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Angie Drakulich was editorial director of Pharmaceutical Technology.
USP helps to improve drug quality in 32 countries.
The US Pharmacopeia has been helping to improve the quality of healthcare in developing countries for some time. Its most recent program, supported by the US Agency for International Development (USAID), is called Promoting the Quality of Medicines (PQM).
The five-year program began in 2009 and focuses on improving access to quality medicines for people around the world. PQM picks up, in part, where the pharmacopeia's Drug Quality and Information Program leaves off—that program began in 2000 and ended this past December—with the additional benefit of building national capacity to monitor drug quality from the product's manufacture to the end user.
PQM staffers work with local governments, USAID missions and partners, the World Health Organization, the US Centers for Disease Control and Prevention, and the Global Pharma Health Fund, to advance strategies to improve drug quality and use; to increase access to current, evidence-based drug information; and to provide technical leadership. The program is running in 32 countries, which are based on USAID's list of priority countries across four regions (Africa, Asia, Latin America and the Caribbean, and Europe).
PQM starts by assessing a country's ability to ensure drug quality and thereby, secure the public health. Scientists associated with the program look at things like regulation, registration, laboratory control, and distribution. Once the evaluation is complete, PQM staff members work with policymakers and country authorities to address weaknesses in the drug quality monitoring system.
Because it's hard to monitor and control important information about drug usage as well as on adverse events in the developing world, PQM also works with national authorities to produce workshops on pharmacovigilance. Anticounterfeiting workshops and public awareness campaigns (see www.youtube.com/uspharmacopeia for video demonstrations) are also part of PQM's work.
According to USP, the greatest challenges in improving health outcomes in developing countries are the lack of access to quality assured medicines, the irrational use of life-saving medicines, and the accompanying potential consequences, such as developing resistance to those medicines.
"The lack of adequate pharmaceutical systems to manage the storage and distribution of needed medicines to remote areas in a timely manner impedes their effectiveness in rural settings," says Patrick Lukulay, director of PQM. "In addition to pharmaceutical interventions, hygiene, and nutrition are also critical in effecting positive health outcomes."
Further efforts that would be helpful to address these barriers, says Lukulay, are coordination of donor efforts for maximum impact within countries and a focus on building sustainable country systems.
"Putting effective mechanisms in place increases country capacity to manage pharmaceutical commodities and encourages country ownership of major transformational initiatives," he adds.