National guidelines for diagnosis and treatment of malaria

Objectives

Provide Tanzania’s national reference framework for malaria diagnosis, treatment, prevention, commodity management, quality assurance, surveillance and monitoring across public and private health services. It supports the Tanzania Malaria Control Strategy and aims to reduce malaria morbidity and mortality through safe, effective, quality-assured, affordable and accessible care.[1][2][3]

• Standardise malaria case management at community, dispensary, health-centre and hospital levels, while allowing referral directly to the level appropriate to illness severity.[4][5]
• Ensure prompt parasite-based diagnosis for suspected malaria, distinguish confirmed malaria from test-negative febrile illness, reduce unnecessary antimalarial use, and strengthen reporting of confirmed cases.[6][7][8]
• Provide effective treatment for uncomplicated malaria, severe malaria, malaria-associated anaemia and malaria in pregnancy, with treatment choices adapted to clinical severity and pregnancy trimester.[3][9][10][11]
• Maintain artemether-lumefantrine as the principal treatment for uncomplicated malaria while efficacy remains at least 90%, and use dihydroartemisinin-piperaquine where artemether-lumefantrine is contraindicated or ineffective.[12]
• Prevent malaria in pregnancy through intermittent preventive treatment with sulfadoxine-pyrimethamine, long-lasting insecticide-treated nets and antenatal-care delivery.[13][14][15]
• Reduce transmission and protect vulnerable populations through integrated vector management, including long-lasting insecticide-treated nets, indoor residual spraying, larval source management and effective artemisinin-based combination therapies.[16][17]
• Contain artemisinin resistance by requiring parasitological confirmation, ensuring access to quality-assured artemisinin-based combination therapies, monitoring therapeutic efficacy, and prohibiting oral artemisinin monotherapies.[18][19][20]
• Tailor interventions to Tanzania’s varied malaria epidemiology, including stable perennial, stable seasonal, highly seasonal and unstable transmission settings, while sustaining control measures to reduce epidemic risk as transmission declines.[21][22]
• Strengthen malaria communication so that communities recognise symptoms, seek treatment within 24 hours, adhere to test results and prescribed treatment, attend antenatal care, and use preventive measures.[23][24]

Implementation

Implementation combines decentralised service delivery, national technical stewardship, regulated medicine and diagnostic supply chains, laboratory quality assurance, routine surveillance and targeted epidemic response. The Ministry of Health and Social Welfare and National Malaria Control Programme coordinate the guideline with health authorities, facilities, pharmaceutical and diagnostic services, professional bodies, development partners and private-sector representatives.[25][24][26]

• Deliver services through four levels of care. Community providers support prevention education, rapid diagnostic testing, treatment of uncomplicated childhood malaria, pre-referral care and referral; dispensaries provide assessment, testing and pre-referral management; health centres manage uncomplicated and selected severe cases; and hospitals provide multidisciplinary severe-malaria care, transfusion, intensive care and advanced investigations.[5][27][28]
• Confirm suspected malaria using microscopy or malaria rapid diagnostic tests according to facility capacity and clinical need. Use microscopy to assess parasite density, investigate suspected treatment failure and monitor severe malaria, while using rapid tests to extend timely access to diagnosis.[8][29]
• Provide artemether-lumefantrine as a six-dose, three-day first-line regimen for uncomplicated malaria, preferably initiating treatment under direct observation; investigate non-response, use blood-smear confirmation where available, and refer cases requiring further assessment.[30][31]
• Manage severe malaria urgently with injectable artesunate as the preferred medicine, followed by a full oral artemether-lumefantrine course when tolerated. Use quinine or artemether where indicated or where artesunate is unavailable, provide pre-referral treatment when transfer is delayed, and deliver supportive care for complications.[32][33][34][35]
• Adapt malaria management for special groups, including quinine for uncomplicated malaria in the first trimester of pregnancy, artemether-lumefantrine in later pregnancy, and tailored prevention and clinical assessment for people living with HIV, neonates, children, travellers and people with sickle cell disease.[11][36][37][38][39]
• Coordinate national forecasting, procurement, storage and distribution through the National Malaria Control Programme, Medical Stores Department, Pharmaceutical Services Section and Integrated Logistics System. Forecast annually with biannual reviews using consumption, morbidity and inventory data; distribute through quarterly logistics cycles; and apply good storage practices, first-expiry-first-out procedures and documented verification of receipt.[24][40]
• Maintain commodity availability and accountability through quarterly end-use verification, supervision of stock management and redistribution of imbalanced stocks. Public and private supply arrangements include facilities, pharmacies, Accredited Medicine Dispensing Outlets, community health workers, wholesalers, importers and regulatory inspection.[41][26]
• Operate diagnostic quality assurance through competency standards, training, supervision, microscopy cross-checking, rapid diagnostic test lot testing, equipment and reagent requirements, accreditation, and reporting lines from facilities through districts to national level.[26][42][43]
• Monitor medicine safety through spontaneous adverse-reaction reporting and active pharmacovigilance. Health professionals report suspected reactions to the Tanzania Food and Drug Authority, which assesses causality and may take regulatory action, including product recall, deregistration or amended product information.[44]
• Use the Health Management Information System and Integrated Disease Surveillance and Response strategy for routine reporting, supported by sentinel districts and weekly surveillance where required. Track confirmed malaria incidence, testing rates and positivity, malaria deaths, intermittent preventive treatment in pregnancy uptake, anaemia, commodity stocks and outbreak signals.[45][46][47][48]
• Respond to epidemics through strengthened diagnosis and treatment, vector control, community mobilisation, emergency commodity stocks, and, when services are overwhelmed, time-limited clinical treatment or mass screening and treatment approaches.[49][18]

Monitoring & Evaluation

The guideline establishes a layered monitoring, evaluation and surveillance system for malaria case management, commodity security, diagnostic quality, treatment efficacy, pharmacovigilance and programme impact. It combines routine facility reporting, the Health Management Information System (HMIS), Integrated Disease Surveillance and Response (IDSR), sentinel surveillance, surveys, therapeutic-efficacy studies and quality-assurance mechanisms.[44][50][45]

• Monitor malaria burden through laboratory-confirmed cases per 1,000 population, malaria test positivity, standardised laboratory-confirmed incidence and death rates, intermittent preventive treatment in pregnancy uptake, and disaggregation by age, sex and pregnancy status.[45][46]
• Operate HMIS across health facilities and IDSR for diseases of public-health importance and epidemic potential; strengthen reporting through standardised diagnosis, recording tools, timely submission, trained staff and designated facility and district focal persons.[45][46]
• Report suspected, clinical or probable, and confirmed malaria separately; count confirmed and clinical or probable cases as malaria-case indicators, while excluding suspected cases and negative test results from reported malaria cases.[50][48]
• Measure the malaria test rate among suspected cases and investigate low testing performance associated with stock-outs, inadequate training or failure to follow diagnostic algorithms.[50]
• Interpret confirmed-case, probable-case and test-positivity trends cautiously, because changes in testing coverage, diagnostic practice, reporting completeness, facility attendance and seasonality can affect observed patterns.[50][45][47]
• Use discharge registers and primary discharge diagnoses for inpatient malaria surveillance; classify admissions and deaths as confirmed where tests are positive, or as clinical where testing was not performed but antimalarial treatment and a malaria discharge diagnosis were recorded.[51]
• Track severe anaemia admissions and deaths, haemoglobin measures, blood transfusions in children under five, Plasmodium species, outpatient attendance and malaria commodity stocks as supporting indicators of malaria burden, severe disease, service use and supply availability.[51][47]
• Compile and analyse facility data through Council Health Management Teams for central reporting, with the National Malaria Control Programme working with selected sentinel districts to improve diagnosis and reporting.[46]
• Use weekly IDSR reporting for total malaria tests, positive tests and clinical cases, supporting rapid outbreak response and measurement of whether epidemics are detected and addressed within two weeks of onset.[48]
• Conduct active detection through fever screening and parasitological testing or testing of defined high-risk groups; use reproductive and child health clinic sentinel surveillance and focal screen-and-treat activities in households, villages and hotspots.[48][52]
• Use surveillance information to guide outbreak response, priority-setting, intervention planning, resource mobilisation and allocation.[45]
• Monitor severe malaria clinically through vital signs, consciousness, respiratory status, fluid balance, urine output, glucose, haemoglobin or haematocrit and parasitaemia; repeat blood-smear testing daily until negative where indicated.[35][53][54]
• Monitor uncomplicated-malaria treatment response through patient review, blood-smear confirmation of suspected treatment failure, and follow-up of patients returning four to 14 days after treatment with continuing symptoms.[31][19]
• Measure parasite clearance on day 3 after artemisinin-based combination therapy, because delayed clearance is an early warning sign of artemisinin resistance; assess first- and second-line medicine efficacy at sentinel sites at least every 24 months and alert authorities when non-response occurs frequently.[18][19]
• Implement diagnostic quality assurance through competent personnel, supervision, supplies, equipment, direct observation, blood-slide cross-checking, rapid diagnostic test storage monitoring, lot testing and hierarchical reporting.[26][42]
• Apply rapid diagnostic test lot testing using 150 tests per lot for consignments with shelf-life below 18 months and 175 tests per lot for longer shelf-life consignments, with quarterly testing when new consignments arrive.[43]
• Conduct quarterly end-use verification of commodity availability at health facilities and Medical Stores Department zonal warehouses; produce stock reports and redistribute commodities where imbalances risk stock-outs.[41][26]
• Use annual commodity forecasting with twice-yearly reviews based on consumption data, morbidity reports, inventory data, in-country stock and supply-pipeline information; capture consumption through Integrated Logistics System request forms and quarterly ordering cycles.[24][40]
• Record order-delivery discrepancies through Verification and Claim Forms and acknowledge correctly received supplies through Goods Received Notes.[40]
• Require health professionals to report suspected adverse medicine reactions, including uncertain associations, through spontaneous yellow-form reporting and active pharmacovigilance; the Tanzania Food and Drug Authority assesses causality and may undertake recall, deregistration or product-information changes.[44]
• Undertake formal impact evaluation to assess the population-level effect of programme scale-up, intervention coverage, malaria morbidity, child mortality and the incremental effect of net-distribution and behaviour-change delivery systems.[50]

Costing & Financing

The supplied material contains no quantified malaria programme budget, expenditure, unit cost, funding gap, allocation, financing target or economic assumption. It instead identifies limited financing sources, budget-related procurement constraints and resource requirements for implementation.[2][3][24][40]

• Receive development-partner support, principally from the Global Fund and the United States President’s Malaria Initiative, for deployment of artemether-lumefantrine in public health facilities from 2007.[2]
• Use the Affordable Medicine Facility for malaria, introduced in 2010, to improve private-sector access to and affordability of quality-assured artemisinin-based combination therapies.[2]
• Recognise World Health Organization and United States Agency for International Development and President’s Malaria Initiative funding for meetings to prepare and publish the guidelines.[25]
• Order malaria commodities according to facility needs and within available budgets, although no facility budget values or funding mechanisms are provided.[40]
• Allow emergency procurement during a national stock-out within the limits established by the Public Procurement Act, 2004, without specifying the monetary limit.[40]
• Identify resource requirements for diagnostics, medicines, quality assurance, logistics, trained personnel, stable electricity where microscopy requires it, storage, supervision and routine reporting, without costing these inputs.[7][8][29]
• Characterise seasonal malaria chemoprevention as cost-effective, safe and feasible for children under five in highly seasonal transmission areas, without presenting a cost-effectiveness estimate or financial plan.[22]
• Note that sentinel surveillance can operate through existing routine health-care delivery systems without extensive financial resources, but provide no quantified cost.[48]