[e-drug] What's a counterfeit? And how many counterfeit drugs are there?

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E-DRUG: What's a counterfeit? And how many counterfeit drugs are there?
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This KEI blog, "What's a counterfeit? And how many counterfeit drugs
are there?" is a comment on an article by Gaurvika ML Nayyar, Joel G.
Breman, Paul N. Newton, and James Herrington in the June 2012 issue of
Lancet Infectious Diseases, titled "Poor-quality antimalarial drugs in
southeast Asia and sub-Saharan Africa." Jamie

http://www.keionline.org/node/1425

[Moderator: Article abstract inserted below. There is also a commentary in the same issue, see title and preview at the bottom]

http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(12)70064-6/abstract

Abstract
Poor-quality antimalarial drugs lead to drug resistance and inadequate treatment, which pose an urgent threat to vulnerable populations and jeopardise progress and investments in combating malaria. Emergence of artemisinin resistance or tolerance in Plasmodium falciparum on the Thailand—Cambodia border makes protection of the effectiveness of the drug supply imperative. We reviewed published and unpublished studies reporting chemical analyses and assessments of packaging of antimalarial drugs. Of 1437 samples of drugs in five classes from seven countries in southeast Asia, 497 (35%) failed chemical analysis, 423 (46%) of 919 failed packaging analysis, and 450 (36%) of 1260 were classified as falsified. In 21 surveys of drugs from six classes from 21 countries in sub-Saharan Africa, 796 (35%) of 2297 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. 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.

Seear M. (Commentary). Pharmaceutical quality: an urgent and unresolved issue. Lancet Infect Dis June 2012

Selling of substandard and counterfeit drugs has been an issue ever since an early herbalist's assistant noted that one pile of dry herbs looked much like another. The only changes have been the increasing expertise and extent of the problem. The international response to counterfeit drugs began with a 1988 World Health Assembly resolution that called for WHO to help prevent and detect the spread of so-called substandard/spurious/falsely-labelled/falsified/counterfeit drugs.1 This and subsequent resolutions culminated in an international meeting in 2006, which resulted in the Declaration of Rome2 and the International Medical Products Anti-Counterfeiting Taskforce (IMPACT).