atualização permanente, podendo comprometer as diretrizes da política nacional de medicamentos.

This paper is a study of the level of knowledge and conduct of the legally responsible pharmacist-in-charge (PIC) at drugstores, regarding certain aspects of pharmaceutical and health legislation. In 2007, 45 PICs were interviewed, of whom 19 did not know the definition of original (innovative) branded drugs, 21 of generic drugs and 25 of similar branded drugs. All PICs knew that it is permitted to administer injectable drugs in the drugstore. However, only two knew that penicillins can be injected, half of them did not know that certain medicines can be fractionated in drugstores, 18 did not know how to dispense correctly a prescription for an active ingredient and 37 believed that the pharmacist can swap any brand name drug with its generic counterpart. Most PICs showed an unsatisfactory level of conduct and knowledge of the professional and health legislation, which points to problems in the undergraduate and in-service training of pharmacists, that could jeopardize the national drug policy guidelines.

Uso racional de medicamentos antineoplásicos e ações judiciais no Estado de São Paulo / Uso racional de medicamentos antineoplásicos y acciones judiciales en el estado de Sao Paulo, Sureste de Brasil / Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, southeastern Brazil

OBJETIVO: Avaliar a racionalidade das ações judiciais e pedidos administrativos recebidos pela Secretaria de Estado da Saúde de São Paulo segundo evidências científicas de eficácia e segurança. MÉTODOS: Estudo descritivo, transversal, baseado em informações da Secretaria de Saúde sobre os medicamentos antineoplásicos solicitados por via judicial, com maior impacto financeiro para o Sistema Único de Saúde em 2006 e 2007. Os fármacos foram avaliados quanto às evidências clínicas de eficácia e segurança, com base na classificação do Micromedex®, em metanálises e revisões sistemáticas. As indicações foram confrontadas com aquelas aprovadas em agências reguladoras. RESULTADOS: Os medicamentos bevacizumabe, capecitabina, cetuximabe, erlotinibe, rituximabe, imatinibe e temozolomida geraram gastos superiores a R$ 40 milhões para atender 1.220 solicitações, com custo médio de R$ 33,5 mil por paciente. Os estudos selecionados não recomendam parte das indicações dos medicamentos prescritos. Cerca de 17 por cento dos pedidos não tinham evidência para a indicação mencionada no pleito, o que equivale a um gasto inadequado de, no mínimo, R$ 6,8 milhões...

OBJECTIVE: To assess the rationality of legal suits and administrative requests requiring anticancer drugs filed against and submitted to the São Paulo State Department of Health, in view of scientific evidence on efficacy and safety. METHODS: A descriptive cross-sectional study was carried out based on information on lawsuits filed by cancer patients requiring anticancer drugs were furnished by the Department of Health. These drugs are among those having the greatest financial impact on the Brazilian Health System in 2006 and 2007. The drugs were assessed according to clinical evidence on efficacy and safety, based on Micromedex® categorization, on systematic reviews and meta-analyses. Indications present in the legal documentation were compared to the indications approved by regulatory agencies. RESULTS: Bevacizumab, capecitabine, cetuximab, erlotinib, rituximab, imatinib, and temozolomide accounted for expenses over R$ 40 million to meet 1220 requests and lawsuits, at an average cost of R$ 33,500 per patient. Selected studies do not recommend all the indications for the prescribed drugs. Approximately 17 percent of requests and lawsuits did not provide evidence for the required indication, and these amounted to inappropriate expenses of, at least, R$ 6.8 million...

OBJETIVO: Evaluar la racionalidad de las acciones judiciales y pedidos administrativos recibidos por la Secretaria Estatal de Salud de Sao Paulo según evidencias científicas de eficacia y seguridad. MÉTODOS: Estudio descriptivo, transversal basado en informaciones de la Secretaria sobre los medicamentos antineoplásicos solicitados por vía judicial, con mayor impacto financiero para el Sistema Único de Salud en 2006 y 2007. Los fármacos fueron evaluados considerando las evidencias clínicas de eficacia y seguridad, con base en la clasificación de Micromedx®, metanálisis y revisiones sistemáticas. Las indicaciones fueron confrontadas con las aprobadas en agencias reguladoras. RESULTADOS: Los medicamentos bevacizumabe, capecitabina, cetuximabe, erlotinibe, rituximabe, imatinibe y temozolomida generaron gastos superiores a R$ 40 millones para atender 1.220 solicitudes, con costo promedio de R$ 33,5 mil por paciente. Los estudios seleccionados no recomiendan parte de las indicaciones de los medicamentos prescritos. Cerca de 17 por ciento de los pedidos no tenían evidencia para la indicación mencionada en el pleito, lo que equivale a un gasto inadecuado de, mínimo, R$ 6,8 millones...

Ley Nº 29459 - Ley de los productos farmacéuticos, dispositivos médicos y productos sanitarios / Law N° 29459 of pharmaceutical products, medical devices and sanitary products

La Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios N.° 29459, publicada ennoviembre de 2009, orienta la regulación de estos productos sustituyendo al Capítulo III de la Ley General de Salud N.º 26842. A través de esta Ley se ha modificado los aspectos más cuestionados en la Ley N.° 26842, al establecer requisitos para solicitar el registro sanitario de productos farmacéuticos que son necesarios para garantizar su eficacia,seguridad y calidad, incluyendo también los plazos necesarios para su evaluación y que el costo de la tasa por registrosanitario sea en función de lo que implique otorgar dicho registro, lo cual incluye también las actividades de control y vigilancia sanitaria. Así mismo, restablece la exigencia de la autorización sanitaria de funcionamiento, previa al inicio delas actividades, previa inspección para verificar el cumplimiento de los dispositivos legales vigentes. La Ley incorpora también tres capítulos específicos sobre acceso, uso racional de productos farmacéuticos, dispositivos médicos y productos sanitarios, así como un capítulo de investigación.

The Law of Pharmaceutical Products, Medical devices and Sanitary products N°. 29459, published in November, 2009, guides the regulations of these products, substituting Chapter III of the General Law of Health N°. 26842. Through this law, the most questioned aspects of the Law N°. 26842 have been modified, establishing requisites to apply for the sanitary registry of pharmaceutical products that are necessary to guarantee their efficacy, security and quality, also including the required terms for their evaluation and the cost of the health registration fee must be according to all what implies to give the registry, including control activities and health surveillance. It also resets the requirement of the operating health approval, prior to the initiation of the activities, and having had a previous inspection to verify the accomplishment of the actual legal devices. The law also incorporates three specific chapters about access, rational use of pharmaceutical products, medical devices and health products, as well as a chapter on research.

Política de medicamentos en Estados Unidos de América / Drug policy in United States of America

La política de medicamentos de los Estados Unidos de América (EEUU) es inconsistente, regula el desarrollo,producción, comercialización y seguridad de los medicamentos en el país, por medio de mecanismos legales así como de instituciones privadas y gubernamentales. Las leyes de patente protegen a la industria farmacéutica y noexiste un mecanismo directo de control de precios ni una política que dé cobertura de acceso a los medicamentosa toda la población de EEUU. La Agencia Federal de Medicamentos y Alimentos (FDA) es el organismo que regulalos medicamentos en EEUU. Varias leyes han sido promulgadas para incrementar el control de calidad, seguridad yasegurar la eficacia de los medicamentos, tales como, la ley de honorarios por la prescripción de drogas al usuario (PDUFA) y la ley de modernización de la FDA (FDAMA). Asimismo, para aumentar el acceso de los pacientes a los medicamentos (Fast track; Orphan Drug Act; Pediatric exclusivity). Por su parte, la ley Hatch-Waxman, ha cumplido una función muy importante al estimular el desarrollo de medicamentos genéricos con mucho éxito y controlar precios en el mercado libre. Finalmente, el sistema de seguro de salud es voluntario y también inconsistente, ofrece varios planesque abarcan desde la obtención personal del seguro por el propio individuo, los seguros auspiciados por el empleador yterminan con varios seguros gubernamentales. Todos estos pueden, o no, contener un subsidio de medicamentos.

The USA federal prescription drug policies are inconsistent. The federal government regulates the development,production, marketing and safety of prescription drugs in the country through various legal mechanisms as well as private and governmental institutions. Patent laws also play an important role in this process protecting the pharmaceutical industry. The government has no direct mechanism to control prices of prescription drugs nor does it have a policy to cover the whole US population with a prescription drug benefit. The FDA is the agency charged with regulation of medicines. Various laws have been enacted over the years to improve quality control, safety and ensure efficacy of prescription drugs as: Prescription Drug User Fee Act (PDUFA) and Food and Drug Administration Modernization Act (FDAMA), as well as increase patient access to prescription drugs (Fast Track; Orphan Drug Act, Pediatric exclusivity). The Hatch-Waxman Act, named for its authors, has played an important role in the development of generic drugs withmuch success and a significant effect on drug prices. The insurance health system is voluntary and also inconsistentoffering various forms of insurance that range from the individual applying for insurance personally, through employerfinanced health insurance, to government run health insurance systems. All health insurance may or may not have a prescription drug benefit.

Desarrollo de la evaluación de productos farmacéuticos, biotecnológicos y equipos médicos: Algunas consideraciones

Se pone en conocimiento de los profesionales de la salud el proceso mediante el cual llegan al mercado los medicamentos y equipos médicos que se utilizan diariamente en la práctica médica. Se exponen las tendencias actuales referentes a este proceso.

In this paper, health professionals will know about the process by which the drugs and medical equipment used in the daily practice of medicine get to the market. The present trends related to this process are also explained.

Propuesta de modelo para la prescripción de medicamentos controlados por tarjeta

Entre los aspectos que contempla el Programa Nacional de Medicamentos, se establece la entrega de medicamentos a los pacientes (sobre todo para tratamiento de enfermedades crónicas no transmisibles) mediante una tarjeta control. Para abrir una inscripción de tarjeta control en la farmacia, el prescriptor expide un certificado con los datos que exige el programa; para ello se utiliza hoy, el modelo 53-63, originalmente concebido para la expedición de certificados médicos. Con vistas a diseñar un modelo que se ajustara a los requerimientos actuales para la prescripción, estudiamos el Programa Nacional de Medicamentos (1998), el Programa para el Uso Racional de Medicamentos (1999) y otros documentos relacionados con el control de los medicamentos. Se elaboró una propuesta de modelo que además de responder estrictamente a las necesidades de información del Programa Nacional de Medicamentos, está diseñada de forma tal que por su tamaño, solo requiere la mitad del papel que se utiliza en el modelo de certificado médico usado hasta ahora para este fin. Existen aproximadamente 1 500 000 pacientes a los cuales, este año, se les ha prescrito algún medicamento de los que se expenden por el sistema de tarjeta control. De utilizar el modelo propuesto, solo por concepto de papel, en 1 año el ahorro sería de 3 300 USD, a los 5 años de 16 500 USD, y a los 10 años se ahorrarían unos 33 000 USD. Además de uniformar la información que se intercambia en relación con este programa nacional, facilita la investigación científica relacionada con la prescripción de estos medicamentos.

The delivery of drugs to patients (mainly for the treatment of non-communicable chronic diseases) is among the aspects included in the National Drug Program. To register a control card in the pharmacy, the prescriber issues a certificate with the necessary data required by the program. At present it is used the form 53-63, which was originally utilized for medical certificates. In order to design a form that adapts to the current requirements for prescription, we studied the National Drug Program (1998), the Program for the Rational Use of Drugs (1999) and other documents related to drug control. A proposal was made that besides meeting the needs of information of the National Drug Program strictly, is designed in such a way that only requires half of the paper that was used up to now in the medical certificate. Approximately 1 500 000 patients have been prescribed this year some of the drugs sold under the control card system. The use of the proposed form just on account of paper will cause a saving of USD 3 300 in the first year, USD 16 500 in the fifth year and USD 33 000 in the tenth year. In addition to standardize the information that is exchanged in connection with this national program, the use of this form makes easy the scientific research related to the prescription of these drugs.