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Sustainable Medicine Program in Tanzania

Established by: Prof. Stephen Byrn, Purdue University College of Pharmacy (PSP), Sr. Zita Ekeocha and Mr. John Chilunda, St. Luke Foundation/Kilimanjaro School of Pharmacy (SLF/KSP) and Prof. Joseph Fortunak, Howard University, Washington, DC.

People living in Africa face a heavy and wide ranging burden of disease that takes an incalculable toll on social and economic development, as well as shortening life expectancy. The HIV/AIDS epidemic, as well as the resurgence of tuberculosis and the continued presence of malaria, have negated earlier improvements in life expectancy in Sub-Saharan countries; including Tanzania. The best treatments for these diseases are medicines taken daily. Although a number of programs provide free medicines for Tanzania and other central African countries these medicines are sometimes of poor quality due to counterfeiting and manufacturing problems or are "out-of-stock". Additionally, the dependence of Tanzania and other central African countries on others for these life-saving medicines creates a feeling of dependence and inadequacy.

Students in the manufacturing course at Kilimanjaro School of Pharmacy/St. Luke's Foundation make Amodiaquin tablets on a Killian tablet press

The sustainable medicine program in Africa is aimed at addressing this problem. This program consists of: (1) educational programs in Pharmaceutical Sciences and Good Manufacturing Practices (GMP); and (2) an actual GMP pharmaceutical manufacturing facility and analytical laboratory at SLF/KSP. The educational programs are aimed at providing source of well-trained manufacturing scientists for pharmaceutical industry in Tanzania and Africa. The planned GMP facility will manufacture needed drugs and will be among the first GMP pharmaceutical manufacturing facilities in all of Sub-Saharan Africa (except for South Africa). The GMP facility will serve as a model for other such facilities throughout Sub-Saharan Africa. The feasibility of establishing a sustainable medicine program in Tanzania is supported by the experience of the former Infusion Units Project in Tanzania, now known as Saint Luke Foundation (SLF). This program has manufactured and distributed infusion solutions throughout Tanzania since 1983. Additionally, the availability of trained personnel and a model facility will combat several current problems especially those related to counterfeited/poor quality medicines.

As part of our program we have designed a 4 course curriculum in advanced GMP manufacturing. This program is being taught to scientists with some experience in GMP manufacturing at the Kilimanjaro School of Pharmacy. This course is supported by UNIDO (United Nations Industrial Development Organization) who provides scholarships to the attendees. So far, three very successful two-week courses have been presented on drug development, GMP, and pharmaceutical manufacturing. In the pharmaceutical manufacturing course which included a two-week laboratory, the students actually synthesized a drug (amodiaquin) and formulated it into tablets.

Once additional funds are obtained we will expand the advanced program and build the GMP facility. A key decision point in the future will be selection of the first medicines to manufacture in the GMP facility. Our current strategy is to focus on pediatric medicines for HIV, malaria, TB, and parasitic diseases. Special attention will be paid to difficult to manufacture drugs, drugs that need taste masking, and drugs that have short shelf lives due to stability problems.

Additionally, we plan to work with St. Luke's Foundation and Tanzanian government officials to develop an appropriate strategy for distribution and cost recovery. This strategy will be based a distribution system accepted and approved by the Government through the TFDA (who are already participating in our courses). Briefly, this distribution system involves the use of Regional, District and other hospitals situated in rural areas throughout Tanzania. In addition, the price and other criteria will be determined in consideration of the needs of the less privileged patients.

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