Fake, Poor Quality Malaria Drugs Threaten Progress
The study was funded by the Fogarty International Center at the US National Institutes of Health in Bethesda, Maryland, where co-author Dr Joel Breman is Senior Scientist Emeritus. He told the press:
"Poor quality antimalarial drugs are very likely to jeopardize the unprecedented progress and investments in control and elimination of malaria made in the past decade."
The emergence of malaria strains that are now resistant to artemisinin drugs on the border between Thailand and Cambodia border means it is imperative that we improve the drug supply to these regions, say Breman and colleagues.
Drugs based on artemisinin are currently the most effective treatment against the malaria parasite, and any reports that it is developing resistance to them will cause great alarm. Analyses suggest that an important driver in the spread of drug resistance is underdosing of patients, such as through use of poor quality or fake drugs.
For the study, Breman and colleagues examined data from published and unpublished studies reporting chemical analyses and assessments of packaging of antimalarial drugs available across Southeast Asia and sub-Saharan Africa.
They found that between 20 and 42% of the drugs were either poor quality or fake.
Poor quality samples include: falsified drugs that are fraudulently manufactured with fake packaging and usually contain no active ingredient or the wrong one; substandard products that are poorly manufactured with either not enough or too much active ingredient; and degraded supplies which start out as good quality but then deteriorate because of poor storage and handling.
From seven countries in Southeast Asia, the resarchers found of 1,437 samples of drugs in five classes: "497 (35%) failed chemical analysis, 423 (46%) of 919 failed packaging analysis, and 450 (36%) of 1260 were classified as falsified".
From 21 countries in sub-Saharan Africa, they found in 21 surveys of drugs from six classes: "796 (35%) of 2,297 failed chemical analysis, 28 (36%) of 77 failed packaging analysis, and 79 (20%) of 389 were classified as falsified".
"Data were insufficient to identify the frequency of substandard (products resulting from poor manufacturing) antimalarial drugs, and packaging analysis data were scarce," write the researchers.
They also note that in regions where malaria is common, antimalaria drugs are widely available, and often self-prescribed, either wrongly or correctly. And, the facilities for monitoring the quality of drugs is poor, and there is low awareness among consumers and healthworkers about the treatments.
Plus there is no regulatory oversight of manufacturing and counterfeiters aren't punished, they add, concluding that:
"Concurrent interventions and a multifaceted approach are needed to define and eliminate criminal production, distribution, and poor manufacturing of antimalarial drugs. Empowering of national medicine regulatory authorities to protect the global drug supply is more important than ever."
Breman and colleagues also point out that it is difficult to assess the size of the problem worldwide because there are no reliable global estimates and no internationally accepted criteria for what constitutes inadequate drugs. There are no standard protocols for testing them or specifying their content, and there are no international scientific and technical meetings to give oversight.
"These findings are a wakeup call demanding a series of interventions to better define and eliminate both criminal production and poor manufacturing of antimalarial drugs," said Breman.
Written by Catharine Paddock PhD
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"Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa"; Gaurvika ML Nayyar, Joel G Breman, Paul N
Newton, James Herrington; The Lancet Infectious Diseases June 2012, Vol. 12 No. 6 pp 488-496; DOI:10.1016/S1473-3099
(12)70064-6; Link to
Additional source:NIH/Fogarty International Center.
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