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    Global Malaria Programme

    M

    ALARIA

    CASE

    M

    AN

    AG

    EM

    EN

    T

    OPERATIONS

    M

    ANUAL

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    MALARIA CASEMANAGEMENT

    OPERATIONS MANUAL

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    Malaria case management: Operations manual

    World Health Organization 2009

    All rights reserved. Te designations employed and the presentation o the material in this publication do notimply the expression o any opinion whatsoever on the part o the World Health Organization concerningthe legal status o any country, territory, city or area or o its authorities, or concerning the delimitation o itsrontiers or boundaries. Dotted lines on maps represent approximate border lines or which there may not yetbe ull agreement.

    Te mention o specifc companies or o certain manuacturers products does not imply that they areendorsed or recommended by the World Health Organization in preerence to others o a similar nature that

    are not mentioned. Errors and omissions excepted, the names o proprietary products are distinguished byinitial capital letters.

    All reasonable precautions have been taken by the World Health Organization to veriy the inormationcontained in this publication. However, the published material is being distributed without warranty o anykind, either expressed or implied. Te responsibility or the interpretation and use o the material lies withthe reader. In no event shall the World Health Organization be liable or damages arising rom its use.

    WHO Library Cataloguing-in-Publication Data :

    Malaria case management: operations manual.

    1.Malaria - epidemiology. 2.Malaria - prevention and control. 3.Malaria - drug therapy. 4.Malaria - diagnosis.5.Case management - administration and organization. 6.Antimalarials. 7.Health services. 8.Health profle.9.Manual. I.World Health Organization. II.Global Malaria Programme.

    ISBN 978 92 4 159808 8 (NLM classifcation: WC 755)

    Acknowledgements

    TeMalaria Case Management Operational Manualis a product o a collaborative workbetween the World Health Organization (WHO) Headquarters and all WHO Regions.Te WHO Global Malaria Programme wishes to acknowledge the valuable contribu-tions o: Hoda Atta (EMRO), Andrea Bosman (HQ), Keith Carter (AMRO), EvaChristophel (WPRO), Mikhail Ejov (EURO), Timasarn Krongthong (SEARO), PaolaMarchesini (AMRO), Leonard Ortega (SEARO), Peter Olumese (HQ), Issa Sanou(AFRO) and Wilson Were (HQ).

    Te document has also been reviewed by Maru Aregawi (HQ), David Bell (WPRO), SoceFall (AFRO), Zamani Ghasem (EMRO), Walter Kazadi (AFRO), Kamini Mendis (HQ),Josephine Namboze (AFRO), Jackson Sillah (AFRO), and Marian Warsame (HQ).

    ii

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    Contents

    1. Introduction ...................................................................................................1

    2. Defning the clinical profle o malaria patients .......................................3

    3. Structure and management o the malaria control programme .............7

    4. Technical aspects o malaria case management ......................................17

    5. Supply chain management and logistics ..................................................29

    6. Quality assurance o malaria diagnosis and antimalarial medicines..........44

    7. Training health workers..............................................................................478. Communication or behavioural change .................................................509. Monitoring, evaluation and supervision o the malaria

    control programme .....................................................................................5510. Reviewing and changing the antimalarial treatment policy ..................66

    11. Pharmacovigilance ......................................................................................70

    12. Integration o malaria case management into otherhealth programmes .....................................................................................72

    13. Working with the private sector ................................................................73

    Annex 1. Health unit monthly stock management ormor medicine and laboratory supplies .......................................................78

    Annex 2. Model checklist or malaria laboratory supervision ..............81

    Annex 3. Malaria case management indicators .......................................83

    Annex 4. Malaria patient card ...................................................................91

    Annex 5. Health unit malaria case register ..............................................94

    Annex 6. Health unit malaria monthly summary report orm .............99

    Annex 7. District malaria monthly summary report orm ................. 103

    Annex 8. Model checklists or malaria case managementsupersivion ................................................................................................ 107

    Annex 9. Model suspect adverse drug reaction report orm .............. 112

    iiiContents

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    Malaria case management: Operations manual

    Abbreviations used

    AIDS acquired immunodefciency syndrome

    AC artemisinin-based combination therapy

    AM artemether

    A artemotil

    AL artemether-lumeantrine

    AS artesunate

    AQ amodiaquinine

    CQ chloroquine

    DI district investigation team

    HIV human immunodefciency virus

    HRP-II histidine-rich protein II

    IN insecticide-treated net

    IP intermittent preventive treatment

    IP1 frst dose o intermittent preventive treatment

    IP2 second dose o intermittent preventive treatment

    M meoquine

    QNN quinine

    RD rapid diagnistic test

    SP suladoxine-pyrimethamine

    WHO World Health Organization

    iv

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    2 Malaria case management: Operations manual

    Artemisinin-based combinations are recommended or treatment o uncom-

    plicated alciparum malaria in all age groups, except during the frst trimester

    o pregnancy, and parenteral quinine, artesunate or artemether are the recom-

    mended treatments or severe malaria.

    1.2 Purpose and aims of the manual

    Te purpose o this manual is to advise those responsible or national malaria

    control programmes on the best ways o ensuring access to early diagnosis and

    appropriate, eective case management based on sound practice and WHOsexperience in the use o artemisinin-based combination treatment. Te manual

    describes malaria programme management, planning and implementation and

    outlines the technical knowledge needed or case management. It is intended

    or adaptation and use in all malaria-endemic countries, irrespective o their

    epidemiological and socioeconomic specifcities.

    Te aim o this manual is to help to ensure that malaria control programmes

    at national, provincial, district (used here to indicate the frst subnational

    administrative level) and community levels are eciently and eectively organ-ized to allow early diagnosis and prompt, eective treatment. Te manual

    provides basic inormation or the successul operation o malaria control

    programmes and defnes the skills required in the ollowing areas:

    t QSPHSBNNFTUSVDUVSFQMBOOJOHBOENBOBHFNFOU

    t BTTFTTNFOUPGUIFBWBJMBCMFJOTUJUVUJPOBMDBQBDJUZBOEIVNBOSFTPVSDFTBOE

    JEFOUJDBUJPOPGXBZTUPTVQQPSUFFDUJWFDBTFNBOBHFNFOU

    t QMBOOJOHFFDUJWFNBMBSJBDBTFNBOBHFNFOUBOEJEFOUJGZJOHUFDIOJDBMBOENBOBHFSJBMFMFNFOUTUIBUSFRVJSFSFWJTJPOPSSFPSJFOUBUJPO

    t MPHJTUJDBMPSHBOJ[BUJPOUPFOTVSFSFHVMBSTVQQMJFTPGNFEJDJOFTEJBHOPTUJDT

    BOEPUIFSDPOTVNBCMFT

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    DIBOHF

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    t DPPSEJOBUJOHBOEJOUFHSBUJOHNBMBSJBDPOUSPMQSPHSBNNFTXJUIPUIFSQVCMJD

    health programmes and the private sector.

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    32. Defining the clinical profile of malaria patients

    1.3 Intended readership

    Te manuals intended readership is personnel responsible or planning,

    organizing and supervising malaria control, especially malaria case manage-ment, at provincial, regional or national level, in ministries o health or inprojects supported by international and multilateral cooperation agencies ornongovernmental organizations.

    Te manual is intended or use in particular by multidisciplinary teamsinvolved in managing national malaria control programmes, includingprogramme managers, epidemiologists, programme supervisors, provincialand district medical ocers, medical superintendents or hospital administra-

    tors, pharmacists, clinicians, nurses, laboratory technicians, parasitologists,statisticians, health educators, logistics ocers and trainers.

    Health project managers dealing with malaria at national, district andcommunity levels, including those responsible or private health services, willalso fnd this manual useul. It could also be used as a resource in medical,nursing, laboratory and public health schools or training in eective malariacase management.

    2. Defining the clinical profileof malaria patients

    One o the frst activities in designing and planning health services ormalaria is identiying the clinical profle o the malaria patients in the area. Teclinical profle varies greatly rom one region o the world to another, dependingon the species o malarial parasite (e.g. Plasmodium alciparum, Plasmodiumvivax and other species) and the epidemiology o malaria (e.g. high or lowtransmission, stable or unstable epidemic) (Fig. 1). Te clinical profle omalaria (Fig. 2) is defned by:

    t UIFBHFBOEQPQVMBUJPOEJTUSJCVUJPOPGNBMBSJBFHNBJOMZJODIJMESFOBOEQSFHOBOUXPNFOPSJOBMMBHFHSPVQT

    t UIF TFWFSJUZPG UIFEJTFBTFFHBDVUFEJTFBTFXJUIIJHINPSCJEJUZJOOPOimmune persons or milder disease with low morbidity such as in partially

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    4 Malaria case management: Operations manual

    Perc

    entage

    100

    50

    5 10 15 20 25 25+

    moderate endemicity

    hyperendemicity

    age groups

    0

    Figure 1 Schematic representation o the incidence rate o clinical malaria in areas ostable malaria and high transmission and in areas o unstable malaria and low tomoderate transmission

    Holoendemic

    severe anaemia

    severe anaemia

    cerebral malaria

    severe anaemia

    cerebral malaria

    cerebral malaria

    Hyperendemic

    Hypoendemic

    Unstable

    Mesoendemic

    1 1 3 54 10 20 30 40years

    organ failure

    Figure 2 Schematic representation o the types o clinical presentation o malaria inrelation to malaria epidemiology

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    5

    JNNVOFQFSTPOTBOEXIFUIFS JUQSPHSFTTFTSBQJEMZUPTFWFSFNBMBSJBBOEEFBUIBOE

    t UIF DMJOJDBM UZQF PGEJTFBTF FH TFWFSF BOBFNJB DFSFCSBMNBMBSJB TJOHMF

    organ or multiple-organ ailure syndromes.

    Te clinical profle o malaria in an area determines the kind o health careservices needed. For instance, i the disease occurs mainly in children, the systemwill ocus on paediatric services. I the disease is acute, rapidly progressing andatal, the health care services must be provided both at the level o the commu-nity (to ensure early treatment) and o tertiary institutions (or intensive care orsevere disease). Tables 13 show the implications or malaria case managementaccording to the clinical profle o malaria in a particular area.

    In areas o stable malaria and high malaria transmission (Table 1), such astropical Arica and Papua New Guinea:

    t NPTUNBMBSJBDBTFTBSFEVFUPP. alciparumBOEBSFQPUFOUJBMMZMFUIBM

    t UIFCVSEFOPGNBMBSJBJTQSFEPNJOBOUMZJODIJMESFO

    t DMJOJDBMDBSFNVTUCFQSPWJEFEBUBMMMFWFMTCVUFTQFDJBMMZBUDPNNVOJUZMFWFMwith home management, and at tertiary institutions with good reerralGBDJMJUJFTGPSJNNFEJBUFUSBOTGFSPGQBUJFOUTXJUITFWFSFEJTFBTF

    t QSFHOBOUXPNFOBOEUIFJSVOCPSOJOGBOUTBSFBUIJHISJTLPGNPSCJEJUZBOEprovision should be made in maternal and child health services or prompt,eective treatment o malaria.

    Table 1 Clinical profle o malaria and implications or case management in areaso stable malaria and high transmission

    Age o

    patient

    Clinical burden (inci-

    dence rate o disease)

    Clinical pictureNotes on diagnosis

    and treatmentInants High

    Mainly ater 4 monthso age

    Fever, high parasitaemia,rapid progression odisease to severe malariaand death

    Treat on clinical suspicion Early treatment in the

    community and reerral veryimportant

    Demand or tertiary careservices or severe malariawill be high

    Children25 years

    Children

    > 5 years

    Low Fever, moderate parasi-

    taemia, semi-immuneand thereore risk osevere disease not veryhigh, except in pregnantwomen

    Seek parasitological confr-

    mation o diagnosis wherepossible

    Adolescentsand adults

    2. Defining the clinical profile of malaria patients

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    6 Malaria case management: Operations manual

    In areas o unstable malaria and low to moderate malaria transmission(Table 2), such as much o tropical Asia, Latin America and Central Asia:

    t CPUIP. vivaxand P. alciparumNBMBSJBBSFPFOQSFWBMFOU

    t NBMBSJBJTBOJNQPSUBOUCVUOPUOFDFTTBSJMZUIFQSFEPNJOBOUQVCMJDIFBMUIQSPCMFN

    t EJBHOPTUJD TFSWJDFT BSF DSJUJDBMMZ JNQPSUBOU UPEJFSFOUJBUFTQFDJFT BOE UPEJTUJOHVJTINBMBSJBGSPNPUIFSGFCSJMFJMMOFTTFT

    t JNNVOJUZUPNBMBSJB JT MPXJOBMM BHFHSPVQT BOE UIFSFGPSF UIF SJTLTGPSEJTFBTFBOEEFBUIGSPNVOSFDPHOJ[FENBMBSJBBSFIJHIBUBMNPTUBMMBHFT

    t NBMBSJB USFBUNFOU TFSWJDFT BU QSJNBSZ IFBMUI DBSF MFWFM BSF JNQPSUBOU JO

    order to prevent severe malaria and mortality.

    In malaria epidemics, which can occur in areas o unstable malaria as well asin areas o stable malaria due to a high inux o non-immune or susceptiblepopulations (Table 3):

    t CPUIP. vivaxand P. alciparumNBMBSJBDBOCFQSFWBMFOU

    t BTJNNVOJUZUPNBMBSJBJT MPXJOBMMBHFHSPVQT UIF SJTLTGPSEJTFBTFBOE

    EFBUIBSFIJHIBUBMMBHFT

    t NBMBSJBDBTFNBOBHFNFOUDBOSBQJEMZPWFSXIFMNCPUIQBFEJBUSJDBOEBEVMUDMJOJDBMTFSWJDFTXJUIJOBTIPSUUJNF

    t EJBHOPTUJDTFSWJDFTBSFDSJUJDBMMZJNQPSUBOUJOPSEFSUPDPOSNBOFQJEFNJDCVUBSFOPUFTTFOUJBMUIFSFBFSEJTFBTFNBOBHFNFOUEVSJOHUIFBDVUFQIBTFo the epidemic consists o mass treatment o ebrile patients.

    Table 2 Clinical profle o malaria and implic ations or case management in areaso unstable malaria and low to moderate transmission

    Age opatient

    Clinical burden (incidencerate o disease)

    Clinical pictureNotes on diagnosis

    and treatment

    Inants Low Fever, moderate to highparasitaemia, rapidprogression o diseaseto severe malaria anddeath i treatment is

    delayed

    Early treatment andreerral important atprimary health care level

    Parasitological confrma-tion o diagnosis recom-

    mended Demands intensive care

    services or managemento severe malaria

    Children25 years

    Children> 5 years

    High

    Adolescentsand adults

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    73. Structure and management of the malaria control programme

    Table 3 Clinical profle o malaria and implications or case management in malariaepidemics

    Age o

    patient

    Clinical burden

    (incidence rateo disease) Clinical picture

    Notes on diagnosis

    and treatment

    Inants High Sudden and large increasein number o patientsFever, high parasitaemia,rapid progression odisease to severe malariaand death i treatment isdelayed

    Early treatment and reer-ral important at primaryhealth care level

    Parasitological confrma-tion o diagnosis is impor-tant, especially in the earlystage o the epidemic

    Demands intensive careservices or managemento severe malaria

    Children25 years

    Children> 5 years

    High

    Adolescentsand adults

    3. Structure and management ofthe malaria control programme

    Te main objective o malaria treatment is to cure inection and to preventdeath rom severe malaria. Tis is achieved by ensuring ecient, eective treat-ment as quickly as possible aer the onset o symptoms ideally, within 24

    hours or alciparum malaria. Tus, the likelihood o severe malaria is reducedand ew cases progress. Another important objective o treatment is to reducethe reservoir o people with malaria inection in order to reduce the chances otransmission o malaria parasites to others.

    o support these objectives, specifc national policies are required to guidemalaria case management services and surveillance. Planning or eectiveservice delivery should be based on the population at risk, the burden o disease,the quality o service and its accessibility. It is the responsibility o the nationalmalaria control programme to defne strategies, with clear short- and long-

    term objectives, and to set targets. In planning or ecient, eective casemanagement, it is important to consider:

    t BDDFTTJCJMJUZuser-riendly diagnostic and treatment services as close to theQBUJFOUTIPNFTBTQPTTJCMF

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    93. Structure and management of the malaria control programme

    tices and quality will be required to establish its role and its capacity to increasethe access o the population to high-quality malaria case management.

    3.1.2 Human resourcesOne o the greatest limitations to ensuring access to early diagnosis and

    eective treatment is the lack o adequately trained, motivated human resourcesin public health, including programme managers, doctors, nurses, pharmacists,laboratory technicians, data managers and other skilled health providers. Inplanning a national, provincial or district case management strategy, a system-atic assessment should be made o existing stang patterns, including:

    t OVNCFSTLJMMTBOEUFSNTPGSFGFSFODFPGLFZQVCMJDIFBMUITUBSFRVJSFEUP

    NBOBHFBNBMBSJBQSPHSBNNFBUOBUJPOBMQSPWJODJBMBOEEJTUSJDUMFWFMTt OVNCFSBOETUBOHMFWFMTPGQIZTJDJBOTOVSTFTBOEPUIFSNFEJDBMPSQBSB-NFEJDBMTUBQSPWJEJOHDVSBUJWFTFSWJDFTBOEUIFJSQPQVMBUJPODPWFSBHF

    t UZQFOVNCFSRVBMJDBUJPOTBOEEJTUSJCVUJPOPGMBCPSBUPSZQSPGFTTJPOBMTBOEUFDIOJDJBOTXIPQFSGPSNNJDSPTDPQZGPSEJBHOPTJTPGNBMBSJB

    t OVNCFS EJTUSJCVUJPO BOE UBTLT PG DPNNVOJUZ IFBMUI XPSLFST BHFOUT PSvolunteers dealing with malaria at village or community level.

    Human resource requirements and stang models to ensure the quality oservice delivery should be evaluated locally on the basis o the resources available.

    Te persons involved in malaria case management at country level are shownin the fgure 3.

    Private sector

    Preventiveservices

    Curativeservices

    Nongovernmentalnot-or-proft sector

    Regulation QA& QC standards

    MALARIA PATIENT

    Public sector

    Technical collegesPostgraduate

    institutes of medicineMedicalcolleges

    Professionalassociations

    Medicinesvendors

    Privatelaboratories

    Privatepractitioners

    Local pharmaceuticalmanuacturers

    Wholesale medicines& supplies dealers

    Trade unions

    Regulation QA& QC standards Ministry o health

    Health institutions

    Community homemanagement o malaria

    National malariacontrol programme

    Local NGOs

    Faith-basedorganizations

    International NGOs

    National drugregulatory committee

    National drugregulatory authority

    Central medicalstores

    Standards& norms

    Figure 3 Malaria case management stakeholders in the national context

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    10 Malaria case management: Operations manual

    3.2 National malaria control programmes

    3.2.1 Structure

    Te administrative structure or malaria control should be integrated intothe organizational structure o health service delivery and the political admin-istration o the country. Te principles advocated by the WHO Global MalariaProgramme or the programme management structure are a well-establishednational malaria control programme under the ministry o health, a provincialor district management structure and clear links with health institutions andcommunities. Te management structures should be politically supported andhave enough resources to provide high-quality services. Even when health

    services are integrated and decentralized, appropriate management structuresare needed to support malaria control activities.

    For eective programme management and implementation o malariacontrol at central level, a minimum number o competent sta is needed. Teminimum stang levels recommended by the WHO Global MalariaProgramme should be sucient to enable specifc ocers to be responsible ormanaging at least the eight key programme areas specifed in the organizationalchart shown in the fgure 4.

    National malariacontrol manager

    Casemanagement

    Treatment,drug ecacyand quality,pharmaco-vigilance

    Insecticideresistance,monitoring

    Epidemicpreparednessand response

    Procurement,supplies

    management,logistics

    Internationalcooperation

    Vectorcontrol andprevention

    Laboratoryservices and

    quality control

    Epidemiology,surveillance

    datamanagement

    Epidemiology,surveillance

    datamanagement

    Planning,monitoring

    and evaluation

    Administration Training

    Figure 4 National malaria control programme structureIEC = information, education and communication

    3.2.2 Functions

    It is the responsibility o the ministry o health through the national malariacontrol programme to design a malaria control strategy, to set objectives andtargets and to ensure implementation o activities, including adequate unding.

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    11

    Tereore, at national level, the main unctions o a national malaria controlprogramme are as ollows:

    t UPGPSNVMBUFNBMBSJBDPOUSPMQPMJDJFT

    t UPEFTJHOBOETVQQPSUBOBUJPOBMNBMBSJBDPOUSPMTUSBUFHZt UPGPSNVMBUFOBUJPOBMNBMBSJBDPOUSPMQMBOTJODMVEJOHTFUUJOHUBSHFUT

    t UPTFUTUBOEBSETBOEDPOEVDURVBMJUZBTTVSBODF

    t UP NPCJMJ[F SFTPVSDFT GPS JNQMFNFOUBUJPO PG BDUJWJUJFT BOE DPPSEJOBUFFYUFSOBMGVOEJOH

    t UPCVJMEDBQBDJUZBOEQSPWJEFUFDIOJDBMTVQQPSU

    t UPTVQFSWJTFNPOJUPSBOEFWBMVBUFNBMBSJBSFMBUFEBDUJWJUJFTJOUIFDPVOUSZ

    t UPDPOEVDUNBMBSJBTVSWFJMMBODFDBTFSFQPSUJOHESVHTBGFUZESVHBOEJOTFD-UJDJEFSFTJTUBODF

    t UPDPPSEJOBUFPQFSBUJPOBMSFTFBSDIPONBMBSJB

    3.2.3 Malaria case management policy

    National malaria control programmes must defne a clear malaria treatmentpolicy based on surveillance o drug ecacy in the country. Te policy shouldstate which medicine(s) are to be used as frst- and second-line treatment or

    uncomplicated malaria and or severe malaria and should provide clear guid-ance or case management in special groups (pregnant women, children agedunder fve and people living with HIV/AIDS). All countries in which P. alci-

    parum malaria is endemic should adopt the use o oral artemisinin-basedcombination treatments or uncomplicated malaria and parenteral artemisininsor quinine or initial treatment o severe malaria. In countries where there is P.vivax malaria, chloroquine or amodiaquine ollowed by primaquine radicaltreatment cure are still eective.

    Case management guidelines should be revised to concord with the agreedpolicies or diagnosis and treatment o malaria. Te national treatment guide-lines should be reected in practice and communicated in a timely manner tothe public and private sectors, including the general population. Te treatmentpolicy should also indicate which antimalarial agents are registered andmarketed in the country. WHO currently encourages all countries in whichartemisinin-based combination treatments are used to stop the marketing oartemisinin derivative monotherapy in order to reduce the spread o resistanceto these medicines.

    o ensure proper coordination, a medical ocer must be appointed tooversee malaria case management within the national programme. Te role othe case management ocer is to acilitate the ormulation, implementation,monitoring and evaluation o the treatment policy. In addition, ocers should

    3. Structure and management of the malaria control programme

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    12 Malaria case management: Operations manual

    be appointed to oversee drug ecacy studies, malaria laboratory services andpharmacovigilance or antimalarial drugs, in close cooperation with thenational drug regulatory authority and the national pharmacovigilance centre.

    A support team o proessional sta is needed or case management activi-ties at national and district levels. It is recommended that a working groupcomposed o clinicians working in central and district hospitals, pharmacists,laboratory technicians and nurses be established, to provide a orum or discus-sion and decision-making on diagnosis and treatment o malaria. Te workinggroup would:

    t QFSJPEJDBMMZSFWJFXBOEBEWJTFUIFOBUJPOBMNBMBSJBDPOUSPMQSPHSBNNFPONBMBSJBUSFBUNFOUQPMJDZ

    t QFSJPEJDBMMZSFWJFXBOEVQEBUFUIFOBUJPOBMHVJEFMJOFTBOEUSBJOJOHNBUF-SJBMTGPSNBMBSJBDBTFNBOBHFNFOU

    t FOTVSFIJHIRVBMJUZUSBJOJOHPGIFBMUIXPSLFSTBOEQBSBNFEJDBMTUB

    t TVQFSWJTFIFBMUIXPSLFSTBOEMBCPSBUPSZUFDIOJDJBOTJO DPMMBCPSBUJPOXJUInational malaria control programme sta.

    3.3 Malaria control at subnational level

    Subnational structures responsible or planning and implementation omalaria prevention and control measures can be at the level o local govern-ment areas, districts, states, regions or municipalities. In most countries,malaria control activities are micro-planned and implemented at subnationalMFWFMUIJTJT UIFSFGPSFBO JNQPSUBOUMFWFMBUXIJDIUPFOTVSFTFSWJDFEFMJWFSZTe malaria programme management structure and capacity should be wellestablished, depending on the degree o decentralization o health services.

    3.3.1 Structure

    o ensure adequate microplanning, supervision, monitoring and evaluationo malaria control activities at subnational level, a ocal point is needed. A posi-tion should be created by the national malaria control programme, or a ocalperson should be identifed at subnational level, e.g. rom the district healthmanagement team. In countries where the malaria control programme is inte-

    grated into peripheral health services, this person will have other tasks toperorm in addition to malaria control. Te district malaria ocer or ocalperson will be responsible or malaria control in the district health manage-ment team and will liaise with other district health sta and partners to ensureeective case management.

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    13

    3.3.2 Functions

    Te main unction o the district health management team is to coordinateand plan all malaria control activities in the district. Te key unctions in

    malaria case management include:

    t QMBOOJOHPOUIFCBTJTPGUIFFQJEFNJPMPHZFYJTUJOHIFBMUITFSWJDFJOGSBTUSVD-UVSFBOEBDDFTTCZUIFQPQVMBUJPOBUSJTL

    t FOTVSJOHUIBUBMMQVCMJDIFBMUIGBDJMJUJFTQSPWJEFHFOFSBMPVUQBUJFOUTFSWJDFTDBUFSJOHGPSNBMBSJBQBUJFOUT

    t FOTVSJOHUIFBWBJMBCJMJUZBOERVBMJUZPGNBMBSJBEJBHOPTUJDTFSWJDFT

    t FOTVSJOHUIFBWBJMBCJMJUZPGFFDUJWFBOUJNBMBSJBMNFEJDJOFT

    t EFTJHOBUJOHUIFGBDJMJUJFTJOUIFEJTUSJDU UIBUXJMMQSPWJEFJOQBUJFOUDBSFGPS

    patients with severe malaria, according to the level o personnel and acili-UJFTBWBJMBCMF

    t FOTVSJOHIJHIRVBMJUZ USBJOJOHPGEJTUSJDUIFBMUIXPSLFSTBOEQBSBNFEJDBMTUBJONBMBSJBDBTFNBOBHFNFOU

    t QSPWJEJOH UFDIOJDBM TVQFSWJTJPO UPIFBMUIXPSLFST BOE MBCPSBUPSZ UFDIOJ-DJBOTJODPMMBCPSBUJPOXJUIUIFEJTUSJDUIPTQJUBMPSIFBMUIDFOUSFTUB

    t TVQFSWJTJOHQSJWBUFQSPWJEFSTUPFOTVSFIJHIRVBMJUZNBMBSJBEJBHOPTJTBOEUSFBUNFOUBDDPSEJOHUPOBUJPOBMUSFBUNFOUHVJEFMJOFT

    t FOTVSJOHUIBUBQQSPQSJBUFNFTTBHFTBOEFEVDBUJPOBMNBUFSJBMTBSFBWBJMBCMFto both providers and the community.

    Planning at district level should cover the entire population, taking intoaccount access to services, because distance, geographical barriers, lack o

    transport and poverty can prevent access to treatment. A signifcant proportiono the population might not be able to reach health acilities owing to remote-ness or extreme poverty. It is important to remember that, in high-transmissionareas, the high case-load seen during peak transmission seasons will requireadditional medical supplies and will entail an increased workload or healthpersonnel. Te diagnostic services (especially microscopy) might be over-whelmed and the quality o the examinations not be assured in the absence oadequate planning.

    A subnational or district supervisory team should be responsible or theoverall coordination and supervision o malaria case management in the healthinstitutions. Tis can be a great challenge in large subnational administrativeareas, because o the diversity o services and the small number o personnelavailable to supervise all acilities.

    3. Structure and management of the malaria control programme

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    3.4 Malaria control at health unit level

    Primary health care acilities play a major role in malaria control and oen

    provide the bulk o malaria case management services in a country, usuallyboth clinical services and overall programme management or communityactivities in the catchment area. District hospitals and large health centresusually have clinical and diagnostic services or outpatients and inpatients, actas reerral centres and give support to lower-level acilities.

    3.4.1 Structure

    Te structure o health units in relation to the community is shown fgure 5.

    primarycareclinic

    hospital orhealth centre

    with beds

    community

    community

    community

    community

    Figure 5 Health unit structure in relation to the community

    3.4.2 Functions

    Health acilities involved in malaria programme planning and provision oservices should have well-established roles. Most acilities provide integratedclinical and community outreach services. o ensure adequate planning andprovision o malaria case management, all health acility sta should be orientedand trained in both managerial and clinical service delivery. Te key unctionso primary health care acilities, depending on the level o stang, include:

    t QMBOOJOH NBMBSJB DPOUSPM BDUJWJUJFT UP FOTVSF FBSMZ BDDFTT UP BQQSPQSJBUFEJBHOPTJTBOEUSFBUNFOUBUIFBMUIVOJUTBOEJOUIFDPNNVOJUZ

    t FOTVSJOH BEFRVBUF QSPWJTJPO BOE BWBJMBCJMJUZ PG BOUJNBMBSJBM NFEJDJOFTEJBHOPTUJDTBOEPUIFSTVQQMJFTGPSIFBMUIVOJUTBOEUIFDPNNVOJUZ

    t FOTVSJOHBDMFBSPXPGQBUJFOUTJOPVUQBUJFOUEFQBSUNFOUTXIPQSFTFOUXJUIGFWFSPSBIJTUPSZPGGFWFSPSBOBFNJB

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    t FOTVSJOHUIBUQBUJFOUTBSFDMJOJDBMMZBTTFTTFEUIBUNBMBSJBJTEJBHOPTFEGSPNa blood smear or rapid diagnostic test and that the patients are treated withBOBQQSPQSJBUFBOUJNBMBSJBMESVH

    t FOTVSJOHUIBUQBUJFOUTXJUITFWFSFNBMBSJBBSFSFGFSSFEBFSJOJUJBMUSFBUNFOUt FOTVSJOH UIBU UIF SFMFWBOU JOGPSNBUJPO JT SFDPSEFE JO B NBMBSJB QBUJFOUSFHJTUFSTVNNBSJ[FENPOUIMZBOEBOBMZTFECFGPSFSFQPSUJOHUPUIFEJTUSJDU

    t BTTJTUJOH JO DPNNVOJUZ NPCJMJ[BUJPO BOE QSPWJEJOH UFDIOJDBM TVQQPSU UPcommunity health workers through training and supervision in malaria control.

    Planning should be based on the population o the area served by the healthunit, to ensure that the services are reasonably planned and accessible. Tecase-load should be supported by adequate supplies and resources to ensure

    that the quality o service delivered is good, thereby encouraging the popula-tion to make good use o the health acility.

    3.5 Malaria control at community level

    Te structure at community level depends on the local situation. For eec-

    tive malaria control, it is important to activate existing community structures.Access to early, eective treatment can be achieved only when the communityis aware o the problem and knows how to deal with it.

    3.5.1 Home management of malaria

    Health service coverage in many malaria-endemic countries is generally low,and many children and adults with ever are treated at home or close to home.Most children die at home without access to the health system. Te behaviour o

    populations in seeking care or ever varies, depending on actors such asgeographical access, poverty, community perceptions and the availability omedicines. It is thereore important to assess whether home management omalaria could be used to improve access to early diagnosis and treatment.

    Implementation o home management requires partners, awareness andsupport. Partnership is important at all levels and can include communitygroups, key departments o ministries o health, other government sectors, theprivate sector, inormal health providers, nongovernmental organizations, the

    mass media and bilateral and global development agencies.In order to implement home management o malaria, the ollowing should

    be planned:

    t TFOTJUJ[BUJPOPGEJTUSJDUIFBMUIUFBNTBOEDPNNVOJUJFTBCPVUUIFTUSBUFHZ

    3. Structure and management of the malaria control programme

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    t TFMFDUJPOPGDPNNVOJUZCBTFEIFBMUIQSPWJEFSTUPCFUSBJOFE UIFOVNCFSdepending on the area to be served, but preerably at least two persons inFBDITFMFDUFEIPVTFIPME

    t USBJOJOHPGDPNNVOJUZCBTFEIFBMUIQSPWJEFSTCZEJTUSJDUBOEIFBMUIGBDJMJUZTUBXJUIUIFJOWPMWFNFOUPGMPDBMMFBEFST

    t FTUBCMJTINFOUPGBTZTUFNGPSSFHVMBSEJTUSJCVUJPOPGNFEJDJOFTEJBHOPTUJDTinormation or behaviour change, job aides and logistical support (e.g.TUPSBHFGBDJMJUJFTGPSNTUJNFST

    t NPOJUPSJOHBOETVQFSWJTJPOPGDPNNVOJUZCBTFEIFBMUIQSPWJEFSTBOEUIFwhole programme through documentation, record-keeping, quality assur-BODFJOGPSNBUJPOBOBMZTJTBOEGFFECBDLUPBMMMFWFMT

    t FWBMVBUJOHUIFTZTUFNUP JODSFBTFNPUJWBUJPOBOEUPTVQQPSUBOENPCJMJ[Fcommunity-based health providers.

    3.5.2 Delivery structure

    Various community-based health providers can deliver prompt, eectivetreatment through home management o malaria. Te providers can be drawnrom the public sector, including existing community health workers andpersons involved in other health-related community programmes. Tose in the

    private or inormal sector include commercial medicine sellers (chemicalcompanies or patent medicine vendors), retail shopkeepers, traditional healersand traditional birth attendants. Tey could be newly trained or the purpose(e.g. malaria health volunteers or agents). o achieve good access, dierentcommunity-based health providers should be recruited, depending on theexisting community structures, resources and community needs.

    3.5.3 Functions

    Communities have a pivotal role in advocating and supporting malariacontrol activities and can improve trust and support or those activities. Temain roles o communities are as ollows:

    t UPTFMFDUDPNNVOJUZCBTFEEJTUSJCVUPSTBOEEJTUSJCVUJPOQPJOUT

    t UPQBSUJDJQBUFJO UIFDPMMFDUJPOBOEEFMJWFSZPGNFEJDJOFTGSPNUIFOFBSFTUEJTUSJCVUJPOQPJOU

    t UPNPCJMJ[FSFTPVSDFTBOETVQQPSUDPNNVOJUZIFBMUIXPSLFST

    Community-based health providers should be selected through a locallyappropriate process, with ull community involvement. Tey should be reliablepersons, preerably mothers or other caregivers, and the community shoulddecide on the number required per area. Te roles o community-based healthproviders are as ollows:

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    t UPBTTFTTBOEQSPWJEFUSFBUNFOUUPQBUJFOUTXJUIGFWFSPSNBMBSJB

    t UPUFMMNPUIFSTDBSFHJWFSTIPX UPUSFBUBOEQSFWFOUNBMBSJBBUIPNFCZFOTVSJOHUIBUQFPQMFTMFFQVOEFSBCFEOFU

    t UPFYQMBJOUIFEBOHFSTJHOTUPNPUIFSTDBSFHJWFST

    t UPSFGFSDIJMESFOXJUIEBOHFSTJHOTUPIFBMUIGBDJMJUJFTBOEFYQMBJOUIFOFFEUPUIFDBSFHJWFST

    t UPGPMMPXVQUSFBUFEDIJMESFOUPFOTVSFUIBUUIFZDPNQMZXJUIUSFBUNFOUBOEBEWJDF

    t UPFOTVSFHPPETUPSBHFPGESVHTBUDPNNVOJUZMFWFM

    t UPSFDPSEEFUBJMTPGQBUJFOUTUSFBUFEESVHTHJWFOPVUDPNFPGUSFBUNFOUBOE

    any adverse drug reactions.For successul community implementation o the home management o malaria

    approach, health acilities and personnel must be equipped to provide training,support and supervision to community resource persons and to establish a reerralservice in the community. Health workers should be sensitized to home manage-ment o malaria, to ensure that their role in the strategy is well understood, so thatthey can support it and promote its adoption and implementation.

    4. Technical aspects of malariacase management

    Te frst symptoms o malaria are nonspecifc and are similar to the symp-toms o a minor systemic viral illness. Tey comprise headache, lassitude,atigue, abdominal discomort and muscle and joint ache, ollowed by ever,chills, sweating, anorexia, vomiting and worsening malaise. Inection withP. vivax and P. ovale, especially, can be associated with well-defned malarialparoxysms, in which ever spikes, chills and rigor occur at regular intervals.

    I treatment is delayed or i ineective antimalarial medicines are given to apatient with alciparum malaria, the disease may progress to severe diseasewithin a ew hours. Tis usually maniests as one or more o the ollowing:coma (cerebral malaria), metabolic acidosis, severe anaemia, and hypogly-caemia and, in adults, acute renal ailure or acute pulmonary oedema.

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    It is thereore important to diagnose or recognize malaria and to treat casespromptly and eectively, bearing in mind the essential components o malariacase management, which are disease recognition or prompt diagnosis, clinicaland parasitological diagnosis, treatment with eective drugs, reerral i neces-sary, counselling and ollow-up.

    Usually, health acilities are classifed into three levels, with separate roles inmalaria case management. At community level (home management), the rolesare recognition and treatment o uncomplicated cases and recognition andreerral o severe disease. Health acilities undertake diagnosis and treatment omalaria cases. Peripheral health acilities manage uncomplicated malaria anddiagnosis and reerral o severe cases aer pre-reerral treatment, while healthcentres and hospitals manage severe cases.

    4.1 Diagnosis of malaria

    Prompt, accurate diagnosis o malaria is part o eective disease manage-ment. High sensitivity in diagnosis is important in all settings, particularly orthe most vulnerable groups, such as young children, in which the disease can

    rapidly be atal. High specifcity can reduce unnecessary treatment with anti-malarial medicines and improve dierential diagnosis o ebrile illness.

    A diagnosis o malaria is based on clinical criteria (clinical suspicion) anddetection o parasites in blood (parasitological or confrmatory diagnosis).

    4.1.1 Clinical diagnosis

    Clinical suspicion alone has little specifcity, as the signs and symptoms o

    malaria are nonspecifc. Malaria is suspected clinically mainly on the basis oever or a history o ever. Te ollowing WHO recommendations are stillconsidered valid or clinical diagnosis:

    o *OTFUUJOHTXIFSFUIFSJTLPGNBMBSJBJTMPXclinical diagnosis o uncompli-cated malaria should be based on the degree o exposure to malaria and ahistory o ever or ever in the previous three days with no eatures o othersevere diseases.

    o *OTFUUJOHTXIFSFUIFSJTLPGNBMBSJB JTIJHIclinical diagnosis should bebased on ever or a history o ever in the previous 24 hours and/or the pres-ence o anaemia, or which pallor o the palms appears to be the most reli-able sign in young children.

    In all settings, clinical suspicion o malaria should be confrmed with a para-sitological diagnosis. However, in settings where parasitological diagnosis is

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    not possible, the decision to provide antimalarial treatment must be based onthe prior probability o the illness being malaria.

    4.1.2 Parasitological diagnosisParasitological diagnosis has the ollowing advantages:

    t JNQSPWFEDBSFPGQBSBTJUFQPTJUJWFQBUJFOUTCFDBVTFPGHSFBUFSDFSUBJOUZUIBUUIFZIBWFNBMBSJB

    t JEFOUJDBUJPOPGQBSBTJUFTQFDJFT

    t JEFOUJDBUJPOPGQBSBTJUFOFHBUJWFQBUJFOUTJOXIPNBOPUIFSEJBHOPTJTNVTUCFTPVHIU

    t BWPJEBODFPGVOOFDFTTBSZVTFPGBOUJNBMBSJBMNFEJDJOFTJOQBSBTJUFOFHBUJWFpatients, thereby reducing side-eects, drug interactions, selection pressureor drug resistance and savings, especially in view o the high cost o artem-JTJOJOCBTFEDPNCJOBUJPOUSFBUNFOUT

    t DPOSNBUJPOPGUSFBUNFOUGBJMVSFT

    Te two methods commonly used or parasitological diagnosis are lightmicroscopy and rapid diagnostic tests or detecting parasite antigens. Lightmicroscopy has the advantage o low cost in situations o high case-load and

    high sensitivity and specifcity when used by well-trained sta. Rapid diagnostictests are generally more expensive, but the prices o some have decreasedrecently so that use is cost-eective in some settings. An operational constraint,however, is that their sensitivity and specifcity are vulnerable to high tempera-tures and humidity.

    Te results o parasitological diagnosis should be available within less thantwo hours o presentation o the patient. I this is not possible, the patient mustbe treated on the basis o a clinical diagnosis. In all cases, i there is a strong

    clinical suspicion, the case should be treated as malaria.WHO recommends parasitological confrmation (microscopy or rapid diag-

    nostic test) beore treatment or all suspected malaria cases. Antimalarial treat-ment on the basis o clinical suspicion should only be given in situations whereparasitological diagnosis is not available, specially in vulnerable populations(children under fve years o age and severe malaria).

    Te choice o using rapid diagnostic tests or microscopy depends on localcircumstances, including the skills available, the use o microscopy or other

    diseases present in the area and the case-load. Light microscopy remains thegold standard or diagnosis, and rapid diagnostic tests should be used wheremicroscopy is not available. When the case-load o patients with ever is high,microscopy is likely to be less expensive than rapid diagnostic tests. Microscopycan be used to identiy species, quantiy parasites and identiy other causes o

    4. Technical aspects of malaria case management

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    ever. In situations where most malaria patients are treated outside the healthservices and in remote areas where good quality microscopy cannot besupported, rapid diagnostic tests might be useul.

    Te national malaria control programme should clearly defne the diagnosispolicy in each area. Further guidance on diagnosis policy is available at http://www.who.int/malaria/diagnosisandtreatment.html, which provides reerencesto publications that also give more details o WHO recommendations on thechoice o rapid diagnostic tests.

    In areas where two or more species o malaria parasite are common, only aparasitological method will permit species diagnosis. In areas where only alci-parum malaria occurs, or where P. vivax, P. malariae or P. ovale occur almost

    always as a co-inection with P. alciparum, rapid diagnostic tests that detectonlyP. alciparum are generally preerable on the grounds o lower cost. Wherealciparum and non-alciparum inections occur commonly as single-speciesinections, combination tests to detect all species and to distinguish P. alci-

    parum rom non-alciparum inections are indicated. Where there is no alci-parum malaria, rapid diagnostic tests to detect non-alciparum species aloneare appropriate (P. vivax-specifc or specifc or malaria caused by all species).

    4.2Treatment of uncomplicated malaria

    Te primary objective in treating uncomplicated malaria is to achieve aclinical and parasitological cure and to eradicate parasites rom the body. Tesecondary objective is to prevent the emergence and spread o resistance toantimalarial medicines. Another important objective o treatment is to reducethe parasite reservoir rom which other persons will become inected, thus

    reducing transmission.

    In the management o severe malaria, the primary objective o antimalarialtreatment is to prevent death. Hence, the prevention o recrudescence andavoidance o minor adverse eects are secondary aims.

    4.2.1 Uncomplicated P. falciparum malaria

    In order to provide the best treatment available (to improve treatment

    outcome) and to counter the threat o resistance oP. alciparum to monothera-pies, combinations o antimalarial medicines are now recommended by WHOor the treatment o alciparum malaria, including women in the second andthird trimesters o pregnancy. Combination therapy is defned as the simulta-neous use o two or more blood schizontocidal drugs with independent modes

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    o action to improve therapeutic ecacy and also to delay the development oresistance to the individual components o the combination.

    Te artemisinin compounds are active against all our species o malaria

    parasites that inect humans and are generally well tolerated. Tese drugs alsohave the advantage, rom a public health perspective, o reducing gametocytecarriage and thus the transmissibility o malaria. With high treatment coverage,this contributes to malaria control in areas o low endemicity. Te artemisinin-based combination treatments currently recommended are (in alphabeticalorder) artemether-lumeantrine, artesunate plus amodiaquine, artesunate plusmeoquine, and artesunate plus suladoxine-pyrimethamine. Te Malariareatment Guidelines are currently being updated (2009), and another AC dihydroartemisinin-piperaquine is being reviewed or inclusion as an option

    or treatment o uncomplicated malaria (the Guidelines update will be postedon the WHO malaria web site as soon as it is available and please, check or itat: http://who.int/malaria).

    Artemether-lumeantrine

    Artemether-lumeantrine is available as fxed-dose combination containing20 mg o artemether and 120 mg o lumeantrine in each tablet. Te recom-mended treatment is a 6-dose regimen over a 3-day period. Te dosing is basedon the number o tablets per dose given twice a day or 3 days, according toQSFEFOFEXFJHIU CBOET oLH UBCMFUoLH UBCMFUToLH3 tablets and over 34 kg: 4 tablets).

    Artesunate plus amodiaquine

    Tis is currently available as co-ormulated tablets in three strengths(25/67.5, 50/135 and 100/270 mg o artesunate and amodiaquine respectivelyin each tablet). Te recommended treatment is a 3-dose regimen over a 3-dayperiod. Te target dose is 4 mg/kg o body weight o artesunate and 10 mg/kg

    o body weight o amodiaquine given as a single daily dose or 3 days. Tecurrent available product is dosed-based on the number o tablets ollowingpre-defned weight bands. Co-packaged blister packs containing 50 mg artesu-nate and 153 mg base-amodiaquine are also available.

    Artesunate plus suladoxine-pyrimethamine

    Artesunate plus suladoxine-pyrimethamine is currently available as sepa-rate, scored tablets containing 50 mg o artesunate and tablets containing500 mg o suladoxine and 25 mg o pyrimethamine. (A similar preparation

    with tablets containing 500 mg o sulalene and 25 mg o pyrimethamine isconsidered to be equivalent to suladoxine-pyrimethamine.) Te total recom-mended treatment is 4 mg/kg o body weight o artesunate given once a day or3 days and a single administration o suladoxine-pyrimethamine 1.25/25 mg/kgo body weight on day 1.

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    Artesunate plus meoquine

    Artesunate plus meoquine is currently available as fxed-dose ormulationswith 25/55 mg and 100/200 mg tablets o artesunate and meoquine, respec-

    tively. Blister packs with separate, scored tablets containing 50 mg o artesunateand 250 mg o meoquine base are also available. Te total recommendedtreatment is 4 mg/kg o body weight o artesunate given once a day or 3 daysand 25 mg/kg o body weight o meoquine base usually split over 2 or 3 days.

    4.2.2 Treatment approaches

    Counselling is encouraged, during which patients or caregivers are told othe importance o taking a ull treatment course, told when to return or

    ollow-up and what to do i they become sicker. Another important approach isto give the frst dose o treatment at the health acility, which might requirereorganization o patient ow.

    Partial treatment should not be given, even when patients are considered tobe semi-immune or the diagnosis is uncertain. A ull course o eective treat-ment should always be given once a decision to give antimalarial treatment hasbeen reached.

    Te artemisinin derivatives (oral ormulations) and other components oartemisinin-based combination treatments should not be available as mono-therapies, and eorts should be made to limit their availability, unless theyserve a specifc need (e.g. suladoxine-pyrimethamine or intermittent preven-tive treatment, chloroquine or P. vivaxmalaria).

    4.2.3 Uncomplicated P. vivax, P. ovaleand P. malariae malaria

    Chloroquine or amodiaquine as monotherapy with primaquine or treat-

    ment oP. vivaxmalaria are still eective. Where artemisinin-based combina-tion treatment has been adopted as frst-line treatment or P. alciparum malaria,it can also be used against P. vivaxmalaria, ollowed by primaquine or radicalcure. Te only exception is artesunate plus suladoxine-pyrimethamine, whichis not eective against P. vivaxin many places. Te recommended treatment oruncomplicated vivax malaria is as ollows:

    t $IMPSPRVJOFNHCBTFLHPGCPEZXFJHIUEJWJEFEPWFSEBZTDPNCJOFEwith primaquine 0.25 mg base/kg o body weight, taken with ood once dailyor 14 days is the treatment o choice or chloroquine-sensitive inections. In

    Oceania and South-East Asia, the dose o primaquine should be 0.5 mg/kgo body weight.

    t "$5TDPNCJOFEXJUIQSJNBRVJOFTIPVMECFHJWFOGPSDIMPSPRVJOFSFTJTUBOUvivax malaria.

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    234. Technical aspects of malaria case management

    t *O NPEFSBUF HMVDPTF QIPTQIBUF EFIZESPHFOBTF EFDJFODZ QSJNBRVJOF0.75 mg base/kg o body weight should be given once a week or 8 weeks. Insevere glucose 6-phosphate dehydrogenase defciency, primaquine shouldnot be given.

    Te resistance oP. ovale and P. malariae to antimalarials is not well charac-terized, and inections caused by these two species are considered to be gener-ally sensitive to chloroquine. Te recommended treatment or the relapsingmalaria caused byP. ovale is the same as that given to achieve radical cure invivax malaria, i.e. chloroquine and primaquine. P. malariae should be treatedwith the standard regimen o chloroquine used or vivax malaria, but it doesnot require radical cure with primaquine as no hypnozoites are ormed ininections with this species.

    P. ovale occurs mainly in areas o stable malaria and high transmission,where the risk o re-inection is high. In such settings, primaquine treatment isnot indicated.

    Rare cases o simian malaria (P. knowlesi) have been detected in humans.Tey should be treated with chloroquine.

    4.3 Management of severe malaria

    In a patient with P. alciparum asexual parasitaemia and no other obviouscause o symptoms, the presence o one or more clinical or laboratory eaturesclassifes the patient as suering rom severe malaria.1 Te clinical maniesta-tions are as ollows:

    t QSPTUSBUJPO

    t JNQBJSFEDPOTDJPVTOFTTt SFTQJSBUPSZEJTUSFTTBDJEPUJDCSFBUIJOH

    t NVMUJQMFDPOWVMTJPOT

    t DJSDVMBUPSZDPMMBQTF

    t QVMNPOBSZPFEFNBSBEJPMPHJDBM

    t BCOPSNBMCMFFEJOH

    t KBVOEJDF

    t IBFNPHMPCJOVSJB

    1. Full defnitions and prognostic actors are described in World Health Organization. Severe alciparummalaria. ransactions o the Royal Society o ropical Medicine and Hygiene, 2000, 94(Suppl. 1):S1S90, andWorld Health Organization. Management o severe malaria: a practical handbook, 2nd ed. Geneva, 2000.

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    Laboratory tests should thereore be carried out or:

    t TFWFSFBOBFNJB

    t IZQPHMZDBFNJB

    t BDJEPTJT

    t SFOBMJNQBJSNFOU

    t IZQFSMBDUBUBFNJB

    t IZQFSQBSBTJUBFNJB

    Te management o severe malaria comprises our main areas: clinical assess-

    ment o the patient, specifc treatment, adjunctive therapy and supportive care.

    A national malaria control programme should defne clear criteria or quali-

    ying a health acility to manage severe cases, including continuity o care(24-hour working), trained sta and minimum equipment. Cases o severe

    anaemia should be treated only in health acilities with transusion services.

    4.3.1 Specific treatment

    Severe malaria is a medical emergency. Aer rapid clinical assessment and

    confrmation o the diagnosis, ull doses o parenteral antimalarial treatment

    should be started without delay with whichever eective antimalarial is frstavailable. wo classes o drug are currently available or this purpose: cinchona

    alkaloids (quinine and quinidine) and artemisinin derivatives (artesunate, arte-

    mether and artemotil). Although there are a ew areas in which chloroquine is

    still eective, parenteral chloroquine is no longer recommended or the treat-

    ment o severe malaria because o widespread resistance. Intramuscular sul-

    adoxine-pyrimethamine is also not recommended.

    In low-transmission areas and outside malaria-endemic areas, artesunate at

    2.4 mg/kg o body weight intravenously or intramuscularly on admission, thenat 12 hours and 24 hours, then once a day is recommended.

    For children in high-transmission areas, either artesunate at 2.4 mg/kg o

    body weight intravenously or intramuscularly on admission, then at 12 hours

    BOEIPVSTUIFOPODFBEBZPSBSUFNFUIFSBUNHLHPGCPEZXFJHIUJOUSB-

    muscularly on admission, then 1.6 mg/kg o body weight per day should be

    given. Tere is insucient evidence to preer one o these medicines rather

    than another.

    Quinine salt can be given at 20 mg/kg o body weight on admission (intrave-

    nous inusion or divided intramuscular injection), then 10 mg/kg o body

    XFJHIUFWFSZIPVSTUIFJOGVTJPOSBUFTIPVMEOPUFYDFFENHLHPGCPEZ

    weight per hour.

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    254. Technical aspects of malaria case management

    Aer initial parenteral treatment and once the patient can tolerate oraltherapy, treatment should be continued and completed with an eective oralantimalarial, comprising a ull course o combination therapy with an eectiveartemisinin-based combination treatment or quinine plus clindamycin ordoxycycline. Doxycline and tetracyclines are contraindicated or children lessthan 8 years o age.

    4.3.2 Pre-referral treatment options

    Te risk or death rom severe malaria is greatest during the frst 24 hours.Patients should be treated with the frst dose o one o the recommended treat-ments, by the parenteral route i possible or intrarectally, beore reerral, unlessthe reerral time is very short. Te treatment could be intramuscular arte-

    mether, artesunate or quinine or a rectal ormulation o artemisinin or artesu-nate. I, however, reerral is impossible, parenteral or rectal treatment should becontinued until the patient can tolerate oral medication, at which time a ullcourse o the recommended artemisinin-based combination treatment oruncomplicated malaria in the locality can be administered.

    Artesunate suppositories2 are given at a dose o 10 mg/kg o body weightdaily. Artesunate suppository are currently available as a 50 mg or 200 mgormulations. Te appropriate single dose o artesunate given by suppository

    should be administered rectally as soon as a presumptive diagnosis o severemalaria is made. In the event that the suppository is expelled rom the rectumwithin 30 minutes o insertion, a second suppository should be inserted and,especially in young children, the buttocks should be held together or 10minutes to ensure retention o the dose. Tis dose should be given once andollowed as soon as possible by defnitive therapy or malaria.

    Te treatment with intramuscular artemether, artesunate or quinine should begiven according to the recommended dosage or each o these three medicines.

    4.3.3 Adjunctive treatment

    In an attempt to reduce the unacceptably high mortality rom severe malaria,various adjunctive treatments or the complications o malaria have been madeavailable (see Table 4).

    2. It should be noted that the results o clinical trials with rectal artesunate relate to a single ormulation andQSFTFOUBUJPOUIBU IBTXFMMDIBSBDUFSJ[FEBCTPSQUJPOLJOFUJDT UIFSFGPSF UIFSFTVMUT DBOOPUOFDFTTBSJMZCFextrapolated to any other rectal ormulation o artesunate. Tis product is being developed within theUNICEF/UNDP/World Bank/WHO Special Programme or Research and raining in ropical Diseases.

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    26 Malaria case management: Operations manual

    Table 4 Immediate clinical management o severe maniestations and complicationso alciparum malaria

    Maniestation/complication Immediate managementa

    Coma (cerebral malaria) Maintain airway, place patient on his or her side,exclude other treatable causes o coma (e.g.hypoglycaemia, bacterial meningitis); avoid harmulancillary treatment such as corticosteroids, heparinand adrenaline; intubate i necessary.

    Hyperpyrexia

    Convulsions

    Administer tepid sponging, anning, cooling blanketand antipyretic drugs.Maintain airways; treat promptly with intravenous orrectal diazepam or intramuscular paraldehyde.

    Hypoglycaemia (blood glucoseconcentration o < 2.2 mmol/l;< 40 mg/100 ml)

    Check blood glucose, correct hypoglycaemia andmaintain with glucose-containing inusion.

    Severe anaemia (haemoglobin< 5 g/100 ml or packed cellvolume < 15%)Acute pulmonary oedemab

    Transuse with screened resh whole blood.Prop patient up at an angle o 45, give oxygen, givea diuretic, stop intravenous uids, intubate and addpositive end-expiratory pressure/continuous positiveairway pressure in lie-threatening hypoxaemia.

    Acute renal ailure

    Spontaneous bleeding andcoagulopathy

    Metabolic acidosis

    Exclude pre-renal causes, check uid balance and

    urinary sodium; i in established renal ailure addhaemofltration or haemodialysis, or i unavailable,peritoneal dialysis. The benefts o diuretics/dopamine in acute renal ailure are not proven.Transuse with screened resh whole blood(cryoprecipitate, resh rozen plasma and plateletsi available); give vitamin K injection.

    Shock Exclude or treat hypoglycaemia, hypovolaemiaand septicaemia. I severe, add haemofltration

    or haemodialysis.Suspect septicaemia, take blood or cultures; giveparenteral antimicrobials, correct haemodynamicdisturbances.

    Hyperparasitaemia Non-immune patients with parasitaemia >20%should continue to receive parenteral therapy wher-ever possible, as there is no evidence or or againstusing oral treatment in this group and the risks arehigh. Alternatively, the frst dose o artemisinin de-rivative can be given parenterally or rectally to ensureadequate absorption. Treatment must be monitoredclosely or the frst 48 hours ater initiating treatment.

    a. It is assumed that appropriate antimalarial treatment will have been started in all cases.

    b. Prevent by avoiding excess hydration.

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    274. Technical aspects of malaria case management

    4.4Treatment during pregnancy

    Pregnant women are at particular risk oP. malariae inection, with serious

    consequences or both the mother and the etus. Te clinical eatures and theconsequences o malaria in pregnancy vary according to the transmissionpattern. Pregnant women are at greater risk o developing severe malaria thanother adults in areas o high to moderate transmission. In low-transmissionareas, the risk or severe malaria is higher than in non-pregnant women, andthe mother or her etus might die rom hypoglycaemia, cerebral malaria orsevere anaemia. In areas o stable transmission, malaria has a greater impactduring the frst and second pregnancies. Te parasite prevalence is higher thanin non-pregnant women, but the inection is usually asymptomatic. Te main

    consequences are low birth weight and maternal anaemia.

    Malaria prevention and control during pregnancy require a three-prongedapproach: eective case management o malaria inections, use o insecticide-treatedbednets and intermittent preventive treatment in area o stable transmission.

    In the management o uncomplicated malaria, during the frst trimester,quinine is given with or without clindamycin. Where quinine is not available orthere is no guarantee o compliance or tolerance, an AC can and should beused. In the second and third trimesters, treat with the artemisinin-based

    combination treatment that is used in the country or the region.

    Te parenteral antimalarial treatment that is locally available or severemalaria should be given in ull doses. In the frst trimester, quinine and artesu-nate can be considered as options. In the second and third trimesters, whereavailable, artesunate is the frst option and artemether the second.

    Intermittent preventive treatment is administration o a ull therapeutic doseo a drug at predetermined intervals during pregnancy. Tis preventive strategyprotects pregnant women rom malaria and reduces the related consequences,

    namely low birth weight, anaemia and severe malaria. Currently, suladoxine-pyrimethamine is the treatment o choice. All pregnant women in areas ostable transmission should receive at least two doses o treatment with sul-adoxine-pyrimethamine during the second and third trimesters (aer quick-ening). Intermittent preventive treatment should be given at least our weeksapart under direct observation at visits to antenatal clinics.

    Women known to be HIV-positive should receive at least three doses ointermittent preventive treatment. I the prevalence o HIV among pregnant

    women is higher than 10%, the national policy should be to deliver three doseso preventive treatment during pregnancy. reatment should not be given toHIV-positive pregnant women receiving daily cotrimoxazole. reatment withsuladoxine-pyrimethamine is contraindicated in cases o hypersensitivity tosulonamides.

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    28 Malaria case management: Operations manual

    4.5 Home management of malaria

    Health service coverage is low in many malaria-endemic countries, and many

    children and adults with ever are treated at home or close to home. In orderto optimize the beneft o artemisinin-based combination treatments againstmalaria, the drugs must be available as widely as possible, i.e. at communitylevel. Tereore, home management o malaria should be implemented in areaswhere there is poor access to health acilities, as the ormal public health deliverysystem will not reach many persons who need treatment.

    Te dissemination o clear, national treatment guidelines, provision oadequately packaged and presented antimalarial agents, use o appropriate

    inormation, education and communication materials, and monitoring odeployment, access and coverage are needed to optimize the benefts o thesenew, eective treatments.

    4.5.1 Uncomplicated malaria

    Te national malaria treatment policy should apply to both diagnosis andtreatment in case management at community level. In areas where parasite-based diagnosis is used, community distributors can be trained to use rapid

    diagnostic tests and ollow the guidelines used in peripheral health units.Te antimalarial medicines used as frst-line treatment in the national treat-

    ment policy should also be used at community level. Tere is no need or a dualpolicy, as the artemisinin-based combination treatments currently recom-mended by WHO can easily be administered by community-based distributors.

    4.5.2 Severe malaria

    Caregivers should promptly recognize the signs and symptoms o severe

    disease, give pre-reerral treatment with artesunate or artemisinin-basedsuppositories and reer patients to the nearest health acility or urther evalua-tion and treatment. Community-based health providers should not keep thesepatients in the community, as they need urther evaluation, treatment andsupportive care, which are not available at community level.

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    295. Supply chain management and logistics

    5. Supply chain managementand logistics

    Tis section o the manual covers practical ways o ensuring that high-quality antimalarial medicines are available to the users continuously inadequate amounts. Te uninterrupted availability o medicines in health acili-ties is one o the most undamental components o an ecient case manage-

    ment system. It will save lives, improve health and promote trust and use ohealth services. As medicines are special commodities and are costly, eortsshould be made to improve current systems or supply management. Incorrectquantifcation, improper storage and distribution resulting in the expiry omedicines seriously reduce the therapeutic benefts to patients.

    As malaria is an acute and potentially atal illness, essential antimalarialmedicines must be available at all levels o the health care system, includingremote rural areas at highest risk or malaria. Strengthening the supply manage-ment o antimalarial medicines can strengthen health services, because allessential medicines are managed and distributed together.

    Te our artemisinin-based combination therapies currently recommendedby WHO as frst-line treatment o alciparum malaria are available in three toour dierent course-o-therapy blister packs with two-year shel lives. Teseeatures o the treatments raise logistic problems or medicine distribution andinormation management systems.

    Antimalarial medicines, like all medicines, are subject to national systems o

    drug registration, which ensure that medicines approved or sale meet thecriteria o ecacy, saety, quality and completeness o packaging inormation.Fixed-dose and co-packaged combination therapies must be registered even ithe individual components are already registered in the country.

    Existing laws and regulations that may limit the prescribing and dispensingo newly registered medicines to specially trained health proessionals shouldbe taken into account in planning home-based management o malaria. Use otrained drug sellers to provide early diagnosis and treatment o malaria near

    the home might be introduced as a research project approved by the nationalhealth authorities. Te results o such demonstration projects within a countrymight help convince policy-makers to adopt new approaches, especially thoserequiring signifcant changes in policy and regulations that might requireincreased fnancial resources.

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    30 Malaria case management: Operations manual

    5.1 Quantification of drug requirements

    Te quantities o antimalarial medicines required can be estimated using the

    standard morbidity method or the consumption method, which are generallyused or large-scale orecasting o drug requirements or annual or semi-annualprocurement cycles. Beore starting quantifcation by either method, theollowing steps must be completed:

    t /PNJOBUFUIFPDJBMTFOJPSQIBSNBDJTUNFEJDBMPDFSPSTFOJPSBENJOJT-trator) responsible or the quantifcation. A person(s) with experience inlarge-scale quantifcation o antimalarial drugs should be consulted at thisstage.

    t 'PSNBDPPSEJOBUJPOXPSLJOHHSPVQDPNQPTFEPGTFOJPSNFEJDBMBENJOJT-trators or clinicians, managers o the health inormation system, pharmacistsand a fnance ocer).

    t %FOFUIFUBSHFUDPWFSBHFGPSUIFRVBOUJDBUJPOCZHFPHSBQIJDBMBSFBBOEhealth acility or community level), specifcally or medicines in the nationalmalaria treatment policy.

    t $POTJEFSXIFUIFSUIFOFFETPGUIFGBDJMJUJFTGPSXIJDIESVHSFRVJSFNFOUTBSFbeing quantifed are expanding or contracting, in the light o the healthsector development plan o the country and the expected impact onconsumption o antimalarial medicines o the policy on pricing and acces-sibility o medicines.

    t $POTJEFSIPXUIFFTUJNBUFTXJMMCFBFDUFECZFYJTUJOHQSFTDSJCJOHQBUUFSOT(i.e. malaria treatment based on presumptive diagnosis) and the expectedextent o change in prescribing practices (i.e. aer introduction or expansiono malaria rapid diagnostic tests).

    t .BLFBSFBMJTUJDQMBO GPSDPNQMFUJPOPGUIFRVBOUJDBUJPOPOUIFCBTJTPGwhether it is to be centralized (managed at central level) or decentralized(each acility compiling its own estimates, which are reviewed and consoli-dated at the district and provincial levels beore submission to the procure-ment oce).

    Te last step is particularly relevant or decentralized systems, in whichquantifcation is based on the consumption method.

    5.1.1 Morbidity methodTe morbidity method may be most appropriate or quantiying drug

    requirements i:

    t UIFBWBJMBCMFDPOTVNQUJPOEBUBBSFJODPNQMFUFPSVOSFMJBCMF

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    315. Supply chain management and logistics

    t QSFTDSJCJOHQBUUFSOTBSFOPUDPTUFFDUJWFBOETZTUFNBUJDJNQSPWFNFOUJTrequired (e.g. persistent reliance on clinical diagnosis in all age groupsEFTQJUFUIFBWBJMBCJMJUZPGNJDSPTDPQZBOESBQJEEJBHOPTUJDUFTUT

    t UIFQSFWJPVTCVEHFUGPSESVHQSPDVSFNFOUXBTJOTVDJFOUUPNFFUSFRVJSF-NFOUTPS

    t UIFIFBMUIGBDJMJUJFTBSFOFXPSSBQJEMZFYQBOEJOHPSBOFXBOUJNBMBSJBMUSFBU-ment is being introduced, so that past consumption data are not a reliableguide to uture requirements.

    Tis is the method o choice or estimating antimalarial drug requirementsin countries in the early phase o implementation o artemisinin-based combi-nation treatments.

    Step 1. Prepare a list of drugs to be quantified

    Te list should contain the antimalarial medicines in the national guidelinesor treatment o alciparum malaria (both uncomplicated and severe) and theother species (see Table 5).

    Step 2. Establish the standard treatment course

    Standard treatment courses across the range o dierent age groups must beestablished. It is preerable to calculate average regimens, on the basis oobserved or reported practices, to make the estimate o requirements morerealistic. As these data are oen not available, the ideal regimens rom standardtreatment guidelines are generally used in the morbidity method.

    Te standard courses o treatment are shown or P. vivaxmalaria in Table 6,or uncomplicated alciparum malaria during the frst trimester o pregnancyand or intermittent preventive treatment with suladoxine-pyrimethamine in

    Table 7, and or severe malaria in Table 8. Te correlations between age andweight should be derived rom national data that reect the actual anthropo-metric and nutritional status o the population.

    Step 3. Estimate the number of malaria episodes requiringtreatment in health facilities

    FNPSCJEJUZNFUIPESFRVJSFTJOGPSNBUJPOPOUIFQPQVMBUJPOCZBHFHSPVQUIFBDUVBMPSQSPKFDUFEJODJEFODFPGNBMBSJBQBUJFOUBUUFOEBODFBUIFBMUIGBDJMJ -

    UJFT BOENBMBSJBUSFBUNFOUQSBDUJDFTBDUVBMPSFYQFDUFE*OGPSNBUJPOGSPNthe routine health management inormation system is oen incomplete or notavailable, and special surveys o representative samples o health acilities mightnot be possible. It may thereore be necessary, instead, to estimate patientcontacts with health acilities that result in malaria treatment.

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    Malaria case management: Operations manual32

    Table 5 WHO-recommended frst- and second-line treatments or uncomplicatedmalaria and treatment or severe malaria

    P. falciparum P. vivax P.malariae P. ovale

    Uncomplicated

    frst line

    ALAS+AQAS+MQAS+SP

    CQPrimaquine

    CQ CQ

    second line ALQNN

    AQPrimaquine

    Severe AS i.v./i.m.AM i.m.QNN i.v./i.m.AT i.m.

    Table 6 Dosing schedule or chloroquine, amodiaquine and primaquine or treatmentoP. vivaxmalaria

    Age Weight(kg)

    Medicine (strength)

    < 4 m.56

    411m.710

    12 y.1114

    34 y.1518

    57 y.1924

    810 y.2535

    1113 y.3650

    >14 y.> 50

    CQ (daily dose)

    tNHCBTFUBCT

    tNHCBTFUBCT

    tNHCBTFNM

    AQ (daily x 3 days)

    tNHCBTFUBCT

    tNHCBTFUBCT

    PQ (daily x 14 days)

    tNHCBTFUBCT

    tNHCBTFUBCT

    tNHCBTFUBCT

    Table 7 Standard treatment courses or treatment o uncomplicated alciparummalaria during the frst trimester o pregnancy, and or intermittent preventive

    treatment with suladoxine-pyrimethamine

    Medicine Daily dose (tablets) Duration o treatment Total tabletsper treatment

    Quinine sulate NHUBCT

    UBCTYUJNFTEBJMZ EBZT 42 tabs

    Suladoxine-pyrimethamine

    500/25 mg tabs

    UBCTJOTJOHMFEBJMZdose

    SFQFBUFEUJNFT(2ndBOErd trimesters)

    9 tabs

    AL = artemether-lumeantrine; AS = artesunate; AQ = amodiaquinine; CQ = chloroquine; M = meoquine;SP = suladoxine-pyrimethamine; QNN = quinine; IPT = intermittent preventive treatment; AM = artemether;AT = artemotil. m. = month; y. = year

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    335. Supply chain management and logistics

    Table 8 Standard treatment courses or treatment o severe malaria, both the loadingdose and the maintenance dose to be repeated during the frst 48 hours otreatment

    AgeWeight(kg)

    Medicine (strength)

    < 4 m.56

    411 m.710

    12 y.1114

    34 y.1518

    57 y.1924

    810 y.2535

    1113 y.3650

    >14 y.50+

    ArtesunateLoading doseMaintenance

    STUIPVST

    Artemether i.m.Loading doseMaintenance

    QuinineLoading doseMaintenance

    Table 9 An example o calculation o requirements o artesunate plus suladoxine-pyrimethamine or artesunate plus meoquine in areas o intense malaria

    transmission

    Age group(years) Population

    (a)

    Febrile episodesper year treatedas malaria(b)

    Percentageattendance athealth acility(c)

    Percentagetreated aterlab diagnosis(d)

    No. treatmentcourses

    (e)

    14 1 0.20 0.80 8 480

    Total 100 000 62 880

    Table 10 An example o calculation o requirements o artemether-lumeantrine in areaso low malaria transmission

    Age group(years)

    Population

    (a)

    Febrile episodesper year treatedas malaria(b)

    Percentageattendance athealth acility(c)

    Percentagetreated aterlab diagnosis(d)

    No. treatmentcourses

    (e)

    11 000 0.50 0.50 0.50

    o 0.50 0.50 0.50 2 125

    914 21 000 0.25 0.40 0.50 1 050

    >14 51 000 0.25 0.20 0.50

    Total 100 000 5 825

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    34 Malaria case management: Operations manual

    Step 4. Calculate the quantities of medicines for each type of

    standard malaria treatment

    Te expected requency o malaria episodes per age group treated in health

    acilities is multiplied by the amount o antimalarial medicine required percorresponding age group, estimated on the basis o the national malaria treat-ment guidelines. Te expected requirement o each drug is the sum o the needsestimated or each age group. An example o calculation o the requirements orartesunate plus suladoxine-pyrimethamine or artesunate plus meoquine inareas o intense transmission is given in Table 9. Te total number o treatmentcourses needed or each age group, e, is obtained by multiplying the number oebrile episodes expected to be treated as malaria (a x b), adjusted by thepercentage coverage oered by the health acilities served by the drug distribu-tion system, c. Te extent o reduction o treatment due to laboratory confrma-tion o diagnosis, d, should also be taken into consideration depending oncoverage by laboratory services (microscopy and rapid diagnostic tests) andexpected compliance with negative results by health providers (see below).

    &YBNQMF

    In the 713 age group

    Te total number o ebrile episodes expected to be treated as malaria =(a x b) = 25 000 x 2 = 50 000 but

    Te number o episodes expected to be seen in health acilities =50 000 x c = 50 000 x 0.4 = 20 000

    however, aer laboratory confrmation

    Te number o episodes to be treated (e) =20 000 x d= 20 000 x 0.9 = 18 000

    An example o calculation o the requirements or artemether-lumeantrinein areas o low transmission is given in Table 10. Te method o calculation andthe actors are the same as or Table 9.

    Te morbidity method allows estimation o total requirements in medicinesor large-scale orecasting, as part o annual procurement cycles. Te estimatesobtained using this method should be compared with estimates derived romthe consumption method, even i they are based on a sample o health acilities

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    355. Supply chain management and logistics

    with good stock records. Tis can indicate the actual drug delivery capacity o

    the health acilities and might lead to reconsideration o some o the assump-

    tions made or the morbidity estimates.

    For special lie-saving and relatively expensive medicines, i.e. those used orthe management o severe malaria (Table 8), estimates must be based on both

    morbidity records (number o malaria inpatients) and previous consumption

    data (even i based on a sample o health services with inpatient acilities). In

    countries where parenteral artemisinin ormulations have been introduced

    recently, or which consumption data are not available, the consumption o

    quinine ampoules can be used to estimate the requirements or artesunate or

    artemether ampoules. Tis requires conversion into equivalent amounts o

    parenteral treatment courses or adults or both medicines, according to theollowing ormulas (derived rom able 8).

    5.1.2 Consumption method

    Te consumption method is based on records o past consumption o indi-

    vidual drugs, adjusted by stock-outs and projected changes in drug use. Te

    method requires inventory records o past consumption or all drugs eligible

    or procurement. I the records o past consumption are accurate and rational,

    this method gives an adequate prediction o uture needs and is the method ochoice in large, well-established drug supply systems with long experience o

    uninterrupted supply.

    Since malaria transmission is seasonal, consumption data or the past 12

    months should be reviewed. I drug requirements are to be estimated or a six-

    month period (semi-annual procurement cycle), the consumption data or the

    same six-month period o the previous year must be used. Te most accurate

    records are stock records and distribution reports rom central, regional and

    district warehouses.

    Consumption is calculated rom these records as:

    otal consumption (or a specifed period) =

    opening stock + medicines received closing stock

    Dispensing records rom health acilities could also be used, in principle, butthis approach is reliable only i records are well kept and complete. It might be

    dicult to obtain consumption data rom patient registers, even i treatments

    are recorded, because this inormation is not routinely reported in health

    management inormation systems.

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    36 Malaria case management: Operations manual

    Records o stock-outs are important or calculating consumption precisely.

    Te simplest approach is to divide the total consumption by the number o

    months reviewed and correct by the average number o months o stock rupture,

    as ollows:Adjusted average monthly consumption =

    consumption during the review period

    No. o months in review period No. o months o stock-out in review period

    5.2 Management of routine ordering

    5.2.1 Quantification of annual requirements

    Once the initial quantifcation has been completed by the morbidity or the

    consumption method, the ollowing steps must be completed to convert the

    estimated drug requirements into potential orders.

    t &TUJNBUFSFRVJSFNFOUTPOUIFCBTJTPGUIFOVNCFSPGTVQQMZQPJOUTBUFBDI

    level, their requency o requisition and delivery, the amount o saety stock

    at each level, in line with the overall plan o starting and expanding thedistribution o antimalarial medicines.

    t $POTJEFSUIFJNQBDUPGMFBEUJNFJODMVEJOHUJNFUPQMBDFBOPSEFSQSPEVD-

    tion time, time or shipment, customs clearance and arrival in the central

    warehouse.

    t "EKVTUUIFBNPVOUTGPSEBNBHFTQPJMBHFFYQJSBUJPOBOEUIFNBOZTZTUFNT

    allow at least 10% or losses. A percentage o loss must be allowed in quanti-

    ying vital items: artemisinin-based combination treatments are more attrac-

    tive to thieves than other medicines because o their high price in the privatesector.

    t "EKVTUUIFRVBOUJUZUPCFPSEFSFEBDDPSEJOHUPQBDLTJ[FNVMUJQMFTPG

    or 50 individual treatment units, according to the supplier), as well as the

    minimal order size required by the supplier.

    t &TUJNBUFUPUBMQSPDVSFNFOUDPTUTPOUIFCBTJTPGDVSSFOUESVHQSJDFTGSPN

    local suppliers and international procurement agencies.

    t "EKVTUUIFFTUJNBUFECVEHFUGPSFYQFDUFEQSJDFJODSFBTFTEVFUPBOUJDJQBUFEinternational devaluation, devaluation o local currency and possible

    increases in shipping costs.

    t 3FEVDFUIFFTUJNBUFERVBOUJUJFTUPDPOGPSNUPCVEHFUSFBMJUJFTJGOFDFTTBSZ

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    375. Supply chain management and logistics

    5.2.2 Calculation of safety stocks

    In order to convert the estimated drug requirements into potential orders to

    cover consumption between two cycles o orders rom the same supplier, the

    amount o medicines that must be held in stock should be calculated. As it isimpossible to orecast demand with complete accuracy or to be certain about

    the suppliers perormance, a certain amount o medicine must be stocked to

    absorb uctuations in supply and demand and to reduce the risk or stock-outs.

    High stock levels, however, increase inventory costs (personnel, storage, risks

    o spoilage, expiry and the), and most public pharmaceutical systems calcu-

    late the minimum saety stock needed to protect against stock ruptures.

    Te commonest method or estimating saety stock needs is to determine

    the average lead time or each item rom the current supplier (interval rom thetime the order is placed to the time the medicines reach the central warehouse)

    and the average consumption. Invoices rom suppliers can be used to calculate

    the average lead time or the last ew procurements. Te saety stock is calcu-

    lated by multiplying the adjusted average monthly consumption by the expected

    lead time, as ollows:

    SS = Ca x L,

    where:

    SS is the saety stock, Ca is the average monthly consumption, adjusted or

    stock rupture, and Lis the lead time between initiation o purchase order

    and receipt o medicines in the warehouse, also calculated in months.

    Te saety stocks o vital items must be increased when consumption varies

    or when the lead time is uncertain. Te simplest approach is to add an arbitrary

    multiplier to the basic ormula, or example, to multiply the saety stock by 1.5.

    A public drug distribution system generally has three types o stores: one or

    more primary stores, which receive purchases and generally serve a whole

    DPVOUSZSFHJPOPSQSPWJODFJOUFSNFEJBUFTUPSFTXIJDISFDFJWFUIFNFEJDJOFT

    distributed by the primary stores and are oen on the site o a regional or

    EJTUSJDUIPTQJUBMBOEIFBMUIGBDJMJUZTUPSFTXIJDISFDFJWFUIFNFEJDJOFTEJTUSJC -

    uted by the intermediate stores. Te physical size o the store at each level is

    determined by the demand or drugs and by the supply requency. Te stocklevels within the supply system and the number o supply points at each level

    constitute the supply pipeline. Te number o levels, the requency o requisi-

    tion and delivery and the amount o saety stock at each level will inuence the

    amount o medicines needed to fll the supply pipeline.

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    38 Malaria case management: Operations manual

    5.2.3 Time and quantity for re-ordering

    A new order should be placed once the stock has reached a minimal level. Inmany situations, the minimal stock level (re-order level) is calculated in the

    same way as the saety stock, i.e. by multiplying the average lead time by theaverage quantity consumed during the same period.

    Once the basic inventory has been established, the question is how muchmedicine should be ordered. Several ormulas are available, but one o the mostcommonly used is the consumption-based re-ordering ormula, in which thequantity o medicines to re-order is based on the adjusted average monthlyconsumption multiplied by the sum o the lead time and procurement periodplus the saety stock level, aer removal o stock on order and stock in inven-

    tory. Tis is expressed as:

    Qo = Ca x (L + PP) + SS (Si + So),

    where:

    Qo is the quantity o medicines to be re-ordered in the next procurementQFSJPECaJTUIFBWFSBHFNPOUIMZDPOTVNQUJPOBEKVTUFEGPSTUPDLSVQUVSF LJTUIFMFBEUJNFPPJTUIFQSPDVSFNFOUQFSJPESSJTUIFTBGFUZTUPDLSi is theTUPDLJOJOWFOUPSZJFUIFXPSLJOHTUPDLQMVTUIFTBGFUZTUPDLBOESo is the

    stock on order but not yet received.As artemisinin-based combination treatments are available in three to our

    dierent course-o-therapy blister packs, calculation o the quantities tore-order requires a review o the consumption (rom stock records) o eachtype o blister pack, adjusted or stock rupture.

    Ordering also requires orecasts o uture needs, the least predictable vari-able in a re-ordering ormula. Te amounts calculated rom the ormula shouldbe adjusted or the expected seasonality o malaria or epidemic risk. I annual

    purchasing is or staggered deliveries or scheduled purchasing (e.g. at six-month intervals), the order to be delivered beore the malaria transmissionseason should be increased, on the basis o consumption during the last compa-rable season. Consumption o antimalarial medicines during the our-monthmalaria transmission season can represent 6070% o annual consumption.

    In countries prone to epidemics o malaria, an appropriate epidemic stock oantimalarial medicines must be added to the quantities to be re-ordered. Tehistory and extent o past malaria epidemics and their geography (epidemic-

    prone districts) will guide the amount and strategic placement o such stocks.Because o the relatively short shel-lie o artemisinin-based combinationtherapies (generally 1820 months residual shel-lie at port o entry), theepidemic stock must be rotated with the routine stock to avoid the risk o expi-ration o medicines with a short shel-lie.

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    395. Supply chain management and logistics

    5.3 Managing distribution

    Storage and distribution costs represent a signifcant component o the

    health budget, and transport costs can be very high, especially in large coun-tries with low population densities. In many endemic countries, a six- or three-month re-order interval (or annual orders with staggered deliveries at six- orthree-month intervals) is useul or reducing inventory costs or artemisinin-based combination treatments. Tis also allows regular replenishment o theinventory with new supplies with adequate residual shel-lie.

    Staggered deliveries make it possible to manage the distribution o smalleramounts o artemisinin-based combination treatments, which might be appro-

    priate in countries in the early phase o implementation, with limited experi-ence in the inventory and distribution o high-value medicines available ind