Shelf-Life Of Malaria Drugs Could Be Extended

Main Category: Tropical Diseases
Article Date: 26 Feb 2009 - 2:00 PDT

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The most important malaria drug passed basic quality tests well beyond its sell-by date, indicating a potential shelf-life extension that could save many lives in the developing world, concludes a new study published today in the Malaria Journal. Artemether-lumefantrine is one of the dominant forms of artemisinin-based combination therapy (ACT) - the current standard of care for malaria. Artemisinin, a plant extract, has a 14-month production cycle from planting to extraction of the active ingredient and when used in combination therapy, has a shelf-life of only two-years. In countries where malaria is most prevalent, limited health care infrastructure complicates efforts to accurately predict demand, as well as procure, distribute, and administer medicines during their approved shelf-life. This typically results in purchasers procuring too little medicine, causing stock-outs and excess mortality, or purchasing too much medicine, causing overstock and drugs expiring on the shelf. Pharmaceutical companies face logistical challenges in managing the supply of raw materials and finished product, and suffer significant financial loses if they are forced to destroy product as a result of inaccurate forecasting.

"Our study suggests, based on the limited evidence we present, that a re-evaluation of the two-year shelf-life of artemether-lumefantrine is warranted," said Dr. Roger Bate, Legatum Fellow at the American Enterprise Institute and lead author on the study. "Our hope is that the publication of this paper will motivate the relevant companies and authorities to prioritize undertaking more detailed and thorough analyses, which would be necessary for such a change in shelf-life."

97% (68 of 70 samples) of fixed dose combination artemether-lumefantrine, between one and 58 months post-expiry, passed thin-layer chromatography, disintegration testing, and near infrared Raman spectrometry testing. These field techniques, validated as 'silver standard', are primarily used for product identification, particularly assessing counterfeit drugs, but provide enough information to indicate probable product stability. The spectrometry data provide useful measurements of apparent product degradation over time, which could be useful for future field surveys. The study's findings argue for further research using more advanced analytical techniques, the 'gold standard', before a longer shelf-life would be firmly established.

"That artemether-lumefantrine has a shelf-life of only two years poses unique logistical challenges and contributes to serious disruptions in treatment availability," said Richard Tren, Director of Africa Fighting Malaria, a non-profit advocacy group. "If the shelf-life were extended this would simplify the logistics of ACT delivery and potentially reduce the cost."

The study also found evidence that health ministry supply chains in some African countries are corrupted, whereby batches of artemether-lumefantrine, which had been sold into the public sector at concessional pricing, were illegally diverted to the private sector where they were sold for profit.

Africa Fighting Malaria is a non-profit health research and advocacy group based in South Africa and Washington DC. The research reported in this study is part of the March of Washingtons project, a campaign to assess anti-malarial drug quality and procure high-quality drugs for malarial countries in Africa.

Samples of artemether-lumefantrine were procured from pharmacies in seven malarial countries in Africa and from the researchers' own stocks. The expired medicines were tested according to protocols established in the scientific literature. The results of this study indicate that further laboratory testing using more sophisticated methodology such as high performance liquid chromatography is warranted with a view to extending the shelf-life of the products. The authors do not advocate for a shelf-life extension at this stage. The research was funded by a grant made to Africa Fighting Malaria by the Ohrstrom Foundation and by the Legatum Institute.

Article title: "Physical and chemical stability of expired fixed dose combination artemether-lumefantrine in uncontrolled tropical conditions"
Authors: Roger Bate, Richard Tren, Kimberly Hess and Amir Attaran
Journal: Malaria Journal
Available at: http://www.malariajournal.com/content/8/1/33

http://www.fightingmalaria.org

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