[Proposed model for managing drugs used for unregistered indications in Colombia]. / Propuesta de un modelo de gestión de medicamentos en indicaciones no registradas en Colombia.

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.

Fallo terapéutico de levotiroxina en el manejo de hipotiroidismo en una institución de salud de Bogotá, D. C. Un estudio analítico de prevalencia / Levothyroxine treatment failure in the management of hypothyroidism in a health institution in Bogotá, D. C. An analytical study of prevalence

Objetivo: el fallo terapéutico con levotiroxina tiene consecuencias para pacientes, profesionales e instituciones de salud, causado en parte por características farmacocinéticas, interacciones y condiciones especiales de toma del medicamento; el principal objetivo del estudio consistió en determinar la asociación de dichas causas. Metodología: estudio analítico de prevalencia para evaluar las principales causas de fallo terapéutico con levotiroxina en el tratamiento del hipotiroidismo. Resultados: el fallo terapéutico se presentó en el 33,8% de la población en estudio. Los factores protectores son el consumo mayor a 60 meses con OR 0,74 (0,56-0,97), el estado socioeconómico estable OR 0,66 (0,58-0,75), siempre tomarlo con agua OR 0,69 (0,55-0,86) y siempre formularse el medicamento OR 0,66 (0,58-0,75). El único factor de riesgo es el antecedente de colon irritable OR 1,53 (1,34-1,73). La regresión logística no presenta ninguna variable estadísticamente significativa asociada posiblemente al tamaño muestral. Conclusiones: se identificaron factores que favorecen el fallo terapéutico (factores de riesgo), y otros que reducen la probabilidad de presentarlo (factores protectores) y el énfasis en ellos puede ser un abordaje diferente al problema que seguramente se presenta en mayor proporción al reportado por este estudio, y sobre el cual no hay soluciones efectivas por la falta de investigación en el tema.

Objective: Levothyroxine therapeutic failure has implications for patients, health professionals and institutions, caused in part by pharmacokinetics, interactions and special conditions of taking the drug, the main objective of the study was to determine the association of these causes. Methodology: Prevalence analytical study to assess the main causes of treatment failure with levothyroxine in the treatment of hypothyroidism. Results: The treatment failure occurred in 33.8% of the study population. The protective factors are consumption over 60 months OR 0.74 (0.56-0.97), stable socioeconomic status OR 0.66 (0.58 to 0.75), always take it with water OR 0.69 (0.55 to 0.86) and the drug formulated always OR 0.66 (0.58-.75). The only risk factor is a history irritable colon OR 1.53 (1.34 to 1.73). Logistic regression did not show any statistically significant variable associated possibly to sample size. Conclusions: We identified factors that favor therapeutic failure (risk factors), and others that reduce the likelihood of presenting (protective factors) and the emphasis on them can be a different approach to the problem probably occurs in greater proportion to that reported by this study, and on which there is no effective solution for the lack of research on the topic.