Falling Short: Ensuring Access to Simple, Safe and Effective First-Line Medicines for Tuberculosis
(2010; 28 pages)


Every tuberculosis (TB) patient in the world has the right to an uninterrupted supply of simple, safe and effective medicines for TB. But for too many TB patients globally, this is not happening. These patients are not getting the treatment they need when they need it.

When manufactured, administered and used correctly, first-line TB medicines are one of the most costeffective health interventions in the world. In the 50 years or so since they were developed, these drugs have been used to successfully treat millions of TB patients. Yet many TB patients around the world are at risk because they are not receiving the medicines they need, whether because of poor quality, interruptions in the drug supply known as stock-outs, or because they receive loose, single-drug pills that complicate treatment. Without consistent access to the right medicines at the right time, TB patients can default on their treatment and continue infecting those around them. Worse, they risk the development of drug-resistant TB strains or even death.

This report presents new evidence to document the challenges currently hindering effective first-line TB treatment worldwide and recommends some potential solutions. At the broadest level, it shows that many patients around the world currently do not have consistent access to quality-assured fixed-dose combination medicines (FDCs)—the gold standard of basic TB care. FDCs are medicines that have two or more drugs combined in a single pill, simplifying treatment for patients. The report also shows that several high-burden countries with growing capacity and the will to act, such as Brazil and China, are taking steps to address the situation. But more is needed to ensure that every TB patient globally receives the appropriate care.

In many countries, TB patients seek treatment predominantly in the private sector, where they may be given loose pills of unknown or substandard quality. Even when FDCs are used in the private sector, they are often not quality assured, and their dosages may vary considerably. In the public sector, on the other hand, there has been significant progress introducing FDCs broadly, but many of them are also of unknown quality. An initial examination of the public sector in 10 selected countries shows that together they spend nearly three-quarters of their procurement budgets for first-line TB drugs—over US$60 million annually—on medicines that are not required to meet the most stringent international quality standards recommended by the World Health Organization (WHO). There is also growing evidence of stock-outs that leave patients without any medicine at all. Issues like formulation and quality matter very little if patients are not able to take their TB medicines on time and every day, as prescribed...As the report shows, there are still a number of gaps in our knowledge about first-line TB medicines, but the need for more research is not an excuse for inaction today. Ultimately, the world cannot continue to gamble with the lives of TB patients. In March 2010, a number of organizations came together in New York City to discuss what is known about the current flow of quality-assured first-line TB medicines. That meeting included representatives from the Bill & Melinda Gates Foundation, the Global Alliance for TB Drug Development (TB Alliance), the Clinton Health Access Initiative (CHAI), the Global Drug Facility (GDF), the International Union Against Tuberculosis and Lung Disease (The Union), Treatment Action Group (TAG), Médecins Sans Frontières (MSF), Management Sciences for Health (MSH), IMS Health and Global Health Strategies.

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