With globalization blurring the line between domestic and foreign medicine production, poor quality medicines are a real and urgent global threat, claims a new research.
In global studies of about 17,000 drug samples, 41% of specimens failed to meet quality standards, the researchers reported. Prevalence of poor quality medicines could undermine decades of successful efforts to combat HIV/AIDS, malaria and tuberculosis.
"Today's medical-product landscape blurs the line between domestic and foreign production, drawing attention to the need for global quality and safety oversight to prevent patient exposure to falsified products," wrote Margaret Hamburg, foreign secretary of the Institute of Medicine, the health arm of the US National Academy of Sciences.
Scientists inspected the quality of about 16,800 samples of anti-malarials, anti-tuberculosis medicines, antibiotics and anti-leishmaniasis drugs and reported from 9 to 41% failed to meet the specifications.
Seven separate studies were carried out, primarily in low-resource settings, and included samples from public and private sources.
"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 non-existent," Jim Herrington from the University of North Carolina noted.
New methodologies to test drug quality are emerging and scientists reported the results of four investigations. Simple paper-based test cards proved to be an economical and portable method to identify very low quality anti-malarials.
More sophisticated approaches using fluorescent and luminescent techniques or other novel technologies can measure with greater precision but may be difficult to use in remote settings, the authors noted.
An urgent and coordinated international response is required to address the pandemic of poor quality drugs, the scientists maintained.
The findings were published online ahead of print by The American Journal of Tropical Medicine and Hygiene