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.

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.

Resumo Este artigo visa analisar as mudanças no mercado de varejo farmacêutico, seguindo as alterações de diretiva no Programa Farmácia Popular (FP), que realiza subvenção de medicamentos no Brasil, em parceria pública privada. Foi realizada análise longitudinal retrospectiva dos medicamentos da classe terapêutica dos agentes que atuam sobre o sistema renina-angiotensina. Os dados obtidos do QuintilesIMS incluíram o varejo farmacêutico em termos do volume e valores de vendas de 2002 a 2013. Análises realizadas consideraram intervenções e reformas ocorridas no FP e seu impacto no mercado farmacêutico da classe terapêutica selecionada, devido a sua relevância para o tratamento da hipertensão. Também se examinou o comportamento do mercado tomando por base as empresas farmacêuticas produtoras. Losartan monodroga representou a maior fatia de mercado entre os antagonistas de angiotensina II. Empresas nacionais obtiveram maior volume de vendas durante o período de estudo, enquanto as empresas multinacionais exibiram maior valor de vendas. Mudanças no mercado farmacêutico coincidiram com a inclusão de produtos específicos na lista de medicamentos abrangidos pelo FP e com aumentos ou isenção de copagamento pelos pacientes.

Abstract This paper aims to analyse changes in the retail pharmaceutical market following policy changes in the Farmácia Popular Program (FP), a medicines subsidy program in Brazil. The retrospective longitudinal analyses focus on therapeutic class of agents acting on the renin-angiotensin system. Data obtained from QuintilesIMS (formerly IMS Health) included private retail pharmacy sales volume (pharmaceutical units) and sales values from 2002 to 2013. Analyses evaluated changes in market share following key FP policy changes. The therapeutic class was selected due to its relevance to hypertension treatment. Market share was analysed by therapeutic sub-classes and by individual company. Losartan as a single product accounted for the highest market share among angiotensin II antagonists. National companies had higher sales volume during the study period, while multinational companies had higher sales value. Changes in pharmaceutical market share coincided with the inclusion of specific products in the list of medicines covered by FP and with increases in or exemption from patient copayment.

Resumo Este artigo visa analisar as mudanças no mercado de varejo farmacêutico, seguindo as alterações de diretiva no Programa Farmácia Popular (FP), que realiza subvenção de medicamentos no Brasil, em parceria pública privada. Foi realizada análise longitudinal retrospectiva dos medicamentos da classe terapêutica dos agentes que atuam sobre o sistema renina-angiotensina. Os dados obtidos do QuintilesIMS incluíram o varejo farmacêutico em termos do volume e valores de vendas de 2002 a 2013. Análises realizadas consideraram intervenções e reformas ocorridas no FP e seu impacto no mercado farmacêutico da classe terapêutica selecionada, devido a sua relevância para o tratamento da hipertensão. Também se examinou o comportamento do mercado tomando por base as empresas farmacêuticas produtoras. Losartan monodroga representou a maior fatia de mercado entre os antagonistas de angiotensina II. Empresas nacionais obtiveram maior volume de vendas durante o período de estudo, enquanto as empresas multinacionais exibiram maior valor de vendas. Mudanças no mercado farmacêutico coincidiram com a inclusão de produtos específicos na lista de medicamentos abrangidos pelo FP e com aumentos ou isenção de copagamento pelos pacientes.

Abstract This paper aims to analyse changes in the retail pharmaceutical market following policy changes in the Farmácia Popular Program (FP), a medicines subsidy program in Brazil. The retrospective longitudinal analyses focus on therapeutic class of agents acting on the renin-angiotensin system. Data obtained from QuintilesIMS (formerly IMS Health) included private retail pharmacy sales volume (pharmaceutical units) and sales values from 2002 to 2013. Analyses evaluated changes in market share following key FP policy changes. The therapeutic class was selected due to its relevance to hypertension treatment. Market share was analysed by therapeutic sub-classes and by individual company. Losartan as a single product accounted for the highest market share among angiotensin II antagonists. National companies had higher sales volume during the study period, while multinational companies had higher sales value. Changes in pharmaceutical market share coincided with the inclusion of specific products in the list of medicines covered by FP and with increases in or exemption from patient copayment.

摘要 目的 识别八个欧洲国家在经济衰退中的医药政策变化，并判别政策措施是否导致药品销售量和支出的减少。 方法 从出版物和药品政策数据库获取八个欧洲国家2008年和2011年之间医药政策变化信息。从医药市场研究数据库中获得每个国家2006年到2011年之间10个销量最高治...

Résumé Objectif Identifier les changements de politique pharmaceutique au cours de la récession économique dans huit pays européens et déterminer si les mesures politiques ont entraîné une baisse des ventes et des dépenses en matière de produits pharmaceutiques. Méthodes Les informations relatives aux changements de la politique pharmaceutique entre 2008 et 2011 dans huit pays européens ont été obtenues à partir des publications et des bases de données sur la politique pharmaceutique. Les données sur le volume et la valeur des ventes trimestrielles des produits entre 2006 et 2011 pour les 10 classes thérapeutiques les plus vendues dans chaque pays ont été obtenues à partir d'une base de données d'études de marché sur les médicaments. Nous avons comparé...

Резюме Цель Идентифицировать изменения фармацевтической политики в период экономического спада в восьми европейских странах и определить, привели ли поли...

Objective To identify pharmaceutical policy changes during the economic recession in eight European countries and to determine whether policy measures resulted in lower sales of, and less expenditure on, pharmaceuticals. Methods Information on pharmaceutical policy changes between 2008 and 2011 in eight European countries was obtained from publications and pharmaceutical policy databases. Data on the volume and value of the quarterly sales of products between 2006 and 2011 in the 10 highest-selling therapeutic classes in each country were obtained from a pharmaceutical market research database. We compared these indicators in economically stable countries; Austria, Estonia and Finland, to those in economically less stable countries, Greece, Ireland, Portugal, Slovakia and Spain. Findings Economically stable countries implemented two to seven policy changes each, whereas less stable countries implemented 10 to 22 each. Of the 88 policy changes identified, 33 occurred in 2010 and 40 in 2011. They involved changing out-of-pocket payments for patients in 16 cases, price mark-up schemes in 13 and price cuts in 11. Sales volumes increased moderately in all countries except Greece and Portugal, which experienced slight declines after 2009. Sales values decreased in both groups of countries, but fell more in less stable countries. Conclusion Less economically stable countries implemented more pharmaceutical policy changes during the recession than economically stable countries. Unexpectedly, pharmaceutical sales volumes increased in almost all countries, whereas sales values declined, especially in less stable countries.

ملخص الغرض تحديد التغيرات في سياسة المستحضرات الصيدلانية أثناء الكساد الاقتصادي في ثمانية بلدان أوروبية، وتحديد ما إذا كانت تدابير السياسة قد أدت إلى انخفاض م...

Resumen Objetivo Identificar los cambios en las políticas farmacéuticas en ocho países europeos durante la recesión económica y determinar si las medidas de política dieron lugar a una reducción en las ventas y a un gasto menor en productos farmacéuticos. Métodos La información sobre los cambios en las políticas farmacéuticas entre 2008 y 2011 en ocho países europeos se obtuvo a partir de publicaciones y bases de datos sobre políticas farmacéuticas. Los datos sobre el volumen y valor de las ventas trimestrales de productos entre 2006 y 2011 en las 10 clases terapéuticas más vendidas en cada país se obtuvieron de una base de datos de investigación del mercado farmacéutico. Comparamos estos indicadores en los países económicamente estables (Austria, Estonia y Finlandia) con los de los países menos estables (Grecia, Irlanda, Portugal, Eslovaquia y España). Resultados Cada uno de los países económicamente estables implementó entre dos y siete cambios de políticas, mientras que los países menos estables implementaron entre 10 y 22 cada uno. De los 88 cambios de políticas identificados, 33 tuvieron lugar en el año 2010 y 40, en el año 2011. Implicaron cambios en los pagos directos por atención sanitaria para pacientes en 16 casos, programas de aumento de precios en 13 casos y recortes de precios en 11. Los volúmenes de ventas aumentaron moderadamente en todos los países excepto en Grecia y Portugal, que experimentaron descensos ligeros a partir de 2009. El valor de las ventas disminuyó en ambos grupos de países, si bien fue mayor en los países menos estables. Conclusión Los países económicamente menos estables implementaron más cambios en las políticas farmacéuticas durante la recesión que los países económicamente estables. Sorprendentemente, los volúmenes de ventas de productos farmacéuticos aumentaron en casi todos los países, mientras que el valor de las ventas disminuyó, especialmente en los países menos estables.

OBJETIVO : Analisar os principais preditores de acesso a medicamentos em condições agudas de saúde. MÉTODOS : Estudo transversal analítico, baseado em inquérito domiciliar realizado em Nicarágua, Honduras e Guatemala. Foram identificados os preditores de: procurar cuidados para a condição aguda no sistema formal de saúde e obter todos os medicamentos procurados para a condição aguda. Os dados foram analisados com SPSS ® v.17, usando estatísticas descritivas e regressão logística multivariada. RESULTADOS : Houve autorrelato de doença aguda em 48,3% dos 2.761 domicílios pesquisados, sendo 59,0% em Nicarágua, 56,2% em Honduras e 30,9% na Guatemala. Indivíduos com doença aguda e pior percepção da gravidade da doença ou menores de 15 anos com seguro saúde tiveram maior chance de procurar cuidado. O acesso a medicamentos está fortemente correlacionado com a busca de cuidado, e a obtenção de todos os medicamentos necessários foi três vezes maior para aqueles que buscaram o sistema formal de saúde (OR 3,0; IC95% 2,3;4,0). Procurar o setor privado, ter alto nível educacional e percepção positiva sobre a qualidade do cuidado e dos medicamentos aumentam a chance de acesso pleno a medicamentos dentro do sistema de saúde. Para os pacientes que não procuraram o setor formal, o acesso pleno aos medicamentos foi mais provável em Honduras ou Nicarágua. Outros importantes preditores incluem localização urbana, maior status econômico e ser do sexo masculino. CONCLUSÕES : Parte da população nos três países obteve medicamentos fora do sistema formal de saúde, o que pode representar risco aos pacientes. Determinantes do acesso pleno a medicamentos, dentro e fora do sistema formal de saúde, foram distintos e assim poderão exigir diferentes estratégias para melhorar o acesso a medicamentos.

OBJECTIVE : To analyze the main predictors of access to medicines for persons who experienced acute health conditions. METHODS : This was a cross-sectional analytic study, based on data from household surveys. We examined the predictors of: (1) seeking care for acute illness in the formal health care system and (2) obtaining all medicines sought for the acute condition. RESULTS : The significant predictors of seeking health care for acute illnesses were urban geographic location, head of household with secondary school education or above, age under 15, severity of illness perceived by the respondent, and having health insurance. The most important predictor of obtaining full access to medicines was seeking care in the formal health care system. People who sought care in the formal system were three times more likely to receive all the medicines sought (OR 3.0, 95%CI 2.3;4.0). For those who sought care in the formal health system, the strongest predictors of full access to medicines were seeking care in the private sector, having secondary school education or above, and positive perceptions of quality of health care and medicines in public sector health facilities. For patients who did not seek care in the formal health system, full access to medicines was more likely in Honduras or Nicaragua than in Guatemala. Urban geographic location, higher economic status, and male gender were also significant predictors. CONCLUSIONS : A substantial part of the population in these three countries sought and obtained medicines outside of the formal health care system, which may compromise quality of care and pose a risk to patients. Determinants of full access to medicines inside and outside the formal health care system differ, and thus may require different strategies to improve access to medicines. 

OBJETIVO : Analizar los principales predictores de acceso a medicamentos en condiciones agudas de salud. MÉTODOS : Estudio transversal analítico, basado en pesquisa domiciliar realizada en Nicaragua, Honduras y Guatemala. Se identificaron los predictores de: buscar cuidados para la condición aguda en el sistema formal de salud y obtener todos los medicamentos buscados para la condición aguda. Los datos fueron analizados con SPSS ® v.17 usando estadísticas descriptivas y regresión logística multivariada. RESULTADOS : Hubo auto relato de enfermedad aguda en 48,3% de los 2.761 domicilios investigados, siendo 59,0% en Nicaragua, 56,2% en Honduras y 30,9% en Guatemala. Individuos con enfermedad aguda y peor percepción de la gravedad de la enfermedad o menores de 15 años con seguro salud tuvieron mayor chance de buscar cuidado. El acceso a medicamentos está fuertemente correlacionado con la búsqueda de cuidado, y la obtención de todos los medicamentos necesarios fue tres veces mayor en aquellos que buscaron el sistema formal de salud (OR 3,0; IC95% 2,3;4,0). Procurar el sector privado, tener alto nivel educativo y percepción positiva sobre la cualidad de cuidado y de los medicamentos aumentan el chance de acceso pleno a medicamentos dentro del sistema de salud. Para los pacientes que no buscaron el sector formal, el acceso pleno a los medicamentos fue más probable en Honduras o Nicaragua. Otros importantes predictores incluyen localización urbana, mayor estatus económico, y ser del sexo masculino. CONCLUSIONES : parte de la población en los tres países obtuvo medicamentos fuera del sistema formal de salud, lo que puede representar riesgo para los pacientes. Determinantes del acceso pleno a los medicamentos, dentro y fuera del sistema formal de salud, fueron distintos y así podrán exigir diferentes estrategias para mejorar el acceso a medicamentos.

OBJETIVO : Analisar os principais preditores de acesso a medicamentos em condições agudas de saúde. MÉTODOS : Estudo transversal analítico, baseado em inquérito domiciliar realizado em Nicarágua, Honduras e Guatemala. Foram identificados os preditores de: procurar cuidados para a condição aguda no sistema formal de saúde e obter todos os medicamentos procurados para a condição aguda. Os dados foram analisados com SPSS ® v.17, usando estatísticas descritivas e regressão logística multivariada. RESULTADOS : Houve autorrelato de doença aguda em 48,3% dos 2.761 domicílios pesquisados, sendo 59,0% em Nicarágua, 56,2% em Honduras e 30,9% na Guatemala. Indivíduos com doença aguda e pior percepção da gravidade da doença ou menores de 15 anos com seguro saúde tiveram maior chance de procurar cuidado. O acesso a medicamentos está fortemente correlacionado com a busca de cuidado, e a obtenção de todos os medicamentos necessários foi três vezes maior para aqueles que buscaram o sistema formal de saúde (OR 3,0; IC95% 2,3;4,0). Procurar o setor privado, ter alto nível educacional e percepção positiva sobre a qualidade do cuidado e dos medicamentos aumentam a chance de acesso pleno a medicamentos dentro do sistema de saúde. Para os pacientes que não procuraram o setor formal, o acesso pleno aos medicamentos foi mais provável em Honduras ou Nicarágua. Outros importantes preditores incluem localização urbana, maior status econômico e ser do sexo masculino. CONCLUSÕES : Parte da população nos três países obteve medicamentos fora do sistema formal de saúde, o que pode representar risco aos pacientes. Determinantes do acesso pleno a medicamentos, dentro e fora do sistema formal de saúde, foram distintos e assim poderão exigir diferentes estratégias para melhorar o acesso a medicamentos.

OBJECTIVE : To analyze the main predictors of access to medicines for persons who experienced acute health conditions. METHODS : This was a cross-sectional analytic study, based on data from household surveys. We examined the predictors of: (1) seeking care for acute illness in the formal health care system and (2) obtaining all medicines sought for the acute condition. RESULTS : The significant predictors of seeking health care for acute illnesses were urban geographic location, head of household with secondary school education or above, age under 15, severity of illness perceived by the respondent, and having health insurance. The most important predictor of obtaining full access to medicines was seeking care in the formal health care system. People who sought care in the formal system were three times more likely to receive all the medicines sought (OR 3.0, 95%CI 2.3;4.0). For those who sought care in the formal health system, the strongest predictors of full access to medicines were seeking care in the private sector, having secondary school education or above, and positive perceptions of quality of health care and medicines in public sector health facilities. For patients who did not seek care in the formal health system, full access to medicines was more likely in Honduras or Nicaragua than in Guatemala. Urban geographic location, higher economic status, and male gender were also significant predictors. CONCLUSIONS : A substantial part of the population in these three countries sought and obtained medicines outside of the formal health care system, which may compromise quality of care and pose a risk to patients. Determinants of full access to medicines inside and outside the formal health care system differ, and thus may require different strategies to improve access to medicines. 

OBJETIVO : Analizar los principales predictores de acceso a medicamentos en condiciones agudas de salud. MÉTODOS : Estudio transversal analítico, basado en pesquisa domiciliar realizada en Nicaragua, Honduras y Guatemala. Se identificaron los predictores de: buscar cuidados para la condición aguda en el sistema formal de salud y obtener todos los medicamentos buscados para la condición aguda. Los datos fueron analizados con SPSS ® v.17 usando estadísticas descriptivas y regresión logística multivariada. RESULTADOS : Hubo auto relato de enfermedad aguda en 48,3% de los 2.761 domicilios investigados, siendo 59,0% en Nicaragua, 56,2% en Honduras y 30,9% en Guatemala. Individuos con enfermedad aguda y peor percepción de la gravedad de la enfermedad o menores de 15 años con seguro salud tuvieron mayor chance de buscar cuidado. El acceso a medicamentos está fuertemente correlacionado con la búsqueda de cuidado, y la obtención de todos los medicamentos necesarios fue tres veces mayor en aquellos que buscaron el sistema formal de salud (OR 3,0; IC95% 2,3;4,0). Procurar el sector privado, tener alto nivel educativo y percepción positiva sobre la cualidad de cuidado y de los medicamentos aumentan el chance de acceso pleno a medicamentos dentro del sistema de salud. Para los pacientes que no buscaron el sector formal, el acceso pleno a los medicamentos fue más probable en Honduras o Nicaragua. Otros importantes predictores incluyen localización urbana, mayor estatus económico, y ser del sexo masculino. CONCLUSIONES : parte de la población en los tres países obtuvo medicamentos fuera del sistema formal de salud, lo que puede representar riesgo para los pacientes. Determinantes del acceso pleno a los medicamentos, dentro y fuera del sistema formal de salud, fueron distintos y así podrán exigir diferentes estrategias para mejorar el acceso a medicamentos.

OBJECTIVES: To assess the possibility of bias due to the limited target list and geographic sampling of the World Health Organization (WHO)/Health Action International (HAI) Medicine Prices and Availability survey used in more than 70 rapid sample surveys since 2001. METHODS: A survey was conducted in Peru in 2005 using an expanded sample of medicine outlets, including remote areas. Comprehensive data were gathered on medicines in three therapeutic classes to assess the adequacy of WHO/HAI's target medicines list and the focus on only two product versions. WHO/HAI median retail prices were compared with average wholesale prices from global pharmaceutical sales data supplier IMS Health. RESULTS: No significant differences were found in overall availability or prices of target list medicines by retail location. The comprehensive survey of angiotensin-converting enzyme inhibitor, anti-diabetic, and anti-ulcer products revealed that some treatments not on the target list were costlier for patients and more likely to be unavailable, particularly in remote areas. WHO/HAI retail prices and IMS wholesale prices were strongly correlated for higher priced products, and weakly correlated for lower priced products (which had higher estimated retailer markups). CONCLUSIONS: The WHO/HAI survey approach strikes an appropriate balance between modest research costs and optimal information for policy. Focusing on commonly used medicines yields sufficient and valid results. Surveyors elsewhere should consider the limits of the survey data as well as any local circumstances, such as scarcity, that may call for extra field efforts.

OBJETIVOS: Evaluar la posibilidad de sesgo debido a la limitación de la lista de referencia y del muestreo geográfico de la encuesta de precios y disponibilidad de medicamentos de la Organización Mundial de la Salud/Health Action International (OMS/HAI) usada en más de 70 muestras de encuestas rápidas desde el 2001. MÉTODOS: En el año 2005, se realizó una encuesta en Perú, con una muestra ampliada de puntos de venta de medicamento, incluso en zonas remotas. Se recogieron datos integrales acerca de los medicamentos de tres clases terapéuticas, con el fin de evaluar la idoneidad de la lista de referencia de medicamentos de la OMS/HAI y el énfasis únicamente en dos versiones del producto. Las medianas de los precios al por menor de la OMS/HAI se compararon con el promedio de precios al por mayor del proveedor de datos mundiales de ventas farmacéuticas IMS Health. RESULTADOS: No se observó ninguna diferencia significativa en la disponibilidad general ni en los precios de los medicamentos de la lista de referencia por localización de venta al por menor. La encuesta integral de los inhibidores de la enzima convertidora de la angiotensina, los antidiabéticos y los productos antiulcerosos reveló que algunos tratamientos que no están en la lista destinataria eran más caros para los pacientes y era más probable que no estuvieran a la venta, sobre todo en las regiones remotas. Los precios al por menor de la OMS/HAI y los precios al por mayor de IMS presentaron una correlación intensa en el caso de los productos de precio más alto, y la correlación fue débil en el caso de los productos de precio más bajo (que tuvieron márgenes de beneficio calculados más altos para el minorista). CONCLUSIONES: El método de la encuesta de la OMS/HAI logra un equilibrio adecuado entre los costos de investigación moderados y la información óptima para la política. El énfasis en los medicamentos de uso frecuente produce unos resultados válidos y suficientes. Los encuestadores de otros lugares deberían tener en cuenta los límites de los datos de la encuesta, así como las circunstancias locales, como la escasez, que puede requerir mayores esfuerzos en el campo.