ABSTRACT
In 2015, the initiative Expand New Drug Markets for TB (endTB) began, with the objective of reducing barriers to access to the new and repurposed TB drugs. Here we describe the major implementation challenges encountered in 17 endTB countries. We provide insights on how national TB programmes and other stakeholders can scale-up the programmatic use of new and repurposed TB drugs, while building scientific evidence about their safety and efficacy. For any new drug or diagnostic, multiple market barriers can slow the pace of scale-up. During 2015-2019, endTB was successful in increasing the number of patients receiving new and repurposed TB drugs in 17 countries. The endTB experience has many lessons, which are relevant to country level introduction of new TB drugs, as well as non-TB drugs and diagnostics. For example: the importation of TB drugs is possible even in the absence of registration; emphasis on good clinical monitoring is more important than pharmacovigilance reporting; national guidelines and expert committees can both facilitate and hinder innovative practice; clinicians use new and repurposed TB drugs when they are available; data collection to generate scientific evidence requires financial and human resources; pilot projects can drive national scale-up.
Subject(s)
Antitubercular Agents , Tuberculosis , Humans , Antitubercular Agents/adverse effects , Pharmacovigilance , Tuberculosis/drug therapy , Drug RepositioningABSTRACT
Guidelines for children with drug-resistant tuberculosis (DR-TB) tend to focus on individual patient care; there is little guidance for national tuberculosis programmes (NTPs) on how to plan, implement and integrate DR-TB services for children. In 2013, through the paediatric tuberculosis (TB) programme started by the Tajikistan Ministry of Health and Médecins Sans Frontières in 2011, 21 children became the first to be treated for multidrug-resistant tuberculosis (MDR-TB) in Tajikistan. We describe the challenges encountered in establishing the programme and the solutions to these challenges, and propose a framework to guide the implementation of paediatric DR-TB care. This framework could prove useful for other NTPs in resource-limited settings.
Les directives relatives aux enfants atteints de tuberculose pharmacorésistante (TB-DR) ont tendance à se focaliser sur la prise en charge des patients individuels; il y a par contre peu de directives destinées aux programmes nationaux de lutte contre la TB (PNT) sur la manière de planifier, mettre en Åuvre et intégrer les services de TB-DR destinés aux enfants. En 2013, dans un programme de prise en charge de la TB pédiatrique démarré par le Ministère de la Santé et Médecins Sans Frontières en 2011, 21 enfants ont été les premiers à être traités pour TB-MDR (TB multi-résistante) au Tadjikistan. Nous décrivons les défis de la mise en Åuvre d'un programme et de leurs solutions et proposons un cadre conceptuel d'aide à la mise en Åuvre de la prise en charge de la TB-DR pédiatrique. Notre cadre pourrait s'avérer utile pour d'autres PNT dans des contextes de ressources limitées.
Las directrices sobre el manejo de los niños con diagnóstico de tuberculosis drogorresistente (TB-MDR) suelen centrarse en la atención del paciente individual; existe poca orientación dirigida a los Programas Nacionales contra la Tuberculosis (PNT) en materia de planeamiento, ejecución e integración de los servicios que se ocupan de la TB-DR en los niños. El Ministerio de Salud y Médecins Sans Frontières iniciaron en el 2011 un programa de TB dirigido a los niños y en el 2013, por primera vez, 21 niños recibieron tratamiento contra la TB-MDR (multidrogorresistente) en Tayikistán. En el presente artículo se describen los obstáculos encontrados durante la introducción del programa, las soluciones que se aportaron y se propone un marco de trabajo encaminado a orientar la ejecución de la atención pediátrica de la TB-MDR. Este marco será útil a otros PNT en entornos con recursos limitados.
