Nigeria malaria control architecture
Nigeria has a population of over 200 million and the highest burden of malaria infections in Africa [31]. The Federal Ministry of Health (FMoH) through the National Coordinator is responsible for malaria control and elimination activities in the country [32]. The National Food and Drug Administration Control (NAFDAC) is responsible for regulatory function of malaria drugs and commodities. The Pharmaceuticals Manufacturing Group (PMG) plays an important role in the production of malaria commodities either independently or serving as franchise for local companies. The Nigerian health system operates a three-tier arrangement consisting of the Federal, State and Local authorities. The federal level formulates policy and controls the tertiary care. The states and local government levels are responsible for implementation of the policy. They are also responsible for regulatory, and implementation of activities related to secondary and primary levels of care respectively. Malaria service delivery, especially case management is channeled through public community and private systems. Health insurance coverage is low. Provision of antimalarials in public primary healthcare facilities is largely free or heavily subsidized while the private system is largely fee for service except few enlisted in health insurance schemes [33]. Doctors are the primary prescribers in the tertiary facilities and to a large extent in the secondary levels [33]. Various other health professionals serve as prescribers in some secondary facilities and mostly in primary health care facilities. There is also a large informal system consisting of Proprietary Patent Medicine Vendors (PPMVs) and Community Pharmacists as prescribers.
Malaria burden and treatment policy in Nigeria
Nigeria, with about 63 million annual cases of malaria, accounts for the largest burden of malaria globally; 26.8% and over 31.9% of the 241 million global malaria disease case and 627,000 deaths respectively [34]. The incidence of malaria in Nigeria reduced from 373 per thousand in 2010 to 314 in 2020 [35, 36]. The prevalence from Malaria Indicator Surveys in children 2–10 years has shown a decline from 42%[37] in 2010 to 23% in 2018[35]. The current National Malaria Strategic Plan (NMSP 2021-25) has adopted a stratification approach to tailor actions in relation to peculiar characteristics of malaria within the various geo-political zones of the country. Since 2004, the treatment policy of malaria in Nigeria evolved from monotherapies to ACT [38]. Additionally, injectable artesunate for severe malaria and chemo-preventive strategies involving the use of intermittent preventive treatments in pregnancy (IPT) and seasonal malaria chemoprevention (SMC) were also adopted [38]. Thus, the country provides a rich experience of different cycles of translational policies on antimalarials for key lessons and adoption of best practices.
Stakeholder engagement in adoption of antimalarial policy change
Due to the spread of resistance to antimalarial monotherapies in the 1990s, the WHO, commissioned a review of literature in which evidence on resistance to chloroquine and other monotherapies was collected and assessed [2, 33]. These meetings resulted in the WHO recommendation to switch to ACTs as global first-line therapy for the treatment of uncomplicated falciparum malaria [39]. Although most endemic countries followed this recommendation and adopted ACTs in their national guidelines, significant delays were experienced between updated guidelines and the actual implementation [40, 41].
Individual countries usually appraise the recommendations of the WHO to reconsider their country-level strategies. Changing first-line therapies however involves a wide range of stakeholders at different levels of the healthcare system [5]. Stakeholder engagement in health policy is therefore critical for translating evidence into policy and implementation [42, 43]. An immersed expert recounted ”……a major challenge in the adoption of change in monotherapy is that the scope of stakeholder engagement is often not well-defined and supported by evidence. Furthermore, tailoring the stakeholder engagement strategies based on learning or analysis of the various stakeholders’ audiences are not well described.” (Interview Expert2) When stakeholder engagement is not well coordinated the messaging also becomes fragmented and unclear [42, 43].
From our case scenario, we developed a framework (Fig. 1) for stakeholder engagement in the introduction and deployment of new antimalarials or alternative strategies to treat malaria. This depicts the interrelations of the stakeholders ranging from those who generate evidence on antimalarial therapeutic efficacy at local and international levels down to the antimalarial end-users. The stakeholders include health policy makers, control and regulatory agencies, distributors, marketers and prescribers (Fig. 1). We employ the five pillars of International Association of Public Participation (IAP2) [44] to synthesize five stakeholder engagement spectra to guide stakeholder engagement of new antimalarials or treatment strategies.
Evolution of antimalarial policy adoption in Nigeria
i. Monotherapy era of pre-2001
Policy documents revealed a historical account of the evolution and adoption of antimalarial treatment policy processes in Nigeria [32, 38, 39, 45]. These reviews showed an evolution in treatment policies during the era of antimalarial monotherapies. Chloroquine provided relative stability in the use of monotherapy. An immersed expert recalled earliest guidance by the WHO on selection of antimalarials recommending a four-point decision scale in the programmatic deployment of antimalarials "...using these scales; antimalarial treatment failure rate < 5% Grace, 6–15%, alert, 16–24% action stage which meant that there is need for identification of replacement molecule. A change was mandated when failure rate is > 25% and the antimalaria molecule should be replaced with another that is more efficacious.” (Interview Expert1).
In Nigeria, efficacy of chloroquine was prolonged despite resistance reported from Southeast Asia a decade earlier [38]. However, from 1988, efficacy in Nigeria declined below 70% [46]. Despite the reduced efficacy of chloroquine, the Nigerian Malaria Control Programme (as it was then called) waited another decade before reacting. This may be related to limited awareness of the WHO policy guidelines by national policy makers. The two experts interviewed opined that an additional factor was the popularity of chloroquine and the perceived concern about the ability of sulphadoxine-pyrimethamine (SP), which was the most viable alternative available, to withstand the same pressure as chloroquine before widespread resistance occurs. Buttressing these fears, was evidence of increasing SP resistance from East Africa where SP had earlier been adopted as the first-line therapy [38]. While the country was in a dilemma, global discussion on the adoption of ACTs began. After the WHO provided evidence on drug resistance to chloroquine, Nigeria in early 2000 was tending towards adopting SP, the only available monotherapy, as their national first-line antimalarial therapy.
ii. Transition era from monotherapy to ACT policy
The transition from monotherapy to ACT policy was not a swift process. An immersed expert commented “...until Nigeria engaged in the conversation of ACT adoption, the country mainly reacted to the growing evidence of treatment failure by adopting strategies to increase compliance to the existing monotherapies. Major interventions were the prepackaging of these monotherapies and the introduction of home management of malaria. Furthermore, there was an extensive interaction between WHO, NMEP, the PMG and the regulatory authorities in which consensus was reached that age-specific antimalarial drugs should become available. While the PMG went ahead to implement these changes, the need for ACT as a strategic cornerstone for the treatment of uncomplicated malaria was gaining momentum at international levels.” (Interview Expert1).
Therapeutic efficacy studies (TESs) conducted in 2002 showed that the corrected adequate clinical and parasitological response (ACPR) for chloroquine and SP in Nigeria were abysmally low at 34.7% and 57.4% respectively [38]. An immersed expert recalled these worrying developments, “…The NMEP identified the next stage of the decision-making of selecting the most appropriate ACT. This was reported as the decision of another stakeholder meeting held in 2004.” (Interview Expert1). The communique of that meeting emphasized the prevalence of both chloroquine and SP resistance in the country, the proven efficacies of the new ACTs as reported from other countries and the need to conduct a local TES on the candidate ACTs (artemether-lumefantrine (AL) and artesunate-amodiaquine (ASAQ)) to inform programmatic deployment. Hence, another TES was conducted in 2004 that indicated efficacies above 90% for both ACTs for the treatment of uncomplicated falciparum malaria [38]. Due to the availability of AL as a co-formulated drug and high level of tolerability, the country adopted AL as the new first-line antimalarial while ASAQ, though a co-first line was reserved as an alternative or provided only by some donors as a cheaper alternative to support care in some areas of the country [38].
An immersed expert narrated “…this decision of the country, despite its intent, did not engage the PMG at any point. It was therefore regarded as a betrayal of the trust that has been built with the PMG. They complained of significant economic loss from the investments made to re-tool and re-register the newly prepackaged monotherapies. The result was that of a significant push back through intense advertisement of monotherapies by the PMG and the lack of uniformity in malaria treatment messaging. The FMoH had to set up a special committee to interphase and handle the change of management process. These issues delayed implementation of ACT use despite the relative early adoption of the ACT policies. Furthermore, several states did not include ACTs in their essential medicine lists and could therefore not invest in the ACTs. In addition, the National Health Insurance Scheme (NHIS) also continued to recommend the use of monotherapies because the capitation fees being charged was significantly related to cost of monotherapies since fever/malaria was the commonest reason for outpatient consultations” (Interview Expert1).
The important lesson learned is that the PMG and NHIS were not adequately engaged as stakeholders in the policy change procedure, leading to inefficient deployment. The same applied for marketers and distributors who had previously invested and engaged in alternative therapies and were not compensated for these investments. There was a long delay before the prescribers had awareness of the policy change because of poor downstream communication to these stakeholder groups.
ACT policy implementation and lessons learnt
Following the adoption phase, Nigeria rolled out implementation of ACT immediately. This was shorter than the average time-lag of 12–18 months between policy adoption and implementation as reported from endemic regions [47, 48]. Although Nigeria encountered some delays in evidence uptake until policy adoption (between 2001 and 2005), this was compensated for by zeal and political will to implement ACT as new treatment regimen. This was in turn reinforced by funding from the global developmental partners [40]. However, there was an immediate push-back among the pharmaceutical companies who had hitherto invested heavily on age-specific pre-packaged chloroquine [49, 50] and those already co-formulating SP for a large demand for Eastern Africa [42].
The implementation strategies were also met with resistance from suppliers, distributors, prescribers, and the end-users. Multiple reasons were adduced for the initial apathy [51]. The antipyretic effects of chloroquine that gave immediate relief to the patients and a sense of effectiveness to the prescribers and the suppliers created a sustained demand for chloroquine. A policy maker mentioned “…the resistance from the private sector who probably at that particular time have invested their resources to produce these monotherapy drugs and were not carried along when this policy of changing to ACT combination drugs came, they were not properly orientated.” (IDI POLREG05).
Other respondents noted that stakeholder engagement with regulatory agencies such as NAFDAC is essential for the adoption of antimalarial treatments. Failure to engage them could lead to delays in the adoption process. A policy maker mentioned “The NAFDAC plays important role in regulation of the newly introduced antimalaria drugs in the country. So, NAFDAC is at the point of entry of any product, irrespective of which program is advancing for such products, NAFDAC need to accredit such drugs. And if that is not done, then there is every tendency that such drug will not be allowed at the program level.” (IDI POLREG02).
Another factor was the cost of chloroquine compared to ACT. In low-income settings like Nigeria, affordability, and accessibility to ACT is crucial. The global supply and demand shortfall for ACT became an immediate burden that warranted WHO, UNICEF and other developmental partners outsourcing the procurement of ACT for the public sectors in the endemic regions, Nigeria inclusive [39, 40]. Evidence from Nigeria in the early period of policy adoption and implementation revealed mixed reports on the problematic transition to ACT in Nigeria. Some end-users and prescribers interviewed cited challenges related to prescribers’ distrust in ACT efficacy compared to the well-known chloroquine, while patients reported discomforting side-effects to amodiaquine.
The post-adoption phase of ACT deployment in Nigeria witnessed more developmental partner support for malaria control activities, robust data generation from efficacy studies and subsequent programme evidence. The ACT case-management strengthened with backup of this evidence then became established in treatment guidelines [38, 52]. In addition, chemoprevention in pregnancy and seasonal campaigns for malaria prevention among under 5-year old children were also introduced [52]. One major fall-out of the post-adoption was the monopoly of the ACT supply by the pharmaceutical industry while global efforts were compelled to patronize the monopoly. This was detrimental to the survival of the local pharmaceutical industries who had previously been major stakeholders in the policy change adoption in Nigeria. To solve this problem and to reduce the high costs of ACTs among the populations in the endemic countries, the global efforts in 2008 developed the Affordable Medicine Facility-malaria (AMFm) which was piloted in seven African countries including Nigeria [53]. This policy attempted to supply ACT at a more affordable rate to the public and private systems through the principle of first line buyers who bought at a highly subsidized rate, and they were allowed a limited profit margin to make the ACTs affordable. After the pilot phase of the AMFm, the scale up was implemented under the nomenclature of Private Sector Co-payment Mechanism (PSCM). The operational model was essentially similar except that there was increasing prettification of the first line buyers in the private sector responsible for a fraction of the cost of the ACTs [54].
The PSCM intervention had an initial positive impact on availability of ACTs which increased significantly over the period of implementation [54]. The impact was observed particularly among PPMVs with associated increased access to ACT by the poor households [54]. But similar to previous subsidized public health interventions, the programmes were not sustainable [53]. Another limitation was that important stakeholders in the downstream of ACT policy uptake were completely neglected [55]. Therefore, this evidence-based novel intervention was discontinued. Nevertheless, AMFm/PSCM still leaves a regulated supply chain for malaria in Nigeria including a stabilized ACT cost. Stakeholder groups reported that inadequate stakeholder engagement at all levels led to the poor uptake of the policy. They suggested that these should be addressed to support the adoption of future antimalarial treatments: “To ensure that all important stakeholders are involved in such important public health intervention, we need to support it with advocacy, communication, mobilization, and sensitization. So, if we just deploy without following it up or without backing it up, we know the Behavioural Change Communication (BCC) component of our general attitude is difficult to attain.” (IDI POLREG03).
The lesson learned was that private sector engagement was challenging since negotiated ACTs were largely available through the public sector. As with PMG, the private sector was hindered following the sudden withdrawal of both the AMFm and PSCM. There was also a mismatch in policy to diagnostically confirm each suspected case of malaria and the actual availability of diagnostic tools.
Moving forward and recommendation
Following the general principles, there is need for stakeholders’ identification/mapping, identification of the policy issues and purpose to engage the stakeholders [44]. Thereafter, strategies of engagement that take into consideration the local and socio-cultural peculiarities are important for an indigenous disease like malaria. Lastly, predetermining measurable policy adoption outcomes and achievable benefits must be set.
For engagement to be very effective, some respondents suggested that the content of messaging and communication regarding the rationale for a change in policy has to be well adapted to the peculiarities of the stakeholders. “They will be able to tell people the benefits of the [new] drugs.” (End-user FGD 01). “…we give them health education about the drug, we should train the community….“ (Suppl FGD 01)
A number of communication channels were recommended as effective strategies for communicating the rationale for a change in policy. Below are extracts of some of the narratives from the stakeholders;
“The government should help us announce very well on the radio and when something like this is available, they should inform the king of the community. He will find a way to disseminate information either through mosque or church when the government announce on the radio. They should tell the King and he will inform the people”. (End-user FGD 05).
“…... in the olden times, we used the town crier…. so, I think we can use the same means. Each community will decide what to do. Some use mosques, some use churches, they will make the announcement there”. (End-user FGD 05).
“If you can embark on door-to-door awareness they will readily accept it”. (End-user FGD 06).
“Whenever you identify the leaders within that community, there's always a particular leader in each section of the community, they will accept it”. (End-user FGD 04).
“Maybe Pastors of the church, the Imam and Alfas and the schools and the clinic, the health workers they would also play a very big role to make sure that the community accepts the drugs” (IDI End-user 03).
Several stakeholders highlighted the importance of making training of health workers an integral part of the deployment process. They suggested that building the capacity of health workers would enable them to provide the right information about rationale for deployment of any new treatments at the community level. Policy makers suggested “People should be enlightened about the drug; they should know the composition of the drug and know the side effects too so that there will be no resistance.” (IDI POLREG08). Another regulatory authority mentioned “They should train them about the new drug that is coming, the composition of the drug, we can hold a seminar or workshop to boost their capacity.” (IDI REG 08). These views were also shared by suppliers “There should be seminar for health workers, they should pay people for attending the seminar.” (Suppl FGD 02)
Engagement with end-users is required for successful adoption of any new antimalarial policy as summed up by a respondent: “There are gatekeepers within the community; it could be traditional ruler, it could be a philanthropist within that community that is well respected and that may have contributed to the development of that environment in one way or the other, so they are key.” (IDI REG01). The perspectives of end-users suggested that there are several reasons why engagement should be an integral part of the having adequate knowledge of any new antimalarial treatment. End-users stated reasons for the engagement: “if they are informed before that if you take this drug, this is the problem, then they will not worry” (End-user FGD 01). Another end-user buttressed this: “Since we all know that initially, so definitely every drug that will be highly effective must come with side effects. So, they should tell the community this is the side effect of this drug.......” (End-user FGD 01). Most end-users suggested that engagement processes that seeks to address issues related to health-seeking behaviour should be adopted: “So I think one of the strategies is to have an early engagement of the local communities, their health-seeking behaviour ultimately influences whatever you are doing, we can reduce all of those obstacles.” (End-User IDI01,). Other respondents during discussion gave insight into drug non-adherence because of lack of end-user engagement “I don’t normally complete the dosage. Once I feel much better, I stop using it.” (End-user FGD 04). “...well we have this mentality of being doctors in the house before going to the medical doctor, we treat with paracetamol and when the patient is not responding we go to the counter to get some malaria drugs like Lonart, so that is what we do primarily but if there is no response we now go to the hospital to see medical doctor.” (End-user IDI 03).
Policy makers and regulators (e.g NAFDAC) should be engaged through adequate, convincing, and locally acceptable evidence. This will give credibility and fidelity to the new antimalarial. As narrated in the policy change era to ACT, the private sector distributors, marketers, and prescribers will play key roles if engaged earlier. Engagement of health practitioners is essential for a transition to a new antimalarial drug or treatment strategy. Several respondents anticipated challenges in private sector, where retailers and prescribers are often guided by patient demand rather than treatment guidelines. Especially in the private sector. This was considered a potential barrier to future adoption and would require active engagement of the private sector stakeholders. The same applies to a large number of informal retailers, as ‘over the counter’ prescription without expert consultation remains common in Nigeria [56]. Some suppliers mentioned that retailers and prescribers are not always aware of the magnitude of drug resistance, its causes and risks, and its implications. Therefore, providing training and information was considered important by some respondents. Such information campaigns should begin with awareness of the threat of antimalarial drug resistance and the risks involved. They should be educated on the benefit of deploying new drugs with a view to delay or prevent multidrug resistance: “So, these are lessons learnt that moving forward, if there's anything of such a nature, and more importantly, when we are at this stage, this is the time we even need to start engaging the patient at the community.” (IDI POLREG05)
Learning from the experiences of the transition from monotherapies to ACT, all stakeholder groups shared the view that implementation programs and behavior change initiatives are important to engage practitioners and patients in a prospective transition to a new therapy. The NMEP, under coordination of the Ministry of Health (MoH), was considered the most credible party to coordinate such initiatives in Nigeria. Some policy makers gave examples of models of engagement that have worked in local communities in the provision of health services that could be adopted for engagement regarding the introduction of new antimalarials: “when we initially introduced the ACT, there's one we called role model. In deploying some of these drugs, role model has key roles to play because if you look at it, it takes a patient like 100 mins to move from his house to facility. But within a household, if we have a respected role model within the community, people will believe in him or her than the people that they, maybe, see them once in blue moon whenever they go to the hospital… but these individuals… we need to look at how we engage them.” (IDI POLREG08).
Proposed framework for stakeholder engagement in adoption of new antimalarials or treatment strategies
From the foregoing, we propose a framework for effective stakeholder engagement for future adoption of new antimalarial treatments or treatment strategies in Nigeria. The framework covers the pathway from generating evidence to making the treatments accessible and affordable to end-users. It also addresses key elements and recommendations on who to engage, the content of engagement and what strategies would support effective engagement with various key stakeholders at different levels of a transition process. The triad of evidence, policy and implementation is envisioned in a well-coordinated stakeholder spectrum with active two-way interrelationships between the stakeholders which will be informed by critically outlined strategies [57]. Adopting the five pillars of IAP2, [44] we identified a five-step approach to engage stakeholders as shown below.
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Inform: provide balanced and objective information on the policy change to the stakeholder in terms of the purpose, opportunities, and limitations of the policy.
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Consult: obtain feedback from the stakeholder on the assessment and their understanding of the policy change with the view of the local alternatives, challenges, and decisions.
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Involve: work directly and together with the stakeholders to ensure that their concerns, aspirations and challenges are understood and taken into consideration.
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Collaborate: reiterate this is a partnership relationship with the stakeholders to take the policy change adoption decision together and to identify preferred best solutions.
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Empower: place the policy adoption in the hands of the stakeholder for sustainable implementation and feedback.
Adapting these to the Nigeria case of antimalarial policy change adoption, we identified critical stakeholders as shown in the conceptual framework (Fig. 1). Putting evidence at the top of policy change adoption, which should trigger the subsequent policy directions that led to the efficacy trials and change in the national antimalarial policy in the country. The policy makers must be actively engaged by the WHO and other isolated research while the policy makers in turn inform, consult, and involve other stakeholders like regulators of malarial drugs, the manufacturers, the distributors, the prescribers, and the end-users.