Febrile neutropenia incidence and the variable toxicity profile between brand and generic docetaxel in the adjuvant treatment of breast cancer with docetaxel and cyclophosphamide regimen

ABSTRACT Objective To assess the incidence of febrile neutropenia without primary granulocyte colony-stimulating factor prophylaxis in patients undergoing chemotherapy with adjuvant docetaxel and cyclophosphamide, and to evaluate the toxicity profile of brand-name docetaxel (Taxotere ® ) and the generic formulation. Methods This retrospective study was conducted using data obtained from electronic medical records of patients treated at a Brazilian cancer center. Patients with breast cancer who underwent adjuvant treatment between January 2016 and June 2019 were selected. Data were analyzed using chi-square and Fisher correlation of variables, and multivariate analyses were adjusted for propensity score. Results A total of 231 patients with a mean age of 55.9 years at the time of treatment were included in the study. The majority (93.9%) had luminal histology, 84.8% were at clinical stage I, and 98.2% had a good performance status. The overall incidence of febrile neutropenia in the study population was 13.4% (31 cases). The use of brand-name docetaxel (Taxotere ® ) was the only factor associated with febrile neutropenia occurrence (OR= 3.55, 95%CI= 1.58-7.94, p=0.002). Conclusion In patients with breast cancer who require treatment with adjuvant docetaxel and cyclophosphamide regimen, the toxicity profile differs between brand-name and generic docetaxel. Regardless of the formulation used, the incidence of febrile neutropenia was less than 20%, which may allow for the omission of primary prophylactic granulocyte colony-stimulating factor use in this setting.

[The war against generics and biosimilars in France: game over?] / Génériques et biosimilaires en France : la fin des polémiques et des palinodies ?

"The war against generics and biosimilars in france: game over? French people seem get accustomed to generics use after a period of approximately two decades punctuated with reluctance, controversies, behavioral barriers, incentives, conventions and regulations. Fortunately the recent so-called Levothyrox crisis and the more confidential one about Valsartan have not had the deleterious impact that was feared. A more peaceful atmosphere if not resignation can now be noticed. Only three kinds of medically justified situations make now them out of hand: in case of narrow therapeutic margin; in the case of child under six if there is no generics adapted to him; in the case of patients showing a contraindication to excipient with known effect. The identification of these situations will ask judgement from the prescribers. The debates concerning biosimilars deployment did not find their root in biosimilars therapeutic indications which are extrapolations from the princeps indications even if biosimilars have been tested in one only of the princeps indications. They came from the French health authorities palinodes about their interchangeability. Far from assisting prescriptions, such palinodes could have generated prescribers' and patients' lack of confidence."

"Génériques et biosimilaires En france : la fin des polémiques et Des palinodies ? Les Français semblent s'accoutumer à l'utilisation des génériques au terme d'un cheminement de près de deux décennies émaillé de réticences, de freins comportementaux, de polémiques, mais aussi d'incitations, de conventions et de textes réglementaires. La récente crise dite du Levothyrox n'aura fort heureusement pas eu les répercussions délétères redoutées et l'ambiance est à l'apaisement sinon à la lassitude. Seuls trois types de situations médicalement justifiées permettent de leur échapper : en cas de médicament à marge thérapeutique étroite ; chez l'enfant de moins de 6  ans si aucun générique n'a de forme adaptée ; chez les patients ayant une contre-indication démontrée à un excipient à effet notoire, lorsque le princeps ne comporte pas cet excipient. Pour ce qui est du déploiement des biosimilaires, les débats ne sont pas venus d'où on les attendait c'est-à-dire de l'extrapolation au bénéfice du biosimilaire, de l'ensemble des indications thérapeutiques du princeps, alors que le biosimilaire n'a été cliniquement testé que dans une seule de ces indications. Ils ont résulté de la palinodie des autorités de santé à propos de leur interchangeabilité. Une palinodie qui, loin de favoriser leur prescription, a bien failli susciter la défiance des patients."

Delivering Benefits at Speed Through Real-World Repurposing of Off-Patent Drugs: The COVID-19 Pandemic as a Case in Point.

Real-world drug repurposing-the immediate "off-label" prescribing of drugs to address urgent clinical needs-is a widely overlooked opportunity. Off-label prescribing (ie, for a nonapproved indication) is legal in most countries and tends to shift the burden of liability and cost to physicians and patients, respectively. Nevertheless, health crises may mean that real-world repurposing is the only realistic source for solutions. Optimal real-world repurposing requires a track record of safety, affordability, and access for drug candidates. Although thousands of such drugs are already available, there is no central repository of off-label uses to facilitate immediate identification and selection of potentially useful interventions during public health crises. Using the current coronavirus disease (COVID-19) pandemic as an example, we provide a glimpse of the extensive literature that supports the rationale behind six generic drugs, in four classes, all of which are affordable, supported by decades of safety data, and targeted toward the underlying pathophysiology that makes COVID-19 so deadly. This paper briefly summarizes why cimetidine or famotidine, dipyridamole, fenofibrate or bezafibrate, and sildenafil citrate are worth considering for patients with COVID-19. Clinical trials to assess efficacy are already underway for famotidine, dipyridamole, and sildenafil, and further trials of all these agents will be important in due course. These examples also reveal the unlimited opportunity to future-proof our health care systems by proactively mining, synthesizing, cataloging, and evaluating the off-label treatment opportunities of thousands of safe, well-established, and affordable generic drugs.

Estimación del ahorro hospitalario con el reemplazo de inmunosupresores genéricos en trasplante renal / Cost savings after switching from innovative tacrolimus to a generic version of the drug in transplant recipients

Background The use of narrow therapeutic index generic immunosuppressant in solid organ transplantation is controversial. Most experiences switching to these drugs have short term follow-up periods, analyze only pharmacokinetic issues and do not systematically include either complications or cost analyses. Aim To analyze the costs and benefits of switching our kidney transplant recipients from innovative tacrolimus to a generic version of the drug. Material and Methods Fifty-seven stable transplant recipients were switched from innovative tacrolimus to a generic version of the drug, maintaining the same dose. They were followed for eight months recording all events during such period. Results We observed two infectious episodes, five allograft biopsies were performed and two patients had acute rejections. Conclusions From the payer's perspective, if all the costs associated with the change to generic tacrolimus are considered, savings related to a lower cost of the drug translate in a real financial loss for the public health system. The analysis also showed that frequent switches, even from one generic drug to a cheaper one is an even worse strategy to save money.

Secular Trends in the Cost of Immunosuppressants after Solid Organ Transplantation in the United States.

BACKGROUND AND OBJECTIVES: Immunosuppressive medications are critical for maintenance of graft function in transplant recipients but can represent a substantial financial burden to patients and their insurance carriers. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: To determine whether availability of generic immunosuppressive medications starting in 2009 may have alleviated some of that burden, we used Medicare Part D prescription drug events between 2008 and 2013 to estimate the average annualized per-patient payments made by patients and Medicare in a large national sample of kidney, liver, and heart transplant recipients. Repeated measures linear regression was used to determine changes in payments over the study period. RESULTS: Medicare Part D payments for two commonly used immunosuppressive medications, tacrolimus and mycophenolic acid (including mycophenolate mofetil and mycophenolate sodium), decreased overall by 48%-67% across organs and drugs from 2008 to 2013, reflecting decreasing payments for brand and generic tacrolimus (21%-54%), and generic mycophenolate (72%-74%). Low-income subsidy payments, which are additional payments made under Medicare Part D, also decreased during the study period. Out-of-pocket payments by patients who did not receive the low-income subsidy decreased by more than those who did receive the low-income subsidy (63%-79% versus 24%-44%). CONCLUSIONS: The decline in payments by Medicare Part D and by transplant recipients for tacrolimus and mycophenolate between 2008 and 2013 suggests that the introduction of generic immunosuppressants during this period has resulted in substantial cost savings to Medicare and to patients, largely reflecting the transition from brand to generic products.

Brazilian generics market change after Farmácia Popular program

ABSTRACT OBJECTIVE To evaluate trends in the use of generic and non-generic medicines to treat hypertension and diabetes under the Farmácia Popular Program (FP) and its impact on generic medicines sales volume and market share in the Brazilian pharmaceutical market. METHODS This longitudinal, retrospective study used interrupted time series design to analyze changes in monthly sales volume and proportion of medicines sales (market share) for oral antidiabetic and antihypertensive medicines for generic versus non-generic products. Analyses were conducted in a combined dataset that aggregate monthly sales volumes from the Farmácia Popular program and from the QuintilesIMS™ (IQVIA) national market sales data from January 2007 to December 2012. The Farmácia Popular program phases analyzed included: a) 2009 reductions in medicines reference prices (AFP-II) and b) 2011 implementation of free medicines program for hypertension and diabetes, the Saúde não tem preço (SNTP - Health has no price). RESULTS Patterns of use for FP-covered antidiabetic and antihypertensive medicines were similar to their use in the market in general. After one year of the decreases in government subsidies in April 2010, market share of antidiabetic and antihypertensive medicines experienced relative declines of -54.5% and -59.9%, respectively. However, when FP-covered medicines were made free to patients, overall market volume for antidiabetic and antihypertensive generics increased dramatically, with 242.6% and 277.0% relative increases by February 2012, as well as non-generics with relative increase of 209.7% and 279% for antidiabetic and antihypertensive medicines, respectively. CONCLUSIONS Ministry of Health policies on the amount of patient cost sharing and on the choice of medicines on coverage lists have substantial impacts on overall generic sales volume in retail pharmacies.

Biosimilars-Emerging Role in Nephrology.

The Food and Drug Administration (FDA) defines a "biosimilar" agent as a biologic that is highly similar to the reference or originator biologic product notwithstanding minor differences in clinically inactive components with no clinically meaningful differences in terms of the safety, purity, and potency. The advantage of biosimilars is that they are usually about 15%-30% less expensive than the reference product, which results in system-wide cost savings and increased patient access. Because biologic drugs are produced by living organisms, they are by nature heterogeneous and identical copies cannot be made, unlike generic versions of small-molecule drugs. Proposed biosimilars must undergo a rigorous evaluation process to demonstrate a high degree of structural and functional similarity with the reference biologic. Once that is confirmed, a stepwise process of comparison with the reference agent with regard to animal trials, pharmacokinetics/pharmacodynamics, immunogenicity, and human efficacy/safety is conducted. The experience with biosimilars in other highly regulated markets where patent protection for originator biologics is not as robust as in the United States has been favorable in terms of safety, efficacy, and cost savings. An FDA approval pathway was created in 2009 to expedite the approval of biosimilars; as of early 2018 nine agents had been approved through that pathway, none in nephrology. The first United States biosimilar epoetin was approved on May 15, 2018, but does not have an interchangeability designation, meaning that prescribers must specifically write for the biosimilar product for patients to receive it. Given the unfamiliarity of biosimilars within the nephrology community it is recommended that educational programs be developed to address this unmet need and for research to be conducted addressing the perceptual, clinical, and economic effect of biosimilars on our patients.

Branded versus generic drug use in chronic disease management in Hong Kong-perspectives of health care professionals and the general public.

INTRODUCTION: The aim of the present study was to evaluate the understanding of generic substitution among health care professionals and members of the general public ("general public") in Hong Kong. METHODS: This cross-sectional descriptive study was performed by using a self-completed anonymous questionnaire from March 2015 to May 2017. The questionnaire included demographic data, knowledge of generic drugs, experiences of generic substitution, and views on policy. RESULTS: A total of 2106 general public, 73 doctors, 22 nurses, and 50 pharmacists responded the questionnaire. In all, 41.2% of the general public was aware that generic drugs have the same active ingredients. Although a majority of the health care professionals knew that generic drugs have the same active ingredients (doctors: 79.5%; nurses: 86.4%; pharmacists: 98.0%), many were unaware of bioequivalence (doctors: 37.0%; nurses: 18.2%; pharmacists: 50.0%). "Efficacy" was ranked as the primary concern among all groups; a substantial portion of respondents reported experiencing adverse drug reactions upon generic substitution (general public: 26.6%; doctors: 23.3%; nurses: 9.1%; pharmacists: 42.0%). At least half of the general public, nurses, and pharmacists considered that patients should be given a choice for generic substitution. However, fewer than one-fifth of doctors and nurses and approximately one-third of pharmacists considered that patient consent was needed prior to generic substitution, compared with approximately two-thirds of the general public. CONCLUSION: The knowledge and perception of generic substitution remains low, both in the general public and among health care professionals. This knowledge deficit could potentially lead to different perspectives among stakeholders regarding generic substitution.

Drug utilization study of two generic antibiotics in a tertiary hospital in Bogotá

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.

Utilización de dos antibióticos genéricos en un hospital de tercer nivel en Bogotá / Drug utilization study of two generic antibiotics in a tertiary hospital in Bogotá

Resumen Introducción. La política farmacéutica de Colombia establece la necesidad de intensificar la investigación en farmacoepidemiología a nivel nacional, especialmente en el caso de los antibióticos. Objetivo. Aportar información farmacoepidemiológica en cuanto a la efectividad, las condiciones de uso y la seguridad de la cefepima y el meropenem genéricos en un hospital de alta complejidad en Bogotá. Materiales y métodos. Se hizo un estudio descriptivo, longitudinal y retrospectivo sobre la utilización de estos medicamentos. Los datos se recolectaron de todas las historias clínicas en las cuales se registraba el uso de cefepima y meropenem. Resultados. Se incluyeron 82 pacientes tratados con cefepima y 91 con meropenem. La mayoría de ellos había estado internada en servicios diferentes a la unidad de cuidados intensivos (59,8 % con cefepima y 52,7 % con meropenem). El 21,9 % de los tratados con cefepima y el 49 % de los tratados con meropenem, tuvieron consulta con un infectólogo, en tanto que en 47 % de los primeros y en 78 % de los segundos, se hizo cultivo o antibiograma. Las condiciones más frecuentemente tratadas con cefepima fueron las infecciones de vías respiratorias (32,5 %) y, con meropenem, las infecciones genitourinarias (34,8 %). Las tasas de éxito terapéutico fueron de 61,7 % para la cefepima y de 63,0 % para el meropenem. Conclusiones. Este estudio aporta información sobre el desempeño terapéutico de dos antibióticos genéricos de uso hospitalario. No hubo reportes de falla terapéutica durante el periodo de estudio. En los casos en que no hubo respuesta al tratamiento, las causas frecuentes fueron las alteraciones farmacocinéticas, las condiciones clínicas desfavorables y la elección inadecuada del tratamiento antimicrobiano.

Abstract 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.

Cannabidiol for treating drug-resistant epilepsy in children: the New South Wales experience.

OBJECTIVE: To evaluate the tolerability and safety of cannabidiol for treating drug-resistant epilepsy in children, and to describe adverse events associated with such treatment. STUDY DESIGN: Prospective, open label cohort study. SETTING: Three tertiary NSW referral centres with paediatric neurology services. PARTICIPANTS: First 40 children enrolled in the NSW Compassionate Access Scheme for children with drug-resistant epilepsy and uncountable daily seizures. INTERVENTION: Children received cannabidiol as an adjunct anti-epileptic drug, titrated to a maximum of 25 mg/kg/day, for up to 12 weeks. OUTCOME MEASURES: Adverse events, withdrawals, and caregiver and physician Global Impression of Change assessments were recorded at 4, 8 and 12 weeks. Seizure frequency could not be reliably recorded because of disease severity. RESULTS: Thirty-nine patients reported at least one adverse event; many were deemed unrelated to cannabidiol treatment. The most frequent treatment-related adverse event was somnolence (15 participants), which resolved spontaneously in ten patients; it was particularly frequent in patients taking higher clobazam doses. Gastrointestinal effects (nausea, vomiting, diarrhoea) were each reported by seven to nine participants. Four children were withdrawn from treatment, including one with elevated transaminase levels. The caregivers of 12 children felt the overall health of their children had much or very much improved; clinicians assessed seven children as being much or very much improved. CONCLUSION: Cannabidiol as an adjunct treatment had some subjective benefit for overall health, with a manageable adverse event profile. Monitoring changes in liver function and awareness of potential drug interactions is essential. Whether the reported benefit is attributable to cannabidiol cannot be established in an open label study of participants with severe intractable epilepsy.

Psychiatrists' Attitude and Use of Second-generation Antipsychotics for the Treatment of Schizophrenia in Taiwan.

OBJECTIVES: This survey aimed to understand the attitude of psychiatrists and their use of commonly prescribed second-generation antipsychotics (SGAs) for the treatment of schizophrenia in Taiwan. It also attempted to identify the factors that might influence their preference for selecting SGAs. METHODS: Psychiatrists were interviewed face-to-face using a structured questionnaire. The questionnaire addressed various issues involved in the treatment of patients with schizophrenia, including the reasons for selecting SGAs, psychiatrists' level of satisfaction with commonly prescribed SGAs, and their current use of SGAs in clinical practice. RESULTS: Gender and age of the psychiatrists, and practice setting were not related to SGA selection. The selection of a SGA might be influenced by characteristics of the psychiatrist, properties of the drugs, and the healthcare insurance system. Most psychiatrists agreed that the performance of brand-name drugs was superior to that of generic drugs. Better symptom control, improvement in cognition, and higher tolerability were among the major factors considered by psychiatrists in Taiwan when prescribing antipsychotics. CONCLUSION: Selection of a SGA in Taiwan is potentially influenced by the characteristics of the psychiatrist, properties of the drug, and the healthcare insurance system. Efficacy and tolerability were among the major determining factors when prescribing antipsychotics for the treatment of patients with schizophrenia.

Factors influencing the preference for purchasing generic drugs in a Southern Brazilian city

ABSTRACT OBJECTIVE The objective of this study is to identify factors associated with the preference for purchasing generic drugs in a medium-sized municipality in Southern Brazil. METHODS We have analyzed data from a population-based cross-sectional study conducted in 2012 with a sample of 2,856 adults (≥ 20 years old). The preference for purchasing generic drugs was the main outcome. The explanatory variables were the demographic and socioeconomic variables. Statistical analyses included Poisson regressions. RESULTS The preference for purchasing generic drugs was 63.2% (95%CI 61.4-64.9). The variables correlated with this preference in the fully adjusted models were: male (prevalence ratio [PR] = 1.08; 95%CI 1.03-1.14), age of 20-39 years (PR = 1.10; 95%CI 1.02-1.20), low socioeconomic status (PR = 1.15; 95%CI 1.03-1.28), and good knowledge about generic drugs (PR= 4.66; 95%CI 2.89-7.52). Among those who preferred to purchase generic drugs, 55.1% have reported accepting to replace the prescribed drug (if not a generic) with the equivalent generic drug. Another correlate of the preference for purchasing generic drugs was because individuals consider their quality equivalent to reference medicines (PR = 2.15; 95%CI 1.93-2.41). CONCLUSIONS Knowledge about generic drugs was the main correlate of the preference for purchasing generic drugs. The greater the knowledge or positive perception about generic drugs, the greater is the preference to purchase them. Therefore, educational campaigns for healthcare professionals and consumers appear to be the best strategy for expanding the use of generic drugs in Brazil.

[The patents game. Generic and biosimilar drugs]. / Juego de patentes. Sobre medicamentos genéricos y biosimilares.

The protection provided by patents on medicines has a limited duration. The expiry of patents expiration allows copies of the drugs to be released, competing with original. At first, they were identical to the original, known as generic drugs, but in recent years, due to the marketing of biological therapies and the expiry of many of their patents, biosimilar drugs have also emerged. These are not exact copies of the original, but, like generic drugs, biosimilar drugs have to demonstrate equivalence to the reference drugs in quality, safety and efficacy. Nevertheless, despite their importance and contribution to sustainability of health system, doctors are sometimes unaware of differences between them, and their impact in terms of clinical and economic effects. An attempt is made to review and clarify certain aspects often unknown by physicians, despite their involvement in their use.

Use of generic medicines by the Brazilian population: an evaluation of PNAUM 2014 / Utilização de medicamentos genéricos na população brasileira: uma avaliação da PNAUM 2014

ABSTRACT OBJECTIVE To analyze the existence of differences in the use of generic medicines in Brazil according to demographic and socioeconomic variables and acquisition sources of the medicines. METHODS Population-based cross-sectional study, conducted with data from the Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines). Data collection took place between September, 2013 and February, 2014 in homes of Brazilian cities (urban area). The use of medicines has been investigated in relation to the treatment of chronic diseases and, in the case of acute events, regarding use over the previous 15 days. Generics were identified by visualization of packaging presented by the users of the medicines. The independent variables used were sex, age, education level, economic class, and region of the Country. The statistical significance of differences between the groups was evaluated by Pearson’s Chi-squared test, considering a 5% significance level. RESULTS The prevalence of generic medicines use was 45.5% (95%CI 43.7–47.3). There was no difference considering education level. The prevalence was higher in females (47.0%; 95%CI 44.9–49.0) than in males (43.1%; 95%CI 40.5–45.8), and were higher with increasing age. Generic medicines were more used in the economic class C (47.0%; 95%CI 44.9–49.1) and in the South (50.6%; 95%CI 46.6–54.6) and Southeast (49.9%; 95%CI 46.8–53.0) regions. Generics accounted for 37.3% of the medicines provided by the Brazilian Unified Health System. CONCLUSIONS Currently, there is a choice of purchase or free provision by the Brazilian Unified Health System, characterized by quality assurance and reduced price regarding branded medicines considered as reference. In the private market, a considerable part of the population is choosing generic medicines thanks to the availability of this option for virtually all medicines most used by the population.

RESUMO OBJETIVO Analisar se há diferença no uso de medicamentos genéricos no Brasil segundo variáveis demográficas, socioeconômicas e fontes de obtenção dos medicamentos. MÉTODOS Estudo transversal de base populacional, conduzido com dados da Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM), com coleta de dados entre setembro de 2013 e fevereiro de 2014 em residências de municípios brasileiros urbanos. O uso dos medicamentos foi investigado em relação ao tratamento de doenças crônicas e, no caso de eventos agudos, quanto ao uso nos últimos 15 dias. Os genéricos foram identificados por visualização das embalagens apresentadas pelos usuários dos medicamentos. As variáveis independentes utilizadas foram sexo, idade, escolaridade, classe econômica e região do País. A avaliação da significância estatística das diferenças entre os grupos foi analisada pelo teste Qui-quadrado de Pearson, considerando nível de significância de 5%. RESULTADOS A prevalência de uso de genéricos foi de 45,5% (IC95% 43,7–47,3). Não houve diferença por escolaridade, as prevalências foram maiores no sexo feminino (47,0%; IC95% 44,9–49,0) em relação ao masculino (43,1%; IC95% 40,5–45,8) e foram crescentes com o aumento da idade. Maiores usos de genéricos foram encontrados na classe econômica C (47,0%; IC95% 44,9–49,1) e nas regiões Sul (50,6%; IC95% 46,6-54,6) e Sudeste (49,9%; IC95% 46,8–53,0). Observou-se ainda que os genéricos representaram 37,3% dos medicamentos disponibilizados pelo Sistema Único de Saúde . CONCLUSÕES Pode-se concluir que hoje existe uma alternativa de compra ou fornecimento gratuito pelo Sistema Único de Saúde, caracterizada por garantia de qualidade e preço reduzido em relação aos medicamentos de marca comercial considerados como referência. No mercado privado, boa parte da população está optando pelo uso de medicamentos genéricos, graças à disponibilidade dessa opção para praticamente todos os medicamentos mais utilizados pela população.

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

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

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

Comparing recurrent antibiotic prescriptions in children treated with a brand name or a generic formulation.

PURPOSE: The aim of this study was to investigate the rate of recurrent prescriptions and hospital admissions in children receiving a brand name or generic antibiotic prescription. METHODS: The data source was a database of reimbursed prescriptions. Outpatient children/adolescents <18 years old (Lombardy Region, Italy) were included. The observational period was February-April 2010. A recurrence was defined as an antibiotic prescription occurring within 28 days after an index prescription. The rate of recurrent prescriptions and hospital admissions was calculated for generic/brand name formulations and for each age strata (0-5, 6-11, and 12-17 years old) for four antibiotics: amoxicillin, amoxicillin clavulanate, clarithromycin, and cefaclor. The percentage of therapy switches was calculated. Cochran-Mantel-Haenszel test was used to compare the age-adjusted outcomes. RESULTS: In all, 17.5% (57 346) of children received at least one recurrent prescription. The rate of recurrent prescriptions was slightly lower in children receiving any generic (OR 0.96; 95%CI 0.93-0.98), compared with any brand name, antibiotic. The percentage of hospital admissions occurring in children initially treated with a brand name (1.01%; 95%CI 0.98-1.08) or generic (1.03%; 0.96-1.06) antibiotic was not different (p = 0.43). For children receiving amoxicillin clavulanate, the hospital admission rate was slightly higher in the brand name group (p = 0.002), while no differences were found for the other active substances. CONCLUSIONS: Children treated with generic antibiotics had no worse safety and effectiveness outcomes when compared with those receiving brand name ones. These results provide additional evidence on the safety of generic antibiotics.