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Volume 22, Number 3—March 2016
Online Report

Global Introduction of New Multidrug-Resistant Tuberculosis Drugs—Balancing Regulation with Urgent Patient Needs

Timothy Sullivan and Yanis Ben AmorComments to Author 
Author affiliations: Icahn School of Medicine at Mount Sinai, New York, New York, USA (T. Sullivan); The Earth Institute at Columbia University, New York (Y. Ben Amor)

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Table

Suggested plan for ensuring the appropriate use of new TB drugs and regimens*

Goals Support Feasibility/precedent
1. Improve DST in high-TB-burden countries
A. Increase number of laboratories performing TB culture and DST Key goal of WHO (1). Funding available from UNITAID, FIND, GLI, Global Drug Facility, Global Fund, United States government, World Bank Ongoing global scale-up of DST during 2006–2015. EXPAND-TB project has improved technology in 97 TB laboratories worldwide (1)
B. Improve TB diagnostic technology in existing laboratories, including rollout of molecular diagnostics WHO, NTPs >3,000 GeneXpert machines procured at concessional prices since WHO recommended use in 2010 (1)
C. Develop a specimen bank of TB strains resistant to new antibiotics WHO, private sector (both diagnostic and pharmaceutical companies) TDR TB strain bank launched by Special Program for Research and Training in Tropical Diseases
2. Improve prescribing practices in high TB burden countries
A. Establish accreditation process for prescribers of new TB drugs National governments, NTPs, pharmaceutical companies Similar programs instituted for laboratory services in low-resource settings (2527)
B. Ban over-the-counter sale of TB drugs Widely supported by many NGOs and other authorities (15) Common practice in many countries; new regulations instituted in India in 2014
3. Support community-based treatment of MDR TB
A. Employ community health workers to assist with MDR TB treatment Supported by WHO (1); to be implemented by local NTPs and NGOs Beneficial role of CHWs in TB care well described (1)
B. Use emerging mobile technologies to monitor for adherence and adverse effects WHO recently acknowledged value of mobile health technology (35) Well-studied for HIV care; data for use in TB management emerging (2934)
C. Enlist support of existing civil society organizations Wide support on global, national, and local level Many such organizations already invested in improving TB care

*TB, tuberculosis; DST, drug-susceptibility testing; WHO, World Health Organization; FIND, Foundation for Innovative New Diagnostics; GLI, Global Laboratory Initiative; EXPAND-TB, Expanding Access to New Diagnostics for TB; NTPs, national TB programs; TDR TB, totally drug-resistant TB; MDR TB, multidrug-resistant TB; NGOs, nongovernmental organizations; CHWs, community health workers.

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Page created: January 26, 2016
Page updated: January 26, 2016
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