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Reducing the Threat of Counterfeits, Investing in the Future of Safe Medicines

The threat of counterfeit and substandard medicines is a problem that not only affects developing countries, but has repercussions felt around the world.

Expanding upon its long-standing commitment to improving the quality of all medicines, the United States Pharmacopeial Convention (USP) has increased its philanthropic outreach with the proposed creation of a new USP-Sub-Saharan Africa Center for Pharmaceutical Advancement and Training (CePAT). It is anticipated that CePAT will be located in Accra, Ghana to serve sub-Sahara Africa as an integrated platform for training, education, consulting and laboratory capabilities, offering a systematic approach to the quality control of medicines in sub-Saharan Africa.

The center will aim to address shortfalls in human and laboratory resources and supply chain control to build the capacity of African professionals in quality control and quality assurance of medicines. USP is a scientific nonprofit organization that sets standards for the identity, strength, quality and purity of medicines, food ingredients and dietary supplements. USP's standards are used in more than 145 countries, and its drug standards are enforceable in the United States by the Food and Drug Administration.

The issues at hand

Sub-Saharan Africa has the lowest life expectancy, the highest infant and under-five mortality rate, as well as the highest maternal mortality rate in the world. It also has the highest burden of HIV infections among adults, malaria mortality rate and tuberculosis prevalence. Moreover, Africa is facing an increasing burden from non-communicable diseases such as cancer and diabetes. The countries in sub-Saharan Africa face fundamental problems that have created an environment where substandard and counterfeit medicines have flourished. These are tied to the limited resources of regulatory infrastructures in African nations, with a shortage of qualified personnel at national laboratories, heavy dependence on imported medicines with a lack of adequate oversight, and poor compliance with Good Manufacturing Practices. CePAT is designed to play an important role in helping to address these challenges.

USP's work in the region

For decades, USP has worked in specific African countries on specific diseases (HIV/AIDS, tuberculosis, and malaria) through grants from the U.S. Agency for International Development (USAID) with the Promoting the Quality of Medicines program (PQM) and predecessor programs. CePAT will complement and build upon this work by significantly scaling up independent USP activity in the region. Activities will cover support for all diseases and all medicines, and will focus on stimulating systemic changes that can be sustained locally. CePAT wil l be the first initiative of the newly created Global Health Impact Program (GHIP) at USP, which is intended to build upon USP's mission of promoting the public health globally, and work done through the PQM program. USP strives to transform the global health landscape by addressing the systemic problems that hamper access to good-quality medicines for patients in need through GHIP.

“The work that USP has been able to do through the PQM program has opened our eyes to new opportunities to provide assistance in sub-Saharan Africa,” said Patrick Lukulay, vice president of global health impact programs at USP. “Our ability to do long-term work in Africa through this center in Ghana will improve health of patients in the region who are desperate for medicines they can trust.”

USP's proven success

The idea for CePAT came as a result of a pilot Technical Assistance Program (TAP) that USP launched last year in seven countries: Ethiopia, Ghana, Kenya, Senegal, Sierra Leone, India and Egypt. Under the program, USP provided training as well as its documentary and reference standards for free or at reduced pricing. During a regional training session in Ghana with the national laboratories of five participating African countries, it became clear that there was a need for a more permanent presence that could deliver training on-demand, tailored to local needs. CePAT will serve as a permanent facility to train local experts and foster a knowledge base, thus creating a lasting and self-sustaining program.

Thanks to TAP, the Sierra Leone Pharmacy Board national laboratory found that two brands of antibiotics on the market were substandard and were able to have them immediately removed from the market by the Pharmacy Board of Sierra Leone.

How to get involved

The USP Board of Trustees has committed $1.5 million of USP funds toward the cost of CePAT's construction. USP is seeking additional funds from outside donors to cover construction costs not covered by USP funds, instrumentation for the training laboratories, staffing costs and to subsidize local use of the center for the first three years. The center is expected to become self-sustaining after three years through the variety of services it will provide to local manufacturers, regulators and others. These are envisioned to include training on topics such as quality control and current good manufacturing practices; quality control testing services for donor agencies, procurement organizations or local manufacturers; and consulting services on supply chain integrity and laboratory design, among other offerings. Using the USP-Africa CePAT as a model, it is anticipated that the program will grow to include other regions such as Latin America and Asia.

To make a contribution to CePAT please contact

For more information, please visit here or email.
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