Three articles co-authored by researchers at the US Pharmacopeial Convention (USP) were published in a supplement to the American Journal of Tropical Medicine and Hygiene (AJTMH), “The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Perspectives," which examined the global extent of poor quality medicines in the developing world. The supplement was co-edited by USP’s Gaurvika M.L. Nayyar, National Institutes of Health’s Joel Breman, and University of North Carolina at Chapel Hill’s Jim Herrington, and draws attention to 17 studies on the global proliferation of substandard and falsified medicines.
Nayyar and the ATJMH supplement co-editors contributed a summary and acknowledgements article. They also authored an article entitled “Responding to the Pandemic of Falsified Medicines,” which offers policy perspectives. In another article, Mustapha Hajjou and other USP colleagues, present results of a large-scale analysis of medicines quality conducted in Africa, Asia, and South America.
This analysis was based on joint activities between countries’ health authorities and the Promoting the Quality of Medicines (PQM) program, a collaborative agreement between the US Agency for International Development (USAID) and USP.
According to the article by Hajjou and colleagues, poor quality medicines identified through medicines quality monitoring (MQM) programs in 17 countries suggest that poor quality medicines pose global threats. In Africa, Asia and South America, 10%, 3.5%, and 11.5% of medicines tested for quality, respectively, were found to be poor quality.Through its collaborations with these countries, PQM collected quality data on 15,063 medicines that were sampled at hundreds of sites in rural and urban areas, and across public and private sectors. Analysis of data from 2003 to 2013 revealed that 5.6% of the samples were either substandard—meaning they failed quality testing, failed visual inspection or were expired—or falsified (counterfeit). In these regions, which include many of the world’s most endemic areas for malaria, 6.5% of antimalarials were found to be poor quality.
PQM’s work on the frontlines of discovering poor quality medicines and facilitating countries’ action against them has provided some evidence of this global trend, while simultaneously how to combat it. Through the Medicines Quality Database (MQDB), PQM provides open access to data collected from their MQM programs. Since PQM researchers use harmonized methods to ensure that medicines samples are tested and collected the same way at all sites across all countries, the MQDB is a useful tool for gaining national, regional, and even global insights on the extent and nature of poor quality medicines. Currently, PQM’s post-marketing surveillance activities only test the quality of a small proportion of medicines on the market in these regions. Increased collaboration with country governments and donor support are needed to strengthen this and other regulatory functions in these regions, according to an USP press statement.