Ethiopia

Ethiopia is the ninth largest country in Africa, but also one of the poorest and least developed countries on the continent. According to the World Health Organization Global Tuberculosis Control: WHO Report 2004, Ethiopia ranks seventh among the world's 22 countries with a high tuberculosis (TB) burden. The number of TB cases is likely to grow greater still as Ethiopia's HIV/AIDS epidemic expands, since nearly one-third of adult TB cases are HIV-positive, and many strains are becoming resistant to anti-tuberculosis medicines.

Resistance to individual first-line anti-TB medicines is increasing, as is multidrug-resistant TB. Factors contributing to drug resistance include poorly managed TB programs, poor patient compliance, drug shortages, and poor quality TB drugs. Ethiopia currently receives funds from the U.S. President's Emergency Plan for AIDS Relief and the Global Health Fund to Fight AIDS, Tuberculosis, and Malaria to procure anti-TB and antiretroviral medicines, and to expand use of the DOTS program to more areas of the country. But there is currently no system in place to assure the quality of those medicines.

USP DQI assessed Ethiopia's national capacity to monitor the quality of anti-tuberculosis medicines as a part of a drug quality assurance system. The assessment confirmed that drug quality control capacity in Ethiopia is very poor, a situation the Drug Administration and Control Authority of Ethiopia would like to change. Ethiopia would benefit from laboratory training and from guidance on registration, distribution, and quality monitoring. USP DQI assistance would follow the methodology it has successfully used at the provincial level in countries around the world—working with drug regulatory authorities to provide basic equipment and reference standards for testing, training in laboratory procedures and testing, assisting with development of a sampling plan, and supplying materials and training to establish a drug information center. The primary objective of this assessment is for Ethiopia to use the findings to develop advocacy tools, raise awareness, and encourage drug regulatory authorities to take appropriate measures to address the problem when poor quality anti-TB medicines are found.