amplification of drug resistance, enhanced infectivity and transmission of disease to others, and death. Ensuring a reliable and affordable supply of high-quality SLDs is a complex public health intervention that, thus far, has not been organized or implemented in a way that allows all providers and patients access to SLDs when they are needed. Some MDR TB patients without access to SLDs through a Green Light Committee (GLC)-approved program may receive appropriate treatment through a government-run or other QA program. However, it is estimated that approximately 90 percent of patients with DR TB are not receiving treatment through a government-run or QA program. In other words, these patients are likely receiving treatment from sources of unknown quality or no treatment at all. In recent years, many countries have been working to scale up MDR TB treatment programs but, as mentioned by several workshop participants, efforts by international organizations and institutions to ensure SLDs are delivered to patients have not kept pace with global MDR TB needs. Challenges facing the global supply chain for SLDs, and the efficient delivery of drugs to patients, include
• The overall market for SLDs is relatively small due to limited diagnostic capacity at the country level.
• Demand-forecasting mechanisms do not fully capture patient needs for SLDs.
• Markets are opaque, with high barriers to entry that may deter manufacturers.
• Drugs to treat MDR TB carry high prices and have a short shelf life (24 months) compared with treatments for drug-susceptible TB.
• Once drugs are ordered, there are lengthy time lines to reach the country.
The July 31–August 1, 2012, workshop was convened by the Forum on Drug Discovery, Development, and Translation (“the Forum”) of the Institute of Medicine (IOM) in Washington, DC, to explore options and opportunities to improve the effectiveness of the global SLD supply chain in delivering drugs to patients. Titled “Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant TB,” the workshop was part of a series sponsored by the Forum to gather information from experts around the world on DR TB prevention, diagnosis, treatment, and management.
The Forum held a foundational workshop in Washington, DC, in 2008. The summary of that workshop, Addressing the Threat of Drug-Resistant Tuberculosis: A Realistic Assessment of the Challenge: Workshop Summary (IOM, 2009), and the accompanying white paper (Keshavjee and Seung, 2008) provided background for and informed the development of four