Comparativo entre preço máximo ao consumidor de medicamentos e preços praticados na internet no Brasil: desalinhamentos e distorções regulatórias / Comparison between maximum consumer prices for medicines and prices practiced on the internet in Brazil: misalignments and regulatory distortions

Resumo Desde 2003, a Câmara de Regulação do Mercado de Medicamentos (CMED) é responsável por estabelecer o preço máximo ao consumidor (PMC) para medicamentos. O objetivo deste estudo é comparar preços praticados na internet com o PMC e verificar como se dá a diferença média de preços entre eles no mercado em dois segmentos de medicamentos existentes no Brasil, os de referência e os genéricos. Foi realizada uma coleta de preços de medicamentos em sítios eletrônicos de farmácias e drogarias e os preços coletados foram comparados com os seus respectivos PMCs para o ano de 2019. Foram analisados 68 fármacos e 268 apresentações comerciais de medicamentos genéricos e de referência relativas a esses fármacos. Observou-se um padrão distinto para a diferença média de preços praticados em relação ao PMC em cada segmento de mercado, sendo que, em sua maioria, os genéricos tendiam a praticar as maiores diferenças e os de referência as menores diferenças. O problema da distorção dos preços praticados em relação ao PMC apontados pela literatura foi confirmado principalmente em relação ao mercado de genéricos. Conclui-se que seria importante uma revisão periódica do PMC levando em conta os preços praticados no varejo.

Abstract Since 2003, the Medicine Market Regulation Chamber (CMED, in portuguese) has been responsible for establishing the maximum consumer prices (MCP) for medicines. The aim of this study is to compare prices practiced on the internet with the MCP and identify the average price difference between them in two segments of existing drugs in Brazil, the reference and the generic ones. Drug prices were collected on websites of pharmacies and drugstores and compared with their respective MCP for the year 2019. The analysis included 68 drugs and 268 commercial presentations of generic and reference drugs related to these drugs. A different pattern was observed for the average price difference in relation to the MCP in each market segment, with most generic drugs tending to show the highest differences and the reference drugs the lowest ones. The problem of price distortion in relation to the MCP pointed out by the literature was confirmed mainly in relation to the generic drug market. It was concluded that a periodic review of the MCP would be important, considering retail prices.

La farmacia de los medicamentos genéricos / The pharmacy of generic drugs

RESUMEN Los medicamentos genéricos son una alternativa para mejorar el acceso a las medicinas que la población necesita y, además, hacen más sostenibles los programas de salud públicos y privados. Se ha seleccionado información y evidencia científica sobre este tipo de medicamentos de tal manera que los lectores -médicos, financiadores, organismos públicos y privados-puedan conformar su propia opinión y ayudar a tomar las decisiones más efectivas y eficientes. La relación existente entre los precios de estos productos y la protección de la propiedad intelectual a través de las patentes de los medicamentos es un centro de conflictos entre la industria farmacéutica y los sistemas de salud. En los Estados Unidos, la ley Hatch-Waxman ha cumplido una función muy importante al estimular el desarrollo de medicamentos genéricos. En un mismo intento, la Unión Europea (UE) ha desarrollado, a través de la Agencia Europea del Medicamento (EMA), una homogeneización en materia de autorización de medicamentos y exclusividad de los datos.

SUMMARY 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.

Knowledge, attitude and practices of rural medical practitioners on generic medicines

Background: An unqualified medical practitioner without any formal registration and practicing allopathic medicine in rural areas in India can be called Rural Medical Practitioner (RMP). RMPs enjoy a great deal of practice in rural areas by taking advantage of lacunae in the public health system. Government of India is currently popularising generic medicines, but still certain doubts exist even among doctors and how far the RMPs are aware of generic medicines is a big issue. They influence a lot of uneducated people, so the knowledge, attitude and practices they follow have a large impact on society.Methods: A cross sectional, prospective study was undertaken to assess the knowledge, attitude and the practices of 152 RMPs on generic medicines for a period of three months. A 23-item questionnaire was well designed, pre-validated and distributed to RMPs in and around Guntur district. The results were analysed using descriptive statistics.Results: 92% of the participants were aware of generic drugs. More than 80% believed that they are equivalent in terms of efficacy and safety to their branded counterparts and are available at reasonable prices. 95.4% RMPs believed that prescribing generic drugs will decrease the pharmaco-economic burden of the country. Almost all of them agreed on the need for the updates and education on generics by means of continuing medical education (CMEs).Conclusions: The participants had good amount of knowledge on generic drugs but there are concerns regarding quality and therapeutic efficacy of generic drugs. Proper awareness about the generic prescription practice may improve the patient compliance by reducing economic burden to the patients.

A Cross-sectional Study Assessing Prescriptions of a Tertiary Care Teaching Institute of Central India using the WHO Core Drug Indicators

The WHO has developed medication use indicators, including prescription indicators with an aim to evaluate the services provided to the population in regard to medications. With the help of these indicators, there will be constant watch on drug prescribing pattern in health care to avoid irrational prescribing.

Policy Effect of the Medicines Procurement Based on Health Insurance Reimbursement Standards in Fujian Province / 中国药学杂志

OBJECTIVE: To analyze the effects of "adjusting structure and vacating space" of the transparent medicines procurement basing health insurance reimbursement standards, through comparing medicines consumption structure of health insurance designated health facilities of Fujian province. And to generate evidence as well as to propose recommendations for policy improvement and experience promotion. METHODS: Based on the 2016 and 2017 provincial medicines pooled procurement database, adopting the pivot table statistical functions of EXCEL software, the consumption value and value in proportion of Class and Ⅱ chemical products (Fujian provincial medicines procurement list therapeutic classification for chemical products), as well as active pharmaceutical ingredients, consumption value and volume (standardized units in tablet/bottle/vial) of originator and generics were analyzed and compared. The consumption value of Class formulations of traditional Chinese medicines (Fujian provincial medicines procurement list therapeutic classification for formulations of traditional Chinese medicines) was also analyzed and compared. RESULTS: Nearly 2.38 billion yuan procurement budget was saved in 2017 through adjustment of the medicines procurement list in Fujian province. There were a certain changes of the consumption structure of medicines. The procurement value of adjuvant and nutraceutical medicines dramatically reduced. The procurement value of medicines for treatment of chronic diseases like hypertension and cancers significantly increased. The procurement volume of generics started to surpass that of the originator, and showed potential competitiveness of generic substitution. However, the originator still dominated the market of quite a number of medicines. Prices of both generics and originators decreased. CONCLUSION: The effect of “adjusting structure and vacating space” has been demonstrated. Fully implementation of the health insurance reimbursement standards will make the above effect more apparent. To promote effective generic competition, Fujian should set the same health insurance reimbursement standard for originator and its generics (quality and efficacy validated) to promote generics substitution.

Drug utilization study in outpatient ophthalmology department of government medical college, Nellore, India

Background: Drug utilization studies are an important part of rational use of drugs. This study was planned to assess drug utilization pattern in Ophthalmology outpatient department.Methods: After approval from Ethics Committee, 620 prescriptions were analyzed according to WHO drug indicators.Results: 2. 4 drugs were prescribed on an average per prescription. Antibiotics (49%) were the most commonly used drugs. Fluoroquinolones (54%) were frequently used. Topical route was preferred route of drug administration. Prescription of generic drugs was not optimal (13%). Duration of therapy was missing in many prescriptions.Conclusions: Generic prescribing can be improved. Duration of therapy should be mentioned in all prescriptions.

"Mulher joga filho na lixeira": mulher-mãe infanticida na mídia / "Women throws son away in the trash can": infanticide mother-woman on media

RESUMO Este trabalho parte de uma inquietação acerca dos dizeres que vêm se constituindo na mídia sobre a mulher em seu papel de mãe em nossa sociedade. Trabalhando na articulação entre a Análise do Discurso e a psicanálise lacaniana, nosso corpus de pesquisa constituiu-se de manchetes de notícias sobre abandono e infanticídio, divulgadas em portais eletrônicos. Tivemos como objetivo central analisar a discursivização da mulher-mãe, a partir do conceito de genérico discursivo e também observar se as manchetes analisadas produzem efeitos que podem ser compreendidos como elementos indiciários de que A mulher, enquanto conjunto, não existe. A análise indicou que as notícias constituem-se como acontecimentos que fogem ao discurso vigente e colocam-se como indícios a serem observados, por apontarem para um deslocamento na contemporaneidade. Esse processo ratifica a existência do grupo das mulheres-mães, mas ao mesmo tempo indica um furo nesse grupo pretensamente homogêneo.(AU)

ABSTRACT This article arises from a concern about the sayings about woman as regards her societal role of mother. Based on the articulation of Discourse Analysis and lacanian psychoanalysis, our research corpus was composed of headlines about abandonment and infanticide conveyed on news online homepages. Our main objective was to analyze the discoursivization about mother-woman, based on the concept of discoursive generics, and to observe if the analyzed headlines produce effects that may be understood as index elements that The woman, as a group, does not exist. Analysis highlighted that news are events that are beyond the current discourses and are index to be observed, since they point to a shift in contemporaneity. This process confirms the existence of the group mothers-women, at the same time as it marks a puncture in this allegedly homogenous group.(AU)

Nonbioequivalent prescription drug interchangeability, concerns on patient safety and drug market dynamics in Brazil / Intercambialidade de medicamentos não-bioequivalentes, segurança do paciente e dinâmica do mercado farmacêutico no Brasil

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.

Study about Information Gathering and Conveyance of Information regarding Generics Added Other Dosage on the Drug Information In-Charge in a Hospital / 医薬品情報学

<b>Objective: </b>To clarify the actual situation about awareness of DI (the Drug Information in-charge) or information shared with the hospital including prescribing physician regarding the generics, which have added with other dosage innovators don’t have.<br><b>Methods: </b>We did the questionnaire and analyzed awareness of DI, route of access to information, situation of transmission for the prescribing physician, and prescription regarding generics added with other dosage (Clopidogrel 50 mg, Quetiapine 12.5 mg, 50 mg, and Tacrolimus 1.5 mg, 3 mg).<br><b>Results: </b>There were many cases that DI obtained the information regarding generics added with other dosage from MRs, magazine or website Web.  On the other hand, in case that conveys information about generics added with other dosage to the prescribing physician wasn’t so many.  And there were various reasons why the Drug Information in-charge didn’t inform to the prescribing physician.<br><b>Conclusion: </b>Analysis of the valid responses was that more than two-thirds of DI recognized about generics added with other dosage of Clopidogrel and Quetiapine.  But share of recognition of DI was below 30% in case of Tacrolimus.  Also, share of transfer to the prescribing physician was about 15% in any case.  Main source of information about generics added with other dosage for DI was from MRs, magazine or website.  As the number of the companies which sell generics added with other dosage of Tacrolimus is few, we assumed that most of DI didn’t recognize it.  In addition, there were many comments which were judged that it isn’t necessary to transmit to the prescribing physician information generics added with other dosage in case of Clopidogrel and Quetiapine in the questionnaire.  On the other hand, though the number of sample was small compare to the case of Clopidogrel and Quetiapine, there was no comment that generics added with other dosage of Tacrolimus isn’t necessary.

Systematic Review on Clinical Equivalence of Generic and Brand-name Drugs in Statin Therapy

BACKGROUND: Generic medications are approved on the basis of bioequivalence with brand medications in healthy volunteers rather than the target population, there remains a substantial uncertainty regarding their clinical effectiveness and safety. The object of this paper is to compare the clinical equivalence of generic statin drugs in patients. METHODS: Literature published before September 2016, which is indexed in PubMed, EMBASE, RISS, comparing generic to brand products in statins. Outcomes included blood lipid level, proportion of days covered (adherence), hospitalization and mortality. RESULTS: 511 citations were screened, of which 11 studies met eligibility criteria (6 randomized clinical trials, 5 observational studies). Generic atorvastatin was clinical equivalent with brand drugs in blood lipid level (3 RCTs) and generic simvastatin was also clinical equivalent with brand drugs (2 RCTs). 2 of 3 studies reported no significant difference in proportion of days covered except 1 study which reported generic statin significantly enhance proportion of days covered (p0.05). 1 study reported that all cause of mortality was significantly low in generic drugs (p<0.0001). CONCLUSION: Published data on comparing clinical efficacy of generic and brand statins were insufficient in both quantity and quality. This systematic review suggests that additional studies on clinical equivalence and safety of generic medications in patients would be needed.

Characterization and comparability of biosimilars: a filgrastim case of study and regulatory perspectives for Latin America

Background: Developing countries have an estimate of ten times more approved biosimilars than developed countries. This disparity demands the need of an objective regulation that incorporates health policies according to the technological and economical capabilities of each country. One of the challenges lies on the establishment of comparability principles based on a physicochemical and biological characterization that should determine the extent of additional non-clinical and clinical studies. This is particularly relevant for licensed biosimilars in developing countries, which have an extensive clinical experience since their approval as generics' in some cases more than a decade. To exemplify the current status of biosimilars in Mexico' a characterization exercise was conducted on licensed filgrastim biosimilars using pharmacopeial and extended characterization methodologies. Results: Most of the evaluated products complied with the pharmacopeial criteria and showed comparability in their Critical Quality Attributes (CQAs) towards the reference product. These results were expected in accordance with their equivalent performance during their licensing as generics. Accordingly' a rational approval and registration renewal scheme for biosimilars is proposed, that considers the proper identification of CQAs and its thoroughly evaluation using selected techniques. Conclusions: This approach provides support to diminish uncertainty of exhibiting different pharmacological profiles and narrows or even avoids the necessity of comparative clinical studies. Ultimately, this proposal is intended to improve the accessibility to high quality biosimilars in Latin America and other developing countries.

Therapeutic potential of biosimilars in dermatology.

The introduction of biologic therapy has revolutionized the treatment of many chronic diseases, including several dermatological disorders. Biological agents promise to satisfy medical needs previously unmet by conventional medicines. Unfortunately, these agents are expensive and out of reach for the majority of patients who need them. Biosimilars are copies of the innovator biological agents and represent an important advance in the field of biological therapeutics. Although they are similar to the original biologic, differences in terms of structure, efficacy, safety and immunogenicity remain a concern. Thus, biosimilars cannot be regarded as bio‑generics. Awareness of the key differences between a biosimilar and its reference biological agent is essential for optimal treatment and safety of patients. The increasing availability of biosimilars provides patients and doctors with less expensive alternatives and increases the accessibility of biologic therapy to needy patients. In this review, we discuss the concept of biosimilars, the need for appropriate regulatory pathways and their current status in dermatology.

Study of variation in price of various antidiabetic drugs available in Indian market.

Background: Diabetes mellitus in early age is on the alarming rise in India, requiring lifelong treatment. There is a wide range of variation in the prices of antidiabetic drugs marketed in India. Hence, we decided to study price variations in the oral antidiabetic drugs available, either singly or in combination, and number of manufacturing companies for each, and to evaluate the difference in cost of different brands of same active drug by calculating percentage variation of cost. Methods: Cost of a particular drug being manufactured by different companies, in the same strength and dosage forms was obtained from “Current Index of Medical Specialties” July-October 2014 and “Indian Drug Review” July 2014. The difference in the maximum and minimum price of the same drug, manufactured by different pharmaceutical companies and percentage variation in price was calculated. Results: Percentage price variation among different group of drugs was found to be as follows: in sulfonylureas, it was highest in glimepiride 2 mg 836.44%, among biguanides - metformin 500 mg 245.55%, among thiazolidionedionespioglitazone 15 mg 600%, among α glucosidase inhibitors - voglibose 284.61% and meglitinides - repaglinide 0.5 mg 181.40%. Among combination therapy glimepiride 1 mg + metformin 500 mg 366.66%, pioglitazone + metformin 207.51%, pioglitazone + glimepiride 268.42% showed maximum variation in price. Conclusion: The average percentage price variation of different brands of the same oral antidiabetic drug manufactured in India is very wide. The appropriate changes in the government policy, sensitizing the prescribers about cost of therapy and proper management of marketing drugs should be directed toward maximizing the benefits of therapy and minimizing negative economic consequences.

DPP-4 Inhibitor for the Treatment of Type 2 Diabetes and Intellectual Property Analysis / 中国药师

DPP-4 inhibitors are new oral hypoglycemic drugs and hot spots developed and launched in recent years, and they pro-vide new choices for the clinical treatment of type 2 diabetes. In China, DPP-4 inhibitors that are approved to use in the treatment of type 2 diabetes are all imported products currently. In the paper, the current intellectual property situation of DPP-4 inhibitors that are developed and approved at home and abroad is researched and analyzed. Reasonable use of the patent information of DPP-4 inhibitors that is about to expire or have failed can provide good guidance for the subsequent development of DPP-4 inhibitors in domestic with promising curative effect and good market prospects, and can generate new patents in order to enhance the market competitiveness.

Toward better quality of anticancer generics in India.

Treatment of cancer is limited by affordability of patients in the many developing countries including India. Generic drug manufacturers have responded to this scenario by making drugs available at affordable costs, often at less than 10% the cost of the original brand. In our practice, it is found that there is a three-fold higher prescription of generic brands compared to innovator, accompanied by cost savings of up to 80% per prescription. Unfortunately, the regulatory environment prevailing in India is not geared to ensure satisfactory quality of generic products. The standards set by the regulatory agencies for establishing equivalence of generics vis-ΰ-vis the innovator product allow anticancer generics to enter markets without undergoing clinical evaluation. Many drug manufacturing units in India flout good manufacturing practice norms, which was evident during the center for drug evaluation and research classifications inspection in the year 2006. Inferior drugs have therefore, made their way into the Indian markets, compromising the quality of care. The system of drug manufacturing and marketing approval needs a major overhaul, including regular inspection of manufacturing facilities. Bioequivalence should be made mandatory for all oral formulations. Unless these measures are rigidly implemented, the benefits of generic substitution would be seriously undermined.

Research on strategy of China pharmaceutical companies coping with competition of authorized generics in American drug market / 中国药学杂志

OBJECTIVE: To study the principle, feature and impact of the authorized generics strategy in American drug market, thus to provide some references for Chinese scholars who research the authorized generics strategy and for China pharmaceutical companies that would face competition in American pharmaceutical market. METHODS: By case study and policies analysis, the ways how the brand-name companies used the authorized generics in American drug market were summarized. RESULTS and CONCLUSION: Successful authorized generics strategy can maintain a large market share of the brand-name companies products. In American drug market, there are some particularities about the authorize generics strategy due to the features of American drug policies and regulations. China pharmaceutical companies should implement different authorized generics strategy according to their own conditions in American drug market at present.

Current situation of availability and cost effectiveness analysis of selected drugs in Anantapur, AP, India.

World Health Organization (WHO) and Health Action International (HAI) recognized the need for a standard methodology to measure medicine prices in countries so that a clearer picture of what patients actually pay for medicines in low and middle-income countries could be obtained. These two organizations jointly published a manual, which described a methodology for collecting data and measuring medicine prices in various countries. By adopting this methodology, in present study we focused to obtain 1. Baseline data for the availability of medicines in the public and private sectors, 2. Cost Effectiveness Analysis or Affordability of model treatment regimen and 3. Comparison of national Most Sold Generics/MSGs in Anantapur. We did our survey in four phases namely survey planning and preparation, sampling, selection of medicines, MSG equivalents, affordability/ cost effectiveness analysis and availability. The results of the study provided stable baseline interventions to improve the availability of medicines in the public sector and reduce the prices in private sector.

Why India should become a global leader in high-quality, affordable TB diagnostics.

The scale up of DOTS in India is one of the greatest public health accomplishments, and yet undiagnosed and poorly managed TB continues to fuel the epidemic such that India continues to have the highest number of TB cases in the world. Recognizing these challenges, the Government of India has set an ambitious goal of providing universal access to quality diagnosis and treatment for all TB patients in the country. Innovative tools and delivery systems in both the public and private sectors are essential for reaching this goal. Fortunately, India has the potential to solve its TB problem with “home-grown” solutions. Just as Indian pharmaceutical companies revolutionized access to high-quality, affordable AIDS drugs through generic production, Indian diagnostic companies could also become the world's hub for high-quality generic diagnostics. In the long term, India has the potential to lead the world in developing innovative TB diagnostics. For this to happen, Indian industry must move from the import and imitation approach to genuine innovation in both product development as well as delivery. This must be supported by permissive policies and enhanced funding by the Indian government and the private sector. Strict regulation of diagnostics, increased attention to quality assurance in laboratories, and greater engagement of the private health care providers are also needed to effectively deliver innovative products and approaches.

"Evangelho das mães": genéricos discursivos em revistas femininas / "Mother's gospel": discursive generics in feminine magazines / "Evangelio de las madres": genérico discursivo en las revistas femininas

Este artigo pretende contrapor duas formas de abordar a feminilidade: uma, da Psicanálise Lacaniana, que argumenta que "A" mulher não existe e relaciona a posição feminina às categorias lógicas de contingência e impossível; e, outra, da revista feminina, que acredita na transparência e naturalidade da mulher. Para ilustrar tal naturalização de sentidos sobre o que é ser uma mulher, será analisado um recorte de uma publicação voltada para o público feminino, Jornal das Môças, de 1944, por meio da Análise do Discurso Pêcheutiana que desnaturaliza os sentidos e remete-os às suas condições de produção.

This article aims oppose two ways of approaching womanhood: one of Lacanian psychoanalysis, which argues that "THE" woman does not exist and relates the feminine position to logical categories of contingency and impossible; and other, that of the woman's magazines, which believes in transparency and naturalness of women. To illustrate this naturalisation of sense about what is to be a woman, we analyse a female 1944 publication's extract from Jornal das Môças, using the Pecheux's Analysis which disnaturalises senses and refers them to their conditions of production.

Este artículo trata de contraponer dos formas de abordar la femineidad: una, del Psicoanálisis Lacaniano, que argumenta que “LA” mujer no existe, y relaciona la posición femenina a las categorías lógicas de contingencia y de imposible; y otra, de la revista femenina, que cree en la transparencia y naturalidad de la mujer. Para ilustrar tal naturalización de sentidos sobre lo que es ser una mujer, será analizado el recorte de una publicación para el público femenino, de Jornal das Môças, de 1944, a través del Análisis del Discurso de Pecheux que desnaturaliza los sentidos y los remite a sus condiciones de producción.

Há riscos na utilização de diferentes formulações de drogas antiepilépticas? Relato da ABE através de entrevista de pessoas com epilepsia / Are there risks in the use of different antiepileptic drug formulations? Report of the Associação Brasileira de Epilepsia trough a survey of people with epilepsy

INTRODUÇÃO: Há controvérsias se drogas antiepilépticas (DAEs) genéricas são intercambiáveis com as de referência, assim como com as similares com respeito a eficácia e efeitos adversos. Este fato é de fundamental importância e ainda mais relevante em países em desenvolvimento com limitações orçamentárias na área de saúde. MÉTODOS: Após aprovação de Comitê de Ética a Associação Brasileira de Epilepsia aplicou um questionário a pessoas com epilepsia (PCE) com 18 questões de múltipla escolha: quatro relacionadas a dados sócio-demográficos e 14 sobre o conhecimento das formulações de DAEs (de referência, genéricas e similares) e da evidência de mudanças clínicas durante a troca (Teste exato de Fisher, significância 05 por cento). RESULTADOS: 731 PCE de seis Hospitais do Sistema Público participaram, sendo que 91 por cento eram de classes sócio-econômicas média e baixas; das PCE maiores de 18 anos, 24,4 por cento tinha menos de 4 anos de escolaridade, 24,4 por cento entre 5 a 8, 45,6 por cento tinha pelo menos 9 anos de estudo; 63 por cento recebia mais de uma DAE (53,3 por cento carbamazepina, 26,3 por cento valproato de sódio); 58,1 por cento obtinha as DAEs de órgãos públicos e 21,2 por cento somente em farmácias privadas. Das 731 PCE consultadas, 60,6 por cento não conhecia as diferentes formulações de DAEs (PCE com maior escolarização responderam mais corretamente, p<0.001); somente 36 por cento sabia que a primeira DAE é a referência (maior escolarização, p<0.001); e 10 por cento considerou genéricos "medicações oficiais do governo". Após serem instruídos sobre as formulações de DAEs, 24,7 por cento não sabia que genéricos são mais baratos do que as medicações de referência, 32,5 por cento considerou sua qualidade pior e somente 30 por cento sabia os detalhes de sua embalagem (classes de maior renda, p=0.004). Durante o último ano, 25,6 por cento receberam diferentes formulações de DAEs (especialmente carbamazepina e valproato de sódio) ...

PURPOSE: Controversy persists whether generic antiepileptic drugs (AEDs) are interchangeable with brand name and similar drugs regarding efficacy and adverse events. This issue is very relevant and still more important in underdeveloped countries with limited health expenditures. METHODS: After Ethical Committee approval the "Associação Brasileira de Epilepsia" applied a questionnaire for people with epilepsy (PWE) with multiple-choice questions: four about sociodemography and 14 regarding formulations knowledge (reference, generic and similar drugs) and clinical change evidence during AED formulation switch (Fisher test, level 05 percent). RESULTS: 731 PWE from six Public System Hospitals participated being 91 percent from middle/low income classes; from the PWE older than 18yrs. 24.4 percent had less than 4 yrs. of education, 24.4 percent between 5 and 8, 45.6 percent had at least 9 yrs. of schooling; 63 percent received more than one AED (53.3 percent carbamazepine, 26.3 percent sodium valproate); 58.1 percent obtained AEDs from public resources and 21.2 percent only in private pharmacies. From the 731 PWE, 60.6 percent did not know the existence of different AED formulations (more educated PWE, high income classes responded more correctly, p<0.001); only 36 percent knew that the first produced drug is the reference (more educated, p<0.001) and 10 percent considered generics "official governmental drugs". After instructed about formulations, 24.7 percent ignored generics are cheaper than reference drugs, 32.5 percent considered their quality worse and only 30 percent knew their packing details (high income classes, p=0.004). During the last year, 25.6 percent received different formulations (mainly carbamazepine, sodium valproate) and 14.5 percent (especially lower educated, p<0.001) referred breakthrough seizures after switching (carbamazepine, sodium valproate, lamotrigine) and 12.2 percent, increased side effects (carbamazepine, ...