Norma nacional y manual de procedimientos técnicos de leishmaniasis

Objectives

Bolivia’s national standard for leishmaniasis establishes a mandatory, nationwide framework for public- and private-sector National Health System personnel. Its overarching purpose is to standardise and unify prevention, timely diagnosis, treatment, control, epidemiological surveillance and entomological surveillance, within the Family, Community and Intercultural Health policy framework.[1][2][3][4]The framework seeks to reduce transmission, complications, disability and mortality; prevent chronic disease; support clinical recovery and biopsychosocial reintegration; and limit growth in case numbers.[5][6]

• Prioritise endemic transmission across Pando, Beni, Santa Cruz, La Paz, Cochabamba, Chuquisaca and Tarija, while recognising that Oruro and Potosí report imported rather than autochthonous cases.[1][7][8]
• Strengthen prevention, care and surveillance for cutaneous, mucosal, mucocutaneous and visceral leishmaniasis, with particular attention to timely detection and management of severe, recurrent or treatment-resistant disease.[1][9][10][11]
• Improve access to health services, medicines, diagnostic supplies, infrastructure and trained staff through advocacy with local and municipal authorities.[2][12][13]
• Promote participatory health management, preventive behaviour, prompt care-seeking and action on social, environmental and occupational determinants of exposure.[2][14][12]
• Reduce human-vector contact and vector populations through environmental management, individual protection, integrated vector control and targeted residual spraying where vectors have adapted to domestic or peri-domestic settings.[15][16][17]
• Address reservoir-related transmission in confirmed visceral-leishmaniasis areas through surveillance and control of infected domestic dogs; routine surveillance of wild reservoirs is considered impracticable.[17][14]

Implementation

Implementation combines a tiered clinical and laboratory service model with mandatory notification, active and passive surveillance, intersectoral vector control, community participation and coordinated action by national, departmental and municipal authorities.[18][13][19][20]The Ministry of Health sets standards, coordinates, supervises and supports national action, including medicine procurement and access to diagnostic and treatment supplies, while departmental health services, municipalities, health networks and facilities implement surveillance, care, referral, prevention and control responsibilities.[12][13][19]

• Deliver care through first-level facilities undertaking case-finding, diagnosis, first-line treatment and follow-up; second-level hospitals receiving referrals and providing first- or second-line treatment; and specialised or third-level services managing complex, recurrent and comorbid cases and coordinating counter-referral.[19][20][21][22]
• Confirm suspected disease through clinical and epidemiological assessment plus laboratory testing, using parasitological, culture, histopathological and immunological methods according to disease form and care level.[23][24][25][26]Use molecular testing through the National Reference Laboratory for Leishmaniasis where routine methods are inconclusive or strain typing is needed.[5]
• Provide first-line treatment principally with meglumine antimoniate, using patient-specific dosing and complete courses, and reserve amphotericin B for severe, refractory or clinically complex cases in facilities with trained personnel and capacity to manage adverse effects.[27][28][29][30]
• Monitor treatment response, adverse effects and longer-term recovery through disease-specific follow-up. Cutaneous disease is reviewed during and after treatment, while mucosal disease requires follow-up for up to two years and visceral disease is followed through twelve months after treatment.[31][32][6]
• Notify and investigate each known case within 24 hours using the National Programme’s standardised clinical and epidemiological form; classify cases as autochthonous or imported and georeference probable infection locations.[33][18]
• Combine routine consultation-based and laboratory-supported passive surveillance with active searches in endemic communities through brigades, campaigns and programmed missions.[18]Investigate outbreaks through multidisciplinary teams, active case-finding within 48 hours, risk-group characterisation, diagnosis and treatment provision, adverse-event follow-up and assessment of chemical control feasibility.[34]
• Conduct continuous entomological surveillance in prioritised foci, covering vector species, distribution, habits, density, seasonal variation and insecticide susceptibility.[34][15][16]Build laboratory and technical capacity through standardised vector identification, taxonomic methods, appropriate infrastructure and a national entomological information system.[15]
• Engage communities, indigenous and territorial organisations, employers, schools, veterinary services, social movements and public and private institutions in planning, education, occupational protection, environmental management, animal control and local oversight.[15][14][12]Employers in endemic areas are expected to provide protective inputs and ensure affected workers can access care, treatment, laboratory investigations, rehabilitation and definitive cure.[12]
• Consolidate confirmed cases weekly and suspected and confirmed cases monthly, submit reports through the health information system, and immediately report severe adverse effects.[19][20][21]Use verified clinical, epidemiological, laboratory and entomological data to construct process, outcome and impact indicators assessed at weekly, monthly, quarterly, half-yearly and annual intervals.[35][36]
• Provide human, financial and material resources at departmental and municipal levels for medicines, reagents, supplies, equipment, forms, education, surveillance, prevention and vector-control campaigns.[13][19]The material does not specify quantified budgets, unit costs, funding gaps or financing targets.[13][19][22]

Monitoring & Evaluation

The framework establishes a national surveillance, reporting and evaluation architecture for leishmaniasis, combining compulsory case notification, clinical and laboratory confirmation, active and passive surveillance, outbreak investigation, entomological monitoring, treatment follow-up, and multi-level data consolidation.[33][18][19][35]It links surveillance to early diagnosis, appropriate treatment, prevention of sequelae and mortality, identification of risk areas, and control of transmission.[6][33]

• Notify and investigate every identified case within 24 hours using the National Programme’s standardised clinical and epidemiological form.[33][18]
• Classify infections as autochthonous or imported and record the probable location of infection, including community, municipality, province and department where available, to support georeferencing and analysis of transmission patterns.[18]
• Conduct passive surveillance through routine consultations and laboratory confirmation, and undertake active case-finding through brigades, campaigns and programmed missions in endemic communities.[18]
• Apply clinical, epidemiological and laboratory criteria to classify suspected cutaneous, mucosal or mucocutaneous, and visceral disease, with confirmation through parasite detection, culture, histopathology, immunological testing or polymerase chain reaction.[33]
• Permit confirmation through an epidemiological link when laboratory testing cannot be accessed and the suspected case has endemic-area exposure and a history consistent with vector contact.[33]
• Monitor treatment completion, clinical recovery, relapse, severe forms and adverse events, with follow-up schedules differentiated by clinical form.[6][33]
• Assess visceral leishmaniasis response through fever resolution, reduced hepatosplenomegaly, improved blood counts, nutritional recovery and improvements in albumin and globulin, recognising that protein normalisation may take several months.[6]
• Monitor cutaneous disease before and after treatment and at one, three and six months, assessing scar formation, re-epithelialisation, regression of inflammation and ulcer closure.[32]
• Follow mucosal disease at treatment completion, at three and six months, and then every six months for up to two years, including ear, nose and throat assessment six months after treatment.[32][6]
• Define an outbreak as a sudden, unusual increase of more than three autochthonous cases in a specified time and place, then initiate multidisciplinary investigation, active searches within 48 hours, risk-group characterisation, treatment access and adverse-event follow-up.[18][34]
• Consolidate confirmed cases weekly and suspected and confirmed cases monthly at departmental and health-network levels, using the National Leishmaniasis Programme database and the relevant national health information system.[19][20]
• Require health-facility directors and first- and second-level services to submit case, laboratory, treatment and follow-up reports weekly and monthly, and to report severe adverse effects immediately.[20][21]
• Validate case and investigation data for authenticity and quality from community to national level, using verified information to develop process, outcome and impact indicators for epidemiological and operational decisions.[35]
• Review process indicators weekly, monthly, quarterly, half-yearly and annually; use outcome indicators to assess achievements by health establishments and programmes, and impact indicators to assess medium- and long-term societal effects.[35][36]
• Use clinical and epidemiological records, databases, laboratory information, entomological surveillance, indicator forms and knowledge-assessment tools in supervision and evaluation.[36]
• Conduct continuous entomological surveillance in priority foci, tracking vector distribution, habits, seasonal variation, population density and insecticide susceptibility.[34][15][16]
• Monitor resistance to public-health insecticides at least annually and submit susceptibility findings promptly to the national medical entomology reference laboratory for corroboration before official reporting of resistance.[16]
• Enable communities to report suspected cases and unusual increases in vector populations, and involve them in planning and oversight of local prevention and control activities.[14][12]

Costing & Financing

Financing responsibilities are distributed across national, departmental, municipal and employer levels, but the material provides no monetary budgets, unit costs, quantified funding gaps, financing targets or economic assumptions.[12][13][19]The Ministry of Health is assigned a central role in procuring medicines and supporting access to diagnostic and treatment supplies, while subnational authorities are expected to resource implementation and local service capacity.[13][19]

• Provide annual Ministry of Health investment in essential, high-quality medicines for leishmaniasis control and prevention of complications, although no expenditure amount is specified.[1]
• Procure medicines nationally for patients outside the comprehensive health insurance scheme, support departmental and municipal procurement of medicines, reagents and supplies, and provide specialised care.[13]
• Allocate departmental human and financial resources for leishmaniasis plans, including medicines, diagnostic reagents, medical supplies, vector-control inputs, equipment, educational materials and prevention, care, surveillance and control campaigns.[13][19]
• Strengthen municipal provision of medicines, laboratory reagents, equipment, health services, prevention campaigns, epidemiological surveillance and entomological surveillance, alongside first- and second-level care capacity.[19]
• Plan diagnostic and treatment supplies and medicines in support of surveillance and case management, without a specified monetary valuation.[18]
• Maintain technical and logistical infrastructure for entomology laboratories, vector identification, taxonomic work and the national entomological information system.[15]
• Require employers in endemic areas to provide or finance protective clothing, repellents, mosquito nets, window screening, residual spraying, medical care, treatment and laboratory investigations for affected workers until rehabilitation and definitive cure.[12]
• Verify availability of the complete quantity of required medicine ampoules before initiating specific treatment, but no medicine prices or procurement costs are given.[37][11]
• Recognise direct lesion scraping as a low-cost, minimally invasive diagnostic method and rK39 testing as economical, while noting that neither method is assigned a monetary value.[25][5]