The American Journal of Tropical Medicine and Hygiene has released a special supplement that includes 17 articles on falsified and substandard medicines. This special issue covers a range of findings on the state of substandard medicines around the world.
Most of the articles address the issue of poor quality malaria drugs and were the focus of a discussion held at the University of North Carolina at Chapel Hill's Gillings School of Global Public Health.
"These important scientific papers have been released just ahead of World Malaria Day, a time for everyone to pause and take stock of efforts to combat this global killer," said American Society of Tropical Medicine and Hygiene (ASTMH) president Dr Chris Plowe. "The findings on substandard drugs are an especially sharp reminder of how much we still have to do. We've come a long way in reducing malaria deaths in many countries. But if we lose momentum, those gains will be reversed – it has happened before. We need to be relentless."
Scientists say the global pandemic of fake medicines poses an urgent risk. Poor quality medicines are a real and urgent threat that could undermine decades of successful efforts to combat HIV/Aids, malaria and tuberculosis, according to the journal’s editors. Scientists report up to 41% of specimens failed to meet quality standards in global studies of about 17,000 drug samples. Among the collection is an article describing the discovery of falsified and substandard malaria drugs that caused an estimated 122,350 deaths in African children in 2013. Other studies identified poor quality antibiotics, which may harm health and increase antimicrobial resistance. However, new methodologies are being developed to detect problem drugs at the point of purchase and show some promise, scientists say.
Seventeen articles in all, detailing various aspects of the issue and proposing possible solutions, are included in the special journal supplement. Several articles suggest policy interventions, including an international framework and the adoption of stricter national laws against drug counterfeiting.
"This problem continues to spread globally, creating an even greater challenge to cooperation among stakeholders, many with limited resources," noted the supplement’s co-editor, Dr Joel Breman, senior scientist emeritus at the National Institutes of Health's Fogarty International Centre. "The need is urgent for collaboration among those with expertise in policy, science, technology, surveillance, epidemiology and logistics, in order to secure global supply chains."
In an introductory essay, former US Food and Drug Administration commissioner Dr Margaret Hamburg, says globalisation has added layers of complexity to the drug supply chain that require greater oversight. "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 Hamburg.
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, as shown by field studies in the supplement," says Dr Jim Herrington, co-editor of the supplement and director of the University of North Carolina's Gillings Global Gateway at Chapel Hill.
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. All of these promising tools require further testing to provide a greater evidence base to guide policymakers, the authors say.
An urgent and coordinated international response is required to address the pandemic of poor quality drugs, the scientists maintain. Policy proposals include a global agreement, similar to the Framework Convention on Tobacco Control and stricter national laws to prosecute those who knowingly sell counterfeit medicines.
[link url="http://astmh.org/Content/NavigationMenu/Publications/ASTMHNews/AJTMHFakeDrugsSupplement/default.htm"]American Society of Tropical Medicine and Hygiene material[/link]
[link url="http://astmh.org/Content/NavigationMenu/Publications/ASTMHNews/AJTMHFakeDrugsSupplement/default.htm"]American Journal of Tropical Medicine and Hygiene abstracts[/link]
[link url="http://www.fic.nih.gov/News/Pages/2015-global-pandemic-of-fake-medicines-poses-urgent-risk.aspx"]National Institutes of Health material[/link]