Fake, Inferior Medicines Pose Worldwide Risks

Poor-quality medicines pose a global threat to human health that could undermine decades of progress against major diseases, including HIV/AIDS, malaria, and tuberculosis, new studies show.

Up to 41% of 17,000 samples of drugs failed to meet international quality standards, according to a special report published last week (Am. J. Trop. Med. Hyg. 2015,DOI: 10.4269/ajtmh.15-0221).

The report included 17 research papers that detail the problem and identify potential solutions for medicines that are faked, substandard at the time of manufacturing, or degraded because of poor storage conditions.

Although there is a long history of faked drugs in the developing world, the problem appears to be spreading. “The pandemic of falsified and substandard medicines is pervasive and underestimated, particularly in low- and middle-income countries where drug regulatory systems are weak or nonexistent,” explains special report coauthor James Herrington of the University of North Carolina.

Among the fake drugs identified in the studies were malaria medications, which caused the deaths of an estimated 122,350 African children in 2013 alone, and antibiotics, which increased the risk of antibiotic resistance.

The report highlights the importance of better drug detection technologies, especially for the developing world. In an accompanying editorial, former FDA commissioner Margaret A. Hamburg says a better international regulatory structure is essential to fulfill “the need for global quality and safety oversight to prevent patient exposure to falsified products.”