May 25, 2012, 10:31 a.m.
MedWire News: Poor-quality and fake anti-malaria drugs are an "immediate and urgent threat" to global efforts to control and eliminate the disease, states a review published in The Lancet Infectious Diseases.
The review found that around 36% of anti-malaria drugs analyzed in southeast Asia and 20% of those in sub-Saharan Africa were fake.
Use of these fake or poor-quality drugs can result in drug resistance because low concentrations of active pharmaceutical ingredients leads to subtherapeutic concentrations in vivo and contributes to the selection of resistant parasites, explain Gaurvika Nayyar (National Institutes of Health, Bethesda, Maryland, USA) and co-authors of the study.
Indeed, emergence of artemisinin resistance or tolerance in Plasmodium falciparum on the Thailand-Cambodia border makes protection of the effectiveness of the drug supply imperative.
Nayyar and team examined the matter of poor-quality anti-malaria drugs, particularly the artemisinins, in a review of published and unpublished studies reporting chemical analyses and assessments of packaging of anti-malaria drugs.
Data from seven countries in southeast Asia including analyses of 1437 samples of drugs in five classes (62% artemisinins) showed that 35% failed chemical analysis, 46% failed packaging analysis, and 36% were classified as falsified (ie, fraudulently manufactured with fake packaging and usually no or a wrong active pharmaceutical ingredient.)
Of the samples that failed chemical assay analysis, 34% had no active ingredient, 4% had low active ingredient, and for 52%, the content was unreported.
Similar results were observed in surveys of over 2500 drugs from six classes from 21 countries in sub-Saharan Africa: 35% failed chemical analysis, 36% failed packaging analysis, and 20% were classified as falsified.
Nayyar and co-authors say that "consumption of falsified antimalarial drugs is related to self-treatment through the unregulated private sector, the cost and inaccessibility of good-quality antimalarial drugs, the scarcity of drug regulation, and the absence of punitive measures for counterfeiters.
"The economic incentives for criminals of drug falsification surpass the risks involved in their production and sale."
They conclude that "concurrent interventions and a multifaceted approach are needed to define and eliminate criminal production, distribution, and poor manufacturing of antimalarial drugs."
Their recommendations include increased investment in medicine regulatory authorities in Africa to encourage country ownership of the problem, adding that: "Currently, only three of the 47 malarious countries in Africa have laboratories that are equipped to chemically analyse antimalarial drugs."