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APHA Scientific Session and Event Listing

Recorded presentation

Jennifer C. Murphy, PharmD and Souly Phanouvong, PharmD, PhD. Drug Quality and Information Program, International Affairs Department, United States Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, 301-816-8592, jcm@usp.org

It is estimated that 10% of commercially available drugs worldwide are fake or counterfeit, with that number increasing to as many as 25% in developing countries, resulting in significantly increased morbidity and mortality. Additionally, the loss of public confidence in the healthcare system is another, less tangible but equally important, consequence. This is of particular concern in Southeast Asia, where a majority of counterfeit products are those indicated in the treatment of serious, and potentially fatal, infectious diseases like malaria, tuberculosis and HIV/AIDS. In fact, the continued use of substandard antimalarial drugs is considered a significant contributing factor in the development of multi-drug resistant strains of malaria. The United States Pharmacopeia Drug Quality and Information Program, in cooperative agreement with the United States Agency for International Development, and in conjunction with regional drug regulatory authorities and the World Health Organization Regional and Country offices, began a drug quality monitoring project to help improve the quality of antimalarials. Thus far, the project reveals an alarming situation. For example, 44% of quinine samples in Cambodia and 41% of artesunate tablets in Laos (all collected from sentinel sites) were determined to be substandard or fake. This presentation will therefore discuss the: 1) estimated prevalence of counterfeit drugs in developing countries; 2) drug quality monitoring program in the Mekong region; and 3) public health ramifications of antimicrobial resistance, especially in relation to infectious diseases. This project is expanding to include other infectious disease agents, including selected antituberculosis, antiretroviral and antibiotic drugs.

Learning Objectives:

• Define substandard and counterfeit drug products.
• Identify four contributing features to poor drug quality assurance and drug quality control programs, common in developing countries.
• Discuss the potential impact of counterfeit or fake drugs on malaria regarding the likely consequences of future treatment options and on antimicrobial resistance in general.

Keywords: Infectious Diseases, Developing Countries

Related Web page: www.uspdqi.org/

Presenting author's disclosure statement:

Any relevant financial relationships? No

Recorded presentation