Subsidizing artemisinin-based combination therapies: a preliminary investigation of the Affordable Medicines Facility - malaria.

Background: The Affordable Medicines Facility - malaria (AMFm) is a subsidy mechanism to lower the price of, and hence increase access to, the best antimalarial medicines, artemisinin-based combination therapies (ACTs). While the AMFm stipulates that only quality-approved products are eligible for subsidy, it is not known whether those products, when actually supplied, are of good quality and comport with established pharmacopeial guidance on formulation and content of active ingredients. This study aimed to assess price and quality of AMFm ACTs, to compare AMFm ACTs with non-AMFm ACTs and artemisinin monotherapies, and to assess whether AMFm ACTs have been pilfered and diverted to a nearby country.

Methods: In all, 140 artemisinin-based antimalarial drugs were acquired from 37 pharmacies in Lagos, Nigeria, and Accra, Ghana. An additional ten samples of AMFm ACTs were collected from Lomé, Togo (not participating in the AMFm). Samples were analyzed using high-performance liquid chromatography.

Results: The AMFm ACTs were lower in price than many of the other drugs collected, but by less than anticipated or stipulated by the participating governments of Nigeria and Ghana. The quality of the AMFm ACTs was not universally good: overall, 7.7% had too little active pharmaceutical ingredient (API) and none had too much - these results are not likely to be as a result of random chance. AMFm ACTs were also found to have been diverted, both to pharmacies in Lagos not participating in the AMFm and to a foreign city (Lomé) where the AMFm is not operational.

Conclusion: The AMFm is at best imperfectly displacing undesirable monotherapies, some portion of which are replaced by ACTs lacking sufficient API, which are often sold at prices exceeding government authorization. ACTs sold at a lower price with low-dose API, potentially extrapolated to approximately 100 million treatments ordered under the AMFm for Nigeria and Ghana, represent a possible concern to public health and the promotion of drug resistance.