Rockville, Md., April 18, 2011 ? Scientists from the national laboratories of five African nations are gathering in Accra, Ghana, this week to take part in technical training that will provide them with improved capacity to detect substandard and counterfeit medicines. The training?which will include participants from Ethiopia, Ghana, Kenya, Senegal and Sierra Leone?is part of a larger Technical Assistance Program (TAP) announced earlier this year and funded by the U.S. Pharmacopeial Convention (USP), a nonprofit public health organization that sets standards for the identity, quality, purity and strength of prescription and over-the-counter medicines.
Under TAP?which is currently a pilot program involving the five sub-Saharan African countries and Egypt but may be expanded in scope?USP is providing a comprehensive package of pharmaceutical reference standards (very pure physical samples used as reference chemicals to test medicines), documentary standards (written specifications) and technical training to assist these countries in improving the quality of their medicines. Constrained by limited resources, the national laboratories in these nations may resort to using unreliable or outdated standards, and/or may not be equipped to offer their analysts the scientific training required to appropriately analyze medicines. As such, these laboratories may not obtain accurate results when they test questionable samples?a serious gap in quality assurance that can lead to severe health outcomes for patients, including prolonged disease and death. The USP-sponsored training being conducted this week will focus on three key topics necessary to appropriately test medicines quality?Fundamentals of High Performance Liquid Chromatography, Microbiology and Effectively Using USPNF (USP's drug compendia).
In all of the participating nations, poor-quality medicines represent a significant public health challenge. In the host country of Ghana, for instance, a recent World Health Organization study found that 39 percent of tested antimalarial medicines failed quality testing?for reasons that include insufficient amounts of the active pharmaceutical ingredient (a serious problem that can lead to the rise in drug-resistant disease parasites) and excess levels of problematic impurities.
"With inferior medicines threatening the lives of citizens every day in Africa, it is essential for governments to be equipped with the tools necessary to accurately gauge the quality of the medicines circulating in their markets. Having a team of scientists trained in essential analytical techniques is a fundamental aspect of a well-functioning regulatory system that protects the domestic drug supply," said Patrick Lukulay, Ph.D., director of the Promoting the Quality of Medicines (PQM) Program, a USP-U.S. Agency for International Development (USAID) program that works in more than 30 countries to help ensure the quality, safety and efficacy of medicines to treat diseases such as malaria and tuberculosis. TAP is a USP initiative that makes USP standards available to promote drug quality in developing countries by leveraging resources toward a common goal.
"As Ghana makes strides to address the devastation caused by substandard or fake medications, we are very pleased to host a delegation of countries seeking to do the same," said Stephen Opuni, M.D., chief executive officer of the Ghana Food and Drugs Board. "This training will enhance our ability to detect such 'medicines,' which can cause as much harm as a disease itself."
The objectives of this week's training are to 1) improve the technical competence of the scientists; 2) familiarize participants with information contained in the USPNF and how to utilize the information to effectively perform quality control analysis; and 3) improve capacity and effectiveness of participating laboratories to identify poor-quality and counterfeit medicines.
The training was driven by the needs of the attending countries, with USP developing the program based on feedback from participants about the technical topics they wanted to see addressed.
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