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Regulatory action needed to stop the sale of oral artemisinin-based monotherapy
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Regulatory action needed to stop the sale of oral artemisinin-based monotherapy
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Regulatory action needed to stop the sale of oral artemisinin-based monotherapy
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Journal Article
Regulatory action needed to stop the sale of oral artemisinin-based monotherapy
2010
Overview
Continued use of oral artemisinin-based monotherapy is widely considered as one of the main contributing factors to the development and spread of resistance to artemisinin and its derivatives. Few patients take the full seven-day course of monotherapy required to achieve high cure rates - most patients tend to discontinue treatment after two or three days due to the rapid resolution of symptoms provided by artemisinin. This results in persistent parasitaemia exposed to sub-therapeutic drug levels. In 2007, the World Health Assembly adopted a resolution to progressively remove oral artemisinin-based monotherapy from the market and instead deploy artemisinin-based combination therapies (ACTs) for the treatment of uncomplicated falciparum malaria. While 34 countries have withdrawn marketing authorization for oral artemisinin-based monotherapy, 29 countries have not yet taken regulatory action. Out of 73 companies involved in the production and marketing of these medicines, a total of 36 companies have de-listed oral artemisinin-based monotherapy from their product catalogues but 37 companies - mainly those targeting the private sector markets of malaria-endemic countries - are still actively providing monotherapy in this sector. Progress made by regulatory authorities at country level shows that phasing out oral artemisinin-based monotherapy from the market is possible through a range of interventions as long as government commitment and strong stewardship of the national regulatory authorities is maintained. [PUBLICATION ABSTRACT]
