Malaria research and its influence on anti-malarial drug policy in Malawi: a case study

Mwendera et al. Health Research Policy and Systems (2016) 14:41 DOI 10.1186/s12961-016-0108-1 RESEARCH Open Access Malaria research and its influence on antimalarial drug policy in Malawi: a case study Chikondi Mwendera1, Christiaan de Jager1*, Herbert Longwe2, Kamija Phiri3, Charles Hongoro1,4 and Clifford M. Mutero1,5 Abstract Background: In 1993, Malawi changed its first-line anti-malarial treatment for uncomplicated malaria from chloroquine to sulfadoxine-pyrimethamine (SP), and in 2007, it changed from SP to lumefantrine-artemether. The change in 1993 raised concerns about whether it had occurred timely and whether it had potentially led to early development of Plasmodium falciparum resistance to SP. This case study examined evidence from Malawi in order to assess if the policy changes were justifiable and supported by evidence. Methods: A systematic review of documents and published evidence between 1984 and 1993, when chloroquine was the first-line drug, and 1994 and 2007, when SP was the first-line drug, was conducted herein. The review was accompanied with key informant interviews. Results: A total of 1287 publications related to malaria drug policy changes in sub-Saharan Africa were identified. Using the inclusion criteria, four articles from 1984 to 1993 and eight articles from 1994 to 2007 were reviewed. Between 1984 and 1993, three studies reported on chloroquine poor efficacy prompting policy change according to WHO’s recommendation. From 1994 to 2007, four studies conducted in the early years of policy change reported a high SP efficacy of above 80%, retaining it as a first-line drug. Unpublished sentinel site studies between 2005 and 2007 showed a reduced efficacy of SP, influencing policy change to lumefantrine-artemether. The views of key informants indicate that the switch from chloroquine to SP was justified based on local evidence despite unavailability of WHO’s policy recommendations, while the switch to lumefantrine-artemether was uncomplicated as the country was following the recommendations from WHO. Conclusion: Ample evidence from Malawi influenced and justified the policy changes. Therefore, locally generated evidence is vital for decision making during policy change. Keywords: Malaria, Anti-malarial drug policy, Chloroquine, Sulfadoxine-pyrimethamine, Lumefantrine-artemether, Malawi Background Research is critical in providing information that can be used for decision making and policy change [1, 2]. For instance, WHO emphasized the importance of evidence when developing policy recommendations on the use of Intermittent Preventive Treatment of malaria in pregnancy with sulfadoxine-pyrimethamine (SP) after reviewing published evidence from various research findings in malaria-endemic regions, including Malawi [3]. On the other hand, experience from many countries has shown * Correspondence: 1 University of Pretoria Centre for Sustainable Malaria Control (UP CSMC), School of Health Systems and Public Health (SHSPH), University of Pretoria, Private Bag X363, Pretoria 0001, South Africa Full list of author information is available at the end of the article how research conducted within the country informs policy [1]. As such, research conducted within a country with valid results is more appropriate to be used to inform policy even though evidence from multi-country studies is more effective for convincing policymakers [1]. However, despite the overwhelming scientific evidence, policy change is not straight forward since it takes into consideration many factors, including the political environment, costs of alternative choices and stakeholders’ views [4, 5]. Choosing the right drug that is efficacious in the treatment of a disease is one step towards policy change, but the change process is often long and tedious, as it involves various stakeholders from both the public and private sectors [5, 6]. © 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Mwendera et al. Health Research Policy and Systems (2016) 14:41 The treatment of uncomplicated malaria has, over the years, undergone transitions worldwide, owing to the development of resistance of the Plasmodium species to first-line anti-malarial drugs [7]. In a few countries in subSaharan Africa (SSA), such as Zambia, Kenya and Tanzania, efficacy data from in vivo studies on chloroquine (CQ) resistance led to policy changes in antimalarial drug treatment from CQ to SP [1, 8, 9]. However, in most SSA countries, the process for health policymaking has proven to be a complex process [6, 10, 11]. For instance, experience from drug policy change in Kenya, from CQ to SP, revealed difficulties in translating data and the process was complicated, with limited options, unknown adverse effects of replacement therapies, cost, and the limited guidance on factors pertinent to changing the drug policy for malaria [9]. In addition, many of the SSA countries are poor and policy change decisions are highly influenced by their economic budget considerations [12]. This was the case in Sudan, where the decision to change the policy for anti-malaria drug treatment was delayed despite the evidence of drug resistance to CQ [13]. Malawi, as one of the resource-limited countries in SSA, experienced changes in anti-malarial drug policies amid concerns over P. falciparum resistance to the firstline anti-malarial drugs and became the first country to change the treatment policy from CQ to SP in 1993 [14] and later to lumefantrine-artemether (LA), an artemisinbased combination therapy (ACT), in 2007 [15]. However, despite the historical changes in first-line antimalarial treatment regimens, in particular from CQ to SP, many questions were raised as to whether the change had been done too early and whether the new drugs would develop resistance quickly [16]. These concerns were raised as a result of uncertainty surrounding the usage of clear-cut evidence on drug efficacy from within the country or region. A systematic review and documents review were conducted to examine whether evidence from past research on anti-malarial drug efficacy conducted in Malawi influenced anti-malarial drug policy changes from CQ to SP and SP to ACT, amidst economic, political and health systems challenges. In addition, views from key informants were sought on their experience and general perceptions on the policy changes. Results from this case study provide valuable insights into whether (...truncated)