Physical and Chemical Stability of Expired Fixed Dose Combination Artemether-Lumefantrine in Uncontrolled Tropical Conditions

Background

Improving access to effective anti-malarial treatment is a priority of most donors, United Nations agencies and national governments. In Africa and Asia, where the disease is most prevalent, limited health care infrastructure complicates efforts to predict clinical demand, 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.

This logistical tight-rope act is more complicated than ever because chloroquine, with a shelf-life of up to five years, has been superseded as the standard of care by artemisinin-based combination therapy (ACT), such as a fixed dose combination artemether-lumefantrine (FDC-ALU), with a shelf-life of only two years. The reduction in shelflife has contributed to serious disruptions in treatment availability in clinics; reluctance among health care workers to adopt the higher standard of care; and practical questions about whether large-scale home treatment schemes for malaria are feasible. Globally, the shorter shelf-life also reduces the margin for error that pharmaceutical manufacturers and large purchasers, like health ministries, have to move in lockstep and balance demand with supply--a balance that, when upset, has caused global shortages and price spikes. . . .

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Roger Bate is a resident fellow at AEI. Richard Tren is the director of Africa Fighting Malaria. Kimberly Hess is a researcher at Africa Fighting Malaria. Amir Attaran is an associate professor and holds the Canada Research Chair in law, population health, and global development policy at the University of Ottawa.

About the Author

 

Roger
Bate
  • Roger Bate is an economist who researches international health policy, with a particular focus on tropical disease and substandard and counterfeit medicines. He also writes on general development policy in Asia and Africa. He writes regularly for AEI's Health Policy Outlook.
  • Phone: 202-828-6029
    Email: rbate@aei.org
  • Assistant Info

    Name: Julissa Milligan
    Phone: 202-862-5905
    Email: julissa.milligan@aei.org
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