A methodological approach for the evaluation of preparedness of pharmaceutical services / Un enfoque metodológico para evaluar el estado de preparación de los servicios farmacéuticos

OBJECTIVE: The aim of this article is to provide an outcome evaluation model for preparedness of pharmaceutical services (PS) in disaster situations. METHODS: A five-step evaluation model development was conducted. The first step was a search of disaster preparedness and PS literature. The second step consisted of a description of the political and organizational aspects, external context, implementation, and performance of PS in disaster preparedness. A theoretical model on PS preparedness in disaster situations, encompassing pharmaceutical services variables and measures of preparedness, was developed as the third step. The fourth step produced a comprehensive theoretical model for evaluating PS preparedness, combining the two approaches used in steps two and three. The fifth and final step examined the development of the indicator framework. RESULTS: The results of this methodological approach are presented in the logic model of PS preparedness and the indicator framework, both of which were developed based on the disaster preparedness and PS literature and organized to provide a structured evaluation approach. CONCLUSIONS: PS was conceptualized as a program that can be evaluated by measurable effects. These effects can only be measured based on documented, on-site conditions before and after an event recognized as a disaster situation. This conceptual approach is context-modulated and therefore only applicable where the logistic cycle has been adopted as the rationale for PS.

OBJETIVO: Proporcionar un modelo de evaluación de resultados relativos al estado de preparación de los servicios farmacéuticos (SF) para situaciones de desastre. MÉTODOS: Se elaboró un modelo de evaluación en cinco pasos. El primer paso fue una búsqueda bibliográfica sobre preparativos para situaciones de desastre y SF. El segundo consistió en una descripción de los aspectos políticos y técnicos, el contexto externo, la implementación y el desempeño de los SF en la preparación para situaciones de desastre. El tercer paso fue la elaboración de un modelo teórico sobre el estado de preparación de los SF para situaciones de desastre, que comprendía variables relativas a los SF y medidas del estado de preparación. El cuarto paso consistió en la creación de un modelo teórico integral para evaluar el estado de preparación de los SF, mediante la combinación de los enfoques usados en los pasos dos y tres. El quinto y último paso fue el análisis de la elaboración del marco de indicadores. RESULTADOS: Se presentan los resultados de este enfoque metodológico en el modelo lógico del estado de preparación de los SF y el marco de indicadores, ambos elaborados con base en la bibliografía sobre preparativos para casos de desastre y SF, y organizados para poder proporcionar un método estructurado de evaluación. CONCLUSIONES: A efectos de la elaboración de este marco conceptual se consideró a los SF como un programa que podría ser evaluado a partir de sus efectos cuantificables. Estos efectos solo pueden ser medidos sobre la base de condiciones documentadas en el lugar de los hechos antes y después del evento considerado una situación de desastre. Este enfoque conceptual está modulado en función del contexto y por lo tanto se considera aplicable solamente donde se haya adoptado el ciclo logístico como fundamento de los SF.

[Right-to-health litigation in three Latin American countries: a systematic literature review]. / Litigios por derecho a la salud en tres países de América Latina: revisión sistemática de la literatura.

OBJECTIVE: Identify and evaluate studies that analyzed characteristics of right-to-health litigation in Brazil, Colombia, and Costa Rica. METHODS: Studies were evaluated that analyzed characteristics of right-to-health litigation identified through a search of PubMed, LILACS, Cochrane Library, and Scirus (April 2012). Two reviewers evaluated the studies. Variables collected were, among others, grounds for litigation, proportion of lawsuits for benefits covered by the health system, and lawsuits on high-cost technologies. RESULTS: Thirty studies were identified (Brazil 19, Colombia 10, and Costa Rica 1). Judgments were frequently in favor of plaintiffs: Colombia (75%-87%), Costa Rica (89.7%), and Brazil (70%-100%). In Colombia, lawsuits were filed for benefits included in the Compulsory Health Plan (range: 41%-69.9%). In Brazil there was considerable variation in the amount of lawsuits between the Exceptional Circumstance Drug Dispensing Program (13%-31%) and basic medicines in the Unified Health System (approximately 50%). Lawsuits on drugs varied as a percentage of all lawsuits (Colombia 11.9%-35.6%, Costa Rica 30.2%, and Brazil 49.6%). A study in Brazil found a statistically significant difference when comparing lawsuits on exceptional drugs versus all other drugs, by social class; and in another study, according to lawsuits from municipalities with better socioeconomic indicators. A concentration of lawsuits on drug prescribing by a limited group of physicians was reported. Prescribing was not always supported by scientific evidence. Another study found that in half of the cases, the cost of legal proceedings was higher than the cost of the services being claimed. CONCLUSIONS: There are similarities in the grounds, nature, and impact of litigation in the context of the countries studied. The studies included show weaknesses of health systems to ensure access to different services as well as in the introduction of new health technologies.

Litigios por derecho a la salud en tres países de América Latina: revisión sistemática de la literatura / Right-to-health litigation in three Latin American countries: a systematic literature review

OBJETIVO: Identificar y evaluar estudios que analizaron las características de los litigios por derecho a la salud en Brasil, Colombia y Costa Rica. MÉTODOS: Se evaluaron estudios que analizaron las características de los litigios por derecho a la salud identificados mediante una búsqueda en PubMed, LILACS, Biblioteca Cochrane, Scirus (Abril, 2012). Dos revisores evaluaron los estudios. Las variables recabadas fueron, entre otras: causales de litigio, proporción de demandas por beneficios cubiertos por el sistema de salud y demandas por tecnologías de alto costo. RESULTADOS: Se identificaron 30 estudios (Brasil 19, Colombia 10 y Costa Rica 1). La decisión judicial fue frecuentemente favorable para los demandantes: Colombia (75%-87%), Costa Rica (89,7%) y Brasil (70%-100%). En Colombia las demandas se efectuaron por beneficios incluidos en el Plan Obligatorio de Salud (rango 41%-69,9%). En Brasil se presentó una variación importante de demandas entre el Programa de Medicamentos de Dispensación Excepcional (13%-31%) y los medicamentos básicos del Sistema Único de Salud (aproximadamente 50%). En relación al total de demandas, las de medicamentos fueron variables (Colombia 11,9%-35,6%, Costa Rica 30,2% y Brasil 49,6%). Un estudio de Brasil encontró una diferencia estadísticamente significativa al comparar las demandas por medicamentos excepcionales versus los demás, según el estrato social; y en otro estudio según las demandas de municipios con mejores indicadores socioeconómicos. Se reportó una concentración de las demandas en la prescripción de medicamentos por un grupo acotado de médicos. La prescripción no fue siempre sustentada por evidencia científica. Otro estudio halló que en la mitad de los casos el costo del proceso judicial resultó ser superior al costo de los servicios demandados. CONCLUSIONES: Existen similitudes en las causales, naturaleza y repercusiones de la judicialización en el contexto de los países estudiados. Los estudios incluidos muestran las debilidades de los sistemas de salud para garantizar el acceso a los distintos servicios así como para la incorporación de las nuevas tecnologías sanitarias.

OBJECTIVE: Identify and evaluate studies that analyzed characteristics of right-to-health litigation in Brazil, Colombia, and Costa Rica. METHODS: Studies were evaluated that analyzed characteristics of right-to-health litigation identified through a search of PubMed, LILACS, Cochrane Library, and Scirus (April 2012). Two reviewers evaluated the studies. Variables collected were, among others, grounds for litigation, proportion of lawsuits for benefits covered by the health system, and lawsuits on high-cost technologies. RESULTS: Thirty studies were identified (Brazil 19, Colombia 10, and Costa Rica 1). Judgments were frequently in favor of plaintiffs: Colombia (75%-87%), Costa Rica (89.7%), and Brazil (70%-100%). In Colombia, lawsuits were filed for benefits included in the Compulsory Health Plan (range: 41%-69.9%). In Brazil there was considerable variation in the amount of lawsuits between the Exceptional Circumstance Drug Dispensing Program (13%-31%) and basic medicines in the Unified Health System (approximately 50%). Lawsuits on drugs varied as a percentage of all lawsuits (Colombia 11.9%-35.6%, Costa Rica 30.2%, and Brazil 49.6%). A study in Brazil found a statistically significant difference when comparing lawsuits on exceptional drugs versus all other drugs, by social class; and in another study, according to lawsuits from municipalities with better socioeconomic indicators. A concentration of lawsuits on drug prescribing by a limited group of physicians was reported. Prescribing was not always supported by scientific evidence. Another study found that in half of the cases, the cost of legal proceedings was higher than the cost of the services being claimed. CONCLUSIONS: There are similarities in the grounds, nature, and impact of litigation in the context of the countries studied. The studies included show weaknesses of health systems to ensure access to different services as well as in the introduction of new health technologies.

A methodological approach for the evaluation of preparedness of pharmaceutical services.

OBJECTIVE: The aim of this article is to provide an outcome evaluation model for preparedness of pharmaceutical services (PS) in disaster situations. METHODS: A five-step evaluation model development was conducted. The first step was a search of disaster preparedness and PS literature. The second step consisted of a description of the political and organizational aspects, external context, implementation, and performance of PS in disaster preparedness. A theoretical model on PS preparedness in disaster situations, encompassing pharmaceutical services variables and measures of preparedness, was developed as the third step. The fourth step produced a comprehensive theoretical model for evaluating PS preparedness, combining the two approaches used in steps two and three. The fifth and final step examined the development of the indicator framework. RESULTS: The results of this methodological approach are presented in the logic model of PS preparedness and the indicator framework, both of which were developed based on the disaster preparedness and PS literature and organized to provide a structured evaluation approach. CONCLUSIONS: PS was conceptualized as a program that can be evaluated by measurable effects. These effects can only be measured based on documented, on-site conditions before and after an event recognized as a disaster situation. This conceptual approach is context-modulated and therefore only applicable where the logistic cycle has been adopted as the rationale for PS.

Definición de medicamento genérico: ¿un fin o un medio? Análisis de la regulación en 14 países de la Región de las Américas / Defining generic drugs: an end or a means? Analysis of regulations in 14 countries in the Region of the Americas

OBJETIVOS: Caracterizar la situación y las tendencias regulatorias relacionadas con los medicamentos competidores en 14 países de América Latina y el Caribe. MÉTODOS: Entre julio de 2004 y abril de 2005 se colectó la información sobre las regulaciones y políticas nacionales que establecían o contenían la definición de medicamento genérico y de los términos asociados en 14 países de América Latina y el Caribe (Argentina, Barbados, Bolivia, Brasil, Colombia, Costa Rica, Ecuador, Guatemala, México, Nicaragua, Panamá, Paraguay, Perú y Venezuela). Además, se recabó información sobre los incentivos para registrar y producir medicamentos competidores, la promoción del uso de la denominación común internacional (DCI), la regulación de los estudios de bioequivalencia y la sustitución de los medicamentos prescritos por alternativas de menor precio al público. RESULTADOS: Se observaron tres tendencias regulatorias: los países que favorecen la financiación de medicamentos competidores, la promoción extendida del uso de la DCI y no ponen restricciones a la sustitución de medicamentos innovadores por competidores (Argentina, Colombia, Costa Rica, Ecuador y Paraguay); los que cuentan con un esquema orientado a la demostración de la equivalencia terapéutica, es decir, los países restringen la sustitución de los medicamentos originales mediante una lista de medicamentos competidores autorizados que deben prescribirse bajo su DCI y llevar rótulos distintivos (Brasil, México, Panamá y Venezuela); y los que se encuentran en una etapa incipiente de su proceso de regulación (Barbados, Bolivia, Guatemala, Nicaragua y Perú). Esta variedad ocasiona dificultades en la caracterización de los mercados farmacéuticos y puede generar segmentaciones ficticias. CONCLUSIONES: Los esfuerzos de armonización deberán tomar en cuenta la posible relación entre las definiciones adoptadas por los países, el desarrollo de los mercados farmacéuticos nacionales y sus políticas de estímulo a la competencia.

OBJECTIVES: To characterize current regulatory practices and trends relating to competing medications in 14 Latin American and Caribbean countries. METHODS: Between July 2004 and April 2005 we collected information on national regulations and policies that established or contained a definition of "generic drug" and related terms in 14 Latin American and Caribbean countries: Argentina, Barbados, Bolivia, Brazil, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Nicaragua, Panama, Paraguay, Peru, and Venezuela. We also compiled information on the incentives to register and produce competing medications, promotion of the use of International Nonproprietary Names (INNs) for pharmaceutical substances, the regulation of bioequivalence studies, and the replacement of prescription medications with less expensive alternatives. RESULTS: We noted three patterns in the regulations: (1) countries that encourage financial support for competing medications, extensively promote the use of INNs, and place no restrictions on the replacement of innovative (proprietary) medications with competing products (Argentina, Colombia, Costa Rica, Ecuador, and Paraguay); (2) countries with policies aimed at showing therapeutic equivalence, which limits substitutions to approved products from a list of authorized competing medications that must be prescribed by their INN and must use distinctive labeling (Brazil, Mexico, Panama, and Venezuela); and (3) countries at a beginning stage in the process of regulation (Barbados, Bolivia, Guatemala, Nicaragua, and Peru). This variety leads to difficulties in characterizing pharmaceutical markets, and can lead to misleading categorizations. CONCLUSIONS: Efforts to harmonize policies should consider the possible relationship among definitions adopted in different countries, the development of national pharmaceutical markets, and national policies to stimulate competition.

[Defining generic drugs: an end or a means? Analysis of regulations in 14 countries in the Region of the Americas]. / Definición de medicamento genérico: un fin o un medio? Análisis de la regulación en 14 países de la Región de las Américas.

OBJECTIVES: To characterize current regulatory practices and trends relating to competing medications in 14 Latin American and Caribbean countries. METHODS: Between July 2004 and April 2005 we collected information on national regulations and policies that established or contained a definition of "generic drug" and related terms in 14 Latin American and Caribbean countries: Argentina, Barbados, Bolivia, Brazil, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Nicaragua, Panama, Paraguay, Peru, and Venezuela. We also compiled information on the incentives to register and produce competing medications, promotion of the use of International Nonproprietary Names (INNs) for pharmaceutical substances, the regulation of bioequivalence studies, and the replacement of prescription medications with less expensive alternatives. RESULTS: We noted three patterns in the regulations: (1) countries that encourage financial support for competing medications, extensively promote the use of INNs, and place no restrictions on the replacement of innovative (proprietary) medications with competing products (Argentina, Colombia, Costa Rica, Ecuador, and Paraguay); (2) countries with policies aimed at showing therapeutic equivalence, which limits substitutions to approved products from a list of authorized competing medications that must be prescribed by their INN and must use distinctive labeling (Brazil, Mexico, Panama, and Venezuela); and (3) countries at a beginning stage in the process of regulation (Barbados, Bolivia, Guatemala, Nicaragua, and Peru). This variety leads to difficulties in characterizing pharmaceutical markets, and can lead to misleading categorizations. CONCLUSIONS: Efforts to harmonize policies should consider the possible relationship among definitions adopted in different countries, the development of national pharmaceutical markets, and national policies to stimulate competition.