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La lamivudina es uno de los medicamentos más prescritos en el mundo, se utiliza para tratar la inmunodeficiencia humana y la hepatitis B. El objetivo del estudio fue evaluar los atributos de calidad y comparar los perfiles de disolución de dos lotes (A y B) del medicamento genérico lamivudina 150 mg tabletas con el medicamento innovador Epivir 150 mg tabletas. Se realizó un estudio analítico, experimental y de corte transversal, se usó un método espectrofotométrico a una longitud de onda de máxima absorción (λ) correspondiente a 270 nm, para medir el porcentaje de fármaco disuelto. El estudio evaluó identificación, contenido, disolución y uniformidad de masas. Se usó el aparato 2 USP (Paleta) 75 rpm, 900 mL de medio de disolución (37 ± 0,5 °C) a en tres medios de disolución: pH 1,2; 4,5 y 6,8. Se retiraron muestras de 5 mL a los 5, 10, 15, 20 y 30 min. Se encontró que ambos lotes de lamivudina genérico (A y B) presentan el mismo perfil cinético de disolución que el medicamento innovador. Ambas formulaciones cumplen con el criterio de medicamentos de disolución muy rápida (85% disuelto en 15 min), y de disolución rápida (85% disuelto en 30 min). Por lo tanto, no fue necesario calcular el factor de similitud. Se concluye que los medicamentos genéricos A y B son equivalentes in vitro con el medicamento innovador Epivir.

During the past three decades the world has been witness to an alarming increase in the shortage of drugs and biomedical products in the field of anesthesia and surgical care. This situation can be particularly challenging when there are no therapeutic alternatives available, as is the case with some supplies and drugs for perioperative use. Anesthesiologists, who play a crucial role in the preparation of the drugs they administer, are particularly aware of these shortages. The reasons for these shortages are diverse and involve problems in supply, demand and government regulation. Among the causes identified are the increase in demand, bidding systems and the sustainability challenges faced by pharmaceutical companies. It is essential to understand these causes in order to seek strategies to reduce the risk of shortages of medicines and supplies. Addressing this challenge requires improving supply chain management, fostering transparency in information on stock-outs, promoting local production of medicines, and strengthening procurement and distribution regulations and policies. The solution to this problem requires a comprehensive and collaborative approach, with multiple stakeholders working together to ensure adequate access to needed medications in the anesthesia and surgical care setting. [ABSTRACT FROM AUTHOR]

Lamivudine is one of the most prescribed drugs in the world, and is used to treat human immunodeficiency and hepatitis B. This study aimed to evaluate the quality attributes and compare the dissolution profiles of two batches (A and B) of generic lamivudine 150 mg tablets with the innovator drug Epivir 150 mg tablets. We conducted an analytical, experimental, cross-sectional study, and used a spectrophotometric method at a wavelength of maximum absorption (λ) corresponding to 270 nm, to measure the percentage of dissolved drug. The study evaluated identification, content, dissolution and mass uniformity. Apparatus 2 USP (Paddle) 75 rpm, 900 mL of dissolution medium (37 ± 0.5 °C) was used in three dissolution media: pH 1.2; 4.5 and 6.8. Samples of 5 mL were obtained at 5, 10, 15, 20 and 30 min. Both batches of generic lamivudine (A and B) were found to have the same dissolution kinetic profile as the innovator drug. Both formulations met the criteria of very fast dissolving (85% dissolved in 15 min), and fast dissolving (85% dissolved in 30 min) drugs. Therefore, it was not necessary to calculate the similarity factor. We concluded that generic drugs A and B are in vitro equivalents to the innovator drug Epivir. [ABSTRACT FROM AUTHOR]

The medicines’ interchangeability represents a necessity in developing countries, because it offers the possibility of accessing lower cost products, it allows to ensure efficacy and safety in pharmacotherapeutic treatments. The study gather researches carried out in the Peruvian state published in high-impact databases such as Scielo, Sciencedirect, Scopus and Pubmed. Of the 553 researches found, only 10 articles met the inclusion and exclusion criteria, drugs such as diazepam, prednisone, amoxicillin, doxycycline, fluconazole, phenytoin sodium, alprazolam, amlodipine, carbamazepine sodium, glibenclamide, moxifloxacin and acetylsalicylic acid were identified. All the articles analyzed the dissolution profile by calculating the similarity factor f2, while, in other cases, they estimated parameters such as weight variation, friability, hardness, quantification, content uniformity, and dissolution profile. The results show that 9 drugs included in the study were analyzed by in vitro studies at different pH (1.2; 4.5 and 6.8), and complied with presenting a similarity factor f2 greater than 50. It is concluded that, the interchangeability of medicines in the Peruvian state is still in process, and that, through strategic alliances with the private sector, a greater number of pharmaceutical alternatives could be had in the patient's recovery.

Hemos tenido la oportunidad de leer su carta relacionada con nuestro artículo de revisión: “Medicamentos bioterapeúticos: uso de toxinas botulínicas en la era de biosimilares” (1). Queremos manifestar nuestro acuerdo con sus comentarios sobre la relevancia del tema en nuestro medio, así como con sus reflexiones sobre la intercambiabilidad de medicamentos y la necesidad de precisar muy bien los conceptos en la materia. En particular, usted hace referencia a la confusión que puede generar la frase de nuestra conclusión: “los medicamentos biológicos no son intercambiables entre sí, aunque demuestren bioequivalencia” Con interés leímos cómo muchos de los compañeros se confundieron con la última parte de la frase pues resulta contradictorio, ya que como usted menciona clásicamente “los estudios de bioequivalencia se realizan para demostrar que el medicamento genérico es equivalente e intercambiable con el medicamento original”.

The medicines’ interchangeability represents a necessity in developing countries, because it offers the possibility of accessing lower cost products, it allows to ensure efficacy and safety in pharmacotherapeutic treatments. The study gather researches carried out in the Peruvian state published in high-impact databases such as Scielo, Sciencedirect, Scopus and Pubmed. Of the 553 researches found, only 10 articles met the inclusion and exclusion criteria, drugs such as diazepam, prednisone, amoxicillin, doxycycline, fluconazole, phenytoin sodium, alprazolam, amlodipine, carbamazepine sodium, glibenclamide, moxifloxacin and acetylsalicylic acid were identified. All the articles analyzed the dissolution profile by calculating the similarity factor f2, while, in other cases, they estimated parameters such as weight variation, friability, hardness, quantification, content uniformity, and dissolution profile. The results show that 9 drugs included in the study were analyzed by in vitro studies at different pH (1.2; 4.5 and 6.8), and complied with presenting a similarity factor f2 greater than 50. It is concluded that, the interchangeability of medicines in the Peruvian state is still in process, and that, through strategic alliances with the private sector, a greater number of pharmaceutical alternatives could be had in the patient's recovery. [ABSTRACT FROM AUTHOR]

El presente artículo recapacita sobre las reformas normativas acontecidas en las últimas décadas respecto al uso racional de los medicamentos, y las medidas operadas en torno a la disminución del gasto farmacéutico. En este contexto, debe destacarse el elevado coste de las terapias biológicas y las dificultades de acceso a las mismas —especialmente en los países en vías de desarrollo—. Los medicamentos biosimilares son poseedores de garantías sanitarias análogas —semejantes o equivalentes— a los medicamentos de referencia, pero no están sometidos a una protección por una patente y facilitan la accesibilidad a los pacientes, así como al reparto equitativo de los recursos terapéuticos. Además, algunos de ellos están incluido en la lista de medicamentos esenciales de la Organización Mundial de la Salud (OMS). Asimismo, se examina el papel de los medicamentos biosimilares como esenciales y la posibilidad de mejorar el acceso equitativo a estos recursos sanitarios a través de la prestación farmacéutica.

Introduction: Knowledge and perception towards generic drugs are topics that emerge as an important factor to explore in medical students. Objective: To determine the differences between medical students from public and private universities on the perception and use of Generic Pharmaceutical Specialties (GFE). Materials and methods: A quantitative observational, cross-sectional, analytical and comparative study was conducted in a universe of 858 students enrolled during 2019-2020 in five medical schools in the Mexican state of Tabasco. Through Google Forms, data were collected from a self-applied form based on a previously validated questionnaire. Descriptive statistics were used to assess student perceptions, and nonparametric tests through an analysis model for difference of means to compare the result between universities. Results: The perception of the dimensions of quality (= 12,51) and efficacy (=6,06) shows an indecisive position in general. On reliability (=6,99), students agreed. The dimensions of preference-experience (=10.649) and accessibility (=7,01), place students in the group of undecideds. In the comparison of means of the GFE perception scale (student's t test), the public university presented a low mean (=24,72), while in the group of private universities it was higher (=26,06). Regarding the use of GFE, the public university presented a mean =38,22, while the group of private universities was lower (=36,70). Conclusions: It is necessary to include in the curricular contents of future medical professionals more information on quality, safety and efficacy of GFE, which will contribute to raising the level of confidence in their prescription. [ABSTRACT FROM AUTHOR]

Copyright of Cadernos de Saude Publica is the property of Escola Nacional de Saude Publica Sergio Arouca and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Arquivos de Ciências da Saúde da UNIPAR is the property of Associacao Paranaense de Ensino e Cultura and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Generic drugs play an important role in healthcare systems as they represent an effective and more affordable alternative for the population. In Peru, a regulation of interchangeability of generic drugs (also called multisource drugs) was stablished to define the procedures and requirements for developing in vivo and in vitro therapeutic equivalence studies, following the gradual application approach and sanitary risk criteria. Compliance with the new regulation will allow greater access to effective, safe and quality generic drugs. Meanwhile, drugs continue to be marketed in the absence of therapeutic equivalence studies. Findings show that some drugs failed in in vivo and in vitro comparisons with the reference product. This regulation represents a great challenge for manufacturers and holders of sanitary registrations in order to demonstrate the interchangeability of their pharmaceutical products with the reference product.

Este artigo apresenta os resultados de pesquisa sobre a indústria farmacêutica no Brasil, no período recente, realizada no âmbito do projeto multicêntrico Complexo Econômico-Industrial da Saúde, Inovação e Dinâmica Capitalista: Desafios Estruturais para a Construção do Sistema Universal de Saúde no Brasil. Os quatro componentes estudados sobre a evolução da indústria farmacêutica no Brasil foram: as políticas industriais do Estado; as mudanças na composição financeira e patrimonial das empresas de capital nacional, a evolução da produção; e o comportamento da balança comercial. As análises levaram em consideração o marco teórico proposto por Luiz Filgueiras e Reinaldo Gonçalves a respeito da implantação de um “modelo liberal e periférico” na economia brasileira a partir dos anos 1990. Foram levantados e analisados dados sobre: a situação das Parcerias de Desenvolvimento Produtivo (PDP) para medicamentos entre 2009 e 2020; da Pesquisa Industrial Anual (PIA), do Instituto Brasileiro de Geografia e Estatística (IBGE), entre 1996 e 2018; e os dados da evolução da balança comercial do setor entre 1996 e 2019. Os resultados evidenciam que a agenda do Estado para o setor favoreceu o crescimento da produção de medicamentos genéricos, dos medicamentos isentos de prescrição (MIP) e deu início a alguns projetos de transferência de tecnologia via PDPs para a produção de medicamentos biológicos e sintéticos. Apesar dessa evolução, o Brasil se mantém dependente da importação de insumos químicos e farmacêuticos e de medicamentos acabados. Isto nos mantém em situação de vulnerabilidade tecnológica e econômica em relação aos fornecedores mundiais, além de um aprofundamento do déficit da balança comercial do setor.

Introducción: La automedicación es la utilización de medicamentos sin receta por elección propia de las personas, lo que puede condicionar riesgos a la salud y generar potencial resistencia antimicrobiana. Objetivo: Identificar el nivel de conocimiento básico y las características de la automedicación en consumidores de medicamentos genéricos en farmacias de un municipio mexicano. Métodos: Se realizó un estudio exploratorio descriptivo y transversal en la población urbana residente en el Municipio de Jalpa de Méndez (87,249 habitantes) Tabasco. La muestra probabilística aleatoria simple (n=383) recolectó información de usuarios compradores de medicamentos genéricos en 7 de las 10 farmacias existentes en la cabecera municipal. Resultados: El perfil de los consumidores de medicamentos genéricos corresponde mayormente a mujeres (53%), entre 18 y 33 años de edad (53.3%), con nivel de escolaridad alta (preparatoria 34% y profesionales 42%), casadas (45%), ocupadas laboralmente (52%) y autodependientes (62%). El nivel de conocimiento predominante fue el medio. Los medicamentos mayormente comprados fueron antiinflamatorios no esteroideos comúnmente denominados AINES (46.3%). La automedicación fue abiertamente reconocida por el 56.60% de los encuestados. Conclusiones: La alta escolaridad se relaciona a la práctica de automedicación en la población estudiada. El patrón de automedicación detectado se caracteriza por la compra sin receta médica en el caso de patologías leves, principalmente debido a la falta de tiempo para acudir al médico y por los bajos costos de las especialidades farmacéuticas genéricas.

Copyright of Revista de Relações Internacionais is the property of Institute of International Relations of Pontifical Catholic University of Rio de Janeiro and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

El objetivo del estudio fue determinar la equivalencia terapéutica evaluada mediante estudios in vitro de cuatro marcas de medicamentos conteniendo amoxicilina, doxiciclina y fluconazol adquiridos en establecimientos farmacéuticos de Lima Metropolitana y establecer su intercambiabilidad con un producto de referencia (PR). Se empleó un método validado de espectrofotometría ultravioleta visible para determinar el perfil de disolución. El factor de similitud (f2) se utilizó para establecer la equivalencia terapéutica, considerándose equivalentes si los valores de f2 se encontraban entre 50 y 100. Para doxiciclina los cuatro medicamentos fueron equivalentes in vitro al PR, para amoxicilina sólo dos medicamentos fueron equivalentes in vitro al PR y para fluconazol ninguno fue equivalente in vitro al PR. Se concluye que algunos medicamentos de amoxicilina y fluconazol que circulan en el mercado nacional no cumplen con la equivalencia terapéutica evaluada mediante estudios in vitro; es decir, no son intercambiables.

Introdução: O registro sanitário é a autorização governamental necessária para que um medicamento possa ser comercializado no Brasil. As exigências relacionadas ao registro sanitário foram reestruturadas a partir de 1999 com a criação da Agência Nacional de Vigilância Sanitária (Anvisa) e com a instituição da Política Nacional de Medicamentos Genéricos. Objetivo: Cerca de 20 anos após a implementação desta política e a criação da Anvisa, este trabalho objetivou descrever o cenário atual de registro de medicamentos sintéticos e semissintéticos, a fim de fornecer subsídios para a tomada de decisão dos agentes reguladores e regulados. Método:Para realizar o levantamento dos dados referentes aos produtos registrados, foi utilizado o Sistema de Produtos e Serviços sob a Vigilância Sanitária (Datavisa), que é de acesso exclusivo aos servidores da Anvisa. Resultados:Foram localizados 6.454 processos de registros de medicamentos sintéticos e semissintéticos válidos, que correspondem a 7.721 produtos diferentes. Mais de 80,0% dos produtos registrados são genéricos ou similares. As empresas nacionais desempenham papel importante no mercado farmacêutico brasileiro, porém ainda é possível identificar dificuldades relacionadas à inovação. Dentre as principais categorias registradas, estão os medicamentos isentos de prescrição médica, os antibacterianos de uso sistêmico, os medicamentos que atuam no sistema nervoso central, os agentes antineoplásicos e os medicamentos para tratamento de síndrome metabólica. As doenças tratadas por esses medicamentos possuem alta prevalência na população brasileira. Conclusões: Os dados apresentados demonstram a efetividade das políticas adotadas e podem ser utilizados na elaboração de novas políticas relacionadas à regularização de medicamentos no Brasil.

Introdução:A regulação de preços no mercado farmacêutico é comum aos países de diversos níveis de desenvolvimento, mas a motivação para sua implementação difere entre países desenvolvidos e em desenvolvimento. Objetivo:Discutir, com base em outras experiências de regulação de preços de medicamentos em países selecionados, a regulação de preços de medicamentos em vigor no Brasil, de modo a acumular evidências da necessidade de melhorias na regulação em vigor. Método:Revisão da literatura sobre modelos regulatórios de preços de medicamentos em países selecionados. Resultados:Com a sistematização da literatura, realizou-se a análise dos diferentes tipos de regulação de preços de medicamentos por grupo de países europeus e em desenvolvimento. Conclusões:A revisão de literatura serviu para observar as diferenças da regulação de preços dos medicamentos em distintos países em comparação com a brasileira e trazer sugestões de como aperfeiçoar a regulação atual para se alcançar resultados mais desejáveis.

Generic drugs play an important role in healthcare systems as they represent an effective and more affordable alternative for the population. In Peru, a regulation of interchangeability of generic drugs (also called multisource drugs) was stablished to define the procedures and requirements for developing in vivo and in vitro therapeutic equivalence studies, following the gradual application approach and sanitary risk criteria. Compliance with the new regulation will allow greater access to effective, safe and quality generic drugs. Meanwhile, drugs continue to be marketed in the absence of therapeutic equivalence studies. Findings show that some drugs failed in in vivo and in vitro comparisons with the reference product. This regulation represents a great challenge for manufacturers and holders of sanitary registrations in order to demonstrate the interchangeability of their pharmaceutical products with the reference product. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the acceptance of generic drugs in the population of Diadema, and identify factors that interfere in their choice, aiming at an improvement in assistance for these patients. Materials and methods: 203 participants were interviewed through a questionnaire containing 23 questions. The interviews were performed in Diadema city/São Paulo - Brazil. Data was expressed inpercentages; however, Chi-square test was also used for some associations and a 95% confidence interval was considered. Results: Most interviewees declared having satisfactory knowledge about generic drugs and reported previous use of it. Eighty-one-point three percent of interviewed people reported that generic drugs had present the expected therapeutic effect, and 85.7% informed they believed in the safety of these drugs. The pharmacy/drugstore was the principal mean of communication to transmit information about generic medications, and a relation was observed between socioeconomic conditions and knowledge/use of these drugs. Conclusion: The studied population showed good acceptance and satisfactory knowledge about generic drugs and most of them believe in its safety. The price, the level of education, and the value of income of the population, and the low frequency of prescription, demonstrated to influence the consumption of generic drugs. Implementation of programs encouraging the prescription of these drugs and campaigns to enlighten information about generic drugs for the population could be beneficial for a better knowledge and use of them, ensuring access to health by all populations. [ABSTRACT FROM AUTHOR]

Copyright of Jornal Brasileiro de Patologia e Medicina Laboratorial is the property of Sociedade Brasileira de Patologia Clinica and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Introduction: The Colombian national pharmaceutical policy establishes as a strategy the generation of greater pharmaco-epidemiological research at the national level, especially in the case of antibiotic drugs. Objective: To provide local pharmaco-epidemiological evidence regarding the effectiveness, conditions of use and safety of generic meropenem and cefepime in a tertiary hospital in Bogotá. Materials and methods: We conducted a descriptive, longitudinal and retrospective drug utilization study. The data were collected from the medical histories of all the patients who had cefepime or meropenem prescribed. Results: We included 82 patients treated with cefepime and 91 treated with meropenem in the study. Most of the patients were in services different from the intensive care unit (taking cefepime: 59.8%, and meropenem: 52.7%). Only 21.9% of the patients treated with cefepime and 49% of those treated with meropenem were seen by an infectious disease specialist. The antibiogram was performed for 47% and 60% of the patients treated with cefepime and meropenem, respectively. The most frequent indication for cefepime were respiratory infections and for meropenem, genitourinary ones. Therapeutic success rates were 61.7% for cefepime and 63.0% for meropenem. Conclusions: This study contributes evidence regarding the therapeutic performance of two generic antibiotics used in tertiary hospitals. There were no reports of therapeutic failure during the study period. In the cases of non-response, pharmacokinetic alterations, unfavorable clinical conditions, and inappropriate choice of antimicrobial treatment were identified as frequent factors.

A pesquisa tem por objeto analisar os efeitos da aplicação do parágrafo único do art. 40 da Lei de Propriedade Industrial, que confere possibilidade de prorrogação da vigência da patente, em relação ao acesso aos medicamentos genéricos. Apresenta algumas reflexões sobre a proteção da propriedade intelectual enquanto direito fundamental. Verifica a situação do processo de análise de pedidos de patentes, de responsabilidade do Instituto Nacional de Propriedade Industrial (INPI), como forma de entender o que levou o legislador a introduzir o referido parágrafo único no art. 40 da Lei de Propriedade Industrial, especialmente no que se refere aos medicamentos genéricos. O método utilizado é o dedutivo, com base na revisão bibliográfica da legislação, doutrina e jurisprudência. Conclui que o parágrafo único do artigo 40 da Lei de Propriedade Industrial, que buscou minimizar os prejuízos dos autores de inventos em face da morosidade no processamento dos pedidos de patentes pelo INPI, que deveria ocorrer apenas em casos excepcionais, é aplicado sistematicamente em face da questão do backlog, retardando a entrada de novos medicamentos genéricos no mercado e, consequentemente, impedindo um maior acesso da população aos medicamentos genéricos, em regra mais baratos, seguros e eficazes que os remédios tradicionais.

A hidroclorotiazida (HCTZ) é um fármaco da classe dos diuréticos tiazídicos, amplamente utilizado no tratamento de pacientes com edema e hipertensão arterial sistêmica leve a moderada, sendo considerado altamente efetivo pelos profissionais da saúde. O objetivo deste trabalho foi avaliar a equivalência farmacêutica e realizar estudos comparativos de perfil de dissolução entre medicamento Referência (R) e três medicamentos Genéricos (G1, G2 e G3) na forma de comprimidos de liberação imediata de HCTZ (25 mg), de acordo com a monografia apresentada na Farmacopeia Brasileira 5ª Ed. (2010) e a legislação nacional vigente. Nos testes físicos e físico-químicos todos os medicamentos G foram aprovados, no entanto, em alguns casos apresentaram diferenças significativas quando comparados ao medicamento R. Em relação ao perfil de dissolução, o qual visa avaliar o fator de semelhança F2, apenas o medicamento G3 não apresentou um perfil semelhante quando comparado ao medicamento R. A intercambialidade entre G3 e R pode estar comprometida, pois há possibilidade de não atingir níveis plasmáticos da HCTZ na velocidade e extensão desejadas. Os resultados deste trabalho podem refletir a qualidade e confiabilidade dos medicamentos genéricos amplamente utilizados pela população brasileira.

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Background: The Brazilian Ministry of Health, by the National Policy on Medication, Ordinance 3916 from October 30th 1998, reinforces the Law of Generics of February 1999 (Law No. 9787 from February 10th, 1999, aiming, among other things, to reduce the prices and make access to medications easier for population). Objective: The main objective was to identify the level of knowledge of the population regarding generic drugs. Method: Descriptive, quantitative study, with 520 users interviewed in four health care units that implemented the Brazilian Family Health Program. Such units represent four health districts in Foz do Iguaçu, PR, Brazil. Results: Most of the interviewed know and/or have heard about generic drugs. For many people, the generic drug represents only a more affordable type of medication. Conclusion: The need for health education to clarify the population's questions was found, so they could identify and acquire their medication safely and with confidence. [ABSTRACT FROM AUTHOR]

Resumo Introdução O desenvolvimento científico e tecnológico, assim como a adoção de políticas públicas voltadas à redução do custo dos medicamentos, tem ampliado o acesso da população a alternativas terapêuticas, as quais incluem medicamentos genéricos, biossimilares, nanomedicamentos e complexos não biológicos. As categorias já comercializadas exigem procedimentos próprios para a garantia de sua qualidade, eficácia terapêutica e segurança. Nesse contexto, o presente estudo procura realizar uma avaliação do cenário atual no Brasil sobre esse tema, apontando para situações que certamente terão de ser enfrentadas em um futuro próximo. Metodologia Foi realizado um levantamento de dados nas bases eletrônicas MEDLINE, PubMed e SCIELO, buscando artigos originais, tanto em português quanto em inglês, indexados retrospectivamente até 1999. Foram utilizados termos de busca relevantes em língua portuguesa e inglesa. Mais de 50 artigos científicos foram encontrados. Resultados e Discussão A maioria dos artigos avaliados aponta problemas tanto na fabricação quanto no controle de medicamentos genéricos e biossimilares, seja no mercado internacional, seja no nacional. No entanto, novas formas medicamentosas estão sendo criadas e necessitam do desenvolvimento de legislação e de metodologias específicas para a garantia da qualidade desses produtos. Uma avaliação do atual sistema brasileiro de registro e controle da qualidade aponta falhas e, especialmente, falta de uma farmacovigilância mais bem estruturada e ativa no país. Conclusão O atual cenário demonstra que os órgãos responsáveis no país necessitam rever a atual sistemática utilizada na fabricação e controle de medicamentos e aprimorá-la, bem como se preparar para o enfrentamento de outras demandas, algumas ainda mais complexas, que já se encontram em desenvolvimento.

Generic medicines give the chance to improve access to medicaments that the population needs, and the possibility of making public and private health programs more sustainable. Information and scientific evidence on this type of medicines has been selected in such a way that the readers - doctors, financiers, public and private organizations - can shape their own opinion and help take the most effective and efficient decisions. The relationship between the prices of these products and the protection of intellectual property through patents for medicines is a center of conflicts between the Pharmaceutical Industry and health systems. In the United States, the Hatch-Waxman Act has played a very important role in stimulating the development of generic drugs. By his side, the European Union (EU) has developed, through the European Medicines Agency (EMA), a homogenization in terms of authorization of medicines and exclusivity of data. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess therapeutic equivalence through in vitro studies of four different brands of pharmaceutical products containing amoxicillin, doxycycline and fluconazole purchased in pharmacies from metropolitan Lima, establishing their interchangeability with a reference product (RP). A validated method of ultraviolet -- visible spectrophotometry was used to determine the dissolution profile. The similarity factor (f2) was used to establish therapeutic equivalence evaluated by in vitro studies, considering two formulations as equivalents if the values were within 50 and 100. The four brands of doxycycline studied were equivalents in vitro to RP. Only two of the four brands of Amoxicillin were equivalent in vitro to RP and none of Fluconazole brands were equivalent in vitro to PR. Therefore, there are some pharmaceutical products containing amoxicillin and fluconazole which are available in the national market and do not meet with therapeutic equivalence evaluated by in vitro studies, in other words, they are not interchangeable. [ABSTRACT FROM AUTHOR]

El objetivo de este trabajo es reflexionar sobre las dificultades en el acceso a los medicamentos, uno de los principales problemas de salud pública en los países en vías de desarrollo. Se analizarán sus posibles causas, tomando como punto de partida el concepto del uso del medicamento como un bien de mercado y no como un bien social. Esta reflexión tendrá su eje en la relación existente entre los precios de estos productos y la protección de la propiedad intelectual a través de las patentes de los medicamentos, entendida como centro de los conflictos ocurridos en la última década entre la Industria Farmacéutica y los países en desarrollo. Se considerarán las principales propuestas implementadas para permitir el acceso a los medicamentos, destacando la política de medicamentos genéricos en su conjunto como modelo regional para confrontar los oligopolios actuales de investigación, producción y comercialización.

Introduction: The Colombian national pharmaceutical policy establishes as a strategy the generation of greater pharmaco-epidemiological research at the national level, especially in the case of antibiotic drugs. Objective: To provide local pharmaco-epidemiological evidence regarding the effectiveness, conditions of use and safety of generic meropenem and cefepime in a tertiary hospital in Bogotá. Materials and methods: We conducted a descriptive, longitudinal and retrospective drug utilization study. The data were collected from the medical histories of all the patients who had cefepime or meropenem prescribed. Results: We included 82 patients treated with cefepime and 91 treated with meropenem in the study. Most of the patients were in services different from the intensive care unit (taking cefepime: 59.8%, and meropenem: 52.7%). Only 21.9% of the patients treated with cefepime and 49% of those treated with meropenem were seen by an infectious disease specialist. The antibiogram was performed for 47% and 60% of the patients treated with cefepime and meropenem, respectively. The most frequent indication for cefepime were respiratory infections and for meropenem, genitourinary ones. Therapeutic success rates were 61.7% for cefepime and 63.0% for meropenem.Conclusions: This study contributes evidence regarding the therapeutic performance of two generic antibiotics used in tertiary hospitals. There were no reports of therapeutic failure during the study period. In the cases of non-response, pharmacokinetic alterations, unfavorable clinical conditions, and inappropriate choice of antimicrobial treatment were identified as frequent factors. [ABSTRACT FROM AUTHOR]

Introduction: the advertising of drugs and dietary supplements on television has a direct impact on the consumption patterns and the public health of the population, thus establishing the need to quantify the frequency of advertising of drugs and dietary supplements and additionally assess the content of the advertising regarding the current regulations of Invima, WHO and SIC. Methodology: during the week of June 27 to July 3, 2016 on a national television channel there were recorded all advertising related to drugs and dietary supplements broadcasted during the family strip from 7:00-21:30. 37 drug advertisements and 4 dietary supplement advertisements were analyzed, and frequency and total duration time were quantified. In addition, a checklist type matrix was used to evaluate compliance with the requirements of the Invima and WHO ethical criteria (only for drug commercials), to subsequently determine the percentage of compliance and non-compliance of each requirement. Results: it was obtained that during the study week the average duration of advertising space during the transmission of the family band was 237.4 minutes, equivalent to approximately 4 hours; and that the proportion of these advertising spaces spread in advertisements of drugs and dietary supplements, corresponded on average to 9.8% to advertisements for drugs and 0.8% to advertisements for dietary supplements. Non-compliance was identified with both the Invima requirements and the WHO ethical criteria, and finally five advertisements of drugs that were under supervision of the SIC by misleading advertising. Conclusions: it was possible to quantify the length of time spent in drug commercials and dietary supplements in relation to the total time of emission of the family band, evidencing a greater proportion in the advertisement of drugs than of dietary supplements [ABSTRACT FROM AUTHOR]

In the general population, there is a great controversy surrounding the use of innovative drugs and their copies called generic drugs. The objective of this study is to quantify the acceptance of patients from the General System of Social Security in Health of Colombia (SGSSS) to the prescription of generic drugs. A descriptive study was carried out with a transversal design. The universe was 63 men and 57 women, all adult patients who attended external consultation of the practice sites of the Faculty of Medicine of Cali-Colombia. It is concluded that if generic drugs are used, it is necessary that doctors and users have confidence in it, the results of the present study show that, although not in the majority, still a significant percentage of the consumers interviewed doubt the quality and the therapeutic results of generics. Worryingly, nearly a quarter of study participants think that generic drugs are fraudulent products. [ABSTRACT FROM AUTHOR]

This study aimed to analyze the evolution of the price of tenofovir (TDF) in Brazil considering the different initiatives for its reduction. The selection criteria for the case were: to have been subject to at least one strategy to overcome patent barrier, which in the case was the support to examination of the patent application (patent opposition); and have been subject of a local production Partnership for Productive Development (PDP). The main results suggest that patent opposition presented in 2005 and 2006 contributed to the decision to reject the patent application in 2009. Brazil is estimated to have paid around US$ 200 million more for the monopoly due to the patent pending application period. There was a reduction in the price of TDF between 2003 and 2013, including during the PDP (2011 to 2013). In 2010, after the PDP announcement, there was an additional 40% decrease in the price of the TDF offered by Gilead, which reflected in the price offered by the PDP. However, the price paid in Brazil for the national product was about ten times higher than the generic offered internationally. [ABSTRACT FROM AUTHOR]

Promoting the use of generic drugs can constitute a core instrument for countries' national pharmaceutical policies, one that reduces drug expenditure while expanding health care access. Despite the potential importance of such policy measures and the differences among national practices, scholars embarking on comparative analysis lack a roadmap for determining which dimensions of generic drug policy to assess and compare. This report fills that gap by considering national rules and regulations across four dimensions deemed crucial to any evaluation: demonstrated therapeutic equivalence; pharmaceutical packaging and labeling; drug prescription; and drug substitution. Furthermore, this report examines how the diverse interests of public and private sector stakeholders might shape generic drug policy and its implementation. To illustrate the challenges and conflicts behind policy development and implementation, this report focuses on the case of Brazil. [ABSTRACT FROM AUTHOR]

O objetivo deste estudo é avaliar a eficácia da regulação da Anvisasobre as condições de concorrência no segmentode medicamentos éticos do setor farmacêuticonegociados em farmácias e drogarias na última décadaDois fatos importantes norteiam o período: a regulamentação dos medicamentos genéricos de 1999 e a regulação porcontrole de preço-tetoocorrida, com mais rigor, a partir de 2003, com a criação da nova Câmara Regulatória de Medicamentos (CMED). Busca-se discutir asprincipais implicações para aconcorrência no segmento, especificamente sobre rivalidade e, em especial, sobre a condição de entrada a partir de informações do setor. A discussão é feita considerando, em paralelo, o ambiente norte-americano de regulação, e seu processo produtivo, que, diferentemente do Brasil, realiza pesquisas e desenvolve medicamentos pioneiros em larga escala. Os resultadosapontam para um aumento da concorrência no setor para o caso de medicamentos com patentes expiradas.

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Introduction: Scientific and technological development, as well as the adoption of public policies aiming drugs cost reduction, has broadened the population's access to therapeutic alternatives. These alternatives include generic drugs, biosimilars, nanomedicines and non-biological complexes. Already marketed categories require their own procedures to guarantee their quality, therapeutic efficacy and safety. This article assesses the current Brazilian scenario in this regard, pointing to situations that will surely have to be addressed in a near future. Methodology: Data was obtained in the electronic databases MEDLINE, PubMed and SCIELO, searching for original articles, both Portuguese and English, retrospectively indexed back to 1999 using relevant search terms, both in English and in Portuguese. More than 50 scientific articles were found. Results and Discussion: Most of the evaluated articles point to problems both in the manufacture and in the control of generic and biosimilar drugs. In fact, scientific publications have proven these problems in the most varied markets including Brazilian. On the other hand, new drug forms are being created and need the development of legislation and specific methodologies to guarantee the quality of these products. An evaluation of the current Brazilian system of registration and quality control points out some flaws and especially the lack of a better structured and active pharmacovigilance in the country. Conclusion: The current scenario demonstrates the need of the responsible organs in the country to review the current system and improve it, as well as to prepare for the confrontation with other, even more complex, demands that are already under development. [ABSTRACT FROM AUTHOR]

Antecedentes: El fortalecimiento de la política de productos competidores (genéricos) se puede acompañar de interrogantes sobre la calidad y, por tanto, sobre la efectividad de algunos de estos medicamentos. Los estudios fase IV son una opción válida para valorar la efectividad y seguridad de estos medicamentos. Objetivos: Valorar la efectividad y seguridad del esquema genérico Lamivudina/Zidovudina/Efavirenz en pacientes con VIH/SIDA que no han recibido terapia antirretroviral, que son atendidos en un programa de atención integral ambulatoria especializada, y comparar estos resultados con los datos de eficacia y seguridad reportados en un estudio de referencia (que utiliza el mismo esquema de medicamentos innovadores y fue realizado con pacientes con condiciones similares). Métodos: Se realizó un estudio clínico abierto no controlado del tipo fase IV. Se valoró la efectividad (disminución de carga viral en plasma y aumento de linfocitos CD4+) y seguridad (reacciones adversas) del esquema genérico Lamivudina/ Zidovudina/Efavirenz durante 12 meses en pacientes mayores de 18 años VIH (+), que no habían recibido terapia antirretroviral y con indicación para recibirla. Los seguimientos clínicos y el seguimiento farmacoterapéutico fueron utilizados como estrategias de valoración y recolección de datos. Los resultados fueron comparados con los resultados reportados en un estudio referencia, contrastando la hipótesis de no inferioridad de dichos resultados. Resultados: El estudio incluyó 47 pacientes, de los cuales 33 estuvieron presentes hasta el final del estudio. Al año de tratamiento, en 28 pacientes (el 85%) la carga viral (valorada por indetectabilidad de las copias de RNAm viral/mL) alcanzó una disminución estadísticamente significativa, mientras que en 30 pacientes (el 91%) el recuento de linfocitos T-CD4+ mayor a 200 células/mm³ alcanzó un aumento progresivo y estadísticamente significativo. Para la comparación se halló un artículo que cumplió con los criterios definidos y se contrastó la hipótesis de no inferioridad. En comparación con el estudio referencia, las proporciones de pacientes [intervalo de confianza del 95%] que lograron indetectabilidad no fueron estadísticamente diferentes: 0,85 [0,69-0,93] versus 0,90 [0,81-0,93], p = 0,7; similarmente, no se encontró diferencias en el incremento promedio [desviación estándar] de linfocitos CD4+: 179 [142] versus 201 [21], p = 0,08. Tampoco se encontró diferencias notorias en el perfil de seguridad. Conclusiones: El esquema genérico evaluado, Lamivudina/Zidovudina/Efavirenz, muestra resultados de efectividad no inferiores a los reportados en un estudio de referencia diseñado para valorar el mismo esquema de medicamentos innovadores.

Os Antimicrobianos são definidos como compostos naturais, sintéticos ou semi-sintéticos, cuja finalidade é prevenir ou tratar de doenças infecciosas causadas por micro-organismos patogênicos. Ele é comercializado sob prescrição médica e possui um medicamento de referência. O medicamento de referência é um produto inovador no mercado, que possui sua própria marca comercial. Ele tem qualidade, eficácia e segurança comprovados cientificamente através de testes que são registrados junto ao órgão federal ANVISA. .O objetivo do estudo é demonstrar a diferença de preços existente entre os medicamentos analisados. O valor dos medicamentos foi levantado através de pesquisa em drogarias, o que nos mostrou uma grande diferença de preço entre os medicamentos e quando comparado com o estudo que avaliou o princípio ativo, o medicamento com melhor custo benefício, são os similares

Resumo: Este estudo compara a percepção, conhecimento e uso de medicamentos genéricos em adultos de Pelotas, Rio Grande do Sul, Brasil, por meio de dois estudos transversais de base populacional realizados em 2002 e 2012. Os desfechos estudados foram: (a) prevalência de utilização de medicamentos genéricos; (b) proporção de uso de medicamentos genéricos entre os demais medicamentos; (c) percepção dos usuários sobre preço e qualidade dos medicamentos genéricos; (d) conhecimento dos usuários sobre medicamentos genéricos; e (e) estratégias de aquisição de medicamentos. A prevalência de uso de medicamentos genéricos aumentou de 3,6% (IC95%: 3,0-4,3) para 26,1% (IC95%: 24,5-27,7) no período de dez anos. A percepção sobre preço e qualidade dos medicamentos genéricos se manteve estável, a identificação das características que diferenciam os medicamentos genéricos dos demais medicamentos melhorou (p < 0,001) e o erro de classificação de medicamento diminuiu (p < 0,001). Houve um aumento significativo na estratégia de aquisição de medicamentos pela substituição do medicamento prescrito pelo medicamento genérico. Entre 2002 e 2012, aumentou o conhecimento e uso de medicamentos genéricos, enquanto a percepção quanto ao menor preço e qualidade equivalente mantiveram-se elevadas.

Abstract The objective of this study was to assess the perceptions of opinion-leaders, patients and their accompanying family members or carers about generic drugs. Three groups of participants were surveyed: (i) 50 customers while they were visiting commercial pharmacies located in São Paulo city, Brazil, (ii) 25 patients and 25 companions while they were waiting at the university outpatient clinic, and (iii) 50 healthcare opinion-leaders from government, hospitals, health plans, academia, and pharmaceutical companies. The questions explored socio-demographic characteristics and perceptions regarding value attributes of generic drugs compared to brand name drugs. Respondents had an average age of 52 years and 53% were women. Respondents believed generic drugs to be cheaper than brand name drugs (97%), and 31% thought generic drugs to be less effective than brand name drugs. Also, generic drugs were perceived by 54% of respondents to be as safe as brand name drugs and 74% would prefer brand name drugs if there was no price difference. In conclusion, multiple factors may contribute to the decision to buy generic drugs; among these, perceived effectiveness, safety and price appear to be the most important factors.