May Pave the Way for Expanded Support to Developing Countries
ROCKVILLE, Md., Feb. 8, 2011 /PRNewswire-USNewswire/ -- Recognizing the vital importance of quality-assured medicines to patients and healthcare providers, the U.S. Pharmacopeial Convention (USP) today announced it has launched a pilot Technical Assistance Program (TAP) to provide developing countries with greater capacity to test the quality of medicines. Under the TAP, participating countries will receive 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. This assistance will further enable participating countries in their efforts to improve the quality of medicines for their citizens. It formalizes and expands upon previous contributions and subsidies USP has made around the world.
While a larger program is envisioned that also may include other countries, regions and elements, the program launch focuses on five sub-Saharan African countries: Ethiopia, Ghana, Kenya, Senegal and Sierra Leone. Each country has committed to improving public health through the activities of its drug quality control laboratories and the TAP will strengthen such efforts by providing tools and training to extend the reach and effectiveness of these laboratories. Many of the pilot countries have been working with USP's Promoting the Quality of Medicines (PQM) program, funded by USAID, which collaborates with local authorities to detect and remove substandard and counterfeit medicines from the market through technical support and public awareness outreach. USP's TAP will complement and reinforce the work done through PQM.
"I am very pleased that USP is able to launch this important pilot program in support of vulnerable populations," said Roger L. Williams, M.D., USP's chief executive officer. "The ability to test essential medicines using good quality standards is a crucial component of efforts to improve public health. The countries in this pilot are committed to strengthening drug quality and lack of key resources should not stand in their way. As a physician, I'm particularly interested in the broadest possible access to high quality, affordable medicines."
USP and other pharmacopeias—for example, those of the European Union, Japan and Great Britain—typically sell reference and documentary standards for use by pharmaceutical manufacturers and quality control laboratories. Laboratories with limited resources may have to fall back on outdated, secondary or inadequately documented standards, which in turn may compromise quality testing. The USP TAP is intended to make such measures unnecessary.
"In Ghana, we are committed to improving public health by many means, and one very important approach is helping to ensure that the medicines people take are of good quality," said Stephen Opuni, M.D., chief executive officer of the Ghana Food and Drugs Board. "We have worked extensively with USP's PQM to identify and remove substandard and counterfeit drugs from our markets. This new USP initiative will help us to test drugs against the most modern and scientifically established standards, which in turn will strengthen our public health programs. While I speak only for Ghana, the same is true for the other countries in this pilot program as well."
Patrick Lukulay, Ph.D., director of the PQM program, agreed: "Without good reference standards, test results produced by laboratories are questionable at best. USP's Technical Assistance Program will increase the extent and scope of quality control and regulators will be able to exercise better oversight of medicines quality in their markets. Additionally, testing against modern standards will help resource-constrained countries to, in effect, collaborate in the fight against counterfeit and substandard medicines. These efforts complement our work supported by USAID."
At the end of the 12-month pilot, USP and the five medicines quality control laboratories will assess progress in such areas as number and variety of drug samples tested; number of substandard or counterfeit drugs detected; and improved access to quality medicines. USP is emphasizing the need to measure, evaluate, and document activities and outcomes resulting from TAP projects. If the pilot is successful, support may be renewed or expanded with the initial participants and the program also may be extended to other countries and include additional features.
To hear more from Dr. Lukalay about USP's TAP, please go to http://www.youtube.com/watch?v=4S7Bq8Vcck4.
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SOURCE U.S. Pharmacopeial Convention