PAN AMERICAN HEALTH ORGANIZATION WORLD HEALTH ORGANIZATION 52nd DIRECTING COUNCIL 65th SESSION OF THE REGIONAL COMMITTEE Washington, DC, USA, 30 September - 4 October 2013 Provisional Agenda Item 4.6 CD52/8 (Eng.) 17 July 2013 ORIGINAL: SPANISH CHRONIC KIDNEY DISEASE IN AGRICULTURAL COMMUNITIES IN CENTRAL AMERICA Concept Paper Introduction 1. Over the past two decades, the subregion of Central America has reported a growing number of cases of people suffering, and dying, from chronic kidney disease (CKD). Among these cases, a type of CKD has been reported whose etiology is not linked to the most frequent causes of CKD such as diabetes mellitus and hypertension. The frequency of this type of CKD is higher than that observed in the Region of the Americas and exhibits an upward trend. The disease is most common among underprivileged young men and farm workers living in agricultural communities. These cases are concentrated along the Pacific coast of Central America and have been associated with various factors, including environmental toxins (probably agrochemicals) and occupational risks (inadequate occupational health in conditions of high temperatures and insufficient water intake), as well as harmful habits such as the use of nephrotoxic medicines, especially non-steroid anti-inflammatories. In this context, this type of chronic kidney disease is a pressing and serious public health problem given its high incidence, prevalence and mortality rates, as well as the unmet health care demand and the burden it represents for the families, communities, health systems, and society as a whole. 2. At the "High-level Meeting on Chronic Kidney Disease from Non-traditional Causes (CKDnT1) in Central America" held in April 2013, the Member States of Central America and the Dominican Republic in the Central American Integration System (SICA) and the Council of Ministers of Health of Central America and the Dominican Republic (COMISCA) recognized, in the "Declaration of San Salvador," that chronic 1 CKDnT is the acronym for Chronic Kidney Disease of unknown causes. CD52/8 (Eng.) Page 2 kidney disease is a significant public health problem in Central America and requires urgent action. 3. This paper examines the current situation of chronic kidney disease in agricultural communities in Central America. The paper also presents the progress made in the clinical and epidemiological characterization of the disease so that the countries of the Region can strengthen cooperation and the response of health systems. Health systems should prioritize and implement urgently actions in the areas of surveillance, prevention, control, and timely treatment. Background 4. In the past decade, and particularly in the past three years, several scientific gatherings and meetings at the highest political level have been held in Central America to discuss chronic kidney disease in agricultural communities in Central America. COMISCA, the Pan American Health Organization (PAHO), and other sectors and institutions have participated in these meetings. 5. The main scientific meetings are described below: (a) The Program on Work and Health in Central America (SALTRA) held workshops in 2005 and 2012 to discuss CKDnT with researchers and other stakeholders from different countries, in collaboration with the Central American Institute for Studies on Toxic Substances of the National University of Costa Rica in Heredia. As a result of the latter workshop, a report was published recently that presents the findings of descriptive studies and proposals for tackling this disease (1). (b) The International Conference and High-level Meeting on Chronic Kidney Disease from Non-traditional Causes in Central America was held in El Salvador in April 2013, under the leadership of the Ministry of Health, working in conjunction with COMISCA and with support from the Spanish Agency for International Development Cooperation (AECID) and PAHO. At the meeting, findings were presented from epidemiological, clinical, histopathological, and environmental toxicology studies that contribute to the knowledge about and characterization of this disease and its associated factors. It was acknowledged that despite the progress made in the past two years, there is still a knowledge gap in relation to the epidemiological behavior, natural history, etiology, and risk factors of CKDnT in the Region and more analytical research on the problem is required at the level of Member States and the Region. It was pointed out that there is no regionallyaccepted case definition of CKDnT and more information is needed about the underlying economic burden and integrated surveillance systems for this disease, including vital statistics. It was recognized that at present, the affected countries lack a multisectorial approach that would enable them to address CKDnT in an CD52/8 (Eng.) Page 3 integrated manner. Similarly, there is a shortage of skilled human resources, infrastructure, and inputs to mount an adequate response (2). 6. The main meetings at the highest political level are described below: (a) At the end of 2009, the Minister of Health of El Salvador requested technical cooperation from PAHO to address this reported disease, which had been widely documented in research and technical reports. The issue was presented by the Minister of Health of El Salvador at various regional forums including SICA, COMISCA, and the Pan American Sanitary Conference, at the meetings of the Group of the Americas during the 2011 World Health Assembly, and at preparatory meetings for the Region of the Americas prior to the United Nations General Assembly High-level Meeting on Noncommunicable Diseases in 2011 (3-8). (b) In response, the Pan American Sanitary Bureau formed an interprogrammatic working group that includes the Representatives of PAHO in Central America. In addition to the work done by this group, COMISCA has coordinated technical cooperation activities, partnerships, subregional and regional consultations, and other activities with the support of PAHO, AECID, and the United States Centers for Disease Control and Prevention (CDC), among others. (c) The Declaration of San Salvador was adopted on 26 April 2013, at the high-level meeting of the Ministers of Health of COMISCA in El Salvador (followed by the international conference). The declaration proposed a definition of the disease as "tubulointerstitial kidney disease in Central America", which mainly effects agricultural communities, and described it as a catastrophic disease and a major health problem (9). Situation Analysis 7. Many countries do not have reliable registries for CKD, nor regular surveillance systems capable of detecting its distribution patterns in the population that could facilitate the identification of trends in and groups of CKD. Most estimates of incidence and prevalence are based on patient records during treatment for end-stage kidney disease or community surveys (10). 8. Numerous epidemiological studies, mainly descriptive, have been conducted to characterize and measure factors associated with this disease. These studies have suggested various causal hypotheses ranging from environmental causes to personal habits and customs, mainly those of impoverished workers. Most of the information and research findings from the past five years were presented at the conference organized by SALTRA in 2012 (11, 12) and at the April 2013 Conference in El Salvador mentioned earlier (2). This information is summarized below. CD52/8 (Eng.) Page 4 Disease Frequency 9. The frequency of CKD in all stages reflects a global prevalence of between 10% and 16% in the adult population, with similar frequency in both sexes. In Latin America, the incidence rate of this disease rose from 27.8 cases per million population (pmp) in 1992 to 188 pmp in 2006, with diabetes as its leading cause (13, 14). 10. In the past two decades, a disconcerting increase in CKD has been observed in Central America, causing thousands of deaths (15, 16). According to the available data (17), the specific mortality rates from chronic kidney failure (ICD 10, N-18),2 in the Region (and over 10 deaths per 100,000) are, in descending order, Nicaragua (42.8), El Salvador (41.9), Peru (19.1), Guatemala (13.6), and Panama (12.3). Canada and Cuba have reported the lowest mortality rates in the Region. Mortality was 17 times higher in Nicaragua and El Salvador compared to Cuba, and three times higher for men than for women. Clinical, Epidemiological, and Environmental Research to Determine Etiology 11. In the view of the participants at the SALTRA network workshop, based on available scientific research (which covers Nicaragua, El Salvador, and other countries), the strongest causal hypothesis for the epidemic is repeated episodes of heat stress and dehydration during heavy work in hot climates. Possible co-factors that interact with heat stress or influence the progression of CKDnt include excessive use of nonsteroidal anti-inflammatory drugs and fructose consumption in rehydration fluids. Possible contributing factors to the epidemic include inorganic arsenic, leptospirosis, exposure to pesticides, and hard water (12). 12. The descriptive studies in El Salvador presented at the International Conference--which have included about 5,000 people over the past several years-- characterize CKD as a chronic, tubulointerstitial nephropathy that mainly affects young men and agricultural workers living and working in obviously disadvantaged communities on the Pacific coast. While there is consensus that this is a multifactorial disease, some of the main factors include exposure to agrochemicals, either through direct prolonged exposure over time or through residual long-standing contamination of the soil, water sources, and crops, compounded by difficult working conditions; exposure to high temperatures; and insufficient water intake, among others factors (2). The clinical and histopathological manifestations of these cases, and the risk factors identified, are very similar to those described by researchers in agricultural communities in Sri Lanka--nephropathy among Sri Lankan farmers--where the excessive number of cases observed has been attributed to agrochemicals (18). 2 International Classification of Diseases (ICD) CD52/8 (Eng.) Page 5 Impact on Health Services 13. CKD imposes a high burden on Central American countries in terms of people's quality of life as well as health services delivery, mainly in hospital networks. Chronic kidney disease in agricultural communities in Central America requires strategies to reorganize services delivery, strengthen human resources capabilities, and reduce treatment costs, including kidney function substitution treatment. The prevalence of kidney function substitution treatment in the Region (19) rose from 162 patients per million population (pmp) in 1991 to 473 pmp in 2006 (59% hemodialysis and 20% peritoneal dialysis), although there are still are countries with very low delivery rates relative to existing demand (13). 14. Specific data from the ministries of health and scientific associations in the subregion indicate that: (a) In El Salvador, hospitalizations for CKD increased by 50% from 2005 to 2012, and it is the leading cause of hospital deaths. There were a total of 1,474 hospitalized cases of CKDnT among the group aged 0-19 years (relative to the total of 39,000 cumulative cases) and the hospitalization rate doubled from 2011 to 2012 (and tripled for those over 50 years of age). According to data submitted by national coordinators or national donation and transplant committees in the countries, approximately 3,100 patients are in substitution treatment (hemodialysis and peritoneal dialysis) in El Salvador, over 3,000 in Guatemala, 1,800 in Panama, and 1,000 in Nicaragua. In Panama, the number of patients on dialysis doubled from 2007 to 2012; in 2013, 1,725 patients were receiving peritoneal dialysis and 142 were receiving hemodialysis. Sixty transplants were performed in 2012. The Dominican Society of Nephrology reported 1,621 patients. (b) The evidence on treatment costs for this disease is still limited and varies from country to country. More details are available on the website of the International Conference (2). Proposal 15. We are faced with a serious public health problem that requires rapid, comprehensive, and coordinated action among sectors, agencies, and ministries. Technical cooperation efforts should focus on the following proposed objectives: (a) Strengthen surveillance and mandatory reporting systems for cases of CKD, using a common case definition. CD52/8 (Eng.) Page 6 (b) Strengthen the countries' capabilities in environmental surveillance and alerts-- water sources, soil, food, etc.--especially in the most affected areas, with emphasis on evaluation of the actions each country has agreed to, taking into account regulatory frameworks and international commitments relating to environmental policies in general. (c) Intensify research to better understand all stages of the disease and increase the use of evidence-based decision-making to inform program and policy alternatives (for example, EVIPNet)3 (25). (d) Strengthen regulatory and control mechanisms to ensure occupational health and hygiene. (e) In policy-making and planning, take into account that the exercise of the right to health can be claimed even in situations of poverty and high burden of disease. The principle of progressive realization facilitates the effective exercise of human rights, taking into account the resources available to each State. Progressive realization should be based on an ethical assessment and prioritization of health needs (20, 21). (f) Promote actions that include a health care model that addresses the disease in all its stages, considering quality of care, patient safety, and equitable access to treatment, including renal replacement therapy. These actions should take into account the framework of the Integrated Health Services Networks and the decisions on chronic noncommunicable diseases made at the United Nations High-level Meeting of the General Assembly (22-25). (g) Promote the creation of a Central American network of toxicological information centers that also includes training for agriculturists and the community in the prevention of pesticide exposure, drawing on the lessons learned, for example, from PLAGSALUD. (h) Encourage the countries of the Region to adopt procurement policies that ensure the quality of supplies and medicines and facilitate economies of scale in the procurement of therapeutic equipment and supplies, for example, through the PAHO Strategic Fund. (i) Raise awareness of this public health issue in civil society and empower the affected communities so that they can participate actively in the prevention and control of the disease, in public policy-making, and in monitoring compliance with the agreements and commitments made. 3 Evidence Informed Policy Network. CD52/8 (Eng.) Page 7 Action by the Directing Council 16. The Directing Council is invited to study the information presented and to consider approving the proposed resolution included in Annex A. Annexes References 1. Silva AS, Marinho F, Soliz P, Ord?nez P, Mart?nez R, Elias V. Spatially clustered chronic kidney disease. In: Mesoamerican nephropathy: Report from the first international research workshop on MeN [Online]; 2012 November 28-30; San Jos? (Costa Rica). Heredia (Costa Rica): Program on Work, Environment, and Health in Central America (SALTRA); Central American Institute for Studies on Toxic Substances (IRET-UNA); 2013, pp. 47-52 (Health, work, and environment series No. 10) [cited 2013 July 23]. Available at: http://www.regionalnephropathy.org/wpcontent/uploads/2013/04/Technical-Report-for-Website-Final.pdf 2. Council of Ministers of Health of Central America and the Dominican Republic; Ministry of Health of El Salvador; National Health Institute. 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Policy on Research for Health [Online]. 49th Directing Council of PAHO, 61st Session of the Regional Committee of WHO for the Americas; 2009 Sep 28-Oct 2; Washington (DC), US. Washington (DC): PAHO; 2009 (Document CD49/10) [cited 2013 Jun 13). Available at: http://www2.paho.org/hq/dmdocuments/2009/CD49-10-e.pdf 8. Lou-Meda R: Prevention of CKD in Guatemala. Clinical Nephrology 2010 Nov; 74 Suppl. 1:S126-8. PAN AMERICAN HEALTH ORGANIZATION WORLD HEALTH ORGANIZATION 52nd DIRECTING COUNCIL 65th SESSION OF THE REGIONAL COMMITTEE Washington, DC, USA, 30 September to 4 October 2013 CD52/8 (Eng.) Annex A ORIGINAL: SPANISH PROPOSED RESOLUTION CHRONIC KIDNEY DISEASE IN AGRICULTURAL COMMUNITIES IN CENTRAL AMERICA THE 52nd DIRECTING COUNCIL, Having considered the concept paper Chronic Kidney Disease in Agricultural Communities in Central America (Document CD52/8); Recalling the importance that the Member States place on the objective of achieving universal health coverage and equitable access to health services; Aware of the Political Declaration of the High-level Meeting of the General Assembly of the United Nations on the Prevention and Control of Noncommunicable Diseases (A/66/L.1); Recognizing the existence of chronic kidney disease in agricultural communities in Central America and that additional research is urgently needed to inform an evidencebased response; Taking into account the Declaration of San Salvador, which recognizes this chronic kidney disease as a serious public health problem that requires urgent action; Aware of the obligation of the Member States to provide a comprehensive, integrated, and solidarity-based response to the health problems of its populations, CD52/8 (Eng.) Annex A -2- RESOLVES: 1. To take note of the concept paper Chronic Kidney Disease in Agricultural Communities in Central America (Document CD52/8). 2. To urge the Member States, as appropriate, to: (a) support the Declaration of San Salvador, which recognizes chronic kidney disease from nontraditional causes in Central America as a serious public health problem; (b) promote the design and implementation of domestic and regional research agendas for chronic kidney disease in order to bridge the knowledge gap; (c) develop an interministerial approach and forge partnerships with other sectors of government, development agencies, civil society, affected communities, academia, private enterprise, and other interested parties, to coordinate efforts, mobilize resources, establish plans at the regional, national, and subnational level, and prioritize the sustainability of actions to promote evidence-based public policies and mitigate, on an urgent basis, the health, social, and economic consequences of this disease; (d) strengthen surveillance for chronic kidney disease, with emphasis on at-risk populations and communities; (e) strengthen their capabilities in environmental and occupational health, taking into account the regulatory frameworks and international commitments and standards; (f) strengthen the health services network to enhance quality of care and patient safety, the availability of human resources, medicines, and health technologies, and the financing of the evidence-based services package. 3. To request the Director to: a) continue to advocate on behalf of effective resource mobilization and to encourage Member States to play an active role in the implementation of this resolution; b) lend technical support to the strengthening of surveillance systems and facilitate advancement of research priorities for chronic kidney disease; -3- CD52/8 (Eng.) Annex A c) promote the strengthening of the countries' capabilities in regard to environmental and occupational health, taking into account the regulatory frameworks and international commitments and standards; d) support country efforts to take a comprehensive approach to evidence-based interventions to address chronic kidney disease, including human resource management and procurement mechanisms for medicines and other critical public health supplies, such as the PAHO Strategic Fund, in order to increase coverage, access, and quality of care; e) continue to alert countries that might face similar situations, and submit an annual progress report to the Governing Bodies on the implementation of this resolution. PAN AMERICAN HEALTH ORGANIZATION Pan American Sanitary Bureau, Regional Office of the WORLD HEALTH ORGANIZATION CD52/8 (Eng.) Annex B Report on the Financial and Administrative Implications of the Proposed Resolution for PASB 1. Agenda item: 4.6: Chronic Kidney Disease in Agricultural Communities in Central America 2. Linkage to Program and Budget 2014-2015:* (a) Categories: Category 2: Noncommunicable diseases and risk factors Reducing the burden of noncommunicable diseases, including cardiovascular diseases, cancers, chronic lung diseases, diabetes, and mental health disorders, as well as disability, violence, and injuries, through health promotion and risk reduction, prevention, treatment, and monitoring of noncommunicable diseases and their risk factors. Category 3: Determinants of health and promoting health throughout the life course Promoting good health at key stages of life, taking into account the need to address the social determinants of health (societal conditions in which people are born, grow, live, work, and age), and implementing approaches based on gender equality, ethnicity, equity, and human rights. Category 4: Health systems Health systems based on primary health care to support universal health coverage. Strengthening health systems with a focus on governance for social protection in health; strengthening legislative and regulatory frameworks and increasing financial protection for progressive realization of the right to health; organizing people-centered, integrated service delivery; promoting access to and rational use of quality, safe, and effective health technologies; strengthening information systems and national health research systems; promoting research for integrating scientific knowledge into health care, health policies, and technical cooperation; facilitating transfer of knowledge and technologies; and developing human resources for health. (b) Program areas and outcomes: Outcome (OCM) 2.1 Increased access to interventions to prevent and manage noncommunicable diseases and their risks factors * Refers to the Proposed PAHO Program and Budget 2014-2015 that was presented to the 152nd Session of the Executive Committee. CD52/8 (Eng.) Annex B -2- OCM 3.3 Increased country capacity to integrate gender, equity, human rights and ethnicity in health OCM 3.4 Increased leadership of the health sector to address the social determinants of health OCM 3.5 Reduced environmental and occupational threats to health OCM 4.1 Increased country capacity to achieve universal health coverage OCM 4.2 Increased access to people-centered integrated health services OCM 4.3 Improved access to and rational use of safe, effective, and quality medicines, medical products and health technologies OCM 4.4 All countries have functioning integrated health information and health research systems OCM 4.5 Adequate availability of a competent, culturally-appropriate, well regulated and distributed, fairly treated health workforce 3. Financial implications: (a) Total estimated cost for implementation over the lifecycle of the resolution (estimated to the nearest US$ 10,000, including staff and activities): The proposed resolution does not include a specific time frame and it is therefore difficult to determine the total cost. Moreover, sine the magnitude and scope of the disease throughout the Region has not yet been established with scientific evidence, it is difficult to arrive at a long-term estimate. Chronic kidney disease requires a long-term commitment from PASB to identify and address the problem as a whole, including all the necessary resources: human, political and financial. (b) Estimated cost for the biennium 2014-2015 (estimated to the nearest US$ 10,000, including staff and activities): The estimated cost for the biennium 2014-2015 is approximately $1,700,000. CD52/8 (Eng.) Annex B -3- Estimated needs are as follows: Area Health Services Amount (US$) 1,000,000 Surveillance and research 300,000 Environment and Safety 300,000 Advocacy 100,000 TOTAL (c) 1,700,000 Of the estimated cost noted in (b), what can be subsumed under existing programmed activities? PASB has human resources in place in all the areas identified, although the issue of chronic kidney disease needs to be included in the advocacy and work plans of the human resources assigned to the issue. In addition, some activities under this initiative are included in the proposed plan of action to tackle chronic disease. It entails close coordination among Pahoa's Health Systems and Services, Chronic Diseases, and Environmental Health areas. 4. Administrative implications: (a) Indicate the levels of the Organization at which the work will be undertaken: This work will be carried out at all levels of the Organization--country, subregional, and regional. (b) Additional staffing requirements (indicate additional required staff full-time equivalents, noting necessary skills profile): N/A (c) Time frames (indicate broad time frames for the implementation and evaluation): The proposed resolution does not propose a particular time frame and considers that a long-term effort and commitment on the part of all Member States and the Bureau is required. PAN AMERICAN HEALTH ORGANIZATION Pan American Sanitary Bureau, Regional Office of the WORLD HEALTH ORGANIZATION CD52/8 (Eng.) Annex C ANALYTICAL FORM TO LINK AGENDA ITEM WITH ORGANIZATIONAL MANDATES 1. Agenda item: 4.6: Chronic Kidney Disease in Agricultural Communities in Central America 2. Responsible unit: Health Systems and Services (HSS) 3. Preparing officer: Dr. Evelina Chapman 4. List of collaborating centers and national institutions linked to this Agenda item: Central American Integration System (SICA); Council of Ministers of Health of Central America and the Dominican Republic (COMISCA); Program on Work and Health in Central America (SALTRA); Central American Institute for Studies on Toxic Substances (IRET-UNA); national coordinators and national donor and transplant committees nephrology areas and dialysis units; regulatory agencies for imports, contraband, storage, sale, distribution, use and final disposal of agrochemicals; national research programs. 5. Link between Agenda item and Health Agenda for the Americas 2008-2017: The proposed resolution is linked to Health Agenda for the Americas 2008-2017 in the following areas of action: ? tackling health determinants; ? increasing social protection and access to quality health services; ? reducing the risk and burden of disease. 6. Link between Agenda item and Proposed Strategic Plan 2014-2019:* The issue of chronic tubulointerstitial kidney disease is directly related to categories 2, 3, and 4 of Pahoa's Strategic Plan 2014-2019: Category 2: Noncommunicable diseases and risk factors Reducing the burden of noncommunicable diseases, including cardiovascular diseases, cancers, chronic lung diseases, diabetes, and mental health disorders, as well as disability, violence, and injuries, through health promotion and risk reduction, prevention, treatment, and monitoring of noncommunicable diseases and their risk factors. * Refers to the Proposed PAHO Strategic Plan 2014-2019 presented at the 152nd session of the Executive Committee. CD52/8 (Eng.) Annex C -2- Category 3: Determinants of health and promoting health throughout the life course Promoting good health at key stages of life, taking into account the need to address the social determinants of health (societal conditions in which people are born, grow, live, work, and age), and implementing approaches based on gender equality, ethnicity, equity, and human rights. Category 4: Health systems Health systems based on primary health care to support universal health coverage. Strengthening health systems with a focus on governance for social protection in health; strengthening legislative and regulatory frameworks and increasing financial protection for progressive realization of the right to health; organizing people-centered, integrated service delivery; promoting access to and rational use of quality, safe, and effective health technologies; strengthening information systems and national health research systems; promoting research for integrating scientific knowledge into health care, health policies, and technical cooperation; facilitating transfer of knowledge and technologies; and developing human resources for health. 7. Best practices in this area and examples from countries within the Region of the Americas: In recent years, several specific actions have been taken in the Region to \tackle and address different aspects related to chronic kidney disease in Central America, although not necessarily the problem as a whole. For example: ? ? ? ? ? Implementation of the project PLAGSALUD "Occupational and Environmental Aspects of Exposure to Pesticides on the Central American Isthmus"--financed by the Danish Agency for International Development (DANITA) and implemented by PAHO/WHO; recognized for its multicounty and long-term approach. Mandates related to agricultural workers' health in Central America as a result of advocacy efforts by SALTRA. Important mandates on water quality throughout the Region. Knowledge and strengths that each country has in public health surveillance of pesticides. Establishment of the POP scale (Peradeniya Organophosphorus Poisoning) 8. Financial implications of this Agenda item: Total estimated cost of the application of the resolution: The proposed resolution does not include a specific time frame and it is therefore difficult to determine the total cost. Moreover, sine the magnitude and scope of the disease throughout the Region has not yet been established with scientific evidence, it is difficult to arrive at a longterm estimate. Chronic kidney disease requires a long-term commitment from PASB to identify and address the problem as a whole, including all the necessary resources: human, political and financial. The estimated cost for the 2014-2015 biennium is approximately US$ 1,700,000. ---