New report highlights urgent need to ensure access to simple, quality-assured TB medicines

14 November 2010 - Berlin, Germany - A new report released today by a consortium of leading international TB organizations, including the Stop TB Partnership, highlights a major issue that is stalling progress: many TB patients worldwide are still not getting simple, quality-assured first-line medicines—raising the threat of drug resistance and heightening the risk of an untreatable epidemic.

Entitled Falling Short: Ensuring Access to Simple, Safe and Effective First-Line Medicines for Tuberculosis, the report demonstrates that TB patients around the world are too often given poor quality medicines or complicated, non-user friendly treatment formulations that consist of up to 16 pills at a time. Additionally, they may be unable to take their medicines as prescribed because of drug stock-outs. Without the appropriate medicine at the right time, patients risk stopping treatment, spreading the disease to others, developing drug resistance or even death.

Quality-assured fixed-dose combination drugs (FDCs) are considered the international "gold standard" for TB treatment and are extremely effective when prescribed and administered correctly. At just US$20-$26 for a full six-month regimen, they are also affordable—even in developing countries where the TB burden is greatest. The drugs for treating drug resistant TB can cost between US$2,000 and US$9,000 per patient and must be taken for up to two years.

The report describes a number of reasons that patients are not currently getting the first-line drugs they need, whether from private sector health providers or public sector ones. In the private sector they may be given single-drug treatments consisting of as many as 16 loose pills at a time as opposed to FDCs, which consist of only three or four. Numerous loose pills make treatment more burdensome for patients and may increase the risk that they will take incomplete treatments and not be completely cured.

Quality assurance is also a serious problem in many places. In the private sector the quality of TB medicines is largely unknown. In the public sector some countries spend large portions of their procurement budgets on TB medicines that are not required to meet standards of quality assurance equivalent to those recommended by the World Health Organization. Even when countries do provide quality-assured FDCs, they may experience stock-outs that leave patients without access to any medicine at all. All of these challenges place patients at risk of ineffective treatment, drug resistance or death.

There are signs of progress, however. A handful of emerging economies with high TB burdens - including China and Brazil - are already leading the drive to improve basic TB treatment. Their national TB programs have made new commitments and pioneered new approaches to ensure that every patient has access to quality-assured FDCs. The Global Drug Facility is also taking steps forward by launching a Rapid Response Facility, which will address some of the key drivers of stock-outs.

Falling Short: Ensuring Access to Simple, Safe and Effective First-Line Medicines for Tuberculosis [.pdf]