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Ensuring access to essential health products: Lessons from Colombia’s leishmaniasis control and elimination initiative [1]
['Carol Vlassoff', 'School Of Epidemiology', 'Public Health', 'University Of Ottawa', 'Ottawa', 'Nora Giron', 'Strategic Fund', 'Pan American Health Organization', 'Washington', 'Dc']
Date: 2024-02
Colombia has established a target of reducing the proportion of accumulated cases of CL from the baseline of a 9.5% reduction in children aged ≤10 between 2012–2019 to a further 10% reduction by 2031. The proportion of cases in children aged ≤10 is used as an indicator of disease prevalence because it is assumed that transmission largely occurs inside dwellings where children tend to spend most of their time. Again, this is below the PAHO/WHO target of reducing by 50% the proportion of children aged ≤10 infected with CL/MCL, due to the many challenges presented by this disease in focal areas (see below) and the inability of the service provider network to reach all necessary populations (MSPS officials).
As of 2022, Colombia had selected two targets for leishmaniasis control and elimination, one each for CL and VL, which are incorporated into the new PDSP [ 9 ]. Its targets have been defined within the context of PAHO/WHO’s regional indicators and adjusted to reflect local realities in the focal leishmaniasis areas. The target for VL in the new PDSP anticipates that the conditions necessary for its elimination as a public health problem will be achieved in 20% of the 47 focal municipalities by 2031 (≤1 case per 10.000 inhabitants), with another 20% on the path toward elimination. Hence 40% of endemic municipalities are targeted for VL elimination, or near elimination, by 2031. Data reported in Colombia’s Strategic Plan for Leishmaniasis 2018–2022 [ 13 ] indicate that there was a progressive and sustained reduction in the number of VL deaths by 50% in all departments and territories by 2021. While this is clearly an impressive achievement, it is unlikely that the other regional target of a reduction to ≤1 case per 10,000 inhabitants in leishmaniasis focal areas will be achieved by 2031, according to MSPS authorities, but they also point out that using national-level elimination targets can mask the actual situation in endemic areas and create a false impression that the disease is no longer a priority, thus undermining disease control efforts. For example, if the entire Colombian population was taken as the denominator, a large part of whom live in non-endemic areas (including the capital, Bogota, with over 8 million people), the international target could appear to be reached, while remaining a significant challenge in chronically endemic areas. Furthermore, understanding the process by which targets are achieved (or not), such as which interventions were successfully employed, is key to creating sustainable solutions.
Colombia’s leishmaniasis program has historically been governed by a series of national public health plans, including the national 10-year Public Health Plan, 2012–2021 (Plan Decimal de Salud Pública, 2012–2021] (PDSP) [ 22 ], under which the Strategic Plan for Leishmaniasis 2018–2022 [ 13 ] was developed. The former encompassed strategies for disease prevention, treatment and rehabilitation, as well as a broader intersectoral approach that emphasized the importance of reducing the economic and social burdens placed upon the population by the disease. Colombia’s new10-year Public Health Plan 2022–2031 (PDSP) [ 9 ] takes an even stronger intersectoral approach, recognizing the impact of social, economic, and cultural inequalities on the burden of disease, and is founded on guaranteeing the fundamental right to health, wellbeing, and quality of life for the Colombian people. It seeks to act upon the social determinants of health through territorial, institutional, and social strategies, to strengthen public health management across geographical territories and with the involvement of all levels of stakeholders. Its four main goals are to [ 1 ] advance toward guaranteeing the fundamental right to health through intersectoral and societal actions to positively affect the determinants of health; [ 2 ] advance toward the improvement of living conditions, wellbeing and quality of life by reducing social inequalities in health; [ 3 ] reduce avoidable mortality, morbidity, and disability, and their impact on years of life lost and healthy life years; and [ 4 ] improve environmental health by protecting ecosystems, mitigating the effects of climate change, and consolidating healthy and sustainable territories. The PDSP, and its emphasis on social solidarity, territorial health sector strengthening, intersectionality, human rights, and the reduction of inequalities, provides an important platform for accelerating action on the challenges posed by multi-dimensional, complex NTDS, including leishmaniais.
The Colombian health system is composed of the following main components: the Ministry of Health and Social Protection (MSPS), territorial health directorates, health-promoting entities (EPS), health-providing institutions (IPS), financing/insurance entities and mechanisms, and other key collaborating institutions. In 2017 the Universal Health Coverage Forum [ 18 ] launched the people-centered health services approach, emphasizing community participation in the development of health policies and services, focused on community needs and preferences, with a view to achieving universal health coverage. In this vein, Colombia’s 32 departments and five districts all play a role in leishmaniasis control, which was governed from 1996 by Resolution 4288 which designated that leishmaniasis services be provided free of charge under the Basic Health Plan (Plan de Atención Básica) [ 19 ]. This was later replaced by Resolutions 518 of 2015 [ 20 ]) and 3280 of 2018 [ 21 ] that authorized the free provision of leishmaniasis services and capacity building, including health education and communication, and services to prevent and control vector-borne diseases, including leishmaniasis.
In the Americas, recent regional and country-level data from 17 countries reported an annual average of 46,684 cases of CL and MCL, and 13 VL endemic countries reported an average of 3,086 cases per year from 2012–2021. Brazil, Colombia, and Peru together reported 68% of the total cases of CL and ML in the Region [ 10 ]. Environmental, social, and economic factors play a role in differences between countries [ 11 , 12 ], including the transmission of cases within and near a dwelling. Overall, the Americas has experienced a decrease in new cases of leishmaniasis over the last few years due, at least partially, to improved access to timely laboratory diagnosis and treatment. However, cases have remained stable or even increased in some countries [ 10 ]. VL cases have declined significantly over the past two decades, but their lethality remains a concern [ 12 ]. Leishmaniasis is endemic throughout Colombia in all but three provinces (Bogotá D.C., San Andrés Islands, and Atlántico), with more than 11 million people at risk [ 13 ], mainly in rural areas, with a wide geographic distribution of vector species and parasites [ 14 , 15 , 16 ]. The total number of leishmaniasis cases fluctuated considerably in the past, with an annual average of 5,900 cases in the 1990s, to an average of 17,100 cases in 2005 and 2006, followed by a downward trend to 2021, when there were 6,175 cases recorded [ 8 ]. CL accounts for 98% of cases, with 77% in men, and 67.7% of cases in the 15–44 age group [ 8 ]. MCL accounts for 1.4% of cases, and VL for 0.2% [ 13 ]. While only 183 cases of VL were reported from 2013–2018, its focal areas are found in 47 municipalities, exposing approximately 800,000 people in two large municipalities, Cartagena and Neiva, and in smaller rural population centers [ 13 ]. The largest recorded outbreak of CL occurred during 2005–2009, with more than 35,000 cases [ 17 ]. Another significant outbreak occurred in the Andean valleys in 2003–2004, with 2,810 CL cases, of which 80% were in the 15–44 age group [ 17 ]. According to MSPS officials, since 2018, surveillance efforts have been complicated due to the COVID-19 pandemic, when active case detection was not possible.
Leishmaniasis control and elimination in Colombia: Challenges and opportunities
Environmental challenges. Like other NTDs, leishmaniasis affects some of the world’s poorest people and is therefore inherently and inextricably linked with social determinants of health (SDH), including inadequate housing; lack of access to financial resources, water, sanitation, and nutritious food; population movements; environmental degradation; and urbanization [7,23]. In Colombia, many conditions favor the transmission of leishmaniasis, such as the mobilization of large population groups from rural to urban areas where they establish settlements in communes and marginalized communities, often coexisting with domestic animals that attract and foster sand fly vectors from nearby surroundings [24]. Despite the challenges such environments present for leishmaniasis prevention and control, the PDSP offers a constructive framework to address these SDH, including promoting the concept of healthy and sustainable territories, fostering the protection of ecosystems, and mitigating the effects of climate change. Concrete actions include a better articulation of public health management and governance in support of primary health care, intersectoral actions and community participation for collective risk management, and vector surveillance and control measures. The latter include the identification of their presence in the intra- and peri-domicilium area, and if necessary, appropriate application of residual insecticide in homes; insecticide-treated bed nets (although the use of bed nets is problematic in some endemic areas of Colombia (Amazon, Atlantic) where people sleep in hammocks, and the nets are not adapted to this application, according to (MSPS officials); and in areas with VL, if indicated, measures to reduce contact of the vector with canine populations [24]. Importantly, Colombia has an integrated approach to collective interventions to control and eliminate vector-borne diseases, including malaria, arboviruses, leishmaniasis, and Chagas disease, whose outbreaks often occur in the same zone sharing the same environmental risks. These are addressed at the national level through Comprehensive Health Care Roadmaps or RIAS (Rutas Integrales de Attention en Salud) for harmonized planning related to health maintenance in different settings (domestic, community, educational, institutional, and informal labor sector). As an illustration of this intensified and intersectoral approach, a pilot project for VL elimination was initiated in Neiva, the capital city of the Department of Huila, coordinated by MSPS and executed by the municipal Secretary of Health with support from PAHO/WHO, which is expected to serve as a demonstration project for other endemic municipalities [25]. Neiva has a high level of poverty [26] with poor sanitation and favorable ecological conditions for leishmaniasis transmission, including a high prevalence in dogs. The control strategy includes strengthening surveillance and the integrated management of vectors, reducing transmission risks through an intersectoral approach, improving diagnosis, treatment, and follow-up of leishmaniasis patients, and community participation, in line with the PDSP. According to MSPS officials, deaths in Neiva have significantly declined as a result of these interventions, but continued efforts to contain leishmaniasis outbreaks will be needed because the parasites and vectors are constantly adapting and spreading into new habitats. A lingering threat to VL prevention is its high prevalence among domestic canines (20%). To address this problem in Neiva, the strategy of culling positive dogs (in an ethically correct manner) was adopted. With the help of veterinarians and the sensitization of community members, the procedure was generally accepted, but the practice is problematic in the long term. Recent evidence from elsewhere suggests that insecticide-impregnated dog collars are a more effective and durable solution. Studies developed with Impregnated collars with slow-release of deltamethrin 4% have demonstrated a 50% effectiveness in decreasing the prevalence of canine leishmaniasis in the Americas, as well as in the abundance of Lutzomyia longipalpis, the most important vector of VL in the Americas, in the intra- and peri-domiciliary areas [27,28]. Colombian authorities are planning to implement this intervention in Neiva because a cost-effectiveness study in Brazil showed that collars impregnated with deltamethrin were considered highly cost-effective in preventing canine VL when used in a public health program [29].
Population-related challenges. In Colombia and many other leishmaniasis affected countries across the Americas, people most at risk of infection experience not only socioeconomic, structural, and environmental disadvantages but also susceptibility to diseases of poverty, such as malaria, other parasitic infections, and malnutrition. This is due to their often poor access to health, sanitation, and educational services [30]. Anecdotal evidence from the interviewed health authorities suggests a link between poor nutrition and VL infection in children, as it seems that only children with severe malnutrition become ill, even though a high percentage of children in an endemic area may be infected. Many vulnerable citizens living far from health centers have to travel on foot to seek care [30], and those who are day laborers cannot spare the time and resources to travel or take their children for care. Additionally, they are often referred to a higher level when reaching first-level care, entailing even more time and expense [30]. The long treatment protocols requiring people to be treated for 20 days consecutively for CL, for Pentavalent antimonial (anti-parasitic) injections in the buttocks need to be administered by a specially trained health worker because they can cause serious adverse effects and are painful, creating fear and discomfort among patients who may delay seeking such services until their illnesses become severe or when traditional remedies fail [30]. Many people living with CL and MCL experience significant social stigma and psychological distress as a result of its disfiguring skin lesions, leading to reduced quality of life, self-deprecation, decreased social participation, and fear of infecting others [30,31]. A recent study in two endemic areas in Colombia found significant levels of perceived or anticipated stigma, mental distress, and restricted social participation among patients with CL, and these associations were higher among rural, compared to urban communities [31]. An earlier study in Colombia found that the type and visibility of the lesions, as well as how long a person had lived with it, affected how stigma was experienced [32]. For example, among new migrants to the Darién area where the research was conducted, becoming infected with CL had a positive effect: the endurance of its course and the curing and scarring of the lesions were taken as a sign of acceptance into the community, whereas the local African descendant population found it incapacitating and disfiguring [32]. There is generally less documentation of stigma and psychological distress attached to VL, but some studies elsewhere have shown associations between VL and reduced quality of life and risk of mental health problems [33]. Colombia’s new 2022–2031 Public Health Plan [9] places considerable emphasis on equity, thus providing an opportunity to address inequities in the leishmaniasis response beyond the traditional measures of mortality, morbidity, and incapacity. This may be particularly useful to examine how targeted interventions can reduce the accumulated socioeconomic and environmental disadvantages linked to related diseases of poverty, a goal that most departments and districts are actively working toward [MSPS officials). These efforts are particularly critical for reducing CL outbreaks and preventing transmission within the home, where continuing infections among children under ten years of age remain a concern. MSPS officials indicated that this will require a shift from the current biomedical approach, based on acquiring and delivering medicines, to a prevention-based approach, based on accelerated efforts to educate and involve community members in leishmaniasis control. It will also involve capacity-strengthening to investigate leishmaniasis outbreaks in focal areas, a challenging task due to its multiple species of parasites, vectors, and transmission scenarios with multiple risk factors and determinants that necessitate responses and resources to be tailored to each individual outbreak. Scaling up of VL control will be based on learnings from the Neiva experience, starting first with departments with culturally similar populations (Tolima and Cundinamarca) but with different models of operation (staffing, management, etc.). While a template applicable to the whole country is not possible, they will look for common elements to generate synergistic goals, guidelines, and verification criteria while allowing for regional adaptations.
Health system challenges. In Colombia, leishmaniasis diagnostics and treatments are mostly in line with the recommendations for comprehensive patient care endorsed by PAHO/WHO and other leishmaniasis experts [34]. Dealing with the many challenges posed by leishmaniasis in Colombia requires a responsive health system coordinated across various sectors at municipal, territorial, and national levels; however, several limitations have been identified in the effectiveness of this response in meeting the needs of affected communities. These include a reliance on national regulations that do not reflect the realities of the affected communities or have inadequate health infrastructures to implement them. A further constraint is the lack of health personnel trained in administering CL treatment at the first level of care, which results in costly delays for patients who are referred to higher levels of the system. New approaches are needed to improve access to treatment, including health team home visits to remote rural areas [30] and capacity-building programs for community health workers to address their own fears and lack of information concerning leishmaniasis in order to better respond to patient needs (MSPS officials). Implementing local treatments and training for practitioners at the first level of care, such as the application of intralesional pentavalent antimonials and thermotherapy, may further help address this need [34]. In Colombia, thermotherapy, the application of local heat over the lesion and surrounding areas, is recommended by some as a local remedy for CL. A recent study showed thermotherapy to be a cost-effective strategy compared to the use of Pentavalent antimonial (anti-parasitic) injections, with multiple benefits, including better patient compliance, simplicity of application, safety, and lower costs [35]. Colombia’s recently updated guidelines [36] contain a recommendation for use of thermotherapy for pregnant women, when indicated, which is in line with PAHO/WHO’s 2022 recommendations [34]. This technology is a great opportunity with a higher safety profile but it requires the regulatory authority (INVIMA) to allow its importation, commercialization, and use. Also, to support its wider use, officials consider that further evaluation within endemic areas is needed to assess its cost-effectiveness vis-à-vis existing treatments, including the costs of equipment, training and implementation, and restrictions on its application. Colombia’s new leishmaniasis guidelines, which contain extensive information on its epidemiology, geographical areas, risk factors, and populations most affected; guidelines for diagnosis and treatment; lines of responsibility, and detailed duties at all levels of the health system [36] clearly demonstrate the complex demands that leishmaniasis entails—from the MSPS level overseeing operations to the local level with medical practitioners and community health workers. It is recommended that diagnosis and treatment of CL be done at the first level of care because diagnosis through direct examination involves minimal cost and has a high sensitivity, at an estimated 85%-90%. This is done through smear diagnosis and biopsy, where available. Offering timely diagnosis to initiate treatment is considered the most important measure in the control of leishmaniasis and the priority activity that the health system should take for the care and control of this disease. The other forms of leishmaniasis must be diagnosed and treated by specialists at higher levels of care [36]. Diagnosis and quality control are overseen by the Department of Public Health Laboratories (Laboratorios de Salud Pública Departamental) which coordinate, at the department level, the training and competency assessment of all persons performing leishmaniasis diagnostics, in coordination with the National Institute of Health, and in accordance with international standards recommended by the WHO.
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