E-DRUG: Shortage of ACT for malaria (5)
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WHO's press release of November 8 ("Surge in Demand Leads to Shortage of Artemisinin-Based Combination Therapy for Malaria") prompted several responses on this network. I wish to address some of the concerns and a few misunderstandings expressed in those messages.
The current demand for artemether-lumefantrine comes as no surprise to WHO.
We forecasted it. What did come as a surprise is the shortage of artemisinin from Chinese suppliers needed to produce this drug, which was communicated to us by Novartis.
We would like to make it clear that if WHO had evidence that Novartis was in breach of its agreement with us regarding artemether-lumefantrine supply, we would take necessary measures.
The current shortage of artemether-lumefantrine is a serious problem for countries that have adopted this medicine as their first-line therapy.
WHO's general recommendation to these countries is to turn to their second-line treatment -- which in most cases is quinine -- in the interim.
Quinine does indeed require three daily doses for seven days. However, it is quite effective, it is registered in the countries concerned, and health workers and consumers in malaria-endemic countries know how to use it. As the problem is expected to be of short duration, this is a more feasible solution than the temporary introduction of alternative ACTs.
Artemether-lumefantrine is the only ACT to have been pre-qualified to date, and Novartis is its sole manufacturer. However, as clearly stated in the WHO press release, there are three other ACTs recommended by WHO:
artesunate-amodiaquine, artesunate-SP and artesunate-mefloquine.
Manufacturers of these drugs are making progress towards prequalification, but have not yet satisfied all criteria. In the meanwhile, WHO and UNICEF are currently procuring these drugs -- which are produced in accordance with good manufacturing practices -- on behalf of countries that have adopted them. We consider prequalification a vital goal, but we also recognize the need for countries in need to procure ACTs now.
WHO and Roll Back Malaria partners are working with the pharmaceutical industry to promote production of quality ACTs in quantities corresponding to world market demand. We hope and expect that there will soon be multiple sources of prequalified products.
Judith Mandelbaum-Schmid
Communications Officer
Roll Back Malaria, WHO
schmidj@who.int