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OBJECTIVES: To describe changes in the private market for selected originators, branded generics ('similares'), and generic products during the 10 years following passage of the Brazilian Generics Law. METHODS: We analyzed longitudinal data collected by IQVIA® on quarterly sales by wholesalers to retail pharmacies in Brazil from 1998 through 2010, grouped by originators, branded generics, and generic products in three therapeutic classes (antibiotics, antidiabetics, and antihypertensives). Outcomes included market share (proportion of the total private market volume), sales volume per capita, prices and number of manufacturers by group. RESULTS: In the private market share, generics became dominant in each therapeutic class but the speed of uptake varied. Originators consistently lost most market share while branded generics varied over time. By the end of the study period, generics were the most sold product type in all classes, followed by branded generics. The number of generic manufacturers increased in all classes, while branded generics increased just after the policy but then decreased slowly through the end of 2010. For approximately 50% of the antibiotics analyzed, branded generics and generics had lower prices than originators. For antidiabetics, branded generic and generic prices were quite similar during the period analyzed. Price trends for the various subclasses of antihypertensive exhibited very different patterns over time. CONCLUSION: Sales of branded generics and originators decreased substantially in the three therapeutic classes analysed following the introduction of the generics policy in Brazil, but the time to market dominance of generics varied by class.
RESUMEN
OBJECTIVES: New antidiabetic medications such as insulin analogues and thiazolidinediones have been introduced over the last decade. This study compares the uptake of new agents in three emerging pharmaceutical markets: Brazil, China, and Thailand. METHODS: Using longitudinal IMS Health sales data, we calculated the quarterly percentage market share for types of insulins and oral hypoglycemic agents from 2002 through 2012 in each country. New oral hypoglycemic agents included: alpha-glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, and non-sulfonylurea secretagogues. RESULTS: While China had the highest use of insulin cartridges and pens (85.6% in 2010), Brazil was the earliest adopter of insulin analogues and had the greatest use of these products overall (44.6% of the insulin market) in 2010, which then decreased by almost half by 2012. Together, sulfonylureas and metformin dominated the markets in Brazil and Thailand (~89% and ~96% respectively) over the 10-year period. Between 2002 and 2012, there was a shift in use from sulfonylureas to metformin; the market share of newer agents remained 10% or less in both countries. In China, however, market share of new oral agents grew rapidly from 13.1% to 44.4%. While metformin use was relatively stable in China (one-third of the market), sulfonylureas declined substantially over the 10-year period (41.5% to 20.8%). CONCLUSION: Given large cost differentials between newer and older insulins and among oral hypoglycemic agents, it is important to evaluate uptake of newer products over time. Uptake patterns differed in the study countries, likely due to different medicines policy approaches. Future research should evaluate how trends in use of antidiabetic products align with national clinical practice guidelines and pharmaceutical policies, as well as the impacts of different patterns of use on cost and clinical outcomes.
RESUMEN
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.
Asunto(s)
Recolección de Datos/métodos , Honorarios Farmacéuticos/estadística & datos numéricos , Preparaciones Farmacéuticas/economía , Inhibidores de la Enzima Convertidora de Angiotensina/economía , Inhibidores de la Enzima Convertidora de Angiotensina/provisión & distribución , Antiinfecciosos/economía , Antiinfecciosos/provisión & distribución , Antiulcerosos/economía , Antiulcerosos/provisión & distribución , Anticonvulsivantes/economía , Anticonvulsivantes/provisión & distribución , Medicamentos Genéricos/economía , Medicamentos Genéricos/provisión & distribución , Hipoglucemiantes/economía , Hipoglucemiantes/provisión & distribución , Perú , Preparaciones Farmacéuticas/provisión & distribución , Farmacias/clasificación , Farmacias/economía , Farmacias/estadística & datos numéricos , Sector Público/economía , Muestreo , Organización Mundial de la SaludAsunto(s)
Recolección de Datos/métodos , Honorarios Farmacéuticos/estadística & datos numéricos , Preparaciones Farmacéuticas/economía , Inhibidores de la Enzima Convertidora de Angiotensina/economía , Inhibidores de la Enzima Convertidora de Angiotensina/provisión & distribución , Antiinfecciosos/economía , Antiinfecciosos/provisión & distribución , Antiulcerosos/economía , Antiulcerosos/provisión & distribución , Anticonvulsivantes/economía , Anticonvulsivantes/provisión & distribución , Medicamentos Genéricos/economía , Medicamentos Genéricos/provisión & distribución , Hipoglucemiantes/economía , Hipoglucemiantes/provisión & distribución , Perú , Preparaciones Farmacéuticas/provisión & distribución , Farmacias/clasificación , Farmacias/economía , Farmacias/estadística & datos numéricos , Sector Público/economía , Muestreo , Organización Mundial de la SaludRESUMEN
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...
Asunto(s)
Recolección de Datos/métodos , Honorarios Farmacéuticos/estadística & datos numéricos , Preparaciones Farmacéuticas/economía , Inhibidores de la Enzima Convertidora de Angiotensina/economía , Inhibidores de la Enzima Convertidora de Angiotensina/provisión & distribución , Antiinfecciosos/economía , Antiinfecciosos/provisión & distribución , Antiulcerosos/economía , Antiulcerosos/provisión & distribución , Anticonvulsivantes/economía , Anticonvulsivantes/provisión & distribución , Medicamentos Genéricos/economía , Medicamentos Genéricos/provisión & distribución , Hipoglucemiantes/economía , Hipoglucemiantes/provisión & distribución , Perú , Preparaciones Farmacéuticas/provisión & distribución , Farmacias/clasificación , Farmacias/economía , Farmacias/estadística & datos numéricos , Sector Público/economía , Muestreo , Organización Mundial de la SaludAsunto(s)
Precio de Medicamento , Estudio de Validación , Farmacias , Muestreo , Perú , Precio de Medicamento , Estudio de Validación , Encuestas de Atención de la Salud , Farmacias , Muestreo , Recolección de Datos , Honorarios Farmacéuticos , Inhibidores de la Enzima Convertidora de Angiotensina , Antiinfecciosos , Antiulcerosos , Anticonvulsivantes , Medicamentos Genéricos , Hipoglucemiantes , Farmacias , Sector Público , Muestreo , Encuestas de Atención de la Salud , Preparaciones Farmacéuticas , Organización Mundial de la SaludAsunto(s)
Recolección de Datos , Honorarios Farmacéuticos , Inhibidores de la Enzima Convertidora de Angiotensina , Antiinfecciosos , Antiulcerosos , Anticonvulsivantes , Medicamentos Genéricos , Hipoglucemiantes , Perú , Farmacias , Sector Público , Muestreo , Preparaciones Farmacéuticas , Organización Mundial de la SaludRESUMEN
This study was designed to investigate the physical characteristics and crystalline structure of 2-hydroxy-N-[3(5)-pyrazolyl]-1,4-naphthoquinone-4-imine (PNQ), a new active compound against Trypanosoma cruzi, the causative agent of American trypanosomiasis. Methods used included differential scanning calorimetry, thermogravimetry, hot stage microscopy, polarized light microscopy (PLM), Fourier-transform infrared (FTIR) spectroscopy, and high-resolution X-ray powder diffraction (HR-XRPD). According to PLM and HR-XRPD data, PNQ crystallized as red oolitic crystals (absolute methanol) or prisms (dimethyl sulfoxide [DMSO]-water) with the same internal structure. The findings obtained with HR-XRPD data (applying molecular location methods) showed a monoclinic unit cell [a = 18.4437(1) A, b = 3.9968(2) A, c = 14.5304(1) A, alpha = 90 degrees , beta = 102.71(6) degrees , gamma = 90 degrees , V = 1044.9(1) A(3), Z = 4, space group P2(1)/c], and a crystal structure (excluding H-positions) described by parallel layers in the direction of the b-axis, with molecules held by homochemical (phenyl-phenyl and pyrazole-pyrazole) van der Waals interactions. In addition, FTIR spectra displayed the NH-pyrazole stretch overlapped with the OH absorption at 3222 cm(-1), typical of -NH and -OH groups associated through H-bondings; and a carbonyl stretching absorption at 1694 cm(-1), indicating a nonextensively H-bonded quinonic C=O, which was in accordance with the solved crystal structure of PNQ. The existence of such cohesive forces shed light on the thermoanalytical data, which revealed that PNQ is a stable solid, unaffected by oxygen that decomposed without melting above 260 degrees C.