Bate Roger, Hess Kimberly, Tren Richard, Mooney Lorraine, Cudjoe Franklin, Ayodele Thompson, Attaran Amir
American Enterprise Institute, Washington, DC, USA,
Africa Fighting Malaria, Washington, DC, USA,
Res Rep Trop Med. 2012 Jul 17;3:63-68. doi: 10.2147/RRTM.S33690. eCollection 2012.
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.
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.
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.
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.
“可负担药品设施-疟疾”（AMFm）是一种补贴机制，旨在降低最佳抗疟药物（以青蒿素为基础的联合疗法，ACTs）的价格，从而增加其可及性。虽然AMFm规定只有质量经批准的产品才有资格获得补贴，但尚不清楚这些产品在实际供应时是否质量良好，是否符合关于制剂和活性成分含量的既定药典指南。本研究旨在评估AMFm的ACTs的价格和质量，将AMFm的ACTs与非AMFm的ACTs及青蒿素单一疗法进行比较，并评估AMFm的ACTs是否被盗用并转移到附近国家。
总共从尼日利亚拉各斯和加纳阿克拉的37家药店获取了140种以青蒿素为基础的抗疟药物。另外从多哥洛美（未参与AMFm）收集了10份AMFm的ACTs样本。使用高效液相色谱法对样本进行分析。
AMFm的ACTs价格低于所收集的许多其他药物，但低于尼日利亚和加纳参与政府预期或规定的幅度。AMFm的ACTs质量并非普遍良好：总体而言，7.7%的产品活性药物成分（API）含量过低，没有产品含量过高——这些结果不太可能是随机产生的。还发现AMFm的ACTs被转移，既转移到了拉各斯未参与AMFm的药店，也转移到了AMFm未实施的外国城市（洛美）。
AMFm充其量只是不完美地取代了不受欢迎的单一疗法，其中一部分被API不足的ACTs所取代，而这些ACTs往往以超过政府授权的价格出售。以较低价格出售且API剂量低的ACTs，据推测可能涉及尼日利亚和加纳根据AMFm订购的约1亿疗程治疗，这可能对公共卫生和耐药性的传播构成担忧。
