AsianScientist (May 22, 2012) – Nearly 40 percent of the malaria drugs sold across Southeast Asia are either poor quality or fake, according to a National Institutes of Health (NIH) study published today in The Lancet Infectious Diseases journal.
Poor quality antimalarial drugs lead to drug resistance and inadequate treatment in vulnerable populations, the authors say. They stress that the emergence of malaria strains that are resistant to artemisinin drugs on the Thailand-Cambodia border make it imperative to improve the drug supply.
“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,” said co-author Dr. Joel Breman, senior scientist emeritus at NIH’s Fogarty International Center.
Poor quality samples were classified as falsified, substandard, or degraded. Falsified products include drugs that were manufactured with fake packaging and usually no or wrong active ingredient. Substandard products were poorly manufactured with inadequate or too much active ingredient. Degraded supplies are good quality drugs that were compromised by poor storage.
Multicountry surveys from seven Southeast Asian countries included data on 1,437 samples of malaria drugs, which showed about one third failed chemical analysis, nearly half were not correctly packaged, and 36 percent were fakes.
In regions where malaria is prevalent, antimalarial drugs are widely distributed and self-prescribed, incorrectly or correctly. The study found there are insufficient facilities to monitor the quality of antimalarial drugs and poor consumer and health-worker knowledge about the therapies.
In addition, there is a lack of regulatory oversight of manufacturing and little punitive action for counterfeiters, the paper’s authors contend.
No reliable global estimates are available on the extent of poor-quality antimalarial drugs because there are no internationally accepted definitions of different types of inadequate drugs, no standard testing protocols or drug content requirements; and no recognized international forum to provide technical and scientific oversight, the study reported.
Artemisinin derivatives are the most effective drugs against malaria, which is why scientists are so concerned at reports from western Cambodia that there are signs of resistance or tolerance to them. Modeling analyses suggest under dosing of patients, through poor quality or fake drugs, can play an important part in the spread of drug resistance.
“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.
The article can be found at: Nayyar GML et al. (2012) Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa.
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Source: NIH.
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