The US Agency for International Development (USAID) and the US Pharmacopeial Convention (USP) recently announced a new program designed to fight the growing problem of substandard and counterfeit drugs in developing countries. The $35-million program, called Promoting the Quality of Medicines (PQM) will work to improve the safety of medicines in approximately 30 countries worldwide by working to strengthen regulatory bodies, increasing the supply of legitimate products, detecting and reducing availability of counterfeits through testing and other methods, and raising public awareness of the dangers of substandard drugs.

“Without good quality, safe medicines to treat diseases such as HIV/AIDS, malaria and tuberculosis, the impact of other health initiatives may be weakened. The PQM program focuses on this critical aspect of combating these diseases,” Gloria Steele, USAID acting assistant administrator for global health, said in a press release.

“The lives of patients are put in serious jeopardy when they take substandard or counterfeit drugs,” Roger L. Williams, MD, chief executive officer of USP, said in a press release. “Such ‘medicines’ have health as well as economic implications. Moreover, substandard medicines contribute to the development of drug-resistant strains of infectious diseases. Such strains are a leading challenge in the fight against malaria, HIV/AIDS and tuberculosis.”

The PQM program is an expansion of a previous collaborative effort between the two organizations called the Drug Quality and Information (DQI) program. Like the DQI program, PQM will be managed by Patrick Lukulay, PhD, director of drug quality and information at USP, who will work with USAID’s Office of Health, Infectious Diseases, and Nutrition, under the direction of Anthony Boni.

Lukulay told Pharmaceutical Technology that the goals of the PQM program are to build capacity in developing countries to improve quality of pharmaceuticals and quality-control testing, to raise awareness of the importance of drug quality and advise people on how to safely buy medicines, and to conduct research in developing countries on the quality of drugs available on the market.

Lukulay also discussed some future projects of the program, such as the upcoming publication of the results of a study about the quality of malaria drugs in Sub-Saharan Africa and the development of a program that would provide reference material at a reduced cost to African countries to aid in quality testing. PQM is also working on the development and promotion of technology to detect counterfeit drugs using hand-held spectroscopic devices, which provide a nondestructive method of finding fake drugs that is significantly faster than traditional wet-chemistry methods. He also discussed the group’s work in creating adverse-drug-reaction data sheets for use in developing countries and PQM’s efforts to gather pharmacovigilance data.

“We are excited about PQM because it is going to give us the opportunity to expand on the work we started over the past decade,” Lukulay said. Some examples of DQI initiatives include the establishment of large-scale continuous monitoring program for quality in Latin America, Africa, and Asia, which led to the seizure of counterfeit versions of the antimalaria drug Coartem (Novartis) from pharmacies in Ghana in July 2009; increasing the capacity of quality control and testing systems in Asia after finding a significant amount of substandard drugs in the Greater Mekong Subregion in 2003; and helping the Global Drug Facility to increase the availability of good quality second-line anti-tuberculosis medicines at affordable prices. Through the DQI’s work in Latin America, Africa, and Asia, he said they are “starting to see an impact.” The new PQI program will allow work to expand into Eastern Europe as well.

“This program allows us to finish the job we have started,” Lukulay said.