Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 467
Filter
1.
São Paulo; s.n; 2021. 446 p.
Thesis in Portuguese | LILACS | ID: biblio-1361999

ABSTRACT

A Cannabis sativa L tem acompanhado a trajetória da humanidade há milênios com destacado papel histórico no desenvolvimento das sociedades humanas. Por suas propriedades singulares e versatilidade é uma das mais antigas plantas cultivadas do mundo e também uma das primeiras plantas a ser utilizada como medicamento e sublimação em rituais religiosos. Durante o século XX, interesses políticos e ideológicos internacionais exacerbaram os atributos psicoativos da planta, tornando-a, proscrita e proibida inclusive ao uso medicinal. No Brasil, ao discurso proibicionista adicionou-se ainda o viés racista, imputando à pessoa escravizada a culpa pela introdução e fumo da erva assassina. Com as notáveis descobertas científicas sobre a cannabis o discurso proibicionista tem perdido força, iniciando-se um movimento global pela legalização que representa o início de uma nova era do entendimento sobre a planta e da concepção sobre o uso de substâncias psicoativas que não mais poderá ser contido pela repressão.


Cannabis sativa L has followed the trajectory of humanity for millennia with an outstanding historical role in the development of human societies. Due to its unique properties and versatility, it is one of the oldest cultivated plants in the world and also one of the first plants to be used as medicine and sublimation in religious rituals. During the 20th century, international political and ideological interests exacerbated the psychoactive attributes of the plant, making it proscribed and prohibited even for medicinal use. In Brazil, the prohibitionist discourse also added a racist bias, blaming slaves for the introduction and smoking of the killer herb. With the remarkable scientific discoveries about cannabis, the prohibitionist discourse has lost strength, starting a global movement for legalization that represents the beginning of a new era of understanding about the plant and the conception of the use of psychoactive substances that can no longer be contained by repression.


Subject(s)
Cannabinoids , Cannabis , Public Health , Criminal Law , Legislation, Drug , Medical Marijuana , Marijuana Use
2.
Med. UIS ; 33(1): 53-58, ene.-abr. 2020.
Article in Spanish | LILACS | ID: biblio-1124985

ABSTRACT

Resumen Los resultados de las investigaciones sobre cannabis medicinal han traído a las mesas de gobierno discusiones sobre su potencial terapéutico y las medidas a tomar para controlar su producción, comercialización y utilización. En Colombia, desde el 2017, el mercado del cannabis medicinal se encuentra regulado; sin embargo, existen brechas entre la norma, disponibilidad y acceso de los pacientes a productos farmacéuticos con derivados del cannabis, aprobados por el ente regulatorio y que cumplan con los estándares de calidad. Desde esta perspectiva, se considera necesario que el gobierno nacional lidere, en coordinación con la academia y el sector productivo, el desarrollo de preparados farmacéuticos a base de cannabis; además de establecer e implementar medidas estratégicas y concertadas, orientadas a mejorar el acceso y la utilización adecuada de los productos farmacéuticos de cannabis medicinal, en especial para los casos en los que se pueda establecer una clara relación riesgo/beneficio. Con ello, se contribuye a mejorar las condiciones de salud de pacientes que se pueden beneficiar de estas opciones, al igual que al desarrollo y consolidación de un sector promisorio para el país. MÉD. UIS.2020;33(1):53-8.


Abstract The results of medical marijuana research have brought to the government tables discussions about their therapeutic potential and the measures to be taken to control their production, commercialization and use. In Colombia, since 2017, the medical cannabis market is regulated; however, there are gaps between the laws, availability and the access of patients to pharmaceutical products with cannabis derivatives approved by the regulatory entity and that comply with the standards of quality. From this perspective, it is necessary for the national government to lead, in coordination with the academy and the productive sector, the development of pharmaceutical preparations based on cannabis and to establish and implement strategic and concerted measures, aimed to improve access and proper use of medical marijuana pharmaceutical products, mainly for cases in which a clear risk/benefit relationship can be established. This would help to improve the health conditions of patients who can get benefits from these options, as well as the development and consolidation of a promising sector for the country. MÉD.UIS.2020;33(1):53-8.


Subject(s)
Humans , Cannabis , Medical Marijuana , Legislation, Drug , Cannabinoids , Federal Government , Pharmaceutical Trade , Marijuana Use , Health Economic-Industrial Complex
3.
Arch. argent. pediatr ; 118(1): 64-67, 2020-02-00.
Article in English, Spanish | LILACS, BINACIS | ID: biblio-1095682

ABSTRACT

En los últimos años, se ha observado un incremento significativo en el interés por la prescripción del cannabis medicinal. En el siguiente artículo, se informa acerca de la escasa base científica que avala la prescripción de estos compuestos en un listado amplio y diverso de patologías médicas. Se considera fundamental que cualquier sustancia que vaya a ser utilizada en humanos siga un protocolo de aprobación estricto y científico, que pueda desligarse de modas o de resultados individuales. Es necesario que, antes de la prescripción de una droga en personas, deba tenerse un panorama claro de cuáles son los usos del compuesto en cuestión, pero, sobre todo, de su seguridad, que es prácticamente desconocida en el cannabis medicinal.


In recent years, the interest in medical cannabis prescription has increased significantly. This article provides information about the little scientific basis supporting the prescription of these products for a wide and diverse range of medical conditions. It is critical for any substance to be used in human beings to follow a strict scientific approval protocol, detached from any trend or individual outcome. Before prescribing any drug to human beings, it is necessary to have a clear picture of its uses, especially its safety, which is practically unknown in the case of medical cannabis.


Subject(s)
Humans , Cannabidiol/adverse effects , Cannabidiol/therapeutic use , Medical Marijuana/adverse effects , Medical Marijuana/therapeutic use , Safety , Dronabinol/therapeutic use , Cannabidiol/pharmacology , Compassionate Use Trials , Legislation, Drug
4.
Braz. arch. biol. technol ; 63: e20190222, 2020. tab, graf
Article in English | LILACS | ID: biblio-1132250

ABSTRACT

Abstract Marijuana (Cannabis sativa) is an important annual medicinal plant that belongs to the Cannabaceae family. It contains 421 substances of 18 chemical types-the most significant compound is δ-9-tetrahydrocannabinol, which causes several effects, both in the Central Nervous System and in several peripheral locations in the organism. The objectives of this scientific review are to mention the anatomical distribution, chemical characteristics and biosynthesis of cannabinoids, as well as its actions mechanisms. The endogenous cannabinoid system, the therapeutic properties of C. sativa and its action on the nociceptive control are described. Finally, the modulators of the cannabinoid system in clinical use are indicated, together with marijuana legalization benefits.


Subject(s)
Humans , Cannabinoids/isolation & purification , Cannabinoids/therapeutic use , Cannabis/chemistry , Legislation, Drug
5.
Article in Chinese | WPRIM | ID: wpr-828355

ABSTRACT

In this paper, we reviewed the history of the registration and classification changes of traditional Chinese medicines(TCM) since the establishment of China's drug regulatory agency, and put forward relevant suggestions. Although China's drug regulatory agency has gone through 22 years, the whole regulatory system was gradually built on the basis of the generic pharmaceutical industry at that time and through continuous exploration and summary of simply experience from foreign regulatory agencies. To a certain extent, the supervision of TCM drugs was also affected by some immature supervision ideas during this period. Based on the newly issued Drug Administration Law and Provisions for Drug Registration, the author puts forward some personal thoughts on the classifications of TCM drug registration. It is hoped that experts in the industry and regulatory agencies will work together to explore and improve the relevant system of TCM registration administration.


Subject(s)
China , Drugs, Chinese Herbal , Legislation, Drug , Medicine, Chinese Traditional , Pharmaceutical Preparations
6.
Medwave ; 20(1): e7825, 2020.
Article in English, Spanish | LILACS | ID: biblio-1087898

ABSTRACT

Los medicamentos constituyen un bien económico que forma parte del gasto público y privado y de la toma de decisiones en salud. El aseguramiento de su calidad, eficacia y seguridad resulta fundamental. Sin embargo, la variada oferta disponible en el mercado chileno, donde se reconocen productos innovadores y genéricos, constituye un escenario confuso para consumidores y proveedores en salud. En esta revisión pretendemos aclarar los conceptos de fármacos bioequivalentes (aplicable a compuestos de tamaño molecular pequeño) y fármacos biosimilares (para compuestos biológicos de mayor complejidad molecular). En ambos casos, el comportamiento en el organismo del principio activo debe ser demostrado mediante estudios realizados para este fin. Una aplicación directa del concepto de bioequivalencia es la intercambiabilidad, definida como la posibilidad de utilizar un producto de un mismo principio activo, mientras la forma farmacéutica y esquema de dosificación sean iguales. Las normas relativas a esta materia y los organismos públicos encargados, no solo debieran garantizar la seguridad y la eficacia en el intercambio entre productos, sino también aspectos relacionados con el costo, la accesibilidad a los fármacos y la implementación de una guía de homogeneización de conceptos y criterios de intercambiabilidad basados en la evidencia, lo cual impactaría en una mejor educación para los usuarios, reduciendo la asimetría de información entre el usuario y la industria. La importancia de la intercambiabilidad destaca en Chile en el contexto del Plan de Garantías Explícitas en Salud (GES) y la Ley de Protección Financiera para Diagnósticos y Tratamientos de Alto Costo en Salud (Ley Ricarte Soto). Sin embargo, no es posible garantizar que todos los productos alternativos al innovador presentes en el mercado chileno son bioequivalentes. El conocimiento disponible en esta temática puede impactar y contribuir a la toma de decisiones en los prescriptores y usuarios, así como en la elaboración de políticas públicas en torno a los productos farmacéuticos bioequivalentes y biosimilares en nuestro país.


Medicines are an economic good and a fundamental component of public and private health spending and decision-making. Assurance of their quality, efficiency, and safety is essential. In Chile, the wide variety of available drugs, including innovator products, and generics­some of which are certified as bioequivalent, while others are not­creates a potentially confusing scenario for both consumers and health providers. In this review, we intend to shed light on the concepts of bioequivalency (the standard permitting interchangeability for small-molecule drugs) and biosimilarity (the standard permitting interchangeability for biological compounds of greater molecular complexity). In both cases, how the active substance interacts with the host organism must be demonstrated by studies designed and carried out for this purpose. Interchangeability is defined as the possibility of using a product of the same active principle, as long as the pharmaceutical form and dosage scheme are the same. Regulations related to bioequivalence and biosimilarity must not only guarantee safety and efficacy when products are interchanged but also facilitate cost savings and access to medicines. Implementation of evidence-based guidelines that standardize concepts of interchangeability could lead to more educated usage and reduced information asymmetry between patients (users) and industry. Drug interchangeability is particularly relevant in two government health initiatives in Chile: the Explicit Guarantees in Health Care (GES) plan, and the Law on Financial Protection for High-Cost Diagnostics and Treatment in Health Care (also known as the "Ricarte Soto Law"). Nonetheless, it is not possible to guarantee that all alternative drug products on the Chilean market are bioequivalents of the reference product. Synthesis of the available knowledge on bioequivalent and biosimilar pharmaceutical products in Chile could facilitate and contribute to stakeholder decision-making and the development of better health policies.


Subject(s)
Therapeutic Equivalency , Drugs, Generic , Biosimilar Pharmaceuticals , Chile , Legislation, Drug
7.
Salud pública Méx ; 61(5): 692-697, sep.-oct. 2019.
Article in English | LILACS | ID: biblio-1127333

ABSTRACT

Abstract: Bisphenol A (BPA), found in plastics and epoxy resins, is one of the most studied chemicals. BPA is regarded as an endocrine disruptor and has been related to adverse health effects in humans. However, some regulatory agencies around the world have concluded that BPA is safe at current human exposure levels. As the scientific community attempts to settle the debate on BPA's health effects, regulatory agencies have been put into a challenging public health policy situation. The United States has implemented no regulatory actions due to safety concerns, while Europe has used the precautionary principle to guide its regulation in the face of scientific uncertainty. In this paper, we explore the debate surrounding BPA regulation and the possibility for countries to introduce guidelines, using Mexico as an example. Policy change determinants analysis suggest that countries can and should impose regulations on BPA.


Resumen: El bisfenol A (BPA), presente en plásticos y resinas epoxi, es uno de los químicos más estudiados. Se considera un disruptor endocrino y se ha relacionado con efectos adversos para la salud humana. Algunas agencias regulatorias en el mundo han concluido que el BPA es seguro a los niveles de exposición humana actuales. Mientas la comunidad científica intenta resolver el debate sobre dichos efectos, las agencias regulatorias enfrentan una difícil situación de política pública. Los Estados Unidos de América no han implementado acciones reglamentarias por razones precautorias, mientras que Europa ha utilizado el principio precautorio para guiar su regulación ante la incertidumbre científica. En este documento exploramos el debate que rodea la regulación del BPA y la posibilidad de que los países introduzcan directrices, usando a México como ejemplo. El análisis de los determinantes del cambio de políticas sugiere que los países pueden y deben regular el BPA.


Subject(s)
Humans , Phenols/toxicity , Benzhydryl Compounds/toxicity , Environmental Exposure/adverse effects , Endocrine Disruptors/toxicity , Legislation, Drug , Public Policy/legislation & jurisprudence , United States , Europe , Mexico
8.
Salud pública Méx ; 61(5): 685-691, sep.-oct. 2019.
Article in Spanish | LILACS | ID: biblio-1127332

ABSTRACT

Resumen: La iniciativa con Proyecto de Decreto por el que se reforma la Ley General de Salud de México presentada en 2019 ante el Congreso de la Unión propone la creación de un sistema de acceso universal y gratuito a los servicios de salud y a medicamentos asociados para la población sin seguridad social y la creación del Instituto de Salud para el Bienestar. Este artículo analiza algunos aspectos sustantivos del Proyecto de Decreto con el objetivo de motivar la reflexión sobre la reforma propuesta y sus componentes más importantes para contribuir a su propósito. Se concluye que los principales temas del proyecto requieren precisión en rubros relevantes, como la transformación del esquema de financiamiento para la atención, el fortalecimiento de la rectoría y gobernanza, la responsabilidad en la provisión de servicios y la regulación y acceso a medicamentos. Las aportaciones de académicos, tomadores de decisiones y organizaciones sociales serán indispensables para una política pública de salud basada en evidencia y con equidad social.


Abstract: The initiative including an Act Project for reforming the Ley General de Salud of Mexico, submitted in 2019 to the Congress of the Union, proposes the creation of a system of universal and free access to health services and associated medicines for the population lacking of social security benefits, and the creation of the Instituto de Salud para el Bienestar. This article analyzes the substantive aspects of the project, with the aim of motivating the reflection of the proposed reform and its most important components, to contribute to achieving its aim. The conclusion is that the main themes of the Project require precision in relevant areas, such as the transformation of the financing scheme for care, the strengthening of stewardship and governance, the responsibility in the provision of services, and the regulation and access to medicines. The contributions of academics, decision makers and social organizations will be essential to create a public health policy based on evidence and social equity.


Subject(s)
Humans , Health Care Reform/legislation & jurisprudence , Health Services Accessibility/legislation & jurisprudence , Legislation, Drug , National Health Programs/legislation & jurisprudence , Health Services Administration/legislation & jurisprudence , Pharmaceutical Preparations/supply & distribution , Delivery of Health Care/legislation & jurisprudence , Government Regulation , Financing, Government/legislation & jurisprudence , Mexico
9.
Ciênc. Saúde Colet ; 24(9): 3395-3406, set. 2019. tab, graf
Article in Portuguese | LILACS | ID: biblio-1019667

ABSTRACT

Resumo Os problemas relacionados ao uso de drogas se mantêm como foco de preocupação em países que têm uma história em comum e trajetórias distintas como Brasil e Portugal. Objetivo: descrever os achados na literatura científica sobre os impactos das mudanças na legislação sobre drogas na assistência a estas pessoas nos dois países. Método: revisão integrativa da literatura, por meio de critérios de inclusão e exclusão, seleção da amostra, análise e categorização dos estudos com a escolha de 21 artigos publicados nas bases PubMed, SciELO e Biblioteca do Conhecimento on-line, mais portarias e leis referentes ao tema. Resultados: Observa-se que é escassa a produção sobre as repercussões das mudanças da legislação para a assistência. Nos dois países, o álcool e o tabaco se mantêm como foco de preocupação. Em Portugal, a preocupação com os problemas relacionados ao uso de heroína diminuiu nos últimos anos, mas as taxas de prevalência do uso de opióides se mantêm muito acima das do Brasil. Os problemas com o crack configuram uma realidade brasileira sem paralelo em Portugal. Em ambos os casos, há iniciativas para a mudança da política em direção à diminuição da abordagem repressiva, com a diferenciação entre usuários e traficantes, o aumento da punição dos traficantes e abrandamento da punição dos usuários.


Abstract Introduction: Substance use problems remain at the core of public concern in countries sharing a common culture and a distinct history like Brazil and Portugal. Objective: To describe findings of scientific literature about the implications of drug legislation change for the care of drug users in Brazil and Portugal. Methods: This is an integrative review of literature that considers inclusion and exclusion criteria, sample selection, analyses and categorization of 21 articles selected that were published in databases PubMed, SciELO and Biblioteca do Conhecimento on-line (B-ON) and included ordinances and laws related to the subject. Results: We observed that production on the repercussions of changes of legislation on care is scarce. Alcohol and tobacco are still a matter of concern in both countries. In Portugal, concerns about heroin-related issues have declined in recent years, but opioids use prevalence rates remain well above those of Brazil. Crack-related problems are a Brazilian reality without parallel in Portugal. In both cases, some actions are in place to change the policy in favor of a reduced repressive approach, with differentiation between users and drug dealers, increased punishment of dealers and reduced punishment of drug users.


Subject(s)
Humans , Substance-Related Disorders/epidemiology , Drug Users/legislation & jurisprudence , Legislation, Drug , Portugal/epidemiology , Brazil/epidemiology , Drug Trafficking/legislation & jurisprudence , Health Policy
10.
Ciênc. Saúde Colet ; 24(8): 2939-2950, ago. 2019. tab
Article in Portuguese | LILACS | ID: biblio-1011866

ABSTRACT

Resumo Este trabalho apresenta uma revisão descritiva de leis e normas adotadas pelos países da Europa, das Américas e Austrália sobre gestão de medicamentos e de seus resíduos. Esta revisão integra pontos relevantes de documentos oficiais das agências reguladoras desses países, bem como de trabalhos científicos importantes. Todos os países pesquisados realizam gestão de medicamentos concomitantemente com a gestão de seus resíduos, atuando desde programas de conscientização sobre o uso racional e os riscos dos medicamentos até na coleta e disposição segura de seus resíduos. A Alemanha, os EUA e a Suécia exigem uma avaliação prévia do impacto ambiental provocado pelo medicamento como critério de seu registro. Em destaque, a Suécia que periodicamente atualiza uma lista de medicamentos essenciais baseada na avaliação do risco e do perigo ambiental de seus resíduos. No Brasil, as medidas legais propostas como prescrição racional e logística reversa ainda não foram efetivamente implementadas. A avaliação prévia de impacto ambiental resguarda os riscos à saúde humana e da biota selvagem causados pela exposição aos resíduos de medicamentos. Portanto, esses modelos internacionais poderiam servir de base para discussões e/ou alterações legais e normativas no Brasil.


Abstract This paper presents a descriptive review of laws and regulations on the management of drugs and the residues thereof adopted by countries in Europe, the Americas and Australia. This review integrates relevant points of official documents of regulatory agencies in these countries, as well as important scientific works. All countries surveyed carry out drug management concomitant with the management of the residues thereof, ranging from awareness programs on the rational use and the risks of drugs through to the collection and safe disposal of such residues. Germany, the USA and Sweden demand a prior assessment of the environmental impact caused by a given drug as a criterion for its registration. Sweden is noteworthy in that it periodically updates a list of essential drugs based on risk assessment and the environmental risks posed by the residues thereof. In Brazil, the legal measures proposed including rational prescription and reverse logistics have not yet been effectively implemented. Prior environmental impact assessment safeguards the risks to human health and the wild biota caused by exposure to drug residues. Therefore, these international models could serve as a basis for discussion and/or legal and regulatory changes in Brazil.


Subject(s)
Humans , Drug Residues/toxicity , Risk Assessment/legislation & jurisprudence , Drug and Narcotic Control , Drugs, Essential/administration & dosage , Drugs, Essential/adverse effects , Environment , Legislation, Drug
11.
Cad. Saúde Pública (Online) ; 35(10): e00053519, 2019. graf
Article in Portuguese | LILACS | ID: biblio-1039383

ABSTRACT

Resumo: Produtos biológicos revolucionaram a terapêutica mundial. O alto custo desses medicamentos, no entanto, ameaça a sustentabilidade dos sistemas de saúde. O desenvolvimento de cópias é tido como uma alternativa econômica, mas devido à complexidade desses produtos, muitos conceitos utilizados para os medicamentos genéricos não se aplicam. A intercambialidade entre produtos biológicos representa um desafio regulatório a ser superado. Este ensaio discute os principais desafios regulatórios relacionados ao estabelecimento de critérios para intercambialidade entre produtos biológicos novos e suas cópias no âmbito do Sistema Único de Saúde (SUS), considerando as diretrizes adotadas pelas principais agências reguladoras de medicamentos do mundo sobre a intercambialidade e o arcabouço regulatório vigente no Brasil para esta questão. Preocupações relacionadas à intercambialidade de produtos biológicos incluem substituição automática, nomenclatura, farmacovigilância, imunogenicidade e extrapolação das indicações terapêuticas e dos dados clínicos de produtos biológicos novos para suas cópias. Embora o sucesso clínico e os benefícios econômicos da alternância entre alguns produtos biológicos novos e seus biossimilares já tenham sido observados, a heterogeneidade das barreiras regulatórias para aprovação das cópias de produtos biológicos entre diferentes países deve ser considerada para a regulamentação da intercambialidade de produtos biológicos no Brasil.


Abstract: Biological products have sparked a worldwide therapeutic revolution. However, the high cost of these products threatens health systems' sustainability. The development of copies is considered an economic alternative, but due to the products' complexity, many concepts used in generic drugs do not apply. Interchangeability between biologicals poses a regulatory challenge. This essay discusses the main regulatory challenges for establishing criteria for interchangeability between new biologicals and their copies in the scope of the Brazilian Unified National Health System (SUS), considering the guidelines adopted by the world's main drug regulatory agencies concerning interchangeability and the prevailing Brazilian regulatory framework on this issue. Concerns related to the interchangeability of biologicals include automatic substitution, nomenclature, pharmacovigilance, immunogenicity, and extrapolation of therapeutic indications and clinical data from new biologicals to their copies. While the clinical success and economic benefits of switching from new biologicals to their biosimilars have already been observed, the heterogeneity between countries in the regulatory barriers to the approval of copies of biologicals should be taken into consideration during the regulation of interchangeability of biologicals in Brazil.


Resumen: Los productos biológicos revolucionaron la terapéutica mundial. El alto coste de estos medicamentos, no obstante, amenaza la sostenibilidad de los sistemas de salud. El desarrollo de copias se considera como una alternativa económica, pero debido a la complejidad de estos productos, muchos conceptos utilizados para los medicamentos genéricos no se aplican a los mismos. La intercambiabilidad entre productos biológicos representa un desafío regulatorio que se debe superar. Este trabajo discute los principales desafíos regulatorios, relacionados con el establecimiento de criterios para la intercambiabilidad entre productos biológicos nuevos y sus copias en el ámbito del Sistema Único de Salud (SUS), considerando las directrices adoptadas por las principales agencias regulatorias de medicamentos del mundo sobre la intercambiabilidad y el armazón regulatorio vigente en Brasil para esta cuestión. Las preocupaciones relacionadas con la intercambiabilidad de productos biológicos incluyen la sustitución automática, nomenclatura, farmacovigilancia, inmunogenicidad y extrapolación de las indicaciones terapéuticas, así como de los datos clínicos de productos biológicos nuevos para sus copias. A pesar de que el éxito clínico y los beneficios económicos de la alternancia entre algunos productos biológicos nuevos y sus biosimilares, ya se han observados, la heterogeneidad de las barreras regulatorias para la aprobación de las copias de productos biológicos entre los diferentes países debe ser considerada para la regulación de la intercambiabilidad de productos biológicos en Brasil.


Subject(s)
Humans , Biological Products , Biosimilar Pharmaceuticals , Legislation, Drug , Brazil , Therapeutic Equivalency , Drugs, Generic , Drug Approval , Pharmacovigilance , Legislation, Pharmacy , National Health Programs
12.
Medicina (B.Aires) ; 78(4): 272-281, ago. 2018. ilus, tab
Article in Spanish | LILACS | ID: biblio-954994

ABSTRACT

Con la aparición de los tratamientos biológicos, se ha modificado la terapéutica de muchas enfermedades, en especial las reumatológicas, dermatológicas y oncológicas. Debido al alto costo de estos productos y el vencimiento de las patentes, la industria farmacológica desarrolla los biosimilares, fármacos que son una versión (copia) de la sustancia de un medicamento biológico original, y que pueden facilitar el acceso a estos tratamientos. Son elaborados de acuerdo a exigencias específicas de organismos reguladores en cuanto a calidad, eficacia y seguridad, y debe demostrarse que son comparables al medicamento de referencia. Este trabajo revisa las normativas regulatorias internacionales y nacionales, las controversias que rodean a los biosimilares y presenta la posición de un grupo de expertos con respecto al uso de biosimilares.


With the appearance of biological treatments, therapeutics has changed in many rheumatological, dermatological and oncological diseases. Due to the high cost of these biological medicaments and the expiration of patents, the pharmacological industry develops biosimilars, drugs that are a version (copy) of the substance of the original biological medicine, with the aim of facilitating access to these treatments. These biosimilars are prepared according to the specific requirements of regulatory bodies in terms of quality, efficacy and safety, and must be shown they are comparable to the reference product. This paper reviews the international and national regulatory framework, the controversies surrounding biosimilars, and presents the position of a group of experts regarding the use of biosimilars.


Subject(s)
Humans , Psoriasis/drug therapy , Dermatologic Agents/administration & dosage , Biosimilar Pharmaceuticals/administration & dosage , Legislation, Drug , Argentina , Societies, Medical , Consensus
13.
Cad. Ibero Am. Direito Sanit. (Impr.) ; 7(2): 48-60, abr./jun. 2018.
Article in Portuguese | LILACS | ID: biblio-969872

ABSTRACT

Objetivo: Este artigo tem o objetivo analisar do ponto de vista sobre o tema do uso do medicamento off label no âmbito da Saúde Suplementar. Metodologia: foi realizado uma revisão da legislação pátria, consultando o inteiro teor das leis e normas que constituem o tema. Foram consultadas as bases de dados legislativos do Senado Federal, bem como a base legal da Agência Nacional de Vigilância Sanitária e a Agência Nacional de Saúde Suplementar. Resultados: há fartura de normas legais para a regulamentação da matéria, sendo que toda a política de tratamento deste tema está consubstanciada na base da pirâmide hierárquica de leis, ou seja, nas portarias e instruções normativas. Conclusão: A existência de previsão de cobertura da doença ou patologia no contrato, há liberdade de prescrição de medicamentos off label pelo médico assistente se aplica. (AU)


Objective: This article aims to analyze from the point of view on the subject of the use of the off label drug in the scope of Supplementary Health. Methods: a review of the national legislation has been carried out, consulting the entire content of the laws and norms that constitute the theme. The legislative databases of the Federal Senate were consulted, as well as the legal basis of the National Sanitary Surveillance Agency and the National Supplementary Health Agency. Results: There are plenty of legal norms for the regulation of the matter, and the whole treatment policy of this theme is based on the hierarchical pyramid of laws, that is, in ordinances and normative instructions. Conclusion: The existence of predicted coverage of the disease or pathology in the contract, there is freedom of prescription of off-label medications by the attending physician applies. (AU)


Objetivo: Este artículo tiene el objetivo de analizar desde el punto de vista sobre el tema del uso del medicamento off label en el ámbito de la Salud Suplementaria. Medotología: se realizó una revisión de la legislación patria, consultando el entero contenido de las leyes y normas que constituyen el tema. Se consultaron las bases de datos legislativos del Senado Federal, así como la base legal de la Agencia Nacional de Vigilancia Sanitaria y la Agencia Nacional de Salud Suplementaria. Resultados: hay abundancia de normas legales para la reglamentación de la materia, siendo que toda la política de tratamiento de este tema está consubstanciada en la base de la pirámide jerárquica de leyes, o sea, en las ordenanzas e instrucciones normativas. Conclusión: La existencia de previsión de cobertura de la enfermedad o patología en el contrato, hay libertad de prescripción de medicamentos fuera de etiqueta por el médico asistente se aplica. (AU)


Subject(s)
Humans , Pharmaceutical Preparations , Products Registration , Off-Label Use/legislation & jurisprudence , Legislation, Drug
14.
Cad. Ibero Am. Direito Sanit. (Impr.) ; 7(1): 215-228, jan.-mar. 2018.
Article in Portuguese | LILACS | ID: biblio-882302

ABSTRACT

Objetivo: O objetivo foi analisar o contexto em que foi proposto e aprovado o diploma legal que autorizou o fornecimento da fosfoetanolamina sintética à luz da legislação brasileira. Metodologia: Tratou-se de um estudo descritivo-analítico, considerando que foi feita uma revisão teórica das informações disponíveis sobre o projeto de Lei da Câmara PL nº 4.639/2016, no Senado Federal PLC nº 3/2016 e da Lei da Fosfoetanolamina, Lei nº 13.269, de 13 de abril de 2016, além da revisão normativa das atribuições e competências da Agência Nacional de Vigilância Sanitária. Resultados: Ocorreu uma substituição de todo o arcabouço jurídico por legislação ordinária de efeitos concretos. Conclusão: A atuação da Agência Nacional de Vigilância Sanitária foi desconsiderada, já que cabe à agência realizar todos os testes e, posteriormente, liberar o medicamento para o consumo


Objective: The objective was to analyze the context in which the aforementioned law was proposed and approved, in light of Brazilian legislation. Methodology: This was a descriptive-analytical study, considering that a theoretical review of the information available on the House Bill PL 4.639 / 2016, Federal Senate PLC No. 3/2016 and the Law of Phosphoethanolamine, Law 13,269, of April 13, 2016, in addition to the normative review of the attributions and competencies of Brazilian Health Surveillance Agency. Results: It is clear that a whole legal framework has been replaced by ordinary legislation with concrete effects. Conclusions: In the case in question, Brazilian Health Surveillance Agency performance was disregarded, since it is up to the Agency to carry out all the tests and subsequently release the product for consumption


Objetivo: El objetivo fue analizar el contexto en que se propuso y aprobó el referido diploma legal, a la luz de la legislación brasileña. Metodología: En el caso de que se trate de un estudio descriptivo-analítico, considerando que se hizo una revisión teórica de las informaciones disponibles sobre el proyecto de Ley de la Cámara PL nº 4.639 / 2016, en el Senado Federal PLC nº 3/2016 y de la Ley de la Fosfoetanolamina, Ley nº 13.269, de 13 de abril de 2016, además de la revisión normativa de las atribuciones y competencias de Agencia Nacional de Vigilancia Sanitaria. Resultados: Ocurrió una sustitución de todo un marco jurídico por legislación ordinaria de efectos concretos. Conclusiones: En el caso en cuestión, la actuación de la Agencia Nacional de Vigilancia Sanitaria fue desconsiderada, ya que corresponde a la Agencia realizar todas las pruebas y, posteriormente, liberar el medicamento para el consumo


Subject(s)
Humans , Antineoplastic Agents , Legislation, Drug , Legislation as Topic
17.
Caracas; s.n; 20170000. 90 p. Tablas.
Thesis in Spanish | LILACS, LIVECS | ID: biblio-1367183

ABSTRACT

Al momento de desarrollar un nuevo medicamento, la forma farmacéutica toma gran importancia representando un gran reto, la selección de los excipientes adecuados para obtener un producto que no se vea afectado en sus características organolépticas, ni físico químicas. La Autoridad Regulatoria implementa a través de normas y/o publicaciones oficiales, concentraciones, límites y advertencias para su empleo en la formulación. En el país rigen las Normas de la Junta Revisora de Productos Farmacéuticos, con el fin de obtener productos farmacéuticos que cumplan con estándares de calidad, seguridad y eficacia, lo que implica la necesidad de actualizar las Normas mencionadas, que datan del año 1998, en este estudio, el Capítulo XI "De los excipientes", aplicado a las formas farmacéuticas líquidas orales. La investigación se efectuó mediante análisis de fuentes secundarias de excipientes contemplados en la normativa nacional e internacional, a efecto de determinar comparación y vigencia; una vez analizadas se elaboró una lista en la cual se actualizan los excipientes. Una vez realizada la comparación de las dos listas de excipientes, se identificó los excipientes utilizados a nivel internacional y se procedió a la elaboración de la Lista de Excipientes ajustado a la necesidad actual.


At the time of developing a new drug, the pharmaceutical form is of great importance representing a great challenge, the selection of suitable excipients to obtain a product that is not affected in its organoleptic or physical chemical characteristics. The Regulatory Authority implements, through standards and / or official publications, concentrations, limits and warnings for its use in the formulation. In order to obtain pharmaceutical products that comply with quality, safety and efficacy standards, the Standards of the Pharmaceutical Products Review Board are in place, which implies the need to update the mentioned Standards, which date from 1998, in This study, Chapter XI "Of the excipients", applied to oral liquid pharmaceutical forms. The investigation was carried out by means of analysis of secondary sources of excipients contemplated in the national and international regulations, in order to determine comparison and validity; once analyzed a list was prepared in which the excipients are updated. After comparing the two lists of excipients, the excipients used at the international level were identified and the List of Excipients adjusted to the current need was drawn up.


Subject(s)
Humans , Pharmaceutical Preparations , Enacted Statutes , Products Registration , Excipients , Health Authorities , Legislation, Drug , Health Surveillance , Public Health
18.
Medicina (B.Aires) ; 77(5): 388-393, oct. 2017.
Article in Spanish | LILACS | ID: biblio-894505

ABSTRACT

En los últimos años se ha generado en la sociedad una gran expectativa sobre la posible utilidad terapéutica de compuestos derivados de la planta de cannabis. Es muy bien sabido que están siendo utilizados en el tratamiento de diversas afecciones, ya sea por prescripción médica o por autoadministración. En un extremo de las opiniones están quienes consideran que es una droga dañina y peligrosa, mientras otros mantienen que es la panacea. No obstante, el simple hecho de que exista un sistema endocannabinoide en el cerebro obliga a estudiarlo en todas sus dimensiones y derivaciones. Se espera que, en el marco de la nueva ley, se puedan dilucidar las controversias y los vacíos del conocimiento. Las posiciones prohibicionistas no deberían ser una categoría de análisis. Independientemente de los efectos terapéuticos demostrados o por demostrar, ya se están vislumbrando severas restricciones al uso de compuestos cannabinoides, similares a las que aún hoy existen para acceder a los opioides (fármacos de utilidad definitivamente comprobada pero sobre los cuales persiste un enorme tabú). En esta revisión, se expone la primera ley sobre el uso medicinal del cannabis promulgada en Argentina. Se señalan los hitos de la historia sobre la marihuana en el país, indisolublemente relacionados con los argumentos prohibicionistas y los de flexibilización en el mundo. Se analiza la evidencia sobre su utilidad terapéutica y el estado actual del uso del aceite de cannabis en nuestro país.


In the last few years, great expectations have risen in the society concerning the eventual therapeutic usefulness of compounds derived from the cannabis plant. It is well known that these compounds are being used in treating certain health conditions, either through medical prescription or self-administration. Extreme opinions range from believing that it is a harmful and dangerous drug to sustaining that it is a panacea. However, the sheer existence of an endocannabinoid system in the brain compels us to study its dimensions and derivations thoroughly. It is expected that controversies and knowledge gaps will be clarified within the framework of this new law. Prohibitionism should not be a category of analysis. Regardless of the therapeutic effects of cannabinoid compounds, demonstrated or to be demonstrated, there are already severe restrictions on their use, which mirror the still existing restrictions to the use of opioids (drugs of definite utility but on which a huge taboo persists). This review presents the first Argentine law on the medical use of cannabis. Milestones in the history of marijuana at the national level are pointed out, which are inextricably linked to world trends either in favor or against prohibition. The current status of the use of cannabis oil in the country and evidences for its therapeutic value are also analyzed. Evidences on its therapeutic value are also analyzed as well as the current status of the use of cannabis oil in our country.


Subject(s)
Humans , History, 20th Century , History, 21st Century , Medical Marijuana/history , Medical Marijuana/therapeutic use , Legislation, Drug , Argentina , Attitude , Government Regulation
19.
Ciênc. Saúde Colet ; 22(8): 2549-2558, Ago. 2017. tab, graf
Article in English | LILACS | ID: biblio-890421

ABSTRACT

Abstract Since the enforcement of Generics Act (1999), three types of pharmaceutically equivalent products are marketed in Brazil: innovative reference (REF), "similar" (S) and generic (G) drugs. The S (brand name) and G (generic name) borrow from REF (brand name) clinical data on safety and efficacy and dosage regimen. G (but not S) is bioequivalent to and interchangeable with REF. Starting in 2003, Brazilian Sanitary Surveillance Agency (Anvisa) has required data on relative bioavailability tests (with REF) to approve (or renew registration of) S drugs. In 2014, Anvisa extended interchangeability notion to similar drugs with a "comparable" bioavailability, i.e., an "equivalent" similar drug (EQ). Drugs for chronic diseases and "critical dose medicines" are listed among the EQ drugs approved. Interchangeability of nonbioequivalent medicines raises deep concerns regarding therapeutic failures and adverse events. Concerns are even more worrisome if patients switch from one drug to another during an ongoing treatment for illnesses such as epilepsy, congestive heart failure, hypertension, diabetes and/or substitutable drugs have a narrow therapeutic index.


Resumo A partir da vigência da lei dos genéricos (1999), três tipos de produtos farmaceuticamente equivalentes são comercializados no Brasil: o medicamento inovador de refência (REF), o produto "similar" (S), e o genérico (G). O similar (nome de fantasia) e o genérico (nome genérico) tomam de empréstimo do REF (nome de fantasia) os dados clínicos de segurança e eficácia e a posologia. G (mas não S) é bioequivalente ao, e intercambiável com REF. Desde 2003, a Agência Nacional de Vigilância Sanitária (Anvisa) exige dados de testes de biodisponibilidade relativa para registrar (ou renovar o registro de) medicamentos S. Em 2014, a Anvisa estendeu o conceito de intercambialidade aos medicamentos similares com biodisponibilidade "comparável", i.e., um medicamento similar "equivalente" (EQ). Medicamentos para doenças crônicas e "fármacos de dose crítica" estão listados entre os produtos EQ aprovados. A intercambialidade de medicamentos não-bioequivalentes suscita grande preocupação quanto a falhas terapêuticas e eventos adversos. Os receios são ainda maiores se os pacientes trocam um medicamento por outro durante o tratamento de doenças como epilepsia, insuficiência cardíaca, hipertensão, diabetes e/ou os produtos farmacêuticos substituídos tem um índice terapêutico estreito.


Subject(s)
Humans , Drugs, Generic/administration & dosage , Prescription Drugs/administration & dosage , Drug Substitution/methods , Legislation, Drug , Brazil , Biological Availability , Therapeutic Equivalency , Drugs, Generic/adverse effects , Drugs, Generic/pharmacokinetics , Treatment Failure , Drug Approval/legislation & jurisprudence , Prescription Drugs/adverse effects , Prescription Drugs/pharmacokinetics , Drug Substitution/adverse effects , Patient Safety , Therapeutic Index
20.
Hacia promoc. salud ; 22(1): 43-55, Junio 21, 2017.
Article in Spanish | LILACS | ID: biblio-953777

ABSTRACT

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.


Subject(s)
Humans , Male , Plants, Medicinal , Cannabinoids , Cannabis , Marijuana Smoking , Legislation, Drug
SELECTION OF CITATIONS
SEARCH DETAIL