RESUMO
En septiembre de 2014, Colombia emitió su norma para la evaluación de los medicamentos biológicos en el marco del proceso de autorización de comercialización. La aproximación colombiana incluye de manera explícita una ruta abreviada para la evaluación de los biológicos competidores que generó una gran polémica a nivel nacional e internacional. En el presente artículo se explica el contexto que justifica la necesidad de adoptar la aproximación abreviada, se analiza de manera crítica la comparabilidad como paradigma para la evaluación de los biogenéricos y se evidencia que la posición de Colombia no es aislada y está basada en tendencias regulatorias globales.
In September 2014, Colombia issued standards for the evaluation of biological drugs within the framework of the marketing authorization process. The Colombian approach explicitly includes a fast track for evaluating competing biologicals, which caused great national and international controversy. This article explains the context that justifies the need for this fast-track approach, critically analyzes comparability as a paradigm for the evaluation of biogenerics, and shows that Colombia’s position is not isolated and is based on global regulatory trends.
Assuntos
Medicamentos Biossimilares , Medicamentos Genéricos , Avaliação de Medicamentos , Aprovação de Drogas , Registro de Produtos , Colômbia , Medicamentos Biossimilares , Medicamentos Genéricos , Avaliação de Medicamentos , Aprovação de DrogasRESUMO
El uso de medicamentos en indicaciones no registradas (INR), conocido como uso “off-label”, es una práctica que genera problemas de uso racional y de acceso cuando no existen alternativas disponibles. Los sistemas de salud deben gestionar esta realidad, sobre todo cuando se trata de decisiones de cobertura, buscando minimizar los riesgos para la salud y estableciendo de forma clara los papeles y las responsabilidades de los agentes involucrados. El Ministerio de Salud y Protección Social de Colombia (MinSalud), junto con con la Universidad Nacional de Colombia y expertos nacionales, diseñaron una propuesta de modelo de gestión del uso de medicamentos en indicaciones no registradas (off-label) y su potencial reembolso con recursos públicos, teniendo en cuenta prácticas internacionales y la realidad nacional. El modelo de gestión es no punitivo y está orientado a la promoción del uso racional de estos medicamentos, de forma que se reduzcan las barreras al acceso cuando su uso está respaldado por pruebas cientificas de calidad. El modelo incorpora elementos de garantías bioéticas del paciente, los papeles y las responsabilidades del prescriptor y de las entidades de gobierno.
The use of drugs for unregistered indications, known as “off-label” use, is a practice that creates problems of rational use and access when other options are not available. Health systems should address this situation, particularly in connection with decisions concerning coverage, while trying to minimize health risks and clearly define the roles and responsibilities of the parties involved. Colombia's Ministry of Health and Social Protection (MinSalud), together with the National University of Colombia and national experts, developed a proposal for a model for managing drugs being used for unregistered indications (off-label) and their potential reimbursement with public resources, taking into account international practices and country characteristics. The management model is non-punitive and is geared toward promoting the rational use of these drugs so that barriers to access are reduced whenever their use is supported by solid scientific evidence. The model addresses patient safeguards in the bioethical domain and the roles and responsibilities of the prescriber and government entities.
Assuntos
Uso Off-Label , Política Nacional de Medicamentos , Colômbia , Uso de MedicamentosRESUMO
PURPOSE: To propose and validate an algorithm to analyze the reports of suspected therapeutic failure (TF) received in pharmacovigilance programs. METHODS: A Delphi consensus method with a group of 12 international experts was used to identify the different causes that prompt TF and to propose an algorithm to analyze reports of suspected lack of efficacy of medicines. A pilot analysis of 50 reports was the basis to evaluate the interrater and intrarater validity of the algorithm. RESULTS: A 10-question algorithm was proposed. The evaluation of 50 reports of suspected TF showed that only 8% could be actually attributed to a manufacturing quality problem, whereas the real reason underlying the alleged TF was the inappropriate use of the prescribed drug in 28%. Minimum information to attribute the cause to a TF was lacking in 31% of these reports. The interrater reliability was "moderate" (kappa coefficient = 0.55), and the intrarater reliability ranged from 0.732 to 0.908 ("substantial" to "almost perfect"). CONCLUSIONS: The proposed TF algorithm is a valid, reliable, and reproducible analysis tool that can help to disentangle the frequent and complex reports of suspected TF.
