Perception of the value of generic drugs in São Paulo, Brazil / Percepção de valor de medicamentos genéricos em São Paulo, Brasil / Percepción del valor de las medicinas genéricas en São Paulo, Brasil

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.

Resumo Avaliar as percepções de formadores de opinião, pacientes e acompanhantes em relação aos medicamentos genéricos. Foram entrevistados três grupos de participantes: (i) 50 clientes durante visitas em drogarias localizadas na cidade de São Paulo, Brasil; (ii) 25 pacientes e 25 acompanhantes durante a espera em ambulatórios clínicos; e (iii) 50 formadores de opinião do governo, hospitais, planos de saúde, academia e empresas farmacêuticas. As questões exploraram características sociodemográficas e as percepções em relação aos atributos de valores dos medicamentos genéricos comparados aos medicamentos de referência. Os respondentes tinham em média 52 anos e 53% eram mulheres. Os participantes acreditavam que os medicamentos genéricos eram mais baratos que os medicamentos de referência (97%) e 31% tinham a percepção que os medicamentos genéricos são menos efetivos. Além disso, 54% acreditavam que os medicamentos genéricos eram tão seguros quanto os medicamentos de referência e, sem uma diferença de preço, 74% preferiam os medicamentos de referências. Em conclusão, múltiplos fatores podem contribuir para a decisão de compra de um medicamentos genéricos; dentre estes, a efetividade, a segurança e o preço aparecem como os fatores mais importantes.

Resume Evaluar las percepciones de los formadores de opinión, pacientes y acompañantes, en relación con las medicinas genéricas. Fueron entrevistados tres grupos: (i) 50 clientes durante visitas a farmacias ubicadas en la ciudad de São Paulo, Brasil; (ii) 25 pacientes y 25 acompañantes durante la espera en ambulatorios clínicos; y (iii) 50 formadores de opinión del gobierno, hospitales, seguros de salud, académicos y empresas farmacéuticas. Las preguntas investigaron características sociodemográficas y las percepciones en relación con los atributos de valores de las medicinas genéricas, comparados con las medicinas de referencia. Los participantes tenían en promedio 52 años y 53% eran mujeres. Los involucrados pensaban que los medicinas genéricas eran más baratos (97%) y 31% tenía la percepción que las medicinas genéricas son menos efectivos. Además, 54% creía que las medicinas genéricas eran tan seguros como las medicinas de referencia y, sin diferencia de precio, 74% preferirían las medicinas de referencia. En conclusión, múltiples factores contribuyen en la decisión de compra de un medicinas genéricas; dentro de los cuales, la efectividad, la seguridad y el precio aparecen como los más importantes.

Appraisal of multifarious brands of Cephradine for their in vitro antibacterial activity against varied microorganisms

The astounding and exceptional growth of generic pharmaceutical Industry in Pakistan has raised certain questions for drug regulatory authorities contemplating their efficacy and quality. The current study focuses on assessing the in-vitro antimicrobial activity of 24 brands of Cephradine 500mg capsules against 4 different strains by employing standardized methods. Disk diffusion method was performed on all brands to look into the susceptibility and resistance patterns. Standard disk of 5 micro g Cephradine powder were used during evaluation. The zones of inhibitions were ranged from 24-40mm against S. aureus, 24-40mm against E. coli, 20-25mm against K. pneumonia and 19-23mm P. mirabilis. On the basis of mean value, the multinational brands were found to have better zone of inhibitions and were better than local Pharmaceutical companies but ANOVA cooperative study showed that all brands of Cephradine showed similar comparable results. Further investigations by employing MIC method, quality of raw material with special emphasis on the shelf-life, excepients and method of manufacturing will be needed to obtain more authenticated results. The price of National and Multinational brands ranges from Rs.156.00-212.00 for 10 capsules. It is concluded that Public health is at risk because of noticeable growing widespread curse of the manufacture and trade of sub-standard or below par pharmaceuticals. The pecuniary accountability of management of pharmaceutical agents is additionally apparent. The results of the study need to be made public to boost the confidence of medical profession about the quality of locally manufactured pharmaceuticals. It will succor the foreign exchange being incurred on the trade in of medicines

Topiramato no tratamento preventivo da migrânea: variação da resposta após mudança para genérico: relato de caso / Topiramate in the preventive treatment of migraine: response variation after switching to the generic formulation: case report

O uso de genéricos se disseminou no Brasil há poucos anos devido ao menor custo do tratamento e a recomendações de balconistas de farmácia. Em pacientes com epilepsia, a troca de anticonvulsivantes originais por genéricos pode provocar crises e modificar o perfil de tolerabilidade em função de variações na bioequivalência e no nível plasmático destes medicamentos. No entanto, na prevenção da enxaqueca não há estudos disponíveis comparando o uso de anticonvulsivantes originais com genéricos na modificação dos parâmetros de eficácia e tolerabilidade. Relatamos o caso de uma paciente com enxaqueca sem aura que apresentou aumento da freqüência de crises e modificação nos efeitos colaterais com a substituição do Topamax® por topiramato genérico, tendo voltado a apresentar melhora ao retomar o uso do preparado original.

The use of generic drugs has been disseminated in Brazil due to the better costs and a pushing behavior of pharmacists. In epileptic patients, the switching from original preparations to generics may trigger seizures or change the tolerability profile promoted by the variations in plasmatic levels and bioequivalence between the different preparations. However, in migraine prevention there are no studies so far evaluating the effects of original and generic anticonvulsants regarding effectiveness and tolerability. We report the case of a patient with migraine without aura who had an increasing frequency of attacks after switching from Topamax® to a generic topiramate. In addition, the patient improved after returning to the original topiramate.

Comparative analysis of patient package inserts of local and imported anti-infective agents in Palestine

The patient package insert is an important source of drug information. The aim of this study was to evaluate and compare the PPI of the anti-infective agents manufactured in Palestine with the imported equivalents. The selection criteria generated 15 different anti-infective agents available as 36 locally manufactured products and 15 imported equivalents. The design of the patient package insert was evaluated in terms of the number of words used in eight main headings and the presence or absence of certain information regarding nine statements. Inserts of locally manufactured products have significantly fewer words than those of imported products with respect to warnings, dosage and administration, and side effects. The most significant difference was found in the warnings. Moreover, differences were found between inserts of local and imported products in terms of the presence of the nine informative statements. Locally manufactured products did not mention inactive ingredients, clinical pharmacology or date of last revision, but all of them provided information on the use of the drug during pregnancy and lactation and on the duration of therapy. However, in general they provided less information than the imported equivalents. Palestinian authorities and local manufacturers should implement appropriate measures to regulate the quality and quantity of information in the patient package insert of locally produced anti-infective agents. PPI improvement will better direct health practices to the benefit of the patients

Brand and generic medications: are they interchangeable?

Generic substitution has become a common practice since the late 1970s in the United States. At that time, many of these generics caused bioavailability problems, which fueled suspicions about their efficacy and safety, and the Food and Drug Administration [PDA] standards for bioequivalence. In Saudi Arabia, the increasing number of local products raised several concerns with regard to switching from brands to generics. Our objective was to review and examine the basis of the controversy surrounding brand and generic interchangeability and to explore a practical approach in pursuing a switch. Articles indexed initially under terms such as generic medications, generic substitution, bioequivalence and bioinequivalence were identified. These terms were used to search the indexing service, MEDLINE [1966-2006]. References from the extracted articles, and additional data sources, including the Code of Federal Regulations and Regulatory Guidance from the FDA Center for Drug Evaluation and Research were also reviewed. For most drugs, bioequivalence testing generally should enable clinicians to routinely substitute generic for innovator products. However, for narrow therapeutic, critical dose drugs, or for highly variable drugs, safe switching between products cannot be assured. These drugs need special precautions and blood level monitoring upon switching. FDA firmly believes that approved generic and brand drugs can be dispensed with the full expectation that the consumer will receive the same clinical benefit. Performing the switch process is an advisable practice to reduce health care costs in countries with strong post-marketing surveillance program, but caution is to be exercised when narrow therapeutic index drugs or highly variable drugs are prescribed

Definición de medicamento genérico: ¿un fin o un medio? Análisis de la regulación en 14 países de la Región de las Américas / Defining generic drugs: an end or a means? Analysis of regulations in 14 countries in the Region of the Americas

OBJETIVOS: Caracterizar la situación y las tendencias regulatorias relacionadas con los medicamentos competidores en 14 países de América Latina y el Caribe. MÉTODOS: Entre julio de 2004 y abril de 2005 se colectó la información sobre las regulaciones y políticas nacionales que establecían o contenían la definición de medicamento genérico y de los términos asociados en 14 países de América Latina y el Caribe (Argentina, Barbados, Bolivia, Brasil, Colombia, Costa Rica, Ecuador, Guatemala, México, Nicaragua, Panamá, Paraguay, Perú y Venezuela). Además, se recabó información sobre los incentivos para registrar y producir medicamentos competidores, la promoción del uso de la denominación común internacional (DCI), la regulación de los estudios de bioequivalencia y la sustitución de los medicamentos prescritos por alternativas de menor precio al público. RESULTADOS: Se observaron tres tendencias regulatorias: los países que favorecen la financiación de medicamentos competidores, la promoción extendida del uso de la DCI y no ponen restricciones a la sustitución de medicamentos innovadores por competidores (Argentina, Colombia, Costa Rica, Ecuador y Paraguay); los que cuentan con un esquema orientado a la demostración de la equivalencia terapéutica, es decir, los países restringen la sustitución de los medicamentos originales mediante una lista de medicamentos competidores autorizados que deben prescribirse bajo su DCI y llevar rótulos distintivos (Brasil, México, Panamá y Venezuela); y los que se encuentran en una etapa incipiente de su proceso de regulación (Barbados, Bolivia, Guatemala, Nicaragua y Perú). Esta variedad ocasiona dificultades en la caracterización de los mercados farmacéuticos y puede generar segmentaciones ficticias. CONCLUSIONES: Los esfuerzos de armonización deberán tomar en cuenta la posible relación entre las definiciones adoptadas por los países, el desarrollo de los mercados farmacéuticos nacionales y sus políticas de...

OBJECTIVES: To characterize current regulatory practices and trends relating to competing medications in 14 Latin American and Caribbean countries. METHODS: Between July 2004 and April 2005 we collected information on national regulations and policies that established or contained a definition of "generic drug" and related terms in 14 Latin American and Caribbean countries: Argentina, Barbados, Bolivia, Brazil, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Nicaragua, Panama, Paraguay, Peru, and Venezuela. We also compiled information on the incentives to register and produce competing medications, promotion of the use of International Nonproprietary Names (INNs) for pharmaceutical substances, the regulation of bioequivalence studies, and the replacement of prescription medications with less expensive alternatives. RESULTS: We noted three patterns in the regulations: (1) countries that encourage financial support for competing medications, extensively promote the use of INNs, and place no restrictions on the replacement of innovative (proprietary) medications with competing products (Argentina, Colombia, Costa Rica, Ecuador, and Paraguay); (2) countries with policies aimed at showing therapeutic equivalence, which limits substitutions to approved products from a list of authorized competing medications that must be prescribed by their INN and must use distinctive labeling (Brazil, Mexico, Panama, and Venezuela); and (3) countries at a beginning stage in the process of regulation (Barbados, Bolivia, Guatemala, Nicaragua, and Peru). This variety leads to difficulties in characterizing pharmaceutical markets, and can lead to misleading categorizations. CONCLUSIONS: Efforts to harmonize policies should consider the possible relationship among definitions adopted in different countries, the development of national pharmaceutical markets, and national policies to stimulate competition.

Avaliação da disponibilidade de medicamentos genéricos em farmácias e drogarias de Maringá (PR) e comparação de seus preços com os de referência e similares / An evaluation of generic medicines availability in pharmacies and drugstores in Maringá (PR) and comparison of their prices in relation with the similars and the references

O debate sobre a implementação de genéricos vem sendo realizado no Brasil desde 1976. Entretanto, somente em 1991, foi elaborado um projeto, visando à implantação dos medicamentos genéricos. A lei nº 9787 ("Lei dos genéricos") só foi publicada no Diário Oficial da União em 11 de fevereiro de 1999. Os objetivos deste trabalho foram verificar a disponibilidade de medicamentos genéricos em farmácias e drogarias, bem como comparar os preços destes medicamentos em relação aos similares e aos de referência. Verificou-se a disponibilidade dos medicamentos genéricos em 22 farmácias e drogarias do município de Maringá, estado do Paraná, de 30 de outubro a 22 de novembro de 2002. Dos 222 princípios ativos disponibilizados no Brasil como genéricos, foram encontrados 71 (32 por cento)...

Respaldo de la reglamentación farmacéutica cubana para la intercambiabilidad terapéutica de los medicamentos genéricos / Support of the Cuban pharmaceutical regulation for the therapeutic interchangeability of generic drugs

Se realizó una caracterización de la Reglamentación Farmacéutica Cubana durante los últimos 24 años, a partir del enfoque internacional sobre los requerimientos de respaldo para la intercambiabilidad terapéutica de los medicamentos genéricos o de múltiples fuentes. Se relacionaron las normativas emitidas sobre prácticas adecuadas de fabricación y control de calidad para medicamentos y para las inspecciones como vía para implementar su cumplimiento; del registro de medicamentos como instrumento sanitario del control de la comercialización en el que son evaluadas las características del producto farmacéutico en función del cumplimiento de los estándares vigentes para demostrar su calidad, seguridad y eficacia. Fueron identificadas las regulaciones a cumplimentar para la rotulación e información de los medicamentos y en particular los lineamientos para la demostración de intercambiabilidad terapéutica y bioequivalencia, en su condición de guías específicas para los genéricos. Fueron incluidos los niveles institucionales de las autoridades de salud nacionales de los instrumentos legales para las directrices y las acciones reglamentarias que amparan de forma general la equivalencia y sustitución clínica de los productos farmacéuticos multiorigen. Se concluyó el satisfactorio nivel normativo alcanzado y se mostró una figura con el resumen cuantitativo de eventos reguladores en el tiempo que evidencian la plataforma de aseguramiento para la intercambiabilidad terapéutica de los genéricos en nuestro país

Experiencia cubana en estudios de bioequivalencia: intercambiabilidad terapéutica de genéricos / Cuban experience in bioequivalence studies: therapeutic interchangeability of generic drugs

Se brindaron elementos de la evolución en Cuba de los estudios de disolución, biodisponibilidad y bioequivalencia de respaldo para nuevos productos farmacéuticos. Se describió el entorno farmacéutico, clínico y sanitario del país que ha propiciado un empleo y fabricación de productos genéricos y la creación de adecuadas condiciones para la investigación y desarrollo de los medicamentos. Fueron relacionados los antecedentes de los estudios de equivalencia terapéutica en productos nacionales referidos a estudios in vitro e in vivo. Se citó la reglamentación básica vigente para establecer la intercambiabilidad terapéutica de los medicamentos en la práctica clínica, que fija las pautas de estos estudios en su condición de ensayos más empleados para demostrarla y se brindaron ejemplos de formulaciones investigadas. Fueron caracterizados los parámetros y condiciones generales bajo las cuales se han realizado estudios de bioequivalencia recientes en una de las instituciones especializadas del país. Se concluyó sobre el satisfactorio nivel alcanzado

Comercialización, prescripción y dispensación de medicamentos con nombres genéricos en Cuba: un enfoque regulador / Marketing, prescription and dispensation of drugs with generic names in Cuba: a regulatory approach

Se realizó una caracterización de los nombres de las especialidades farmacéuticas aprobadas en Cuba desde 1959 al 2001 y se evaluó el empleo de las Denominaciones Comunes Internacionales y genéricos como herramientas de apoyo a la prescripción y dispensación que favorecen su uso racional. Se definieron y se mostraron en el tiempo las disposiciones de la reglamentación farmacéutica nacional al respecto. Se concluyó el amplio uso de esta nomenclatura en los medicamentos producidos por la industria farmacéutica nacional y la activa regulación sanitaria en los últimos años, en concordancia con las recomendaciones de la OMS