Abstract
BackgoundSulphadoxine/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.MethodsA 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.ResultsFollowing 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, announced in April 2004. Funding requirements were approved by the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) and over 60 million US$ were agreed in principle in July 2004 to procure AL and implement the policy change. AL arrived in Kenya in May 2006, distribution to health facilities began in July 2006 coincidental with cascade in-service training in the revised national guidelines. Both training and drug distribution were almost complete by the end of 2006. 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.ConclusionDecisions 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.
Highlights
In recent years the threat posed by failing, but inexpensive, antimalarial monotherapies led to an international effort to replace these drugs with relatively more expensive but considerably more effective artemisinin-based combination therapies (ACTs) for the management of uncomplicated malaria [1,2,3]
Establishing the evidence and basis for drug policy change Following the official transition from CQ to SP in 1998 the Ministry of Health (MoH)'s Division of Malaria Control (DOMC) and research partners maintained a series of surveillance studies on the sensitivity of SP and amodiaquine (AQ) [9,10], the recommended first and second-line treatments for uncomplicated malaria respectively
By 2001, the year the National Malaria Strategy was officially launched, concerns were raised about growing evidence of a decline in SP clinical efficacy as measured through the standard World Health Organization (WHO) day 14 clinical and parasitological sensitivity test
Summary
In recent years the threat posed by failing, but inexpensive, antimalarial monotherapies led to an international effort to replace these drugs with relatively more expensive but considerably more effective artemisinin-based combination therapies (ACTs) for the management of uncomplicated malaria [1,2,3]. Several authors have commented on the difficulties facing national antimalarial drug policy change when these changes involved moving from one inexpensive failing drug, such as chloroquine (CQ) to an widely available, inexpensive but more efficacious monotherapy such as sulphadoxine-pyrimethamine [4,5,6,7,8]. These observations during the 1990's and early 2000's highlighted the complexity of drug policy change and implementation for malaria case-management in Africa. This paper reviews the evidence used to effect this policy change and the political and economic challenges facing the Kenyan MoH prior to and during the implementation of the policy 32 months after the policy change was announced
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