Antimalarial therapies in endemic regions identified as poorly manufactured

In a survey of antimalarial drugs from 21 countries in sub-Saharan Africa and seven countries in Southeast Asia, many were poor quality or fake. Researchers, therefore, suggest the need for a multifaceted approach to address this issue.

“Despite a dramatic rise in reports of poor-quality antimalarial drugs over the past decade, the issue is much greater than it seems because most cases are probably unreported, reported to the wrong agencies, or kept confidential by pharmaceutical companies,” Gaurvika Nayyar, BS, of the Fogarty International Center at the NIH, said in a press release.

Nayyar and colleagues pooled data from published and unpublished studies, including chemical analyses and assessments of packaging of antimalarial drugs in sub-Saharan Africa and Southeast Asia. From Southeast Asia, there were 1,437 samples from five classes of drugs evaluated. In sub-Saharan Africa, analysis was available for 2,634 samples from six classes of drugs.

Among the drugs from Southeast Asia, 35% failed chemical analysis, 46% failed packaging analysis and 36% were considered fake. Among the drugs from sub-Saharan Africa, 35% failed chemical analysis, 36% failed packaging analysis and 20% were considered fake, according to the study abstract.

“More than 3 billion people are at risk for malaria, which is endemic in 106 countries,” Nayyar said in the press release. “Between 655,000 and 1.2 million people die every year from Plasmodium falciparum infection. Much of this morbidity and mortality could be avoided if drugs available to patients were efficacious, high quality and used correctly.”

In an accompanying editorial, Michael Seear, MD, of the British Columbia Children’s Hospital in Vancouver, Canada, called for more research to clarify the extent and cause of poor drug quality. “Drug quality is dependent on the overlapping effects of poor manufacturing standards, criminal counterfeiting, adulteration with inactive or toxic fillers, relabeling of time-expired drugs, and degradation during storage,” Seear wrote. “Reliable research concerning counterfeiting is limited, and almost no information is available about the other four factors.”

Disclosure: Ms. Nayyar and Dr. Seear report no relevant financial disclosures.