Availability and prices of medications used during COVID-19 pandemic / Disponibilidad y precios de medicamentos utilizados durante la pandemia de COVID-19

Objectives: The present COVID-19 pandemic has impacted all of us, but the pandemic’s impact and repercussions are perceived differently by individuals and governments. Locking down had an impact on pharmaceutical manufacturing, supply, and distribution, causing a medicine shortage. This study aimed to assess drugs used frequently during the pandemic in Iraq their availability and prices and determine how medications are affordable for patients. Study design: This was a pilot study. Methods: This study enrolled 30 pharmacies from rural and urban areas located in Babil governorate, Iraq; from 1 January until 1 March 2021. Results: According to the results, there was a difference between expensive and inexpensive medicines. Medication availability shows that many COVID-19 used medications had no local production like ipratropium, budesonide, Enoxaparin, remdesivir, and others. Levofloxacin vial 500 mg, cost more than 9000 Iraqi dinars, which is more than one day of Iraqi wage (1 day of salary = 8333 Iraqi Dinar; levofloxacin is normally given for seven days, so the total cost will be 583333 Iraqi Dinar for the entire course) that’s rather than other medications and for one family member. Local production prices are high in comparison to imported ones, as in (levofloxacin and Favipiravir). Many medications had increased their prices after the pandemic due to demand, availability and exchange rate. Conclusion: The Iraqi government has to provide medications for the Iraqi people in public hospitals and clinics so that patients do not need to go to private ones. Medications prices have to be controlled uninformed by the government.(AU)

Políticas de regulación de precios de medicamentos: consideraciones desde la economía de la salud / Drug price regulation policies: considerations from health economics

El objetivo de este artículo es resumir la evidencia y las principales recomendaciones sobre políticas de regulación de precios de medicamentos y analizar las experiencias de Colombia y Brasil en este ámbito. Para lograr esto, se utiliza la Guía de Políticas Nacionales de Regulación de Precios de la Organización Mundial de la Salud publicada en 2020 y se realiza una revisión narrativa de la literatura para examinar los casos de Colombia y Brasil. Del análisis realizado, se destaca la importancia de una definición amplia de las políticas de regulación de precios, que incluya tanto las medidas directas como las indirectas que influyen en el precio. En particular, se encontró que las políticas de promoción y uso de genéricos y biosimilares tienen una sólida evidencia en términos de sus efectos en el precio y el gasto. Asimismo, es conveniente considerar un enfoque integral en las políticas de regulación de precios, teniendo en cuenta las sinergias y la necesidad de complementarlas con otras intervenciones en el mercado farmacéutico. Finalmente, para el caso nacional es necesario avanzar hacia una mayor cobertura efectiva de los medicamentos, para luego establecer precios de compra o reembolso, tal como se realiza en la mayoría de los países desarrollados que emplean ampliamente esta forma de regulación.

Análise de preços praticados nas aquisições de medicamentos pelos consórcios de saúde em comparação com as instituições municipais para o período de 2017 a 2018 / Analysis of practical prices in the acquisition of medicines by the health consortia compared to municipal institutions in the period from 2017 to 2018

Objetivo: Identificar se as aquisições de medicamentos realizadas pelos Consórcios de Saúde foram mais eficientes, em termos econômicos, que as compras realizadas individualmente pelas Instituições Municipais, para os anos de 2017 e 2018. Métodos: Análise descritiva da amostra, empregando as medidas de tendência central, análise econômica e cálculo do percentual econômico. Resultados: Os valores obtidos mostraram eficiência nas compras dos consórcios, refletidos na maior quantidade adquirida e no menor preço praticado, para a maioria dos itens analisados no período de referência. Conclusão: As compras pelos Consórcios de Saúde proporcionaram mais economia em comparação com as compras realizadas pelas Instituições Municipais, mostrando-se como uma opção para obter economicidade dos recursos destinados à saúde.

Objective: To identify whether the drug purchases made by the Health Consortia were more efficient, in economic terms, than the purchases made individually by the Municipal Institutions, for the years 2017 and 2018. Methods: Descriptive analysis of the sample, using the trend measures central, economic analysis and calculation of the economic percentage. Results: The values obtained showed efficiency in consortium purchases, reflected in the greater quantity acquired and the lower price practiced, for most of the items analyzed in the reference period. Conclusion: Purchases by Health Consortia provided more savings compared to purchases made by Municipal Institutions, proving to be an option to obtain economic resources for health.

Cannabidiol para la epilepsia resistente a fármacos en Argentina: evaluación de tecnología sanitaria / Cannabidiol for drug-resistant epilepsy in Argentina: health technology assessment

INTRODUCCIÓN: El cannabidiol (CBD), un derivado de la planta de cannabis, está autorizado como especialidad medicinal para su comercialización en Argentina y otros países con el fin de tratar la epilepsia resistente a fármacos. Se encuentran en estudio otras potenciales indicaciones. MÉTODOS: Se realizó una evaluación de tecnología sanitaria para la Comisión Nacional de Evaluación de Tecnologías de Salud (CONETEC) sobre CBD para epilepsia resistente a fármacos en Argentina. RESULTADOS: Se describen aspectos legales, regulatorios y económicos, las evidencias disponibles sobre eficacia y seguridad en epilepsia y el impacto presupuestario. DISCUSIÓN: La evaluación pone de manifiesto una serie de desafíos para el sistema de salud argentino, relacionados con el mercado del CBD para la epilepsia en el país, su tamaño, los distintos actores y su comportamiento. Se indaga acerca de la estructura de costos, los márgenes de ganancia, y se mencionan algunas estrategias que fueron puestas en práctica por la industria farmacéutica en Argentina y otros países. Se discute el impacto de la competencia en los precios y se describen potenciales herramientas del Estado para la regulación como el uso de precios de referencia internacionales, la evaluación de tecnologías sanitarias y las compras mancomunadas, así como la articulación con productores nacionales y actores internacionales.

INTRODUCTION: Cannabidiol (CBD), a derivative of the cannabis plant, is authorized as a medicinal product for sale in Argentina and other countries for the treatment of drug-resistant epilepsy. Other potential indications are under study. METHODS: A health technology assessment was conducted for CONETEC (National Commission for Health Technology Assessment), analyzing CBD for drug-resistant epilepsy in Argentina. RESULTS: Legal, regulatory and economic aspects are described as well as the available evidence on efficacy and safety in epilepsy, and the budget impact. DISCUSSION: The assessment highlights a series of challenges for the Argentine health system, related to the CBD market for epilepsy, its size, the different actors, and their behavior. Inquiries are made about cost structure and profit margins, mentioning some strategies that were put into practice by the pharmaceutical industry in Argentina and other countries. The impact of competition on prices is discussed, and potential State tools for price regulation like the use of international reference prices, health technology assessment and joint purchases, as well as articulation with national producers and international actors are described.

O preço da vida

O premiado diretor Adam Wishart autorizou a Colabore com o Futuro a legendar e divulgar no Brasil o documentário "O Preço da Vida" (The Price of Life). Nesse filme patrocinado pela BBC Two, Adam mostra como foi feita a decisão sobre a incorporação do Lenalidomida (importante medicamento para mieloma múltiplo) pela NICE (Agência Sanitária do Reino Unido). Muito interessante assistir para entender melhor como funciona o processo de ATS - Avaliação de Novas Tecnologias - sob o aspecto do paciente que precisa do medicamento, do governo que tem um orçamento limitado, e do fabricante, que tem um custo alto para produzir a droga e por isso precisa cobrar caro pela mesma. Os conflitos muito humanos que surgem abrem para debate uma questão moral maior - quanto vale a vida e quanto deve pagar a sociedade?

Consideraciones sobre la innovación incremental en medicamentos / Considerations regarding Incremental Drug Innovation

El concepto de innovación incremental abarca las adaptaciones resultantes del análisis de la utilización de los medicamentos existentes, con el fin de incorporar una modificación o proponer un nuevo uso diseñado para beneficiar a los pacientes. Puede clasificarse en 6 distintas categorías, en función de la naturaleza o del objetivo de la innovación realizada. La innovación incremental puede resultar muy interesantes para los profesionales sanitarios porque estas variaciones aportan mejoras en el tratamiento, en la continuación de los tratamientos, en la disminución de efectos adversos o en la adherencia. La innovación incremental tiene también una excelente acogida desde la perspectiva del paciente, puesto que facilita el tratamiento y en muchos casos abre una expectativa terapéutica a determinados subgrupos, inexistente antes de la comercialización del medicamento. Es interesante asimismo para el Sistema Nacional de Salud, ya que determinados pacientes tratados con innovaciones incrementales obtienen mejores resultados en salud y requieren con menor frecuencia hacer uso de otros servicios sanitarios. Desde una perspectiva económica, muchas empresas farmacéuticas radicadas en nuestro país relevantes desde un punto de vista estratégico, podrían asimismo mejorar con este tipo de innovaciones el arsenal terapéutico aportando productos necesarios que, lamentablemente, no tienen en la actualidad las condiciones idóneas de viabilidad. Por todo ello, la promulgación de una normativa española que ampare y aporte seguridad jurídica a los titulares de la autorización de comercialización de este tipo de innovaciones parece necesaria. Esta futura normativa debería incluir un procedimiento para calificar las innovaciones incrementales de interés para el Sistema Nacional de Salud y tener efectos económicos para garantizar su comercialización efectiva.(AU)

The concept of incremental innovation encompasses adaptations resulting from the analysis of the use of existing medicinal products, in order to incorporate a modification or propose a new use designed to benefit patients. It can be classified into 6 different categories, depending on the nature or objective of the innovation carried out. Incremental innovation can be very interesting for health professionals because these variations provide improvements in treatment, in the continuation of treatments, in the reduction of adverse effects or in adherence. Incremental innovation is also very well received from the patient’s perspective, since it facilitates treatment and in many cases opens up a therapeutic expectation for certain subgroups that did not exist before the medicinal product was marketed. It is also interesting for the National Health System, since certain patients treated with incremental innovations obtain better health results and require less frequent use of other health services. From an economic perspective, many pharmaceutical companies established in our country and relevant from a strategic point of view, could also improve the therapeutic arsenal with this type of innovations by providing products of therapeutic interest that, unfortunately, do not currently have the ideal conditions for viability. For all these reasons, the promulgation of a Spanish regulation that protects and provides legal certainty to the marketing authorization holders of this type of innovations seems necessary. This future regulation should include a procedure to qualify incremental innovations of interest to the National Health System and have economic effects to guarantee their effective commercialization.(AU)

Seguridad social y medicamentos Mecanismos de cobertura de dos obras sociales en contexto de inflación 2011-2019 / Social security and medicines: coverage mechanisms of two health insurance organizations in the context of inflation, 2011-2019

INTRODUCCIÓN: La elevada inflación argentina puede comprometer el acceso a los medicamentos, incluso con cobertura de la seguridad social. El objetivo de este estudio fue describir la evolución entre 2011 y 2019 de la cobertura del Instituto Nacional de Servicios Sociales para Jubilados y Pensionados (INSSJyP, también conocido como PAMI) y del Instituto de Obra Médico Asistencial (IOMA) para una selección de medicamentos de uso ambulatorio, fuera de patente, de consumo frecuente en patologías prevalentes, y evaluar si la evolución del ingreso de los beneficiarios acompañó el aumento del gasto de bolsillo para estos fármacos. MÉTODOS: Se registró la evolución del precio de venta al público (PVP) y de la cobertura por INSSJyP y por IOMA en los cuatrienios 2011-2015 y 2015-2019 para una selección de 10 fármacos utilizados en enfermedades crónicas de alta prevalencia. Se calculó la evolución del gasto de bolsillo para las presentaciones promedio, más barata y más cara de cada fármaco, y se comparó con la evolución de los ingresos de los beneficiarios. RESULTADOS: La cobertura promedio del INSSJyP para los fármacos estudiados subió de 63% en 2011 a 73% en 2019. La cobertura del PVP promedio por el IOMA fue de 55% en 2011 y descendió a 36% en 2019, debido a la demora en la actualización de los montos fijos. Para los beneficiarios de ambas instituciones el gasto de bolsillo creció menos que el ingreso en 2011-2015 pero lo superó ampliamente en 2015-2019. DISCUSIÓN: El sistema de cobertura por monto fijo tiene ventajas conceptuales, pero requiere una actualización oportuna de los valores con la inflación

Drug prices in Latin American countries: the case of rheumatoid arthritis Biosimilars

Abstract Background: The objective of this paper is to analyze the prices of biological drugs in the treatment of Rheumatoid Arthritis (RA) in three Latin American countries (Brazil, Colombia and Mexico), as well as in Spain and the United States of America (US), from the point of market entry of biosimilars. Methods: We analyzed products authorized for commercialization in the last 20 years, in Brazil, Colombia, and Mexico, comparing them to the United States of America (USA) and Spain. For this analysis, we sought the prices and registries of drugs marketed between 1999 and October 1, 2019, in the regulatory agencies' databases. The pricing between countries was based on purchasing power parity (PPP). Results: The US authorized the commercialization of 13 distinct biologicals and four biosimilars in the period. Spain and Brazil marketed 14 biopharmaceuticals for RA, ten original, four biosimilars. Colombia and Mexico have authorized three biosimilars in addition to the ten biological ones. For biological drug prices, the US is the most expensive country. Spain's price behavior seems intermediate when compared to the three LA countries. Brazil has the highest LA prices, followed by Mexico and Colombia, which has the lowest prices. Spain has the lowest values in PPP, compared to LA countries, while the US has the highest prices. Conclusions: The economic effort that LA countries make to access these medicines is much higher than the US and Spain. The use of the PPP ensured a better understanding of the actual access to these inputs in the countries analyzed.(AU)

Critérios de definição de preços de medicamentos no Brasil e em países selecionados: uma revisão comparada / Criteria for setting drug prices in Brazil and selected countries: a comparative review

Objetivos: Comparar os critérios de formação de preços de medicamentos no Brasil e em países selecionados, analisar o mecanismo de formação de preços de medicamentos no Brasil e analisar o mecanismo de formação de preços de medicamentos em países selecionados. Métodos: Foi realizada uma revisão narrativa da literatura por meio do levantamento de informações em bases de dados, em sites das agências nacionais e organismos internacionais e em literatura "cinzenta", a respeito dos sistemas de saúde e mecanismos de formação de preços de medicamentos no Brasil e nos países selecionados (Austrália, Canadá, Espanha, Estados Unidos, França, Grécia, Itália, Nova Zelândia e Portugal). Resultados: A maioria dos países pesquisados utiliza o referenciamento externo e interno de preços, realiza ajustes e correções de preços ao longo do tempo e faz estudos de avaliação econômica. O valor da terapia ou seu benefício para o paciente ou sistema de saúde é um fator importante tanto na determinação do preço como da incorporação no sistema de saúde. Conclusão: Este trabalho permitiu identificar as semelhanças entre as práticas recomendadas e implementadas internacionalmente e as realizadas no Brasil, bem como os problemas relacionados à definição de preços das novas terapias, além das lacunas no modelo regulatório atual

Objectives: To compare the criteria for setting prices of medicines in Brazil and in selected countries, to analyze the mechanism for setting prices of medicines in Brazil and to analyze the mechanism for setting prices of medicines in selected countries. Methods: A narrative review of the literature was carried out by collecting information in databases, on websites of national agencies and international organizations and in "gray" literature, regarding health systems and price formation mechanisms of medicines in Brazil and selected countries (Australia, Canada, Spain, United States, France, Greece, Italy, New Zealand and Portugal). Results: Most of the countries surveyed use external and internal price referencing, make price adjustments and corrections over time and carry out economic evaluation studies. The value of therapy or its benefit to the patient or health care system is an important factor in both pricing and incorporation into the health care system. Conclusion: This work allowed identify the similarities between the practices recommended and implemented internationally and those carried out in Brazil, as well as the problems related to the pricing of new therapies, in addition to the gaps in the current regulatory model

Assessment of public hospital drug supply financing through the public-private partnership: pharmacists' perspectives

In Nigeria, drug financing by the public has been challenged by financial constraints through public fund due to a limited fund available to the government to meet all its demands. The objectives of this study were to determine the variability of the hospital patient prices of same drugs under the PublicPrivate Partnership (PPP) and in Private Retail Community Pharmacy (PRCP), and to investigate the perceived efficiency and effectiveness of the PPP by comparing it with the Drug Revolving Fund (DRF) model in drug supply financing. This study was conducted in Nigeria utilizing a mixed method. Mann-Whitney U test analysis was used to compare the median drug price of the two facilities. The majority (76.19%) of the drugs were sold at a cheaper rate in the hospital than what was obtained in the PRCP with no significance difference (p > 0.05). Dominant responses from the focused group discussions supported the PPP model. This study shows that the median patient price of the basket of matched pairs of same drugs in the hospital under the PPP and in the PRCP was identical. Overall, the participants were of the opinion that the PPP model was more efficient and effective than DRFin the financing drug supply

Evaluation of new medicines in Spain and comparison with other European countries / Evaluación de nuevos medicamentos en España y comparación con otros países europeos

OBJECTIVE: To compare the use of health technology assessment (HTA) as a tool to support pricing and reimbursement (P&R) of new medicines in Spain with England, Sweden, France and Germany. METHOD: For each country, the literature is used to identify the purpose and timing of the P&R decision, the HTA and decision-making procedures used to generate evidence, and the criteria used to make decisions. RESULTS: Results are presented as a summary of the HTA landscape for P&R of new medicines in each country.comparisons are made between Spain and other countries regarding the procedure and implementation of HTA. CONCLUSIONS: Based on these assessments, we made recommendations for how HTA might develop in Spain with the aim of improving governance and efficiency. Spain has made considerable progress in recent years, but still falls short of international standards in terms of independence of the HTA agencies and decision-making committees from political influence and industrial policy, the setting of prices of medicines in relation to health gain, improve the transparency of the process and results of the evaluation, and promote the participation of stakeholders. In common with other countries, Spain needs to clarify the role of cost-effectiveness criteria. Further progress needs to be made to coordinate effort across the various agencies, strengthen technical staff, and ensure equitable access to medicines between regions

OBJETIVO: Comparar el uso de la evaluación de tecnologías sanitarias (ETS) como instrumento para apoyar la fijación de precios y el reembolso de nuevos medicamentos en España con otros países europeos como Inglaterra, Suecia, Francia y Alemania. MÉTODO: Se realiza una revisión de la literatura para identificar, en cada país, el objetivo y la cronología de la decisión, los procedimientos para realizar la ETS y los criterios para tomar decisiones. RESULTADOS: Se presenta una descripción narrativa de la situación en cada país y una comparación entre España y otros países sobre los procedimientos y la implementación de ETS. CONCLUSIONES: Basándose en estas evaluaciones, se propone una serie de recomendaciones para mejorar el proceso. España ha avanzado significativamente en ETS en los últimos años, pero aún falta garantizar la independencia de las agencias de ETS, eliminar la influencia de la política económica e industrial de los comités de decisiones sanitarias, fijar precios basados en el valor terapéutico, mejorar la transparencia del proceso y de los resultados de las evaluaciones, y por último, aumentar la participación de los grupos de interés. Al igual que en otros países de su entorno, España tiene que clarificar el papel de la evaluación económica como criterio de decisión. Hace falta una mejor coordinación entre las diversas agencias que participan en ETS en España, fomentar el personal técnico y monitorizar la equidad de acceso a nuevos medicamentos entre las comunidades autónomas

Efeito das "promessas terapêuticas" sobre os preços de medicamentos em tempos de pandemia / Effect of "therapeutic promises" on drug prices in times of pandemic

Objetivo: Analisar o preço real de aquisição de medicamentos anunciados como promessas terapêuticas para tratamento da COVID-19 no Brasil. Métodos: Identificaram-se os medicamentos que estão sendo estudados e/ou noticiados como promissores e, posteriormente, analisaram-se os custos de aquisição desses medicamentos por uma drogaria do interior do estado de Minas Gerais, entre janeiro e junho de 2020. Resultados: Sete (87,5%) medicamentos apresentaram aumento do valor de compra no período estudado. Dexametasona e ivermectina apresentaram elevação de mais de 200% no preço. A menor elevação foi o polivitamínico, 5,44%. A hidroxicloroquina foi o único medicamento (12,5%) que não sofreu variação no preço e só foi adquirida nos três primeiros meses do ano de 2020. Conclusão: O preço de aquisição da maioria dos medicamentos anunciados como "promessas terapêuticas" para tratamento da Covid-19 no Brasil sofreu aumento significativo no período da pandemia.

Objective: To analyze the real purchase price of drugs announced as therapeutic promises for the treatment of Coronavirus disease in Brazil. Methods: The drugs that are being studied and/or announced as promising were identified and, subsequently, the costs of purchasing these drugs by a drugstore in the countryside of the state of Minas Gerais were analyzed between January and June 2020. Results: A total of seven (87.5%) drugs showed an increase in the purchase price in the period studied. Dexamethasone and ivermectin showed an increase of more than 200% in price. The lowest increase was the multivitamin, 5.44%. Hydroxychloroquine was the only drug (12.5%) that did not change its price and was only purchased in the first three months of 2020. Conclusion: The purchase price of the vast majority of drugs announced as "therapeutic promises" for the treatment of Covid-19 in Brazil suffered a significant increase during the pandemic period.

Availability of biological cancer drugs under research: registration and price in Brazil, Colombia, and Mexico / Disponibilidade de medicamentos biológicos contra o câncer: registro e preço no Brasil, Colômbia e México

Abstract This study seeks to understand biological cancer drug availability through registration and prices of the biological agents used for cancer therapy and authorized for sale in the last 5 years in Brazil, Colombia, and Mexico, comparing the data to those for the United States of America (USA) and Spain. The regulatory agencies' websites were assessed for drugs registered between January 1, 2014, and February 20, 2019. Drug prices were sought in the clerical databases. Prices were also compared using purchasing power parity (PPP). The comparison between the purchasing power (PP) of the three Latin American countries is hampered by market heterogeneity and uncertainty in the data. There is no registration synchronization. The average difference between the launch time in the USA and in the other countries is 1.6 to 2.6 years. The USA has the lowest PPP values, compared to the Latin American countries studied, but higher prices. Differences in registration time reveal issues in drug access in the Latin American countries studied or a lack of equity between countries. The economic effort that these countries make to have access to these supplies is much higher than that of the USA and Spain.

Resumo Este estudo busca entender a disponibilidade de medicamentos contra o câncer biológico por meio do registro e preços dos agentes biológicos utilizados na terapia do câncer e autorizados para venda nos últimos cinco anos no Brasil, Colômbia e México, comparando os dados com os dos Estados Unidos da América (EUA) e Espanha. Os sites das agências reguladoras foram consultados para medicamentos registrados entre 1º de janeiro de 2014 e 20 de fevereiro de 2019. Os preços dos medicamentos foram procurados nas bases de dados administrativas. Os preços também foram comparados usando a paridade do poder de compra (PPP). A comparação entre o poder de compra (PP) dos três países da América Latina é dificultada pela heterogeneidade de mercado e incerteza nos dados. Não há sincronização de registro. A diferença média entre o tempo de lançamento nos EUA e nos outros países é de 1,6 a 2,6 anos. Os EUA têm os menores valores de PPP, em comparação com os países latino-americanos estudados, mas preços mais altos. As diferenças no tempo de registro revelam problemas no acesso a medicamentos nos países latino- americanos estudados ou falta de equidade entre os países. O esforço econômico que esses países fazem para ter acesso a esses suprimentos é muito maior do que o dos EUA e da Espanha.

O Regimento dos preços dos medicamentos... na farmácia brasileira oitocentista / Regulation of drug prices in nineteenth-century Bazilian pharmacy

Em 5 de novembro de 1808, dom João de Bragança promulgou um alvará sobre o exercício dos boticários e o preço das drogas e ordenou a criação de um regulamento para taxar o custo dos medicamentos comercializados no Brasil. Publicado pela primeira vez em 1809, o Regimento dos preços dos medicamentos... ganhou novas edições nos anos subsequentes e tornouse um indispensável instrumento de trabalho para os envolvidos com a feitura e o comércio dos remédios. Este texto situa historicamente e destaca esse documento brevemente explorado pelos pesquisadores da história da farmácia brasileira, visto ter sido uma das primeiras iniciativas do governo luso-brasileiro condizentes com a atividade farmacêutica no Brasil no século XIX

La guía farmacoeconómica una herramienta útil en salud pública / The pharmacoeconomic guide a useful tool in public health

Resumen Introducción: Los medicamentos son insumos que generan gastos en salud y las guías de evaluación económica son muy útiles, porque permiten valorar la relación costo y efecto que producen los medicamentos en las personas; pero también, en los sistemas de salud y la sociedad. Objetivo: Realizar una revisión descriptiva del tema de las guías farmacoeconómicas. Método: Se seleccionaron documentos de interés, en texto completo, desde las bases de datos y sitios en Internet, entre 1998-2018 mediante las palabras clave. Se realizó una lectura crítica de cada documento y se desarrolló una síntesis en cada sección en que se organizó este documento. Resultados: Los medicamentos son tecnologías en salud que requieren de evaluaciones económicas y la aplicación de las guías farmacoeconómicas, generan resultados de utilidad para el proceso de toma de decisión en el sector salud. Las guías, se desarrollaron hace más de treinta años; en algunos países son de carácter obligatorio, en otros no son de uso obligatorio o solo de recomendación, cuentan con ventajas y desventajas, objetivos, alcances, diferentes denominaciones o nombres, justificaciones, audiencias específicas y procesos particulares para su elaboración que dependen de un conjunto de factores; existen agencias evaluadoras en algunos países en el ámbito internacional. El contenido de una guía es general y cumple con los criterios estándares establecidos; su existencia es un aporte a la mejora de la calidad en diferentes áreas. Conclusión: Los hallazgos evidencian que una guía farmacoeconómica es un recurso útil para la evaluación económica de medicamentos, que genera resultados conducentes a acciones de interés en salud pública.

Abstract Introduction: Medications are inputs that generate health expenditures and economic evaluation guides are very useful because they allow us to assess the cost and effect of medicines on people, besides health systems and society. Objective: To conduct a descriptive review relative to the topic of pharmacoeconomic guidelines. Method: Full text material was selected from the databases and Internet sites, between 1998-2018, for which keywords were used. After a critical reading of every document, summaries were made for each section in which this document was organized. Results: Medications are health technologies that must have economic evaluations, and pharmacoeconomic guidelines generate useful results for the decision-making process that affects the health sector. Guidelines were made more than thirty years ago; in some countries they are mandatory and in others not mandatory or only a recommendation, they have advantages and disadvantages, objectives, scope, denominates names, justifications, specific audiences and a particular process for its development that depends on a set of factors; there are evaluation agencies in some countries in the international arena. The content of a guide is general and meets the criteria of established standards, its existence contributes to the improvement of quality in different areas. Conclusion: The results evidence that application of a pharmacoeconomic guide is useful to medicines economic evaluation, which generates results that lead to actions that are of interest in public health.

Precios, disponibilidad y asequibilidad de insulina en farmacias públicas y privadas en Perú

[RESUMEN]. Objetivo. Medir el precio, disponibilidad y asequibilidad de insulina y metformina, como comparador, en farmacias públicas y privadas en seis regiones del Perú. Métodos. Estudio transversal con uso de la metodología adaptada de la Organización Mundial de la Salud/Acción Internacional para la Salud (OMS/AIS). Se encuestaron farmacias públicas y privadas de seis regiones del Perú. Se recolectaron datos de disponibilidad y precio de insulina (todos los tipos) y metformina en presentación de 850 mg. La disponibilidad se expresa en porcentajes y los precios se reportan en medianas. La asequibilidad se define como el número de días que debe laborar una persona con el salario mínimo para cubrir el costo de un mes de tratamiento. Resultados. La disponibilidad en farmacias públicas es de 63,2% para insulina regular y 68,4% para isófana-NPH, pero se observaron diferencias de disponibilidad entre los niveles de atención y entre las regiones. En farmacias privadas, la variedad de insulina es mayor, pero la disponibilidad es menor del 11%. La mediana de precios para la insulina humana en farmacias privadas fue entre tres a cuatro veces mayor que en farmacias públicas. En comparación, la disponibilidad de metformina alcanza 89,5% en farmacias públicas y 77,7% en privadas. La asequibilidad en farmacias públicas para un mes de tratamiento con insulina humana o metformina genérica es menor a lo percibido por un día laborable. Conclusiones. El precio de insulinas humanas y de metformina genérica en farmacias públicas es asequible. Sin embargo, se necesitan esfuerzos para mejorar su disponibilidad en las regiones y los niveles de atención.

[ABSTRACT]. Objective. Measure and compare the price, availability, and affordability of insulin and metformin in public and private pharmacies in six regions of Peru. Methods. Cross-sectional study using the World Health Organization/Health Action International (WHO/HAI) revised methodology. Public and private pharmacies in six regions of Peru were surveyed. Data were collected on availability and prices for insulin (all types) and 850 mg metformin. Availability is expressed as percentages and prices are reported in medians. Affordability is defined as the number of days that a person must work at minimum wage to cover the cost of one month of treatment. Results. Availability in public pharmacies is 63.2% for regular insulin and 68.4% for NPH (isophane) insulin, but differences in availability were observed between levels of care and between regions. Private pharmacies have a greater variety of insulin, but availability is less than 11%. The median price of human insulin was three to four times higher in private pharmacies than in public pharmacies. In comparison, availability of metformin was 89.5% in public pharmacies and 77.7% in private ones. Affordability in public pharmacies for one month of treatment with human insulin or generic metformin is less than one day’s wages. Conclusions. The price for human insulin and generic metformin in public pharmacies is affordable. However, efforts are needed to improve their availability in the different regions and levels of care.

[RESUMO]. Preço, disponibilidade e acessibilidade à insulina em farmácias públicas e privadas no Peru RESUMO Objetivo. Avaliar o preço, a disponibilidade e a acessibilidade à insulina e metformina, como comparativo, em farmácias públicas e privadas em seis regiões do Peru. Métodos. Estudo transversal conduzido com metodologia adaptada da Organização Mundial da Saúde/Ação Internacional para a Saúde (OMS/AIS). Farmácias públicas e privadas foram pesquisadas em seis regiões do Peru com a coleta de dados sobre a disponibilidade e os preços da insulina (de todos os tipos) e metformina na apresentação de 850 mg. A disponibilidade é expressa em porcentagem e os preços estão descritos como mediana. A acessibilidade foi definida no estudo como o número de dias que um indivíduo que ganha salário mínimo precisa trabalhar para arcar com o custo de um mês de tratamento. Resultados. A disponibilidade em farmácias públicas da insulina regular foi de 63,2% e da insulina isófana (NPH) foi de 68,4%, porém se observou diferença de disponibilidade entre os níveis de atenção e as regiões. Nas farmácias privadas, a variedade de insulinas é maior, mas a disponibilidade é inferior a 11%. A mediana de preços para a insulina humana nas farmácias privadas é 3 a 4 vezes maior que nas farmácias públicas. Comparativamente, a disponibilidade da metformina foi de 89,5% nas farmácias públicas e 77,7% nas farmácias privadas. A acessibilidade nas farmácias públicas para um mês de tratamento com insulina humana ou metformina genérica é inferior à remuneração de um dia de trabalho. Conclusões. As insulinas humanas e a metformina genérica têm preço acessível nas farmácias públicas. Porém, esforços devem ser empreendidos para aumentar a disponibilidade destes medicamentos nos níveis de atenção e nas regiões.

Medication dispensing, additional therapeutic recommendations, and pricing practices for acute diarrhoea by community pharmacies in Germany: a simulated patient study

Background: In Germany over-the-counter medications (OTC) - which since 2004 are no longer subject to binding prices - can only be purchased in pharmacies. Pharmacy owners and their staff therefore have a special responsibility when dispensing, advising on and setting the prices of medications. Objective: The aim of this study was to assess medication dispensing, additional therapeutic recommendations and pricing practices for acute diarrhoea in adults and to evaluate the role of the patient's approach (symptom-based versus medication-based request) in determining the outcome of these aspects. Methods: A cross-sectional study was conducted from 1 May to 31 July 2017 in all 21 community pharmacies in a medium-sized German city. Symptom-based and medication-based scenarios related to self-medication of acute diarrhoea were developed and used by five simulated patients (SPs) in all of the pharmacies (a total of 84 visits). Differentiating between the different test scenarios in terms of the commercial and active ingredient names and also the prices of the medications dispensed, the SPs recorded on collection forms whether the scenario involved generic products or original preparations as well as whether recommendations were made during the test purchases regarding an additional intake of fluids. Results: In each of the 84 test purchases one preparation was dispensed. However, a preparation for oral rehydration was not sold in a single test purchase. On the other hand, in 74/84 (88%) of test purchases, medications with the active ingredient loperamide were dispensed. In only 35/84 (42%) of test purchases, the patient was also recommended to ensure an 'adequate intake of fluids' in addition to being dispensed a medication. In symptom-based scenarios significantly more expensive medications were dispensed compared to the medication-based scenarios (Wilcoxon signed rank test: z = -4.784, p < 0.001, r = 0.738). Also within the different scenarios there were enormous price differences identified - for example, in the medication-based scenarios, even for comparable loperamide generics the cheapest preparation cost EUR 1.99 and the most expensive preparation cost EUR 4.53. Conclusions: Oral rehydration was not dispensed and only occasionally was an adequate intake of fluids recommended. There were also enormous price differences both between and within the scenarios investigated

No disponible

Evaluación de la Calidad vs precio de comprimidos de Metformina de 850mg de producción nacional e importados, comercializados en Paraguay utilizados para el control de diabetes / Quality vs. price evaluation of national and imported 850 mg metformin tablets marketed for the control of diabetes in Paraguay

La metformina es un fármaco de primera elección, solo o combinado, en el tratamiento inicial de pacientes con diabetes tipo 2, cuya prevalencia a nivel nacional es de 8,0% en hombres y 8,3% en mujeres, con un gasto anual de 283 USD/persona. El estudio fue realizado con el objetivo de evaluar la calidad fisicoquímica y precio de comprimidos de 850 mg de metformina comercializados en nuestro país. Se analizaron medicamentos de producción nacional e importada, conteniendo 850 mg de metformina HCl, tomando como referencia la Farmacopea de los Estados Unidos (USP 38). Para evaluar la calidad de los productos se realizaron ensayos físicos químicos, además de los perfiles de disolución según el medio propuesto por la USP 38. Los resultados obtenidos se encontraron dentro de las especificaciones de valoración, entre 96% y 101% de metformina y los perfiles de disolución entre 70% y 90% de la cantidad declarada en 20 minutos, con una eficiencia de disolución (EF) entre 58% y 93%, mostrando que no existe diferencia estadísticamente significativa (p=0,41). La variación de precios encontrados fue entre 3,6 USD y 8,4 USD. Los productos analizados pueden ser intercambiables en cuanto a la calidad y los perfiles de disolución in vitro, siendo una herramienta para demostrar intercambiabilidad de productos farmacéuticos, buscando el precio más accesible en el mercado nacional y facilitando el tratamiento adecuado sobre todo para la población de escasos recursos manteniendo la calidad y eficacia del mismo(AU)

Evaluation of the effects of a generic substitution policy implemented in Chile

Chile implemented a generic substitution policy in 2014 to improve access to medicines. This study aims to measure if the generic substitution policy had an effect on the sales volume and prices of referent and the branded generic products with demonstrated bioequivalence (BEQ) in the private pharmaceutical market. The volume and total private sales of medicines sold at private sector retail outlets between November 2011 and October 2016 were considered in the analysis. We calculated the total number of daily defined doses (DDD) by adding up the number of DDDs of different presentations with the active pharmaceutical ingredient (API). We determined the ratio of the median prices of all BEQ per DDD presentations compared with the median price of the corresponding referent presentations per DDD in 2011 and 2016. Sixteen APIs representing 231 different conventional-release presentations were included in the analysis. Overall, the volume of sales of the referent products decreased over time after the intervention. However, this reduction was not mirrored by an increase in the corresponding branded generic BEQ volumes overall. In all cases, the median price per DDD of the referent was higher than its BEQ counterpart in 2011 and 2016. Since referent products are more costly than branded BEQ generic products, reducing their consumption-and increasing the BEQ availability-should improve access to medicines in Chile. However, this must be accompanied by promotion of BEQ products to ensure savings for consumers in the long term. Future research should focus on identifying facilitating and inhibiting factors of generic substitution.