Studies Show Poor Quality Medicines Pose Global Threat

Rockville, Md., April 20, 2015 ' Three articles co-authored by researchers at the U.S. Pharmacopeial Convention (USP) were published today in a Supplement to the American Journal of Tropical Medicine and Hygiene (AJTMH). Entitled 'The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Perspectives,' 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 and burden of ineffective, and potentially toxic and fatal, substandard and falsified medicines.

'USP is committed to collaborating with agencies around the world to help strengthen regulatory systems, sustainably, to ensure all people have access to safe, good quality foods and medicines,' stated Kelly S. Willis, USP's Senior Vice President for Global Public Health. 'Poor quality medicines are a serious public health issue that threatens the lives of patients worldwide and potentially undermines millions of dollars in investments in the prevention and control of malaria, tuberculosis, HIV/AIDS, and other diseases.'

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 unique 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 U.S. Agency for International Development (USAID) and USP. In distinct ways, the three articles shed light on the global extent and burden of poor quality medicines, which to date is poorly measured and largely unknown.

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 percent, 3.5 percent and 11.5 percent 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 percent 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 percent 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 combatting it. In 2013, PQM reported that in Ghana, more than 90 percent of uterotonics (oxytocin and ergometrine)'medicines used to stop bleeding during childbirth'failed quality tests. In addition, through effective coordination, partnering and robust monitoring of medicines quality, in the Greater Mekong Sub-region, the PQM program has contributed to the reduction of falsified and substandard medicines.

'Our MQM programs have identified significant quantities of poor quality medicines in global markets for over a decade,' stated Hajjou. 'The data that we collect and share publicly has led to their removal from these markets, but clearly more work is needed to increase the availability of good quality medicines. PQM aims to intensify surveillance in these regions, not only to optimize countries' capacity to measure the extent of the problem, but also to help increase enforcement and achieve a more sustained effect.'

Through the Medicines Quality Database (MQDB), PQM provides open access to data collected from their MQM programs. Since PQM researchers utilize 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. It is freely available; http://www.usp.org/global-health-programs/promoting-quality-medicines-pqmusaid/medicines-quality-database-mqdb.

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.

Supporting sustainable regulatory system strengthening is a central component of PQM's global public health vision. The World Health Assembly's (WHA) resolutions WHA 67.20 on Regulatory System Strengthening and the WHA 65.19 that established the Member States mechanism on Substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products have provided the impetus for more focus on confronting falsified and substandard medicines. Through PQM, USP is collaborating with USAID to contribute to the global efforts.

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The U.S. Pharmacopeial Convention (USP) is a global health organization that improves lives through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP's standards are used worldwide. For more information about USP, visit http://www.usp.org.

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