Backgound: Sulphadoxine/sulphalene-pyrimethamine (SP) was adopted in Kenya as first line therapeutic for uncomplicated malaria in 1998. By the second half of 2003, there was convincing evidence that SP was failing and had to be replaced. Despite several descriptive investigations of policy change and implementation when countries moved from chloroquine to SP, the different constraints of moving to artemisinin-based combination therapy (ACT) in Africa are less well documented. Methods:A narrative description of the process of anti-malarial drug policy change, financing and implementation in Kenya is assembled from discussions with stakeholders, reports, newspaper articles, minutes of meetings and email correspondence between actors in the policy change process. The narrative has been structured to capture the timing of events, the difficulties and hurdles faced and the resolutions reached to the final implementation of a new treatment policy.Results: Following a recognition that SP was failing there was a rapid technical appraisal of available data and replacement options resulting in a decision to adopt artemether-lumefantrine (AL) as the recommended first-line therapy in Kenya, The article examines why it took over 32 months from announcing a drug policy change to completing early implementation. Reasons included: lack of clarity on sustainable financing of an expensive therapeutic for a common disease, a delay in release of funding, a lack of comparative efficacy data between AL and amodiaquine-based alternatives, a poor dialogue with pharmaceutical companies with a national interest in antimalarial drug supply versus the single sourcing of AL and complex drug ordering, tendering and procurement procedures. Conclusion:Decisions to abandon failing monotherapy in favour of ACT for the treatment of malaria can be achieved relatively quickly. Future policy changes in Africa should be carefully prepared for a myriad of financial, political and legislative issues that might limit the rapid translation of drug policy change into action.

Abstract. A key bench mark of successful therapeutic policy implementation, and thus effectiveness, is that the recommended drugs are available at the point of care. Two years after artemether-lumefathrine (AL) was introduced for the management of uncomplicated malaria in Kenya, we carried out a cross-sectional survey to investigate AL availability in government facilities in seven malaria-endemic districts. One of four of the surveyed facilities had none of the four AL weight-specific treatment packs in stock; three of four facilities were out of stock of at least one weight-specific AL pack, leading health workers to prescribe a range of inappropriate alternatives. The shortage was in large part caused by a delayed procurement process. National ministries of health and the international community must address the current shortcomings facing antimalarial drug supply to the public sector.The widespread failure of chloroquine and sulfadoxine pyrimethamine (SP) in the treatment of malaria in Africa during the late 1990s resulted in a turbulent public health debate, which led to universal acceptance that mono-therapies that failed to cure up to one in four patients should be replaced by highly efficacious artemisinin-based combination therapy (ACT). 1-3 More than 40 countries in Africa have now adopted ACT as their first line treatment recommendation for uncomplicated malaria. 4 Beyond the difficulties of changing national treatment policies, a key bench mark of successful policy implementation, and thus effectiveness, is that the recommended drugs are available at the point of care. [5][6][7] In most countries, ACTs are supplied only to the public, formal health sector managed by the government and its mission sector partners. In 2006, Kenya implemented a change in malaria treatment policy in all public facilities from SP to the ACT artemetherlumefantrine (AL), largely supported by the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM). 7 Two years after AL introduction, we carried out a crosssectional survey to investigate AL availability in government facilities. From August 18 through October 2, 2008, 164 facilities (115 dispensaries, 30 health centers, and 19 hospitals) were assessed in seven districts in Nyanza, Western, and Coast Provinces, Kenya, that were highly endemic for malaria. At each facility, information was collected on the availability of AL packs for the four patient weight groups either through direct review of stock cards or through phone interviews. Health workers were also asked what they prescribed in the absence of AL.One (25.6%) of four of the surveyed facilities had none of the four AL weight-specific treatment packs in stock, with such complete stockouts more common in dispensaries (30.4%) than in health centers (20.0%) and hospitals (5.3%). Furthermore, three (75.0%) of four facilities were out of stock of at least one weight-specific AL pack (Table 1 ). It was particularly worrying that packs for the youngest age group, the group most at risk of malaria mortality, were absent...

Summary Objectives  To examine access to, timing and use of artemisinin‐based combination therapy among rural Kenyan febrile children before and following the introduction of artemether‐lumefantrine (AL) as first‐line antimalarial drug policy. Methods  In August 2006, a cohort was established within 72 rural clusters in four sentinel districts to monitor the period prevalence of fever and treatment in children aged 0–4 years through four repeat cross‐sectional surveys (one prior to introduction of AL and three post‐AL introduction: January–June 2007). Mothers/guardians of children were asked about fever in the last 14 days and related treatment actions including the timing, drugs used, dosing and adherence supported by visual aids of commonly available drug products. Results  A total of 2526 child‐observations were recorded during the four survey rounds. The period prevalence of fever was between 20% and 26% with little variation between survey rounds. The overall proportion of children with fever receiving antimalarial drugs for their fever was 31 % (95% CI, 26–36%) and the proportion of febrile children receiving antimalarial drugs within 48 h was 23.3% (95% CI, 18.6–28.0%). The proportion of febrile children who received first‐line recommended AL within 48 h was 10.2% (95% CI, 7.0–13.4%), compared to only 4.6% (95% CI, 3.8–5.4%) of children receiving sulphadoxine‐pyrimethamine first‐line therapy in 2001. Conclusions  Although Kenya was less than a year into the new policy implementation and AL is restricted to the public formal sector, access to antimalarial drugs among children within 48 h and to the first‐line therapy has improved. But it remains well below national and international targets. The continued use of amodiaquine and artemisinin monotherapies constrains effective implementation of artemisinin‐based combination therapy policy in Kenya.

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