title: [Proposed model for managing drugs used for unregistered indications in Colombia].
abstract: 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.
authors.forename: Egdda Patricia
authors.initials: EP
authors.lastname: Vanegas
authors.forename: Ángela Patricia
authors.initials: ÁP
authors.lastname: Acosta
authors.forename: Claudia Patricia Vaca
authors.initials: CP
authors.lastname: González
authors.forename: José Julián López
authors.initials: JJ
authors.lastname: Gutiérrez
authors.forename: Laura Angélica
authors.initials: LA
authors.lastname: Pineda
authors.forename: Javier Humberto
authors.initials: JH
authors.lastname: Guzmán
authors.forename: Alejandro
authors.initials: A
authors.lastname: Gaviria
authors.forename: Fernando
authors.initials: F
authors.lastname: Ruiz
mesh_terms: D026688:Bioethical Issues; D003105:Colombia; D006297:Health Services Accessibility; D006801:Humans; D054539:Medication Therapy Management / Q000941:ethics / Q000331:legislation & jurisprudence*; D008962:Models, Theoretical; D056687:Off-Label Use / Q000941:ethics / Q000331:legislation & jurisprudence*; D012051:Reimbursement Mechanisms