Pautas de Tratamiento en Casos de Malaria

Objectives

Provide a national framework for standardised malaria case management across Venezuela, covering suspected infection, diagnosis, treatment, follow-up and discharge, while supporting malaria elimination through universal access to timely diagnosis and effective treatment in public, private and community health services.[1][2]The framework responds to increased malaria incidence and transmission risk, particularly in Bolívar, Amazonas and Sucre, and seeks to reduce complications, deaths, transmission and the emergence or spread of antimalarial resistance.[3][4][5]

• Ensure early parasitological diagnosis and complete, species-appropriate treatment for Plasmodium vivax, P. falciparum, P. malariae, P. ovale, P. knowlesi and mixed infections.[3][5][6]
• Prevent progression from uncomplicated to severe malaria, protect pregnant women and fetuses, avert death and neurological harm, and reduce the human parasite reservoir.[5]
• Integrate prevention, epidemiological and entomological surveillance, timely diagnosis and treatment, and vector control within the National Malaria Elimination Programme.[4]
• Prioritise rapid recognition, hospital management and immediate parenteral treatment of severe malaria, including severe disease due mainly to P. falciparum but also potentially associated with P. vivax.[7][8]
• Address the distinct needs of pregnant women, infants under six months, children, people living with HIV, patients with tuberculosis, and other people at elevated risk of severe disease or medicine-related harm.[9][10][11][12]
• Improve medicine safety through pharmacovigilance that detects, assesses, understands and prevents adverse drug effects and suspected lack of treatment effectiveness.[13][14]

Implementation

Implement the guidance nationally through standardised, evidence-informed treatment schemes, simplified weight-based dosing tables, supervised administration, clinical follow-up and referral pathways.[3][5][15]The Ministry of Popular Power for Health defines treatment schemes using Pan American Health Organization and World Health Organization recommendations and therapeutic-efficacy evidence from Venezuela and the region, while the Directorate-General for Environmental Health provides regulatory and stewardship functions.[4][5]

• Disseminate standardised procedures to public and private services from primary care to hospital level, supported by the Ministry of Popular Power for Health, the Pan American Health Organization and World Health Organization, professional societies, hospitals, the Venezuelan Social Security Institute, health-sciences institutions and the Cuban Medical Mission.[1][3]
• Confirm malaria using thick blood films, rapid diagnostic tests, blood smears, polymerase chain reaction or newer methods where available; use thick blood films rather than rapid tests for clinical follow-up.[2][16]
• Deliver outpatient oral chemotherapy for uncomplicated malaria without severe features, combining blood-stage treatment with anti-hypnozoite therapy for P. vivax and P. ovale where indicated and safe.[15]
• Adapt treatment by parasite species, body weight, disease severity, pregnancy status, age, glucose-6-phosphate dehydrogenase deficiency risk, co-morbidities and potential medicine interactions.[15][17][18][12]
• Withhold primaquine during pregnancy, breastfeeding and in children under six months, and stop it if dark urine or jaundice develops after the first dose.[17][18][19]
• Refer pregnant women for obstetric consultation and manage severe malaria in pregnancy as a high-risk multidisciplinary obstetric emergency, including intensive-care transfer where feasible.[16][20]
• Provide the first injectable artesunate dose at primary-care level before referral for suspected severe malaria where transfer is difficult, then hospitalise patients for continuous vital, haemodynamic and metabolic monitoring.[2][7][21]
• Use injectable artesunate as first-line treatment for severe malaria regardless of species or age, with artemether or quinine reserved when artesunate is unavailable or unsuitable; switch to the relevant complete oral regimen once oral treatment is tolerated.[8][22][23]
• Monitor treatment response through scheduled parasitological checks for relapse or recrudescence, including checks on days 1, 3, 7, 14, 21 and 28, using thick and thin blood films.[24][19]
• Monitor severe cases clinically and through laboratory assessment, including consciousness, respiratory status, blood pressure, urine output, blood glucose, haemoglobin or haematocrit, renal function, electrolytes, acid-base status and parasitaemia.[25][26][27]
• Provide antimalarial medicines free of charge to all people diagnosed with malaria, with the Venezuelan State responsible for acquisition and distribution.[5]
• Coordinate pharmacovigilance through the National Institute of Hygiene Rafael Rangel and its National Centre for Pharmacological Vigilance, regional centres, health professionals, the pharmaceutical industry and the World Health Organization monitoring network.[13]
• Report suspected adverse reactions and lack of effectiveness through the F-PERC-086 form, validate and enter reports in VigiFlow, assess causality and safety signals, and submit information to the National Centre for Pharmacological Vigilance.[14]

The material does not set out a consolidated national indicator framework, reporting timetable, budget, expenditure target or formal accountability architecture beyond clinical follow-up, surveillance activities and pharmacovigilance processes.[4][12][14]

Monitoring & Evaluation

The guidance embeds monitoring within malaria case management, severe-disease management, parasitological follow-up and pharmacovigilance, while not providing a consolidated programme-level performance framework, routine reporting timetable, evaluation methodology or formal accountability structure.[1][4][12][14]

• Use thick blood films to confirm malaria and assess treatment progress; rapid diagnostic tests are not recommended for clinical follow-up.[2]
• Conduct parasitological checks after relapse or suspected recrudescence on days 1, 3, 7, 14, 21 and 28, using thick and thin blood films rather than rapid diagnostic tests.[24][19]
• Classify recrudescence when a patient returns within 30 days of completing treatment with a positive blood film, and use therapeutic-efficacy evidence from Venezuela and the region to inform treatment schemes.[4][5]
• Monitor severe malaria continuously through vital, haemodynamic and metabolic assessment, because complications may arise within hours.[7]
• Assess severe malaria using clinical signs including impaired consciousness, seizures, respiratory distress, shock, oliguria, jaundice and abnormal bleeding, together with laboratory findings such as hypoglycaemia, acidosis, severe anaemia, hyperlactataemia, renal dysfunction, thrombocytopenia and electrolyte disturbance.[7][8]
• Record temperature, respiratory status, pulse, blood pressure and consciousness every four hours in severe cases; monitor haemoglobin, haematocrit, glucose, urea, creatinine and electrolytes periodically.[25]
• Examine blood films every 12 hours, especially during the first two to three treatment days, to assess parasitaemia and response to antimalarial medicines.[25][26]
• Record fluid intake and output, or weigh patients daily where output cannot be measured, and assess urine output for haemoglobinuria or oliguria.[25][26]
• Monitor blood glucose at least every four hours when quinine is used, owing to the risk that quinine may worsen hypoglycaemia.[23]
• Monitor plasma bicarbonate, blood gases, arterial pH and oxygen saturation in severe malaria-associated acidosis, and repeat relevant acid-base, haematological, glucose, renal and electrolyte measurements during clinical management.[28][27]
• Recheck blood glucose 30 minutes after treating hypoglycaemia and adjust dextrose infusion according to subsequent measurements.[29][30]
• Label injectable artesunate boxes or ampoule packaging with the patient’s name and administration date and time to support supervision, safe administration and identification of staff-training needs.[8][21][31]
• Conduct monthly thick-film and blood-smear follow-up for mothers treated during pregnancy and for infants under six months, continuing until six months after delivery or until the child reaches six months of age.[9][32]
• Monitor pregnant women with severe malaria through glucose, haemoglobin, creatinine and platelet testing, alongside foetal heart-rate assessment, biophysical profiles, Doppler studies and assessment for threatened preterm labour where indicated.[20][11]
• Test cord blood by thick film and blood smear when transplacental transmission is suspected and at delivery under the applicable maternal and newborn protocol.[9][11]
• Conduct parasitological follow-up for patients whose antiretroviral or tuberculosis medicines may reduce antimalarial exposure or increase recurrence, including those receiving efavirenz or rifampicin-containing treatment.[12]
• Use spontaneous pharmacovigilance reporting to identify suspected adverse drug reactions and lack of effectiveness, with regional centres responsible for receiving, validating, processing and entering reports into a database.[13][14]
• Apply the National Centre for Pharmacological Vigilance causality-assessment algorithm, detect safety signals, submit data through VigiFlow, and use the F-PERC-086 form for reports by health professionals and the public.[14]
• Capture reporter, patient, clinical-event, medicine, batch, dosage, treatment-date, outcome and follow-up information in adverse-event reports; the reporting form also records dechallenge, rechallenge and prior notifications.[33][34][35]
• Maintain medicine-control records identifying batch, pharmaceutical manufacturer, active salt and active-base quantities.[36][37]

Costing & Financing

Financing information is limited: the Venezuelan State acquires antimalarial medicines and distributes them free of charge to all people diagnosed with malaria, but the material does not provide monetary budgets, unit costs, expenditure allocations, funding sources, funding gaps, resource-mobilisation plans or economic assumptions.[5]

• Provide antimalarial medicines through State acquisition and free distribution to people diagnosed with malaria.[5]
• Require service resources for diagnosis, including thick blood films, blood smears, rapid diagnostic tests and, where available, polymerase chain reaction or newer diagnostic methods; no costs are specified.[16]
• Require hospital-care inputs for severe malaria, including injectable antimalarials, laboratory testing, oxygen, monitoring, fluids, blood products, vascular access, ventilation and renal-replacement interventions where clinically necessary; no resource valuation is provided.[38][27][39][40]
• Require pharmacovigilance inputs including reporting forms, their distribution and collection, database entry and VigiFlow use, but no monetary valuation or financing arrangement is specified.[14]