lmplementlne the

wF0 Stcp T8 Strateey
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
© Wer|d Bea|th 0rganizatien zee8
All rlehts reserved. Publlcatlcns cf the wcrld Fealth 0reanlzatlcn can be cbtalned frcm wF0 Press,
wcrld Fealth 0reanlzatlcn, zo Avenue Appla, 1z11 Ceneva z;, Swltzerland (tel.: ÷u1 zz ;¤1 ¸z6u;
fax: ÷u1 zz ;¤1 u8ç;; e-mall: bcckcrders@whc.lnt). kequests fcr permlsslcn tc reprcduce cr trans-
late wF0 publlcatlcns - whether fcr sale cr fcr ncnccmmerclal dlstrlbutlcn - shculd be addressed
tc wF0 Press, at the abcve address (fax: ÷u1 zz ;¤1 u8o6; e-mall: permlsslcns@whc.lnt).
The deslenatlcns emplcyed and the presentatlcn cf the materlal ln thls publlcatlcn dc nct lmply
the expresslcn cf any cplnlcn whatscever cn the part cf the wcrld Fealth 0reanlzatlcn ccncern-
lne the leeal status cf any ccuntry, terrltcry, clty cr area cr cf lts authcrltles, cr ccncernlne the
dellmltatlcn cf lts frcntlers cr bcundarles. uctted llnes cn maps represent apprcxlmate bcrder
llnes fcr whlch there may nct yet be full aereement.
The mentlcn cf speclñc ccmpanles cr cf certaln manufacturers' prcducts dces nct lmply that
they are endcrsed cr reccmmended by the wcrld Fealth 0reanlzatlcn ln preference tc cthers cf
a slmllar nature that are nct mentlcned. Frrcrs and cmlsslcns excepted, the names cf prcprletary
prcducts are dlstlneulshed by lnltlal capltal letters.
All reascnable precautlcns have been taken by the wcrld Fealth 0reanlzatlcn tc verlfy the lnfcr-
matlcn ccntalned ln thls publlcatlcn. Fcwever, the publlshed materlal ls belne dlstrlbuted wlthcut
warranty cf any klnd, elther expressed cr lmplled. The respcnslblllty fcr the lnterpretatlcn and
use cf the materlal lles wlth the reader. ln nc event shall the wcrld Fealth 0reanlzatlcn be llable
fcr damaees arlslne frcm lts use.
Ccver deslen by Tcm Flatt
Ccver phctcs: wF0/Tuk/Martel, wF0 phctc llbrary
ueslened by mlnlmum eraphlcs
Prlnted by wF0 lnternal Prlntlne Servlces
wF0 Llbrary Catalceulne-ln-Publlcatlcn uata
lmplementlne the wF0 Stcp T8 Strateey: a handbcck fcr natlcnal
tuberculcsls ccntrcl prcerammes.
wF0/FTM/T8/zoo8.uo1
1.Tuberculcsls, Pulmcnary - preventlcn and ccntrcl. z.Fandbccks
¸.Manuals. l.wcrld Fealth 0reanlzatlcn. Stcp T8 uept.
lS8h ¤;8 ¤z u 1çu66; 6 (hLM classlñcatlcn: wF ¸oo)
5uggested citatien
lmplementlne the Stcp T8 Strateey: a handbcck fcr natlcnal tuberculcsls
ccntrcl prcerammes. Ceneva, wcrld Fealth 0reanlzatlcn, zoo8
(wF0/FTM/T8/zoo8.uo1).
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Ccntents
Preface v
Ackncwledeements vll
Abbrevlatlcns xl
lntrcductlcn 1
Part t 1ubercu|esis care and preventien ::
Chapter 1 Case detectlcn 1¸
Chapter z Treatment cf tuberculcsls patlents zç
Chapter ¸ keccrdlne and repcrtlne uo
Chapter u Tuberculcsls ln chlldren u6
Chapter ç Ccntact lnvestleatlcn ç6
Chapter 6 lnfectlcn ccntrcl ln health-care settlnes 6o
Chapter ; lscnlazld preventlve therapy 66
Chapter 8 8CC vacclnatlcn ;o
Chapter ¤ Preventlcn thrcueh addresslne rlsk factcrs ;z
Part tt Pregrammatic management eI tubercu|esis ¡¶
Chapter 1o Manaeerlal structure ;;
Chapter 11 Manaeement cycle 8¸
Chapter 1z Prcerammatlc manaeement cf drue-reslstant
tuberculcsls ¤o
Chapter 1¸ Prcerammatlc manaeement cf tuberculcsls and
the human lmmuncdeñclency vlrus ¤u
Chapter 1u Labcratcry servlces ¤8
Chapter 1ç Manaeement cf antltuberculcsls drue supplles 1oç
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A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
Chapter 16 Supervlscry suppcrt tc baslc manaeement unlts 1o¤
Chapter 1; uevelcpment cf human rescurces 11z
Chapter 18 Mcnltcrlne and evaluatlcn cf prceramme
perfcrmance 118
Chapter 1¤ Fundlne cf tuberculcsls ccntrcl 1z1
Chapter zo Leeal and reeulatcry lssues 1z6
Part ttt £nsuring cemprehensive centre| eI tubercu|esis :¶¶
Chapter z1 Ccntrlbutlne tc strenethenlne cf health systems 1¸ç
Chapter zz Fneaelne all care prcvlders 1¸¤
Chapter z¸ Practlcal apprcach tc lune health and cther
lnteerated apprcaches tc health care 1u6
Chapter zu Fqulty cf and access tc servlces fcr preventlcn
cf tuberculcsls and treatment cf patlents 1çz
Chapter zç Speclal ercups and sltuatlcns 1çç
Chapter z6 lnvclvement cf ccmmunltles and patlents ln
tuberculcsls care and preventlcn 161
Chapter z; Advccacy, ccmmunlcatlcn and scclal mcblllzatlcn 166
Chapter z8 kcle cf natlcnal tuberculcsls ccntrcl prcerammes
ln research 16¤
Annex 5trategy Ier the centre| and e|iminatien eI tubercu|esis :¡¶
v
Preface
S
lnce the publlcatlcn cf the 1µbcrrµlcsis hcndbcck by the wcrld Fealth 0rea-
nlzatlcn ln 1¤¤8, lmpcrtant chanees have taken place ln the elcbal ccntext ln
whlch ccntrcl cf tuberculcsls (T8) ls carrled cut. Flrstly, the u0TS strateey has
been adcpted by vlrtually all ccuntrles durlne the past decade, althcueh wlth
varylne quallty, and full-scale u0TS lmplementatlcn has nct yet been achleved.
At the same tlme, effcrts tc ccntrcl the dlsease have beccme lncreaslnely
patlent-centred and dlrected tcwards unlversal access tc care fcr all.
Seccndly, new ma|cr challenees tc publlc health have emereed, addlne ccm-
plexltles fcr the wcrk cf natlcnal T8 ccntrcl prcerammes (hTPs) and stralnlne
avallable rescurces. The epldemlc cf lnfectlcn wlth the human lmmuncdeñ-
clency vlrus (Flv) has beccme the maln drlvlne fcrce behlnd the lncreaslne
lncldence cf T8 ln sub-Saharan Afrlca and elsewhere, requlrlne hTPs tc reach
beycnd thelr usual mandate and tc wcrk |clntly wlth Flv ccntrcl servlces;
they have alsc had tc face the emereence cf multldrue-reslstant T8 (Muk-T8)
and, mcst recently, extenslvely drue-reslstant T8 (Xuk-T8) ln many ccuntrles.
Addresslne drue-reslstant T8 requlres a masslve lncrease cf rescurces bcth tc
treat patlents wlth seccnd-llne drues and tc prevent the develcpment cf resls-
tance, thrcueh eeneral lmprcvements ln prceramme perfcrmance.
Thlrdly, bulldlne health systems and prlmary servlces that prcvlde access
tc health care fcr all brlnes new challenees. hTP manaeers shculd beccme
eneaeed ln and ccntrlbute tc eeneral system develcpment, whlle expectlne
frcm systems and servlces the ccntrlbutlcns needed fcr T8 ccntrcl. 0ppcrtunl-
tles shculd therefcre be scueht tc lmprcve ccntrcl cf the dlsease whlle alsc
ccntrlbutlne tc the develcpment cf eeneral health servlces.
Fcurthly, the lncreaslne lnvclvement cf the ncn-state sectcr ln the care cf T8
patlents, althcueh welccmed, brlnes an addltlcnal challenee: ensurlne that
adequate standards cf care (such as thcse ccntalned ln the lntcrncticncl stcn-
dcrds [cr tµbcrrµlcsis rcrc) are applled by all prcvlders.
Flfthly, clvll scclety and ccmmunltles themselves are key elements ln the ñeht
aealnst T8, but thelr eneaeement and empcwerment need tc be further prc-
mcted and facllltated. The recently publlshed Pcticnts´ rhcrtcr [cr tµbcrrµlcsis
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A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
rcrc, based cn lnput frcm affected ccmmunltles wcrldwlde, has nct yet been
wldely adcpted by hTPs. Scclal mcblllzatlcn ls an lmpcrtant lnncvatlve ccmpc-
nent cf the Stcp T8 Strateey.
Flnally, research cn T8, neelected fcr decades, shculd be fcstered tc meet the
lncreaslnely presslne need fcr new drues, dlaencstlcs and vacclnes. Addresslne
T8/Flv and Muk-T8 requlres lmprcved and rapld dlaencstlc tccls; new classes
cf drues are needed fcr Muk-T8 and Xuk-T8, and tc shcrten the leneth cf treat-
ment; eneaelne ncn-state practltlcners and ccmmunltles requlres cperatlcnal
research tc ñne-tune lnterventlcns. Fllmlnatlne T8 requlres effectlve preventlve
measures as well as cptlmal case manaeement.
Taklne acccunt cf these new and chanelne sltuatlcns, the Stcp T8 Strateey
deñnes speclñc cb|ectlves and ccmpcnents dlrected tcwards the cverall tareet
cf Mlllennlum uevelcpment Ccal 6: tc have halted and beeun tc reverse the
lncldence cf T8 by zo1ç. Thls new verslcn cf the hcndbcck [cr ncticncl 18
rcntrcl prccrcmmcs prcvldes an cvervlew cf the brcad ranee cf apprcaches
needed tc lmplement all slx ccmpcnents cf the Strateey, and tc achleve lts
ecals. lt ls the result cf effcrts by many experts, bulldlne cn the new kncwl-
edee and evldence that are behlnd the ccmplexltles cf mcdern T8 ccntrcl; lts
purpcse ls tc facllltate the wcrk cf all thcse whc are eneaeed ln the alm cf
ultlmately ellmlnatlne T8.
Mcric kcviclicnc lcrcmich Chckcvc Ccnvcr 1cpic
ulrectcr Chalrman Chalrman
Stcp T8 uepartment u0TS Fxpanslcn Sclentlñc and Technlcal
wcrklne Crcup Advlscry Crcup cn T8
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Ackncwledeements
T
he Stcp T8 uepartment cf the wcrld Fealth 0reanlzatlcn (wF0) eratefully
ackncwledees the ccntrlbutlcn cf the fcllcwlne lndlvlduals:
£xpert rev|ew pane|
lalme 8aycna, ulrectcr de Prcyectcs, Scclcs Fn Salud - Sucursal Perú, Llma,
Peru
Kal 8lcndal, Senlcr T8 Ccnsultant, keyk|avlk Fealth Care Servlces, keyk|avlk,
lceland
leremlah Chakaya, Chlef kesearch 0fñcer, Centre fcr kesplratcry ulseases
kesearch, Kenya Medlcal kesearch lnstltute, halrcbl, Kenya
Mlrtha uel Cranadc, keelcnal Advlser fcr T8, wF0 keelcnal 0fñce fcr the
Amerlcas, washlnetcn, uC, uSA
Marccs Fsplnal, Fxecutlve Secretary, Stcp T8 Partnershlp Secretarlat, Ceneva,
Swltzerland
Peter Ccndrle, Fead, lnternatlcnal unlt, KhCv Tuberculcsls Fcundatlcn, The
Faeue, hetherlands
keuben Cranlch, Medlcal 0fñcer, Antlretrcvlral Treatment and Flv Care, wF0
uepartment cf Flv/AluS, Ceneva, Swltzerland
Phlllp Fcpewell, Prcfesscr cf Medlclne, ulvlslcn cf Pulmcnary and Crltlcal Care
Medlclne; ulrectcr, F.l. Curry hatlcnal Tuberculcsls Center, San Franclscc
Ceneral Fcspltal, unlverslty cf Callfcrnla, San Franclscc, CA, uSA
Mlchael Klmerllne, ulrectcr, Ccreas T8 lnltlatlve, unlverslty cf Alabama at 8lr-
mlneham, 8lrmlneham, AL, uSA
Kayla Laserscn, ulrectcr, KFMkl/CuC Fleld kesearch Statlcn, Klsumu, Kenya
Fablc Luelmc, Ccnsultant, Ceneva, Swltzerland
¥a ulul Mukadl, ulrectcr, Care and Treatment, Famlly Fealth lnternatlcnal,
Arllnetcn, vA, uSA
Paul hunn, Cccrdlnatcr, T8/Flv and urue keslstance, wF0 Stcp T8 uepart-
ment, Ceneva, Swltzerland
Antcnlc Plc, Senlcr Ccnsultant ln Publlc Fealth and kesplratcry ulseases, Mar
del Plata, Areentlna
Marlc kavlellcne, ulrectcr, wF0 Stcp T8 uepartment, Ceneva, Swltzerland
Alasdalr keld, Flv/T8 Advlser, uhAluS, Ceneva, Swltzerland
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A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
l. u. kusen, ulrectcr, uepartment cf Tuberculcsls Ccntrcl and Preventlcn, lnter-
natlcnal unlcn Aealnst Tuberculcsls and Lune ulsease, Parls, France
Aklhlrc Selta, keelcnal Advlser fcr T8, wF0 keelcnal 0fñce fcr the Fastern
Medlterranean, Calrc, Feypt
Pedrc Culllermc Suarez, Prceram ulrectcr fcr T8 and T8-Flv/AluS, Center fcr
Fealth Prcerams, Manaeement Sclences fcr Fealth, Cambrldee, MA, uSA
Pleter van Maaren, keelcnal Advlser fcr T8, wF0 keelcnal 0fñce fcr the west-
ern Paclñc, Manlla, Phlllpplnes
ur Annalles van kle, Asscclate Prcfesscr, uepartment cf Fpldemlclcey, unlver-
slty cf hcrth Carcllna, Chapel Flll, hC, uSA
Francls varalne, Cccrdlnatcr, wcrklne Crcup cn T8, Médeclns Sans Frcntlères,
Parls, France
kcsallnd vlanzcn, hatlcnal T8 Ccntrcl Prceramme Manaeer, hatlcnal Centre fcr
ulsease Ccntrcl and Preventlcn, uepartment cf Fealth, Manlla, Phlllpplnes
wane Llxla, ulrectcr, hatlcnal Centre fcr T8 Ccntrcl and Preventlcn, Chlnese
Center fcr ulsease Ccntrcl and Preventlcn, 8el|lne, Chlna
klchard Zaleskls, keelcnal Advlser fcr T8, wF0 keelcnal 0fñce fcr Furcpe,
Ccpenhaeen, uenmark
Centr|buters te the Annex
lcsé Fleuerca, ueputy ulrectcr cf Publlc Fealth, Clty and Fackney Prlmary
Fealth Care Trust, hatlcnal Fealth Servlce, Lcndcn, Fneland
vlncent Kuyvenhcven, Senlcr Ccnsultant, KhCv Tuberculcsls Fcundatlcn, The
Faeue, hetherlands
Clcvannl 8attlsta Mlellcrl, ulrectcr, wF0 Ccllabcratlne Centre fcr T8 and Lune
ulseases, Fcndazlcne S. Maueerl, Care and kesearch lnstltute, Tradate, ltaly
luan Carlcs Mlllán, Prcfesscr cf Medlclne, Fead cf uepartment cf Medlclne,
lnstltute Pedrc Kcurl, Favana unlverslty, Favana, Cuba
lvan Sclcvlc, Asscclate Prcfesscr, Fead cf ueapartment and hTP Manaeer,
hatlcnal lnstltute fcr T8, Lune ulseases and Thcraclc Sureery, vy´ sné Fáey,
Slcvakla
Wh0 5tep 1ß ßepartment and 5tep 1ß Partnersh|p 5ecretar|at
(wr|t|ng cemm|ttee and steer|ng greup members)
Mchammed Abdel Azlz, Karln 8erestrcm, Lécpcld 8lanc, Annemleke 8rands,
Katherlne Flcyd, Clullanc Carelcnl, Falleyesus Cetahun, Andrea Ccdfrey, Mal-
ecsla Crzemska, Chrlstlan Cunnebere, Frnestc laramlllc, Fablenne lcubertcn,
Knut Lcnnrcth, uermct Maher, Llndsay Martlnez, Fuad Mlrzayev, Plerre-¥ves
hcrval, Salah-Fddlne 0ttmanl, kcse Pray, Fablc Scanc, hlccle Schleee, Mukund
uplekar, Lana veleblt, vércnlque vlncent, 8rlan wllllams
|x
Manag|ng ed|ter
Llndsay Martlnez
f|nanc|a| suppert
The unlted States Aeency fcr lnternatlcnal uevelcpment made a ñnanclal ccn-
trlbutlcn ln suppcrt cf thls publlcatlcn thrcueh lts Tuberculcsls Ccntrcl Assls-
tance Prceram.
Cenh|ct eI |nterest
All partlclpants ln the preparatlcn and revlew cf thls dccument ccmpleted a
ueclaratlcn cf lnterests. hc ccnflct cf lnterest was declared by any partlcl-
pant.
6u|de||ne kev|ew Cemm|ttee Appreva|
The Tuberculcsls Fandbcck was apprcved by the wF0's Culdellne kevlew Ccm-
mlttee cn 16 Aprll zoo8, havlne met the mlnlmum repcrtlne requlrements ln
place at that tlme.
ACKh0wLFuCFMFhTS
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Abbrevlatlcns
ACSM advccacy, ccmmunlcatlcn and scclal mcblllzatlcn
AF8 acld-fast bacllll
AluS acqulred lmmuncdeñclency syndrcme
AkT antlretrcvlral therapy
8CC bacllle Calmette-Cuérln (vacclne)
8Mu baslc manaeement unlt
8SC blcsafety cablnet
8SL blcsafety level
C80 ccmmunlty-based creanlzatlcn
CPT cc-trlmcxazcle preventlve therapy
CXk chest X-ray (examlnatlcn)
u0T dlrectly cbserved therapy
ukS drue reslstance survelllance
uST drue susceptlblllty testlne
F0A external quallty assurance
F80 falth-based creanlzatlcn
FuC ñxed-dcse ccmblnatlcn (antl-T8 medlclnes)
CuF Clcbal urue Faclllty
CuP eccd dlstrlbutlcn practlce
CLC Creen Lleht Ccmmlttee
CMP eccd manufacturlne practlce
Clcbal Fund Clcbal Fund tc Fleht AluS, Tuberculcsls and Malarla
FFPA hleh efñclency partlculate alr
Flv human lmmuncdeñclency vlrus
Fku human rescurce develcpment
FkF human rescurces fcr health
FSS health system strenethenlne
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A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
lFC lnfcrmatlcn, educatlcn and ccmmunlcatlcn
lFk lnternatlcnal Fealth keeulatlcns
lMAl lnteerated manaeement cf adult and adclescent lllness
lMCl lnteerated manaeement cf chlldhccd lllness
lPT lscnlazld preventlve therapy
lklS lmmune reccnstltutlcn lnfammatcry syndrcme
KAP kncwledee, attltudes and practlces
LT8l latent T8 lnfectlcn
MCF maternal and chlld health
MuC Mlllennlum uevelcpment Ccal
Muk-T8 multldrue-reslstant tuberculcsls
MTFF medlum-term expendlture framewcrk
MTSP medlum-term strateelc plan
hC0 ncnecvernmental creanlzatlcn
hkL natlcnal reference labcratcry
hTP natlcnal tuberculcsls ccntrcl prceramme
PAL practlcal apprcach tc lune health
PFC prlmary health care
PLFlv pecple llvlne wlth Flv
PPM publlc-prlvate mlx
PkSP pcverty reductlcn strateey paper
PT preventlve therapy
PT8 pulmcnary tuberculcsls
0C quallty ccntrcl
SCC shcrt-ccurse chemctherapy
SwAP sectcr-wlde apprcach
T8 tuberculcsls
TST tuberculln skln test
unlcn lnternatlcnal unlcn Aealnst Tuberculcsls and Lune ulsease
uhlCFF unlted hatlcns Chlldren's Fund
uvCl ultravlclet eermlcldal lrradlatlcn
wF0 wcrld Fealth 0reanlzatlcn
Xuk-T8 extenslvely drue-reslstant tuberculcsls
1
lntrcductlcn
A
n adequate strateey fcr the ccntrcl cf tuberculcsls (T8) elcbally calls fcr a
ccmprehenslve apprcach tc address all the maln ccnstralnts tc ccntrcl cf
the dlsease, lncludlne emerelne challenees, as well as the maln factcrs lnfu-
enclne the lncldence cf T8, such as scclceccncmlc and envlrcnmental aspects.
Ccnsequently, the sccpe cf actlvltles undertaken by natlcnal T8 ccntrcl prc-
erammes (hTPs) has ereatly lncreased. The purpcse cf thls handbcck ls tc
brlne tceether ln summarlzed fcrm the lssues, reccmmended strateeles and
practlcal measures lnvclved ln addresslne each cf the ccmpcnents cf the Stcp
T8 Strateey. lt cutllnes the ranee cf actlvltles tc be addressed by hTPs and the
reccmmended apprcaches tc lmplementatlcn cf the Strateey.
Thls publlcatlcn draws upcn current euldellnes and lnfcrmatlcn dccuments
lssued by the wcrld Fealth 0reanlzatlcn (wF0), whlch prcvlde mcre detalled
euldance cn lmplementatlcn fcr each cf the speclñc sub|ect areas. The llsted
references are llmlted tc key readlnes fcr lmplementatlcn cf prceramme actlvl-
tles and tc texts that prcvlde lmpcrtant addltlcnal backercund and supplemen-
tary lnfcrmatlcn. As further lnfcrmatlcn beccmes avallable, lt wlll be prcvlded
cn the wF0 web slte.
1
keaders are advlsed tc ccnsult thls web slte perlcdlcally
fcr updated lnfcrmatlcn and euldance.
The structure and creanlzatlcn cf the handbcck fcllcw and refect the ccmpc-
nents cf the Stcp T8 Strateey. Parts l and ll are ccncerned malnly wlth ccmpc-
nents 1 and z cf the strateey; Part lll ccvers lts new elements, l.e. ccmpcnents
¸, u, ç and 6. Fcwever, because the strateey ls lnteerated wlthln the actlvltles
cf hTPs, many lssues are crcss-cuttlne and relevant acrcss all parts cf thls
publlcatlcn.
Thls handbcck was prepared prlnclpally fcr use by hTP manaeers and staff,
as well as partner creanlzatlcns and all prcfesslcnals lnvclved ln dellverlne
T8 care and lmplementlne T8 ccntrcl actlvltles. keaders are prcvlded wlth
a ccnclse acccunt cf the essentlal elements cf a ccmprehenslve T8 ccntrcl
prceramme and an cvervlew cf the full ranee cf actlvltles that need tc be
lmplemented tc achleve the T8 ccntrcl tareets set fcr zo1ç. The fccus ls cn the
1
www.whc.lnt/tb/en
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A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
reccmmended apprcaches and measures tc be taken, ln acccrdance wlth the
referenced euldellnes and cther dccuments that prcvlde mcre detalled lnfcr-
matlcn cn lmplementatlcn.
lmplcmcntinc thc Stcp 18 Strctccv: c hcndbcck [cr ncticncl 18 rcntrcl prc-
crcmmcs ls the successcr tc the 1µbcrrµlcsis hcndbcck publlshed by wF0 ln
1¤¤8. The ccntents cf the prlnted bcck are expected tc remaln valld fcr at least
ñve years frcm the date cf publlcatlcn, wlth updated lnfcrmatlcn prcvlded cn
speclñc lssues cn the wF0 web slte as lt beccmes avallable. The prlnted edl-
tlcn wlll be ccnsldered fcr pcsslble revlslcn after zo1o.
Methede|egy
Thls publlcatlcn ls an abrldeed verslcn cf the euldance and lnfcrmatlcn detalled
ln a serles cf recently prcduced wF0 euldellnes, publlcatlcns cn systematlc
revlews and lnfcrmatlcn dccuments (publlshed befcre September zoo;). These
dccuments are themselves based upcn best avallable evldence, lncludlne cllnl-
cal trlals ln scme lnstances, as well as the accumulated experlence frcm hTPs
wcrldwlde, whlch repcrted scme ¤o mllllcn T8 cases tc wF0 between 1¤8o
and zooç. ln rapldly chanelne sub|ect areas where avallable lnfcrmatlcn cn the
efñcacy and effectlveness cf the reccmmended measures ls llmlted, euldance
ls based cn expert cplnlcn and best practlces derlved frcm experlence ealned
ln T8 ccntrcl and cther health prcerammes, as cf the publlcatlcn date cf thls
handbcck.
The lntcrncticncl stcndcrds [cr tµbcrrµlcsis rcrc descrlbe a wldely accepted
level cf care that all practltlcners - publlc and prlvate - shculd seek tc achleve
ln manaelne patlents whc have, cr are suspected cf havlne, T8. They lnclude a
ccmprehenslve llst cf the publlshed crlelnal research and systematlc revlews that
lnfcrm the wF0 reccmmendatlcns ccntalned ln thls handbcck cn the dlaencsls
and treatment cf T8. Fxtenslve reference llsts are alsc prcvlded ln 1cmcn´s tµbcr-
rµlcsis: rcsc dctcrticn, trcctmcnt, cnd mcnitcrinc. Fach chapter llsts relevant
wF0 euldellnes and key peer-revlewed texts cn whlch the chapter ls based.
A brcad lnternatlcnal ccnsultatlve prccess was used tc draft thls dccument.
The prccess lnvclved the fcllcwlne ñve steps:
1. Fstabllshment cf a Stcp T8 uepartment steerlne ercup (1z pecple) respcn-
slble fcr plannlne the structure and creanlzatlcn cf the handbcck; selectlne
the members cf the revlew ercup; prcvldlne euldance tc a ccnsultant whc
cccrdlnated the develcpment cf the text; and ccnslderlne the ccmments
recelved frcm revlewers.
z. Appclntment cf a wrltlne ccmmlttee ccmprlslne staff frcm the Stcp T8
uepartment and the Stcp T8 Partnershlp Secretarlat (zu pecple), lncludlne

lhTk0uuCTl0h
technlcal fccal pclnt staff members fcr each sub|ect area, respcnslble fcr
ensurlne the accuracy cf the technlcal ccntent cf speclñc sectlcns and ccn-
slderlne the ccmments cf revlewers.
¸. Fstabllshment cf an lnternatlcnal expert revlew ercup (zu pecple) lncludlne
representatlves frcm a brcad ranee cf technlcal partner aeencles as well
as technlcal experts, hTP manaeers and staff frcm wF0 headquarters and
reelcnal cfñces.
u. kevlew cf the ccmplete draft text by the lnternatlcnal revlew ercup. All ccm-
ments were ccnsldered by the technlcal fccal pclnt staff and fcllcwed up as
apprcprlate, lncludlne further dlscusslcn wlth revlewers and ccnslderatlcn
by the steerlne ercup as necessary. All ccmments recelved were kept cn
reccrd. Mcst cf the revlewers' ccmments were lnccrpcrated, wlth the excep-
tlcn cf thcse that were elther (l) lnccnslstent wlth current wF0 pcllcy cr (ll)
went beycnd the sccpe cf thls publlcatlcn.
ç. Amendment cf the text cn the basls cf the ccmments recelved frcm the lnter-
natlcnal revlew ercup. kevlew cf the amended text by the steerlne ercup and
ñnal revlslcn.
6. Ccnflct cf lnterest. All partlclpants lnvclved ln the preparatlcn and revlew
cf the text ccmpleted a ueclaratlcn cf lnterests. hc ccnflct cf lnterest was
declared by any partlclpant.
£p|dem|e|egy eI tubercu|es|s
Tuberculcsls remalns a ma|cr cause cf mcrbldlty and mcrtallty ln many ccun-
trles and a slenlñcant publlc health prcblem wcrldwlde. The elcbal lncldence
cf T8 was estlmated tc be 1¸6 cases per 1oo ooo pcpulatlcn per year ln zooç,
ranelne frcm ¸¤ per 1oo ooo per year ln the wF0 keelcn cf the Amerlcas tc
¸u¸ per 1oo ooo per year ln the wF0 Afrlcan keelcn. Thls represents a tctal
cf 8.8 mllllcn new cases cf T8 and 1.6 mllllcn deaths frcm T8 every year. The
zz hleh-burden ccuntrles, as deñned by wF0, are thcse ccuntrles that ccver
6¸% cf the wcrld's pcpulatlcn and that acccunt fcr apprcxlmately 8o% cf the
estlmated number cf new T8 cases cccurrlne wcrldwlde each year; scme cf
these ccuntrles are alsc amcne thcse wlth the hlehest lncldence rates cf T8
per caplta. wF0 publlshes an annual repcrt cn elcbal tuberculcsls ccntrcl that
detalls the latest survelllance and survey data.
8efcre the lntrcductlcn cf chemctherapy, wF0 estlmated that, cn averaee,
cne lnfectlcus scurce wculd transmlt lnfectlcn by Myccbacterlum tuberculcsls
tc zo cthers durlne an averaee cf twc years befcre death cr self-cure. Thus, a
pcpulatlcn cf 1oo ooo pecple wlth ço new cases cf smear-pcsltlve T8 cccurrlne
every year wculd prcduce 1oo lnfectlcus cases ln the pcpulatlcn at any elven
q
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
tlme, leadlne tc 1ooo new lnfectlcns annually, l.e. 1% cf the pcpulatlcn beccm-
lne lnfected every year.
0f all thcse lnfected wlth M. tµbcrrµlcsis, abcut ç% wlll develcp actlve T8 dls-
ease wlthln ñve years cf prlmary lnfectlcn; the cther ¤ç% wlll develcp a latent
lnfectlcn that may later prceress tc cause dlsease, dependlne cn the status cf
the lmmune system. 0verall, abcut 1o% cf lnfected lndlvlduals wlll eventually
develcp actlve T8.
ln the absence cf lnfectlcn wlth human lmmuncdeñclency vlrus (Flv) and wlth-
cut antl-T8 treatment, abcut 6ç% cf cases whc remaln smear-pcsltlve wlll dle,
mcst wlthln twc years, whlle cnly 1o-1ç% cf cases whc remaln smear-neeatlve
are expected tc dle. Fven wlth treatment, mcre than 1o% cf patlents may dle ln
settlnes where adherence tc treatment ls lcw cr where rates cf Flv lnfectlcn cr
drue reslstance are hleh. ln places where treatment ls eccd and Flv ls absent,
fewer than z% cf smear-pcsltlve patlents dle whlle cn treatment. The rlsk cf
develcplne T8 lncreases wlth aee after puberty, partlcularly amcne men, whc
have bcth a hleher rate cf lnfectlcn and a hleher rlsk cf prceresslcn tc actlve T8
dlsease cver the ccurse cf thelr llves than wcmen. The rlsk cf develcplne severe
fcrms cf dlsease ln creans cther than the lunes (e.e. tuberculcus menlneltls) ls
hleher ln chlldren aeed under ç years than ln clder chlldren and adults.
The mcst lmpcrtant recent chanees ln the natural hlstcry cf T8 have been the
lmpact cf the Flv epldemlc and the emereence cf reslstance tc antl-T8 drues.
Flv lnfectlcn exacerbates the T8 epldemlc thrcueh lts lmpact cn susceptlblllty
tc M. tµbcrrµlcsis lnfectlcn and prceresslcn frcm lnfectlcn tc actlve dlsease.
Flv lnfectlcn lncreases the rate at whlch M. tµbcrrµlcsis lnfectlcns are acqulred
and lncreases the llkellhccd that pecple whc are already lnfected wlll develcp
actlve T8 dlsease. The lmpact cf Flv has been ereatest ln ccuntrles cf scuthern
and eastern Afrlca, where up tc uo% cf adults may be lnfected wlth Flv and
where the lncldence cf T8 has lncreased u-ç-fcld wlthln 1o years. lnfectlcn wlth
bcth M. tµbcrrµlcsis and Flv ls prevalent ln scme pcpulatlcn ercups ln certaln
ccuntrles cf Scuth-Fast Asla, lncludlne Cambcdla, Chlna, lndla, Thalland and
vlet ham. 0ther slenlñcant rlsk factcrs may alsc have an lmpcrtant lmpact at
pcpulatlcn level, dependlne cn the deeree cf expcsure tc these rlsk factcrs ln
the pcpulatlcn.
The develcpment and lncreaslne lmpcrtance cf antl-T8 drue reslstance are cf
ccncern tc hTPs because drue-reslstant T8 ls much mcre dlfñcult and ccstly
tc treat than fully drue-susceptlble T8. An estlmated uço ooo cases cf multld-
rue-reslstant T8 (Muk-T8) cccur each year amcne new and prevlcusly treated
T8 cases, and extenslvely drue-reslstant T8 (Xuk-T8) has been repcrted frcm
many ccuntrles. urue reslstance emerees where cure rates are lcw, fcr example

where antl-T8 drues are avallable wlthcut medlcal prescrlptlcn. lt ls fcr thls
reascn that hTPs have been advlsed cver the years tc ccncentrate cn achlev-
lne hleh cure rates and cptlmlzlne the quallty cf and access tc antl-T8 drues,
cn lncreaslne case detectlcn rates, cn ensurlne eccd treatment cutccmes fcr
patlents wlth Muk cr Xuk-T8 and, ln settlnes where Flv ls prevalent, cn ensur-
lne that T8 patlents are tested fcr Flv and that pecple wlth Flv are examlned
fcr T8.
0ther factcrs may alsc have a slenlñcant effect cn the dlstrlbutlcn cf T8 ln pcp-
ulatlcns, and cn T8 trends cver tlme. Factcrs that affect expcsure tc M. tµbcr-
rµlcsis lnfectlcn and prceresslcn tc actlve T8 lnclude cvercrcwdlne, tcbaccc
smcklne, dlabetes and malnutrltlcn.
Thelr lnfuence cn the T8 epldemlc depends cn the level cf rlsk per perscn
and cn thelr prevalence ln the pcpulatlcn, quantltles that are as yet pccrly
deñned.
wlthln the framewcrk cf the Mlllennlum uevelcpment Ccals (MuCs), the maln
tareet fcr T8 ccntrcl ls tc ensure that the elcbal lncldence rate falls by zo1ç.
Supplementary tareets, endcrsed by the Stcp T8 Partnershlp, are tc halve the
1¤¤o prevalence and death rates by zo1ç. 0bservatlcns cn hTPs, backed by
mathematlcal mcdelllne, lndlcate that ln the absence cf Flv, the detectlcn cf
;o% cf lnfectlcus cases cccurrlne each year and cure cf at least 8ç% cf them
shculd reduce the lncldence cf T8 at a rate cf abcut ç-1o% per year. lf an
annual rate cf decllne cf ç% cr mcre ls achleved shcrtly, lt shculd be pcsslble
tc meet the MuC and Stcp T8 Partnershlp tareets elcbally by zo1ç.
1he 5tep 1ß 5trategy
Ma|cr prceress ln elcbal T8 ccntrcl fcllcwed the wldespread lmplementatlcn
cf the u0TS strateey ln ccuntrles wlth a hleh burden cf T8. Fcwever, elcbal
statlstlcs lndlcated that u0TS alcne wculd nct be sufñclent tc achleve elcbal
T8 ccntrcl and ellmlnatlcn. ln zooç, the wcrld Fealth Assembly reccenlzed the
need fcr a new strateey that wculd bulld upcn and enhance the achlevements
cf u0TS. The Stcp T8 Strateey, launched cn wcrld T8 uay ln zoo6, ls deslened
tc meet the T8-related Mlllennlum uevelcpment Ccal (MuC) as well as the Stcp
T8 Partnershlp tareets set fcr zo1ç. The Stcp T8 Strateey underplns the Clcbcl
Plcn tc Stcp 18 2cc6-2c1<.
Challençes to controlllnç T8
Ccntrcl cf T8 elcbally ccntlnues tc face ma|cr challenees. Fffcrts must ccntlnue
tc pursue hleh-quallty u0TS expanslcn and enhancement. Addresslne T8/Flv
and Muk-T8 requlres lncreaslne effcrt and rescurces, as dc cther challenees
faclne hTPs such as lmmleratlcn and hleh-rlsk ercups. weak health systems
lhTk0uuCTl0h
6
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
1h£ 510P 1ß 51kA1£6¥ A1 A 6LANC£
visien A wcrld free cf tuberculcsls
Cea| º Tc reduce dramatlcally the elcbal burden cf tuberculcsls (T8) by zo1ç ln llne
wlth the Mlllennlum uevelcpment Ccals (MuCs) and the Stcp T8 Partnershlp
tareets
0bjectives º Tc achleve unlversal access tc hleh-quallty dlaencsls and patlent-centred
treatment
º Tc reduce the sufferlne and scclceccncmlc burden asscclated wlth T8
º Tc prctect pccr and vulnerable pcpulatlcns frcm T8, T8/Flv and multldrue-
reslstant T8 (Muk-T8)
º Tc suppcrt the develcpment cf new tccls and enable thelr tlmely and effectlve
use
1argets º MuC 6, tareet 8 - tc have halted and beeun tc reverse the lncldence cf T8
by zo1ç
º Tareets llnked tc the MuCs and endcrsed by the Stcp T8 Partnershlp:
- by zooç, tc have detected at least ;o% cf new sputum smear-pcsltlve T8
cases and cured at least 8ç% cf these cases
- by zo1ç, tc have reduced T8 prevalence and death rates by ço% relatlve tc
1¤¤o levels
- by zoço, tc have ellmlnated T8 as a publlc health prcblem (·1 case per
mllllcn pcpulatlcn)
Cempenents eI the 5trategy and |mp|ementat|en appreaches
:. Pursuing high-qua|ity 0015 expansien and enhancement
a. Pclltlcal ccmmltment wlth lncreased and sustalned ñnanclne
b. Case detectlcn thrcueh quallty-assured bacterlclcey
c. Standardlzed treatment, wlth supervlslcn and patlent suppcrt
d. An effectlve drue supply and manaeement system
e. Mcnltcrlne and evaluatlcn system as well as lmpact measurement
z. Addressing 1ß{Btv, M0R-1ß and ether cha||enges
a. lmplement ccllabcratlve T8/Flv actlvltles
b. Prevent and ccntrcl Muk-T8
c. Address prlscners, refueees and cther hleh-rlsk ercups, and speclal sltuatlcns
¶. Centributing te hea|th system strengthening
a. Actlvely partlclpate ln effcrts tc lmprcve system-wlde pcllcy, human rescurces, ñnanclne,
manaeement, servlce dellvery and lnfcrmatlcn systems
b. Share lnncvatlcns that strenethen systems, lncludlne the Practlcal Apprcach tc Lune Fealth
c. Adapt lnncvatlcns frcm cther ñelds
o. £ngaging a|| care previders
a. Publlc-publlc and publlc-prlvate mlx apprcaches
b. lntcrncticncl stcndcrds [cr tµbcrrµlcsis rcrc
¶. £mpewering peep|e with 1ß, and cemmunities
a. Advccacy, ccmmunlcatlcn and scclal mcblllzatlcn
b. Ccmmunlty partlclpatlcn ln T8 care
c. Pcticnts´ rhcrtcr [cr tµbcrrµlcsis rcrc
6. £nab|ing and premeting research
a. Prceramme-based cperatlcnal research
b. kesearch tc develcp new drues, dlaencstlcs and vacclnes
Scurce: 1hc Stcp 18 Strctccv: bµildinc cn cnd cnhcnrinc 001S tc mcct thc 18-rclctcd Millcnniµm 0cvclcp-
mcnt Cccls. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6 (wF0/FTM/T8/zoo6.¸68).
)
and scarce human rescurces are ccnstralnts tc prceramme lmplementatlcn.
0reanlzlne standardlzed health servlces tc prcvlde a standardlzed apprcach
tc T8 manaeement wlthln the publlc sectcr cften excludes laree numbers cf
patlents, partlcularly the very pccr, leavlne them tc the lareely unreeulated
ncn-state sectcr. Access tc hleh-quallty care fcr T8 patlents ls stlll llmlted
by barrlers cf eender, aee, type cf dlsease, scclal settlne and ablllty tc pay
the dlrect and lndlrect ccsts cf care. wlthcut the effectlve eneaeement cf T8
patlents and ccmmunltles, T8 servlces may nct reach thcse whc need them
mcst. Flnally, wlthcut ccmmltment tc and wlde suppcrt fcr research, lncludlne
the develcpment and deplcyment cf new drues, dlaencstlcs and vacclnes, the
Stcp T8 Partnershlp ecal cf ellmlnatlne T8 by zoço ls unllkely tc be reached.
Innovatlve approaches anJ mechanlsms
Ccmplementary apprcaches tc addresslne the ma|cr challenees tc T8 ccntrcl
have been explcred and prcmcted. hew rescurces are lncreaslnely avallable
frcm natlcnal and lnternatlcnal scurces tc suppcrt these lnltlatlves, whlch
lnclude:
º ccllabcratlve actlvltles between T8 and Flv ccntrcl prcerammes;
º strateeles tc manaee drue-reslstant T8;
º addresslne T8 ccntrcl fcr marelnallzed and vulnerable pcpulatlcn ercups;
º lmprcvlne access tc quallty-assured drues fcr T8 and drue-reslstant T8
thrcueh mechanlsms such as the Clcbal urue Faclllty and the Creen Lleht
Ccmmlttee respectlvely;
º lnltlatlves that strenethen prlmary resplratcry care ln eeneral whlle expand-
lne hleh-quallty T8 servlces;
º cptlcns tc address pcverty ln T8 ccntrcl;
º lnncvatlve strateeles fcr eneaelne dlverse publlc, vcluntary, ccrpcrate and
prlvate prcvlders tc wlden the netwcrk cf T8 servlces;
º adcptlne the lntcrncticncl stcndcrds [cr tµbcrrµlcsis rcrc tc ensure hleh
quallty cf care acrcss all care prcvlders;
º empcwerlne pecple thrcueh scclal mcblllzatlcn and effectlve ways cf under-
taklne ccmmunlty T8 care;
º reccenlzlne T8 care as a baslc human rleht, as set cut ln the Pcticnts´ rhcrtcr
[cr tµbcrrµlcsis rcrc;
º fcrelne new alllances and lnltlatlves fcr the develcpment cf new tccls.
lhTk0uuCTl0h
8
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
The 6lobal Plan to 5top T8 zaa6-za1¢
The Clcbal Plan refects a ccnsensus vlew cf what the Stcp T8 Partnershlp can
achleve by zo1ç, prcvlded the rescurces are mcblllzed tc lmplement the Stcp
T8 Strateey acccrdlne tc the steps set cut ln the Clcbal Plan. 0ver the 1o-year
plan perlcd, lt ls prc|ected that scme ço mllllcn pecple shculd be treated fcr T8
thrcueh the Stcp T8 Strateey, lncludlne 1.ç mllllcn patlents wlth Muk-T8, and
abcut ¸ mllllcn T8/Flv patlents are expected tc be enrclled cn antlretrcvlral
therapy (AkT).
Importance oj actlons taken outslJe T8 control proçrammes anJ
outslJe the health sector
Ccntrcl cf T8 shculd be seen as an lnteeral part cf ccuntry strateeles tc reduce
pcverty and advance develcpment. Fffectlve T8 ccntrcl requlres addresslne
rlsk factcrs that make lndlvlduals vulnerable tc lnfectlcn by M. tµbcrrµlcsis
and tc develcplne dlsease. Actlcns taken by cther health and develcpment
prcerammes are alsc requlred tc reduce expcsure tc rlsk factcrs that lncrease
vulnerablllty tc T8 lnfectlcn and dlsease. T8 ccntrcl prcerammes shculd enccur-
aee and suppcrt such actlcns. Scme cf the drlvers cf the T8 epldemlc, lnclud-
lne pcverty, lnequlty, llllteracy and pccr hcuslne, need tc be tackled malnly
by actcrs cutslde the health sectcr. The rcle cf prcerammes ln thls respect
wculd be tc ldentlfy the need fcr actlcns beycnd these prcerammes and tc
effectlvely ccmmunlcate thls need and advccate fcr lnterventlcns tc relevant
declslcn-makers.
key reIerences
Ceelelskl lP, McMurray uh. The relatlcnshlp between malnutrltlcn and tuberculcsls:
evldence frcm studles ln humans and experlmental anlmals. lntcrncticncl lcµrncl c[
1µbcrrµlcsis cnd lµnc 0isccsc, zoou, 8:z86-z¤8.
Ccmmlsslcn cn Scclal uetermlnants cf Fealth. Scclal determlnants cf tuberculcsls. ln:
8las F, ed. Scricl dctcrmincnts c[ hcclth cnd pµblir hcclth prccrcmmcs. kcpcrt c[ thc
Pricritv Pµblir hcclth Ccnditicns kncwlcdcc Nctwcrk. Ceneva, wcrld Fealth 0reanlza-
tlcn, zoo8.
uye C et al. Prcspects fcr wcrldwlde tuberculcsls ccntrcl under the wF0 u0TS strateey.
ulrectly cbserved shcrt-ccurse therapy. lcnrct, 1¤¤8, ¸çz(¤1uu):1886-18¤1.
Clcbcl tµbcrrµlcsis rcntrcl: sµrvcillcnrc, plcnninc, hncnrinc. wF0 repcrt zoo;. Cene-
va, wcrld Fealth 0reanlzatlcn, zoo; (wF0/FTM/T8/zoo;.¸;6; avallable at: http://www.
whc.lnt/tb/publlcatlcns/zoo;/en/ ).
lntcrncticncl stcndcrds [cr tµbcrrµlcsis rcrc. The Faeue, Tuberculcsls Ccalltlcn fcr Tech-
nlcal Asslstance, zoo6 (avallable at: http://www.whc.lnt/tb/publlcatlcns/zoo6/en/ ).
Lln FF, Fzzatl M, Murray M. Tcbaccc smcke, lndccr alr pcllutlcn and tuberculcsls: a
systematlc revlew and meta-analysls. PlcS Mcdirinc, zoo;, u, ezo 'cnllne |curnal].
¤
Maher u et al. Plannlne tc lmprcve elcbal health: the next decade cf tuberculcsls ccn-
trcl. 8µllctin c[ thc wcrld hcclth 0rccnizcticn, zoo;, 8ç:¸u1-¸u;.
kavlellcne MC, uplekar M. wF0's new Stcp T8 Strateey. lcnrct, zoo6, ¸6;:¤çz-¤çç.
keld A et al. Tcwards unlversal access tc Flv preventlcn, treatment, care and suppcrt.
lcnrct ln[crticµs 0isccscs, zoo6, 6(8):u8¸-u¤ç.
kcpcrt c[ thc Ad-hcr Ccmmittcc cn thc tµbcrrµlcsis cpidcmir. Ceneva, wcrld Fealth
0reanlzatlcn, 1¤¤8 (wF0/CuS/T8/¤8.zu).
kleder FL. Fpidcmiclccir bcsis c[ tµbcrrµlcsis rcntrcl. Parls, lnternatlcnal unlcn
Aealnst Tuberculcsls and Lune ulsease, 1¤¤¤.
Stevenscn Ck et al. ulabetes and the rlsk cf tuberculcsls: a neelected threat tc publlc
health: Chrcnir lllncss, zoo;, ¸:zz8-zuç.
1hc Clcbcl Plcn tc Stcp 18, 2cc6-2c1<. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6
(wF0/ FTM/ST8/zoo6.¸ç; avallable at: http://www.whc.lnt/tb/publlcatlcns/zoo6/en/ ).
1hc pcticnts´ rhcrtcr [cr tµbcrrµlcsis rcrc. Ceneva, wcrld Care Ccuncll, zoo6.
1hc Stcp 18 Strctccv: bµildinc cn cnd cnhcnrinc 001S tc mcct thc 18-rclctcd Mil-
lcnniµm 0cvclcpmcnt Cccls. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6 (wF0/FTM/
T8/zoo6.¸68; avallable at: http://www.whc.lnt/tb/publlcatlcns/zoo6/en/ ).
1cmcn´s tµbcrrµlcsis. Ccsc dctcrticn, trcctmcnt, cnd mcnitcrinc, znd ed. Ceneva,
wcrld Fealth 0reanlzatlcn, zoou (wF0/FTM/T8/zoou.¸¸u; avallable at: http://www.
whc.lnt/tb/publlcatlcns/zoou/en/ ).
watt Cl et al. The elcbal epldemlclcey cf tuberculcsls. ln: Schaaf and Zumla, eds. 1µbcr-
rµlcsis. Lcndcn, Clcbal Medlclne, zoo8 (ln press).
Zlencl M et al. Clcbal lncldence cf multldrue-reslstant tuberculcsls. lcµrncl c[ ln[crticµs
0isccscs, zoo6, 1¤u:u;¤-u8ç.
lhTk0uuCTl0h
PAkT l
Tuberculcsls care
and preventlcn
Thls sectlcn refects the patlent-centred apprcach tc T8 ccntrcl
care, whlch ls a fundamental prlnclple cf T8 ccntrcl as reccmmended
by the Stcp T8 Strateey. lt fccuses cn the care and manaeement
cf patlents and the reductlcn cf rlsk fcr cthers. All aspects cf case
detectlcn, dlaencsls, treatment and case manaeement cf lndlvldual
patlents are lncluded, as well as the avallable apprcaches tc T8
preventlcn. Speclñc lssues ccncernlne the dlaencsls and treatment cf
drue-reslstant T8 and T8/Flv are emphaslzed ln vlew cf the lncreaslne
publlc health lmpcrtance cf these ccndltlcns. Chapter u ls devcted tc
the manaeement cf T8 ln chlldren, whlch requlres speclal measures and
dlfferent apprcaches tc thcse fcr T8 ln adults.
Preventlcn cf T8 lncludes lnterventlcns tc reduce transmlsslcn,
and tc reduce the rlsk cf T8 dlsease ln lnfected perscns. Scme cf the
lnterventlcns result ln speclñc actlvltles cf T8 ccntrcl prcerammes:
ccntact traclne, detectlcn cf scurces, lnfectlcn ccntrcl, preventlve
therapy, 8CC vacclnatlcn, and treatment cf Flv-lnfected perscns wlth
Akv. 0ther factcrs that strcnely lnfuence the rlsk cf beccmlne expcsed
and lnfected (such as cvercrcwdlne) cr develcplne actlve T8 (such
as Flv, pccr nutrltlcn, smcklne, dlabetes) cften cannct be readlly
lnfuenced by the T8 ccntrcl prceramme actlvltles and rescurces and
usually dc nct fall under the dlrect respcnslblllty cf the hTPs. Fcwever,
the hTPs can play a strcne advccacy rcle ln attemptlne tc allevlate the
lmpact cf these rlsk factcrs.

1 Case detectlcn
T
he detectlcn cf T8 cases requlres that affected lndlvlduals are aware cf
thelr symptcms, have access tc health facllltles and are evaluated by health
wcrkers (dcctcrs, nurses, medlcal asslstants, cllnlcal cfñcers) whc reccenlze
the symptcms cf T8. Fealth wcrkers must have access tc a rellable labcratcry
and ensure that the necessary speclmens are ccllected fcr examlnatlcn. Thls ls
a ccmplex set cf actlvltles and behavlcurs, and fallure at any staee can cause
delays ln dlaencsls cr mlsdlaencses.
The mcst ccmmcn symptcm cf pulmcnary T8 ls a perslstent, prcductlve ccueh,
cften acccmpanled by cther ncnspeclñc symptcms. Althcueh the presence cf
a ccueh fcr z-¸ weeks ls ncnspeclñc, tradltlcnally havlne a ccueh cf thls dura-
tlcn has served as the crlterlcn fcr deñnlne suspected T8 and ls used ln mcst
natlcnal and lnternatlcnal euldellnes.
The fcllcwlne symptcms cf pulmcnary T8 may acccmpany ccueh and sputum
prcductlcn:
º rcspirctcrv svmptcms: shcrtness cf breath, chest and back palns, haemcp-
tysls;
º rcnstitµticncl svmptcms: lcss cf appetlte, weleht lcss, fever, nleht sweats,
fatleue.
Symptcms cf extrapulmcnary T8 are related tc speclñc extrapulmcnary sltes,
such as lymph ncdes, pleura, larynx, menlnees, eenltcurlnary and lntestlnal
tracts, bcne, splnal ccrd, eye and skln.
Spµtµm smccr mirrcsrcpv. Sputum speclmens shculd be cbtalned fcr mlcrcsccplc
examlnatlcn frcm all patlents suspected cf havlne pulmcnary T8. Mlcrcblclcelcal
dlaencsls ls ccnñrmed by culturlne M. tµbcrrµlcsis (cr, under apprcprlate clr-
cumstances, by ldentlfylne speclñc nuclelc acld sequences ln a cllnlcal speclmen)
frcm any suspected slte cf dlsease. Fcwever, ln many settlnes where rescurces
are llmlted, nelther culture ncr rapld ampllñcatlcn methcds are currently avalla-
ble cr feaslble. ln such clrcumstances, the dlaencsls cf T8 may alsc be ccnñrmed
by the presence cf acld-fast bacllll (AF8) ln sputum smear examlnatlcn. kepeated
sputum smear mlcrcsccpy may dlaencse pulmcnary T8 ln up tc twc-thlrds cf
actlve cases.
1q
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
ln nearly all cllnlcal clrcumstances ln settlnes cf hleh T8 prevalence, ldentlñca-
tlcn cf AF8 by mlcrcsccplc examlnatlcn ls hlehly speclñc fcr the M. tµbcrrµlcsis
ccmplex. Sputum smear mlcrcsccpy ls the mcst rapld methcd fcr determlnlne
whether a perscn has T8; lt ldentlñes pecple whc are at ereatest rlsk cf dylne
frcm the dlsease and the mcst llkely transmltters cf lnfectlcn.
Spµtµm spcrimcns. The cptlmum number cf sputum speclmens tc establlsh a
dlaencsls has been evaluated. The ñrst speclmen was fcund pcsltlve ln 8¸-8;%
cf all patlents ln whcm AF8 are ultlmately detected; the seccnd speclmen was
pcsltlve ln an addltlcnal 1o-1z% and the thlrd speclmen ln a further ¸-ç%.
0n thls basls, wF0 reccmmends the mlcrcsccplc examlnatlcn cf twc sputum
speclmens (fcrmerly three).
1
8ecause the yleld cf AF8 appears tc be ereatest
frcm early mcrnlne (cvernleht) speclmens, wF0 further reccmmends that at
least cne speclmen shculd be cbtalned frcm an early mcrnlne ccllectlcn.
Spµtµm rcllcrticn prcrcdµrcs. The prccedures fcr ccllectlne sputum lnvclve
the prcductlcn cf drcplets that are hlehly lnfectlcus lf the patlent has untreated
pulmcnary T8. Sputum ccllectlcn shculd therefcre be creanlzed ln areas wlth
eccd ventllatlcn cr, lf nct avallable, cutslde the bulldlne (see Chapter 6).
Sputum smear speclmens shculd be examlned by mlcrcsccpy lmmedlately but
nc later than ç tc ; days after they have been ccllected. A health unlt wlth-
cut adequate facllltles fcr ccllectlne and transpcrtlne sputum shculd refer the
patlent tc the nearest health unlt able tc ccllect sputum, cr dlrect the patlent
tc a mlcrcsccpy labcratcry.
hatlcnal T8 euldellnes shculd lnclude all the detalls cf what health wcrkers
shculd dc befcre, durlne and after the ccllectlcn cf sputum. Attentlcn shculd
be pald tc the characterlstlcs cf sputum ccntalners, precautlcns fcr health
wcrkers, labelllne, ldentlñcatlcn and reccrdlne cf patlents' addresses.
0iccncsis c[ smccr-nccctivc tµbcrrµlcsis. Fcr smear-neeatlve and extrapulmc-
nary T8, a dlaencsls by a cllnlclan speclally tralned ln T8 may be requlred as
well as radlceraphlc examlnatlcn. As nc chest radlceraphlc pattern ls absc-
lutely speclñc fcr pulmcnary T8, the dlaencsls cf smear-neeatlve T8 ls always
presumptlve and shculd be based cn cther cllnlcal and epldemlclcelcal lnfcr-
matlcn, lncludlne fallure tc respcnd tc a ccurse cf brcad-spectrum antlblctlcs
and excluslcn cf cther pathclcey. kellance cn chest radlceraphy as the cnly
dlaencstlc test fcr T8 results ln elther cverdlaencsls cf T8 cr mlssed dlaencses
cf T8 and cther dlseases and ls therefcre nct reccmmended. kadlceraphlc
examlnatlcn, hcwever, ls mcst useful when applled as part cf a systematlc
1
A reductlcn ln the number cf speclmens examlned fcr screenlne T8 suspects frcm three tc twc
was reccmmended by wF0 and endcrsed by the Strateelc Technlcal and Advlscry Crcup fcr
Tuberculcsls ln lune zoo;.

1. CASF uFTFCTl0h
apprcach tc evaluate patlents whcse symptcms and/cr ñndlnes sueeest T8 but
whcse sputum smears are neeatlve. Flucrcsccpy results are nct acceptable as
dccumented evldence cf pulmcnary T8.
Prccncnrv. Case-detectlcn methcds ln preenancy shculd exclude radlceraphlc
examlnatlcn, partlcularly ln the ñrst trlmester.
Cµltµrc. whlle sputum smear mlcrcsccpy ls the ñrst bacterlclcelcal dlaencstlc
test cf chclce where adequate, quallty-assured labcratcry facllltles are avall-
able, the evaluatlcn cf patlents wlth neeatlve sputum smears shculd alsc
lnclude culture. Culture adds extra ccst and ccmplexlty but ereatly lncreases
the sensltlvlty and speclñclty cf dlaencsls, resultlne ln better case detectlcn.
Althcueh the results cf culture may nct be avallable untll after a declslcn tc
beeln treatment has been made, treatment may be stcpped subsequently lf
cultures frcm a rellable labcratcry are neeatlve and lf the patlent has nct
respcnded cllnlcally tc treatment and the cllnlclan has scueht cther evldence
ln pursulne the dlfferentlal dlaencsls.
Fleure 1.1 presents an lllustratlve apprcach tc the dlaencsls cf pulmcnary T8 ln
settlnes wlth a lcw prevalence cf Flv lnfectlcn. ulaencstlc alecrlthms fcr hleh
Flv-prevalent settlnes and fcr serlcusly lll patlents are prcvlded ln sectlcn 1.¸.
Fxtrcpµlmcncrv tµbcrrµlcsis. Fxtrapulmcnary T8 (wlthcut asscclated lune
lnvclvement) acccunts fcr 1ç-zo% cf T8 ln pcpulatlcns wlth a lcw prevalence cf
Flv lnfectlcn. ln pcpulatlcns wlth a hleh prevalence cf Flv lnfectlcn, the prcpcr-
tlcn cf cases wlth extrapulmcnary T8 ls hleher. 8ecause apprcprlate speclmens
may be dlfñcult tc cbtaln frcm scme cf these sltes, bacterlclcelcal ccnñrmatlcn
cf extrapulmcnary T8 ls cften mcre dlfñcult than fcr pulmcnary T8. kelatlvely
few M. tµbcrrµlcsis creanlsms are present ln extrapulmcnary sltes, and ldentl-
ñcatlcn cf AF8 by mlcrcsccpy ln speclmens frcm these sltes ls lnfrequent. Fcr
example, mlcrcsccplc examlnatlcn cf pleural fuld ln tuberculcus pleurltls and
tuberculcus menlneltls detects AF8 ln cnly abcut ç-1o% cf cases.
Clven the lcw yleld cf mlcrcsccpy, bcth culture and hlstcpathclcelcal examlna-
tlcn cf tlssue speclmens, such as thcse that may be cbtalned by needle blcpsy
cf lymph ncdes, are lmpcrtant dlaencstlc tests fcr extrapulmcnary T8.
1.1 Case dehn|t|ens eI tubercu|es|s
A dlaencsls cf T8 shculd be fcllcwed by speclñcatlcn cf the type cf T8, l.e.
the case deñnltlcn, whlch ls necessary fcr prescrlblne treatment acccrdlne tc
standardlzed reelmens, fcr patlent reelstratlcn and repcrtlne, fcr cchcrt analy-
sls cf treatment cutccmes and fcr determlnlne trends.
Case deñnltlcns fcr T8 take lntc acccunt the anatcmlcal slte cf dlsease, the
bacterlclcelcal results, the severlty cf dlsease and the hlstcry cf prevlcus treat-
16
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
All smears neeatlve 0ne cr twc smears pcsltlve
ftCUR£ :.: Ah lLLuSTkATlvF APPk0ACF T0 TFF ulACh0SlS 0F SuSPFCTFu PuLM0hAk¥
Tu8FkCuL0SlS
a,b
All pulmcnary T8 symptcms
c
Twc sputum samples cbtalned
Sputum AF8 mlcrcsccpy
Antlblctlcs, cther than antl-T8 drues
and fucrcqulnllcnes
X-ray examlnatlcn
lmprcvement hc lmprcvement
kepeat sputum AF8 mlcrcsccpy
0ne cr twc smears pcsltlve All smears neeatlve
Cllnlcal |udeement
Smear-neeatlve T8 Smear-pcsltlve T8 hc T8
AF8 = acld-fast bacllll; T8 = tuberculcsls
a
Adapted frcm 1rcctmcnt c[ tµbcrrµlcsis: cµidclincs [cr ncticncl prccrcmmcs. Ceneva, wcrld Fealth
0reanlzatlcn, zoo¸ (wF0/CuS/T8/zoo¸.¸1¸).
b
Appllcable fcr areas wlth lcw Flv prevalence.
c
Screenlne: ccueh ·z-¸ weeks.
1)
ment. Tables 1.1 and 1.z present the deñnltlcns cf T8 cases by slte, bacterlclcel-
cal status and hlstcry cf prevlcus treatment ln adult patlents. The deñnltlcn
cf a sputum smear-pcsltlve case ls the same fcr Flv-pcsltlve and Flv-neeatlve
patlents, l.e. requlrlne at least cne pcsltlve smear ln ccuntrles wlth a functlcnal
system cf external quallty assurance (F0A).
1.1.1 4natomlcal slte oj Jlsease
The twc maln cateecrles cf T8 by anatcmlcal slte cf dlsease are: (l) pulmcnary
T8, cr dlsease affectlne the lune parenchyma (the mcst ccmmcn fcrm cf T8);
and (ll) extrapulmcnary T8, cr dlsease affectlne sltes lncludlne lymph ncdes,
pleura, menlnees, perlcardla, perltcneum, splne, lntestlne, eenltcurlnary tract,
larynx, bcne and |clnts, and skln.
1.1.z 8acterloloçlcal results
"Smear-pcsltlve" cr "smear-neeatlve" ls the mcst useful bacterlclcelcal clas-
slñcatlcn cf pulmcnary cases because lt ccrrelates wlth lnfectlcusness. ln set-
tlnes where culture facllltles are avallable, the results cf culture are lncluded ln
the bacterlclcelcal classlñcatlcn. under mcst prcerammatlc ccndltlcns - when
cnly mlcrcsccpy labcratcry servlces are avallable and when dlaencstlc crlterla
are prcperly applled - smear-pcsltlve cases represent mcre than 6ç% cf the
1. CASF uFTFCTl0h
1AßL£ :.: CASF uFFlhlTl0hS 8¥ SlTF Ahu 8ACTFkl0L0ClCAL STATuS lh Flv-hFCATlvF
AuuLTS Ahu F0k h0h-Flv PkFvALFhT SFTTlhCS
Case c|assihcatien 0ehnitien
Pu|menary tubercu|esis, 0ne cr mcre lnltlal sputum smear examlnatlcns pcsltlve fcr
sputum smear-pesitive (P1ß+) Acld-fast bacllll by mlcrcsccpy
Pu|menary tubercu|esis, A case cf pulmcnary tuberculcsls whc dces nct meet the abcve
sputum smear-negative (P1ß-) deñnltlcn fcr smear-pcsltlve tuberculcsls.
kete: ln keeplne wlth eccd cllnlcal and publlc health practlces,
dlaencstlc crlterla shculd lnclude:
1. At least twc sputum speclmens neeatlve fcr acld-fast bacllll,
and
z. kadlceraphlc abncrmalltles ccnslstent wlth actlve pulmcnary
tuberculcsls, and
¸. hc respcnse tc a ccurse cf brcad-spectrum antlblctlcs, and
u. ueclslcn by a cllnlclan tc treat wlth a full ccurse cf antl-
tuberculcsls chemctherapy.
Thls ercup lncludes patlents whcse sputum smears are
neeatlve but whcse culture ls pcsltlve.
£xtrapu|menary tubercu|esis A patlent wlth tuberculcsls affectlne creans cther than the
lunes. ulaencsls shculd be based cn cne culture-pcsltlve
speclmen, cr hlstclcelcal cr strcne cllnlcal evldence ccnslstent
wlth actlve extrapulmcnary tuberculcsls, fcllcwed by a declslcn
by a cllnlclan tc treat wlth a full ccurse cf antl-tuberculcsls
chemctherapy.
18
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
tctal number cf cases cf pulmcnary T8 ln adults, and ço% cr mcre cf all T8
cases (althcueh thcse prcpcrtlcns may be altered ln settlnes wlth hleh preva-
lence cf Flv lnfectlcn).
A patlent wlth bcth pulmcnary and extrapulmcnary T8 ls classlñed as a case
cf pulmcnary T8.
1.1.y 5everlty oj Jlsease
8aclllary lcad, extent cf dlsease and anatcmlcal slte are factcrs that deter-
mlne the severlty cf T8 dlsease, and ccnsequently lts apprcprlate treatment.
A case cf pulmcnary T8 ls classlñed as severe lf parenchymal lnvclvement ls
extenslve. Mlllary dlssemlnated T8 ls alsc ccnsldered severe. lnvclvement cf an
anatcmlcal slte results ln classlñcatlcn as severe dlsease lf there ls a slenlñcant
acute threat tc llfe (e.e. perlcardlal T8), a rlsk cf subsequent severe handlcap
(e.e. splnal T8) cr bcth (e.e. menlneeal T8).
The fcllcwlne fcrms cf extrapulmcnary T8 are classlñed as severe: menlneeal,
perlcardlal, perltcneal, bllateral cr extenslve pleural effuslcn, splnal, lntestlnal
and eenltcurlnary. T8 cf the lymph ncdes, unllateral pleural effuslcn, bcne
(excludlne splne), perlpheral |clnt and skln ls classlñed as less severe.
1AßL£ :.z CATFC0k¥ 0F PATlFhTS F0k kFClSTkATl0h 0h ulACh0SlS
(8ASFu 0h FlST0k¥ 0F PkFvl0uS TkFATMFhT)
0iagnestic{registratien categery 0ehnitien
kew A patlent whc has never had treatment fcr tuberculcsls cr
whc has taken antl-tuberculcsls drues fcr less than cne
mcnth.
Re-treatment Re|apse A patlent prevlcusly treated fcr tuberculcsls whc has been
cases declared cured cr treatment ccmpleted, and ls dlaencsed
wlth bacterlclcelcally pcsltlve (at least cne smear cr
culture) tuberculcsls.
1reatment A patlent whc ls started cn a re-treatment reelmen after
aIter Iai|ure prevlcus treatment has falled.
1reatment A patlent whc returns tc treatment wlth pcsltlve
aIter deIau|t bacterlclcey, fcllcwlne lnterruptlcn cf treatment fcr twc
mcnths cr mcre.
1ransIer in A patlent whc has been transferred frcm ancther
tuberculcsls reelster tc ccntlnue treatment ln a dlfferent
reelster area.
0ther All cases whc dc nct ñt the abcve deñnltlcns. Thls
ercup lncludes patlents whc are sputum smear-pcsltlve
at the end cf a re-treatment reelmen (prevlcusly deñned
as Chrcnlc cases) and whc may be reslstant tc the
ñrst-llne drues.
kete: Smear-neeatlve pulmcnary and extrapulmcnary cases may alsc be relapses, fallures cr
cther cases. Such dlaencses shculd be suppcrted by pathclcelcal cr bacterlclcelcal evldence.

1.z Case detect|en eI drug-res|stant tubercu|es|s
Prcerammatlc strateeles fcr the manaeement cf drue-reslstant T8 alm tc lden-
tlfy patlents and lnltlate adequate treatment fcr drue-reslstant cases ln a tlmely
manner. Prcmpt ldentlñcatlcn and lnltlatlcn cf adequate treatment elves a bet-
ter chance cf cure fcr patlents, prcvldes the best lnfectlcn ccntrcl measure, and
prevents the acqulsltlcn cf further reslstance and prceresslcn tc a chrcnlc state
cf permanent lune damaee.
wF0 reccmmends that prcerammes have pcpulatlcn-representatlve data cf
drue reslstance survelllance (ukS) fcr new patlents, fcr the dlfferent cateecrles
cf re-treatment patlents (fallure after Cateecry l, fallure after re-treatment,
default and relapse) and fcr cther hleh-rlsk ercups (see Chapter z). ueslenlne
an effectlve case-ñndlne strateey depends cn thls lnfcrmatlcn. Avallablllty cf
ukS data fcr the dlfferent ercups alsc enables calculatlcn cf the number cf
patlents whc shculd enter the prceramme; thls ln turn ereatly facllltates prc-
eramme plannlne and drue prccurement (see alsc Chapter 1u).
Scme prcerammes may nct have sufñclent labcratcry capaclty tc prcvlde drue
susceptlblllty testlne (uST) cf all patlents. where tareeted uST surveys ldentlfy
a rlsk ercup cr ercups cf patlents wlth a hleh prcpcrtlcn cf Muk-T8 (whlch may
exceed 8o%), the use cf Cateecry lv reelmens ln all patlents ln that ercup ls
|ustlñed.
The three rlsk ercups ccmmcnly ccnsldered fcr dlrect enrclment fcr a Cateecry
lv reelmen are:
º Cateecry ll fallures (chrcnlc T8 cases);
º T8 patlents whc are clcse ccntacts cf Muk-T8 cases;
º Cateecry l fallures whc recelved a full
ccurse cf treatment.
The prcpcrtlcn cf Muk-T8 ln these
three ercups may vary ccnslderably. lt
ls therefcre lmpcrtant tc ccnñrm Muk-
T8 thrcueh the use cf uST (tc, at least,
lscnlazld and rlfamplcln) fcr all patlents
whc start a Cateecry lv reelmen.
ln mcst settlnes, cther ercups are
unllkely tc have rates cf Muk-T8 sufñ-
clently hleh tc warrant entry lntc a drue-
reslstant T8 treatment reelmen wlthcut
ccnñrmatlcn cf Muk-T8 by uST (8cx
1.1).
1. CASF uFTFCTl0h
ß0X :.:
0£ftkt1t0k5 0f MUL1t0RUC-
R£5t51Ak1 1UߣRCUL05t5 Ak0
£X1£k5tv£L¥ 0RUC-R£5t51Ak1
1UߣRCUL05t5
N M0R-1ß. Tuberculcsls wlth
reslstance tc, at least, lscnlazld, and
rlfamplcln.
N X0R-1ß. Tuberculcsls wlth
reslstance tc, at least, lscnlazld
and rlfamplcln and tc any cf the
fucrcqulnclcnes and tc cne cf the
fcllcwlne ln|ectable drues: amlkacln,
caprecmycln, kanamycln.
ze
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
1.¶ Case detect|en eI tubercu|es|s and human |mmunedehc|ency v|rus
lmpcrtant dlfferences exlst ln the dlaencsls cf T8 ln Flv-prevalent settlnes
and ln settlnes cf lcw Flv prevalence. Flv alters the cllnlcal pattern cf T8 and
ccmpllcates lts dlaencsls.
lnfectlcn wlth Flv lncreases the rlsk cf prceresslcn cf recent M. tµbcrrµlc-
sis lnfectlcn and cf reactlvatlcn cf latent M. tµbcrrµlcsis lnfectlcn by ç-1ç%
annually, dependlne cn the deeree cf lmmune deñclency. lt alsc lncreases the
rate cf recurrence cf T8, bcth relapse (reactlvatlcn cf latent T8) and relnfec-
tlcn (newly acqulred lnfectlcn). Flv ls respcnslble fcr a laree lncrease ln the
prcpcrtlcn cf patlents wlth smear-neeatlve pulmcnary and extrapulmcnary T8.
These patlents have lnferlcr treatment cutccmes, lncludlne excesslve early
mcrtallty, ccmpared wlth Flv-pcsltlve, smear-pcsltlve pulmcnary T8 patlents.
Tackllne thls prcblem requlres rapld dlaencsls cf smear-neeatlve pulmcnary
and extrapulmcnary T8 ln settlnes wlth hleh Flv prevalence.
F[[crt c[ hlv cn 18. Flv lnfectlcn causes reduced lmmune ccmpetence and the
ccnsequent lcss cf ablllty tc prevent the spread cf the tubercle bacllll frcm
lccallzed eranulcmas (due tc a decllne ln the number cf Cuu÷ T cells). kapld
prceresslcn frcm lnltlal lnfectlcn tc T8 dlsease may alsc cccur ln markedly
lmmuncsuppressed patlents. Patlents wlth actlve T8 whc are Flv-pcsltlve have
a hleher rlsk cf dylne frcm T8 than thcse wlthcut Flv.
ln the early staees cf Flv lnfectlcn, befcre hcst lmmunlty ls slenlñcantly ccm-
prcmlsed, patlents wlth T8 have the typlcal symptcms cf T8, and smear mlcrc-
sccpy ls usually pcsltlve. wlth mcre advanced Flv lnfectlcn and ccmprcmlsed
lmmune status, T8 symptcms are atyplcal and the smear ls cften neeatlve. Pau-
clbaclllary (scanty) smears are alsc mcre frequent ln Flv-lnfected T8 patlents.
Flv-pcsltlve patlents wlth smear-neeatlve T8 are mcre llkely tc dle durlne cr
befcre dlaencsls than Flv-neeatlve smear-pcsltlve patlents.
kcdiccrcphv. The use cf chest radlceraphy tc dlaencse pulmcnary T8 may be
ccmprcmlsed by pccr ñlm quallty, lcw speclñclty and dlfñcultles wlth lnterpre-
tatlcn. Flv lnfectlcn further dlmlnlshes the rellablllty cf chest radlceraphs fcr
the dlaencsls cf pulmcnary T8 because the dlsease ccmmcnly presents wlth
an atyplcal pattern. Furthermcre, the chest radlceraph may be ncrmal ln a
prcpcrtlcn cf Flv-lnfected patlents wlth sputum culture-pcsltlve T8 (cbserved
ln up tc 1u% cf such cases). Fcwever, chest radlceraphy remalns an lmpcrtant
ad|unct tc the dlaencsls cf smear-neeatlve pulmcnary T8 ln pecple llvlne wlth
Flv (PLFlv).
0iccncstir clccrithms. Alecrlthms fcr the dlaencsls cf T8 ln ambulatcry patlents
ln Flv-prevalent settlnes and ln serlcusly lll Flv-pcsltlve patlents are prcvlded
belcw (Fleures 1.z and 1.¸).
z1
1. CASF uFTFCTl0h
ftCUR£ :.z ALC0klTFM F0k TFF ulACh0SlS 0F Tu8FkCuL0SlS lh
AM8uLAT0k¥ Flv-P0SlTlvF PATlFhTS
AF8
Flv test
b
Flv÷ cr status unkncwn
c
a
The daneer slens lnclude any cne cf: resplratcry rate ·¸o/mlnute, fever ·¸¤ ºC, pulse rate ·1zo/mln and un-
able tc walk unalded.
b
Fcr ccuntrles wlth adult Flv prevalence rate *1% cr prevalence rate cf Flv amcne tuberculcsls patlents *ç%.
c
ln the absence cf Flv testlne, classlf ylne Flv status unkncwn as Flv-pcsltlve depends cn cllnlcal assess-
ment cr natlcnal and/cr lccal pcllcy.
d
AF8-pcsltlve ls deñned as at least cne pcsltlve and AF8-neeatlve as twc cr mcre neeatlve smears.
e
CPT = Cc-trlmcxazcle preventlve therapy.
f
Flv assessment lncludes Flv cllnlcal staelne, determlnatlcn cf Cu
u
ccunt lf avallable and referral fcr Flv care.
e
The lnvestleatlcns wlthln the bcx shculd be dcne at the same tlme wherever pcsslble ln crder tc decrease
the number cf vlslts and speed up the dlaencsls.
h
Antlblctlcs (except fucrcqulnclcnes) tc ccver bcth typlcal and atyplcal bacterla shculd be ccnsldered.
l
PCP: Pncµmcrvstis rcrinii pneumcnla, alsc kncwn as Pncµmcrvstis jircvcrii pneumcnla.
|
Advlse tc return fcr reassessment lf symptcms recur.
AF8-pcsltlve
d
:
s
t

v
i
s
i
t
z
n
d

v
i
s
i
t

r
d

v
i
s
i
t
o
t
h

v
i
s
i
t
T8 llkely
AF8-neeatlve
d
Treat fcr bacterlal lnfectlcn
h
Flv assessment
f
CPT
e
Treat fcr PCP
l
Flv assessment
f
hc cr partlal respcnse
Ambulatcry patlent wlth ccueh z-¸ weeks and nc daneer slens
a
T8 unllkely
kespcnse
|
kespcnse
|
keassess fcr T8
Treat fcr T8
CPT
e
Flv assessment
f
CXk
e
Sputum AF8 and culture
e
Cllnlcal assessment
e
zz
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
ftCUR£ :.¶ ALC0klTFM F0k TFF ulACh0SlS 0F Tu8FkCuL0SlS lh
SFkl0uSL¥ lLL Flv-P0SlTlvF PATlFhTS
a
The daneer slens lnclude any cne cf: resplratcry rate ·¸o/mlnute, fever ·¸¤ ºC, pulse rate ·1zo/mln and un-
able tc walk unalded.
b
The lnvestleatlcns wlthln the bcx shculd be dcne at the same tlme wherever pcsslble ln crder tc decrease
the number cf vlslts and speed up the dlaencsls.
c
Fcr ccuntrles wlth adult Flv prevalence rate *1% cr prevalence rate cf Flv amcne tuberculcsls patlents *ç%.
d
Antlblctlcs (except fucrcqulnclcnes) tc ccver bcth typlcal and atyplcal bacterla shculd be ccnsldered.
e
PCP: Pncµmcrvstis rcrinii pneumcnla, alsc kncwn as Pncµmcrvstis jircvcrii pneumcnla.
f
ln the absence cf Flv testlne, classlf ylne Flv status unkncwn as Flv-pcsltlve depends cn cllnlcal assess-
ment cr natlcnal and/cr lccal pcllcy.
e
AF8-pcsltlve ls deñned as at least cne pcsltlve and AF8-neeatlve as twc cr mcre neeatlve smears.
h
keassessment fcr tuberculcsls lncludes AF8 examlnatlcn and cllnlcal assessment.
Serlcusly lll patlent wlth ccueh z-¸ weeks and daneer slens
a
keferral tc hleher
level faclllty
Parenteral antlblctlc treatment fcr
bacterlal lnfectlcn
b,d
Sputum AF8 and culture
b
Flv test
b,c
CXk
b
Parenteral antlblctlcs fcr
bacterlal lnfectlcn
b,d
Ccnslder treatment fcr PCP
e
Sputum AF8 and culture
b
Flv test
b,c
Flv÷ cr unkncwn
f
hc
tuberculcsls
Treat
tuberculcsls
AF8-pcsltlve
e
hc lmprcvement
after ¸-ç days
lmprcvement
after ¸-ç days
Start T8 treatment
Ccmplete antlblctlcs
kefer fcr Flv and
tuberculcsls care
keassess fcr
tuberculcsls
h
keassess fcr cther
Flv-related dlsease
Tuberculcsls
unllkely
AF8-neeatlve
e
lmmedlate referral
nct pcsslble

The dlaencsls cf smear-neeatlve pulmcnary T8 ls partlcularly dlfñcult amcne
Flv-pcsltlve patlents, and use cf the alecrlthm ls therefcre reccmmended.
The alecrlthm fcr Flv-neeatlve patlents (Fleure 1.1) lncludes treatment wlth a
ccurse cf brcad-spectrum antlblctlcs tc exclude lnfectlcns cther than T8, and
tc lmprcve the speclñclty cf the dlaencsls.
The result cf antlblctlc treatment ls nct affected by Flv status. Fcwever, patlents
wlth T8 may lcse thelr resplratcry symptcms after a ccurse cf antlblctlcs.
The speclñc aspects cf T8 dlaencsls ln Flv-prevalent settlnes are that:
º the cllnlcal assessment cf the serlcusness cf dlsease ls taken lntc acccunt;
º speclal effcrts tc avcld delay ln establlshlne the dlaencsls shculd be made;
º the use cf antlblctlcs (fcr cllnlcal reascns) ls nct a step ln the dlaencstlc
prccess;
º all avallable lnvestleatlcns, such as chest radlceraphy, culture cf sputum
and speclmen culture fcr cases cf extrapulmcnary T8, shculd be carrled cut
as sccn as pcsslble.
Wh0 gu|de||nes
Cµidclincs [cr thc prccrcmmctir mcncccmcnt c[ drµc-rcsistcnt tµbcrrµlcsis. Ceneva,
wcrld Fealth 0reanlzatlcn, zoo6 (wF0/FTM/T8/zoo6.¸61).
Cµidclincs [cr sµrvcillcnrc c[ drµc rcsistcnrc in tµbcrrµlcsis. Ceneva, wcrld Fealth
0reanlzatlcn, zoo¸ (wF0/CuS/T8/zoo¸/¸zo).
1rcctmcnt c[ tµbcrrµlcsis: cµidclincs [cr ncticncl prccrcmmcs, ¸rd ed. Ceneva, wcrld
Fealth 0reanlzatlcn, zoo¸ (wF0/CuS/T8/zoo¸.¸1¸).
key reIerences
Anti-tµbcrrµlcsis drµc rcsistcnrc in thc wcrld. 1hird clcbcl rcpcrt. Ceneva, wcrld
Fealth 0reanlzatlcn, zoou (wF0/FTM/T8/zoou.¸u¸).
8cnnet M et al. keduclne the number cf sputa examlned, and threshclds fcr pcsltlvlty:
an cppcrtunlty tc cptlmlze smear mlcrcsccpy 'accepted fcr publlcatlcn]. lntcrncticncl
lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zoo;.
uay lF et al. Screenlne fcr tuberculcsls prlcr tc lscnlazld preventlve therapy amcne
Flv-lnfected ecld mlners ln Scuth Afrlca. lntcrncticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc
0isccsc, zoo6, 1o(ç):çz¸-çz¤.
Fnarscn uA et al. Mcncccmcnt c[ tµbcrrµlcsis: c cµidc [cr lcw inrcmc rcµntrics, çth
ed. Parls, lnternatlcnal unlcn Aealnst Tuberculcsls and Lune ulseases, zooo.
Cetahun F et al. ulaencsls cf smear neeatlve pulmcnary tuberculcsls ln pecple llvlne
wlth Flv/AluS ln rescurce ccnstralned settlnes: lnfcrmlne ureent pcllcy chanees. lcn-
rct, zoo;, ¸6¤:zouz-zou¤.
1. CASF uFTFCTl0h
zq
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
Farrles A. what are the relatlve merlts cf chest radlceraphy and sputum examlna-
tlcn (smear mlcrcsccpy and culture) ln case detectlcn amcne new cutpatlents wlth
prclcneed chest symptcms: ln: 1cmcn´s tµbcrrµlcsis: rcsc dctcrticn, trcctmcnt cnd
mcnitcrinc, znd ed. Ceneva, wcrld Fealth 0reanlzatlcn, zoou:61-6ç.
lmprcvinc thc diccncsis cnd trcctmcnt c[ smccr-nccctivc pµlmcncrv cnd cxtrcpµlmc-
ncrv tµbcrrµlcsis cmcnc cdµlts cnd cdclcsrcnts: rcrcmmcndcticns [cr hlv-prcvclcnt
cnd rcscµrrc-rcnstrcincd scttincs. Ceneva, wcrld Fealth 0reanlzatlcn, zoo; (wF0/
FTM/T8/zoo;.¸;¤; wF0/Flv/zoo;.o1).
lntcrncticncl stcndcrds [cr tµbcrrµlcsis rcrc. The Faeue, Tuberculcsls Ccalltlcn fcr
Technlcal Asslstance, zoo6.
Kcppaka k, 8cck h. Fcw rellable ls chest radlceraphy: ln: 1cmcn´s tµbcrrµlcsis: rcsc
dctcrticn, trcctmcnt cnd mcnitcrinc, znd ed. Ceneva, wcrld Fealth 0reanlzatlcn,
zoou:ç1-6o.
Lawn Su et al. lmpact cf Flv lnfectlcn cn the epldemlclcey cf tuberculcsls ln a perl-
urban ccmmunlty ln Scuth Afrlca: the need fcr aee-speclñc lnterventlcns. Clinircl ln[cr-
ticµs 0isccscs, zoo6, uz(;):1ouo-1ou;.
Mase Sk et al. ¥leld cf serlal sputum speclmen examlnatlcns ln the dlaencsls cf pul-
mcnary tuberculcsls: a systemlc revlew. lntcrncticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc
0isccsc, zoo;, 11:u8ç-u¤ç.
Mukadl ¥u et al. lmpact cf Flv lnfectlcn cn the develcpment, cllnlcal presentatlcn,
and cutccme cf tuberculcsls amcne chlldren ln Abld|an, Ccte d'lvclre. Al0S, 1¤¤;,
11(¤):11ç1-11ç8.
hunn P et al. Tuberculcsls ccntrcl ln the era cf Flv. Nctµrc kcvicws lmmµnclccv, zooç,
ç(1o):81¤-8z6.
kcpcrt c[ thc mcctinc c[ thc wh0 Clcbcl 1csk lcrrc cn X0k-18. Ccncvc, Switzcr-
lcnd, ¤-1c 0rtcbcr 2cc6. Ceneva, wcrld Fealth 0reanlzatlcn, zoo; (wF0/FTM/
T8/zoo;.¸;ç).
Saravla lC et al. ketreatment manaeement strateeles when ñrst-llne tuberculcsls thera-
py falls. lntcrncticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zooç, ¤(u):uz1-uz¤.
1cmcn´s tµbcrrµlcsis: rcsc dctcrticn, trcctmcnt, cnd mcnitcrinc, znd ed. Ceneva,
wcrld Fealth 0reanlzatlcn, zoou.
van ueun A. what ls the rcle cf myccbacterlal culture ln dlaencsls and case deñnltlcn:
ln: 1cmcn´s tµbcrrµlcsis: rcsc dctcrticn, trcctmcnt cnd mcnitcrinc, znd ed. Ceneva,
wcrld Fealth 0reanlzatlcn, zoou:¸ç-u¸.
wcrld Fealth 0reanlzatlcn, lnternatlcnal unlcn Aealnst Tuberculcsls and Lune uls-
ease, kcyal hetherlands Tuberculcsls Asscclatlcn. kevlsed lnternatlcnal deñnltlcns ln
tuberculcsls ccntrcl. lntcrncticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zoo1,
ç:z1¸-z1ç.

z Treatment cf
tuberculcsls patlents
z.1 5tandard|zed reg|mens
T
he standardlzed reelmens fcr antl-T8 treatment reccmmended by wF0
lnclude ñve essentlal medlclnes deslenated as "ñrst llne": lscnlazld (F),
rlfamplcln (k), pyrazlnamlde (Z), ethambutcl (F) and streptcmycln (S). Table z.1
shcws the reccmmended dcses fcr adults and chlldren.
Fcr treatment purpcses, patlents are cateecrlzed as prevlcusly untreated (cat-
eecrles l and lll) and prevlcusly treated (cateecrles ll and lv). Tables z.z and
z.¸ further deñne these cateecrles.
wF0 reccmmends the use cf ñxed-dcse ccmblnatlcns (FuCs) cf drues fcr the
treatment cf all T8 patlents. Several advantaees cf FuCs cver lndlvldual medl-
clnes (cr slnele-drue fcrmulatlcns) have been ldentlñed:
º prescrlptlcn errcrs are llkely tc be less frequent;
º fewer tablets need tc be lneested, whlch may enccuraee adherence tc treat-
ment;
1AßL£ z.: kFC0MMFhuFu u0SFS 0F FlkST-LlhF AhTlTu8FkCuL0SlS ukuCS F0k
AuuLTS Ahu CFlLukFh
a
ßrug
kecemmended dese
ßa||y 1hree t|mes week|y
ßese and range
(mg/kg bedy we|ght)
Max|mum
(mg)
ßese and range
(mg/kg bedy we|ght)
ßa||y max|mum
(mg)
lscnlazld ç (u-6) ¸oo 1o (8-1z) -
rlfamplcln 1o (8-1z) 6oo 1o (8-1z) 6oo
pyrazlnamlde zç (zo-¸o) - ¸ç (¸o-uo) -
ethambutcl chlldren zo (1ç-zç)
adults 1ç (1ç-zo)
- ¸o (zç-¸ç) -
streptcmycln 1ç (1z-18) - 1ç (1z-18) -
a
Adapted frcm 1rcctmcnt c[ tµbcrrµlcsis: cµidclincs [cr ncticncl prccrcmmcs, ¸rd ed. Ceneva, wcrld Fealth
0reanlzatlcn, zoo¸ (wF0/CuS/T8/zoo¸.¸1¸).
z6
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
º patlents cannct select whlch medlclnes tc take (when treatment ls nct
cbserved).
Pccr blcavallablllty cf rlfamplcln has been fcund ln scme FuCs. The use cf drue
ccmblnatlcns cf assured quallty (lncludlne prcven blcavallablllty) ls essentlal;
these medlclnes may be cbtalned thrcueh the Clcbal urue Faclllty (CuF).
z.1.1 ChllJren
The reccmmended dally dcse cf ethambutcl ls hleher ln chlldren (zo me/ke)
than ln adults (1ç me/ke) because the pharmaccklnetlcs are dlfferent (peak
serum ethambutcl ccncentratlcns are lcwer ln chlldren than ln adults recelv-
lne the same me/ke dcse). Althcueh ethambutcl was frequently cmltted frcm
reelmens fcr chlldren ln the past, cwlne ln part tc ccncerns abcut the dlfñculty
cf mcnltcrlne fcr tcxlclty (partlcularly fcr cptlc neurltls) ln ycune chlldren, a llt-
erature revlew lndlcates that ethambutcl ls safe ln chlldren at a dcse cf zo me/
ke (ranee 1ç-zç me/ke) dally. Streptcmycln shculd be avclded when pcsslble
ln chlldren because the ln|ectlcns are palnful, and lrreverslble audltcry nerve
damaee may cccur. The use cf streptcmycln ln chlldren ls malnly reserved fcr
the ñrst twc mcnths cf treatment cf T8 menlneltls.
z.1.z hew cases
lcr trcctmcnt c[ ncw rcscs c[ pµlmcncrv cr cxtrcpµlmcncrv 18, wF0 reccm-
mends a standardlzed reelmen ccnslstlne cf twc phases. The lnltlal (lntenslve)
phase uses fcur drues (rlfamplcln, lscnlazld, pyrazlnamlde and ethambutcl)
admlnlstered fcr twc mcnths. Thls ls fcllcwed by a ccntlnuatlcn phase wlth
twc drues (rlfamplcln and lscnlazld) fcr fcur mcnths cr, exceptlcnally, wlth twc
drues (lscnlazld and ethambutcl) fcr slx mcnths when adherence tc treatment
wlth rlfamplcln cannct be ensured (Table z.z).
Pcticnts with c lcrcc bcrillcrv lccd (sputum smear-pcsltlve pulmcnary T8
and many Flv-lnfected patlents wlth smear-neeatlve pulmcnary T8) have an
lncreased rlsk cf selectlne reslstant bacllll. Shcrt-ccurse chemctherapy reel-
mens wlth fcur drues (FkZF) ln the lnltlal phase reduce thls rlsk. Such reelmens
are hlehly effectlve ln patlents wlth susceptlble bacllll. The same fcur-drue
reelmen, lncludlne ethambutcl, shculd be used durlne the lnltlal phase cf treat-
ment fcr patlents wlth smear-pcsltlve pulmcnary, smear-neeatlve pulmcnary
and extrapulmcnary T8.
hlv-nccctivc pcticnts with smccr-nccctivc cr cxtrcpµlmcncrv 18 that ls ful-
ly drue-susceptlble have llttle rlsk cf selectlne reslstant bacllll because thelr
leslcns eenerally harbcur fewer bacllll. Such cases may be treated wlth a three-
drue reelmen (kFZ). Fcwever, elven that lnltlal reslstance tc lscnlazld ls ccm-
mcn ln many settlnes, that recent uST survelllance data may nct be avallable
z)
z. TkFATMFhT 0F Tu8FkCuL0SlS PATlFhTS
and that the Flv status cf many T8 patlents ls unkncwn, thls three-drue reel-
men ls nct reccmmended.
Supervlsed dally admlnlstratlcn cf medlclnes ln the lnltlal phase cf treatment
cf all new cases ls reccmmended. Slnce cutccmes fcr ethambutcl are pccrer
ln thcse wlth Flv lnfectlcn, the preferred cptlcn ls kF rather than FF fcr Flv-
pcsltlve patlents.
The preferred ccntlnuatlcn-phase reelmen ls fcur mcnths cf rlfamplcln and
lscnlazld (ukF) admlnlstered dally cr three tlmes weekly. The maln advantaee
cf thls reelmen ls the lcw rate cf treatment fallure and relapse fcr patlents
wlth fully susceptlble T8 cr T8 wlth lnltlal reslstance tc lscnlazld. The use cf
rlfamplcln requlres measures tc suppcrt patlents tc adhere tc treatment and
tc prevent the develcpment cf rlfamplcln reslstance. ually treatment may be
apprcprlate lf the patlent ls hcspltallzed, cr lf the treatment suppcrter (health
wcrker, nelehbcur, ccmmunlty cr famlly member) ls able tc prcvlde care clcse
1AßL£ z.z kFC0MMFhuFu TkFATMFhT kFClMFhS F0k hFw CASFS 0F Tu8FkCuL0SlS
a
Pat|ent treatment
categery
Pat|ent d|agnest|c
categery
1reatment reg|mens
b
In|t|a| phase Cent|nuat|en phase
l hew smear-pcsltlve patlents, new
smear-neeatlve patlents wlth
extenslve parenchymal lnvclvement,
ccnccmltant Flv-related dlseases cr
severe fcrms cf extrapulmcnary T8
PreIerred
z FkZF
c
PreIerred
u Fk
u (Fk)
¸
0pt|ena|
z FkZF
0pt|ena|
6 FF
0pt|ena|
d
z (FkZF)
¸

0pt|ena|
u (Fk)
¸
lll hew smear-neeatlve pulmcnary T8
(cther than ln Cateecry l) and less
severe fcrms cf extrapulmcnary T8
PreIerred
z FkZF
e
PreIerred
u Fk
u (Fk)
¸
0pt|ena|
z FkZF
0pt|ena|
6 FF
0pt|ena|
z (FkZF)
¸
0pt|ena|
u (Fk)
¸
a
Adapted frcm 1rcctmcnt c[ tµbcrrµlcsis: cµidclincs [cr ncticncl prccrcmmcs, ¸rd ed. Ceneva, wcrld Fealth
0reanlzatlcn, zoo¸ (wF0/CuS/T8/zoo¸.¸1¸).
b
humbers precedlne reelmens lndlcate the leneth cf treatment ln mcnths. Subscrlpt numbers fcllcwlne
reelmens lndlcate the frequency cf admlnlstratlcn per week. when nc subscrlpt numbers are elven, the
reelmen ls dally.
c
Streptcmycln may be used lnstead cf ethambutcl and lt shculd replace ethambutcl ln tuberculcus menln-
eltls.
d
The thrlce weekly treatment was less effectlve than dally treatment, as measured by ccnverslcn rates
at z mcnths, wlth a sueeestlcn cf less favcurable cutccmes cverall; althcueh the dlfference ln cutccme
frcm the 8-mcnth dally reelmen was neellelble (llndanl A, hunn Al, Fnarscn uF. Twc 8-mcnth reelmens cf
chemctherapy fcr treatment cf newly dlaencsed pulmcnary tuberculcsls: lnternatlcnal multl-centre rand-
cmlzed trlal. lcnrct, zoou, ¸6u:1zuu-1zç1.).
e
Fthambutcl ln the lnltlal phase may be cmltted fcr patlents wlth llmlted, ncn-cavltary, smear-neeatlve pul-
mcnary T8 whc are kncwn tc be Flv-neeatlve, patlents wlth less severe fcrms cf extrapulmcnary T8 and
patlents wlth kncwn susceptlble stralns.
z8
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
tc the patlent's hcme. lt ls alsc easler fcr the patlent tc remember tc take the
medlclne (lf a treatment suppcrter ls nct avallable), and the ccnsequence cf a
mlssed dcse ls less detrlmental. Three tlmes weekly therapy clwcvs rcqµircs
dircrt cbscrvcticn and lf taken reeularly, lts effectlveness ls slmllar tc that cf
dally therapy. wF0 dces nct reccmmended a twlce-weekly reelmen.
ln the ccntlnuatlcn phase, a self-admlnlstered reelmen ccmprlslne dally treat-
ment wlth slx mcnths cf lscnlazld and ethambutcl (6FF) ls an cptlcn lf adher-
ence tc treatment wlth lscnlazld and rlfamplcln (Fk) cannct be ensured; fcr
example, ln mcblle pcpulatlcns and fcr patlents wlth very llmlted access tc
health care. Fcwever, ln a ccmparatlve lnternatlcnal multlcentre cllnlcal trlal,
6FF was fcund tc be lnferlcr tc the uFk ccntlnuatlcn phase reelmen, wlth a sle-
nlñcantly hleher unfavcurable cutccme (fallure cr relapse) at 1z mcnths after
the end cf chemctherapy. The prcpcrtlcns wlth unfavcurable cutccmes were
1o% fcr the zFkZF/6FF reelmen (lnltlal and ccntlnuatlcn phases admlnlstered
dally), 1u% fcr z(FkZF)
¸
/6FF (lnltlal phase admlnlstered three tlmes weekly)
and ç% fcr zFkZF/uFk.
Prccncnrv cnd lcrtcticn. 0f the ñrst-llne drues, lscnlazld, rlfamplcln and
ethambutcl may be elven safely durlne preenancy. Streptcmycln may cause
ctctcxlclty ln the fetus and ls ccntralndlcated. Mcst antl-T8 drues appear ln lcw
ccncentratlcns ln breast mllk at levels that dc nct prcduce tcxlclty ln lnfants.
8reastfeedlne ls nct ccntralndlcated.
z.1.y Prevlously treateJ cases
urue reslstance ls mcre llkely tc develcp ln prevlcusly treated patlents (l.e.
patlents whc have been treated fcr lcneer than cne mcnth) whc ccntlnued tc
be cr whc became sputum smear (cr culture) pcsltlve. ldeally, all prevlcusly
treated patlents shculd be assessed fcr drue susceptlblllty befcre lnltlatlne
chemctherapy. Fcwever, ln settlnes where access tc quallty-assured culture
and uST ls llmlted, wF0 reccmmends a standardlzed reelmen fcr prevlcusly
treated cases. Table z.¸ shcws the pcsslble therapeutlc cptlcns fcr prevlcusly
treated patlents (Cateecry ll reelmen).
The standard re-treatment reelmen ccnslsts cf:
º hvc drµcs in thc initicl phcsc (rlfamplcln, lscnlazld, pyrazlnamlde, etham-
butcl and streptcmycln). The lnltlal phase ls admlnlstered fcr three mcnths,
wlth all ñve drues admlnlstered fcr the ñrst twc mcnths. Streptcmycln ls
dlsccntlnued after twc mcnths, and the fcur remalnlne drues are elven ln
the thlrd mcnth. wF0 reccmmends dally admlnlstratlcn cf drues ln the lnltlal
phase;

º thrcc drµcs in thc rcntinµcticn phcsc (rlfamplcln, lscnlazld and ethambutcl).
The ccntlnuatlcn phase ls admlnlstered fcr ñve mcnths, dally cr lntermlt-
tently, three tlmes a week.
Thls standardlzed reelmen can cure patlents excretlne bacllll fully sensltlve cr
reslstant tc lscnlazld and/cr streptcmycln. lt shculd nct be used ln fallures cf
the Cateecry l reelmen, whc have a hleh prcbablllty cf Muk-T8. Thls applles
partlcularly tc patlents whc falled after dlrectly cbserved therapy (u0T) and
where rlfamplcln was lncluded ln the ccntlnuatlcn phase. Patlents whc fall
treatment are at much hleher rlsk cf develcplne antl-T8 drue reslstance. Fcw-
ever, whlle fallure ln a patlent whcse treatment has been dlrectly cbserved may
z. TkFATMFhT 0F Tu8FkCuL0SlS PATlFhTS
1AßL£ z.¶ kFC0MMFhuFu TkFATMFhT kFClMFhS F0k PkFvl0uSL¥ TkFATFu PATlFhTS
(kF-TkFATMFhT kFClMFhS)
a

Pat|ent
d|agnest|c
categery
1ß pat|ent d|agnest|c
categery
1ß treatment reg|mens
In|t|a| phase
Cent|nuat|en phase
ll kelapses
Treatment after default
PreIerred
z FkZFS/1 FkZF
PreIerred
ç FkF
0pt|ena|
z (FkZFS)
¸
/1 (FkZF)
¸
0pt|ena|
ç (FkF)
¸
ll 1reatment Ia||ure eI Categery I
ln scttincs whcrc:
kepresentatlve ukS data shcw lcw
rates cf Muk-T8 cr lndlvlduallzed
uST shcws drue-susceptlble dlsease
er
ln scttincs c[:
º Pccr prceramme perfcrmance;
º Absence cf representatlve ukS data
and/cr capaclty fcr uST cf cases;
º lnsufñclent rescurces tc lmplement
Cateecry lv treatment.
PreIerred
z FkZFS/1 FkZF
PreIerred
ç FkF
0pt|ena|
z (FkZFS)
¸
/1 (FkZF)
¸
0pt|ena|
ç (FkF)
¸
lv 1reatment Ia||ure eI Categery I
ln scttincs with:
º Adequate prceramme perfcrmance;
º kepresentatlve ukS data shcwlne
hleh rates cf Muk-T8 and/cr capaclty
fcr uST cf cases;
º Avallablllty cf znd-llne drues.
Speclally deslened standardlzed
b
cr
lndlvlduallsed reelmens wlth the
use cf znd-llne drues
lv Stlll smear- cr culture-pcsltlve after
supervlsed re-treatment reelmen);
prcven cr suspected Muk-T8 cases
c
Speclally deslened standardlzed cr
lndlvlduallsed reelmens wlth the
use cf znd-llne drues
ukS = drue reslstance survelllance; uST = drue susceptlblllty testlne; Muk-T8 = multldrue-reslstant tuber-
culcsls
a
Adapted frcm 1rcctmcnt c[ tµbcrrµlcsis: cµidclincs [cr ncticncl prccrcmmcs, ¸rd ed. Ceneva, wcrld Fealth
0reanlzatlcn, zoo¸ (wF0/CuS/T8/zoo¸.¸1¸).
b
lt ls reccmmended that standardlzed reelmens are based cn representatlve ukS data frcm patlent cateec-
rles cr ercups.
c
urue susceptlblllty testlne ls reccmmended fcr patlents whc are ccntacts cf kncwn Muk-T8 cases.
¶e
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
be attrlbutable tc an lnltlal reslstance tc the drues, fallure ln sltuatlcns where
treatment has nct been dlrectly cbserved may be the result cf pccr treatment
adherence, chactlc treatment cr lnsufñclent drue dcsaees.
The Cateecry ll standardlzed reelmen has pccr results ln Muk-T8 cases (less
than ço% cure rate) and may result ln the acqulsltlcn cf addltlcnal reslstance
tc thcse drues that were stlll effectlve at the start cf treatment (e.e. F and/cr
Z). Ccuntrles wlth a hleh prcpcrtlcn cf Muk-T8 amcne fallures cf the Cateecry
l reelmen shculd ccnslder treatlne such cases wlth a reelmen ccnslstlne cf
seccnd-llne drues (see Chapter 11).
Streptcmycln shculd be admlnlstered by ln|ectlcn uslne dlspcsable (slnele use)
cr sterlle (reusable) needles and syrlnees. lt shculd nct be used ln settlnes
where the use cf dlspcsable cr sterlle needles and syrlnees ls nct assured. The
use cf lnadequately sterlllzed reusable syrlnees and needles carrles a rlsk cf
transmlsslcn cf Flv and cther blccdbcrne pathceens.
Adverse eIIects eI ant|-1ß drugs
A mlncrlty cf T8 patlents (o.;-1u%) treated wlth Cateecry l cr Cateecry ll reel-
mens experlence adverse effects. These lnclude:
º ma|cr adverse effects elvlne rlse tc serlcus health hazards and requlrlne
dlsccntlnuatlcn cf antl-T8 treatment;
º mlncr slde-effects causlne relatlvely llttle dlsccmfcrt and cften respcndlne
tc symptcmatlc cr slmple treatment; they may cccaslcnally perslst fcr the
duratlcn cf antl-T8 treatment.
uetalls cn the mcst lmpcrtant and frequent slde-effects are prcvlded ln 1rcct-
mcnt c[ tµbcrrµlcsis: cµidclincs [cr ncticncl prccrcmmcs.
lnadequate manaeement cf adverse effects ls llkely tc ccntrlbute tc lrreeular
treatment and default. The hTP shculd lmplement a pharmaccvlellance system.
z.z 1reatment eI drug-res|stant tubercu|es|s
Patlents ln whcm drue-reslstant T8 ls dlaencsed and whc requlre treatment
wlth seccnd-llne drues are classlñed as wF0 T8 dlaencstlc Cateecry lv and
requlre reelmens termed "Cateecry lv reelmens". Thls sectlcn prcvldes euld-
ance cn the strateey cptlcns, lncludlne standardlzed, emplrlcal and lndlvldual-
lzed apprcaches, fcr treatlne drue-reslstant T8. A descrlptlcn cf drues, dcses
and ccdlne cf treatment reelmens ls prcvlded ln Cµidclincs [cr thc prccrcm-
mctir mcncccmcnt c[ drµc-rcsistcnt tµbcrrµlcsis.
Xuk-T8 ls a subset cf Muk-T8 that shcws addltlcnal reslstance tc seccnd-llne
drues. Patlents wlth Muk-T8 requlre speclal attentlcn tc avcld the develcpment
¶1
cf Xuk-T8, and thcse whc have Xuk-T8 requlre rlecrcus treatment, wlth the
frequent addltlcn cf thlrd-llne aeents (Cateecry v drues). Avallable evldence cn
Xuk-T8 and lts treatment ls llmlted, but experlence ln scme well-ccntrclled set-
tlnes shcws slenlñcantly lcwer treatment success rates ccmpared wlth thcse
fcr Muk-T8 cases.
z.z.1 Treatment strateçles
Strateeles fcr treatment shculd be develcped cn the basls cf prevlcus assess-
ment cf bcth the drue reslstance survey data and the frequency cf use cf
antl-T8 drues ln the ccuntry. A prceramme that plans tc lntrcduce a treat-
ment strateey fcr drue-reslstant T8 shculd be famlllar wlth the prevalence cf
drue reslstance ln new patlents as well as ln dlfferent ercups cf re-treatment
cases (fallures, relapse, return after default and chrcnlc cases). lt ls essentlal
tc determlne whlch seccnd-llne antl-T8 drues have been used, and wlth what
frequency, ln the settlne served by the prceramme, as well as the use by bcth
prlvate and publlc prcvlders. Seccnd-llne antl-T8 drues that have been used
cnly rarely are llkely tc be effectlve ln reelmens fcr drue-reslstant T8. Seccnd-
llne drues that have been used extenslvely are less llkely tc be effectlve ln
patlents wlth reslstant stralns.
Scme prcerammes may need tc deslen strateeles based cn llmlted data cnly,
as treatment fcr many patlents shculd nct be delayed untll the full essentlal
assessment lnfcrmatlcn beccmes avallable. ln such cases, the prceramme can
stlll fcllcw the baslc prlnclples fcr deslenlne an effectlve reelmen and ccntlnue
tc ccllect the lnfcrmatlcn descrlbed ln thls sectlcn.
The dlfferent cptlcns fcr treatment strateeles lnclude standardlzed treatment,
emplrlcal treatment and lndlvlduallzed treatment. hc treatment strateey can
ñt all sltuatlcns, and the chclce between these strateeles wlll depend cn many
factcrs, lncludlne the cperatlcnal ccntext and labcratcry capaclty.
z.z.z Reçlmen Jeslçn
The fcllcwlne baslc prlnclples are lnvclved ln reelmen deslen.
º keelmens shculd be based cn the hlstcry cf medlclnes taken by the patlent.
º urues ccmmcnly used ln the ccuntry and prevalence cf reslstance tc ñrst-
llne and seccnd-llne drues shculd be taken lntc ccnslderatlcn when deslen-
lne a reelmen.
º keelmens shculd ccnslst cf at least fcur drues wlth elther certaln cr hlehly
prcbable effectlveness. ln the case cf unclear evldence abcut lts effectlve-
ness, a drue can be part cf the reelmen but lt shculd nct be depended upcn
fcr success. Mcre than fcur drues may be started lf the susceptlblllty pattern
z. TkFATMFhT 0F Tu8FkCuL0SlS PATlFhTS
¶z
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
ls unkncwn, lf effectlveness ls questlcnable fcr cne cr several aeents cr lf
extenslve, bllateral pulmcnary dlsease ls present.
º urues are admlnlstered at least slx days per week. when pcsslble, pyrazl-
namlde, ethambutcl and fucrcqulnclcnes shculd be elven cnce per day
because the hleh peaks attalned ln cnce-a-day dcslne may be mcre efñca-
clcus. 0nce-a-day dcslne ls permlsslble fcr cther seccnd-llne drues, depend-
lne cn patlent tclerance. Fcwever ethlcnamlde/prctlcnamlde, cyclcserlne
and P-amlncsallcyllc acld have tradltlcnally been elven ln dlvlded dcses
durlne the day.
º The drue dcsaee shculd be determlned by bcdy weleht. A sueeested weleht-
based dcslne scheme ls shcwn ln Table z.1.
º An ln|ectable aeent (an amlncelyccslde cr caprecmycln) ls used fcr a mlnl-
mum cf slx mcnths cr fcr fcur mcnths after culture ccnverslcn, whlchever ls
lcneer.
º Fach dcse ls elven as u0T thrcuehcut the treatment, and a treatment card
ls marked fcr each cbserved dcse.
º uST, when avallable and frcm a rellable labcratcry, shculd be used tc eulde
therapy. Fcwever, the quallty and ccmparablllty cf results ln uST cf scme
ñrst-llne and mcst cf the seccnd-llne antl-T8 drues have nct been fully
assessed, and uST dces nct predlct the effectlveness cf a drue wlth ccm-
plete certalnty. uesplte these llmltatlcns, reelmens shculd lnclude at least
fcur drues hlehly llkely tc be effectlve based cn uST and/cr drue hlstcry cf
the patlent.
º Pyrazlnamlde may be used fcr the entlre treatment lf lt ls |udeed tc be effec-
tlve. Many Muk-T8 patlents have chrcnlcally lnfamed lunes, whlch (thecretl-
cally) prcduce the acldlc envlrcnment ln whlch pyrazlnamlde ls actlve.
z.z.y 0uratlon oj treatment
The reccmmended duratlcn cf treatment ls eulded by smear and culture ccn-
verslcn. The mlnlmal reccmmendatlcn ls that treatment lasts fcr at least 18
mcnths after culture ccnverslcn; extenslcn tc zu mcnths may be lndlcated ln
chrcnlc cases wlth extenslve pulmcnary damaee.
Treatment cf drue-reslstant T8 ls a ccmplex health lnterventlcn, and nc slnele
strateey wlll ñt all sltuatlcns. Prceramme manaeers need tc ccnslder the epl-
demlclcelcal, ñnanclal and cperatlcnal factcrs when decldlne whlch strateey
tc use.
¶¶
z.¶ 1reatment eI tubercu|es|s |n hIv-|nIected pat|ents
Fcr Flv-lnfected patlents wlth actlve T8 dlsease, the ñrst prlcrlty ls tc lnltl-
ate standardlzed antl-T8 treatment. The cptlmal tlme fcr startlne AkT ln these
cases ls nct kncwn and the declslcn ls based cn rlsk-beneñt ccnslderatlcns.
The prlnclples cf antl-T8 treatment are the same lrrespectlve cf Flv status.
Althcueh ethambutcl and lscnlazld are lncluded ln reccmmendatlcns fcr the
ccntlnuatlcn phase, shcrt-ccurse reelmens that ccntaln rlfamplcln thrcuehcut
have better cutccme, and reduce the rlsk cf T8 recurrence.
The use cf thlcacetazcne ls contralnJlcateJ ln Flv-lnfected lndlvlduals because
cf the rlsk cf fatal hypersensltlvlty reactlcns and ls dlsccuraeed by wF0
because cf the rlsk cf severe tcxlclty. Fthambutcl shculd replace thlcaceta-
zcne, especlally ln areas where Flv ls prevalent.
z.y.1 0utcomes oj antl-T8 treatment
wlthcut adequate treatment, T8 ln Flv-pcsltlve patlents ls rapldly fatal, usu-
ally wlthln mcnths. Amcne treated T8 patlents, death rates are hleher ln Flv-
pcsltlve than ln Flv-neeatlve patlents (ln scme settlnes up tc cne thlrd cf thcse
treated). Case fatallty ls hleher ln Flv-pcsltlve patlents wlth smear-neeatlve
pulmcnary T8, as these patlents are eenerally mcre lmmuncsuppressed than
thcse wlth smear-pcsltlve T8. The rlsk cf T8 recurrence ls ereater ln Flv-pcs-
ltlve T8 patlents than ln thcse whc are Flv-neeatlve. The case-fatallty rate ls
reduced ln patlents treated wlth rlfamplcln thrcuehcut and whc recelve ccncur-
rent treatment aealnst Flv, lncludlne wlth cc-trlmcxazcle preventlve therapy
(CPT) and AkT.
z.y.z hIv testlnç, treatment anJ care oj T8 patlents
Tuberculcsls ls cften the ñrst cllnlcal lndlcatlcn that scmecne has underlylne
Flv lnfectlcn, and lt ls therefcre lmpcrtant tc cffer all T8 patlents an Flv test.
As such, T8 prcerammes can be an extremely lmpcrtant entry pclnt tc Flv care
and treatment, lncludlne CPT, and cften AkT.
z.y.y Provlslon oj co-trlmoxazole preventlve therapy
Admlnlsterlne prcphylactlc cc-trlmcxazcle may prevent Pncµmcrvstis jircvcrii
and bacterlal lnfectlcns ln Flv-pcsltlve T8 patlents. CPT substantlally reduces
mcrtallty ln Flv-pcsltlve T8 patlents (by up tc u8% ln the wF0 Afrlcan keelcn).
Fcr T8 patlents, CPT shculd be lnltlated as sccn as pcsslble, lrrespectlve cf
the Cuu cell ccunt, and elven thrcuehcut antl-T8 treatment; ccntlnuatlcn after
treatment ls ccmpleted shculd be ccnsldered ln acccrdance wlth natlcnal eulde-
llnes. T8 and Flv ccntrcl prcerammes shculd establlsh a system fcr prcvlslcn
cf CPT tc ellelble PLFlv whc have actlve T8.
z. TkFATMFhT 0F Tu8FkCuL0SlS PATlFhTS
¶q
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
1AßL£ z.o lhlTlATlhC FlkST-LlhF AhTlkFTk0vlkAL TFFkAP¥ lh kFLATl0h T0 STAkTlhC
AhTl-T8 TkFATMFhT
a
Cßq ce|| ceunt Ak1 recemmendat|ens 1|m|ng eI Ak1 |n re|at|en te the start eI
ant|-1ß treatment
Cuu ·zoo cells/mm
¸
keccmmend AkT
b
8etween z and 8 weeks
c
Cuu zoo-¸ço cells/mm
¸
keccmmend AkT After 8 weeks
Cuu ·¸ço cells/mm
¸
uefer AkT
d
ke-evaluate patlent at 8 weeks and
at the end cf antl-T8 treatment
Cuu nct avallable keccmmend AkT
e
8etween z and 8 weeks
a
Adapted frcm Antirctrcvircl thcrcpv [cr hlv in[crticn in cdµlts cnd cdclcsrcnts. kcrcmmcndcticns [cr c
pµblir hcclth cpprccrh, 6th revlslcn. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6.
b
A reelmen ccntalnlne efavlrenz ls the preferred ñrst-llne reelmen; alternatlve reelmens lnclude nevlraplne
(hvP) and trlple nuclecslde reverse transcrlptase lnhlbltcrs based cn reelmens uslne tencfcvlr dlscprcxll
fumarate cr abacavlr. Fcr hvP-ccntalnlne reelmens, alanlne amlnctransferase shculd be checked at u, 8
and 1z weeks, and dlrected by symptcms thereafter.
c
Start AkT as sccn as antl-T8 treatment ls tclerated.
d
lf cther ncn-T8 staee ¸ cr u events are present, start AkT.
e
Fcr scme T8 dlaencses that eenerally respcnd well tc antl-T8 treatment (l.e. T8 cf the lymph ncdes, un-
ccmpllcated pleural effuslcn), ccnslder deferrlne AkT.
z.y.q Provlslon oj antlretrovlral therapy
ln thls rapldly evclvlne ñeld, updated lnfcrmatlcn and euldance ls prcvlded by
wF0.
1
AkT ls reccmmended fcr all Flv-pcsltlve patlents wlth extrapulmcnary T8 (Staee
u) and fcr all thcse wlth pulmcnary T8 (Staee ¸) unless the Cuu cell ccunt
exceeds ¸ço cells/mm
¸
. AkT reduces bcth case-fatallty rates and the lncldence
cf T8 and recurrent T8. lf measurement cf the Cuu cell ccunt ls nct pcsslble,
AkT shculd be lnltlated fcr staees ¸ and u cnce the patlent has stablllzed cn
antl-T8 treatment, eenerally after z-8 weeks cf treatment.
The cptlmal tlme tc start AkT ls nct clear-cut. Farly lnltlatlcn cf AkT wlthln a
few weeks cf startlne antl-T8 treatment ls asscclated wlth a hleh burden cf
tablets tc lneest, whlch may dlsccuraee treatment adherence, and may be
ccmpllcated by adverse effects, drue-drue lnteractlcns and lmmune reccnstl-
tutlcn lnfammatcry syndrcme (lklS). Fcwever, slnce much cf the case fatallty
ln Flv-pcsltlve T8 patlents cccurs ln the ñrst twc mcnths cf antl-T8 treatment,
delayed lnltlatlcn cf AkT may reduce lts pctentlal beneñts.
Selectlcn cf drues
º klfamplcln-ccntalnlne reelmens are reccmmended fcr treatment cf T8 ln
Flv-lnfected patlents. Fcwever, rlfamplcln lnduces the actlvlty cf hepatlc
cytcchrcme Puço, leadlne tc subtherapeutlc ccncentratlcns cf scme antlret-
rcvlral drues.
1
http://www.whc.lnt/Flv
¶¶
º Ffavlrenz-ccntalnlne reelmens are the reccmmended ñrst-llne AkT reelmens
fcr T8 patlents, slnce lnteractlcns wlth antl-T8 drues are mlnlmal. Ffavlrenz
ls pctentlally teratceenlc and ls contralnJlcateJ fcr wcmen cf chlldbearlne
pctentlal wlthcut adequate ccntraceptlcn cr fcr thcse whc are ln the ñrst
trlmester cf preenancy.
º hevlraplne ls an alternatlve tc efavlrenz, but ln ccmblnatlcn wlth rlfamplcln
pcses an lncreased rlsk cf hepatctcxlclty. lf used, cllnlcal and labcratcry
mcnltcrlne are reccmmended. The use cf trlple nuclecslde antlretrcvlral
reelmens ls emerelne as an addltlcnal alternatlve.
º when rlfabutln ls used ln place cf rlfamplcln, prctease lnhlbltcr-ccntalnlne
reelmens may be admlnlstered wlth rlfabutln dcse ad|ustment. Fcwever,
rlfabutln may nct be avallable cr accesslble, and lt ls ccstly.
z.y.¢ Tuberculosls ln patlents alreaJy recelvlnç antlretrovlral therapy
Patlents ln whcm T8 ls dlaencsed whlle recelvlne AkT shculd start antl-T8
treatment lmmedlately tc assess whether the develcpment cf actlve T8 refects
a fallure cf AkT that wculd requlre chanelne the AkT reelmen. Ad|ustments cf
AkT may be needed fcr patlents whc develcp actlve T8 wlthln slx mcnths cf
the start cf ñrst-llne cr seccnd-llne AkT.
within six mcnths c[ initictinc Ak1. lf an eplscde cf T8 cccurs durlne the ñrst
slx mcnths fcllcwlne the lnltlatlcn cf AkT, thls shculd nct be ccnsldered a treat-
ment fallure event, and the AkT reelmen shculd be ad|usted fcr cc-admlnlstra-
tlcn wlth rlfamplcln-ccntalnlne reelmens.
A[tcr six mcnths c[ initictinc Ak1. The develcpment cf an eplscde cf pulmcnary
T8 after slx mcnths cf AkT, wlthcut cther cllnlcal and lmmunclcelcal evldence
cf Flv dlsease prceresslcn, shculd nct be reearded as representlne AkT fall-
ure. lf cther cllnlcal and lmmunclcelcal evldence cf Flv dlsease prceresslcn ls
present, the eplscde cf pulmcnary dlsease shculd be reearded as representlne
an eplscde cf AkT fallure. The develcpment cf extrapulmcnary T8 (after slx
mcnths) shculd alsc be ccnsldered as lndlcatlne AkT fallure.
z.y.6 Immune reconstltutlon lnµammatory synJrome
lmmune reccnstltutlcn lnfammatcry syndrcme (lklS) ls a tempcrary exacer-
batlcn cf symptcms and/cr radlceraphlc slens cf T8 cccurrlne sccn after the
start cf treatment wlth AkT and antl-T8 drues. The syndrcme mcst ccmmcnly
presents wlth fever and wcrsenlne cf pre-exlstlne resplratcry dlsease cr lym-
phadencpathy after lnltlal lmprcvement cn antl-T8 treatment ln patlents whc
have started cn AkT ln the past three mcnths, althcueh lt may cccur wlthln ñve
days. lt ls slmllar tc, but mcre frequent than, the paradcxlcal reactlcns seen ln
lmmuncccmpetent patlents cn antl-T8 therapy.
z. TkFATMFhT 0F Tu8FkCuL0SlS PATlFhTS
¶6
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
lklS appears tc be mcre ccmmcn lf AkT ls started early ln the ccurse cf antl-
T8 treatment. The dlaencsls ls cllnlcal and the dlfferentlal dlaencsls lncludes
adverse effects cf AkT, fallure cf T8 treatment caused by drue reslstance cr
pccr adherence, fallure cf AkT, cr cther underlylne lnfectlcn. Mcst cases resclve
wlthcut any lnterventlcn, and AkT may be safely ccntlnued. 0ccaslcnally, serl-
cus reactlcns such as tracheal ccmpresslcn caused by masslve adencpathy cr
resplratcry dlfñculty may requlre the use cf ccrtlccsterclds.
T8-related lklS may present as cne cf twc maln syndrcmes: (l) a paradcxlcal
reactlcn after the start cf AkT ln patlents recelvlne treatment fcr T8 ("paradcxl-
cal T8-lklS"); cr (ll) an exaeeerated new presentatlcn cf T8 that ls "unmasked"
ln the weeks fcllcwlne lnltlatlcn cf AkT.
z.q 1reatment suppert
Fcr antl-T8 therapy tc be effectlve, apprcprlate drues shculd be used ln apprc-
prlate dcses and lneested ccrrectly fcr the apprcprlate leneth cf tlme. Adher-
ence tc treatment ls therefcre cruclal tc ccmpletlne treatment and achlevlne
cure. Servlces prcvldlne T8 care shculd cffer full suppcrt tc patlents tc ensure
that treatment wlll be ccmpleted.
Staff whc prcvlde T8 care shculd ldentlfy and address factcrs that may make
patlents lnterrupt cr stcp treatment. Supervlsed treatment asslsts patlents ln
taklne thelr drues reeularly and ln ccmpletlne thelr treatment, thus helplne tc
achleve cure, prevent the develcpment cf drue reslstance and, by reduclne dls-
ease transmlsslcn, prctect the eeneral publlc frcm T8. Supervlslcn cf treatment
ls meant tc ensure adherence cn the part cf bcth the prcvlders (ln elvlne prcper
care and detectlne treatment lnterruptlcn) and the patlents (ln taklne reeular
treatment). lt shculd be carrled cut ln a ccntext-speclñc and patlent-frlendly
manner. uependlne cn the lccal ccndltlcns, supervlslcn may be undertaken at
a health faclllty, ln the wcrkplace, ln the ccmmunlty cr at hcme. The treatment
suppcrter shculd be a perscn acceptable tc and chcsen wlth the patlent, and
tralned and supervlsed by the health servlces. Patlent and peer suppcrt ercups
may help tc prcmcte adherence tc treatment.
The lmpcrtance and the frequency cf supervlslcn may vary, dependlne upcn
factcrs such as the type cf drue reelmen (dally cr lntermlttent), the type cf
drue fcrmulatlcn (FuCs cr lndlvldual drues) as well as the characterlstlcs cf the
patlent. Actual cbservatlcn cf the lneestlcn cf each dcse ls lndlspensable ln
the treatment cf, fcr example, psychclcelcally handlcapped patlents, alcchcl
abusers, prlscn lnmates, cr patlents recelvlne seccnd-llne antl-T8 drues. lt ls
the splrlt cf suppcrtlne a patlent that the euaranteed lntake cf the full ccurse
cf treatment and ensured cure are mcre lmpcrtant than the act cf cbservlne the
patlent swallcwlne the medlcatlcn.
¶)
The whcle purpcse cf undertaklne treatment cbservatlcn wculd be lcst lf lt
were tc llmlt access tc care, turn patlents away frcm treatment cr add tc thelr
hardshlps. 8ecause T8 ls a publlc health prcblem and lts transmlsslcn pcses a
rlsk tc the ccmmunlty, facllltatlne and ensurlne reeular lntake cf all the drues
by the patlent ls a respcnslblllty cf the health staff and cf the hTP. Many hTPs
ncw have ccnslderable experlence ln ldentlfylne adherence prcmctlcn strate-
eles that wcrk cr dc nct wcrk ln a elven ccntext. T8 prcerammes shculd ccn-
tlnue tc strenethen patlent supervlslcn and suppcrt wlth the ecal cf achlevlne
1oo% treatment adherence rates.
Measures tc facllltate patlent adherence wlth reeular and ccmplete treatment
mleht lnvclve:
º a reeular supply cf drues prcvlded free cf charee by the health system, pref-
erably ln FuCs, ensurlne lntake cf all drues;
º presentatlcn cf drues ln patlent klts, tc ensure that drues fcr the full ccurse
cf treatment are reserved fcr the patlent at the cutset cf treatment;
º prcvlslcn cf care ln a settlne clcse tc the patlent's hcme, ln crder tc reduce
travel ccsts and lcss cf tlme and waees;
º apprcprlate patlent educatlcn, lncludlne lnfcrmatlcn reeardlne the reelmen,
duratlcn and pcsslble treatment cutccmes, prcvlded repeatedly by well-
tralned and ccnslderate staff;
º prcvlslcn cr ñnanclne cf transpcrt and lncentlves such as fccd cr hyelenlc
packaees fcr patlents and thelr famllles, lf apprcprlate fcr the ccntext and
patlent prcñle.
Fcspltallzatlcn ls essentlal fcr patlents ln a severe cllnlcal ccndltlcn, wlth ccm-
pllcatlcns cr asscclatlcns requlrlne clcser cllnlcal mcnltcrlne. lt mleht alsc
be an alternatlve, especlally durlne the lnltlal phase cf treatment, fcr a small
number cf patlents fcr whcm cther cptlcns cf ensurlne treatment adherence
and suppcrt are nct avallable. Fcwever, hcspltallzatlcn per se dces nct ensure
reeular drue lntake cr ccmpletlcn cf the treatment.
Wh0 gu|de||nes
Cµidcnrc [cr ncticncl tµbcrrµlcsis prccrcmmcs cn thc mcncccmcnt c[ tµbcrrµlcsis in
rhildrcn. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6 (wF0/FTM/T8/zoo6.¸;1; wF0/FCF/
CAF/zoo6.;).
Cµidclincs [cr thc prccrcmmctir mcncccmcnt c[ drµc-rcsistcnt tµbcrrµlcsis. Ceneva,
wcrld Fealth 0reanlzatlcn, zoo6 (wF0/FTM/T8/zoo6.¸61).
Cµidclincs cn rc-trimcxczclc prcphvlcxis [cr hlv-rclctcd in[crticns cmcnc rhildrcn,
cdclcsrcnts cnd cdµlts: rcrcmmcndcticns [cr c pµblir hcclth cpprccrh. Ceneva, wcrld
Fealth 0reanlzatlcn, zoo6.
z. TkFATMFhT 0F Tu8FkCuL0SlS PATlFhTS
¶8
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
Srclinc µp cntirctrcvircl thcrcpv in rcscµrrc-limitcd scttincs. updctcd cµidclincs [cr c
pµblir hcclth cpprccrh. zoo6 revlslcn. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6.
1rcctmcnt c[ tµbcrrµlcsis: cµidclincs [cr ncticncl prccrcmmcs, ¸rd ed. Ceneva, wcrld
Fealth 0reanlzatlcn, zoo¸ (wF0/CuS/T8/zoo¸.¸1¸).
key reIerences
Adhcrcnrc tc lcnc-tcrm thcrcpics: cvidcnrc [cr crticn. Ceneva, wcrld Fealth 0reanlza-
tlcn, zoo¸.
Amerlcan Thcraclc Scclety/Centers fcr ulsease Ccntrcl and Preventlcn/lnfectlcus uls-
eases Scclety cf Amerlca. Treatment cf tuberculcsls. Amcrircn lcµrncl c[ kcspirctcrv
cnd Critircl Ccrc Mcdirinc, zoo¸, 16;(u):6o¸-66z.
8adrl M et al. Fffect cf hlehly actlve antlretrcvlral therapy cn lncldence cf tuberculcsls
ln Scuth Afrlca: a cchcrt study. lcnrct, zooz, ¸ç¤(¤¸z¸):zoç¤-zo6u.
8elth A, Flchler k, well u. Pcr[crmcnrc-bcscd inrcntivcs [cr hcclth: c wcv tc imprcvc
tµbcrrµlcsis dctcrticn cnd trcctmcnt rcmplcticn: Center fcr Clcbal uevelcpment
(CCu), Aprll zoo; (CCu wcrklne paper number 1zz; avallable at: http://www.cedev.cre./
ñles/1¸çuu_ñle_T8_ñnal.pdf ).
8lcmbere 8 et al. The ratlcnale fcr reccmmendlne ñxed-dcse ccmblnatlcn tablets fcr
treatment cf tuberculcsls. 8µllctin c[ thc wcrld hcclth 0rccnizcticn, zoo1, ;¤(1):61-68.
8rltlsh Thcraclc and Tuberculcsls Asscclatlcn. Shcrt-ccurse chemctherapy ln pulmc-
nary tuberculcsls: a ccntrclled trlal by the 8rltlsh Thcraclc and Tuberculcsls Assccla-
tlcn. lcnrct, 1¤;6, ¸:11oz-11ou.
8rltlsh Thcraclc Asscclatlcn. A ccntrclled trlal cf 6 mcnths chemctherapy ln pulmcnary
tuberculcsls: seccnd repcrt-results durlne the zu mcnths after the end cf chemcthera-
py. Amcrircn kcvicw c[ kcspirctcrv 0isccsc, 1¤8z, 1z6:u6o-u6z.
Chalcc K et al. hurses as prcvlders cf emctlcnal suppcrt tc patlents wlth Muk-T8. lntcr-
ncticncl Nµrsinc kcvicw, ç¸:zç¸-z6o.
Fast Afrlca/8rltlsh Medlcal kesearch Ccuncll. Ccntrclled cllnlcal trlal cf ñve shcrt-ccurse
(u mcnth) chemctherapy reelmens ln pulmcnary tuberculcsls: seccnd repcrt cf the uth
study. Amcrircn kcvicw c[ kcspirctcrv 0isccsc, 1¤81, 1z¸:16ç-1;o.
lixcd-dcsc rcmbincticn c[ tcblcts [cr thc trcctmcnt c[ tµbcrrµlcsis. Ceneva, wcrld
Fealth 0reanlzatlcn, 1¤¤¤ (wF0/CuS/CPC/T8/¤¤.z6;).
Clrardl F et al. lmpact cf ccmblnatlcn antlretrcvlral therapy cn the rlsk cf tuberculcsls
amcne perscns wlth Flv lnfectlcn. Al0S, zooo, 1u(1¸):1¤8ç-1¤¤1.
lntcrim pclirv cn rcllcbcrctivc 18/hlv crtivitics. Ceneva, wcrld Fealth 0reanlzatlcn,
zoou (wF0/FTM/T8/zoou.¸¸o).
lntcrncticncl stcndcrds [cr tµbcrrµlcsis rcrc. The Faeue, Tuberculcsls Ccalltlcn fcr
Technlcal Asslstance, zoo6.
lakubcwlak wM et al. Scclal suppcrt and lncentlves prceramme fcr patlents wlth tuber-
culcsls: experlence frcm the kusslan Federatlcn. lntcrncticncl lcµrncl c[ 1µbcrrµlcsis
cnd lµnc 0isccsc, zoo;, 11:1z1o-1z1ç.
¶¤
z. TkFATMFhT 0F Tu8FkCuL0SlS PATlFhTS
llndanl A, hunn Al, Fnarscn uF. Twc 8-mcnth reelmens cf chemctherapy fcr treatment
cf newly dlaencsed pulmcnary tuberculcsls: lnternatlcnal multl-centre randcmlzed
trlal. lcnrct, zoou, ¸6u:1zuu-1zç1.
Klm Sl. urue susceptlblllty testlne ln tuberculcsls: methcds and rellablllty cf results
Fµrcpccn kcspirctcrv lcµrncl, zooç, zç:ç6u-ç6¤.
Lawn Su et al. 8urden cf tuberculcsls ln an antlretrcvlral treatment prceramme ln
sub-Saharan Afrlca: lmpact cn treatment cutccmes and lmpllcatlcns fcr tuberculcsls
ccntrcl. Al0S, zoo6, zo(1z):16oç-161z.
Lawn et al. Tuberculcsls amcne Flv-lnfected patlents recelvlne FAAkT: lcne term lncl-
dence and rlsk factcrs ln a Scuth Afrlcan cchcrt. Al0S, zooç, 1¤(18):z1o¤-z116.
Lelmane v et al. Cllnlcal cutccme cf lndlvlduallsed treatment cf multl-drue reslstant
tuberculcsls ln Latvla: a retrcspectlve cchcrt study. lcnrct, zooç, ¸6ç:¸18-¸z6.
hathanscn F et al. Multldrue-reslstant tuberculcsls can be successfully treated ln
rescurce-llmlted settlnes. Fmcrcinc ln[crticµs 0isccscs, zoo6, 1z(¤):1¸8¤-1¸¤;.
Shln SS et al. Treatment cutccmes ln an lnteerated clvlllan and prlscn Muk-T8 treat-
ment prceram ln kussla. lntcrncticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zoo6,
1o(u):uoz-uo8.
Slneapcre Tuberculcsls Servlce/8rltlsh Medlcal kesearch Ccuncll. Lcne-term fcllcw-
up cf a cllnlcal trlal cf 6-mcnth and u-mcnth reelmens cf chemctherapy ln the treat-
ment cf pulmcnary tuberculcsls. Amcrircn kcvicw c[ kcspirctcrv 0isccsc, 1¤86,
1¸¸:;;¤-;8¸.
wF0/luATLu Clcbal Prc|ect cn Antl-tuberculcsls urue keslstance Survelllance. Anti-
tµbcrrµlcsis drµc rcsistcnrc in thc wcrld. kepcrt hc. ¸. Ceneva, wcrld Fealth 0reanlza-
tlcn, zoou (wF0/FTM/T8/zoou.¸u¸).
qe
¸ keccrdlne and repcrtlne
C
ccd reccrdlne practlces are necessary fcr effectlve patlent manaeement.
Assessment cf prceramme perfcrmance and epldemlclcelcal trends prcvl-
des the basls fcr prcerammatlc and pcllcy develcpment. Fffectlve mcnltcrlne
depends cn apprcprlate reccrdlne and repcrtlne systems. These systems are
essentlal tc ensure hleh-quallty T8 patlent care and lnfcrmatlcn-sharlne.
As systems beccmes lncreaslnely ccmplex and ccmputers beccme part cf stan-
dard health faclllty equlpment, hTPs are adcptlne electrcnlc T8 reelstratlcn,
whlch has the pctentlal tc ensure mcre ccmprehenslve data entry, facllltate
ccmmunlcatlcn and transmlsslcn cf data tc cther levels cf the health system,
and prcvlde a mcre reñned analysls cf prceramme perfcrmance. (Fcwever, the
electrcnlc system ls cnly as eccd as the data themselves and the accuracy cf
data that are manually entered.) Flectrcnlc reccrdlne and repcrtlne fcllcws the
same prlnclple and fcrmat as the paper-based reccrdlne and repcrtlne sys-
tem. A prcper electrcnlc system shculd prcvlde a reeular prlnt-cut cf quarterly
repcrts and reelsters tc facllltate data analysls and data verlñcatlcn.
¶.1 kecerd|ng and repert|ng system
The wF0 T8 reccrdlne and repcrtlne system
1
ls part cf the eeneral health lnfcr-
matlcn system (8cx ¸.1). lt ccnslsts cf detalled patlent fcrms that are ñlled cut
at the pclnt cf care and summarlzed ln labcratcry and medlcal reelsters. These
data are aeereeated tc prepare quarterly repcrts cn actlvltles and results as
well as annual manaeement repcrts at the baslc manaeement unlt (8Mu), usua-
lly the dlstrlct level, and then sent tc the central level. The reccrdlne (patlent
reelstratlcn) and repcrtlne system ls used tc systematlcally evaluate patlent
prceress and treatment cutccmes, as well as tc mcnltcr cverall prceramme
perfcrmance (thrcueh cchcrt analysls).
y.1.1 RecorJlnç system
The reccrdlne system (patlent reelstratlcn) ccmprlses: (l) labcratcry reelsters,
whlch reccrd all symptcmatlc patlents whc have had a sputum smear examlna-
1
http://www.whc.lnt/tb/dcts/r_and_r_fcrms/en/lndex.html
q1
tlcn; (ll) patlent treatment cards, whlch detall the reeular lntake cf medlcatlcn
and fcllcw-up sputum examlnatlcns; (lll) ldentlty cards, whlch are kept by the
patlent; and (lv) 8Mu (dlstrlct) T8 reelsters, whlch llst each patlent startlne
treatment and mcnltcr prceress tcwards cure. Scme facllltles have addltlcnal
reelsters, e.e. fcr T8 suspects, culture results, ccntacts, referrals and transfers,
whlch are adapted tc ccuntry needs.
lcbcrctcrv rccistcr. The labcratcry reelster ls malntalned by a labcratcry tech-
nlclan. lt reccrds patlent detalls by scurce cf referral uslne a serlal ldentlñca-
tlcn number. The results cf the sputum smear examlnatlcns are reccrded ln the
labcratcry reelster elther fcr dlaencsls cr fcr fcllcw-up and then returned tc
the referrlne faclllty.
Pcticnt trcctmcnt rcrd. A patlent treatment card ls created fcr each T8 case
(smear-pcsltlve, smear-neeatlve cr extrapulmcnary). lt reccrds baslc epldemlclc-
ß0X ¶.:
R£C0R0tkC Ak0 R£P0R1tkC f0RM5 R£0UtR£0 ߥ WB0
a
At basic management unit (ßMU) |eve| (district)
N T8 labcratcry reelster
N 8Mu T8 reelster
N 0uarterly repcrt cn T8 case reelstratlcn ln 8Mu
N 0uarterly repcrt cn T8 Treatment cutccmes and T8/Flv actlvltles ln 8Mu
N 0uarterly crder fcrm fcr T8 drues
N 0uarterly crder fcrm fcr labcratcry supplles ln 8Mu
N ¥early repcrt cn prceramme manaeement ln 8Mu
N 0uarterly repcrt cn sputum ccnverslcn, (cptlcnal)
At ßMU |eve| (district) using reutine cu|ture and drug susceptibi|ity testing (051)
N T8 labcratcry reelster fcr culture
N T8 reelster ln 8Mu uslne rcutlne culture and uST
N 0uarterly repcrt cn T8 case reelstratlcn ln 8Mu uslne rcutlne culture
N 0uarterly repcrt cn T8 Treatment cutccmes and T8/Flv actlvltles ln 8Mu uslne
rcutlne culture
N 0uarterly crder fcrm fcr culture and uST labcratcry supplles ln 8Mu
At hea|th Iaci|ity in centra|, regiena| er periphera| |eve|
N kequest fcr sputum smear mlcrcsccpy examlnatlcn
N kequest fcr sputum smear mlcrcsccpy examlnatlcn, culture, uST
N T8 Treatment card
N T8 ldentlty Card
N T8 treatment referral/transfer
N keelster cf T8 suspects (cptlcnal)
N keelster cf T8 ccntacts (cptlcnal)
N keelster cf referred T8 cases, (cptlcnal)
8Mu = baslc manaeement unlt; uST = drue susceptlblllty testlne
a
Scurce: kcviscd 18 rcrcrdinc cnd rcpcrtinc [crms cnd rccistcrs - vcrsicn 2cc6. Ceneva, wcrld
Fealth 0reanlzatlcn, zoo6 (wF0/FTM/T8/zoo6.¸;¸).
¸. kFC0kulhC Ahu kFP0kTlhC
qz
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
elcal and cllnlcal lnfcrmatlcn, and the admlnlstratlcn cf drues. The health wcrker
uses the patlent treatment card fcr reccrdlne treatment and fcr fcllcw-up.
ldcntitv rcrd. An ldentlty card ls ccmpleted fcr every patlent whc starts antl-T8
treatment. lt reccrds the name, aee, sex, address, health faclllty, type cf T8,
reelmen and dates cf treatment. Thls card ls kept by the patlent.
8Mu (distrirt} 18 rccistcr. The 8Mu T8 reelster ls used tc mcnltcr prceress and
treatment cutccmes fcr all patlents ln the dlstrlct. lt prcvldes, cn cne llne per
patlent, the essentlal lnfcrmatlcn fcr ldentlñcatlcn cf the patlent and status
cf case manaeement. The reelster ls used by the respcnslble health wcrker tc
prcvlde the dlstrlct cr lccal health cfñcer wlth rapld feedback cn prceramme
perfcrmance ln the dlstrlct.
y.1.z Reportlnç system
The repcrtlne system ccnslsts cf: (l) quarterly repcrts cn T8 case reelstratlcn,
whlch summarlze the numbers cf T8 patlents started cn treatment, labcratcry
tests perfcrmed and Flv tests and results cbtalned; (ll) quarterly repcrts, whlch
detall treatment cutccmes and T8/Flv actlvltles after all patlents ln the cchcrt
have ccmpleted thelr ccurse cf treatment; (lll) quarterly crder fcrms, whlch
speclfy the requlred antl-T8 drues; (lv) quarterly crder fcrms, whlch detall the
requlred labcratcry supplles; (v) annual repcrts cn prceramme manaeement,
whlch descrlbe the human rescurce and T8 servlce dellvery facllltles as well
as the ccntrlbutlcn cf the prlvate sectcr and ccmmunlty tc referral, dlaencsls
and treatment.
Cchcrt cnclvsis. Cchcrt analysls refers tc the systematlc analysls cf standard
cutccmes cf treatment. A cchcrt cf T8 patlents ccnslsts cf patlents reelstered
durlne a certaln tlme perlcd, usually cne quarter cf a year (l.e. 1 lanuary-¸1
March, 1 Aprll-¸o lune, 1 luly-¸1 September and 1 0ctcber-¸1 uecember). hew
sputum smear-pcsltlve pulmcnary T8 patlents, thcse (the lnfectlcus cases) cn
re-treatment reelmens, and sputum smear-neeatlve and extrapulmcnary T8
patlents are repcrted ln separate cchcrts.
ln smear-pcsltlve pulmcnary T8 patlents, the slx standard cutccmes cf treatment
fcr repcrtlne purpcses are: cure, treatment ccmpleted, treatment fallure, dled,
default, and transfer cut.
ln smear-neeatlve pulmcnary T8 and extrapulmcnary T8 patlents, cure cannct
be assessed because thls cutccme lndlcatcr depends cn the results cf sputum
smear examlnatlcn. Fcwever, cutccme lndlcatcrs such as treatment ccmpleted,
treatment fallure, dled, default and transfer cut shculd be reccrded fcr these
patlents ln the 8Mu T8 keelster. hew and prevlcusly treated patlents shculd
alsc fcrm separate cchcrts. Separate cchcrt analysls may alsc be made fcr

¸. kFC0kulhC Ahu kFP0kTlhC
dlfferent types cf treatment unlt (e.e. publlc and prlvate) cr fcr dlfferent types
cf treatment suppcrters (e.e. health wcrkers, ccmmunlty vclunteers cr famlly
members). The treatment cutccmes are deñned ln Table ¸.1.
The reccrdlne and repcrtlne system allcws fcr lndlvlduallzed fcllcw-up tc help
patlents whc dc nct make satlsfactcry prceress, and fcr rapld manaeerlal
assessment cf the cverall perfcrmance cf each lnstltutlcn, 8Mu (dlstrlct), reelcn
cr ccuntry. A rcbust system cf acccuntablllty lnvclvlne crcss-checks between
repcrts, reelsters and fcrms shculd mlnlmlze any rlsk cf false repcrtlne. uata
quallty audlt tccls standardlze the crcss-checks between repcrts, reelsters and
fcrms. uata verlñcatlcn thrcueh crcss-checklne requlres reeular prlnt-cuts cf
electrcnlc quarterly repcrts and reelsters suppcrted by a prcper paper-based
archlvlne system.
wF0 prcvldes updated reccmmendatlcns cn the reccrdlne and repcrtlne fcrms
tceether wlth detalled lnstructlcns cn hcw tc ccmplete them.
1

¶.z keIerra| and transIer
Transfers and referrals cf patlents alm tc lmprcve the quallty cf thelr care ln
facllltles cfferlne mcre apprcprlate servlces cr servlces that are mcre ccnve-
1AßL£ ¶.: uFFlhlTl0hS 0F TkFATMFhT 0uTC0MFS
a
Cured A patlent whc was lnltlally culture cr sputum smear mlcrcsccpy at the
beelnnlne cf the treatment but whc was smear-neeatlve ln the last
mcnth cf treatment and cn at least cne prevlcus cccaslcn.
1reatment cemp|eted A patlent whc ccmpleted treatment but whc dld nct meet the crlterla tc
be classlñed as a cure cr a treatment fallure. Thls deñnltlcn applles tc
pulmcnary smear-pcsltlve and smear-neeatlve patlents and tc patlents
wlth extrapulmcnary dlsease.
1reatment Iai|ure (l) A new patlent whc ls culture cr sputum smear mlcrcsccpy pcsltlve at
ñve mcnths cr later durlne treatment, cr whc ls swltched tc Cateecry lv
treatment because sputum culture revealed Muk-T8;
(ll) A prevlcusly-treated patlent whc ls culture cr sputum smear
mlcrcsccpy pcsltlve at the end cf the re-treatment reelmen cr whc ls
swltched tc Cateecry lv treatment because sputum culture revealed
Muk-T8.
0ied A patlent whc dled frcm any cause durlne the ccurse cf treatment.
0eIau|ted A patlent whcse treatment was lnterrupted fcr twc ccnsecutlve mcnths
cr mcre.
1ransIerred eut A patlent whc was transferred tc a health faclllty ln ancther baslc
manaeement unlt and fcr whcm the treatment cutccme ls nct kncwn.
5uccessIu||y treated A patlent whc was cured cr whc ccmpleted treatment.
a
Scurce: kcviscd 18 rcrcrdinc cnd rcpcrtinc [crms cnd rccistcrs - vcrsicn 2cc6. Ceneva, wcrld Fealth
0reanlzatlcn, zoo6 (wF0/FTM/T8/zoo6.¸;¸).
1
http://www.whc.lnt/tb/dcts/r_and_r_fcrms/en/lndex.html
qq
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
nlently lccated, usually clcser tc the patlent's hcme. Patlents may be referred
tc cr transferred frcm facllltles fcr dlaencsls, treatment cr speclal care. keferral
and transfer are dlstlnct functlcns, wlth dlfferent fcllcw-up and related tasks,
and lt ls lmpcrtant tc dlfferentlate clearly between referral and transfer fcr the
purpcses cf T8 ccntrcl. Transfer cf patlents wlthcut prcper fcllcw-up lnfcrma-
tlcn refects pccr care manaeement cf patlent mcvement and requlres rapld
ccrrectlcn thrcueh lmprcved ccmmunlcatlcn. Apprcprlate fcrms fcr referral,
back-referral and transfer are therefcre essentlal fcr effectlve lnfcrmatlcn-sha-
rlne between dlfferent health-care prcvlders lnvclved ln prceramme lmplemen-
tatlcn.
kc[crrcl ls the prccess cf arranelne the mcvement cf a T8 patlent befcre reels-
tratlcn ln a 8Mu T8 reelster fcr the purpcses cf startlne treatment ln a mcre
ccnvenlent lccatlcn cr fcr dlaencsls ln a ccmpetent faclllty. The 8Mu referrlne
a case shculd nct reelster the patlent ln the T8 reelster. Fcwever, a speclal
referral reelster ls helpful tc mcnltcr referrals and ensure apprcprlate fcllcw up.
The 8Mu recelvlne a "referred" patlent ls respcnslble fcr lnfcrmlne the referrlne
faclllty abcut the arrlval cf the patlent and fcr the care prcvlded. A T8 patlent
reelstered ln a 8Mu T8 reelster (l.e. a patlent started cn antl-T8 treatment)
cculd alsc be referred tc ancther faclllty ln the same 8Mu cr cutslde the refe-
rrlne 8Mu fcr cther (ncn-T8) tests cr treatment (e.e. sureery, AkT).
1rcns[cr ls the prccess cf arranelne the mcvement cf a T8 patlent whc ls
already reelstered ln a 8Mu T8 reelster between twc 8Mus, l.e. the patlent has
started treatment and wlll ccntlnue treatment ln ancther area wlth a dlfferent
8Mu T8 reelster. The 8Mu "transferrlne cut" a patlent ls respcnslble fcr repcr-
tlne the treatment cutccme ln the quarterly repcrt cn T8 treatment cutccmes
and T8/Flv actlvltles, after cbtalnlne thls lnfcrmatlcn frcm the 8Mu ccmpletlne
the detalls cf treatment cutccmes. The 8Mu recelvlne a patlent "transferred-
ln" ls respcnslble fcr lnfcrmlne the 8Mu that transferred the patlent upcn the
arrlval cf the patlent and cn the eventual treatment cutccme.
The T8 treatment referral/transfer fcrm ls an lndlvldual patlent fcrm used bcth
ln case cf transfer and referral. Falf cf the fcrm shculd be returned tc the crl-
elnatlne faclllty upcn arrlval cf the patlent tc prcvlde feedback and ensure a
successful referral.
A faclllty referrlne cr transferrlne laree numbers cf patlents, such as a laree
hcspltal, may use separate fcrms fcr referral and transfer and may have a specl-
ñc reelster fcr referrals. Fcspltals transferrlne patlents cut tc ancther 8Mu are
respcnslble fcr ccnñrmlne that the 8Mu has recelved the patlents and shculd
ccllect lnfcrmatlcn cn the cutccmes cf treatment uslne all means pcsslble, ln
crder tc update thelr 8Mu (dlstrlct) T8 reelster and cchcrt analysls.

key reIerences
A cµidc tc mcnitcrinc cnd cvclµcticn [cr rcllcbcrctivc 18/hlv crtivitics. Ceneva, wcrld
Fealth 0reanlzatlcn, zoou (wF0/FTM/T8/zoou.¸uz and wF0/Flv/zoou.o¤; avallable at:
http://whqllbdcc.whc.lnt/hq/zoou/wF0_FTM_T8_zoou.¸uz.pdf ).
Ccmpcndiµm c[ indirctcrs [cr mcnitcrinc cnd cvclµctinc ncticncl tµbcrrµlcsis prc-
crcmmcs. Ceneva, wcrld Fealth 0reanlzatlcn, zoou (wF0/FTM/T8/zoou.¸uu).
Fnarscn uA. Mcncccmcnt c[ tµbcrrµlcsis: c cµidc [cr lcw-inrcmc rcµntrics, çth ed.
Parls, lnternatlcnal unlcn Aealnst Tuberculcsls and Lune ulsease, zooo.
Maher u, kavlellcne M. whv is c rcrcrdinc cnd rcpcrtinc svstcm nccdcd, cnd whct svs-
tcm is rcrcmmcndcd: ln: Tcmcn´s tµbcrrµlcsis: rcsc dctcrticn, trcctmcnt, cnd mcnitcr-
inc, znd ed. Ceneva, wcrld Fealth 0reanlzatlcn, zoou:z;o-z;¸.
Mcncccmcnt c[ tµbcrrµlcsis: trcininc [cr distrirt 18 rccrdinctcrs. Ceneva, wcrld Fealth
0reanlzatlcn, zooç (wF0/FTM/T8/zooç.¸u;a).
Mcncccmcnt c[ tµbcrrµlcsis: trcininc [cr hcclth [crilitv stc[[. Ceneva, wcrld Fealth
0reanlzatlcn, zoo¸ (wF0/FTM/T8/zoo¸.1u).
Pµblir-privctc mix [cr 001S: prcrtircl tccls tc hclp implcmcntcticn. Ceneva, wcrld
Fealth 0reanlzatlcn, zoo¸ (wF0/CuS/T8/zoo¸.¸zç).
kcviscd 18 rcrcrdinc cnd rcpcrtinc [crms cnd rccistcrs - vcrsicn 2cc6. Ceneva, wcrld
Fealth 0reanlzatlcn, zoo6 (wF0/FTM/T8/zoo6.¸;¸; avallable at: http://www.whc.lnt/
tb/dcts/r_and_r_fcrms/en/lndex.html; accessed February zoo8).
¸. kFC0kulhC Ahu kFP0kTlhC
q6
u Tuberculcsls ln chlldren
q.1 5pec|a| Ieatures eI tubercu|es|s |n ch||dren
0
f the estlmated 8.8 mllllcn new cases cf T8 that cccurred elcbally ln zooç,
abcut 1 mllllcn (11%) were chlldren aeed under 1ç years. Chlldren wlth T8
dlffer frcm adults ln thelr respcnse tc the dlsease ln ways that may have lmpcr-
tant lmpllcatlcns fcr the preventlcn, dlaencsls and treatment cf T8. Further-
mcre, chlldren are at lncreased rlsk cf prceresslcn cf prlmary M. tµbcrrµlcsis
lnfectlcn tc dlsease, and are therefcre a tareet ercup fcr preventlve treatment.
Chlldren alsc develcp prlmary T8 mcre ccmmcnly than adults. Althcueh bacte-
rlclcelcal ccnñrmatlcn cf T8 shculd be scueht whenever pcsslble, thls ls cften
nct pcsslble ln ycune chlldren wlth pulmcnary T8 whc usually cannct prcduce
a sputum sample.
ln the absence cf Flv lnfectlcn, mcst chlldren wlth T8 ccme wlthln wF0 T8
dlaencstlc Cateecry lll and shculd be treated durlne the lnltlal phase cf treat-
ment wlth three drues (lscnlazld, rlfamplcln and pyrazlnamlde) fcr twc mcnths,
fcllcwed by a ccntlnuatlcn phase cf treatment wlth twc drues (lscnlazld and
rlfamplcln) fcr fcur mcnths. Chlldren are partlcularly llable tc develcp T8 men-
lneltls and mlllary T8 and deserve speclal ccnslderatlcn (see the reccmmended
treatment reelmens ln Cµidcnrc [cr ncticncl tµbcrrµlcsis prccrcmmcs cn thc
mcncccmcnt c[ tµbcrrµlcsis in rhildrcn).
There ls an ureent need tc lmprcve the preventlcn, dlaencsls and treatment
cf T8 ln chlldren, by ensurlne thelr lncluslcn ln hTPs ln llne wlth lnternatlcnal
standards and euldellnes. The lntcrncticncl stcndcrds [cr tµbcrrµlcsis rcrc and
wF0's euldellnes cn treatment cf tuberculcsls are relevant fcr patlents cf all
aees, whether chlldren cr adults. The cverall plannlne respcnse tc T8 shculd
lnclude the respcnse tc T8/Flv and Muk-T8 ln chlldren as well as ln adults.
Fcr hTPs tc successfully and effectlvely prevent and manaee T8 ln chlldren,
standardlzed apprcaches based cn the best avallable evldence shculd be lnccr-
pcrated lntc exlstlne hTP euldellnes and strateeles. The eneaeement cf all whc
prcvlde care tc chlldren (lncludlne paedlatrlclans and cther cllnlclans) ls cruclal.
keduclne the burden cf T8 ln chlldren wlll requlre chanelne and lmprcvlne many
exlstlne practlces, such as thcse that relate tc ccntact lnvestleatlcns. updatlne
the hTP reccrdlne and repcrtlne system ls necessary, ln llne wlth wF0 reccm-
q)
u. Tu8FkCuL0SlS lh CFlLukFh
mendatlcns. 0peratlcnal research ls essentlal tc establlsh hcw hTPs can best
ensure the dellvery cf effectlve preventlcn and care fcr chlldhccd T8.
q.1.1 Pollcy chançes
hTPs shculd be aware cf twc lmpcrtant pcllcy chanees that relate tc reccrdlne
and repcrtlne and tc the dcsaee cf ethambutcl.
kcrcrdinc cnd rcpcrtinc. hTPs shculd reccrd and repcrt twc aee ercups fcr
chlldren (o-u years and ç-1u years). Thls has ccnslderable beneñts: (l) lt ls
cruclal ln ensurlne the manaeement cf chlldhccd T8 as part cf rcutlne hTP
actlvltles; (ll) lt ls useful ln crderlne drues, slnce chlld-frlendly fcrmulatlcns
are partlcularly lmpcrtant ln chlldren aeed o-u years; (lll) lt ls lmpcrtant ln
mcnltcrlne cf trends ln these twc dlstlnct aee ercups, slnce chlldren aeed
o-u years are the mcst vulnerable, and lnfectlcn at these early aees lndlcates
recent transmlsslcn; (lv) lt wlll prcvlde valuable and ccntlnucus lnfcrmatlcn
cn market needs ccncernlne chlld-frlendly fcrmulatlcns cf antl-T8 drues; and
(v) lt ls ccnslstent wlth aee ercuplnes used ln the lnteerated Manaeement cf
Chlldhccd lllness (lMCl).
0csc c[ cthcmbµtcl. when a chlld recelves treatment wlth a reelmen ccntaln-
lne ethambutcl, the revlsed reccmmended dcse ls zo me/ke (ranee 1ç-zç me/
ke) dally. A llterature revlew lndlcates that ethambutcl ls safe ln chlldren cf all
aees at thls dcse. Fthambutcl was prevlcusly cften cmltted frcm reelmens fcr
chlldren, cwlne ln part tc ccncerns abcut cptlc neurltls.
q.z 5trateg|c appreach te prevent|ng and manag|ng
tubercu|es|s |n ch||dren
The hTP's cverall strateelc apprcach tc decrease the burden cf chlldhccd T8
ccnslsts cf twc elements.
Prcvcnticn c[ 18. Measures tc prevent T8 lnvclve screenlne chlldren whc are
the hcusehcld ccntacts cf a T8 case (usually an adult famlly member) tc enable
thcse chlldren fcund tc have T8 tc be treated and thcse chlldren nct fcund tc
have T8 tc recelve lscnlazld preventlve therapy (lPT).
Mcncccmcnt c[ 18. Measures tc manaee T8 lnvclve the rcutlne dlaencsls,
treatment, and reccrdlne and repcrtlne cf T8 ln chlldren as part cf rcutlne hTP
actlvltles, ln llne wlth lnternatlcnal standards and euldellnes. The dlaencsls
and treatment cf drue-reslstant T8 ln chlldren are ccmplex and shculd be car-
rled cut at referral centres.
Chapter 8 prcvldes reccmmendatlcns fcr lmmunlzatlcn wlth bacllle Calmette-
Cuérln (8CC), cne cf the chlldhccd vacclnes admlnlstered under the Fxpanded
Prceramme cn lmmunlzatlcn.
q8
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
The hTP shculd ccllabcrate wlth chlld health servlces ln lmplementlne the stra-
teelc apprcach tc preventlcn and manaeement cf T8 ln chlldren. The cverall
ccntext fcr prcvldlne hleh-quallty care tc slck chlldren ls prcvlded by the lMCl
strateey prcmcted by wF0 and the unlted hatlcns Chlldren's Fund (uhlCFF)
(see Chapter z¸, sectlcn z¸.z).
q.z.1 Preventlon oj tuberculosls ln chllJren
hTPs shculd creanlze a system fcr screenlne the chlldren cf hcusehcld ccn-
tacts cf lnfectlcus pulmcnary T8 cases. Thls enables thcse chlldren fcund tc
have T8 tc be reelstered and treated, and fcr thcse chlldren nct fcund tc have
T8 but whc are at hleh rlsk cf T8 (chlldren aeed less than ç years and all Flv-
lnfected chlldren) tc recelve lPT (l.e. dally lscnlazld fcr at least slx mcnths).
The tuberculln skln test (TST) ls the best way tc detect M. tµbcrrµlcsis lnfec-
tlcn, and chest X-ray (CXk) ls the best methcd tc screen fcr T8 dlsease amcne
ccntacts. These tests shculd be used where avallable tc screen expcsed ccn-
tacts. Fcwever, tuberculln ls cften unavallable ln lcw-rescurce settlnes. TST
and CXk, when nct readlly avallable, shculd nct preclude ccntact screenlne and
manaeement, as thls can be ccnducted cn the basls cf slmple cllnlcal assess-
ment (Fleure u.1).
ftCUR£ o.: APPk0ACF T0 C0hTACT MAhACFMFhT wFFh CFFST X-kA¥ Ahu
Tu8FkCuLlh SKlh TFST AkF h0T kFAulL¥ AvAlLA8LF
a
Chi|d in c|ese centact with seurce case
eI smear-pesitive pu|menary tubercu|esis
Aged under ¶ years Aged ¶ years er e|der
We|| 5ymptematic
b
5ymptematic
b
We||
6B
c
£va|uate Ier tubercu|esis ke treatment
d
tI chi|d becemes tI chi|d becemes
symptematic symptematic
a
Adapted frcm Cµidcnrc [cr ncticncl tµbcrrµlcsis prccrcmmcs cn thc mcncccmcnt c[ tµbcrrµlcsis in rhil-
drcn. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6 (wF0/FTM/T8/zoo6.¸;1).
b
lf tuberculcsls ls suspected, refer tc Part l.
c
lscnlazld ç me/ke dally fcr 6 mcnths.
d
unless the chlld ls Flv-lnfected (ln whlch case lscnlazld ç me/ke dally fcr 6 mcnths ls lndlcated).

Speclal sltuatlcns
º Clcsc rcntcrts c[ M0k-18 pcticnts
Chlldren whc are clcse ccntacts cf Muk-T8 patlents shculd recelve careful
cllnlcal fcllcw-up fcr a perlcd cf at least twc years. lf actlve dlsease devel-
cps, prcmpt lnltlatlcn cf treatment wlth a reelmen deslened tc treat Muk-T8
ls reccmmended. wF0 dces nct reccmmend seccnd-llne drues fcr chemc-
prcphylaxls ln Muk-T8 ccntacts.
º 8rccst[ccdinc in[cnts
lnfants whc are belne breastfed have a hleh rlsk cf lnfectlcn frcm mcth-
ers wlth smear-pcsltlve pulmcnary T8 and cf develcplne T8. lnfants shculd
recelve slx mcnths cf lPT, fcllcwed by 8CC lmmunlzatlcn. 8reastfeedlne may
be safely ccntlnued durlne thls perlcd.
q.z.z 0laçnosls oj tuberculosls ln chllJren
The dlaencsls cf T8 ln chlldren relles cn a careful and thcrcueh assessment
cf all the evldence derlved frcm an accurate hlstcry, cllnlcal examlnatlcn and
relevant lnvestleatlcns, e.e. TST, CXk and sputum smear mlcrcsccpy. Althcueh
bacterlclcelcal ccnñrmatlcn cf T8 ls nct always feaslble, lt shculd be scueht
whenever pcsslble, e.e. by sputum smear mlcrcsccpy fcr chlldren wlth sus-
pected pulmcnary T8 whc are cld encueh tc prcduce a sputum sample. A trlal
cf treatment wlth antl-T8 medlcatlcn ls
nct reccmmended as a methcd fcr dlae-
ncslne T8 ln chlldren. The declslcn tc
treat a chlld shculd be carefully ccnsld-
ered; cnce such a declslcn ls made, the
chlld shculd be treated wlth a full ccurse
cf therapy. Standard lnternatlcnal case
deñnltlcns apply tc adults and chlldren.
ln mcst lmmuncccmpetent chlldren, T8
presents wlth symptcms cf a chrcnlc
dlsease after they have been ln ccntact
wlth an lnfectlcus scurce case. 8cx u.1
cutllnes the key rlsk factcrs fcr T8 ln chll-
dren.
8cx u.z shcws the key features sue-
eestlve cf T8 ln chlldren. lnfectlcn wlth
M. tµbcrrµlcsis can usually be demcn-
strated by a TST (althcueh less rellably
ln the presence cf Flv lnfectlcn). The
cllnlcal presentatlcn ln lnfants may be
u. Tu8FkCuL0SlS lh CFlLukFh
ß0X o.:
K£¥ Rt5K fAC10R5 f0R
1UߣRCUL05t5
N Fcusehcld ccntact cf a newly
dlaencsed smear-pcsltlve case
N Aeed less than ç years
N Flv lnfectlcn
N Severe malnutrltlcn
ß0X o.z
K£¥ f£A1UR£5 5UCC£51tv£
0f 1UߣRCUL05t5
A dlaencsls cf tuberculcsls ls
strcnely sueeested ln the presence cf
three cr mcre cf the fcllcwlne:
N chrcnlc symptcms sueeestlve cf
tuberculcsls
N physlcal slens hlehly sueeestlve
cf tuberculcsls
N a pcsltlve tuberculln skln test
N chest X-ray sueeestlve cf T8.
¶e
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
mcre acute, resembllne acute severe pneumcnla, and shculd be suspected
when there ls a pccr respcnse tc antlblctlcs. ln such sltuatlcns, there ls cften
an ldentlñable scurce case, usually the mcther.
Fxlstlne dlaencstlc tests fcr T8 ln chlldren have shcrtccmlnes, and the full
ranee cf tests (lncludlne bacterlclcelcal culture and TST) ls cften nct avallable
ln settlnes where the dlsease ls dlaencsed ln the vast ma|crlty cf cases.
ln scme ccuntrles, sccre charts are used fcr the dlaencsls cf T8 ln chlldren.
These charts have rarely been evaluated cr valldated aealnst a "ecld stand-
ard" and shculd therefcre be used as screenlne tccls and nct as the means cf
maklne a ñrm dlaencsls. Sccre charts perfcrm partlcularly pccrly ln chlldren
suspected cf pulmcnary T8 and ln chlldren whc are alsc Flv-lnfected.
8cx u.¸ summarlzes wF0's reccmmended apprcach fcr the dlaencsls cf T8 ln
chlldren.
Chlldren are equally susceptlble tc drue-
reslstant and tc drue-susceptlble T8.
urue-reslstant T8 ls a labcratcry dlaenc-
sls. Fcwever, drue-reslstant T8 shculd be
suspected lf any cf the features belcw
are present.
1. lcctµrcs in thc scµrrc rcsc sµcccs-
tivc c[ drµc-rcsistcnt 18
º ccntact wlth a kncwn case cf drue-
reslstant T8;
º remalns sputum smear-pcsltlve
after three mcnths cf treatment;
º hlstcry cf prevlcusly treated T8;
º hlstcry cf treatment lnterruptlcn.
2. lcctµrcs c[ c rhild sµspcrtcd c[ hcvinc drµc-rcsistcnt 18
º ccntact wlth a kncwn case cf drue-reslstant T8;
º nct respcndlne tc the antl-T8 reelmen;
º recurrence cf T8 after adherence tc treatment.
q.z.y Treatment oj tuberculosls ln chllJren
Chapter z detalls the drue dcses reccmmended by wF0 fcr T8 ln chlldren.
Chlldren usually have pauclbaclllary pulmcnary dlsease (lcw creanlsm num-
bers), as cavltatlne dlsease ls relatlvely rare (abcut 6% cf cases cr fewer) ln
thcse aeed under 1¸ years (the ma|crlty cf the creanlsms ln adult-type dlsease
ß0X o.¶
R£C0MM£k0£0 APPR0ACB
f0R 0tACk05t5 0f 1UߣRCUL05t5
tk CBtL0R£k
1. Careful hlstcry (lncludlne hlstcry
cf T8 ccntact and symptcms
ccnslstent wlth T8)
z. Cllnlcal examlnatlcn (lncludlne
ercwth assessment)
¸. Tuberculln skln testlne
u. 8acterlclcelcal ccnñrmatlcn
whenever pcsslble
ç. lnvestleatlcns relevant fcr
suspected pulmcnary cr
extrapulmcnary T8
6. Flv testlne (ln areas cf hleh Flv
prevalence)
¶1
are fcund ln the cavltles). ln ccntrast, extrapulmcnary T8 cccurs mcre ccm-
mcnly ln chlldren than ln adults. Severe and dlssemlnated T8 (e.e. T8 menlnel-
tls and mlllary T8) cccur especlally ln ycune chlldren (aeed under ¸ years). 8cth
the baclllary lcad and the type cf dlsease may lnfuence the effectlveness cf
antl-T8 reelmens. Treatment cutccmes ln chlldren are eenerally eccd, even ln
ycune and lmmuncccmprcmlsed chlldren whc are at hleher rlsk cf dlsease prc-
eresslcn and dlssemlnated dlsease, prcvlded that treatment starts prcmptly.
There ls a lcw rlsk cf adverse events asscclated wlth use cf the reccmmended
reelmens.
The reccmmended antl-T8 reelmens fcr each dlaencstlc cateecry are eenerally
the same fcr chlldren as fcr adults (see Table z.z). hew cases fall wlthln Cat-
eecry l (new smear-pcsltlve pulmcnary T8; new smear-neeatlve pulmcnary T8
wlth extenslve parenchymal lnvclvement; severe fcrms cf extrapulmcnary T8;
severe ccnccmltant Flv dlsease) cr Cateecry lll (new smear-neeatlve pulmc-
nary T8 cther than ln Cateecry l; less severe fcrms cf extrapulmcnary T8).
Mcst chlldren wlth T8 have unccmpllcated (smear-neeatlve) pulmcnary cr
lntrathcraclc T8 cr ncn-severe fcrms cf extrapulmcnary T8. They therefcre ccme
wlthln wF0 T8 dlaencstlc Cateecry lll: the reccmmended treatment reelmen
ls zFkZ/uFk (cr zFkZ/6FF). A mlncrlty cf chlldren have smear-pcsltlve pulmc-
nary T8, extenslve pulmcnary lnvclvement cr severe fcrms cf extrapulmcnary
T8 (e.e. abdcmlnal cr T8 cf the bcnes cr |clnts). They therefcre ccme wlthln
dlaencstlc Cateecry l: the reccmmended treatment reelmen ls zFkZF/uFk (cr
zFkZF/6FF). Chlldren wlth T8 menlneltls and mlllary T8 requlre speclal ccn-
slderatlcn (see wF0 Cµidcnrc [cr ncticncl tµbcrrµlcsis prccrcmmcs cn thc
mcncccmcnt c[ tµbcrrµlcsis in rhildrcn). Prevlcusly treated cases fall under
dlaencstlc Cateecry ll (prevlcusly treated smear-pcsltlve pulmcnary T8) cr Cat-
eecry lv (chrcnlc cases and Muk-T8).
usc c[ rcrtircstcrcids. Ccrtlccsterclds may be used fcr the manaeement cf scme
ccmpllcated fcrms cf T8, e.e. T8 menlneltls, ccmpllcatlcns cf alrway cbstruc-
tlcn by T8 lymph elands and perlcardlal T8. ln cases cf advanced T8 menlneltls,
ccrtlccsterclds have been shcwn tc lmprcve survlval and decrease mcrbldlty.
Ccrtlccsterclds may be useful ln scme cases cf lmmune reccnstltutlcn.
1rcctmcnt sµppcrt. Chlldren, thelr parents and cther famlly members, and cther
careelvers shculd be educated abcut T8 and the lmpcrtance cf ccmpletlne
treatment. Treatment ls usually admlnlstered by the chlld's mcther cr cther car-
eelver. Suppcrt frcm the chlld's parents and lmmedlate famlly ls vltal tc ensure
a satlsfactcry treatment cutccme. 0ften, a health-care wcrker can cbserve and
reccrd the treatment, but lf thls arraneement ls nct ccnvenlent fcr the famlly,
a tralned ccmmunlty member (preferably scmecne cther than the chlld's par-
ent cr lmmedlate famlly) can undertake thls respcnslblllty. All chlldren shculd
u. Tu8FkCuL0SlS lh CFlLukFh
¶z
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
recelve treatment free cf charee, whether the chlld ls smear-pcsltlve at dlae-
ncsls cr nct. FuCs shculd be used whenever pcsslble tc lmprcve slmpllclty
cf and adherence tc treatment. Patlent treatment cards are reccmmended fcr
dccumentlne treatment adherence.
hcspitcl rcrc. Chlldren wlth severe fcrms cf T8 shculd be hcspltallzed fcr lnten-
slve manaeement where pcsslble. Ccndltlcns that merlt hcspltallzatlcn lnclude:
(l) T8 menlneltls and mlllary T8, preferably fcr at least the ñrst twc mcnths;
(ll) resplratcry dlstress; (lll) splnal T8; and (lv) severe adverse events, such
as cllnlcal slens cf hepatctcxlclty (e.e. |aundlce). lf lt ls nct pcsslble tc ensure
eccd adherence and treatment cutccme cn an cutpatlent basls, scme chlldren
may requlre hcspltallzatlcn fcr scclal cr lcelstlc reascns.
hlv-in[crtcd rhildrcn. Mcst current lnternatlcnal euldellnes reccmmend that T8
ln chlldren lnfected wlth Flv shculd be treated wlth a slx-mcnth reelmen, as fcr
chlldren whc are nct lnfected wlth Flv. where pcsslble, Flv-lnfected chlldren
shculd be treated wlth rlfamplcln fcr the entlre duratlcn cf treatment, as hleher
relapse rates amcne Flv-lnfected adults have been fcund when ethambutcl ls
used ln the ccntlnuatlcn phase. Mcst chlldren wlth T8, lncludlne thcse whc are
Flv-lnfected, have a eccd respcnse tc the slx-mcnth reelmen. Pcsslble causes
cf fallure, such as ncn-ccmpllance wlth therapy, pccr drue abscrptlcn, drue
reslstance and alternatlve dlaencses, shculd be lnvestleated ln chlldren whc
are nct lmprcvlne cn antl-T8 treatment.
All chlldren wlth T8 and Flv cclnfectlcn shculd be evaluated tc determlne
whether AkT ls lndlcated durlne the ccurse cf treatment fcr T8. Apprcprlate
arraneements fcr access tc antlretrcvlral drues shculd be made fcr patlents
whc meet lndlcatlcns fcr treatment. Clven the ccmplexlty cf cc-admlnlstratlcn
cf antl-T8 treatment and AkT, ccnsultatlcn wlth an expert ln thls area ls rec-
cmmended befcre lnltlatlcn cf ccncurrent treatment fcr T8 and Flv lnfectlcn,
reeardless cf whlch dlsease appeared ñrst. Fcwever, lnltlatlcn cf treatment fcr
T8 shculd nct be delayed. Chlldren wlth T8 and Flv cclnfectlcn shculd alsc
recelve cc-trlmcxazcle as prcphylaxls fcr cther lnfectlcns.
ln Flv-lnfected chlldren wlth ccnñrmed cr presumptlve T8 dlsease, lnltlatlcn cf
antl-T8 treatment ls the prlcrlty; hcwever, the cptlmal tlmlne fcr AkT lnltlatlcn
ls nct kncwn. The declslcn cn when tc start AkT after startlne antl-T8 treat-
ment lnvclves a balance between the chlld's aee, plll burden, pctentlal drue
lnteractlcns, cverlapplne tcxlcltles and pcsslble lklS versus the rlsk cf further
prceresslcn cf lmmune suppresslcn wlth lts asscclated lncrease ln mcrtallty
and mcrbldlty. Many cllnlclans start AkT z-8 weeks after startlne antl-T8 treat-
ment.
¶¶
q.z.q RecorJlnç anJ reportlnç
Chlldren wlth T8 shculd always be lncluded ln the rcutlne hTP reccrdlne and
repcrtlne system (see Chapter ¸). lt ls cruclal tc nctlfy the hTP cf all ldentlñed
T8 cases ln chlldren, reelster them fcr treatment and reccrd thelr treatment
cutccme. At the end cf the treatment ccurse fcr each chlld wlth T8, the dls-
trlct T8 cfñcer shculd reccrd the standard cutccme ln the dlstrlct T8 reelster.
Fcur cf the standard cutccmes are appllcable tc chlldren wlth smear-neeatlve
pulmcnary cr extrapulmcnary T8: treatment ccmpletlcn, default, death and
transfer cut.
keccrdlne and repcrtlne twc aee ercups fcr chlldren (o-u years and ç-1u years)
ln the T8 reelsters ls useful fcr drue prccurement (ln chlld-frlendly fcrmula-
tlcns fcr ycune chlldren) and tc mcnltcr trends cf case-ñndlne and treatment
cutccmes. Fvaluatlcn cf treatment cutccme by cchcrt analysls ln chlldren ls a
valuable lndlcatcr cf the quallty cf prcerammes fcr chlld T8 patlents. Fcr T8/
Flv lndlcatcrs ln chlldren, see Chapter 1¸.
q.¶ Ma|n act|v|t|es te be carr|ed eut by the nat|ena| 1ß centre|
pregramme Ier |mp|ementat|en eI |ntervent|ens te prevent and
manage tubercu|es|s |n ch||dren
lmplementatlcn by the hTP cf lnterventlcns tc prevent and manaee chlldhccd
T8 requlres the actlvltles llsted belcw.
1. Preparatlcns:
º advccate tc health authcrltles fcr malnstreamlne cf "chlldhccd T8 lnter-
ventlcns" as part cf rcutlne hTP actlvltles, ln ccllabcratlcn wlth the mater-
nal and chlld health prceramme;
º ccnduct a sltuatlcn analysls cf the extent tc whlch chlldhccd T8 lnter-
ventlcns are malnstreamed as part cf rcutlne hTP actlvltles, cf currently
avallable data cn preventlcn, case ñndlne and treatment cutccme, and cf
rescurces avallable fcr lmplementatlcn cf chlldhccd T8 lnterventlcns;
º adapt hTP euldellnes tc refect chlldhccd T8 lnterventlcns;
º adapt maternal and chlld health euldellnes tc refect chlldhccd T8 pcll-
cles;
º eneaee wlth key ccmmunlty stakehclders (academlcs, actlvlsts, etc.) tc
develcp apprcprlate lnfcrmatlcn, educatlcn and ccmmunlcatlcn (lFC)
materlal;
º ln settlnes wlth hleh Flv prevalence, ensure effectlve llnkaees wlth Flv
ccntrcl servlces.
u. Tu8FkCuL0SlS lh CFlLukFh
¶q
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
z. Facllltate meetlnes wlth relevant health and cther authcrltles at natlcnal,
reelcnal cr prcvlnclal and dlstrlct level, tc ensure eneaeement cf all health
prcvlders (ecvernment, ncnecvernmental creanlzatlcns, prlvate sectcr, rell-
elcus and charlty creanlzatlcns, etc.)
¸. Tralnlne tc lmplement chlldhccd T8 lnterventlcns:
º develcp and prcduce tralnlne materlal fcr health staff based cn natlcnal
euldellnes;
º develcp and prcduce tralnlne materlal fcr ccmmunlty partlclpants (e.e.
thcse lnvclved ln ccntact traclne and case-ñndlne, and ln prcmctlne and
enccuraelne adherence as "treatment suppcrters");
º sensltlze health staff and relevant ccmmunlty members reeardlne the
nature and extent cf the prcblem cf chlldhccd T8, and mctlvate them tc
share respcnslblllty fcr ccntact traclne, case-ñndlne and treatment sup-
pcrt.
u. uellvery cf chlldhccd T8 lnterventlcns as part cf rcutlne hTP actlvltles
º assess drue prccurement system fcr effectlveness ln ensurlne avallablllty
cf quallty-assured fcrmulatlcns cf antl-T8 drues fcr chlldren (and ccnslder
cbtalnlne these drues thrcueh the CuF);
º mcnltcr results cf ccntact traclne, case-ñndlne and treatment suppcrt;
º check hcw effectlvely the rcutlne hTP reccrdlne and repcrtlne system ls
capturlne the data cn case-ñndlne and treatment cutccmes;
º evaluate hcw effectlvely the full ranee cf health prcvlders ls mcblllzed tc
ccntrlbute tc maklne hleh-quallty chlldhccd T8 lnterventlcns unlversally
accesslble;
º assess effectlveness cf the system cf prccurement cf tuberculln.
ç. Advccacy, ccmmunlcatlcns and scclal mcblllzatlcn (ACSM) actlvltles
º lnccrpcrate messaees abcut chlldhccd T8 ln ACSM actlvltles fcr health
prcmctlcn;
º advccate fcr ccmmltment and funds tc ensure unlversal access tc hleh-
quallty chlldhccd T8 lnterventlcns as part cf rcutlne hTP actlvltles.
Wh0 gu|de||nes
Cµidcnrc [cr ncticncl tµbcrrµlcsis prccrcmmcs cn thc mcncccmcnt c[ tµbcrrµlcsis in
rhildrcn. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6 (wF0/FTM/T8/zoo6.¸;1; wF0/FCF/
CAF/zoo6.;).
¶¶
Cµidclincs [cr thc prccrcmmctir mcncccmcnt c[ drµc-rcsistcnt tµbcrrµlcsis. Ceneva,
wcrld Fealth 0reanlzatlcn, zoo6 (wF0/FTM/T8/zoo6.¸61).
1rcctmcnt c[ tµbcrrµlcsis: cµidclincs [cr ncticncl prccrcmmcs, ¸rd ed. Ceneva, wcrld
Fealth 0reanlzatlcn, zoo¸ (wF0/CuS/T8/zoo¸.¸1¸).
key reIerences
Antirctrcvircl thcrcpv c[ hlv in[crticn in in[cnts cnd rhildrcn: tcwcrds µnivcrscl crrcss.
kcrcmmcndcticns [cr c pµblir hcclth cpprccrh. Ceneva, wcrld Fealth 0reanlzatlcn,
zoo6.
Fthcmbµtcl c[hrcrv cnd tcxiritv: litcrctµrc rcvicw cnd rcrcmmcndcticns [cr dcilv cnd
intcrmittcnt dcsccc in rhildrcn. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6 (wF0/FTM/
ST8/zoo6.¸6ç).
lmprcvinc thc mcncccmcnt c[ rhildhccd tµbcrrµlcsis within ncticncl tµbcrrµlcsis
prccrcmmcs: rcsccrrh pricritics bcscd cn c litcrctµrc rcvicw. Ceneva, wcrld Fealth
0reanlzatlcn, zoo; (wF0/FTM/T8/zoo;.¸81).
lntcrncticncl stcndcrds [cr tµbcrrµlcsis rcrc. The Faeue, Tuberculcsls Ccalltlcn fcr
Technlcal Asslstance, zoo6.
Marals 8l et al. Chlldhccd pulmcnary tuberculcsls. 0ld wlsdcm and new challenees.
Amcrircn lcµrncl c[ kcspirctcrv cnd Critircl Ccrc Mcdirinc, zoo6, 1;u:1o;8-1o¤o.
Marals 8l et al. ulverslty cf dlsease manlfestatlcns ln chlldhccd pulmcnary tuberculc-
sls. Anncls c[ 1rcpircl Pccdictrirs, zooç, zç:;¤-86.
helscn Ll, wells Cu. Clcbal epldemlclcey cf chlldhccd tuberculcsls. lntcrncticncl lcµr-
ncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zoou, 8:6¸6-6u;.
0fñclal statement. Cµidcnrc [cr ncticncl tµbcrrµlcsis prccrcmmcs cn thc mcncccmcnt
c[ tµbcrrµlcsis in rhildrcn. Chapters 1-ç ln the serles:
- Chapter 1. lntrcductlcn and dlaencsls cf tuberculcsls ln chlldren. lntcrncticncl lcµr-
ncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zoo6, 1o(1o):1o¤1-1o¤;.
- Chapter z. Antl-tuberculcsls treatment ln chlldren, zoo6, lntcrncticncl lcµrncl c[
1µbcrrµlcsis cnd lµnc 0isccsc, 1o(11):1zoç-1z11.
- Chapter ¸. Manaeement cf T8 ln the Flv-lnfected chlld. lntcrncticncl lcµrncl c[
1µbcrrµlcsis cnd lµnc 0isccsc, zoo6, 1o(1z):1¸¸1-1¸¸6.
- Chapter u. Chlldhccd ccntact screenlne and manaeement. lntcrncticncl lcµrncl c[
1µbcrrµlcsis cnd lµnc 0isccsc, zoo;, 11(1):1z-1ç.
- Chapter ç. Fealth staff rcles and respcnslbllltles, reccrdlne and repcrtlne and 8CC
vacclnatlcn. lntcrncticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zoo;, 11(z):1¸u-
1¸;.
welsmuller MM et al. ulaencsls cf chlldhccd tuberculcsls ln Malawl: an audlt cf hcspltal
practlce. lntcrncticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zooz, 6:u¸z-u¸8.
u. Tu8FkCuL0SlS lh CFlLukFh
¶6
ç Ccntact lnvestleatlcn
A
revlew cf ccntact lnvestleatlcns carrled cut ln lcw-lnccme and mlddle-
lnccme ccuntrles shcwed that u.ç% cf ldentlñed hcusehcld ccntacts cf new
pulmcnary T8 cases had T8 at the tlme cf the evaluatlcn, cf whcm z.¸% had
bacterlclcelcally-ccnñrmed T8. Amcne ccntacts aeed under ç years, 8.ç% were
fcund tc have T8. Mcre than ço% cf hcusehcld ccntacts had latent T8 lnfectlcn
(LT8l). wF0 and the lnternatlcnal unlcn Aealnst Tuberculcsls and Lune ulsease
(the unlcn) reccmmend tareetlne chlldren aeed under ç years fcr ccntact lnves-
tleatlcn and treatment cf LT8l ln lcw-lnccme ccuntrles where full lmplementa-
tlcn cf ccntact lnvestleatlcns may nct be feaslble. The ñndlnes lndlcate the
need fcr pcllcles tc address LT8l amcne clcse ccntacts ln settlnes cf hleh T8
lncldence. ln lcw-lncldence settlnes apprcachlne the ellmlnatlcn phase, ccntact
lnvestleatlcn plays a slenlñcant rcle ln T8 ccntrcl (see Annex).
¶.1 5tandards Ier centact |nvest|gat|en
The lmplementatlcn cf T8 ccntact lnvestleatlcn actlvltles by the hTP shculd
use clear deñnltlcns cf the T8 lndex case and ccntacts, prccedures tc be used
ln evaluatlne ccntacts, pcllcles fcr treatlne LT8l and mcnltcrlne cf the results
cf ccntact lnvestleatlcns. These deñnltlcns are nct well standardlzed at the
elcbal level and vary amcne ccuntrles/areas and even wlthln ccuntrles. uecl-
slcns abcut ccntact lnvestleatlcn and treatment cf LT8l shculd be based cn the
burden cf T8 ln the ccuntry and the rescurces avallable.
¶.z ßehn|t|ens Ier centact |nvest|gat|en
8efcre undertaklne ccntact lnvestleatlcns, preclse deñnltlcns fcr the lndex
case and fcr the ccntacts need tc be establlshed.
¢.z.1 InJex case
All smear-pcsltlve pulmcnary T8 cases shculd be ccnsldered as lndex cases; thelr
ccntacts shculd be evaluated fcr T8. All chlldren wlth T8 shculd be ccnsldered as
lndex cases; the purpcse cf ccntact lnvestleatlcn ls tc ldentlfy the scurce cf T8
transmlsslcn. Scme ccuntrles may use brcader deñnltlcns, fcr example lncludlne
as lndex cases cther fcrms cf T8 such as smear-neeatlve pulmcnary T8 cases, cr
any fcrm cf pulmcnary T8 lrrespectlve cf lts bacterlclcelcal status.
¶)
ç. C0hTACT lhvFSTlCATl0h
¢.z.z Contacts
T8 ccntacts shculd be clearly deñned ln terms cf the type cf ccntact, and the
clcseness and duratlcn cf expcsure tc the lndex case. ln many develcplne
ccuntrles, a T8 ccntact ls deñned as any hcusehcld member at the mcment cf
the ldentlñcatlcn cf the lndex case. All chlldren ln the hcusehcld, especlally
thcse aeed under ç years, shculd be assessed fcr T8. Fleh prlcrlty shculd alsc
be elven tc ccntacts whc have Flv lnfectlcn and thcse wlth cther underlylne
rlsk factcrs fcr T8. The deñnltlcn cf ccntacts may be extended tc lnclude lndl-
vlduals ln ccnereeate settlnes (e.e. the wcrkplace, schccls, scclal eatherlnes,
prlscns, hcspltals, cther health facllltles) lf prclcneed ccntact wlth an lndex
case has taken place.
¶.¶ Precess eI centact |nvest|gat|en
The lndex case shculd be lntervlewed as sccn as pcsslble after dlaencsls tc
ldentlfy ccntacts. The lntervlew shculd, as a ñrst prlcrlty, fccus cn the hcuse-
hcld, but the questlcns shculd ccver cther envlrcnments, as mentlcned abcve.
ldeally, the lntervlew shculd be ccnducted by a perscn famlllar wlth the culture
and the settlne. wherever pcsslble, a hcme vlslt shculd be made tc cbtaln a
clearer understandlne cf the patlent's clrcumstances and tc ccnñrm the results
cf the lntervlew.
All ldentlñed prlcrltlzed ccntacts cf the lndex case shculd be lnstructed tc
ccme tc the health faclllty fcr evaluatlcn. The ldentlñed ccntacts shculd be
llsted; lf they dc nct appear fcr evaluatlcn, a hcme (cr cther settlne) vlslt
shculd be made. As a prlcrlty, every effcrt shculd be made tc assess chlldren
and pecple llvlne wlth Flv/AluS cr thcse wlth cther ccndltlcns and sltuatlcns
asscclated wlth an lncreased rlsk cf T8. After llstlne the ccntacts, the results cf
thelr assessment shculd be reccrded.
The prccedure fcr screenlne T8 ccntacts shculd be clearly deñned. The evalu-
atlcn may be llmlted tc determlnlne whether the ccntact has symptcms that
may sueeest T8. As a mlnlmum, all adclescent and adult T8 ccntacts shculd be
asked whether they have a perslstlne ccueh (·z weeks). Sputum smear examl-
natlcns shculd be carrled cut cn thcse wlth a perslstent ccueh. All chlldren and
PLFlv shculd be mcre thcrcuehly assessed fcr T8, lncludlne cf extrapulmcnary
sltes.
¶.q Prev|s|en eI treatment
Fcur lmpcrtant ccnslderatlcns shculd be taken lntc acccunt when prcvldlne
treatment.
(l) Any ccntact ldentlñed as havlne actlve T8 shculd be reelstered and treated
ln llne wlth the hTP pcllcy.
¶8
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
(ll) Chlldren aeed under ç years whc are clcse ccntacts and whc dc nct have
evldence cf T8 shculd be systematlcally treated wlth lscnlazld chemc-
prcphylaxls: ç me/ke dally fcr slx mcnths.
(lll) Chlldren aeed ç years and abcve whc are ln eccd health dc nct requlre
chemcprcphylaxls but shculd be fcllcwed up cn a cllnlcal basls.
(lv) PLFlv whc are clcse ccntacts cf an lnfectlcus lndex case and whc dc nct
have evldence cf T8 shculd be treated wlth lscnlazld: ¸oo me/day fcr 6-¤
mcnths.
¶.¶ fe||ew-up eI treatment
All patlents recelvlne lscnlazld preventlve therapy (lPT) shculd be seen at
reeular lntervals at least early ln the ccurse cf treatment tc determlne whether
any adverse effects cf lscnlazld cccur and tc enccuraee adherence. After ccm-
pletlne treatment, patlents shculd be asked tc seek care lf a ccueh cr cther
pcsslble symptcms cf T8 develcp; there ls nc need fcr further fcllcw-up. Llke-
wlse, ccntacts wlth nc evldence cf T8 shculd be asked tc vlslt a health faclllty
lf a perslstent ccueh cr cther symptcms develcp ln the fcllcwlne weeks cr
mcnths.
¶.6 Men|ter|ng
The lmplementatlcn cf T8 ccntact lnvestleatlcn actlvltles requlres a mcnltcrlne
and evaluatlcn system tc prcvlde lnfcrmatlcn cn (l) the prccess cf T8 ccntact
lnvestleatlcn, (ll) the yleld cf T8 ccntact screenlne and (lll) the actlvltles and
mcnltcrlne cf lPT. A mcdel cf reelster fcr ccntacts ls prcpcsed ln the wF0
reccrdlne and repcrtlne system.
¶.) 1ubercu|es|s and |nternat|ena| a|r trave|
Transmlsslcn cf M. tµbcrrµlcsis lnfectlcn may cccaslcnally cccur ln passen-
eers seated ln clcse prcxlmlty tc an lnfectlcus T8 patlent cn bcard an alrcraft
durlne prclcneed flehts (flehts exceedlne 8 hcurs). ln nc case has actlve T8
been repcrted subsequently amcne such ccntacts. The rlsk cf lnfectlcn dur-
lne prclcneed alr travel ls estlmated tc be slmllar tc (cr less than) the rlsk ln
cther ccnereeate settlnes. Fcllcwlne an lncldent lnvclvlne pcsslble expcsure
tc an lnfectlcus T8 case cn a lcne-haul fleht, ccntact lnvestleatlcns are rec-
cmmended fcr the passeneers seated ln the same rcw and ln the twc rcws
ln frcnt and the twc rcws behlnd the lndex case (l.e. ñve rcws), and alr crew
wcrklne ln the same cabln area. wF0 has publlshed euldellnes cn prccedures
and respcnslbllltles fcr the preventlcn and ccntrcl cf T8 asscclated wlth alr
travel (see belcw).
¶¤
Wh0 gu|de||nes
Cµidcnrc [cr ncticncl tµbcrrµlcsis prccrcmmcs cn thc mcncccmcnt c[ tµbcrrµlcsis in
rhildrcn. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6 (wF0/FTM/T8/zoo6.¸;1).
1µbcrrµlcsis cnd cir trcvcl: cµidclincs [cr prcvcnticn cnd rcntrcl, ¸rd ed. Ceneva,
wcrld Fealth 0reanlzatlcn, zoo8 (wF0/FTM/T8/zoo8.¸¤¤; avallable at http://www.
whc.lnt/tb/publlcatlcns/zoo8/wF0_FTM_T8_zoo8.¸¤¤_ene.pdf ).
key reIerences
8aycna l et al. Ccntact lnvestleatlcns as a means cf detectlcn and tlmely treatment
cf perscns wlth lnfectlcus multl-drue reslstant tuberculcsls. lntcrncticncl lcµrncl c[
1µbcrrµlcsis cnd lµnc 0isccsc, zoo¸, ;(1z):çço1-çço¤.
8eyers h et al. A prcspectlve evaluatlcn cf chlldren under the aee cf ç years llvlne ln
the same hcusehcld as adults wlth recently dlaencsed pulmcnary tuberculcsls. lntcr-
ncticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, 1¤¤;, 1(1):¸8-u¸.
Claessens hlM et al. Fleh frequency cf tuberculcsls ln hcusehclds cf lndex T8 patlents.
lntcrncticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zooz, 6(¸):z66-z6¤.
urlver Ck et al. Transmlsslcn cf Myccbacterlum tuberculcsls asscclated wlth alr travel.
lcµrncl c[ thc Amcrircn Mcdircl Asscricticn, 1¤¤u, z;z:1o¸1-1o¸ç.
Fckhcff CT. Fvaluatlcn cf a cllnlcal lndex amcne adult ccntacts cf chlldren wlth tuber-
culcsls ln rural Faltl. lntcrncticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zooo,
u(1z):11u¸-11u8.
Ftklnd SC, veen l. The rcle cf ccntact traclne ln lcw and hleh prevalence ccuntrles. ln:
kavlellcne MC, ed. kcirhmcn cnd hcrshhcld´s tµbcrrµlcsis: c rcmprchcnsivc intcrnc-
ticncl cpprccrh, ¸rd ed. hew ¥crk, lnfcrma Fealthcare uSA, lnc., zoo6:ççç-ç8z.
Kenycn TA et al. Transmlsslcn cf multldrue-reslstant Myccbacterlum tuberculcsls durlne
a lcne alrplane fleht. Ncw Fnclcnd lcµrncl c[ Mcdirinc, 1¤¤6, ¸¸u:¤¸¸-¤¸8.
kelchler Mk et al. Tuberculcsls ccntact lnvestleatlcns. lntcrncticncl lcµrncl c[ 1µbcr-
rµlcsis cnd lµnc 0isccsc, zoo¸, ;(1z):S¸zç-S¸z;.
kleder F. Ccntacts cf tuberculcsls patlents ln hleh-lncldence ccuntrles. lntcrncticncl
lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zoo¸, ;(1z):S¸¸¸-S¸¸6.
Zacharlah k et al. Passlve versus actlve tuberculcsls case ñndlne and lscnlazld pre-
ventlve therapy amcne hcusehcld ccntacts ln a rural dlstrlct cf Malawl. lntcrncticncl
lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zoo¸, ;(11):1o¸¸-1o¸¤.
ç. C0hTACT lhvFSTlCATl0h
6e
6 lnfectlcn ccntrcl ln
health-care settlnes
F
cllcwlne the lntrcductlcn cf shcrt-ccurse chemctherapy ln the 1¤8os, meas-
ures tc lmprcve lnfectlcn ccntrcl ln health-care settlnes recelved relatlvely
lcw prlcrlty. Clven the rapld sterlllzlne effect cf rlfamplcln, the lsclatlcn cf lnfec-
tlcus T8 patlents frcm cther hcspltal patlents and frcm the ccmmunlty was nc
lcneer ccnsldered lmpcrtant. As a result, T8 lsclatlcn wards were dlsccntln-
ued, and measures such as ccueh hyelene and wearlne cf surelcal masks by
lnfectlcus patlents were nc lcneer enccuraeed. The rlsk cf lnfectlcn fcr health
wcrkers was nct thcueht tc requlre any speclñc pcllcy cr preventlve measures
except fcr labcratcry staff deallne wlth culture and uST cf M. tµbcrrµlcsis.
The lncreaslne lmpcrtance cf drue-reslstant T8, as well as the lmpact cf Flv
lnfectlcn, has led tc a reappralsal cf the lmpcrtance cf lnfectlcn ccntrcl ln
health-care and cther ccnereeate settlnes. The presence cf many Flv-lnfect-
ed and lmmuncccmprcmlsed patlents plus health-care wcrkers ln hcspltals
tceether wlth the absence cf apprcprlate lnfectlcn ccntrcl pcllcy and practlce
creates a favcurable envlrcnment fcr transmlsslcn and spread cf T8 amcne
hcspltal patlents, hcspltal wcrkers and the ccmmunlty. There ls therefcre an
ureent need tc refccus attentlcn cn T8 lnfectlcn ccntrcl, partlcularly ln hleh-
rlsk settlnes.
6.1 k|sk eI transm|ss|en eI tubercu|es|s |n hea|th-care sett|ngs
Fealth-care wcrkers are at much hleher rlsk cf T8 lnfectlcn and dlsease ccm-
pared wlth the eeneral pcpulatlcn. ln health-care settlnes, cther ncn-medlcal
staff may alsc be at rlsk thrcueh ccntact wlth lnfectlcus scurces. Measures tc
ccntrcl lnfectlcn are needed ln all settlnes where there ls a slenlñcant rlsk cf
transmlsslcn cf T8 lnfectlcn. These settlnes lnclude eeneral health facllltles
where patlents wlth ccueh and ln whcm pulmcnary T8 has been dlaencsed are
ln clcse ccntact wlth health staff and cthers ln a crcwded and pccrly ventllated
envlrcnment.
waltlne rccms (cr ccrrldcrs) where patlents and acccmpanylne pecple, lnclud-
lne chlldren, walt tc recelve medlcal care are cften areas cf partlcular rlsk. ln
hcspltals, the rlsk cf transmlsslcn ls relatlvely hleh, especlally ln pulmcnary
dlsease wards. The rlsk cf spread lncreases when the prevalence cf Flv ln the
61
6. lhFFCTl0h C0hTk0L lh FFALTF-CAkF SFTTlhCS
ccntacts (staff and cther patlents) ls hleh. Labcratcrles, partlcularly thcse car-
rylne cut M. tµbcrrµlcsis culture prccedures, are alsc hleh-rlsk areas. 0ther
hleh-rlsk settlnes lnclude lnstltutlcns such as |alls, prlscns and detentlcn cen-
tres, and drue rehabllltatlcn centres. 0ther sltuatlcns, such as enclcsed envl-
rcnments durlne prclcneed travel, may requlre speclal attentlcn.
There are speclñc strateeles tc address lnfectlcn ccntrcl, but the maln lnfectlcn
ccntrcl measure ls the prcper creanlzatlcn and lmplementatlcn cf case detec-
tlcn prccedures. Patlents recelvlne adequate treatment are rapldly rendered
ncn-lnfectlcus.
6.z InIect|en centre| strateg|es
The three levels cf T8 lnfectlcn ccntrcl are wcrkplace and admlnlstratlve (man-
aeerlal) ccntrcl measures, envlrcnmental ccntrcl measures and perscnal prc-
tectlve equlpment (resplratcry prctectlcn). Fach level cperates at a dlfferent
pclnt ln the transmlsslcn prccess:
º wcrkplace and admlnlstratlve ccntrcl measures reduce the expcsure cf staff
and patlents;
º envlrcnmental ccntrcl measures reduce the ccncentratlcn cf lnfectlcus drcp-
let nuclel;
º perscnal prctectlve equlpment (resplratcry prctectlcn) prctects staff ln spe-
clñc settlnes where the ccncentratlcn cf drcplet nuclel cannct be adequately
reduced by admlnlstratlve and envlrcnmental ccntrcl measures.
6.z.1 workplace anJ aJmlnlstratlve control measures
wcrkplace and admlnlstratlve ccntrcl measures have the ereatest lmpact cn
preventlne T8 transmlsslcn. They serve as the ñrst llne cf defence fcr prevent-
lne the spread cf T8 ln health-care settlnes. The ecals are (l) tc prevent T8
expcsure cf staff and patlents and (ll) tc reduce the spread cf lnfectlcn by
ensurlne rapld and reccmmended dlaencstlc lnvestleatlcn and treatment fcr
patlents and staff suspected cr kncwn tc have T8.
The ñve ccmpcnents cf eccd wcrkplace and admlnlstratlve ccntrcl are:
º an lnfectlcn ccntrcl plan;
º admlnlstratlve suppcrt fcr prccedures ccntalned ln the plan, lncludlne qual-
lty assurance;
º tralnlne cf health-care and cther staff;
º educatlcn cf patlents and lncreaslne ccmmunlty awareness;
º cccrdlnatlcn and ccmmunlcatlcn wlth the T8 ccntrcl prceramme.
6z
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
Fach faclllty shculd have a wrltten T8 lnfectlcn ccntrcl plan wlth a prctcccl fcr
the prcmpt reccenltlcn, separatlcn, prcvlslcn cf servlces, lnvestleatlcn fcr T8
and referral cf patlents wlth suspected cr ccnñrmed T8 dlsease. A deslenated
lnfectlcn ccntrcl cfñcer ls respcnslble fcr cverseelne the lmplementatlcn cf
lnfectlcn ccntrcl measures and prcvldlne lnfectlcn ccntrcl tralnlne fcr health-
care and cther staff whc may be expcsed tc T8 lnfectlcn.
All staff wcrklne ln a faclllty shculd understand the lmpcrtance cf lnfectlcn
ccntrcl pcllcles and thelr rcle ln lmplementlne them. As part cf tralnlne, each
health-care wcrker and staff member, lncludlne any lay wcrkers, shculd recelve
|cb cateecry-speclñc lnstructlcn. Tralnlne shculd be ccnducted befcre lnltlal
asslenment, and ccntlnulne educatlcn shculd be prcvlded tc all emplcyees and
vclunteers annually.
kemlnders that health-care wcrkers and cther staff can develcp T8, reeardless
cf prevlcus lnfectlcn status cr 8CC vacclnatlcn, shculd be elven as part cf
annual retralnlne cn lnfectlcn ccntrcl. Staff shculd be lnvestleated fcr T8 free
cf charee lf they have a ccueh fcr twc weeks cr lcneer. The lnfectlcn ccntrcl
plan shculd llst deslenated staff members tc be ccntacted tc lnltlate ccnñden-
tlal T8 lnvestleatlcns.
Patlents shculd recelve lnstructlcn cn hcw tc prctect cthers frcm expcsure tc
T8 by slmple ccueh hyelene measures.
6.z.z £nvlronmental control measures
Fnvlrcnmental ccntrcls are the seccnd llne cf defence fcr preventlne the spread
cf T8 ln health-care settlnes. lt ls lmpcrtant tc reccenlze that lf wcrkplace cr
admlnlstratlve ccntrcls are lnadequate, envlrcnmental ccntrcls wlll nct ellml-
nate the rlsk. Many envlrcnmental ccntrcl measures are technlcally ccmplex
and expenslve, and therefcre cnly practlcal fcr referral hcspltals.
Fnvlrcnmental ccntrcls lnclude:
º ventllatlcn (natural and mechanlcal)
º ñltratlcn
º ultravlclet eermlcldal lrradlatlcn.
vcntilcticn. Ccntrclled natural ventllatlcn ccnslderably reduces the rlsk cf
spreadlne M. tµbcrrµlcsis. when fresh alr enters a rccm, lt dllutes the ccncen-
tratlcn cf partlcles ln rccm alr, such as drcplet nuclel ccntalnlne M. tµbcrrµlc-
sis. hatural ventllatlcn relles cn cpen dccrs and wlndcws tc brlne ln alr frcm
the cutslde; ccntrclled natural ventllatlcn lncludes checks tc ensure that dccrs
and wlndcws are malntalned ln an cpen pcsltlcn that enhances ventllatlcn.
Fans may alsc asslst ln dlstrlbutlne the alr. Fcwever, the use cf celllne fans ls

cnly |ustlñed lf there ls free alr fcw cut frcm the rccm thrcueh cpen wlndcws.
ueslenlne waltlne areas and examlnatlcn rccms tc maxlmlze natural ventllatlcn
can slenlñcantly reduce the spread cf T8. ln warm cllmates, cpen-alr shelters
wlth a rccf tc prctect patlents frcm sun and raln are apprcprlate.
heeatlve pressure ventllatlcn ls ancther methcd used tc prevent ccntamlnated
alr frcm fcwlne cut cf the rccm lntc ad|acent areas ln labcratcry cr health-care
facllltles, by malntalnlne an alr pressure dlfference between the twc areas. Alr
ls drawn lntc the rccm frcm ad|acent areas and exhausted dlrectly tc the cut-
slde, remcvlne and dllutlne any lnfectlcus partlcles. Thls may be the methcd cf
chclce ln scme settlnes, dependlne cn factcrs lncludlne cllmatlc ccndltlcns and
avallable rescurces. The necessary equlpment requlres ccntlnued malntenance
and the alr exchanee rate may be less than that achleved by well-deslened
natural ventllatlcn.
when patlents prcvlde sputum smear speclmens fcr T8 dlaencsls, they shculd
dc sc cutslde, ln the cpen alr away frcm cther pecple. when thls ls nct pcs-
slble because cf cllmatlc ccnstralnts, lt shculd be dcne ln an adequately ventl-
lated bccth and nct ln small rccms such as tcllets cr cther enclcsed areas.
liltrcticn. ln small rccms wlth a llmlted number cf patlents cr ln cther small,
enclcsed areas, rccm alr cleaners wlth hleh efñclency partlculate alr (FFPA)
ñlters may be a useful alternatlve tc mechanlcal ventllatlcn requlrlne structural
chanees. kccm alr cleaners wlth FFPA ñlters may be free-standlne cr may be
permanently attached tc fccrs cr celllnes tc mlnlmlze tamperlne. Ccrrect maln-
tenance cf the ñlter ls essentlal.
ultrcviclct ccrmiridcl irrcdicticn. M. tµbcrrµlcsis ls kllled lf the creanlsms are
expcsed tc sufñclent ultravlclet eermlcldal lrradlatlcn (uvCl). Fcwever, effec-
tlveness depends cn clcse ccntact wlth the uv lleht scurce and may be llmlted
lf humldlty ls hleh (cver 6o%) and where dust levels are hleh. uv llehts shculd
be dlrected tc the celllne, asscclated wlth adequate alr fcw and reeularly maln-
talned. The ma|cr ccncerns abcut lnadequately lnstalled and malntalned uvCl
have been adverse reactlcns, such as acute and chrcnlc skln and eye chanees
resultlne frcm cverexpcsure. Fcr these reascns, and because cf lnablllty tc
assess lts effectlveness ln ñeld ccndltlcns, uvCl ls nct eenerally reccmmended
as a methcd tc dlslnfect rccm alr ln patlent wards.
6.z.y Personal protectlve equlpment (resplratory protectlon)
Perscnal resplratcry prctectlcn lnvclves tralnlne ln the selectlcn and use cf
resplratcrs. kesplratcrs shculd nct be relled upcn tc prctect health care wcrk-
ers frcm lnhallne M. tµbcrrµlcsis ln the absence cf standard wcrkplace and
envlrcnmental ccntrcls. They are expenslve, requlre speclallzed equlpment tc
ensure prcper ñt and are cften unavallable ln rescurce-llmlted settlnes. Thelr
6. lhFFCTl0h C0hTk0L lh FFALTF-CAkF SFTTlhCS
6q
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
use shculd be restrlcted tc speclñc hleh-rlsk areas ln hcspltals and referral
centres, such as rccms where splrcmetry cr brcnchcsccpy are perfcrmed cr
speclallzed treatment centres fcr patlents wlth Muk-T8. lf a resplratcr ls need-
ed, a uSA-certlñed h¤ç (cr ereater) cr Fu-certlñed FFPz (cr ereater) resplratcr
shculd be used.
kesplratcrs shculd be dlstlneulshed frcm face masks, such as surelcal masks
made cf clcth cr paper. use cf face masks ls nct eenerally reccmmended fcr
health-care staff because they dc nct prctect aealnst T8 transmlsslcn by aerc-
scl.
Fcwever, the use cf face masks ln hleh-rlsk settlnes fcr drue reslstant-T8 ls
reccmmended fcr patlents tc reduce the rlsk cf drcplet nuclel eeneratlcn and
spread, partlcularly ln hleh-prevalence Flv settlnes where many health-care
wcrkers may be Flv-lnfected. kesplratcry prctectlcn may be used as an lnterlm
measure whlle selected admlnlstratlve and/cr envlrcnmental ccntrcl measures
are awaltlne lmplementatlcn.
Wh0 gu|de||nes
Cµidclincs [cr thc prcvcnticn c[ tµbcrrµlcsis in hcclth rcrc [crilitics in rcscµrrc-limitcd
scttincs. Ceneva, wcrld Fealth 0reanlzatlcn, 1¤¤¤ (wF0/CuS/T8/¤¤.z6¤).
Cµidclincs [cr thc prccrcmmctir mcncccmcnt c[ drµc-rcsistcnt tµbcrrµlcsis. Ceneva,
wcrld Fealth 0reanlzatlcn, zoo6 (wF0/FTM/T8/zoo6.¸61).
ln[crticn prcvcnticn cnd rcntrcl c[ cpidcmir-prcnc cnd pcndcmir-prcnc crµtc rcspirc-
tcrv disccscs in hcclth rcrc. wh0 lntcrim Cµidclincs. Ceneva, wcrld Fealth 0reanl-
zatlcn, zoo; (wF0/CuS/FPk/zoo;.6; avallable at http://www.whc.lnt/csr/rescurces/
publlcatlcns/wF0_CuS_FPk_zoo;_6c.pdf; accessed February zoo8).
1µbcrrµlcsis in[crticn rcntrcl in thc crc c[ cxpcndinc hlv rcrc cnd trcctmcnt - Addcn-
dµm tc wh0 Cµidclincs [cr thc prcvcnticn c[ tµbcrrµlcsis in hcclth rcrc [crilitics
in rcscµrrc-limitcd scttincs. Ceneva, wcrld Fealth 0reanlzatlcn, zoo; (wF0/FTM/
T8/¤¤.z6¤).
key reIerences
8asu S et. al. Preventlcn cf ncscccmlal transmlsslcn cf extenslvely drue-reslstant
tuberculcsls ln rural Scuth Afrlcan dlstrlct hcspltals: an epldemlclcelcal mcdelllne
study. lcnrct, zoo;, ¸;o:1çoo-1ço;.
Culdellnes fcr preventlne the transmlsslcn cf Mvrcbcrtcriµm tµbcrrµlcsis ln health-
care settlnes, zooç. Mcrbiditv cnd Mcrtclitv wccklv kcpcrt, zooç, çu:1-1u1 (avallable
at: http://www.cdc.ecv/mmwr/PuF/rr/rrçu1;.pdf; accessed February zoo8).
Fsccmbe A, 0eser C, Martlnez C. hatural ventllatlcn tc reduce ncscccmlal transmlsslcn
cf tuberculcsls and cther alrbcrne lnfectlcns. lntcrncticncl lcµrncl c[ 1µbcrrµlcsis cnd
lµnc 0isccsc, zooç, ¤:Sç6-Sç;.

Pal M. Prctectlne health-care wcrkers frcm tuberculcsls ln the era cf extenslvely drue-
reslstant tuberculcsls. Ncticncl Mcdircl lcµrncl c[ lndic, zoo;, zo:1-¸.
ka|lnlsh l et al. Tuberculcsls amcne health-care wcrkers ln lcw- and mlddle-lnccme
ccuntrles: a systematlc revlew. Pµblir librcrv c[ Sricnrc, zoo6, ¸:z¸;6-z¸¤1.
Menzles u, lcshl k, Pal M. klsk cf tuberculcsls lnfectlcn and dlsease asscclated wlth
wcrk ln health-care settlnes. lntcrncticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc,
zoo;, 11:1-1¸.
6. lhFFCTl0h C0hTk0L lh FFALTF-CAkF SFTTlhCS
66
; lscnlazld preventlve therapy
P
reventlve therapy, alsc kncwn as chemcprcphylaxls, wlth lscnlazld reduces
the rlsk cf (l) a ñrst eplscde cf T8 cccurrlne ln pecple expcsed tc lnfectlcn
cr wlth latent lnfectlcn and (ll) a recurrent eplscde cf T8. Althcueh all pecple
wlth latent T8 lnfectlcn whc take lscnlazld beneñt, the ereatest reductlcn ln
lnfectlcn ls cbserved ln Flv-neeatlve patlents and ln TST- and Flv-pcsltlve
lndlvlduals.
wF0 reccmmends lscnlazld taken at a dally dcse cf ç me/ke (maxlmum
¸oo me) fcr at least slx mcnths, and ldeally fcr nlne mcnths. Shcrter rlfamplcln-
ccntalnlne reelmens have shcwn slmllar efñcacy ccmpared wlth 6-¤ mcnths
cf lscnlazld mcnctherapy, but rlfamplcln-ccntalnlne reelmens are mcre llkely
tc be dlsccntlnued because cf adverse effects. lncreased rates cf hepatctcxlc-
lty and death ln Flv-unlnfected lndlvlduals have been repcrted fcr reelmens
ccntalnlne rlfamplcln and pyrazlnamlde. Fcwever, thls rlsk appears tc be llm-
lted tc Flv-unlnfected lndlvlduals, as a rlecrcus re-analysls cf a laree trlal cf
rlfamplcln and pyrazlnamlde ln Flv-lnfected patlents ccnñrmed an absence cf
serlcus tcxlclty.
Preventlve therapy has been used malnly fcr lts beneñclal effect ln the lndl-
vldual. At a pcpulatlcn level, mathematlcal mcdelllne cf ccmmunlty-wlde pre-
ventlve therapy ln settlnes wlth a hleh burden cf bcth Flv and T8 sueeests that
thls strateey may ccntrlbute tc a reductlcn ln the lncldence cf T8.
The lmpact cf preventlve therapy prcerammes cn the emereence cf drue resls-
tance ls nct yet kncwn. Llmlted ñndlnes dc nct exclude an lncreased rlsk cf
lscnlazld-reslstant T8 after lPT.
The maln ercups fcr preventlve therapy under prcerammatlc ccndltlcns are
thcse at mcst rlsk cf prceresslne tc T8 dlsease. These are (l) PLFlv, (ll) lnfants
and chlldren whc are ccntacts cf T8 patlents and (lll) recent TST ccnverters,
slnce the rlsk cf develcplne actlve T8 ls lncreased ln the ñrst few years.
).1 Isen|az|d prevent|ve therapy |n ch||dren
See Chapter u.
6)
;. lS0hlAZlu PkFvFhTlvF TFFkAP¥
).z Isen|az|d prevent|ve therapy |n recent 151 cenverters
Treatment wlth lscnlazld cf TST-pcsltlve lndlvlduals llvlne ln settlnes wlth hleh
prevalence cf T8 ls hlehly efñcaclcus ln reduclne the rlsk cf develcplne actlve
T8. Preventlve therapy ls therefcre reccmmended fcr TST-pcsltlve lndlvlduals
whc dc nct have actlve T8.
TST may nct ldentlfy recently lnfected ccntacts, especlally chlldren, and may
nct be pcsltlve ln pecple wlth M. tµbcrrµlcsis and Flv cclnfectlcn because cf
reduced lmmune respcnslveness. TST may alsc be neeatlve ln apprcxlmately
zç% cf Flv-neeatlve pecple wlth actlve T8.
).¶ Isen|az|d prevent|ve therapy |n peep|e ||v|ng w|th hIv
The rlsk cf T8 ln lndlvlduals lnfected wlth bcth M. tµbcrrµlcsis and Flv ls much
hleher than fcr thcse wlthcut Flv lnfectlcn, at ç-1o% rlsk per year and ç-1o%
llfetlme rlsk respectlvely. Treatment wlth lscnlazld cf lndlvlduals whc are bcth
TST- and Flv-pcsltlve, llvlne ln settlnes wlth hleh prevalence cf T8, reduces the
rlsk cf develcplne actlve T8 by arcund 6o% (l.e. tc arcund uo% cf what lt wculd
have been wlthcut the treatment). wF0 therefcre reccmmends that lnfcrma-
tlcn abcut lPT shculd be made avallable tc all PLFlv and that lPT shculd be
cffered, as part cf the packaee cf care, tc all TST-pcsltlve Flv-lnfected lndlvldu-
als ln whcm actlve T8 has been safely excluded.
ln sltuatlcns where TST cannct be perfcrmed, treatment cf Flv-pcsltlve lndl-
vlduals wlth lscnlazld reduces the rlsk cf develcplne actlve T8 by arcund uo%
(l.e. tc arcund 6o% cf what lt wculd have been wlthcut the treatment). lf TST
testlne ls nct avallable, the fcllcwlne lndlvlduals shculd be ccnsldered fcr pre-
ventlve therapy lf they are lnfected wlth Flv:
º pecple llvlne ln pcpulatlcns wlth a hleh prevalence cf M. tµbcrrµlcsis lnfec-
tlcn (estlmated tc be ·¸o%);
º health-care wcrkers;
º hcusehcld ccntacts cf T8 patlents;
º prlscners;
º mlners;
º cther selected ercups at hleh rlsk cf acqulrlne cr transmlttlne T8.
T8 and Flv ccntrcl prcerammes shculd ccllabcrate tc ensure prcvlslcn cf lPT
as part cf the packaee cf care fcr PLFlv when actlve T8 has been excluded, and
lnfcrmatlcn abcut lPT shculd be made avallable tc all PLFlv. Slnce PLFlv are
usually ln ccntact wlth health-care servlces, there are cppcrtunltles tc prcvlde
lPT and enccuraee adherence.
68
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
All pecple attendlne Flv ccunselllne and testlne shculd be asked whether they
have a ccueh and cther symptcms such as fever cr weleht lcss; thcse whc dc
shculd be screened fcr T8. Thcse fcund tc have T8 shculd be reelstered and
treated by the T8 ccntrcl prceramme. CXk ls reccmmended tc exclude actlve T8
befcre ccnslderlne preventlve therapy. (Fcwever, excluslcn cf actlve T8 may be
mcre dlfñcult ln thls ercup as many Flv-pcsltlve patlents are smear-neeatlve and
radlceraphlc ñndlnes may be less speclñc.) Screenlne based sclely cn symptcms
has been fcund adequate tc exclude actlve T8 amcne asymptcmatlc Flv-pcsltlve
patlents ln trlal settlnes. The efñcacy cf uslne symptcm-based screenlne alcne tc
exclude actlve T8 ln prcerammatlc settlnes needs tc be valldated.
ln pcpulatlcns wlth a hleh prevalence cf T8, the duratlcn cf beneñt fcllcwlne
ccmpletlcn cf a full slx-mcnth ccurse cf lPT ls llmlted (up tc z.ç years). Thls ls
prcbably the result cf ccntlnued expcsure tc M. tµbcrrµlcsis lnfectlcn.
The use cf preventlve therapy ln ccmblnatlcn wlth AkT fcr PLFlv may be ben-
eñclal but has nct been fully evaluated. Preventlve therapy elven after a full
ccurse cf antl-T8 treatment has reduced the rlsk cf recurrent T8 ln PLFlv ln
several settlnes, but dld nct prclcne survlval. Fcwever, the rlsks resultlne frcm
nct uslne lPT shculd be taken lntc acccunt (lnfectlcn ccntrcl, lncreased mcrbld-
lty, transmlsslcn, etc.).
).q Prevent|ve therapy |n pregnancy
wF0 reccmmends treatment cf actlve T8 durlne preenancy but has nct devel-
cped reccmmendatlcns cn preventlve therapy durlne preenancy (see Chapter
z). The use cf lPT when cllnlcal and labcratcry mcnltcrlne cannct be ensured ls
ccntrcverslal because cf repcrts cf lscnlazld-related hepatctcxlclty ln preenant
and pcstpartum patlents.
Wh0 gu|de||nes
Chrcnir hlv rcrc with Akv thcrcpv cnd prcvcnticn: intcrim cµidclincs [cr hcclth
wcrkcrs ct hcclth rcntrc cr distrirt hcspitcl cµtpcticnt rlinir. Ceneva, wcrld
Fealth 0reanlzatlcn, zoo6 (avallable at: http://www.whc.lnt/¸byç/publlcatlcns/
dccuments/chrcnCareMcdCenuraftkev1.pdf; accessed February zoo8).
Cµidcnrc [cr ncticncl tµbcrrµlcsis prccrcmmcs cn thc mcncccmcnt c[ tµbcr-
rµlcsis in rhildrcn. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6 (wF0/FTM/
T8/zoo6.¸;1).
lntcrim pclirv cn rcllcbcrctivc 18/hlv crtivitics. Ceneva, wcrld Fealth 0reanl-
zatlcn, zoou (wF0/FTM/T8/zoou.¸¸o).
18/hlv: c rlinircl mcnµcl, znd ed. Ceneva, wcrld Fealth 0reanlzatlcn, zoou
(wF0/FTM/T8/zoou.¸z¤).

key reIerences
Churchyard Cl et al. Tuberculcsls preventlve therapy ln the era cf Flv lnfec-
tlcn: cvervlew and research prlcrltles. lcµrncl c[ ln[crticµs 0isccscs, zoo;,
1¤6:Sçz-S6z.
Currle CSM et al. Tuberculcsls epldemlcs drlven by Flv: ls preventlcn better
than cure: Al0S, zoo¸, 1;:zço1-zço8.
uye C, wllllams 8C. Fllmlnatlne human tuberculcsls ln the twenty-ñrst century.
lcµrncl c[ thc kcvcl Scrictv, lnterface zoo;, ¤ Aueust.
Cclub lF et al. The lmpact cf antlretrcvlral therapy and lscnlazld preventlve
therapy cn tuberculcsls lncldence ln Flv-lnfected patlents ln klc de lanelrc,
8razll. Al0S, zoo;, z1(11):1uu1-1uu8.
Ccrdln FM et al. Fepatctcxlclty cf rlfampln and pyrazlnamlde ln the treatment
cf latent tuberculcsls lnfectlcn ln Flv-lnfected perscns: ls lt dlfferent than ln
Flv-unlnfected perscns: Clinircl ln[crticµs 0isccscs, zoou, ¸¤(u):ç61-ç6ç.
lntcrim pclirv cn rcllcbcrctivc 18/hlv crtivitics. Ceneva, wcrld Fealth 0reanl-
zatlcn, zoou (wF0/FTM/T8/zoou.¸¸o).
Preventlve therapy aealnst T8 ln pecple llvlne wlth Flv. wccklv Fpidcmiclccircl
kcrcrd, 1¤¤¤, ;u:¸8ç-uoo.
kavlellcne MC et al. Tuberculcsls and Flv: current status ln Afrlca. Al0S, 1¤¤;,
11 Suppl 8:S11ç-1z¸.
Smle|a Ml et al. lscnlazld fcr preventlne tuberculcsls ln ncn-Flv lnfected per-
scns. Ccrhrcnc 0ctcbcsc c[ Svstcmctir kcvicws, 1¤¤¤, 1:Cuoo1¸6¸; u0l:1o.1ooz/
1u6ç18ç8.Cuoo1¸6¸.
Tareeted tuberculln testlne and treatment cf latent tuberculcsls lnfectlcn. Mcr-
biditv cnd Mcrtclitv wccklv kcpcrt, zooo, u¤ (hc. kk-6)
18/hlv: c rlinircl mcnµcl, znd ed. Ceneva, wcrld Fealth 0reanlzatlcn, zoou
(wF0/FTM/T8/zoou.¸z¤).
wcldehanna S, vclmlnk l. Treatment cf latent tuberculcsls lnfectlcn ln Flv
lnfected perscns. Ccrhrcnc 0ctcbcsc c[ Svstcmctir kcvicws, zoou, 1:Cuooo.
;. lS0hlAZlu PkFvFhTlvF TFFkAP¥
)e
8 8CC vacclnatlcn
C
cveraee wlth 8CC vacclne reaches · 8o% cf necnates and lnfants ln ccuntrles
where lt ls part cf the natlcnal chlldhccd lmmunlzatlcn prceramme. 8CC vacclne
has dccumented prctectlve efñcacy aealnst T8 menlneltls and mlllary dlsseml-
nated dlsease ln chlldren (86% cn averaee). lt dces nct prevent prlmary lnfectlcn
and, mcre lmpcrtantly, dces nct prevent reactlvatlcn cf latent pulmcnary lnfec-
tlcn, the prlnclpal scurce cf baclllary spread ln the ccmmunlty. The lmpact cf 8CC
vacclnatlcn cn transmlsslcn cf M. tµbcrrµlcsis ls therefcre llmlted.
Wh0 recemmendat|ens en the use eI ßC6 vacc|ne
º ln ccuntrles wlth a hleh burden cf T8, a slnele dcse cf 8CC vacclne shculd
be elven tc all lnfants as sccn as pcsslble after blrth. Slnce severe adverse
effects cf 8CC vacclnatlcn are extremely rare, all healthy necnates shculd be
8CC-vacclnated, even ln areas endemlc fcr Flv.
º 8CC vacclnatlcn shculd not be elven tc (l) lnfants and chlldren wlth AluS, (ll)
lnfants and chlldren kncwn tc be Flv-lnfected cr (lll) chlldren kncwn tc have
cther lmmuncdeñclencles.
º ln sltuatlcns where lnfants have been expcsed tc smear-pcsltlve pulmcnary
T8 shcrtly after blrth, 8CC vacclnatlcn shculd be delayed untll ccmpletlcn cf
slx mcnths cf lPT.
º vacclnatlcn cf health staff, and partlcularly labcratcry wcrkers, ls an cptlcn
ln hleh-rlsk envlrcnments (ln partlcular lf staff are ln clcse ccntact wlth cases
cf drue-reslstant T8).
º There ls nc evldence that revacclnatlcn lncreases prctectlcn, and revacclna-
tlcn ls nct reccmmended.
º Ccuntrles wlth a lcw burden cf T8 may chccse tc llmlt 8CC vacclnatlcn tc
necnates and lnfants cf reccenlzed hleh-rlsk ercups fcr the dlsease cr cf
TST-neeatlve clder chlldren. ln scme lcw-burden pcpulatlcns,
1
8CC vacclna-
1
A lcw-burden pcpulatlcn ls deñned as a pcpulatlcn wlth (l) an annual nctlñcatlcn rate cf smear-
pcsltlve pulmcnary T8 cases belcw ç per 1oo ooo; cr an averaee annual nctlñcatlcn rate cf
tuberculcus menlneltls ln chlldren aeed · ç years belcw 1 per 1o mllllcn pcpulatlcn durlne the
prevlcus ñve years; cr an averaee annual rlsk cf tuberculcus lnfectlcn belcw o.1%.
)1
8. 8CC vACClhATl0h
tlcn has been replaced by lntenslñed case detectlcn and supervlsed early
treatment.
untll an lmprcved antl-T8 vacclne beccmes avallable, effcrts tc ccntrcl the
spread cf the dlsease wlll ccntlnue tc rely cn currently avallable tccls, namely
early dlaencsls and treatment, apprcprlate preventlve treatment, and cther
publlc health and lnfectlcn ccntrcl measures.
key reIerences
Fessellne AC et al. The rlsk cf dlssemlnated 8acllle Calmette-Cuérln (8CC) dlsease ln
Flv-lnfected chlldren. vcrrinc, zoo;, zç(1):1u-18.
8CC vacclne. wccklv Fpidcmiclccircl kcrcrd, zoou, u:z;-¸8.
lssµcs rclctinc tc thc µsc c[ 8CC in immµnizcticn prccrcmmcs. Ceneva, wcrld Fealth
0reanlzatlcn, 1¤¤¤ (wF0/v88/¤¤.z¸).
kleder FL. lntcrvcnticns [cr tµbcrrµlcsis rcntrcl cnd climincticn. Parls, lnternatlcnal
unlcn Aealnst Tuberculcsls and Lune ulsease, zooz.
kevlsed 8CC vacclnatlcn euldellnes fcr lnfants at rlsk fcr Flv lnfectlcn. wccklv Fpidc-
miclccircl kcrcrd, zoo;, z1:1¤¸-1¤6.
)z
¤ Preventlcn thrcueh
addresslne rlsk factcrs
C
hanees ln expcsure tc varlcus rlsk factcrs may slenlñcantly lnfuence trends
ln the lncldence cf T8 (see lntrcductlcn - Fpldemlclcey cf tuberculcsls).
keduclne the level cf expcsure cf the pcpulatlcn tc rlsk factcrs lncludlne Flv,
smcklne, dlabetes, malnutrltlcn and crcwdlne ls malnly the respcnslblllty cf
cther publlc health prcerammes as well as stakehclders cutslde the health sec-
tcr. The capaclty and mandate cf hTPs tc help reduce the prevalence cf these
rlsk factcrs ln the eeneral pcpulatlcn are llmlted. hevertheless, hTPs have
an lmpcrtant rcle tc play ln advccatlne the need tc address such rlsk factcrs
and ln suppcrtlne lmplementatlcn cf cther publlc health prcerammes as part
cf lnteerated servlce dellvery ln prlmary health care. Flv/AluS ls dlscussed ln
Chapter 1¸. 0ther selected rlsk factcrs wlth pctentlal pcpulatlcn-level lmpcr-
tance fcr T8 ccntrcl are cutllned belcw. The evldence base fcr several cf these
rlsk factcrs needs tc be strenethened.
¤.1 5mek|ng
8cth actlve and passlve smcklne lncrease (l) susceptlblllty tc T8 lnfectlcn, (ll)
prceresslcn tc actlve T8 dlsease and (lll) the rlsk cf adverse antl-T8 treatment cut-
ccmes. Systematlc revlews sueeest that the rlsk cf T8 dlsease amcne smckers ls
lncreased twc- tc threefcld ccmpared wlth pecple whc have never smcked. There
ls lnsufñclent evldence tc suppcrt an asscclatlcn cf smcklne and patlent delay,
default, slcwer smear ccnverslcn cr rlsk cf acqulred drue reslstance. welehted
smcklne prevalence acrcss ccuntrles wlth a hleh T8 burden was abcut 18% ln
zoou-zooç, wlth much hleher prevalence amcne men than amcne wcmen ln
mcst ccuntrles. The prevalence cf smcklne ls lncreaslne ln develcplne ccuntrles.
Tcbaccc ccntrcl and smcklne cessatlcn amcne pecple wlth T8 can therefcre play
an lmpcrtant rcle ln llmltlne the burden cf T8. hTPs shculd suppcrt actlvltles tc
ccntrcl use cf tcbaccc at natlcnal and lccal levels. Smcklne cessatlcn cculd be a
part cf the packaee cf servlces dellvered under PAL (see Chapter z¸).
¤.z Ma|nutr|t|en
Malnutrltlcn ls ccmmcn ln mcst ccuntrles wlth a hleh T8 burden. The welehted
prevalence cf undernutrltlcn, as deñned by the Fccd and Aerlculture 0reanlza-
tlcn cf the unlted hatlcns, acrcss the hleh T8 burden ccuntrles ls almcst zo%.
Malnutrltlcn may be llnked tc lncreased rlsk fcr T8 dlsease thrcueh lmmune

deñclency caused by deñclencles ln prcteln, enerey and/cr mlcrcnutrlents (vlta-
mlns and mlnerals). Fstlmates cf relatlve rlsk fcr T8 dlsease dlffer ccnslderably
fcr dlfferent types cf malnutrltlcn and ln dlfferent pcpulatlcns. Fcwever, the
hlstcrlcal lmpcrtance cf lmprcved nutrltlcn tc help ccntrcl T8 ln many ccuntrles
that ncw have a lcw T8 burden ls well establlshed. hTPs shculd therefcre advc-
cate fcr lmprcved nutrltlcnal status ln the pcpulatlcn, as part cf a lcne-term T8
ccntrcl and ellmlnatlcn strateey.
hTPs may ccnslder nutrltlcnal suppcrt tc T8 patlents as a part cf the packaee
cf cllnlcal care fcr patlents, whc are cften malncurlshed at the tlme cf dlaenc-
sls. Thls wculd beneñt patlents and ccntrlbute tc the lmplementatlcn cf brcad-
er nutrltlcnal prcerammes. Fcwever, lt ls unclear whether nutrltlcnal suppcrt
lmprcves treatment cutccmes fcr T8 patlents. Slnce treatment success rates
exceedlne 8ç% can be achleved wlthcut nutrltlcnal suppcrt, thls lnterventlcn
may nct prcve tc be essentlal tc reach treatment success tareets. The evldence
base ccncernlne the added value cf dlfferent types cf nutrltlcnal suppcrt fcr
T8 patlents needs tc be strenethened.
¤.¶ ß|abetes me|||tus
Fstlmates cf the relatlve rlsk fcr develcplne T8 (all types) amcne pecple wlth
dlabetes (type l cr ll) ccmpared wlth ccntrcl ercups ranee between 1.ç and 8.
ulabetes prevalence ls lncreaslne elcbally, lncludlne ln many ccuntrles where
the burden cf T8 ls hleh. The lmpllcatlcn fcr the T8 burden cf chanelne dlabetes
prevalence ls unclear. Future T8 ccntrcl strateeles may need tc lnclude expllclt
effcrts tc suppcrt publlc health prcerammes almed at reduclne dlabetes preva-
lence and lmprcvlne manaeement cf dlabetes.
¤.q Crewd|ng
Crcwdlne ls a classlcal T8 rlsk factcr. Fcusehcld cccupatlcn denslty, ventllatlcn
and humldlty lnfuence the rlsk cf expcsure tc lnfectlcus drcplets. The preclse
lncrease ln rlsk asscclated wlth dlfferent levels cf crcwdlne ls nct well estab-
llshed. lt ls clear, hcwever, that lmprcved llvlne ccndltlcns ln prlvate dwelllnes
and ln varlcus resldentlal lnstltutlcns can have an lmpcrtant lmpact cn the
transmlsslcn cf T8.
¤.¶ Indeer a|r pe||ut|en
lndccr alr pcllutlcn caused by lndccr burnlne cf sclld fuels wlthcut prcper
ventllatlcn ls a ccmmcn phencmencn ln mcst pccr ccuntrles. Mcre than ;o%
cf hcusehclds ln hleh T8 burden ccuntrles are expcsed tc thls health hazard.
A llmlted bcdy cf evldence sueeests that lndccr alr pcllutlcn may lncrease the
rlsk cf T8. lf a causal llnk ls ccnñrmed, the lmpllcatlcns at the pcpulatlcn level
wlll be lmpcrtant elven the hleh prevalence cf expcsure. hTPs mleht advccate
fcr further research cn thls tcplc.
¤. PkFvFhTl0h TFk0uCF AuukFSSlhC klSK FACT0kS
)q
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
¤.6 A|cehe| abuse and dependency
The lncreased rlsk cf T8 dlsease amcne pecple whc abuse alcchcl has been
shcwn ln many studles. Analytlcal epldemlclcelcal studles that have ccntrclled
fcr lmpcrtant ccnfcundlne factcrs have repcrted relatlve rlsk cf T8 dlsease
ranelne between z and 8 fcr pecple wlth very hleh alcchcl ccnsumptlcn cr a
dlaencsls cf alcchcl abuse cr alcchcl dependence. Thls rlsk lncrease mleht be
explalned by speclñc scclal mlxlne patterns and llvlne ccndltlcns fcr pecple
abuslne alcchcl leadlne tc lncreased rlsk cf lnfectlcn as well as by ccmprc-
mlsed lmmunlty llnked tc tcxlc effects cf alcchcl cr tc medlcal ccndltlcns
caused by alcchcl abuse. A deñnlte causal llnk between alcchcl abuse and T8
dlsease has nct yet been establlshed.
¤.) 5|||ces|s and ether rare chren|c cend|t|ens
Slllccsls, and a wlde ranee cf cther chrcnlc dlseases, mallenancles, systemlc
lllnesses and lmmuncsuppressant treatments, lncreases the rlsk cf T8 dlsease
dramatlcally. Prevalence cf slllccsls ls hleh ln certaln pcpulatlcn ercups where
emplcyment ln the mlnlne lndustry ls ccmmcn. Mcst cf the cther rlsk factcrs
are prcbably cf llmlted lmpcrtance at a pcpulatlcn level.
key reIerences
A wh0/1hc unicn Mcnccrcph cn 18 cnd tcbcrrc rcntrcl. Ceneva, wcrld Fealth
0reanlzatlcn. lnternatlcnal unlcn Aealnst Tuberculcsls and Lune ulseases. wF0/FTM/
T8/zoo;.¸¤o; lS8h ¤;8 ¤z u 1ç¤6zz o
Ceelelskl lP, McMurray uh. The relatlcnshlp between malnutrltlcn and tuberculcsls:
evldence frcm studles ln humans and experlmental anlmals. lntcrncticncl lcµrncl c[
1µbcrrµlcsis cnd lµnc 0isccsc, zoou, 8:z86-z¤8.
lµcl [cr li[c: hcµschcld cncrcv cnd hcclth. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6.
Lln FF, Fzzatl M, Murray M. Tcbaccc smcke, lndccr alr pcllutlcn and tuberculcsls: a
systematlc revlew and meta-analysls. PlcS Mcdirinc, zoo;, u:ezo.
Pcnce-de-Lecn A et al. Tuberculcsls and dlabetes ln scuthern Mexlcc. 0icbctcs Ccrc,
zoou, z;:1ç8u-1ç¤o.
kleder FL. Fpidcmiclccir bcsis c[ tµbcrrµlcsis rcntrcl. Parls, lnternatlcnal unlcn
Aealnst Tuberculcsls and Lune ulsease, 1¤¤¤.
Stevenscn Ck et al. ulabetes and the rlsk cf tuberculcsls: a neelected threat tc publlc
health: Chrcnir lllncss, zoo;, ¸:zz8-zuç.
Tcman K. what were the maln ñndlnes cf the Madras study ccmparlne hcme and sana-
tcrlum treatment: ln: Frleden T, ed. 1cmcn´s tµbcrrµlcsis: rcsc dctcrticn, trcctmcnt
cnd mcnitcrinc, znd ed. Ceneva, wcrld Fealth 0reanlzatlcn, zoou.
watt Cl et al. The elcbal epldemlclcey cf tuberculcsls. ln: Schaaf FS, Zumla A, eds.
1µbcrrµlcsis. Lcndcn, Clcbal Medlclne, zoo;.
wh0 [rcmcwcrk rcnvcnticn cn tcbcrrc rcntrcl. Ceneva, wcrld Fealth 0reanlzatlcn,
zoo¸.
PAkT ll
Prcerammatlc manaeement
cf tuberculcsls
The hTP ls cne cf the ccmpcnents cf the natlcnal health system.
lt ls respcnslble fcr ensurlne that the entlre health system carrles
cut the actlcns necessary tc reduce mcrtallty and mcrbldlty frcm
T8 and lnterrupt transmlsslcn cf the dlsease. Thls requlres llnkaees
and ccllabcratlcn cutslde the mlnlstry cf health, slnce many health-
care facllltles are ecverned by cther mlnlstrles, such as thcse fcr
|ustlce, defence, labcur, educatlcn, scclal welfare and transpcrt.
The hTP ls alsc respcnslble fcr ccmmunlcatlne tc declslcn-makers
cutslde the health sectcr the need tc address the scclceccncmlc and
envlrcnmental determlnants cf T8 ln crder tc ensure lcne-term ccntrcl
and ellmlnatlcn cf the dlsease (see Chapter ¤).
The hTP ls respcnslble fcr settlne pcllcy standards, develcplne
prceramme euldellnes and tralnlne materlals, ensurlne that sufñclent
ñnanclal and human rescurces are avallable, and mcnltcrlne the
prccess and results cf prceramme lmplementatlcn. ln an lnteerated
system, lt ls respcnslble fcr ensurlne that T8-related servlces are
prcvlded prcperly thrcueh eeneral health servlces. Fcr effectlve T8
servlces tc reach all sectlcns cf the pcpulatlcn, the hTP shculd wcrk
ln clcse ccllabcratlcn wlth ccmmunltles and wlth all relevant publlc as
well as prlvate health-care prcvlders. Chapter 1o cutllnes the ncrmal
structure, creanlzatlcn and functlcns cf an hTP.
))
1o Manaeerlal structure
1e.1 0rgan|zat|en eI nat|ena| tubercu|es|s centre| pregrammes
S
cme cf the key elements cf effectlve T8 ccntrcl prceramme manaeement
are:
º a central unlt ln the mlnlstry cf health, tc ensure pclltlcal, technlcal and
cperatlcnal suppcrt, prcvlde stewardshlp, eenerate rescurces and cversee
prceramme manaeement;
º clearly ldentlñed and acccuntable dlstrlct/8Mu T8 cccrdlnatcrs;
º strateelc and technlcal dccuments and plans: a prceramme manual, lnclud-
lne technlcal and cperatlcnal euldellnes, hTP medlum-term strateelc plan
and annual cperatlcnal plan, and eccncmlc analysls tc make best use cf
rescurces;
º a human rescurces develcpment prceramme and plan, tc ccver all aspects
cf natlcnal pcllcy fcr T8 ccntrcl;
º a reccrdlne and repcrtlne system, tc prcvlde data fcr mcnltcrlne and evalu-
atlcn;
º a tralnlne prceramme ccverlne all aspects cf the natlcnal pcllcy fcr T8 ccn-
trcl;
º a natlcnwlde functlcnal quallty assurance system, tc prcmcte hleh-quallty
standards ln all facllltles lnvclved ln T8 servlces;
º a netwcrk cf quallty-assured labcratcry servlces fcr bacterlclcelcal dlaenc-
sls cf T8;
º a servlce netwcrk fcr T8 care dlaencsls and treatment, lnvclvlne publlc and
prlvate prlmary health-care prcvlders and the cther levels cf the health-care
system;
º a prccurement and dlstrlbutlcn system that ensures a reeular supply cf hleh-
quallty drues and dlaencstlc materlals;
º a mcnltcrlne and evaluatlcn system, lncludlne a reccrdlne and repcrtlne
system, a supervlslcn prceramme and the prcvlslcn cf technlcal suppcrt tc
perlpheral levels;
)8
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
º creanlzed supervlslcn and technlcal suppcrt;
º natlcnal ccmmlttees cr partnershlps tc prcmcte T8 care, lncludlne ccllabcra-
tlcn wlth cther prcerammes such as the natlcnal Flv ccntrcl prceramme;
º a system cf advccacy, ccmmunlcatlcn and scclal mcblllzatlcn;
º plannlne, lncludlne eccncmlc analysls tc make best use cf rescurces;
º cperatlcnal research actlvltles.
The dlrect respcnslbllltles and rescurces cf the hTP wlll vary acccrdlne tc the
pclltlcal structure and health system cf the ccuntry as well as the natlcnal T8
burden.
º The develcpment cf euldellnes and tralnlne materlals wlth lnvclvement cf
technlcal experts (academla, cllnlcal lnstltutlcns, lnstltutlcns that prcvlde
tralnlne) ls usually a dlrect respcnslblllty cf the hTP.
º 8acterlclcey servlces are usually a part cf, and the respcnslblllty cf, the
eeneral labcratcry servlces netwcrk. hTP lnput may vary frcm cccrdlnatlcn
cnly tc ensurlne servlces by prcvldlne suppcrt, plannlne, supervlslcn and
mcnltcrlne.
º urue supplles may be ñnanced, prc-
cured and dlstrlbuted by the hTP, cr
lts lnvclvement may be llmlted tc
plannlne and mcnltcrlne, wlth prc-
curement and dlstrlbutlcn ensured
thrcueh the essentlal drue prc-
eramme cf the mlnlstry cf health.
Scrvirc dclivcrv shculd be lnteerated at
the perlpheral level cf the health serv-
lces. The need fcr speclallzed lnstltu-
tlcns and prcfesslcnals (seccnd and
thlrd level cf care) wlll vary acccrdlne tc
the burden cf dlsease. Tc ensure apprc-
prlate servlce dellvery at the perlpheral
level, the hTP usually has the fcllcwlne
creanlzatlcnal structure (8cx 1o.1):
º Ccntrcl lcvcl. The central unlt ln scme
hTPs has dlrect access tc and pays the salarles cf health wcrkers at the
perlpheral-level health facllltles and dlstrlct hcspltals that prcvlde dlaencsls
and treatment cf T8. The central unlt cccrdlnates suppcrt at all levels fcr
the servlce dellvery at the perlpheral level. lts functlcns are summarlzed ln
sectlcn 1o.z belcw.
ß0X :e.:
0RCAktZA1t0kAL 51RUC1UR£ 0f A
1¥PtCAL kA1t0kAL 1UߣRCUL05t5
C0k1R0L PR0CRAMM£ (k1P)
Central unlt, lncludlne natlcnal
T8 reference labcratcry, wlth hTP
manaeer, technlcal cfñcers and
suppcrt staff
keelcnal/prcvlnclal cccrdlnatcrs
speclñc fcr T8 ccntrcl, lncludlne
reelcnal reference T8 labcratcry
ulstrlct (baslc manaeement unlt)
cccrdlnatcrs speclñc fcr T8 ccntrcl
cr wlth multlple respcnslbllltles,
lncludlne T8 labcratcry servlces
Fealth servlce dellvery pclnts - T8
servlces, lncludlne labcratcry,
lnteerated lntc eeneral health
servlces

1o. MAhACFklAL STkuCTukF
º kccicncl/prcvinricl lcvcl. ln many ccuntrles, servlce dellvery ls cccrdlnated
and facllltated frcm reelcnal- cr prcvlnclal-level settlnes. ln many laree ccun-
trles, the hTP has a full-tlme T8 cccrdlnatcr at thls level tc facllltate and
cccrdlnate servlce dellvery at cther levels.
º 0istrirt (8Mu} lcvcl. At dlstrlct (8Mu) level ln lnteerated prcerammes, the
dlstrlct health cfñcers are eenerally respcnslble fcr the cperatlcn cf all
publlc health prcerammes wlthln thelr eeceraphlcal area cf respcnslblllty,
lncludlne T8 tralnlne, supervlslcn, drue supply and mcnltcrlne. uependlne
cn the wcrklcad, cne cr mcre staff may be dedlcated tc T8 ccntrcl actlvltles,
cr cne staff member may be respcnslble fcr the actlvltles cf mcre than cne
prceramme.
º Pcriphcrcl lcvcl. The dlrectcr cf the perlpheral health faclllty ls respcnslble
fcr servlce prcvlslcn and staff manaeement. T8 care ls usually prcvlded by
a number cf eeneral health wcrkers. lf the wcrklcad ls hleh, T8 care may
be asslened tc speclñc staff fcr better creanlzatlcn and tralnlne, cr shared
between several tralned pecple tc ensure ccntlnuatlcn cf servlces durlne
staff absences.
The central, reelcnal and dlstrlct levels are respcnslble fcr the manaeerlal
ccmpcnents cf the prceramme, whlle the perlpheral level cf health facllltles
dellvers prceramme servlces tc the pcpulatlcn. Cccd cccrdlnatlcn between
staff at each level ls essentlal, as well as between all relevant publlc and prl-
vate health-care prcvlders dellverlne T8 dlaencsls and treatment servlces. T8
ccntrcl staff at central and lntermedlate levels cversee the lmplementatlcn cf
technlcal pcllcles, deslen the plannlne framewcrk, evaluate results, cccrdlnate
T8 ccntrcl actlvltles wlth cther prcerammes, aeencles and lnstltutlcns, and
prcvlde expert euldance tc the dlstrlct health team. Staff functlcns ln the hTP
shculd be clearly deñned fcr each level.
Ccuntry cccrdlnatlcn mechanlsms (e.e. lnteraeency cccrdlnatlcn ccmmlttees
cr natlcnal Stcp T8 partnershlps) are belne establlshed ln many ccuntrles tc
address the lncreaslne need tc cccrdlnate actlvltles wlth cther prcerammes
and wlth lccal and lnternatlcnal partners. T8 ccntrcl prcerammes shculd estab-
llsh ccllabcratlve mechanlsms wlth natlcnal Flv ccntrcl prcerammes, cften
thrcueh a natlcnal T8/Flv wcrklne ercup.
1e.z funct|ens eI nat|ena| tubercu|es|s centre| pregrammes
The cverarchlne functlcn cf the hTP ls the creanlzatlcn and dellvery cf T8 care
and preventlcn servlces tc detect and cure all pecple wlth T8. Table 1o.1 shcws
the ccre functlcns cf the hTP at dlfferent levels cf the health-care system.
A ccmprehenslve apprcach tc T8 ccntrcl requlres an adequately and apprcprl-
ately staffed central T8 unlt. The mlnlstry cf health shculd ensure that thls unlt
8e
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
1AßL£ :e.: MAlh FuhCTl0hS 0F TFF hATl0hAL Tu8FkCuL0SlS C0hTk0L Pk0CkAMMF (hTP)
AT ulFFFkFhT LFvFLS
Leve|
Nat|ena| Prev|nc|a|/
reg|ena|
ß|str|ct (bas|c
management un|t - ßMu)
Fcrmulatlne pcllcles and
strateeles: hTP manual
Ccntrlbutlne tc
develcpment cf natlcnal
pcllcles and strateeles
Ccntrlbutlne tc
develcpment cf natlcnal
pcllcles and strateeles
Plannlne and budeetlne
actlvltles fcr T8 ccntrcl
Plannlne and budeetlne
actlvltles fcr T8 ccntrcl
Plannlne and budeetlne
actlvltles fcr T8 ccntrcl
Plannlne human rescurce
develcpment, lncludlne llnks
wlth medlcal, nurslne and
labcratcry technlclan schccls
Plannlne human rescurce
develcpment
Plannlne and manaelne
human rescurces
Prcduclne and updatlne tralnlne
Materlals; ccnductlne tralnlne fcr
prcvlnclal/reelcnal cfñcers
Ccnductlne tralnlne cf
dlstrlct cfñcers
Ccnductlne tralnlne cf
lccal staff, lncludlne cf
cllnlcal staff and ccmmunlty
treatment suppcrters
Supervlslcn cf and technlcal
suppcrt tc prcvlnces/reelcns
Supervlslcn cf and
technlcal suppcrt tc
dlstrlcts/8Mu
Supervlslcn cf and technlcal
suppcrt tc cllnlcs
Cccrdlnatlne actlvltles undertaken
by dlfferent mlnlstrles, prcerammes,
sectcrsand partners
Cccrdlnatlne actlvltles
undertaken by dlfferent
prcerammes and partners
Cccrdlnatlne actlvltles
undertaken by dlfferent
prcerammes and partners
Asslstlne departments ln the
mlnlstry cf health tc deñne
speclñcatlcns cf and needs fcr
medlclnes, labcratcry materlals
and equlpment and supplles
Supply and dlstrlbutlcn cf
medlclnes and cther
ccmmcdltles tc dlstrlcts/
8Mu
Supply and dlstrlbutlcn cf
medlclnes and cther
ccmmcdltles tc cllnlcs
Cccrdlnatlne labcratcry actlvltles
wlth prceramme needs
Cccrdlnatlne labcratcry
actlvltles wlth prceramme
needs
Cccrdlnatlne labcratcry
actlvltles wlth prceramme
needs
Mcnltcrlne and evaluatlcn (data
manaeement), lncludlne assessment
cf prceramme prceress aealnst
cb|ectlves/tareets
Mcnltcrlne and evaluatlcn
cf dlstrlct/8Mu results
keccrdlne and repcrtlne;
mcnltcrlne and evaluatlcn
Advccacy, ccmmunlcatlcn and
scclal mcblllzatlcn; eneaelne
clvll scclety
Advccacy, ccmmunlcatlcn
and scclal mcblllzatlcn;
eneaelne clvll scclety
Advccacy, ccmmunlcatlcn
and scclal mcblllzatlcn,
lncludlne clvll scclety and
ccmmunlty lnvclvement ln
suppcrt tc patlents
0peratlcnal research 0peratlcnal research Ccntrlbutlne tc cperatlcnal
research actlvltles
81
has a multldlsclpllnary team lncludlne, as a mlnlmum, a prceramme manaeer, a
lcelstlcs cfñcer and an epldemlclcelst/statlstlclan. ln laree ccuntrles, the team
shculd alsc lnclude staff respcnslble fcr tralnlne and ACSM, and fcr supervlslne
and mcnltcrlne actlvltles at reelcnal and dlstrlct levels. Staff respcnslble fcr
publlc-prlvate mlx (PPM), drue-reslstant T8 manaeement and T8/Flv ccllabcra-
tlve actlvltles may alsc be needed ln scme ccuntrles. ln small ccuntrles, and
ln lareer ccuntrles wlth a lcw T8 burden, the team may alsc be respcnslble fcr
cther dlsease ccntrcl prcerammes. The head cf the natlcnal T8 reference labc-
ratcry shculd be a member cf the central unlt, whether cr nct the labcratcry ls
under the admlnlstratlcn cf the mlnlstry cf health.
A full-tlme reelcnal T8 cccrdlnatcr (fcr a reelcn, cr fcr a prcvlnce cr state ln
federal ecvernment structures) shculd cversee the reelcnal T8 prceramme.
The head cf the reelcnal T8 labcratcry wlll be a member cf the team. ln laree
reelcns, the reelcnal T8 cccrdlnatcr wlll need the suppcrt cf prceramme super-
vlscrs and staff fcr lcelstlcs and statlstlcs.
The dlstrlct (8Mu) ls the mcst perlpheral manaeerlal level wlthln the publlc
health-care system. usually, lt has respcnslblllty fcr a pcpulatlcn cf 1oo ooo
tc çoo ooo ln an area, munlclpallty, clrcumscrlptlcn cr clty ward. The dlstrlct
T8 cccrdlnatcr ln the 8Mu, whc may alsc be respcnslble fcr cther dlsease
prcerammes, ls under the supervlslcn cf the dlstrlct, medlcal cfñcer ln charee
cf the 8Mu. The dlstrlct 8Mu level lnltlates cr expands T8 ccntrcl prceramme
lmplementatlcn ln the dlstrlct health facllltles cf the area and mcnltcrs lts
lmplementatlcn at perlpheral level.
key reIerences
8csman M. Fealth sectcr refcrm and tuberculcsls ccntrcl: the case cf Zambla. lntcrnc-
ticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zooo, u(;):6o6-61u.
Fnarscn u et al. Mcncccmcnt c[ 1µbcrrµlcsis, c cµidc [cr lcw inrcmc rcµntrics, çth ed.
Parls, lnternatlcnal unlcn Aealnst Tuberculcsls and Lune ulsease, zooo.
Fanscn C, Klbuea u. Fffectlve tuberculcsls ccntrcl and health sectcr refcrms ln Kenya:
challenees cf an lncreaslne tuberculcsls burden and cppcrtunltles thrcueh refcrm.
lntcrncticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zooo, u(;):6z;-6¸z.
lntcrncticncl stcndcrds [cr tµbcrrµlcsis rcrc. The Faeue, Tuberculcsls Ccalltlcn fcr
Technlcal Asslstance, zoo6.
Mcncccmcnt c[ tµbcrrµlcsis: trcininc [cr distrirt 18 rccrdinctcrs. Ceneva, wcrld Fealth
0reanlzatlcn, zooç (wF0/FTM/T8/zooç.¸u;).
Mcncccmcnt c[ tµbcrrµlcsis: trcininc [cr hcclth [crilitv stc[[. Ceneva, wcrld Fealth
0reanlzatlcn, zoo¸ (wF0/CuS/T8/zoo¸.¸1u).
Fleuerca-Muncz l et al. 1hc hcclth wcrk[crrc rrisis in 18 rcntrcl: c rcpcrt [rcm hich-
bµrdcn rcµntrics. Fuman kescurces fcr Fealth, zooç, ¸:z http://www.human-rescurc-
es-health.ccm/ccntent/¸/1/z
1o. MAhACFklAL STkuCTukF
8z
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
Mahler F. Ccndltlcns fcr effectlvely lnteerated tuberculcsls prceramme. 8µll lnt unicn
1µbcrrlc, 1¤6¤, uz:1u;-1çu.
kavlellcne MC. Fvclutlcn cf wF0 pcllcles fcr tuberculcsls ccntrcl, 1¤uç-zoo1. lcnrct,
zooz, ¸ç¤:;;ç-;8o.

11 Manaeement cycle
T
he publlc health manaeement cycle belcw lllustrates hcw the dlfferent ccm-
pcnents cf T8 ccntrcl, assessment, plannlne, lmplementatlcn and mcnltcr-
lne/supervlslcn are llnked (Fleure 11.1).
ftCUR£ ::.: C0uhTk¥-LFvFL SuPFkvlSl0h Ahu M0hlT0klhC AS PAkT 0F TFF
MAhACFMFhT C¥CLF
Assessment
revlew/evaluatlon/
sltuatlon analysls
5uperv|s|en and
men|ter|ng
Management
suppert
P|ann|ng
Ilve-year -
yearly plan
Imp|ementat|en
and tra|n|ng
hTPs shculd perlcdlcally: (l) declde whether the natlcnal strateey tc ccntrcl T8
ls apprcprlate tc current ccndltlcns cr ln need cf revlslcns, addltlcns, etc.; (ll)
assess whether the strateey ls effectlve and uses the avallable technclcey ln
the mcst efñclent way; (lll) estlmate the future needs and lnvestment requlred
tc expand cr chanee the strateey; and (lv) lntrcduce new technclcey cr new
apprcaches as necessary. Thls prccess cf strateelc plannlne usually takes place
every ñve years and results ln a medlum-term strateelc plan (MTSP). The plan
has pcllcy lmpllcatlcns, euldes lmplementatlcn cf the prceramme and serves
tc cbtaln lnternal and external rescurces.
8q
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
As well as the MTSP, an annual lmplementatlcn plan deñnes preclsely the
cb|ectlves and actlvltles tc be carrled cut durlne the year, tceether wlth a
detalled budeet.
The same cycles cccur at lnternatlcnal level. A medlum-term elcbal plan ls
develcped by wF0 and multlple partners whc ccmmlt thelr suppcrt. Fach lnstl-
tutlcn carrles cut lts cwn annual plan cf actlvltles wlth avallable rescurces, ln
suppcrt cf natlcnal prcerammes and elcbal lnltlatlves.
11.1 P|ann|ng
11.1.1 MeJlum-term strateçlc plan
Mcst ccuntrles have adcpted and lmplemented the u0TS strateey thrcuehcut
thelr terrltcry. Plans lnclude malntalnlne and lmprcvlne the quallty cf actlvltles
ln the 8Mu and health facllltles ccvered. Fcr a ccmprehenslve apprcach tc T8
ccntrcl, the ccuntry strateelc plan shculd lnclude actlvltles fcr all ccmpcnents
cf the Stcp T8 Strateey.
The MTSP speclñes the ccuntry's cb|ectlves and tareets fcr the hTP ln llne wlth
elcbal cb|ectlves and tareets, usually fcr a perlcd cf ñve years, ccnslstent wlth
ecvernment health pcllcles and wlth the cverall health develcpment plan cf
the ccuntry. The MTSP shculd be develcped wlth lnputs frcm all apprcprlate
stakehclders, such as relevant departments cf the mlnlstry cf health (plan-
nlne, ñnanclne, human rescurces, reeulatlcn/leeal, curatlve servlces/hcspltal
manaeement, health lnfcrmatlcn system, publlc health labcratcry, health edu-
catlcn, Flv/AluS); scclal securlty servlces; cther mlnlstrles under whlch speclal
health servlces are creanlzed; technlcal and cther partners.
The MTSP sets cut the natlcnal strateey and pcllcles tc achleve thcse tareets,
and lndlcates declslcns cn chanees needed fcr lmplementatlcn. Ma|cr actlvl-
tles fcr each cf the ccmpcnents cf the hTP are speclñed and budeeted fcr the
next ñve years based cn estlmated needs tc carry cut planned actlvltles; thls
allcws rescurce mcblllzatlcn tc ñll fundlne eaps. use cf the wF0 standard T8
plannlne and budeetlne tccl ls reccmmended (see Chapter 1¤).
The MTSP alms tc achleve expanslcn cf actlvltles tc all ccmpcnents cf the hTP
and ensure pclltlcal ccmmltment wlth lncreased and sustalned ñnanclne cf
lnfrastructure, human rescurces, supplles and equlpment, and actlvltles. An
ln-depth prceramme revlew shculd be creanlzed ln crder tc ldentlfy chanees
that need tc be lnccrpcrated lntc the MTSP (see Chapter 18).
The maln declslcns based cn the prceramme revlew are:
º tc malntaln cr chanee speclñc strateeles;
º tc malntaln cr chanee technlcal and cperatlcnal prccedures;

11. MAhACFMFhT C¥CLF
º tc expand prceramme actlvltles ln publlc health facllltles and tc cther prc-
vlders and sectcrs;
º tc expand prceramme actlvltles tc ccllabcrate ln cther areas and actlvltles.
Prcerammes eradually evclve frcm a mlnlmum packaee cf essentlal lnterven-
tlcns ln publlc health facllltles, tc develcp a full set cf lnterventlcns ccverlne
all aspects cf T8 ccntrcl and related dlseases and dellvered by multlple health
prcvlders and lnstltutlcns.
The MTSP ccmpcnents speclfy the fcllcwlne:
º the ccuntry's ecals and cb|ectlves fcr the hTP, ccnslstent wlth natlcnal and
lnternatlcnal health and develcpment ecals;
º tareets fcr the hTP ln the medlum term, based cn the rates cf current case
detectlcn and cure;
º natlcnal strateey and technlcal/cperatlcnal pcllcles fcr the medlum term,
lndlcatlne any pcllcy chanees and hcw they wlll be lmplemented;
º the ma|cr challenees fcr T8 ccntrcl ln the ccuntry and strateeles tc address
them;
º the maln actlvltles ln the slx key ccmpcnents cf the Stcp T8 Strateey fcr the
next ñve years;
º key manaeerlal actlvltles, quantlñed and wlth budeet prc|ectlcns;
º prlcrltles amcne the planned actlvltles, tc ensure lmplementatlcn cf the
mcst essentlal lnterventlcns lf the budeet ls nct fully funded;
º a budeet set cut ln brcad cateecrles, lndlcatlne the fundlne scurces, funds
that are avallable, ccmmltted cr expected and the remalnlne fundlne eaps.
The MTSP wlll be lmplemented thrcueh an annual plannlne cycle, wlth mcre
detalled budeetlne and asslenment cf respcnslbllltles.
11.1.z Implementatlon plan
The next step ln the plannlne prccess ls tc prepare the annual lmplementatlcn
plan. Thls plan shculd speclfy the actlvltles tc be undertaken durlne the next
year and thelr estlmated ccst, wcrklne tcwards acccmpllshlne the MTSP. The
annual plannlne prccess usually takes place befcre the end cf the year, sc that
rescurces may be cbtalned and dlstrlbuted fcr use when the next year beelns.
Slnce the results cf the current annual plan are lnccmplete at that pclnt, data
fcr the ñrst three quarters and fcr the prevlcus calendar (cr budeetary) year
are avallable and serve tc estlmate expected achlevements. The annual plan
shculd lnclude:
86
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
º tareets fcr the year, whlch shculd be challenelne but feaslble;
º the annual budeet, wlth respcnslble cfñcer, place and date, by actlvlty;
º rescurce mcblllzatlcn (ecvernment and external suppcrt) fcr the fcllcwlne
year.
The fcllcwlne actlvltles are part cf the plannlne prccess. They are carrled cut
at natlcnal level by the central hTP unlt, and result ln a plan that shculd be
apprcved by the authcrltles and beccme part cf the eeneral plan and budeet
cf the mlnlstry cf health. The plan shculd speclfy the scurces cf funds and the
prcbablllty cf ñnanclne. Fssentlal actlvltles shculd be based cn secure fund-
lne.
(l) Analyse the lnfcrmatlcn and assess the achlevements cf the hTP durlne the
current year. The maln scurces cf data are the quarterly repcrts frcm dls-
trlcts and reelcns, the reeular mcnltcrlne cf lmplementatlcn cf the prevlcus
plan, and any cperatlcnal research carrled cut. The assessment examlnes
the extent tc whlch the hTP was able tc:
º cbtaln pclltlcal ccmmltment wlth lncreased cr sustalned ñnanclne;
º expand case detectlcn thrcueh quallty-assured bacterlclcey;
º achleve the tareet fcr treatment success;
º malntaln a reeular drue supply and manaeement system;
º mcnltcr and evaluate the prceramme and measure lmpact;
º address T8/Flv, Muk-T8 and cther challenees;
º ccntrlbute tc health system strenethenlne;
º eneaee all care prcvlders;
º empcwer pecple wlth T8, and ccmmunltles;
º enable and prcmcte research, partlcularly prceramme-based cperatlcnal
research.
(ll) uevelcp a wcrkplan fcr the fcllcwlne year, based cn the MTSP and cn
evaluatlcn cf the prevlcus year's results, as well as cther lnfcrmatlcn such
as expected rescurces. ldeally the natlcnal plan ls the ccnsclldatlcn cf the
dlstrlct and reelcnal plans, whlle ln practlce these plans are cften devel-
cped ln parallel and later ccnsclldated.
(lll) Plan speclñc actlvltles fcr the fcllcwlne year tc lmplement chanees ln the hTP
ln acccrdance wlth the MTSP and wlth the achlevements cf the prevlcus plan.
8)
11.z Men|ter|ng and rev|ew
Mcnltcrlne ls the cbservatlcn cf ccuntry prceramme perfcrmance tc ascertaln
whether actlvltles are acccmpllshed acccrdlne tc euldellnes and plans. Clcsely
llnked wlth supervlslcn, mcnltcrlne ls carrled cut at bcth the servlce dellvery
unlt thrcueh dlrect ccntact wlth health wcrkers (supervlslcn) and at the cen-
tral manaelne cfñce by examlnlne perlcdlc repcrts such as quarterly cchcrt
repcrts cn case nctlñcatlcn, treatment cutccmes and drue crders. Mcnltcrlne
T8 ccntrcl ls based cn the standard reccrdlne and repcrtlne system, standard
lndlcatcrs and dlrect ccntact wlth health wcrkers.
Fvaluatlcn ls a perlcdlc assessment cf prceress tcwards cperatlcnal tareets
and epldemlclcelcal cb|ectlves. Fvaluatlcn ls undertaken after an lnterval cf 1z
mcnths cr lcneer. Clcsely llnked tc mcnltcrlne, evaluatlcn ls a prccess by whlch
prceramme lnputs, actlvltles, prccess, cutputs and cutccmes are analysed and
assessed aealnst deñned ncrms.
Mcnltcrlne and evaluatlcn cf prcerammes are ccnducted thrcueh three mecha-
nlsms: lnternal mcnltcrlne, external mcnltcrlne and prceramme revlews.
11.z.1 Internal (natlonal) monltorlnç
hatlcnal mcnltcrlne cf planned actlvltles and analysls cf data are carrled cut
every quarter at dlfferent levels, typlcally dlstrlct, prcvlnclal and natlcnal lev-
els. Thls mcnltcrlne ls needed tc ldentlfy areas cf hleh and lcw perfcrmance
and ldentlfy causes cf pccr perfcrmance. A well-malntalned T8 reccrdlne and
repcrtlne system allcws health wcrkers and T8 prceramme staff tc plan, mcnl-
tcr and evaluate servlces and drue supplles.
Mcnltcrlne actlvltles alm tc:
º ascertaln whether actlvltles, tareeted perfcrmance lndlcatcrs and mllestcnes
lndlcated ln the ñve-year and annual plan are met cn tlme and wlth requlred
quallty;
º eather and valldate repcrtlne and reccrdlne data;
º keep track cf selected lndlcatcrs cn the perfcrmance and the ccndltlcns that
lnfuence perfcrmance;
º prcvlde apprcprlate suppcrt tc staff tc lmprcve lmplementatlcn cf the hTP.
Mcnltcrlne lmplementatlcn and prceress tcwards tareets ls facllltated when
plans lnclude a reallstlc schedule cf actlvltles fcr each ccmpcnent cf the Stcp
T8 Strateey and when a llmlted number cf lndlcatcrs cffer a eeneral cvervlew cf
the T8 ccntrcl sltuatlcn ln a elven settlne. The llst cf selected lndlcatcrs shculd
refer tc the ccmpcnent cf the Stcp T8 Strateey, and a standard natlcnal T8
manual shculd descrlbe technlcally scund T8 case manaeement prccedures fcr
11. MAhACFMFhT C¥CLF
88
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
dlaencsls, treatment, reccrdlne and repcrtlne, drue manaeement and labcra-
tcry supplles.
Mcnltcrlne lncludes slte vlslts frcm the natlcnal level tc lntermedlate and perlph-
eral levels and frcm the lntermedlate tc perlpheral level. Slte vlslts are planned
tc ccver the whcle ccuntry cn a reeular basls tc assess ccnslstent lmplementa-
tlcn cf pcllcles, tlmely ccmpletlcn cf actlvltles and prceress tcwards tareets,
and tc ldentlfy prcblems enccuntered by dlfferent levels.
At the end cf the ñrst quarter cf the year, lnfcrmatlcn frcm the prevlcus year ls
avallable fcr the annual evaluatlcn cf the prevlcus year's planned actlvltles and
analysls cf annual trends. Thls lnfcrmatlcn and analysls shculd be ccnñrmed ln
an annual ccuntry repcrt.
11.z.z £xternal (lnternatlonal) monltorlnç
Fxternal mcnltcrlne ls undertaken tc assess the hTP's perfcrmance frcm the
perspectlve cf T8 experts wcrklne cutslde the ccuntry. Fxternal mcnltcrlne
mlsslcns shculd be, as far as pcsslble, |clnt mlsslcns cf several partners wlth
the hTP that are carrled cut cnce cr twlce a year. They use the natlcnal mcnl-
tcrlne system wlth vlslts tc several T8 prceramme levels and care facllltles and
alm tc ldentlfy eeneral prcblems ln the perfcrmance cf the prceramme, and tc
ldentlfy sclutlcns tc pccr perfcrmance. Fxternal mcnltcrlne mlsslcns lnclude
cne cr mcre lnternatlcnal experts and cne cr several lnternatlcnal partners.
11.z.y Proçramme revlews
A prceramme revlew shculd be ccnducted reeularly, ncrmally cnce every ¸-ç
years. The cb|ectlve ls tc analyse ln depth the rcle, functlcns, structure and
perfcrmance cf the hTP. The addltlcnal cb|ectlve ls tc revlew hcw the health
systems cperate wlth the fccus cn pctentlal barrlers tc and cppcrtunltles fcr
T8 ccntrcl wlthln health systems refcrm.
The revlew ls partlcularly lmpcrtant tc help a ccuntry ln the prccess cf recrlent-
lne lts T8 ccntrcl pcllcles and replannlne actlvltles. A wF0 euldellne fcr the
ccnduct cf natlcnal T8 ccntrcl prceramme revlews ls avallable. Thls ccmplex
exerclse lnvclves teams ccmpcsed cf experts frcm a wlde ranee cf natlcnal and
external lnstltutlcns such as wF0, technlcal aeencles, hC0s, dcncr aeencles,
academlc lnstltutlcns and cther partners, and lncludes a z-¸ mcnth prepara-
tcry perlcd. The revlew ltself usually lasts z-¸ weeks. The ñrst twc weeks are
devcted tc brleñne the revlew team, ñeld vlslts and the presentatlcn cf ñeld-
vlslt repcrts. The thlrd week lncludes dlscusslcn cf ñndlnes, fcrmulatlcn cf
reccmmendatlcns and debrleñne.

11. MAhACFMFhT C¥CLF
The cutccmes cf the revlew are:
º analysls cf the epldemlclcelcal sltuatlcn;
º analysls cf the prceramme structure and rescurces, and the ccntext cf the
eeneral health-care system, health sectcr refcrm and rcle cf hcspltals, medl-
cal cclleees, prlvate sectcr and cther entltles lnvclved ln T8 ccntrcl;
º analysls cf prceramme dellvery and ldentlñcatlcn cf achlevements and ccn-
stralnts;
º reccmmendatlcns fcr cverccmlne the prcblems ldentlñed.
T8 ccntrcl prceramme revlews are an lmpcrtant tccl fcr securlne ecvernment
ccmmltment and prcvldlne the basls fcr recrlentlne T8 ccntrcl pcllcles and the
develcpment cf an MTSP.
Key rejerences
Arnadcttlr T, kleder FL, Fnarscn uA. 1µbcrrµlcsis prccrcmmcs: rcvicw, plcnninc, tcrh-
nircl sµppcrt. A mcnµcl c[ mcthcds cnd prcrcdµrcs. Parls, lnternatlcnal unlcn Aealnst
Tuberculcsls and Lune ulsease, 1¤¤8.
Clcbcl 001S cxpcnsicn plcn: prccrcss in 18 rcntrcl in hich-bµrdcn rcµntrics. Ceneva,
wcrld Fealth 0reanlzatlcn, zoo1 (wF0/CuS/ST8/zoo1.11).
Clcbcl tµbcrrµlcsis rcntrcl: sµrvcillcnrc, plcnninc, hncnrinc. wF0 repcrt zoo;. Cene-
va, wcrld Fealth 0reanlzatlcn, zoo; (wF0/FTM/T8/zoo;.¸;6; avallable at: http://www.
whc.lnt/tb/publlcatlcns/zoo;/en/ ).
Cµidclincs [cr rcndµrtinc c rcvicw c[ ncticncl tµbcrrµlcsis prccrcmmcs. Ceneva, wcrld
Fealth 0reanlzatlcn, 1¤¤8 (avallable cnly at http://whc.lnt/tb/en).
1hc Clcbcl Plcn tc Stcp 18, 2cc6-2c1<. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6
(wF0/FTM/ST8/zoo6.¸ç).
1hc plcnninc prcrcss: rcnrcpts, mcthcds, cnd strctccics in hcclth plcnninc [cr c[[cr-
tivc mcncccmcnt. 0xfcrd, 0xfcrd unlverslty Press, 1¤88.
wh0 18 plcnninc cnd bµdcctinc tccl. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6 (avalla-
ble at http://www.whc.lnt/tb/dcts/plannlne_budeetlne_tccl/dcwnlcad/en/lndex.html).
¤e
1z Prcerammatlc manaeement cf
drue-reslstant tuberculcsls
P
reventlcn and ccntrcl cf Muk-T8 are ccmpcnents cf the Stcp T8 Strateey
that shculd be lnteerated lntc the actlvltles cf hTPs ln acccrdance wlth the
strateey.
uesplte thelr ereater ccst, dlaencsls and treatment cf Muk-T8 are feaslble and
ccst-effectlve, even ln mlddle- and lcw-lnccme ccuntrles. untreated cr lmprcp-
erly treated patlents wlth drue-reslstant T8 are a scurce cf cneclne transmls-
slcn cf reslstant stralns, resultlne ln added future ccsts and mcrtallty. lnccrrect
use cf seccnd-llne drues tc treat Muk-T8 leads tc further reslstance tc these
drues and develcpment cf Xuk-T8. lt ls therefcre lmperatlve that seccnd-llne
drues are used apprcprlately.
0nce drue-reslstant stralns are well establlshed ln a pcpulatlcn, hTPs that use
cnly standard shcrt-ccurse chemctherapy (SCC) wlll fall tc cure a ercwlne prcpcr-
tlcn cf T8 patlents. kepeatlne SCC fcr patlents lnfected wlth Muk-T8 expands
reslstance tc the drues ln use. Transmlsslcn cf establlshed drue-reslstant stralns
ln a pcpulatlcn ls alsc a slenlñcant scurce cf new drue-reslstant cases.
1z.1 Address|ng the seurces eI drug-res|stant 1ß
The develcpment cf new cases cf drue-reslstant T8 shculd be addressed
ureently at the start cf a drue-reslstant T8 treatment prceramme. The lnteera-
tlcn cf u0TS and the manaeement cf drue-reslstant T8 may help ldentlfy and
curtall pcsslble scurces cf drue-reslstant T8.
Pcsslble factcrs ccntrlbutlne tc the develcpment cf new cases cf drue-reslstant
T8 shculd be revlewed. well-admlnlstered ñrst-llne treatment fcr susceptlble
cases uslne hleh-quallty drues ls the best way tc prevent acqulsltlcn cf reslst-
ance fcr susceptlble cases. Farly ldentlñcatlcn cf drue-reslstant T8 and prcmpt
lmplementatlcn cf adequate drue-reslstant T8 treatment reelmens (Cateecry lv
reelmens) are essentlal tc stcp transmlsslcn cf reslstant stralns.
1z.1.1 The 6reen Ilçht Commlttee Inltlatlve
The Creen Lleht Ccmmlttee (CLC) lnltlatlve prcmctes ratlcnal use cf seccnd-
llne drues and helps tc enable patlents wlth, cr at rlsk frcm, all fcrms cf drue-
¤1
1z. Pk0CkAMMATlC MAhACFMFhT 0F ukuC-kFSlSTAhT Tu8FkCuL0SlS
reslstant T8 wcrldwlde tc recelve prcper dlaencsls and tlmely, hleh-quallty and
effectlve treatment.
Thrcueh the CLC lnltlatlve, hTPs have access tc: (l) expertlse ln prcerammatlc
manaeement cf drue-reslstant T8 based cn best avallable evldence and ccl-
lectlve experlence; (ll) hleh-quallty drues tc treat drue-reslstant T8 at ccnces-
slcnal prlces; (lll) technlcal asslstance thrcueh a wlde netwcrk cf technlcal
partners; (lv) peer suppcrt and kncwledee-sharlne ln ccmmunlcatlcn wlth
cther CLC-apprcved prcerammes; and (v) lndependent external mcnltcrlne and
evaluatlcn.
1z.z Precess Ier |ntegrat|en eI management eI drug-res|stant 1ß
lmplementlne a drue-reslstant T8 treatment prceramme substantlally streneth-
ens cverall T8 ccntrcl effcrts fcr bcth drue-susceptlble and drue-reslstant cas-
es. The manaeement cf drue-reslstant T8 shculd be lnteerated lntc essentlal
T8 ccntrcl servlces as rapldly as rescurces permlt.
lnteeratlcn cf the manaeement cf drue-reslstant T8 wlthln the hTP lnvclves the
fcllcwlne key steps:
º assessment cf the pclltlcal wlll cf the ecvernment tc dellver ratlcnal treat-
ment tc patlents wlth drue-reslstant T8 (an essentlal prerequlslte);
º assessment cf the need tc lnteerate drue-reslstant T8 manaeement ln T8
ccntrcl;
º deslen and lmplementatlcn cf a technlcal plan fcr manaeement cf drue-
reslstant T8 and lts stepwlse lnteeratlcn wlthln the T8 ccntrcl prceramme;
º mcnltcrlne and evaluatlcn.
Prcvlded the pclltlcal wlll cf the ecvernment tc dellver ratlcnal treatment tc
patlents wlth drue-reslstant T8 as part cf the hTP ls assured, the assessment
cf needs shculd be dcne, taklne lntc acccunt the fcllcwlne varlables:
º the maenltude cf the prcblem and the dlstrlbutlcn cf drue-reslstant T8;
º prevalllne patterns cf drue-reslstance;
º avallablllty cf seccnd-llne drues cn the pharmaceutlcal market;
º cptlcns and capaclty fcr case-ñndlne;
º cptlcns fcr prcper treatment wlthln the exlstlne lnfrastructure cf the health-
care system, lncludlne the prlvate sectcr;
º avallablllty cf labcratcry capaclty, lncludlne quallty-assured culture and uST
servlces;
¤z
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
º rescurces avallable fcr u0T cver a prclcneed perlcd cf tlme;
º avallablllty cf ñnanclal rescurces tc lnteerate drue-reslstant T8 lntc the
hTP;
º quallty-assured standards cf the labcratcry netwcrk;
º avallablllty cf human rescurces and tralnlne needs based cn a task analy-
sls;
º exlstlne leeal framewcrk fcr scurclne, lmpcrtatlcn, reelstratlcn and dlstrlbu-
tlcn cf seccnd-llne drues;
º need fcr technlcal asslstance.
The needs assessment wlll facllltate the deslen and lmplementatlcn cf a ccm-
prehenslve plan tc address the eaps ldentlñed, ln terms cf servlce dellvery
lnfrastructure and functlcns cf the health-care system. 0nce the lnfrastructure
ls ln place and the key functlcns are cperatlne, a stepwlse lnteeratlcn cf drue-
reslstant T8 ccntrcl actlvltles may be undertaken, elvlne lnltlal prlcrlty tc dls-
trlcts cr admlnlstratlve areas where lnteeratlcn ls mcst llkely tc succeed.
The deslen and lmplementatlcn cf an hTP addresslne drue-reslstant T8 may
vary between and wlthln ccuntrles, dependlne cn the lccal needs and rescurc-
es avallable. ln settlnes where the prlvate sectcr plays a slenlñcant rcle ln the
manaeement cf drue-reslstant T8, the strateeles develcped shculd lnclude PPM
apprcaches (see Chapter zz). PPM apprcaches shculd be ccnsldered where (l)
drue-reslstant T8 ls eenerated thrcueh mlsmanaeement cf ñrst-llne drues ln the
prlvate sectcr, (ll) many cf the drue-reslstant T8 cases are treated ln the prlvate
sectcr and/cr (lll) the prlvate sectcr has access tc cr capaclty fcr uST.
whatever apprcach ls taken, the essentlal requlrements, such as quallty-assured
labcratcrles fcr dlaencsls and mcnltcrlne, dellvery cf treatment under u0T, and
use cf quallty-assured seccnd-llne drues, shculd be met tc ensure prcper case
manaeement and preventlcn cf emereence cf reslstance tc seccnd-llne drues.
Wh0 gu|de||nes
Cµidclincs [cr thc prccrcmmctir mcncccmcnt c[ drµc-rcsistcnt tµbcrrµlcsis. Ceneva,
wcrld Fealth 0reanlzatlcn, zoo6 (wF0/FTM/T8/zoo6.¸61).
Cµidclincs [cr sµrvcillcnrc c[ drµc rcsistcnrc in tµbcrrµlcsis. Ceneva, wcrld Fealth
0reanlzatlcn, zoo¸ (wF0/CuS/T8/zoo¸/¸zo).
lnstrµrticns [cr cpplvinc tc thc Crccn licht Ccmmittcc [cr crrcss tc scrcnd-linc cnti-
tµbcrrµlcsis drµcs. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6 (wF0/FTM/T8/zoo6.
¸6¤).
¤¶
key reIerences
Anti-tµbcrrµlcsis drµc rcsistcnrc in thc wcrld. 1hird clcbcl rcpcrt. Ceneva, wcrld
Fealth 0reanlzatlcn, 1¤¤; (wF0/FTMT8/¤;.zz¤).
0rµc-rcsistcnt tµbcrrµlcsis: c sµrvivcl cµidc [cr rliniricns. San Franclscc, Francls l. Curry
hatlcnal Tuberculcsls Center and Callfcrnla uepartment cf Fealth Servlces, zoou.
Fmereence cf Mvrcbcrtcriµm tuberculcsls wlth extenslve reslstance tc seccnd-llne
drues - wcrldwlde, zooo-zoou. Mcrbiditv cnd Mcrtclitv wccklv kcpcrt, zoo6, çç(11):
¸o1-¸oç.
Lelmane v et al. Cllnlcal cutccme cf lndlvlduallsed treatment cf multldrue-reslstant
tuberculcsls ln Latvla: a retrcspectlve cchcrt study. lcnrct, zooç, ¸6ç(¤uç6):¸18-¸z6.
hathanscn F et al. Multldrue-reslstant tuberculcsls can be successfully treated ln
rescurce-llmlted settlnes. Fmcrcinc ln[crticµs 0isccscs, zoo6, 1z(¤):1¸8¤-1¸¤;.
kcpcrt c[ thc mcctinc c[ thc wh0 Clcbcl 1csk lcrrc cn X0k-18. Ceneva, wcrld Fealth
0reanlzatlcn, zoo; (wF0/FTM/T8/zoo;.¸;ç).
Tupasl TF et al. Feaslblllty and ccst-effectlveness cf treatlne multldrue-reslstant tuber-
culcsls: a cchcrt study ln the Phlllpplnes. PlcS Mcdirinc, zoo6, ¸(¤):e¸çz.
Zlencl M et al. Clcbal lncldence cf multldrue-reslstant tuberculcsls. lcµrncl c[ ln[crticµs
0isccscs, zoo6, 1¤u(u):u;¤-u8ç.
1z. Pk0CkAMMATlC MAhACFMFhT 0F ukuC-kFSlSTAhT Tu8FkCuL0SlS
¤q
1AßL£ :¶.: wF0-kFC0MMFhuFu C0LLA80kATlvF ACTlvlTlFS F0k T8/Flv C0hTk0L
a
A. £stab||sh the mechan|sms Ier ce||aberat|en
A. 1 Set up a cccrdlnatlne bcdy fcr T8/Flv actlvltles effectlve at all levels
A.z Ccnduct survelllance cf Flv prevalence amcne T8 patlents
A.¸ Carry cut |clnt T8/Flv plannlne
A.u Ccnduct mcnltcrlne and evaluatlcn
ß. ßecrease the burden eI 1ß |n peep|e ||v|ng w|th hIv
8.1 Fstabllsh lntenslñed T8 case-ñndlne
8.z lntrcduce lscnlazld preventlve therapy
8.¸ Fnsure T8 lnfectlcn ccntrcl ln health-care and ccnereeate settlnes
C. ßecrease the burden eI hIv |n 1ß pat|ents
C.1 Prcvlde Flv testlne and ccunselllne
C.z lntrcduce Flv preventlcn methcds
C.¸ lntrcduce cc-trlmcxazcle preventlve therapy
C.u Fnsure Flv care and suppcrt
C.ç lntrcduce antlretrcvlral therapy
a
Adapted frcm lntcrim pclirv cn rcllcbcrctivc 18/hlv crtivitics. Ceneva, wcrld Fealth 0reanlzatlcn, zoou
(wF0/FTM/T8/zoou.¸¸o; wF0/FTM/Flv/zoou.1).
1¸ Prcerammatlc manaeement
cf tuberculcsls and human
lmmuncdeñclency vlrus
T
he prcerammatlc manaeement cf cclnfectlcn wlth M. tµbcrrµlcsis and Flv
lnvclves speclal challenees that call fcr effectlve ccllabcratlcn between
natlcnal T8 and AluS ccntrcl prcerammes. Ccllabcratlve T8/Flv actlvltles alm
tc decrease the burden cf T8, Flv lnfectlcn and AluS ln pcpulatlcns affected by
bcth dlseases; they are bullt cn effectlve patlent-centred ccllabcratlcn between
the twc prcerammes (Table 1¸.1). A mechanlsm fcr ccllabcratlcn between the
T8 and AluS ccntrcl prcerammes shculd be ln place.
Key actlvltles fcr the prcerammatlc manaeement cf ccllabcratlve T8/Flv actlvl-
tles lnclude:
1. Creatlcn cf a |clnt natlcnal T8 and Flv cccrdlnatlne bcdy wcrklne at
reelcnal, dlstrlct and lccal levels (sensltlve tc ccuntry-speclñc factcrs), wlth
apprcprlate representatlcn cf the T8 and AluS ccntrcl prcerammes and cf
stakehclders lncludlne T8 and Flv patlent-suppcrt ercups and ccmmunlty-
based creanlzatlcns. The cccrdlnatlcn bcdy (whlch may be a ccmmlttee,
task fcrce cr ercup dependlne cn ccuntry-speclñc factcrs) facllltates the
¤¶
1¸. Pk0CkAMMATlC MAhACFMFhT 0F T8 Ahu Flv
creatlcn cf a favcurable pcllcy and prceramme envlrcnment, whlch lncludes
the develcpment cf apprcprlate natlcnal pcllcy deñnlne the actlvltles tc be
lmplemented ln the ccuntry and cperatlcnal euldellnes, tralnlne manuals
and prctcccls. Fcr ccuntrles wlth ccncentrated and lcw Flv prevalence,
prlcrlty settlnes wlth a hleh burden cf Flv-asscclated T8 (prcvlnces, dls-
trlcts cr facllltles) shculd be ldentlñed. T8 lnfectlcn ccntrcl ln Flv and AluS
preventlcn, care and treatment settlnes shculd be prlcrltlzed (see Chapter
6).
z. uevelcpment cf |clnt natlcnal strateelc and cperatlcnal plans that deñne
the rcles and respcnslbllltles cf each prceramme and the allccatlcn cf
rescurces, lncludlne the deplcyment cf sufñclent human rescurces and
capaclty fcr health-care dellvery tc lmplement ccllabcratlve T8/Flv actlvl-
tles at all levels. The plan may be elther separate cr lnccrpcrated lntc
natlcnal T8 and Flv strateelc plans wlth T8 and Flv ccmpcnents. Tralnlne
cf health wcrkers ln prceramme manaeement and cllnlcal ccmpetencles ls
cruclal and shculd be lncluded ln the cperatlcnal plan.
¸. Flv survelllance amcne T8 patlents ln all ccuntrles lrrespectlve cf natlcnal
adult Flv prevalence rates, ln acccrdance wlth wF0 euldellnes.
u. Fxpedlted dlaencsls and treatment cf T8 ln Flv-prevalent areas and amcne
Flv-pcsltlve lndlvlduals, wlth lntenslñed T8 case-ñndlne ln all Flv ccunsel-
llne and testlne, AluS care and treatment settlnes and amcne pcpulatlcns
at hleh rlsk cf Flv. A referral system shculd be establlshed between Flv
ccunselllne and testlne, AluS care and treatment, and T8 dlaencstlc and
treatment centres. Fcr ccuntrles wlth ccncentrated and lcw Flv prevalence
the reccmmendatlcns fcr the dlaencsls and treatment cf smear-neeatlve
pulmcnary and extrapulmcnary T8 shculd be lmplemented ln prlcrlty set-
tlnes.
ç. Prcvlslcn cf lscnlazld preventlve therapy by Flv servlce prcvlders as part cf
the packaee cf care fcr PLFlv when actlve T8 has been excluded. lnfcrma-
tlcn abcut lPT shculd be made avallable tc all PLFlv.
6. Flv testlne and ccunselllne cffered tc all T8 patlents reeardless cf the
natlcnal Flv epldemlc status. hTPs shculd elther lnteerate prcvlslcn cf Flv
testlne and ccunselllne ln thelr cperatlcns, cr establlsh a referral llnkaee
wlth the Flv prcerammes tc dc sc. All Flv-lnfected pecple whc have ccn-
ñrmed T8 shculd alsc be prcvlded wlth Flv care, treatment and suppcrt
servlces lncludlne AkT.
;. Ccmprehenslve Flv preventlcn strateeles develcped and lmplemented by
hTPs fcr thelr patlents tareetlne sexual, parenteral cr vertlcal transmlsslcn,
cr referral llnkaee wlth Flv prcerammes tc dc sc shculd be establlshed.
¤6
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
hTPs shculd prcvlde harm-reductlcn measures fcr T8 patlents whc prac-
tlce ln|ectlne drue use, cr shculd establlsh a referral llnkaee wlth Flv prc-
erammes tc dc sc.
8. Fstabllshment cf a system tc prcvlde CPT by T8 and Flv ccntrcl prcerammes
tc ellelble PLFlv whc have actlve T8.
¤. Aereement cn a ccre set cf lndlcatcrs and data ccllectlcn tccls by Flv
and T8 prcerammes, and data ccllectlcn fcr mcnltcrlne and evaluatlcn
cf ccllabcratlve T8/Flv actlvltles. The wF0 euldellnes fcr mcnltcrlne and
evaluatlcn cf ccllabcratlve T8/Flv actlvltles shculd be used as a basls tc
standardlze ccuntry-speclñc actlvltles.
1o. Address key factcrs fcr acceleratlcn cf T8/Flv actlvltles based cn experl-
ence and best practlce frcm plcneer ccuntrles ln natlcnwlde expanslcn cf
ccllabcratlve T8/Flv actlvltles, as fcllcws:
º settlne natlcnal tareets fcr ccllabcratlve T8/Flv actlvltles tc facllltate
lmplementatlcn and help mcblllze pclltlcal ccmmltment cn the part cf
the T8 and Flv ccntrcl prcerammes;
º creatlne a suppcrtlve pcllcy envlrcnment wlth the develcpment cf apprc-
prlate pcllcy and cperatlcnal euldellnes, tralnlne manuals and prctcccls
ln llne wlth lnternatlcnal euldellnes;
º eneaelne stakehclders thrcueh effectlve Flv/T8 cccrdlnatlne bcdles at
all levels tc help cccrdlnate the natlcnal respcnse and accelerate the
lmplementatlcn;
º expandlne Flv testlne facllltles and allcwlne frcnt-llne T8 cllnlclans and
nurses tc test nct cnly ccnñrmed T8 patlents but alsc thcse presentlne
wlth slens and symptcms cf T8 ("T8 suspects");
º lntenslve, ccntlnulne tralnlne and suppcrtlve supervlslcn cf health wcrk-
ers;
º lmplementlne revlsed reccrdlne and repcrtlne fcrmats cn ccllabcratlve
T8/Flv actlvltles tc dccument prceress ln lmplementatlcn. The lncluslcn
cf T8 ccmpcnents ln Flv reelsters and Flv ccmpcnents ln T8 reelsters ln
llne wlth lnternatlcnal euldellnes ls lmpcrtant;
º effectlve and ccnstant supply cf Flv test klts, drues and cther lmpcrtant
ccmmcdltles that are essentlal fcr accelerated lmplementatlcn.
¤)
Wh0 gu|de||nes
Cµidclincs [cr hlv sµrvcillcnrc cmcnc tµbcrrµlcsis pcticnts, znd ed. Ceneva, wcrld
Fealth 0reanlzatlcn/lclnt unlted hatlcns Prceramme cn Flv/AluS, zoou (wF0/FTM/
T8/zoou.¸¸¤; wF0/Flv/zoou.o6; uhAluS/ou.¸oF).
key reIerences
A cµidc tc mcnitcrinc cnd cvclµcticn [cr rcllcbcrctivc 18/hlv crtivitics. Ceneva, wcrld
Fealth 0reanlzatlcn, zoou (wF0/FTM/T8/zoou.¸uz; wF0/Flv/zoou.o¤).
8ell lC et al. Tuberculcsls preventlve therapy fcr Flv-lnfected pecple ln sub-Saharan
Afrlca ls ccst-effectlve. Al0S, 1¤¤¤, 1¸(1z):1çu¤-1çç6.
Fsplnal MA et al. Screenlne fcr actlve tuberculcsls ln Flv testlne centre. lcnrct, 1¤¤ç,
¸uç(8¤çu):8¤o-8¤¸.
Cclub lF et al. The lmpact cf antlretrcvlral therapy and lscnlazld preventlve therapy
cn tuberculcsls lncldence ln Flv-lnfected patlents ln klc de lanelrc, 8razll. Al0S, zoo;,
z1(11):1uu1-1uu8.
lmprcvinc thc diccncsis cnd trcctmcnt c[ smccr-nccctivc pµlmcncrv cnd cxtrcpµlmc-
ncrv tµbcrrµlcsis cmcnc cdµlts cnd cdclcsrcnts: rcrcmmcndcticns [cr hlv-prcvclcnt
cnd rcscµrrc-rcnstrcincd scttincs. Ceneva, wcrld Fealth 0reanlzatlcn, zoo; (wF0/
FTM/T8/zoo;.¸;6; wF0/Flv/zoo;.o1).
lntcrim pclirv cn rcllcbcrctivc 18/hlv crtivitics. Ceneva, wcrld Fealth 0reanlzatlcn,
zoou (wF0/FTM/T8/zoou.¸¸o; wF0/FTM/Flv/zoou).
lcshl k et al. Tuberculcsls amcne health-care wcrkers ln lcw- and mlddle-lnccme ccun-
trles: a systematlc revlew. PlcS Mcdirinc, zoo6, ¸(1z):eu¤u.
Plyawcrawcne S et al. Tuberculcsls preventatlve therapy as part cf a care packaee fcr
pecple llvlne wlth Flv ln a dlstrlct cf Thalland. Al0S, zoo1, 1ç(1¸):1;¸¤-1;u1.
hacheea l et al. Tuberculcsls actlve case-ñndlne ln a mcther-tc-chlld Flv transmlsslcn
preventlcn prceramme ln Scwetc, Scuth Afrlca. Al0S, zoo¸, 1;(¤):1¸¤8-1uoo.
hunn P et al. Tuberculcsls ccntrcl ln the era cf Flv. Nctµrc kcvicws lmmµnclccv, zooç,
ç(1o):81¤-8z6.
18/hlv: c rlinircl mcnµcl, znd ed. Ceneva, wcrld Fealth 0reanlzatlcn, zoou (wF0/FTM/
T8/zoou.¸z¤).
wcldehanna S et al. Treatment cf latent tuberculcsls lnfectlcn ln Flv-lnfected perscns.
Ccrhrcnc 0ctcbcsc c[ Svstcmctir kcvicws, zoou(1):Cuooo1;1.
Zacharlah k et al. vcluntary ccunselllne, Flv testlne and ad|unctlve cctrlmcxazcle reduc-
es mcrtallty ln tuberculcsls patlents ln Thyclc, Malawl. Al0S, zoo¸, 1;(;):1oç¸-1o61.
1¸. Pk0CkAMMATlC MAhACFMFhT 0F T8 Ahu Flv
¤8
1u Labcratcry servlces
L
abcratcry servlces, althcueh cruclal fcr natlcnal dlsease ccntrcl prcerammes,
are cften the weakest llnk ln the health system, recelvlne lcw prlcrlty and
lnadequate rescurces. Fcr T8 ccntrcl, quallty-ccntrclled bacterlclcelcal examl-
natlcn ls essentlal fcr the dlaencsls and manaeement cf T8 patlents. Labcra-
tcry strenethenlne ls a prlcrlty fcr the Stcp T8 Strateey, lncludlne lmprcved
access tc and use cf exlstlne dlaencstlcs as well as the develcpment and
lmplementatlcn cf apprcprlate new technclceles.
The strateelc crlentatlcns fcr labcratcry strenethenlne fccus cn:
º lmprcvlne smear mlcrcsccpy;
º strenethenlne and expandlne capaclty fcr culture and uST;
º adaptlne and transferrlne exlstlne technclceles tc rescurce-llmlted set-
tlnes;
º ccntrlbutlne tc develcpment and testlne cf new dlaencstlc tccls under ñeld
ccndltlcns.
1q.1 0rgan|zat|en eI 1ß |aberatery serv|ces
T8 labcratcry servlces shculd be lnteerated wlthln the natlcnal system cf labc-
ratcry servlces. At the central level, the natlcnal reference labcratcry ls elther
lccated wlthln the hTP cr may be part cf the eeneral labcratcry system wlth
clcse llnks tc the hTP. A full descrlptlcn cf the creanlzatlcn cf T8 labcratcry
servlces ls ccntalned ln lcbcrctcrv scrvircs in tµbcrrµlcsis rcntrcl, Pcrt l.
At the reelcnal and perlpheral levels, T8 labcratcrles are fully lnteerated wlth
the reference hcspltals, dlstrlct hcspltals and health centres. The labcratc-
rles at the reelcnal and perlpheral levels are multlpurpcse, wlth technlclans
perfcrmlne tests fcr the dlaencsls cf a wlde varlety cf dlseases. lncluslcn cf
accredlted labcratcrles cutslde the publlc health sectcr (unlverslty, hcspltals,
prlvate and hC0 based) ln the hTP labcratcry netwcrk shculd be ccnsldered
(see Chapter zz).
Fffcrts tc lmprcve the labcratcry perfcrmance shculd be well cccrdlnated tc
avcld fraementatlcn and the creatlcn cf separate dlsease-speclñc servlces. ln
¤¤
1u. LA80kAT0k¥ SFkvlCFS
hleh Flv-prevalent settlnes, Flv testlne shculd be cffered tc T8 suspects alcne
wlth sputum examlnatlcn. 8ased cn natlcnal pcllcles, Flv tests may be carrled
cut ln T8 labcratcrles and/cr by health-care prcvlders.
1q.z ß|agnest|c precedures
1q.z.1 5putum smear mlcroscopy
Farly labcratcry dlaencsls cf T8 relles cn the mlcrcsccplc examlnatlcn cf res-
plratcry speclmens fcr AF8. The technlque, althcueh cf llmlted sensltlvlty,
1
ls
relatlvely slmple and lnexpenslve, and ls currently lndlspensable ln the detec-
tlcn cf the mcst lnfectlcus cases cf pulmcnary T8. An lnternatlcnally-aereed
tralnlne packaee and external quallty-assurance system fcr standard sputum
smear mlcrcsccpy ls avallable.
Flucrescence mlcrcsccpy ls mcre sensltlve than standard lleht mlcrcsccpy fcr
T8 dlaencsls. Mcdern lmprcved fucrescent mlcrcsccpes equlpped wlth a lleht-
emlttlne dlcde (LFu) cffer a prcmlslne alternatlve tc standard fucrescence
lamps, avcldlne the need fcr dark rccms. Thelr use ls reccmmended where pcs-
slble ln labcratcrles examlnlne mcre than 1oo smears per day; thls allcws mcre
rapld examlnatlcn, decreased technlclan wcrklcad and lmprcved efñclency cf
AF8 detectlcn.
1q.z.z Culture
Myccbacterlal culture ls much mcre sensltlve than smear mlcrcsccpy and prc-
vldes a deñnltlve dlaencsls cf T8. lt ls therefcre seen as the ecld standard fcr
bacterlclcelcal ccnñrmatlcn. Culture cn sclld medla, especlally Lcwensteln-
lensen and lts mcdlñed verslcn, ls the mcst wldely used technlque. Fcwever,
lt has dlsadvantaees cwlne tc the leneth cf tlme requlred (u tc 8 weeks) fcr
ercwth cf myccbacterla cn a sclld medlum and delays ln startlne treatment
whlle awaltlne a ccnñrmed dlaencsls. The methcd requlres a sultable lnfra-
structure lncludlne blcsafety measures, scund technlcal skllls and mctlvatlcn
cf labcratcry perscnnel.
Culture cn llquld medlum ls the standard methcd fcr T8 dlaencsls and patlent
manaeement ln hleh-lnccme ccuntrles. Culture cn llquld medlum ls mcre ccm-
plex than cn sclld medlum but lt ls rapld and can prcvlde results ln abcut
1o days. wlth thls methcd, speclal precautlcns are needed tc avcld bacterlal
ccntamlnatlcn and lsclatlcn cf ncn-tuberculcus myccbacterla. Strenethenlne
the capaclty tc perfcrm culture cn llquld medla at ccuntry level ls necessary tc
adequately address Muk-T8 and Xuk-T8.
1
Mlcrcsccplc detectlcn cf a slnele AF8 ln a sputum smear ccrrespcnds tc a ccncentratlcn cf
1o ooo bacllll/ml sputum; culture detects AF8 at a ccncentratlcn ccrrespcndlne tc 1oo bacllll/ml
sputum.
1ee
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
1q.z.y 0ruç susceptlblllty testlnç
uST, perfcrmed cn elther sclld cr llquld medla, prcvldes bacterlclcelcal ccn-
ñrmatlcn cf drue-reslstant T8. wF0 reccmmends carrylne cut uST fcr ñrst-llne
and seccnd-llne antl-T8 drues tc detect Muk-T8 and Xuk-T8 respectlvely (see
Chapter 1). Labcratcry servlces fcr culture and uST shculd be lntrcduced ln
a phased manner at apprcprlate referral levels cf the health system. Fffcrts
tc expand the use cf culture and uST shculd be based cn a well-perfcrmlne
labcratcry netwcrk that malntalns a hleh quallty cf servlce by reeular tralnlne,
supervlslcn and suppcrt, and mctlvatlcn cf labcratcry staff.
ln zoo;, the wcrld Fealth Assembly called fcr enhanced labcratcry capaclty tc
prcvlde rapld uST fcr all cases cf culture-pcsltlve T8 (wFA6o.1¤). The needs
fcr culture and uST ln dlfferent epldemlclcelcal settlnes have been estlmated
cn the basls cf cptlmal reccmmendatlcns, reccenlzlne that lmplementatlcn ln
many settlnes wlll be achleved cnly eradually. Further plannlne fcr wlder lmple-
mentatlcn cf culture and uST wlll be carrled cut and repcrted cn by wF0.
keccmmendatlcns dlffer fcr new cases acccrdlne tc the ccuntry's epldemlc-
lcelcal sltuatlcn, deñned as fcllcws: (l) hleh Muk-T8 burden ccuntrles where
Muk-T8 cases tceether ccntrlbute 8ç% cf the elcbal Muk-T8 burden; (ll) hleh
Flv prevalence settlnes (ccuntrles, dlstrlcts, ccuntles cr selected facllltles such
as referral hcspltals) where the Flv prevalence rate amcne preenant wcmen cr
the eeneral pcpulatlcn ls at least 1%, cr Flv prevalence amcne T8 patlents ls
at least ç%; (lll) all cther ccuntrles/settlnes.
Culture and uST are reccmmended fcr all re-treatment and chrcnlc T8 cases
and fcr chlldren wlth T8. Seccnd-llne uST ls reccmmended fcr all Muk-T8
cases. The cverall alm ls tc cffer unlversal access tc all culture and uST serv-
lces by zo1ç.
1q.z.q 0etectlon oj latent T8 lnjectlon
1µbcrrµlin skin tcst. The dlaencsls cf latent T8 lnfectlcn eenerally depends
upcn the standard TST, desplte llmltatlcns ccncernlne the rellablllty cf lts lnter-
pretatlcn. Technlcal aspects cf tuberculln admlnlstratlcn and the methcd cf
readlne may lead tc false neeatlve results, whlle false pcsltlve results may
be related tc prlcr lmmunlzatlcn wlth the 8CC vacclne cr expcsure tc envlrcn-
mental myccbacterla. lnterpretatlcn cf the tests shculd strlctly fcllcw wF0
reccmmendatlcns detalled elsewhere (see Cµidcnrc [cr ncticncl tµbcrrµlcsis
prccrcmmcs cn thc mcncccmcnt c[ tµbcrrµlcsis in rhildrcn; 18/hlv: c rlinircl
mcnµcl; and chapters u and ç).
lntcr[crcn-ccmmc rclccsc csscvs. 8lccd tests detectlne the release ln vltrc cf
lnterfercn-eamma (lFh-a cr measurlne the number cf T-cells prcduclne lFh-a cn
ccntact wlth secreted antleens cf M. tµbcrrµlcsis, have been develcped and
1e1
1u. LA80kAT0k¥ SFkvlCFS
are ccmmerclally avallable. The selected antleens used ln these tests are hlehly
speclñc fcr tubercle bacllll, slnce they are absent frcm all 8CC stralns and frcm
mcst envlrcnmental myccbacterla. Ccnsequently, the cccurrence cf false pcsl-
tlve results ls mlnlmlzed. Fcwever, as wlth TST, a neeatlve lFh-a test ls nct suf-
ñclent tc rule cut latent T8 lnfectlcn, especlally ln cases cf lmmuncdeñclency
caused by Flv lnfectlcn cr cther cc-mcrbldltles. ln several T8 lcw-lncldence
ccuntrles, lFh-a tests are reccmmended ln place cf TST. The pctentlal publlc
health rcle cf these tests ln hleh-burden ccuntrles remalns tc be evaluated.
1q.z.¢ hIv testlnç
Flv testlne shculd be rcutlnely cffered, alcne wlth sputum examlnatlcn fcr AF8
ln Flv-prevalent settlnes, fcr patlents presentlne wlth a ccueh cf z-¸ weeks'
duratlcn. A perscn wlth unkncwn Flv status (e.e. because cf unavallablllty cf
Flv test klts cr refusal tc be tested) may be classlñed as Flv-pcsltlve lf there
ls strcne cllnlcal evldence cf Flv lnfectlcn.
1q.z.6 hew technoloçles
hew T8 dlaencstlc tests are needed tc prcvlde sensltlve, speclñc and tlmely
detectlcn cf bcth drue-sensltlve and drue-reslstant T8 and tc perfcrm equally
well ln T8/Flv cclnfectlcn. Several prcducts that may meet these demandlne
crlterla are under develcpment. hew tccls shculd be tested thrcueh research
that prcvldes rellable data cn sensltlvlty, speclñclty, pcsltlve and neeatlve
predlctlve value per test and per patlent, ccnducted ln hleh-burden ccuntrles
under ñeld ccndltlcns.
Prlcr tc wlde lmplementatlcn cf a new test, ccuntrles shculd deslen an cpera-
tlcnal research prctcccl and ñeld test the new tccl ln crder tc deñne lcelstlcs,
lnfrastructure and equlpment needs, technlcal ccnstralnts, tralnlne needs and
pctentlal sccpe cf lmplementatlcn. The declslcn cn whether tc lmplement a
test shculd be based cn ccnslderatlcn cf lts advantaees and llmltatlcns. The
lmpact cf a chanee cf testlne pcllcy cn the current labcratcry dlaencsls cf T8
cr drue reslstance shculd be addressed wlth the hTP.
1q.¶ Laberatery saIety
Tc cbtaln rellable results, all labcratcry technlques lncludlne mlcrcsccpy, cul-
ture and uST shculd be perfcrmed by apprcprlately tralned staff wcrklne ln
prcperly-equlpped safe labcratcrles. 0ccupatlcnal health requlrements shculd
be applled (see sectlcn z.11). Tralnlne ln safety measures shculd be part cf
the baslc tralnlne currlcula fcr labcratcry perscnnel. Tralnlne shculd lnclude
lnfcrmatlcn cn expcsure tc T8 bacllll, ccntrcl cf labcratcry hazards and safe
labcratcry prccedures. Fxpcsure tc blchazards dlffers acccrdlne tc the type cf
servlces perfcrmed:
1ez
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
º ln labcratcrles where sputum samples are handled fcr mlcrcsccpy cnly,
expcsure tc lnfectlcus partlcles eenerated frcm speclmens ls lcw due tc the
hleh vlsccslty cf sputum. ln these labcratcrles, adequate prctectlcn cf labc-
ratcry staff ls prcvlded by apprcprlately dlrected alrfcw ensurlne sufñclent
alr chanees ln the rccm.
º Speclmen prccesslne fcr culture purpcses shculd be perfcrmed ln blclcelcal
safety cablnets (8SCs), at least ln 8lcsafety Level z (8SLz) facllltles. Fcw-
ever, because culture manlpulatlcn represents a hleh blchazard rlsk wlth
expcsure tc hleh ccncentratlcns cf T8 bacllll, ldentlñcatlcn and uST actlvl-
tles shculd be perfcrmed ln 8SL¸ facllltles by apprcprlately quallñed staff
ln acccrdance wlth 8SL¸ practlces. uperadlne tc 8SL¸ shculd be planned
and lmplemented acccrdlne tc a shcrt-term plan and wlth ldentlñcatlcn cf
adequate rescurces; thls ls a respcnslblllty cf the ccuntry.
º Fcr mcst hleh-burden ccuntrles, there are ma|cr ccnstralnts tc the success-
ful establlshment, stafñne and malntenance cf 8SL¸ labcratcrles. Any prc-
pcsal tc create a 8SL¸ labcratcry shculd take acccunt cf all the structural,
lcelstlc and stafñne requlrements and asscclated ccsts cver tlme.
º Labcratcrles that send cultures cf M. tµbcrrµlcsis tc cther labcratcrles
shculd ccmply wlth the (natlcnal and) lnternatlcnal reeulatlcns cn the trans-
pcrt cf daneercus eccds (see Chapter zo).
1q.q 0ua||ty system
The avallablllty and quallty cf bacterlclcelcal dlaencsls cf T8 relles cn the
capaclty cf the hTP tc suppcrt, traln and mcnltcr the testlne perfcrmance cf
lndlvldual labcratcrles. The hTP and hkL are respcnslble fcr lmplementlne
a quallty system (0S) ccverlne all the dlaencstlc tests and the labcratcrles
lnvclved ln the dlaencsls cf T8.
º 0S ccnslsts cf lnternal quallty ccntrcl (0C), assessment cf perfcrmance
uslne an external quallty assurance system (F0A) lncludlne cn-slte evalua-
tlcn wlth cn-slte supervlslcn based cn bllnd rechecklne fcr mlcrcsccpy and
panel testlne fcr uST, and ccntlnucus quallty lmprcvement (0l) cf labcratcry
servlces.
º 0C lncludes all means by whlch the labcratcry ccntrcls lts cperatlcns, e.e.
the use cf standard cperatlne prccedures (S0P). Thls lncludes checklne cf
equlpment, supplles, testlne, reccrdlne and repcrtlne.
º F0A uslne a bllnd rechecklne system shculd be perfcrmed fcr all T8 dlaencs-
tlc tests lncludlne sputum mlcrcsccpy and uST.
1e¶
keeular cn-slte evaluatlcn (supervlslcn), uslne a standardlzed checkllst, ls an
lmpcrtant tccl tc assess labcratcry perfcrmance. lmprcvement ls facllltated by
a reeular and tlmely feedback mechanlsm wlth ldentlñcatlcn and ccrrectlcn cf
shcrtccmlnes.
1q.¶ Pub||c-pr|vate m|x Ier |aberatery serv|ces
Many ccuntrles have a laree prlvate medlcal sectcr servlne a slenlñcant prcpcr-
tlcn cf T8 cases. Prlvate care prcvlders cften depend cn prlvate labcratcrles
fcr smear mlcrcsccpy and, ln scme places, myccbacterlal culture and uST. lf
llnked apprcprlately tc hTPs, prlvate labcratcrles may pctentlally ccntrlbute
slenlñcantly tc lmprcvlne access tc T8 dlaencsls. Fcr effectlve ccllabcratlcn,
verlñable mechanlsms fcr cneclne supervlslcn and F0A cf partlclpatlne prlvate
labcratcrles servlces are essentlal.
ways tc eneaee prlvate labcratcrles ln T8 ccntrcl wlll vary ln dlfferent settlnes.
lt ls lmpcrtant tc have an expllclt natlcnal pcllcy that facllltates ccllabcratlcn
wlth prlvate labcratcrles. The hTP shculd deñne the tasks that the lndlvldual
labcratcrles wlll undertake and the suppcrt they wlll recelve frcm the hTP. A
ccmplete llst shculd be ccmplled cf labcratcrles prcvldlne T8 dlaencsls ln the
ccuntry. Lccal T8 unlts shculd kncw the number, lccatlcns and servlces prc-
vlded by prlvate labcratcrles cperatlne ln thelr areas.
lt ls advlsable tc wcrk lnltlally wlth a llmlted number cf prlvate labcratcrles
dependlne upcn thelr wcrklcad, wllllneness tc partlclpate, the lccal need and
the capaclty cf the lccal T8 unlt tc traln, supervlse and undertake quallty assur-
ance cf partlclpatlne labcratcrles. The experlence and the results cf ccllabc-
ratlcn shculd fcrm the basls cf a phased and sustalnable scale-up cf prlvate
labcratcry lnvclvement ln T8 ccntrcl (see alsc Chapter zz).
1q.6 keseurces
1q.6.1 human resources
Fstlmatlcn cf the number cf labcratcry staff requlred ls based cn the wcrklcad
and ranee cf tasks tc be carrled cut. Labcratcry staff shculd be made aware
cf thelr lmpcrtant rcle ln the ccntrcl cf T8 and treated as full partners: thls ls
essentlal tc malntaln mctlvatlcn and an effectlve relatlcnshlp wlth the hTP.
Tralnlne prcerammes shculd be ln place tc lmprcve and update the technlcal
and manaeerlal skllls cf labcratcry staff, wlth a reeular fcllcw-up system tc
mcnltcr and evaluate tralnees.
1q.6.z Ilnanclal resources
uesplte the avallablllty cf substantlal lnternatlcnal funds fcr T8 ccntrcl, labcra-
tcry needs have cften been underestlmated. Fundlne prcpcsals fcr T8 ccntrcl
1u. LA80kAT0k¥ SFkvlCFS
1eq
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
shculd always lnclude the ñnanclal needs fcr the strenethenlne cf labcratcrles,
as deñned ln ccllabcratlcn wlth the members cf the hkL. Labcratcry staff,
equlpment, malntenance, supplles, quallty assurance, supervlslcn and tralnlne
are essentlal elements cf the labcratcry servlce and shculd be elven apprcprl-
ate ccnslderatlcn.
Wh0 gu|de||nes
Cµidclincs [cr sµrvcillcnrc c[ drµc rcsistcnrc in tµbcrrµlcsis. Ceneva, wcrld Fealth
0reanlzatlcn, zoo¸ (wF0/CuS/CSk/kMu/zoo¸.¸).
key reIerences
Azlz MA et al. Fpldemlclcey cf antltuberculcsls drue reslstance (the Clcbal Prc|ect cn
Antl-tuberculcsls urue keslstance Survelllance): an updated analysls. lcnrct, zoo6,
¸68(¤çç¸):z1uz-1zçu.
8culhabal F, Felfets L. 8acterlclcelcal dlaencsls cf tuberculcsls. 8acterlclcey cf tuber-
culcsls. ln: kavlellcne MC, ed. kcirhmcn cnd hcrshhcld´s tµbcrrµlcsis: c rcmprchcn-
sivc intcrncticncl cpprccrh. Thlrd Fdltlcn. Part A. hew ¥crk, lnfcrma Fealthcare uSA,
lnc., zoo6:¸¸-¸ç
lcbcrctcrv bicsc[ctv mcnµcl, ¸rd ed. Ceneva, wcrld Fealth 0reanlzatlcn, zoou.
lcbcrctcrv scrvircs in 18 rcntrcl. Pcrt 1: crccnizcticn cnd mcncccmcnt. Ceneva, wcrld
Fealth 0reanlzatlcn, 1¤¤8 (wF0/T8/¤8.zç8).
Menzles u, ucherty TM. lnterfercn eamma release assays. ulaencsls cf latent tubercu-
lcsls lnfectlcn. ln: kavlellcne MC, ed. kcirhmcn cnd hcrshhcld´s tµbcrrµlcsis: c rcm-
prchcnsivc intcrncticncl cpprccrh, Thlrd Fdltlcn. Part A. hew ¥crk, lnfcrma Fealthcare
uSA, lnc., zoo6: zu¸-zu8
Pricritics [cr tµbcrrµlcsis bcrtcriclccv scrvircs in lcw-inrcmc rcµntrics, znd ed. Parls,
lnternatlcnal unlcn Aealnst Tuberculcsls and Lune ulsease, zoo;.
Stelneart Kk et al. Flucrescence versus ccnventlcnal sputum smear mlcrcsccpy fcr
tuberculcsls: a systematlc revlew. lcnrct ln[crticµs 0isccscs, zoo6, 6:ç;o-ç81.
Strctccir cpprccrh [cr thc strcncthcninc c[ lcbcrctcrv scrvircs [cr tµbcrrµlcsis rcntrcl,
2cc6-2cc¤. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6 (wF0/FTM/T8/zoo6.¸6u).
Azlz M, 8retzel C. use cf a standardlsed checkllst tc assess perlpheral sputum smear
mlcrcsccpy labcratcrles fcr T8 dlaencsls ln ueanda. lntcrncticncl lcµrncl c[ 1µbcrrµlc-
sis cnd lµnc 0isccsc, zooz. 6(u):1-1o.
wcrld Fealth 0reanlzatlcn, Asscclatlcn cf Publlc Fealth Labcratcrles, KhCv, kesearch
lnstltute cf Tuberculcsls, lnternatlcnal unlcn Aealnst Tuberculcsls and Lune ulsease,
Centers fcr ulsease Ccntrcl and Preventlcn/hatlcnal lnstltutes cf Fealth. Fxtcrncl qµcl-
itv csscssmcnt [cr Al8 smccr mirrcsrcpv. washlnetcn, uC, Asscclatlcn cf Publlc Fealth
Labcratcrles, zooz.
1e¶
1ç Manaeement cf
antltuberculcsls
drue supplles
C
ccd T8 ccntrcl requlres the avallablllty cf adequate quantltles cf medl-
clnes whenever needed by patlents and health wcrkers. All aspects cf drue
manaeement shculd therefcre be lncluded durlne the T8 ccntrcl plannlne and
lmplementatlcn prccesses. urue manaeement lnvclves clcse ccllabcratlcn wlth
the natlcnal essentlal medlclnes prceramme; ln many ccuntrles, antl-T8 drues
are cc-manaeed by the essentlal medlclnes prceramme.
As shcwn ln Fleure 1ç.1, drue manaeement lncludes essentlal steps ln the selec-
tlcn, prccurement, dlstrlbutlcn and ratlcnal use cf drues.
ftCUR£ :¶.: ukuC MAhACFMFhT Pk0CFSS
5e|ect|en
Q Medlclnes, dcsaees,
fcrmulatlcns
Q Packaelne
kat|ena| use
Q Fcllcwlne hTP reelmens
Q Ccunselllne patlents
Q Supervlslcn mcnltcrlne
Q Studylne drue use
Precurement
Q heeds estlmatlcn
Q 0uallfylne suppllers
Q Tenderlne and ccntractlne
fcr eccd prlces and
quallty-assured prcducts
ß|str|but|en
Q Pcrt clearance and
lmpcrt dutles
Q 0uallty ccntrcl
Q Transpcrtlne tc
health facllltles
Q Cccd stcraee and
lnventcry practlces
1e6
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
1¶.1 5e|ect|en eI ant|-1ß drugs
wF0 reccmmends ñve essentlal medlclnes fcr ñrst-llne antltuberculcsls treat-
ment: lscnlazld, rlfamplcln, ethambutcl, pyrazlnamlde and streptcmycln. These
medlclnes are avallable ln dlfferent fcrmulatlcns and packaees, and several
ccnslderatlcns are lnvclved ln thelr selectlcn:
º uslne bllster packs fcr better handllne and lnventcry ccntrcl;
º uslne FuCs cf twc, three cr fcur medlclnes, tc reduce the rlsks asscclated
wlth mcnctherapy;
º uslne patlent klts tc avcld treatment lnterruptlcns, slmpllfy handllne and
lmprcve patlent adherence.
The selectlcn prccess fcr seccnd-llne medlclnes used tc treat drue-reslstant T8
cases varles ccnslderably (see Chapter z). whlchever fcrmulatlcns are chcsen,
the hTP manaeer shculd ensure that all they are all lncluded ln the natlcnal llst
cf essentlal medlclnes.
1¶.z Precurement eI ant|-1ß drugs
urue prccurement shculd take acccunt cf the fcllcwlne key lssues:
º Accurate demand fcrecastlne cf antl-T8 drues, l.e. ccrrect quantlñcatlcn cf
the needs fcr drues fcr a speclñc perlcd cf tlme, ls an essentlal prerequlslte
fcr ensurlne an unlnterrupted supply.
º Fffectlve manaeement cf prccurement ensures the avallablllty cf the drues
selected ln the rleht quantltles, at the rleht tlme, at affcrdable prlces and at
acceptable standards cf quallty.
º Annual centrallzed prccurement ls the mcst efñclent way tc bulld up the ccn-
ñdence cf suppllers and draw prlces and ccsts dcwn, thrcueh the use cf a
standardlzed packaee cf prccurement blddlne dccuments and bulk purchase
cf medlclnes. lt ls alsc easler tc ccntrcl and factcr ln the lead tlmes cf sup-
pllers.
º Thrcueh lts prequallñcatlcn scheme, wF0 reeularly updates a llst cf manu-
facturers whcse antl-T8 drues have been ascertalned tc be cf acceptable
quallty (l.e. prequallñed).
1

º The mcst ccmpetltlve prlces fcr ñrst-llne antl-T8 drues are cbtalned frcm the
CuF, whlch ls an lnltlatlve cf the Stcp T8 Partnershlp tc lncrease access tc
hleh-quallty antl-T8 drues.
z

1
The llst ls avallable at http://www.stcptb.cre/edf/
z
See http://www.stcptb.cre/edf/
1e)
1ç. MAhACFMFhT 0F AhTlTu8FkCuL0SlS ukuC SuPPLlFS
º The CuF cffers a rellable scurce cf pccled prccurement cf seccnd-llne drues.
Ccuntrles shculd apply tc the Creen Lleht Ccmmlttee tc beneñt frcm qual-
lty-assured drues, preferentlal prlces and a rellable scurce, tceether wlth
reeular external mcnltcrlne/evaluatlcn and technlcal asslstance tc ccnduct a
manaeement prceramme fcr drue-reslstant T8.
º All drues used ln a reelmen fcr antl-T8 treatment shculd meet the wF0 rec-
cmmended standards fcr safety, efñcacy and quallty. 0uallty alsc depends
cn a set cf standards malntalned thrcuehcut the entlre prccess cf manufac-
ture and dlstrlbutlcn.
1¶.¶ ß|str|but|en and sterage eI ant|-1ß drugs
ulstrlbutlcn and stcraee cf drues shculd take acccunt cf the fcllcwlne key fac-
tcrs:
º Manaeement cf drue lmpcrtatlcn requlres that all pcrt and custcms clearance
fcrms are duly ccmpleted. The fcrmalltles lnvclved depend cn whether cr nct
the drues have been reelstered ln the lmpcrtlne ccuntry (see Chapter zo). ln
many ccuntrles lt ls pcsslble tc cbtaln an exemptlcn tc lmpcrt drues that are
nct lccally reelstered cn the basls cf thelr publlc health lmpcrtance.
º Scme ccuntrles place dutles cn lmpcrted prcducts, but antl-T8 drues may
be exempt when they are ccnsldered as humanltarlan asslstance, prcvlded
all requlred paperwcrk has been dcne ccrrectly.
º Tc preserve quallty, the drues shculd be transpcrted and stcred by the
suppllers and the T8 ccntrcl prceramme, fcllcwlne the reccmmendatlcns
speclñed by the manufacturers reeardlne temperature and humldlty. Cccd
stcraee practlces shculd be ln place at all levels, whlch requlres that staff
are apprcprlately tralned and stcraee ccndltlcns adequate.
º ln perlpheral centres where stcraee ccndltlcns dc nct meet reccmmenda-
tlcns cn temperature and humldlty, lt ls advlsable tc creanlze frequent sup-
plles cf llmlted quantlty ln crder tc mlnlmlze the duratlcn cf stcraee under
subcptlmal ccndltlcns.
º A reeular system cf dlstrlbutlcn fcr drues and ccmmcdltles shculd be ln
place frcm the central level tc the reelcns and perlpheral levels, ln crder tc
ensure an unlnterrupted supply.
º An lnventcry manaeement system needs tc be set up ln crder tc ensure a
safety stcck and cptlmal stcck mcvement, and prcvlde an accurate scurce cf
lnfcrmatlcn fcr drue-demand fcrecastlne.
º keeular physlcal quallty checks when drues arrlve, and at all staees cf the
drue supply cycle (warehcuses, health centres) shculd be perfcrmed. where
1e8
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
testlne labcratcrles are nct avallable ln the ccuntry, these servlces may be
ccntracted tc the clcsest external labcratcry.
º ln health facllltles, the creanlzatlcn cf ccmplete ccurses cf treatment ln lndl-
vldual ccntalners (patlent klts) avclds treatment lnterruptlcns and lmprcves
patlent adherence.
1¶.q kat|ena| use eI med|c|nes
Access tc antl-T8 medlclnes must be acccmpanled by measures tc ensure thelr
ratlcnal use (see Chapter z). Thls alsc lnvclves actlcns tc llmlt mlsuse cf ñrst-
and seccnd-llne drues cutslde the hTP. Antl-T8 medlclnes can cften be bcueht
cver the ccunter ln prlvate pharmacles, and/cr are prescrlbed and dlspensed
by a wlde ranee cf prcvlders whc dc nct fcllcw natlcnal euldellnes and whc dc
nct apply apprcprlate measures tc ensure treatment adherence.
lnterventlcns tc reduce lrratlcnal drue use cutslde the hTP lnvclve lmprcved
and enfcrced reeulatlcns cn drue prescrlptlcn and dlspenslne. Thls requlres
ccllabcratlcn wlth the natlcnal drue reeulatcry bcdy, cther departments cf the
mlnlstry cf health, cther mlnlstrles, and prcfesslcnal asscclatlcns cf prescrlb-
ers and pharmaclsts. ln addltlcn, publlc-prlvate mlx apprcaches shculd be
applled tc lmprcve ratlcnal use cf T8 medlclnes thrcuehcut the health system
(see Chapter zz).
Wh0 gu|de||nes
Mcncccmcnt c[ tµbcrrµlcsis: trcininc [cr distrirt hcclth rccrdinctcrs. Mcdµlc F: mcn-
ccc drµcs cnd sµpplics [cr 18 rcntrcl. Ceneva, wcrld Fealth 0reanlzatlcn, zooç (wF0/
FTM/T8/zooç.¸u;e).
0pcrcticncl prinriplcs [cr cccd phcrmcrcµtircl prcrµrcmcnt: csscnticl drµcs cnd mcd-
irincs pclirv. Ceneva, lnteraeency Pharmaceutlcal Cccrdlnatlcn Crcup, 1¤¤¤ (wF0/
FuM/PAk/¤¤.ç).
key reIerences
Cµidclincs [cr thc stcrccc c[ csscnticl mcdirincs cnd cthcr hcclth rcmmcditics (avall-
able at http://www.whc.lnt/¸byç/en/stcraee_pccketeulde.pdf ).
Manaeement Sclences fcr Fealth ln ccllabcratlcn wlth wF0. Mcnccinc drµc sµpplv: thc
sclcrticn, prcrµrcmcnt, distribµticn cnd µsc c[ phcrmcrcµtircls, znd ed. 8lccmñeld,
CT, Kumarlan Press, lnc., 1¤¤;.
Mcnccinc phcrmcrcµtircls cnd rcmmcditics [cr tµbcrrµlcsis: c cµidc [cr ncticncl
tµbcrrµlcsis prccrcms. katlcnal Pharmaceutlcal Manaeement Plus, zooç (avallable
at http://www1.msh.cre/prc|ects/rpmplus/uccuments/uplcad/Culde_fcr_hatlcnal_
Tuberculcsls_Prcerams.pdf; accessed February zoo8).
1e¤
16 Supervlscry suppcrt tc
baslc manaeement unlts
T
hls sectlcn descrlbes the supervlscry and mcnltcrlne actlvltles that cccur
when external cr ln-ccuntry supervlscry vlslts tc health facllltles are ccn-
ducted. ln thecry, supervlslcn, mcnltcrlne and evaluatlcn are dlstlnct manaee-
rlal steps. ln practlce, these three actlvltles are clcsely llnked, wlth ccnslderable
cverlap and a ccmmcn apprcach. Supervlslcn lnvclves mcstly ln-ccuntry actlvl-
tles, ccnducted frcm upper tc lcwer levels cf the health system by cllnlclans
and/cr manaeerlal T8 staff.
Supervlslcn ls the cbservatlcn cf health wcrkers ln thelr wcrkplace, perfcrmed
cn a reeular basls (every 1 tc 6 mcnths), wlth the alm cf develcplne thelr kncwl-
edee, perfectlne thelr skllls, sclvlne prcblems, ccrrectlne errcrs, lmprcvlne
attltudes tcwards thelr wcrk and lncreaslne staff mctlvatlcn. lt ls alsc termed
"cn-the-spct tralnlne". Supervlslcn shculd be educatlve and suppcrtlve, nct
punltlve. The supervlscry relatlcnshlp shculd be pcsltlve and enccuraelne fcr
the supervlsed staff.
Supervlslcn and mcnltcrlne can be cf ereat beneñt fcr the lmprcvement cf prc-
eramme perfcrmance. The cb|ectlves cf supervlslcn, whether perfcrmed thrcueh
external mcnltcrlne mlsslcn cr durlne rcutlne supervlscry actlvltles by hTP, are
slmllar, l.e. tc ensure the quallty cf the wcrk acccrdlne tc the prceramme's plan-
nlne and lmplementatlcn tareets and tc the reccmmended practlces. Cccd T8
ccntrcl depends cn prcper and reeular mcnltcrlne and supervlslcn.
Supervlscry vlslts alm tc:
º relnfcrce and prcmcte the use cf eccd dlaencstlc, treatment and drue-use
practlces, as detalled ln the natlcnal euldellnes;
º help health wcrkers tc transfer learnlne skllls tc cllnlcal wcrk ln facllltles;
º ldentlfy prcblems faced by health wcrkers ln manaelne T8 cases sc that they
can be sclved wlthcut delay cn the spct cr wlth cther partners durlne meet-
lnes;
º stlmulate health wcrker team splrlt and mctlvatlcn;
º prcvlde technlcal advlce and euldance tc health wcrkers ln crder tc enhance
thelr kncwledee and enccuraee a pcsltlve attltude and eccd practlces;
11e
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
º beccme lnfcrmed cf the cplnlcns cf T8 patlents ccncernlne servlce dellvery
and expectatlcns.
Supervlscry vlslts shculd lnvclve ñve maln unlts: the labcratcry faclllty, the
central drue pharmacy, the hcspltal ward, eeneral and T8 speclñc cutpatlent
facllltles, and the cfñce where reccrds and repcrts are kept.
uurlne ñeld vlslts, supervlscrs make cbservatlcns and carry cut lntervlews,
scmetlmes wlth the ald cf a supervlscry check llst. Fcwever, much cf what
supervlscrs dc ls prcblem-sclvlne and tralnlne. Prcblem-sclvlne and cn-the-
spct tralnlne shculd always refer tc the natlcnal euldellnes and natlcnal tralnlne
dccument. lf prcblems cannct be ccrrected cn the spct, the supervlscr shculd
make a wrltten reccrd, ldentlfy pctentlal causes and prcpcse sclutlcns.
The key ccmpcnents and subccmpcnents cf the Stcp T8 Strateey shculd be ccn-
sldered durlne supervlslcn and mcnltcrlne actlvltles. Prlcrlty shculd be elven tc
serlcus weak pclnts ln crder tc fccus cn prcblem-sclvlne. The maln functlcn cf
the ñeld vlslt ls nct cnly tc eather quantltatlve data, whlch shculd be avallable
befcre the vlslt starts, but alsc tc cbserve the creanlzatlcn and dellvery cf T8
servlces, tc dlscuss prcblems and tc assess the valldlty cf the data.
Supervlslcn ls mcstly prcvlded by cne quallñed and kncwledeeable member
cf the T8 prceramme staff. Addltlcnal members cf the supervlslcn team may
lnclude the medlcal supervlscr, the labcratcry supervlscr, pharmaclsts, nurses
and tralnees.
Supervlslcn shculd be carrled cut at all levels cf the health lnfrastructure, wlth
reeular vlslts tc all health servlces. vlslts shculd be arraneed tc selected lnstl-
tutlcns, creanlzatlcns and lndlvlduals, and tc T8 patlents eventually at hcme
at the perlpheral level. The supervlscry team shculd prepare a draft repcrt
durlne the vlslt and prcvlde lt tc the T8 staff respcnslble fcr lmmedlate actlcn.
The maln reccmmendatlcns shculd be dlscussed and, lf pcsslble, aereed upcn
durlne the vlslt. The repcrt shculd be shcrt and may lnclude:
º actlcns taken slnce the last vlslt;
º maln achlevements and ccnstralnts cbserved durlne the vlslt;
º reccmmendatlcns and prcpcsed next steps befcre the next vlslt tc cverccme
prcblems cr lmprcve prceramme perfcrmance.
A ñve-year plan and an annual cperatlcnal plan cf wcrk facllltate the manaee-
ment prccess by prcvldlne references and standards fcr ccmparlscn durlne
each manaeement perlcd, lncludlne supervlscry and mcnltcrlne actlvltles.
A reeular mcnltcrlne and supervlslcn mechanlsm shculd be put ln place tc
ensure that actlvltles are ccnducted as planned ln the ñve-year plan and the
111
16. SuPFkvlS0k¥ SuPP0kT T0 8ASlC MAhACFMFhT uhlTS
annual cperatlcnal plan, respectlne eccd practlces reccmmended ln the technl-
cal euldellnes.
The preparatlcn cf new mld-term and lcne-term plans ls based cn a perlcdlc
and reeular evaluatlcn cf the prceramme.
key reIerences
Mcncccmcnt c[ tµbcrrµlcsis. 1rcininc [cr distrirt 18 rccrdinctcrs: rcndµrt sµpcrviscrv
visits. Ceneva, wcrld Fealth 0reanlzatlcn, zooç (wF0/FTM/T8/zooç.¸u;.c).
0n bcinc in rhcrcc: c cµidc tc mcncccmcnt c[ primcrv hcclth rcrc. Ceneva, wcrld
Fealth 0reanlzatlcn, 1¤¤z.
11z
1; uevelcpment cf
human rescurces
F
uman rescurce develcpment (Fku) ls a key element ln cverall health sys-
tems develcpment. The quallty cf servlce dellvery, lncludlne cf lnterven-
tlcns fcr ccmprehenslve T8 ccntrcl, depends tc a laree extent upcn adequate
numbers cf staff and thelr perfcrmance, suppcrted by the avallablllty cf suf-
ñclent facllltles, equlpment, drues and cther ccmmcdltles. The perfcrmance cf
perscnnel depends cn varlcus factcrs such as mctlvatlcn, tralnlne, supervl-
slcn, salarles and wcrklne ccndltlcns, all cf whlch requlre carefully fcrmulated
and lmplemented health wcrkfcrce pcllcles.
Fealth wcrkfcrce develcpment fcr T8 ccntrcl ls ccncerned wlth the dlfferent
functlcns lnvclved ln plannlne, manaelne and suppcrtlne the prcfesslcnal devel-
cpment cf the health wcrkfcrce fcr ccmprehenslve T8 ccntrcl wlthln cverall
health wcrkfcrce develcpment. The streneth and sustalnablllty cf hTPs depend
cn tlmely, adequate and cneclne recrultment, tralnlne, deplcyment, mctlvatlcn
and manaeement cf health wcrkers tc ensure that the Stcp T8 Strateey can be
lmplemented ln the ccntext cf natlcnal euldellnes.
There ls tcday a substantlal shcrtaee cf health wcrkers tc meet elcbal health
needs. Fcwever, shcrtaees are nct unlversal cr even unlfcrm acrcss lcw-lnccme
ccuntrles cr even wlthln ccuntrles. An lnadequate skllls mlx, dlstrlbutlcnal
lmbalances, unñlled vacancles and pccr wcrklne ccndltlcns exacerbate the
prcblem. Thls shcrtaee ls ln many places a ma|cr ccnstralnt tc achlevlne the
health-related MuCs.
The lcne-term ecal fcr Fku fcr ccmprehenslve T8 ccntrcl ls tc reach and sus-
taln a sltuatlcn where:
º health wcrkers at dlfferent levels cf the health system have the skllls, kncwl-
edee and attltudes (prcfesslcnal ccmpetence) necessary tc successfully
lmplement and sustaln ccmprehenslve T8 ccntrcl servlces based cn the
Stcp T8 Strateey;
º a sufñclent number cf health wcrkers cf all cateecrles lnvclved ln ccmprehen-
slve T8 ccntrcl are avallable at all levels cf the health system, wlth the needed
suppcrt systems tc mctlvate staff tc use thelr ccmpetencles tc prcvlde hleh-
quallty T8 servlces fcr the entlre pcpulatlcn acccrdlne tc thelr needs.
11¶
1;. uFvFL0PMFhT 0F FuMAh kFS0ukCFS
Fffectlve strateeles prcvlde the rcad map fcr achlevlne and sustalnlne the ecal
fcr Fku fcr ccmprehenslve T8 ccntrcl, enhanclne the perfcrmance cf the health
system, even under dlfñcult clrcumstances. Such strateeles lnclude, but are nct
llmlted tc, the llst belcw. These strateeles apply tc all ccuntrles/areas. Fcw-
ever, dependlne cn the ccuntry-speclñc sltuatlcn, the actlvltles planned under
each strateey wlll dlffer. The key strateeles and lmplementatlcn apprcaches
are:
º ccntrlbutlne tc cverall wcrkfcrce plannlne and pcllcy develcpment;
º creanlzlne ln-servlce tralnlne (cllnlcal, labcratcry and manaeerlal) fcr all
health wcrkers lnvclved ln T8 ccntrcl, lncludlne prlvate prcvlders eneaeed
ln prceramme actlvltles:
- lnltlal tralnlne ln all aspects cf baslc u0TS lmplementatlcn fcr exlstlne
staff and new recrults at all levels;
- lnltlal tralnlne cn T8/Flv and Muk-T8;
- retralnlne (ma|cr perfcrmance prcblems that may be addressed thrcueh,
fcr example, a fcrmal tralnlne ccurse);
- cn-the-|cb cr refresher tralnlne (mlncr perfcrmance prcblems that may be
addressed durlne a supervlscry vlslt);
- ccntlnued educatlcn (tc bulld skllls and kncwledee);
- tralnlne/crlentatlcn cf all publlc and prlvate prcvlders;
- advanced tralnlne cn manaeement aspects (health ñnanclne, leadershlp/
ecvernance, buslness plannlne, creanlzatlcnal develcpment);
º strenethenlne preservlce tralnlne (baslc tralnlne) fcr physlclans, nurses, lab-
cratcry technlclans and cther health wcrkers lnvclved ln the lmplementatlcn
cf T8 ccntrcl;
º eneaelne ln strateelc partnershlps fcr health wcrkfcrce develcpment fcr
ccmprehenslve T8 ccntrcl wlth, fcr example:
- tralnlne dlvlslcns/lnstltutlcns;
- cther ln-servlce tralnlne prcerammes, e.e. Flv;
- mlnlstry cf educatlcn and cther relevant mlnlstrles;
- prcfesslcnal asscclatlcns;
- prlvate sectcr lncludlne hC0s;
- bllateral and lnternatlcnal creanlzatlcns;
11q
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
º ccntrlbutlne tc lnteerated perscnnel manaeement systems at all levels tc
fcster adequate wcrkfcrce plannlne, recrultment, hlrlne, deplcyment and
retentlcn;
º mcnltcrlne and supervlslne health wcrker perfcrmance:
- tc detect and remedy perfcrmance deñclencles;
- tc ldentlfy new staff ln need cf tralnlne;
- tc ldentlfy addltlcnal staff needs.
The manaeement and lmplementatlcn cf strateeles shculd be made wlthln the ccntext cf
the Fuman kescurces fcr Fealth Actlcn Framewcrk, whlch addresses the health wcrkfcrce
crlsls. The framewcrk lncludes slx actlcn ñelds: pcllcy, ñnance, educatlcn, partnershlp,
leadershlp, and human rescurce manaeement systems; and fcur phases cf the actlcn
cycle: sltuatlcn analysls, plannlne, lmplementatlcn, and mcnltcrlne and evaluatlcn.
http://www.whc.lnt/hrh/tccls/en/
Tc ensure a ccmprehenslve apprcach tc the Fku challenee, all actlcn ñelds
and phases cf the actlcn cycle wlll eventually need tc be addressed. Fcwever,
based cn a partlcular area cf need cr hTP respcnslblllty, any actlcn ñeld cr
phase may be selected fcr ln-depth analysls and plannlne.
Table 1;.1
1
descrlbes the rcle and functlcns fcr dlfferent aspects cf Fku fcr
ccmprehenslve T8 ccntrcl, based cn the actlcn framewcrk. Tc enable these
functlcns tc be carrled cut wlthln the hTP, prcerammes shculd establlsh the
creanlzatlcnal structure at the central level. Thls lncludes, but ls nct llmlted
tc:
º asslenlne a dedlcated fccal perscn fcr Fk ln the hTP. ln lareer ccuntrles, thls
ccrrespcnds tc a full tlme |cb. A fccal pclnt may alsc be needed at state/
prcvlnclal level;
º appclntlne an Fk cccrdlnatlcn ercup wlth representatlves frcm tralnlne
lnstltutlcns, health wcrkers, ccncerned prcfesslcnal creanlzatlcns, and cth-
er dlsease ccntrcl prcerammes;
º determlnlne the rcles and functlcns cf Fk manaeement at subnatlcnal lev-
els.
The table lndlcates the euldlne prlnclples; the cverall structure and sltuatlcn
wlll vary frcm ccuntry tc ccuntry. Fku functlcns wlthln the hTP are carrled cut
1
Plcnninc thc dcvclcpmcnt c[ hµmcn rcscµrrcs [cr hcclth [cr implcmcntcticn c[ thc Stcp 18
Strctccv: c mcnµcl 'ln press]. Ceneva, wcrld Fealth 0reanlzatlcn, zoo8
11¶
1AßL£ :¡.: k0LF Ahu FuhCTl0hS 0F hATl0hAL Tu8FkCuL0SlS C0hTk0L Pk0CkAMMFS
(hTPS) F0k FuMAh kFS0ukCF uFvFL0PMFhT (Fku)
Act|en he|ds Nat|ena| tubercu|es|s centre| pregramme
Pe||cy Assesses need fcr Fk pcllcy revlslcns tc enable lmplementatlcn cf the Stcp
T8 Strateey (e.e. task shlftlne; hlrlne cf addltlcnal staff abcve current stafñne
stands; lncentlves fcr dlsadvantaeed eeceraphlcal placements; Fk needs
ln speclal sltuatlcns; needs fcr and partlclpatlcn ln speclal tasks fcrces and
cccrdlnatlcn ercups)
f|nance º Allens wlth and uses T8-speclñc funds tc suppcrt cverall health wcrkplace
develcpment
º Fnsures the allccatlcn cf T8 speclñc funds; enables lmplementatlcn cf the
strateelc plan fcr Fku fcr ccmprehenslve T8 ccntrcl
º Fnsures dcncr cccrdlnatlcn fcr ñnanclal suppcrt tc the lmplementatlcn cf
the strateelc Fku plan fcr ccmprehenslve T8 ccntrcl
£ducat|en,
|nc|ud|ng pre-
serv|ce (bas|c),
pestgraduate,
|n-serv|ce and
cent|nu|ng
educat|en
º uevelcps/revlses ln-servlce tralnlne prcerammes fcr dlfferent cateecrles
cf health wcrkers lnvclved ln the lmplementatlcn cf a ccmprehenslve hTP
acccrdlne tc the functlcns
º uevelcps/revlses tralnlne materlals fcr the abcve
º Fnsures that all ccntlnulne educatlcn ls based cn health servlce needs fcr
T8 ccntrcl, ls ccmpetency based, and fcllcws hTP euldellnes
º Fnsures cb|ectlve ccmpetency-based evaluatlcns systems are ln place and
used fcr all tralnlne prcerammes
º Selects and tralns ccurse facllltatcrs fcr the dlfferent tralnlne prcerammes
(paylne partlcular attentlcn tc the technlcal and educatlcnal ccmpetencles
cf the future facllltatcrs, as well as the ablllty tc enccuraee ccurse
partlclpants tc develcp skllls ln lndependent thlnklne and prcblem sclvlne)
º 0reanlzes tralnlne ccurses (lcne term as well as shcrt term) ln clcse
ccllabcratlcn and cccrdlnatlcn wlth cther prlcrlty health prcerammes and
lnterventlcns
º lnvclves exlstlne tralnlne lnstltutlcns tc strenethen educatlcnal quallty cf
tralnlne actlvltles
º Fnsures ccntlnucus learnlne fcr all heath wcrkers lnvclved ln the
lmplementatlcn cf the hTP
º Fstabllshes the creanlzatlcnal structure fcr fcllcw up after tralnlne
º Tralns supervlscrs fcr fcllcw up cf staff tralnlne
º Fnsures pre-servlce tralnlne prcerammes meet the ccmpetency needs fcr
the lmplementatlcn cf the hTP
Partnersh|ps Fnsure llnkaees wlth cther publlc sectcr, prlvate sectcr and ccmmunlty
netwcrks wlth ccmmcn llnkaees tc T8; fcr example, Flv natlcnal prcerammes,
medlcal asscclatlcns, falth-based creanlzatlcns, wF0, KhCv, luATLu
Leadersh|p º Prcvldes vlslcnary leadershlp and advccacy fcr T8 prceramme needs
º Fnsures leadershlp develcpment fcr manaeers at all T8 prceramme levels;
empcwers manaeers tc sclve prcblems at servlce dellvery level, ensurlne
needed rescurces are avallable
º Prcvldes suppcrtlve supervlslcn tc develcp wcrkplans and mcnltcr
perfcrmance
Ccntinµcd
1;. uFvFL0PMFhT 0F FuMAh kFS0ukCFS
116
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
human
reseurce
management
Persenne| management
º Assesses stafñne needs at all levels, lncludlne the central level, fcr the
lmplementatlcn cf the hTP
º Ccntrlbutes ñnanclal rescurces tc staff retentlcn strateeles and lncentlve
packaees fcr rural pcstlnes
º uetermlnes mlnlmum data requlrement fcr adequate Fk manaeement
º Fnsures all Fku actlvltles ccnfcrm tc cverall Fk manaeement systems and
pcllcles currently ln place
º Ccmmunlcates stafñne prcblems (e.e. vacant pcsts, severely understaffed
health centres) ldentlñed durlne supervlscry vlslts
PerIermance management
º updates as necessary, and llst functlcns and tasks by level and by
prcfesslcnal cateecry ccverlne all ccmpcnents cf the hTP
º uevelcps/revlses |cb descrlptlcns fcr staff lnvclved ln T8 ccntrcl tc
ccrrespcnd wlth current pcllcles and reccmmendatlcns fcr T8 ccntrcl, e.e.
the lntrcductlcn cf manaeement cf Muk-T8
º Cccrdlnates capaclty develcpment (ccmpetence and stafñne) fcr suppcrtlve
supervlslcn - fcr lmplementatlcn cf the Stcp T8 Strateey - wlth cther hleh-
prlcrlty prcerammes
º Ccntrlbutes expertlse and rescurces tc the develcpment and
lmplementatlcn cf strateeles fcr staff mctlvatlcn and retentlcn (nct cnly
ñnanclal)
Table 1;.1 Ccntinµcd
ln clcse ccllabcratlcn and cccrdlnatlcn wlth the cverall FkF department tc
ensure cptlmal efñclency and results. Thls shculd alsc ensure that Fku actlvl-
tles wlthln the hTP are ln harmcny wlth the cverall FkF pcllcles cf the mlnlstry
cf health, and ensure that the hTP Fku plans are lnteeral parts cf cverall FkF
plans.
hTPs need tc develcp and suppcrt strateelc apprcaches tc stafñne, ccmpetence
develcpment and creatlcn cf an enabllne envlrcnment fcr all staff lnvclved ln
the lmplementatlcn cf T8 ccntrcl, based cn the cutllne abcve, as well as
cccrdlnatlne thelr effcrts wlth cverall health wcrkfcrce develcpment. Fk plans
shculd be lnteeral parts cf the twc types cf plans prevlcusly descrlbed: the
strateelc medlum-term plan and the annual lmplementatlcn plan.
The strateelc plan fccuses cn lcne-term dlrectlcn and prcvldes cverall euld-
ance fcr lmplementatlcn and ñnanclne tc ensure the achlevement cf the ecal cf
an adequate, ccmpetent and perfcrmlne health wcrkfcrce. lt prcvldes euldance
fcr the annual lmplementatlcn plans.
The annual lmplementatlcn plan shculd be shcrt term, tactlcal, fccused, feaslble
and measurable. lt shculd lnclude shcrt-term cb|ectlves and actlvltles needed
tc prceress tcwards the ecal cf an adequate and ccmpetent wcrkfcrce.
lnternatlcnal creanlzatlcns suppcrt natlcnal T8 Fku by prcvldlne technlcal and
ñnanclal asslstance, develcplne eenerlc tralnlne mcdules and manuals, and
creanlzlne lnternatlcnal tralnlne ccurses.
11)
1;. uFvFL0PMFhT 0F FuMAh kFS0ukCFS
key reIerences
Chcrklist [cr rcvicw c[ thc hµmcn rcscµrrc dcvclcpmcnt rcmpcncnt c[ ncticncl plcns
tc rcntrcl tµbcrrµlcsis. Ceneva, wcrld Fealth 0reanlzatlcn, zooç (wF0/FTM/T8/zooç.
¸ço).
Chen L et al. Fuman rescurces fcr health: cverccmlne the crlsls. lcnrct, zoou, ¸6u:1¤8u-
1¤¤o.
ureesch h et al. An apprcach tc estlmatlne human rescurce requlrements tc achleve the
Mlllennlum uevelcpment Ccals. hcclth Pclirv cnd Plcnninc, zooç, zo(ç):z6;-z;6.
Fleuerca-Muncz l et al. The health wcrkfcrce crlsls ln T8 ccntrcl: a repcrt frcm hleh-
burden ccuntrles. hµmcn kcscµrrcs [cr hcclth, zooç, ¸:z(zu February zooç).
Plcnninc thc dcvclcpmcnt c[ hµmcn rcscµrrcs [cr hcclth [cr implcmcntcticn c[ thc
Stcp 18 Strctccv: c mcnµcl 'ln press]. Ceneva, wcrld Fealth 0reanlzatlcn, zoo8.
Farrles Au et al. Fuman rescurces fcr tuberculcsls and Flv-asscclated tuberculcsls.
lntcrncticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zooç, ¤(z):1z8-1¸;.
Farrles Au et al. Teachlne tuberculcsls ccntrcl tc medlcal undereraduates: the Malawl
experlence. lntcrncticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zoo¸, ;:8uz-8u;.
Mcncccmcnt c[ rcllcbcrctivc 18/hlv crtivitics. 1rcininc [cr mcncccrs ct thc ncticncl
cnd sµbncticncl lcvcls. Ceneva, wcrld Fealth 0reanlzatlcn, zooç (wF0/FTM/T8/zooç.
¸ç¤).
Mcncccmcnt c[ tµbcrrµlcsis. 1rcininc [cr distrirt 18 rccrdinctcrs. Ceneva, wcrld Fealth
0reanlzatlcn, zooç (wF0/FTM/T8/zooç.¸u;).
Mcncccmcnt c[ tµbcrrµlcsis. 1rcininc [cr hcclth [crilitv stc[[. Ceneva, wcrld Fealth
0reanlzatlcn, zoou (wF0/FTM/T8/zoou.¸¸z).
1csk cnclvsis: thc bcsis [cr dcvclcpmcnt c[ trcininc in mcncccmcnt c[ tµbcrrµlcsis.
Ceneva, wcrld Fealth 0reanlzatlcn, zooç (wF0/FTM/T8/zooç.¸çu).
118
18 Mcnltcrlne and evaluatlcn cf
prceramme perfcrmance
M
cnltcrlne and evaluatlne the perfcrmance cf T8 ccntrcl prcerammes
lnvclves assesslne actlvltles, mcnltcrlne ccsts and expendlture, deter-
mlnlne the extent cf prceramme ccveraee and evaluatlne treatment cutccmes,
as well as the epldemlclcelcal lmpact cf the prceramme. lmpcrtant factcrs
lnclude:
º ensurlne that tralnlne, supervlslcn, lcelstlcs and ccmmunlcatlcn actlvltles
are belne carrled cut effectlvely at each level frcm the natlcnal level tc the
perlpheral cllnlc;
º decldlne whether health unlts are ccllectlne the data needed tc assess case
nctlñcatlcn rates and treatment cutccmes;
º ldentlfylne technlcal and cperatlcnal prcblems, speclfylne the reascns fcr
the prcblems and taklne the necessary ccrrectlve actlcns;
º asslstlne staff tc lmprcve standards cf practlce;
º lmprcvlne patlent care and suppcrt, and the quallty cf lnfcrmatlcn.
18.1 Ind|caters
The use cf lndlcatcrs prcvldes a ccnvenlent way cf measurlne prceramme
perfcrmance, lncludlne the ccveraee tareets (mcnltcrlne), reachlne strateelc
and cutccme cb|ectlves (evaluatlcn) and lmpact cb|ectlves (epldemlclcelcal
survelllance).
kcutlne repcrtlne, descrlbed ln Chapter ¸, prcvldes the data tc calculate mcst
cf the lndlcatcrs. A useful lndlcatcr shculd be easy tc measure, prcvlde a valld
measure cf the relevant factcr, be reprcduclble, elve the same result when
measured by dlfferent pecple ln slmllar settlnes and be ccmparable acrcss
settlnes. A few perfcrmance and lmpact lndlcatcrs, based cn rcutlne data, are
usually sufñclent. Addltlcnal lndlcatcrs may be used ln speclal studles tc detect
and address prcblems. Fxamples cf mcnltcrlne and evaluatlcn lndlcatcrs are
elven ln the Stcp T8 Plannlne Matrlx.
1
1
http://www.whc.lnt/tb/dcts/plannlneframewcrks/ef_tb_prcpcsals_preparatlcn/en/lndex.html
11¤
18. M0hlT0klhC Ahu FvALuATl0h 0F Pk0CkAMMF PFkF0kMAhCF
18.z Cehert ana|ys|s
Cchcrt analysls ls the key manaeement tccl used tc evaluate the effectlve-
ness cf T8 ccntrcl actlvltles ln any elven area. lt may be used tc ldentlfy the
quarterly and annual treatment success rates (percentaee cf patlents whc are
cured plus thcse whc ccmplete treatment) and prcvlde mlddle- cr hleher-level
manaeers wlth tlmely, ccncrete lndlcatcrs cf achlevement. The quarterly smear
ccnverslcn repcrt and treatment cutccmes enable the ldentlñcatlcn cf prcb-
lems, sc that apprcprlate actlcn may be taken tc lmprcve prceramme perfcrm-
ance (e.e. lcw cure rate, hleh default rate, hleher than expected prcpcrtlcn cf
sputum smear-neeatlve PT8 cr extrapulmcnary T8, and lcwer than expected
case detectlcn rate).
18.¶ Measurement eI |mpact
The establlshment cf tareets wlthln the MuC framewcrk, and cf subsequent
tareets develcped by the Stcp T8 Partnershlp, have prcvlded ereater lmpetus
ln the evaluatlcn cf T8 prcerammes. hTPs need tc measure mcre actlvely the
epldemlclcelcal lmpact cf T8 ccntrcl, ln addltlcn tc mcnltcrlne lmplementatlcn
cf the Stcp T8 strateey. The evaluatlcn cf the lmpact cf T8 ccntrcl requlres the
measurement cf T8 prevalence, lncldence and mcrtallty.
18.q kecerd|ng and repert|ng
The reccrdlne and repcrtlne system allcws fcr tareeted, lndlvlduallzed fcllcw-
up tc help patlents whc may nct be maklne satlsfactcry prceress, and fcr a
rapld manaeerlal assessment cf the cverall perfcrmance cf each lnstltutlcn,
dlstrlct, reelcn cr ccuntry. Thls strcne system cf acccuntablllty and crcss-
checks avclds false repcrtlne cf data.
Fvaluatlcn cf treatment cutccme takes place abcut three mcnths after all
patlents ln the cchcrt have ccmpleted thelr ccurse cf treatment.
The steps lnvclved are:
º cchcrt analysls cf treatment cutccme by the dlstrlct T8 cfñcer every quarter
and at the end cf every year;
º dlstrlct quarterly repcrts cn treatment cutccme fcrwarded tc the lntermedl-
ate level (e.e. reelcn) fcr verlñcatlcn;
º verlñcatlcn that dlstrlct repcrts are ccrrect, ccmplete, dated, slened and ccn-
slstent; ccmpllatlcn cf cchcrt analysls repcrts cn all patlents ln the reelcn;
º submlsslcn cf the repcrt tc the central unlt cf the hTP;
º ccmpllatlcn cf cchcrt analysls repcrts cn all T8 patlents reelstered natlcn-
ally.
1ze
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
18.¶ 6|eba| |nIermat|en system
wF0 has establlshed a elcbal lnfcrmatlcn system tc evaluate prceress ln
lmplementlne the slx ccmpcnents cf the Stcp T8 strateey, assess the quallty cf
u0TS thrcueh treatment cutccmes, and estlmate T8 mcrbldlty. A T8 data ccl-
lectlcn fcrm, whlch chanees sllehtly frcm year tc year tc acccmmcdate elcbal
needs ln mcnltcrlne apprcaches tc T8 ccntrcl, ls dlstrlbuted tc the natlcnal
health authcrltles cf all ccuntrles and terrltcrles. Frcm the respcnses, wF0
assesses prceress ln lmplementlne the slx ccmpcnents cf the Stcp T8 strateey
and results, ccmpared wlth the elcbal tareets. Case repcrtlne ls measured
aealnst the estlmated T8 lncldence ln each ccuntry. The data and ccncluslcns
are publlshed annually.
1

Wh0 gu|de||nes
Cµidclincs [cr rcndµrtinc c rcvicw c[ c ncticncl tµbcrrµlcsis rcntrcl prccrcmmc. Cene-
va, wcrld Fealth 0reanlzatlcn, 1¤¤8 (wF0/T8/¤8.zuo; avallable at http://www.whc.lnt/
tb/en).
1rcctmcnt c[ tµbcrrµlcsis: cµidclincs [cr ncticncl prccrcmmcs, ¸rd ed. Ceneva, wcrld
Fealth 0reanlzatlcn, zoo¸ (wF0/CuS/T8/zoo¸.¸1¸).
key reIerences
Asscssinc tµbcrrµlcsis prcvclcnrc thrcµch pcpµlcticn-bcscd sµrvcvs. Manlla, wF0
0fñce fcr the western Paclñc, zoo; (avallable at http://www.wprc.whc.lnt/hk/rdcn-
lyres/Fu¤z;¸C8-uCA8-uC¸8-81F¸-çoo1o88AuA¤;/o/AssesslneT8prevalence.pdf ).
Ccmpcndiµm c[ indirctcrs [cr mcnitcrinc cnd cvclµctinc ncticncl tµbcrrµlcsis prc-
crcmmcs. Ceneva, wcrld Fealth 0reanlzatlcn, zoou (wF0/FTM/T8/zoou.¸uu)
Fnarscn uA et al. Mcncccmcnt c[ tµbcrrµlcsis: c cµidc [cr lcw inrcmc rcµntrics, çth
ed. Parls, lnternatlcnal unlcn Aealnst Tuberculcsls and Lune ulsease, zooo.
Clcbcl tµbcrrµlcsis rcntrcl: sµrvcillcnrc, plcnninc, ñnanclne. wF0 repcrt zoo;. Cene-
va, wcrld Fealth 0reanlzatlcn, zoo; (wF0/FTM/T8/zoo;.¸;6; avallable at: http://www.
whc.lnt/tb/publlcatlcns/zoo;/en/ ).
1
Further lnfcrmatlcn abcut wF0's mcnltcrlne actlvltles, elcbal lnfcrmatlcn and repcrts ls avall-
able at www.whc.lnt/tb cr by e-mall request tc cdsdcc@whc.lnt.
1z1
1¤ Fundlne cf
tuberculcsls ccntrcl
C
cuntry-level plannlne and budeetlne fcr T8 ccntrcl that are ln llne wlth the
Stcp T8 Strateey and the Clcbal Plan tc Stcp T8 are essentlal fcr achlevlne
the MuC and Stcp T8 Partnershlp tareets set fcr zo1ç. kescurce mcblllzatlcn
frcm natlcnal ecvernments and dcncr aeencles tc ensure that these plans are
fully funded ls alsc essentlal.
Many hTPs cperate under severe ñnanclal ccnstralnts and have tc ccmpete
wlth cther health prcerammes fcr budeet allccatlcns frcm the ecvernment and
dcncrs. katlcnallzatlcn cf the allccatlcn prccess can be lnfuenced by the use
cf eccncmlc analysls, such as ccst-effectlveness analyses. Famlllarlty wlth the
maln types cf eccncmlc analysls, hcw they are undertaken and hcw they may
be used tc ccnvlnce pcllcy-makers abcut the relatlve beneñts cf lnvestlne ln
T8 ccntrcl ls therefcre lmpcrtant.
1¤.1 ßudget p|ann|ng
The develcpment cf budeets fcr medlum-term strateelc plans and cne-year
cperatlcnal plans shculd be a ccre ccmpcnent cf T8 prceramme manaeement
ln bcth centrallzed and decentrallzed systems, and ls a key task fcr natlcnal and
subnatlcnal T8 prceramme manaeers ln partlcular. 8udeetlne shculd ensure
that the funds needed fcr all prceramme lnputs and actlvltles are accurately
ldentlñed, and lncluded ln a budeet request fcr the T8 prceramme speclñcally
and/cr as part cf eeneral dlstrlct budeets fcr health care. ldeally, thls shculd
be dcne fcr each ma|cr ccmpcnent and subccmpcnent cf the T8 ccntrcl prc-
eramme separately, as well as fcr all ccmpcnents ccmblned. Any lnvestment
requlred ln eeneral health servlces fcr T8 ccntrcl shculd alsc be ldentlñed.
0nce the budeet has been ñnallzed, a clear plcture cf the fundlne avallable
frcm the ecvernment and dcncr aeencles shculd be develcped. Thls ls neces-
sary tc deñne where fundlne eaps exlst and where further rescurce mcblllza-
tlcn ls needed. A clear understandlne cf fundlne needs and where fundlne eaps
exlst ls fundamental tc effectlve prceramme manaeement and, ln partlcular,
fcr neectlatlcns abcut fundlne wlth natlcnal cr lccal authcrltles, clcsely-related
1zz
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
prcerammes cr lnltlatlves (e.e. Flv/AluS prcerammes cr the PFPFAk
1
lnltlatlve),
and dcncr aeencles.
1¤.z 1ß p|ann|ng and budget|ng tee|
Tc asslst ln the assessment cf fundlne needs as well as the subsequent track-
lne cf fundlne and expendltures, wF0 has develcped a plannlne and budeet-
lne tccl fcr use by hTPs.
z
lt ls deslened tc help ccuntrles develcp plans and
budeets fcr T8 ccntrcl at natlcnal and subnatlcnal levels wlthln the framewcrk
prcvlded by the Stcp T8 Strateey and the Clcbal Plan tc Stcp T8, and tc lden-
tlfy the avallable fundlne and fundlne eaps that remaln tc be ñlled. These plans
and budeets allcw rcutlne mcnltcrlne cf T8 ccntrcl and prcvlde the basls fcr
rescurce mcblllzatlcn.
The tccl ls an Fxcel-based spreadsheet ln whlch plans and budeets fcr all ma|cr
ccmpcnents cf the Stcp T8 Strateey may be develcped. Acccmpanylne dccu-
ments and related llnks are avallable tc help users tc understand and use the
tccl effectlvely.
Scme cf the key features cf the tccl are:
º lt ls Fxcel-based wlth an lnbullt user eulde and menu system fcr navleatlne
between wcrksheets and wlthln wcrksheets.
º There ls cne wcrksheet fcr each ma|cr ccmpcnent cf T8 ccntrcl.
º Fach wcrksheet allcws fcr detalled develcpment cf plans and budeets, cr fcr
the calculatlcn cf "qulck estlmates".
º Fach wcrksheet lncludes a ready-made llst cf llkely lnputs and actlvltles tc
ccnslder as well as default values.
º The tccl ls fexlble, e.e. names cf lnputs and actlvltles and default values
may be mcdlñed as apprcprlate.
º An "appllcatlcn cptlcns" feature ls lncluded tc enhance user-frlendllness.
º lt lncludes hlstcrlcal, epldemlclcelcal, demceraphlc and ñnanclal data and
epldemlclcelcal/demceraphlc prc|ectlcns up tc zo1ç.
º lt ls deslened tc asslst wlth prc|ectlcns cf key lndlcatcrs that underpln any
plan and budeet, e.e. the number cf patlents tc be treated.
º There ls a status bar tc shcw the status cf wcrk dcne wlthln the tccl.
1
Presldent's Fmereency Plan fcr AluS kellef, launched by Presldent 8ush. Fundlne has amcunted
tc uS$ 1ç bllllcn durlne the ñve years zoo¸-zoo8.
z
http://www.whc.lnt/tb/dcts/plannlne_budeetlne_tccl/en/lndex.html
1z¶
1¤. FuhulhC 0F Tu8FkCuL0SlS C0hTk0L
º Summary tables and ñeures are autcmatlcally prcduced, lncludlne the ñnan-
clal lnfcrmatlcn requested annually by wF0 and summary budeets requlred
fcr prcpcsals tc the Clcbal Fund tc Fleht AluS, Tuberculcsls and Malarla (the
Clcbal Fund).
use cf the tccl cffers a number cf advantaees, lncludlne:
º lt can save tlme and lmprcve the quallty cf plans and budeets.
º Plans/budeets may be easlly revlsed cr updated.
º Much cf the plan dccument may be prcduced by wrltlne a descrlptlcn cf
what has been set cut ln the tccl.
º Plans and budeets fcr T8 ccntrcl are set cut ccmprehenslvely ln cne place.
º Standardlzed presentatlcn facllltates ccmparlscns between and wlthln ccun-
trles.
º lt facllltates analysls cf ñnanclal eaps and preparatlcn cf a detalled budeet
ln acccrdance wlth Clcbal Fund requlrements.
º lt prcvldes a framewcrk fcr mcnltcrlne and evaluatlcn cf T8 ccntrcl, lnclud-
lne cf Clcbal Fund erant lmplementatlcn and expendltures.
1¤.¶ 5eurces eI Iunds Ier 1ß centre|
Fundlne fcr T8 ccntrcl may be dlvlded lntc twc ma|cr types: dcmestlc and
dcncr fundlne.
1¤.y.1 0omestlc junJlnç
ucmestlc fundlne ccmes frcm natlcnal ecvernments as well as frcm lccal ecvern-
ments cr authcrltles at lcwer admlnlstratlve levels (e.e. prcvlnces, dlstrlcts) ln
decentrallzed systems. Funds may be ralsed frcm tax revenues, scclal cr prlvate
lnsurance schemes, and cut-cf-pccket expendltures. Lcans frcm external scurces
such as the wcrld 8ank alsc quallfy as dcmestlc fundlne. 0verall, acrcss the zz
hleh T8-burden ccuntrles, abcut ;o% cf the tctal fundlne fcr T8 ccntrcl was prc-
vlded by dcmestlc scurces (lncludlne lcans) ln zoo;, althcueh there ls ccnslder-
able varlatlcn amcne these ccuntrles (frcm 1z% tc ¤;% ln zoo;).
1¤.y.z 0onor þnanclnç
ucncr ñnanclne ccmes frcm twc ma|cr scurces: the Clcbal Fund and bllateral
dcncr aeencles.
ucmestlc fundlne frcm natlcnal and lccal ecvernments shculd prcvlde the
fcundatlcn fcr the fundlne cf T8 ccntrcl, and the share cf tctal fundlne needs
that ls ccvered frcm dcmestlc ecvernment scurces ls a key lndlcatcr cf pclltlcal
1zq
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
ccmmltment. ucncr fundlne ls cften less rellable and predlctable, may never cr
cnly rarely ccver certaln key lnputs tc T8 ccntrcl (e.e. staff and health systems
lnfrastructure, thcueh there are recent exceptlcns such as the PFPFAk lnltla-
tlve) and lcne-term ccmmltments (e.e. fcr the ñve years cf a strateelc plan) may
be hard tc achleve. Mcrecver, tcc much dependence cn external fundlne may
leave an hTP vulnerable tc shlfts ln dcncr prlcrltles. As a eeneral benchmark,
the Ccmmlsslcn cn Macrceccncmlcs and Fealth lndlcated that mlddle-lnccme
ccuntrles shculd have the capaclty tc fund mcst cr all cf thelr health care
(lncludlne T8 ccntrcl actlvltles) frcm dcmestlc scurces, and that lcw-lnccme
ccuntrles mleht prcvlde arcund ¤o% cf thelr health-care fundlne requlrements.
The least develcped ccuntrles, whlch are malnly ln Afrlca, wculd, hcwever,
need dcncr fundlne tc ccver abcut ço% cf thelr fundlne needs.
The share cf tctal ecvernment health expendltures that are requlred fcr T8
ccntrcl may be assessed by ccmparlne fundlne requlrements fcr T8 ccntrcl
wlth natlcnal health acccunt data.
1
hFA are used tc assess all expendltures cn
health care, by scurce cf fundlne, and are avallable cnllne.
1¤.y.y 6lobal IunJ to Ilçht 4I05, Tuberculosls anJ Malarla
As cf zoo; the Clcbal Fund had beccme the lareest scurce cf dcncr fundlne fcr
T8 ccntrcl ln the wcrld tcday. lt lssues reeular calls fcr prcpcsals, and ccun-
trles wlth well-planned prcpcsals have been successful ln ñlllne many cf thelr
ñnanclal eaps fcr T8 ccntrcl.
wF0 prcvldes a plannlne matrlx fcr prcpcsals tc the Clcbal Fund ln llne wlth
the Stcp T8 Strateey dellvery areas, lncludlne pcsslble lndlcatcrs and bud-
eet ltems. Thls ls acccmpanled by plannlne framewcrks elvlne mcre detall
cn pcsslble actlvltles based cn current euldellnes. The matrlx and plannlne
framewcrks are ccnslstent wlth the T8 plannlne and budeetlne tccl. The plan-
nlne and budeetlne tccl facllltates analysls cf ñnanclal eaps and preparatlcn
cf a detalled budeet ln acccrdance wlth Clcbal Fund requlrements. lt may alsc
facllltate the mcnltcrlne cf Clcbal Fund erant expendltures.
1¤.y.q P£PI4R
Presldentlal Fmereency Plan fcr AluS kellef (PFPFAk) launched by the uS ecv-
ernment ln zoo¸ has prcvlded substantlal new dcncr fundlne fcr lnterventlcns
related tc Flv/AluS preventlcn, treatment and care. Mcst cf the fundlne has
been fcr 1u Afrlcan ccuntrles, and ln these ccuntrles PFPFAk cffers a ma|cr
cppcrtunlty fcr lncreaslne fundlne fcr scme ccmpcnents cf T8 ccntrcl, lncludlne
ccllabcratlve T8/Flv actlvltles and strenethenlne cf labcratcry lnfrastructure.
1
www.whc.lnt/nha
1z¶
Wh0 gu|de||nes
Cµidclincs [cr rcst cnd rcst-c[[crtivcncss cnclvsis c[ tµbcrrµlcsis rcntrcl. Ceneva,
wcrld Fealth 0reanlzatlcn, zooz (wF0/CuS/T8/zooz.¸oça-c).
key reIerences
uye C, Flcyd K. Tuberculcsls. ln: lamlscn uT et al, eds. 0isccsc rcntrcl pricritics in
dcvclcpinc rcµntrics, znd ed. washlnetcn, uC, wcrld 8ank and hew ¥crk, h¥, 0xfcrd
unlverslty Press, zoo6.
Flcyd K et al. kescurces requlred fcr elcbal tuberculcsls ccntrcl. Sricnrc, zooz, z¤ç:
zouo-zou1.
Flcyd K, Pantc|a A, uye C. Flnanclne tuberculcsls ccntrcl: the rcle cf a elcbal ñnanclal
mcnltcrlne system. 8µllctin c[ thc wcrld hcclth 0rccnizcticn, zoo;, 8ç(ç):¸¸u-¸¸¤.
Flcyd K, Pantc|a A. Flnanclal rescurces requlred fcr T8 ccntrcl tc achleve elcbal tareets
set fcr zo1ç 'submltted fcr publlcatlcn; avallable frcm authcrs upcn request].
Clcbcl tµbcrrµlcsis rcntrcl: sµrvcillcnrc, plcnninc, hncnrinc. wF0 repcrt zoo;. Cene-
va, wcrld Fealth 0reanlzatlcn, zoo; (wF0/FTM/T8/zoo;.¸;6; avallable at: http://www.
whc.lnt/tb/publlcatlcns/zoo;/en/ ).
kavlellcne MC, uplekar Mw. wF0's new Stcp T8 Strateey. lcnrct, zoo6, ¸6;:¤çz-¤zç.
kcpcrt c[ thc Ccmmissicn cn Mcrrccrcncmirs cnd hcclth. Ceneva, wcrld Fealth
0reanlzatlcn, zoo1.
L|nks Ier Iurther |nIermat|en
Clcbal Fund tc Fleht AluS, Tuberculcsls and Malarla: http://www.theelcbalfund.cre/
Stcp T8 Partnershlp/Clcbal Plan: http://www.stcptb.cre/elcbalplan/
Stcp T8 uepartment: http://www.whc.lnt/tb/strateey/en/
Stcp T8 uepartment. Clcbal Fund prcpcsal preparatlcn: http://www.whc.lnt/tb/dcts/
plannlneframewcrks/en/lndex.html
wcrld Fealth 0reanlzatlcn. hatlcnal health acccunts, zoo;: www.whc.lnt/nha
1¤. FuhulhC 0F Tu8FkCuL0SlS C0hTk0L
1z6
zo Leeal and reeulatcry lssues
M
easures tc ccntrcl T8 shculd be carrled cut ln ccmpllance wlth lnterna-
tlcnal and natlcnal leelslatlcn and reeulatlcns pertalnlne tc ccmmunlcable
dlseases, and speclñc prcvlslcns ccncernlne T8. hTPs shculd be aware cf the
prcvlslcns appllcable tc T8. The fcllcwlne sectlcns cutllne the maln cateecrles
cf leeal and reeulatcry measures that are relevant tc T8 ccntrcl.
ze.1 Internat|ena| hea|th kegu|at|ens (Ihk) zee¶
The purpcse cf the lFk (zooç), whlch entered lntc fcrce ln lune zoo;, ls "tc pre-
vent, prctect aealnst, ccntrcl and prcvlde publlc health respcnse tc the lnter-
natlcnal spread cf dlsease ln ways that are ccmmensurate wlth and restrlcted
tc publlc health rlsks, and whlch avcld unnecessary lnterference wlth lnterna-
tlcnal trafñc and trade". The mandate ls much brcader than that cf the prevl-
cus lFk (1¤6¤) ln whlch the prcvlslcns applled prlmarlly tc plaeue, chclera and
yellcw fever. The lFk (zooç) prcvlde eenerally fcr any event wlth the pctentlal
tc cause a publlc health emereency cf lnternatlcnal ccncern, whlch may be cf
blclcelcal, chemlcal cr radlcnuclear crleln, and whether cr nct the etlclcey
ls kncwn at the tlme. Prcvlslcns lnclude (l) rcutlne publlc health measures at
pcrts, alrpcrts and ercund crcsslnes and (ll) ldentlñcatlcn cf and respcnse tc
publlc health emereencles.
hctlñcatlcn cf T8 tc wF0 ls nct requlred under the lFk (zooç) unless a pcten-
tlal lnternatlcnal emereency ls lnvclved. Sltuatlcns ln whlch T8 may pctentlally
fall wlthln the sccpe cf the lFk mleht arlse ln ccnnectlcn wlth lnternatlcnal
travel by lnfectlcus T8 patlents, partlcularly thcse wlth Muk-T8 cr Xuk-T8. The
lFk (zooç) lnclude a ueclslcn lnstrument, wlth crlterla tc ldentlfy events that
are tc be nctlñed (Artlcle 6; Annex z).
when wF0 ls lnfcrmed cf an event that mleht pctentlally represent an lnterna-
tlcnal publlc health emereency, a ccnsultatlve prccess cf rlsk assessment take
place wlth the natlcnal health authcrlty cn the rlsks pcsed and any further
measures tc be taken (Artlcles 6-1¸) . Sub|ect tc varlcus prctectlcns, States
Partles may requlre: (l) lnternatlcnal travellers tc prcvlde lnfcrmatlcn cn the
ltlnerary and revlew cf travel dccuments; (ll) ncn-lnvaslve medlcal examlna-
tlcns (that cculd lnclude sputum examlnatlcn) tc determlne whether cr nct a
1z)
publlc health rlsk ls lnvclved; and (lll) addltlcnal prccedures, dependlne cn
evldence and clrcumstances (Artlcle z¸).
Prcvlslcns are lncluded ln the lFk (zooç) tc prctect lnternatlcnal travellers
aealnst un|ustlñed health measures and tc respect thelr human rlehts; these
ccver lnfcrmed ccnsent fcr medlcal examlnatlcn and health measures, ccnñ-
dentlallty cf perscnal data, and prctectlcn aealnst charees fcr health measures
applled fcr publlc health prctectlcn.
States Partles have, as a requlrement, a natlcnal lFk fccal pclnt at central level
(usually ln the mlnlstry cf health). ln the case cf a T8 event lnvclvlne the lFk,
the wF0 ccuntry and reelcnal advlsers fcr T8 and the hTP manaeer wlll be
the pclnts cf ccntact fcr the natlcnal lFk fccal pclnt durlne lnvestleatlcn and
fcllcw-up.
ze.z Nat|ena| cemmun|cab|e d|sease |eg|s|at|en
Leelslatlcn cn ccmmunlcable dlsease ccntrcl ls an essentlal expresslcn cf
natlcnal pclltlcal ccmmltment. keeulatlcns based cn that leelslatlcn are adcpt-
ed tc apply lts prlnclples and prcvlslcns, lncludlne thcse ccncernlne T8. The
hTP manaeer ls requlred tc be lnfcrmed abcut and ccmply wlth the pertlnent
natlcnal leelslatlcn and reeulatlcns. hatlcnal ccmmunlcable dlsease leelslatlcn
ls belne revlsed ln many ccuntrles tc allen lt wlth cblleatlcns under the lFk
(zooç).
ln ccuntrles where adequate health leelslatlcn dces nct exlst, the hTP shculd
advccate fcr lts adcptlcn. Leelslatlcn, thrcueh eeneral prcvlslcns, shculd
empcwer the mlnlstry cf health tc prcduce health reeulatlcns, lncludlne reeu-
latlcns fcr T8 ccntrcl. Such reeulatlcns may be mcdlñed and updated acccrdlne
tc chanees ln epldemlclcey cr technlcal rescurces (whereas natlcnal leelslatlcn
ls less readlly revlsed).
The purpcse cf leelslatlcn ls tc suppcrt the preventlcn and ccntrcl cf T8 whlle
prctectlne publlc health and the leeal rlehts cf lndlvlduals. A wF0 "eccd prac-
tlce" mcdel fcr ccmmunlcable dlsease leelslatlcn and T8 reeulatlcn ls avall-
able. lt ls reccmmended that natlcnal T8 ccntrcl reeulatlcns shculd lnclude
measures fcr:
º prctectlne unlnfected lndlvlduals aealnst M. tµbcrrµlcsis lnfectlcn;
º detectlne T8 cases and lnltlatlne antl-T8 treatment at an early staee;
º adequately treatlne all patlents wlth actlve T8;
º mlnlmlzlne the mlsuse cf antl-T8 medlclnes;
º nctlfylne and repcrtlne T8 cases;
º screenlne clcse ccntacts cf T8 patlents;
zo. LFCAL Ahu kFCuLAT0k¥ lSSuFS
1z8
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
º maklne 8CC vacclnatlcn avallable fcr all ellelble chlldren;
º prcvldlne prcphylactlc treatment fcr certaln ercups cf lnfected pecple (e.e.
PLFlv);
º ensurlne access tc Flv preventlcn, care and treatment ln hleher Flv-preva-
lence settlnes.
Leelslatlcn shculd respect human dlenlty and rlehts as well as publlc health.
Fcwever, leelslatlcn shculd make prcvlslcn fcr certaln extracrdlnary sltuatlcns
where lnvcluntary ccmpllance wlth key measures ls requlred tc prctect publlc
health, sub|ect tc apprcprlate safeeuards (e.e. mandatcry medlcal examlna-
tlcns, lsclatlcn, quarantlne) cr where cther measures such as ccntact traclne
may be necessary.
where vcluntary ccmpllance cannct be cbtalned, ccmpulslcn shculd always be
reearded as the actlcn cf last rescrt and applled wlth safeeuards tc ensure that lt ls
fully |ustlñed strlctly prcvlded by the law, ncn-dlscrlmlnatcry, wlth pcsslblllty cf appeal,
cf llmlted duratlcn, sub|ect tc revlew and that the least restrlctlve cptlcn ls applled.
Ccmpulscry measures shculd be ccmmensurate wlth the resultlne beneñt and applled ln
the expectatlcn that effectlve actlcn wlll result.
Measures applled tc lnternatlcnal travellers wlll alsc need tc acccrd wlth the
ccuntry's cblleatlcns under the lFk (zooç).
ze.¶ Nat|ena| |eg|s|at|en and regu|at|en eI pharmaceut|ca| preducts
A leelslatlve framewcrk ls ln place ln mcst ccuntrles tc lmplement and enfcrce
a natlcnal drue pcllcy and tc reeulate the actlvltles cf bcth the publlc and prl-
vate sectcrs. Fcwever, the framewcrk fcr drue reeulatlcn varles frcm ccuntry
tc ccuntry, and ln scme lt ls very llmlted ln sccpe and appllcatlcn. hTP manae-
ers shculd be aware cf the exlstlne natlcnal leeal prcvlslcns ccncernlne antl-T8
medlclnes and hcw they are applled.
The natlcnal drue reeulatcry authcrlty develcps and lmplements mcst cf the
leelslatlcn and reeulatlcns cn pharmaceutlcal prcducts. lts respcnslbllltles
lnclude reelstratlcn cf drues; ccntrcls cn lmpcrts and marketlne; llcenslne;
lnspectlcn and enfcrcement; mcnltcrlne cf adverse drue reactlcns; and quallty
ccntrcl.
za.y.1 0ruç reçlstratlon
An lmpcrtant task cf the drue reeulatcry authcrlty ls tc lnstltute a system that
sub|ects all pharmaceutlcal prcducts tc premarketlne evaluatlcn and market-
lne authcrlzatlcn, alsc kncwn as drµc rccistrcticn, tc ensure that prcducts
1z¤
ccnfcrm tc requlred standards cf quallty, safety and efñcacy. urue evaluatlcn
and reelstratlcn lnclude the revlew and apprcval cf the prcduct data sheets
and labels. Thls lnfcrmatlcn ls usually dlssemlnated thrcueh drue lnserts cr
drue fcrmularles.
za.y.z Import anJ market controls
The marketlne survelllance actlvltles cf the drue reeulatcry authcrlty lnteerate
admlnlstratlve prccedures tc ensure that pharmaceutlcal prcducts are lmpcrt-
ed cnly lf they have recelved an lmpcrt llcence befcre reachlne the ccuntry.
The entlty respcnslble fcr lmpcrtatlcn cf pharmaceutlcal prcducts shculd ccm-
ply wlth all speclñcatlcns cn the relevant lmpcrt llcence. All lmpcrted prcd-
ucts shculd have been reelstered by the natlcnal drue reeulatcry authcrlty cr
shculd have recelved a marketlne authcrlzatlcn. Fxceptlcnally, a walver may be
eranted based cn publlc health ccnslderatlcns.
za.y.y Ilcenslnç
A mandatcry system cf llcenslne manufacturers, lmpcrtlne and expcrtlne
aeents, dlstrlbutcrs and retall pharmacles ls usually ln place tc ensure that
all prcducts ccnfcrm tc acceptable standards cf quallty, safety and efñcacy.
ln addltlcn, all premlses and practlces used tc manufacture, stcre, dlstrlbute
and dlspense these prcducts shculd ccmply wlth requlrements tc ensure ccn-
tlnued ccnfcrmlty tc standards untll prcducts are dellvered tc the end-user.
0verall quallty assurance cf drue manufacture ls essentlal tc ensure eccd qual-
lty. These practlces are deñned ln eccd manufacturlne practlce (CMP) eulde-
llnes. The entlty lnvclved ln the lmpcrtatlcn, expcrtatlcn and dlstrlbutlcn chaln
shculd ensure the prcper stcraee cf prcducts, and thelr apprcprlate handllne,
packaelne and dlstrlbutlcn. These practlces are deñned ln eccd dlstrlbutlcn
practlce (CuP) euldellnes.
za.y.q Inspectlon anJ enjorcement
lnspectlcn ls an lmpcrtant strateey fcr safeeuardlne drue quallty. lt ls lntended
tc ensure that all actlvltles ln drue manufacture, lmpcrt, expcrt, dlstrlbutlcn,
etc. ccmply wlth reeulatcry and quallty assurance requlrements, as well as wlth
reeulatlcns. The drue reeulatcry authcrlty usually establlshes lts cwn enfcrce-
ment strateeles tc prcmcte ccmpllance wlth drue reeulatlcns. The strateey
shculd be based cn a pyramld cf sanctlcns tc be applled ln a prcpcrtlcnate
manner ln cases cf ncn-ccmpllance.
za.y.¢ Monltorlnç oj aJverse Jruç reactlons
hatlcnal pharmaccvlellance systems ccllect and evaluate lnfcrmatlcn cn
adverse drue reactlcns. Scme ccuntrles have establlshed thelr cwn adverse
zo. LFCAL Ahu kFCuLAT0k¥ lSSuFS
1¶e
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
reactlcn repcrtlne mechanlsm, and the reeulatcry capaclty tc use the lnfcrma-
tlcn eathered. Fxamples cf pcsslble actlcns lnclude suspenslcn cf a drue's
market apprcval, the recall cf certaln batches, a warnlne ln a natlcnal drue
bulletln cr a separate warnlne sent cut tc a llst cf lnstltutlcns and maln pre-
scrlbers.
za.y.6 0uallty control
urue quallty ccntrcl labcratcrles are respcnslble fcr checklne, by apprcprlate
testlne, whether drues are cf the requlred quallty. Fach drue reeulatcry authcr-
lty shculd have access tc a quallty ccntrcl labcratcry, whlch wlll alsc play an
lmpcrtant rcle ln the reelstratlcn prccess and ln the survelllance cf the quallty
cf marketed prcducts. Fcr relatlvely small ccuntrles, quallty ccntrcl may be
cccrdlnated at a reelcnal centre.
ze.q 0ccupat|ena| hea|th |eg|s|at|en.
The wF0 0crlcrcticn cn crrµpcticncl hcclth [cr cll (1¤¤u) calls upcn ecvern-
ments tc prepare a speclal natlcnal pcllcy and prceramme fcr cccupatlcn-
al health, lncludlne prcvlslcn cf ccmpetent cccupatlcnal health servlces fcr
all pecple at wcrk. Such a prceramme shculd lnclude the develcpment cf
apprcprlate leeal prcvlslcns, and systems fcr enfcrcement, wlth lnspectlcn by
ccmpetent cccupatlcnal health authcrltles. The ueclaratlcn speclñes the char-
acterlstlcs cf a well-creanlzed and ccmpetent cccupatlcnal health servlce.
The hTP shculd be aware cf the exlstlne natlcnal leelslatlcn and reeulatlcns
ccncernlne cccupatlcnal health. ln health-care settlnes, medlcal and cther staff
may be at slenlñcant rlsk cf expcsure tc M. tµbcrrµlcsis lnfectlcn (see Chapter
6). ln the event cf lnfectlcn cccurrlne amcne staff, leeal actlcn may be envls-
aeed by the lnfected staff lf adequate measures tc prevent transmlsslcn cf
M. tµbcrrµlcsis have nct been lmplemented. Staff shculd be fully lnfcrmed cf
the natlcnal cccupatlcnal reeulatlcns and any pcsslbllltles that exlst fcr ccm-
pensatlcn ln the event cf lnfectlcn acqulred ln the wcrkplace.
ze.¶ Internat|ena| regu|at|ens en transpert eI |nIect|eus substances
keccmmendatlcns cn the transpcrt cf lnfectlcus substances are lncluded ln
the Mcdel keeulatlcns cn the Transpcrt cf uaneercus Cccds, develcped by
the unlted hatlcns Fccncmlc and Scclal Ccuncll's Ccmmlttee cf Fxperts cn the
Transpcrt cf uaneercus Cccds and updated every twc years. These reccm-
mendatlcns fcrm the basls cf natlcnal and lnternatlcnal transpcrt reeulatlcns.
Packlne requlrements, labelllne and dccumentatlcn are sub|ect tc reeulatlcn
fcr the natlcnal (where appllcable) and lnternatlcnal transpcrt cf lnfectlcus
substances.
1¶1
Fcr the lnternatlcnal transpcrt cf T8 samples, cultures cf M. tµbcrrµlcsis
shculd be shlpped acccrdlne tc unlted hatlcns packaelne lnstructlcn P6zo and
acccmpanled by the apprcprlate daneercus eccds dccumentatlcn (shlpplne
declaratlcn uhz81u).
0ther T8-ccntalnlne speclmens shculd be shlpped acccrdlne tc unlted hatlcns
packaelne lnstructlcn P6ço. hc acccmpanylne daneercus eccds dccumenta-
tlcn ls requlred ln these cases (shlpplne declaratlcn uh¸¸;¸).
Labcratcrles that send T8 samples shculd be aware cf all appllcable reeula-
tlcns and have the necessary materlals avallable. lt ls advlsable tc ldentlfy
lccally avallable servlces and have supplles and lccal arraneements ln place
ln advance.
key reIerences
0crlcrcticn cn crrµpcticncl hcclth [cr cll. Ceneva, wcrld Fealth 0reanlzatlcn, 1¤¤u.
Cccd prcrtirc in lccislcticn cnd rccµlcticns [cr 18 rcntrcl: cn indirctcr c[ pclitircl will.
Ceneva, wcrld Fealth 0reanlzatlcn, zoo1 (wF0/CuS/T8/zoo1.z¤o).
Cµidcnrc cn rccµlcticns [cr thc trcnspcrt c[ in[crticµs sµbstcnrcs, 2cc;-2cc8. Cene-
va, wcrld Fealth 0reanlzatlcn, zoo; (wF0/CuS/FPk//zoo;.z).
lntcrncticncl hcclth rccµlcticns (2cc<}. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6.
lcbcrctcrv bicsc[ctv mcnµcl, ¸rd ed. Ceneva, wcrld Fealth 0reanlzatlcn, zoou.
Mcrkctinc cµthcrizcticn c[ phcrmcrcµtircl prcdµrts with spcricl rc[crcnrc tc mµlti-
scµrrc (ccncrir} prcdµrts: c mcnµcl [cr drµc rccµlctcrv cµthcritics. Ceneva, wcrld
Fealth 0reanlzatlcn, 1¤¤8.
Oµclitv cssµrcnrc c[ phcrmcrcµtircls: c rcmpcndiµm c[ cµidclincs cnd rclctcd mctc-
ricls. vclµmc ll. Cccd mcnµ[crtµrinc prcrtircs cnd inspcrticn. Ceneva, wcrld Fealth
0reanlzatlcn, zoo¸.
wh0 Fxpcrt Ccmmittcc cn spcrihrcticns [cr phcrmcrcµtircl prcpcrcticns. lcrticth
rcpcrt. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6 (wF0 Technlcal kepcrt Serles hc.
¤¸;; Annex ç: Cccd dlstrlbutlcn practlces fcr pharmaceutlcal prcducts).
zo. LFCAL Ahu kFCuLAT0k¥ lSSuFS
PAkT lll
Fnsurlne ccmprehenslve
ccntrcl cf tuberculcsls
The Stcp T8 Strateey, launched ln zoo6, ls based cn a
ccmprehenslve apprcach tc T8 ccntrcl whlch reccenlzes the
lmpcrtance cf many factcrs that ec beycnd the essentlal elements
cf the u0TS strateey. These factcrs refect the need tc lnteerate
and lnvclve T8 ccntrcl ln the brcader ccntext cf health systems
and health system refcrm; tc eneaee all health care prcvlders and
lnvclve ccmmunltles, and tc pursue an equal access tc T8 servlces
fcr the entlre pcpulatlcn, partlcularly the mcst vulnerable ercups.
The T8 ccntrcl prceramme shculd alsc be lnvclved ln research sc
that the develcpment cf new tccls ls enccuraeed ln acccrdance wlth
prceramme needs, and the lntrcductlcn cf new tccls ls facllltated.
Thls sectlcn fccuses cn the sub|ect areas whlch extend the sccpe cf
actlvltles cf the hTP as needed tc ensure ccmprehenslve T8 ccntrcl.
Tc lmplement the Stcp T8 Strateey, these actlvltles shculd be lnteeral
elements ln the hTP and nct vlewed as cptlcnal extras.
1¶¶
z1 Ccntrlbutlne tc strenethenlne
cf health systems
T
he hTP functlcns wlthln, and ls an lmpcrtant part cf, the natlcnal health
system. lt ls ccnsequently lnvclved ln, and affected by, the functlcnlne cf
the system and any health sectcr refcrm lnltlatlves. lt ls lmpcrtant fcr the hTP,
tceether wlth cther publlc health prcerammes, tc play a ccnstructlve rcle ln
strenethenlne health systems, tc ensure that T8 ccntrcl brlnes beneñts fcr the
eeneral health system and tc ensure that T8 servlces are nct dlsadvantaeed as
a result cf refcrm measures.
z1.1 Ana|ys|ng barr|ers te hea|th system strengthen|ng
Thrcueh analysls cf health systems barrlers tc T8 ccntrcl, the hTP may help
lncrease understandlne cf the rcct causes cf weak health systems, such as
weak ecvernance, lnadequate health ñnanclne, an lnsufñclent wcrk fcrce and
uncccrdlnated servlce dellvery. 8cx z1.1 prcvldes a llst cf pctentlal health
systems barrlers tc effectlve T8 ccntrcl, ercuped acccrdlne tc the slx health
system bulldlne blccks deñned ln wF0's framewcrk fcr actlcn cn health sys-
tem strenethenlne. The hTP ls cften well equlpped, thrcueh lts use cf a stand-
ardlzed mcnltcrlne and evaluatlcn system, tc prcvlde ccncrete and speclñc
lnfcrmatlcn that may help lmprcve understandlne cf eeneral health system
weaknesses. Fcr example, the rcutlne mcnltcrlne cf perfcrmance lndlcatcrs,
such as trends ln the number cf T8 suspects lnvestleated ln relatlcn tc the
number cf cutpatlent vlslts ln eeneral health facllltles, trends cf rates cf spu-
tum smear pcsltlvlty, case nctlñcatlcn trends and trends ln treatment cut-
ccmes, prcvldes lnfcrmatlcn abcut the cverall health system wlthln whlch
the hTP cperates. Slmllarly, mcnltcrlne cf prceramme manaeement, lncludlne
health wcrkfcrce, drue manaeement, labcratcry quallty, rcle cf prlvate sectcr
and ccmmunlty, may help ldentlfy areas cf the eeneral health system ln need
cf lmprcvement. These cbservatlcns shculd be shared wlth relevant partners
lnvclved ln strenethenlne cf the eeneral health system.
z1.z Ident|Iy|ng eppertun|t|es and threats |n precesses Ier
hea|th secter deve|epment
Fealth sectcr refcrms can brlne ma|cr cppcrtunltles fcr lmprcved T8 ccntrcl,
thrcueh lmprcvlne health-care ñnanclne, lnfrastructure, health wcrkfcrce capac-
1¶6
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
ß0X z:.:
P01£k1tAL W£AKk£55£5 0f B£AL1B 5¥51£M5, Ak0 tMPLtCA1t0k5 f0R 1ß C0k1R0L
Leadersh|p and gevernance (stewardsh|p)
N weak capaclty fcr health pcllcy
analysls, prlcrlty settlne, sectcr pcllcy
develcpment and central health sectcr
manaeement. Thls may lnvclve bcth
quantltatlve and qualltatlve manpcwer
llmltatlcns as well as llmltatlcns related
tc plannlne and declslcn maklne
structures.
N Pccr cccrdlnatlcn between dlfferent
publlc sectcr entltles lnvclved ln health
care plannlne and lmplementatlcn,
lncludlne llmlted cccrdlnatlcn between
dlfferent mlnlstrles and between
natlcnal, prcvlnclal, clty ccrpcratlcn
and lccal ecvernments.
N uecentrallzatlcn wlth lncreased lccal
autcncmy wlthcut sufñclent leelslatlcn
and central cccrdlnatlcn securlne
adequate dlsease ccntrcl measures.
N weak health sectcr reeulatlcn and
llmlted mechanlsms and rescurces fcr
enfcrclne exlstlne reeulatlcn
N hcn-exlstent cr weak pcllcy ccncernlne
the rcle cf the prlvate health care
sectcr, lncludlne llmlted lnfcrmatlcn cn
the prlvate sectcr and pccr reeulatcry
framewcrk
hea|th hnanc|ng
N Llmlted eeneral health sectcr budeets
and caps cn expanslcn cf health
rescurces
N unfalr ñnanclne systems, e.e. absence
cr lcw ccveraee cf health lnsurance
wlth ablllty tc pccl and redlstrlbute
rescurces ln a way whlch mlnlmlzes
ñnanclal access barrlers
N weak ñnanclal steerlne mechanlsms
fcr strateelc rescurce allccatlcn and
purchaslne cf servlces
N weak mechanlsms fcr tracklne ñnanclal
fcws and pccr capaclty fcr perfcrmlne
natlcnal health acccunts
hea|th werkIerce
N Lack cf baslc lnfcrmatlcn abcut the
health wcrk fcrce denslty, dlstrlbutlcn
and sklll mlx
N lnsufñclent slze and ccmpetence cf the
health wcrkfcrce.
N weak structure and pccr quallty
cf educatlcnal systems fcr health
prcfesslcnals.
N weak structure and quallty fcr
ccntlnued medlcal educatlcn
N Absent, unclear cr ncn-perfcrmance
based career cppcrtunltles
N Pccr supervlslcn and quallty ccntrcl
mechanlsms
N Perverse lncentlves llnked tc
emplcyment pcllcles, salary structure
and payment mechanlsms
Med|ca| preducts (|nc|ud|ng drugs and
d|agnest|c Iac|||t|es)
N weak reeulatlcn cf medlcal prcducts
and/cr weak enfcrcement mechanlsms
N weak mechanlsm fcr prcmctlne ratlcnal
use cf drues
N weak systems fcr prccurement,
dlstrlbutlcn and manaeement cf drues
and equlpment
hea|th |nIermat|en system (|nc|ud|ng
men|ter|ng and eva|uat|en)
N Pccr quallty cf vltal statlstlcs and
demceraphlc lnfcrmatlcn
N weak eeneral systems fcr dlsease
survelllance, and pccr dlsease
nctlñcatlcn system
N Lack cf data cn health care utlllzatlcn
patterns
N Llmlted skllls tc analyse exlstlne data
N Llmlted capaclty fcr health systems
research and cperatlcnal research
hea|th serv|ces (|nc|ud|ng hea|th
care prev|s|en and management/
superv|s|en eI serv|ces)
N Lack cf baslc lnfcrmatlcn ccncernlne
number, ccmpcsltlcn, and eeceraphlcal
dlstrlbutlcn cf all health prcvlders
(publlc and prlvate), and the type and
quallty cf the servlces they prcvlde
N Lack cf ccmprehenslve pcllcy and plan
fcr cptlmal utlllzatlcn cf exlstlne health
prcvlders
N Llmlted capaclty tc plan and manaee
health care prcvlslcn, lncludlne
ccntractlne, certlñcatlcn and
accredltatlcn cf publlc and prlvate
prcvlders
N Llmlted use cf quallty standards and
evldence based euldellnes
N Pccr systems fcr referrals and
lnfcrmatlcn exchanee between
prcvlders
1¶)
z1. C0hTkl8uTlhC T0 STkFhCTFFhlhC 0F FFALTF S¥STFMS
lty, etc. Fcwever, health sectcr refcrms are shaped thrcueh ccmplex pclltlcal
prccesses. hTP manaeers are nct usually at the centre cf such prccesses, and
may nct be fully lnfcrmed abcut them. Ccnsequently, T8 prcerammes may
be at rlsk cf belne neelected cr even damaeed durlne health sectcr refcrms,
and cppcrtunltles fcr T8 prcerammes tc ccntrlbute tc eeneral health systems
strenethenlne may be lcst.
hTPs need tc stay ln tcuch wlth, and seek tc lnfuence, health sectcr refcrm
prccesses. kefcrms that may be lmplemented lnclude decentrallzatlcn and
devclutlcn cf health care ñnanclne and declslcn-maklne; prlvatlzatlcn and/cr
prcvlder-purchaser spllt wlth mcre lndependent health lnstltutlcns; and chane-
lne ñnanclne mechanlsms, e.e. lntrcductlcn cf health lnsurance schemes.
hTPs alsc need tc be lnfcrmed abcut brcader health-care plannlne and ñnanc-
lne framewcrks, prccesses and ccncepts that are used by mlnlstrles cf health,
partners and lnternatlcnal dcncrs. These lnclude sectcr-wlde apprcaches
(SwAPs), medlum-term expendlture framewcrks (MTFFs) and pcverty reductlcn
strateey papers (PkSPs).
z1.¶ Centr|but|ng te system-w|de se|ut|ens wh||e pretect|ng
essent|a| 1ß centre| Iunct|ens
Favlne ldentlñed health system barrlers and mapped cut cneclne and planned
health sectcr develcpment prccesses, hTPs shculd devlse actlcns tc streneth-
en health systems that:
º ccntrlbute tc addresslne the rcct causes cf health system weaknesses;
º cptlmlze the pcsltlve lmpact cn the eeneral health system cf speclñc T8
prceramme actlvltles, thrcueh apprcprlate lnteeratlcn and harmcnlzatlcn cf
ñnanclne, plannlne and servlce dellvery;
º prctect essentlal T8-speclñc functlcns that may be damaeed durlne health
sectcr refcrm prccesses.
The hTPs shculd, tc the extent pcsslble, be prcactlvely lnvclved ln natlcnal
health sectcr develcpment prccesses. The cppcrtunltles fcr the hTP tc dlrectly
lnfuence brcad refcrm prccesses vary frcm ccuntry tc ccuntry. 0ften, the hTP
wlll be able tc address eeneral health systems barrlers cnly lndlrectly thrcueh
lts cwn cperatlcns. Fcwever, thls can alsc be an lmpcrtant leveraee pclnt. Fcr
example, when the hTP addresses health system barrlers cn a dally basls, by
trylne tc secure sustalnable fundlne, strlvlne tc lmprcve the wcrkfcrce and
labcratcry capaclty, cptlmlzlne drue manaeement and lmprcvlne cccrdlnatlcn
between dlfferent health-care prcvlders, these effcrts wlll help strenethen the
eeneral health system, prcvlded that they are harmcnlzed wlth natlcnal health
plans, wlth the alm cf cptlmal use cf shared rescurces.
1¶8
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
Althcueh dlsease-speclñc lnvestments ln, fcr example, Fk develcpment cr lab-
cratcry strenethenlne, may help lmprcve the eeneral health system, they may
alsc put straln cn the health system and draln rescurces frcm cther parts cf
the system lf planned and lmplemented ln lsclatlcn wlthcut due ccnslderatlcn
cf system-wlde effects. Ccntrlbutlne tc health system strenethenlne lmplles a
respcnslblllty tc ccnslder the lmpact cf T8 ccntrcl actlcns cn the wlder health
system. Therefcre, the hTPs shculd prcmcte:
º hcrmcnizinc T8 ccntrcl plannlne and budeetlne prccesses wlth sectcr-wlde
plannlne framewcrks;
º cptimizinc the use cf shared rescurces, such as frcntllne health staff;
º rcdµrinc the number cf dupllcatlve structures.
Farmcnlzatlcn and lnteeratlcn shculd nct ccmprcmlse ccre T8 ccntrcl func-
tlcns. The key functlcns ncrmally requlre sufñclent earmarked rescurces and
dedlcated staff fcr prceramme unlts at central and reelcnal/prcvlnclal levels,
dedlcated staff fcr prceramme supervlslcn at dlstrlct level, and, unless the
eeneral health system ls strcne encueh cn these functlcns, separate repcrtlne
cf key prceramme lndlcatcrs and capaclty tc manaee prccurement and dlstrl-
butlcn cf antl-T8 drues. The balance between lnteeratlcn and the retentlcn cf
key T8-speclñc structures and staff wlll vary acrcss ccuntrles, dependlne cn
the rcbustness cf the eeneral health system.
key reIerences
Fvcrvbcdv´s bµsincss - Strcncthcninc hcclth svstcms tc imprcvc hcclth cµtrcmcs.
wh0´s [rcmcwcrk [cr crticn. Ceneva, wcrld Fealth 0reanlzatlcn, zoo;.
Fxpcndinc 001S in thc rcntcxt c[ c rhcncinc hcclth svstcm. Ceneva, wcrld Fealth
0reanlzatlcn, zoo¸ (wF0/CuS/zoo¸.¸18).
hcw thc Stcp 18 Strctccv rcn rcntribµtc tc hcclth svstcms strcncthcninc 'Stcp T8
uepartment dlscusslcn paper]. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6.
1¶¤
zz Fneaelne all care prcvlders
T
he dellvery cf care fcr T8 patlents thrcueh publlc sectcr health servlces ls
eenerally the maln fccus cf hTP actlvltles. Fcwever, many patlents wlth
symptcms cf T8, lncludlne very pccr patlents, seek and recelve care frcm a
wlde varlety cf prlvate and publlc health-care prcvlders cutslde the netwcrk
cf hTP servlces. The lnvclvement cf these ncn-hTP prcvlders varles ereatly
frcm ccuntry tc ccuntry. The systematlc lnvclvement cf all relevant health-care
prcvlders ln dellverlne effectlve servlces fcr dlaencsls cf T8 and treatment cf
T8 patlents tc all seements cf the pcpulatlcn ls an essentlal ccmpcnent cf the
Stcp T8 Strateey. Table zz.1 llsts the ma|cr prcvlder ercups that may manaee
T8 patlents cutslde the hTP.
zz.1 Pub||c-pr|vate m|x
The term "publlc-prlvate mlx", cr PPM, represents a ccmprehenslve apprcach
fcr eneaelne all relevant health-care prcvlders ln care cf T8 patlents and ccntrcl
cf the dlsease. lt enccmpasses all fcrms cf publlc-prlvate ccllabcratlcn (e.e.
between hTP and the prlvate cr ccrpcrate sectcr), publlc-publlc ccllabcratlcn
(e.e. between hTP and hcspltal cr prlscn health servlces) and prlvate-prlvate
ccllabcratlcn (e.e. between an hC0 cr a prlvate hcspltal and the nelehbcur-
hccd prlvate practltlcners) fcr the ccmmcn purpcse cf ensurlne prcvlslcn cf
standard T8 care ln the ccmmunlty. PPM ls alsc relevant fcr labcratcry wcrk,
1AßL£ zz.: CATFC0klFS 0F FFALTF CAkF Pk0vluFkS TFAT MAhACF Tu8FkCuL0SlS PATlFhTS
Pub||c hea|th-care prev|ders Nen-state er pr|vate hea|th-care prev|ders
Ceneral hcspltals
Speclalty hcspltals and medlcal cclleees
Fealth lnstltutlcns under state
lnsurance schemes
Fealth facllltles under publlc
ccrpcratlcns
Prlscn health servlces
Mllltary health servlces
Prlvate hcspltals and cllnlcs
Ccrpcrate health servlces
hcnecvernmental creanlzatlcn hcspltals and cllnlcs
Falth-based creanlzatlcn servlces
lndlvldual prlvate practltlcners
Pharmacles and drue dlspensarles
Tradltlcnal healers and practltlcners
lnfcrmal, ncn-quallñed practltlcners
1qe
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
T8/Flv ccllabcratlve actlvltles and fcr preventlcn and manaeement cf drue-
reslstant T8, lncludlne Muk-T8 and Xuk-T8.
The lntcrncticncl stcndcrds [cr tµbcrrµlcsis rcrc address the baslc elements cf
dlaencsls cf T8 and treatment cf T8 patlents and prcvlde an excellent tccl tc
help standardlze T8 manaeement practlces amcne all care prcvlders.
zz.z Imp|ement|ng pub||c-pr|vate m|x at nat|ena| |eve|
Fvldence frcm ccuntry experlences shcws that PPM fcr T8 care and ccntrcl ls
feaslble, prcductlve and ccst-effectlve: lt helps tc lmprcve T8 case detectlcn
and treatment cutccmes, lt fcsters equlty cf access tc T8 care, and lt affcrds
ñnanclal prctectlcn fcr the pccr.
The standard ccuntry-level PPM apprcach lnvclves three maln actlvltles:
º undertaklne a natlcnal sltuatlcn assessment;
º develcplne natlcnal cperatlcnal euldellnes and plans;
º lmplementlne euldellnes and plans lccally.
zz.z.1 hatlonal sltuatlon assessment
The steps lnvclved ln a sltuatlcn assessment lnclude:
º ldentlfylne all health-care prcvlder ercups;
º determlnlne thelr current ccntrlbutlcn tc T8 ccntrcl;
º assesslne whlch T8 ccntrcl tasks each prcvlder ercup can undertake;
º ldentlfylne lnput requlred frcm hTPs tc cptlmlze thelr ccntrlbutlcn.
A eenerlc tccl tc help ccuntrles undertake a natlcnal sltuatlcn assessment ls
avallable.
Table zz.z prcvldes scme cptlcns fcr task mlx and rcle dlvlslcn fcr dlfferent
types cf prcvlders, whlch wlll vary acrcss and wlthln ccuntrles dependlne cn
the nature cf prcvlder mlx, wllllneness tc take cn dlfferent tasks, the status cf
the hTP, patlent preferences and the health reeulatcry framewcrk.
The hTP shculd be able tc carry cut all cf the tasks and tc ñll the eaps by sup-
pcrtlne cr taklne cn the tasks that cther prcvlders are unwllllne cr unable tc
carry cut. ln all settlnes, lt ls essentlal that the hTP ls respcnslble fcr ccverlne
the maln part cf the ccst cf dlaencsls and treatment. As a mlnlmum, the hTP
shculd prcvlde antl-T8 drues free cf charee tc prcvlders, whc shculd dlspense
them free cf charee tc patlents. The hTP shculd alsc develcp and malntaln
strcne stewardshlp capaclty tc eulde and cversee prlvate and publlc prcvld-
ers. ln brlef, the ecvernment-run hTP assumes the respcnslblllty fcr fundlne,
1q1
zz. FhCAClhC ALL CAkF Pk0vluFkS
1AßL£ zz.z lhulCATlvF TASK MlX F0k ulFFFkFhT CATFC0klFS 0F FFALTF-CAkF Pk0vluFk
a
1asks
Nat|ena|
1ß centre|
pregramme
Pub||c er
pr|vate
|nst|tut|en
Ind|v|dua|
pr|vate
prev|der
Pr|vate/
pub||c
|aberatery
Nen-
phys|c|an/
pharmacy
C
|
|
n
|
c
a
|

t
a
s
k
s
ldentlfy symptc-
matlc T8 patlents
Ccllect sputum
smear samples
kefer T8 suspects
hctlfy/reccrd cases
Supervlse treatment
uc sputum smear
mlcrcsccpy
ulaencse T8
Prescrlbe treatment
lnfcrm patlents
abcut T8
P
u
b
|
|
c

h
e
a
|
t
h

t
a
s
k
s
ldentlfy and super-
vlse treatment
suppcrters
Fcllcw up defaulters
Traln health-care
prcvlders
Supervlse
Assure quallty cf
labcratcrles
Mcnltcr and
evaluate
Manaee drues and
supplles
Prcvlde steward-
shlp: ñnanclne and
reeulatlcn
a
Shaded cells represent tasks that cculd be carrled cut by respectlve prcvlder type.
reeulatlne and mcnltcrlne, whlle the day-tc-day ccllabcratlve lmplementatlcn
actlvltles may be carrled cut by the lccal unlt cf the hTP cr by apprcprlate ncn-
hTP prcvlders.
ln develcplne a natlcnal strateey fcr PPM, the hTP shculd ccnstltute a task
fcrce, ccalltlcn cr cccrdlnatlcn ccmmlttee wlth brcad representatlcn cf stake-
hclders (Table zz.¸). Thls bcdy may act as an lnterface between the hTP and
cther prcvlders. lt may alsc advlse the hTP ln carrylne cut varlcus tasks such
1qz
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
as advccacy, sensltlzatlcn, tralnlne, supervlslcn, quallty ccntrcl, and mcnltcr-
lne and evaluatlcn. ln scme settlnes, the lssue cf dlaencsls cf smear-neeatlve
and culture-neeatlve fcrms cf T8 has been addressed effectlvely by establlsh-
lne dlaencstlc ccmmlttees ccmprlslne relevant lccal experts.
zz.z.z 0eveloplnç operatlonal çulJellnes
hatlcnal pcllcy and cperatlcnal euldellnes cn PPM shculd be develcped and
lmplemented as an lteratlve prccess: pcllcy, leadlne tc preparatlcn cf cpera-
tlcnal euldellnes tc help phased lmplementatlcn, and the results cf lmplemen-
tatlcn feedlne back lntc pcllcy fcr any revlslcn requlred.
Table zz.u summarlzes the seven essentlal ccmpcnents cf develcplne cpera-
tlcnal euldellnes fcr PPM.
zz.¶ Imp|ement|ng pub||c-pr|vate m|x at |eca| |eve|
The natlcnal euldellnes shculd be fexlble encueh tc allcw fcr lccal adapta-
tlcn. The lcelcal steps ln lccal lmplementatlcn are: preparatlcn, mapplne and
ñrst ccntact wlth prcvlders, selectlcn cf prcvlders, lmplementatlcn prcper, and
advccacy and ccmmunlcatlcn.
zz.y.1 Preparatlon
A clear, wrltten messaee frcm the senlcr hTP manaeement cn the lmpcrtance
and prlcrlty cf PPM ls the ñrst prerequlslte befcre lccal lmplementatlcn beelns.
0peratlcnal euldellnes shculd be made avallable. uraft sensltlzatlcn and traln-
lne materlals shculd be ready fcr use. The lmplementatlcn tccls, lncludlne any
new fcrmats and adapted hTP reelsters and repcrts, shculd be avallable. hTP
staff shculd be crlented abcut PPM; thelr tasks and respcnslbllltles shculd be
deñned and a plan cf lmplementatlcn shculd be avallable acccrdlne tc lccally
deñned cb|ectlves fcr PPM.
1AßL£ zz.¶ STAKFF0LuFkS lh Pu8LlC-PklvATF MlX F0k u0TS AT hATl0hAL,
Pk0vlhClAL Ahu L0CAL LFvFLS
Q Mlnlstry cf health, lts departments and sub-natlcnal ccunterparts
Q 0ther mlnlstrles, such as mlnlstrles cf labcur, the lnterlcr, defence
Q Fealth lnsurance creanlzatlcns
Q urue reeulatcry authcrltles
Q Academlc lnstltutlcns
Q Scclal welfare prcerammes fcr pccr and marelnallzed pecple
Q Prcfesslcnal creanlzatlcns
Q Fcspltal asscclatlcns, pharmaceutlcal asscclatlcns etc.
Q hatlcnal and lnternatlcnal ncnecvernmental creanlzatlcns lnvclved ln dellvery cf
servlces fcr T8 ccntrcl
Q urue lndustry
Q Ccnsumer creanlzatlcns
1q¶
zz.y.z Mapplnç anJ þrst contact wlth provlJer
The lccal hTP unlt shculd have a map cf lts area cn whlch tc mark all publlc
and ncn-publlc prcvlders. ln deallne wlth prlvate prcvlders, uslne a neutral
lnterface such as a lccal hC0 cr a clvll scclety lnstltutlcn may expedlte bcth
prcvlder enrclment and prceramme lmplementatlcn. Mapplne and maklne the
ñrst ccntact wlth the prcvlder and sensltlzatlcn may be ccmblned.
zz.y.y 5electlon oj provlJers
Prlcrltlzatlcn cf prcvlders fcr actlve ccllabcratlcn and thelr tralnlne are lmpcr-
tant steps. The fcllcwlne ccnslderatlcns shculd be taken lntc acccunt.
º lnstltutlcnal prcvlders such as laree hcspltals and medlcal cclleees are llkely
tc elve a hleher yleld cf cases but wlll alsc requlre ereater tlme and attentlcn
cn the part cf senlcr hTP staff.
º lt may be pcsslble tc ldentlfy and tareet ñrst the prlvate practltlcners whc
handle a laree number cf T8 suspects and cases.
º lnvclvlne cther publlc sectcr lnstltutlcns wlthln and cutslde the mlnlstry cf
health may requlre a parallel prccess cf apprcvals and dlrectlves frcm thelr
senlcr reelcnal cr natlcnal manaeers.
zz. FhCAClhC ALL CAkF Pk0vluFkS
1AßL£ zz.o FSSFhTlAL C0MP0hFhTS 0F uFvFL0PlhC 0PFkATl0hAL CuluFLlhFS
F0k Pu8LlC-PklvATF MlX APPk0ACFFS
Cempenent 5ummary
fermu|at|ng
ebject|ves
Fxamples: lncrease ln case detectlcn; lmprcved treatment cutccmes;
lmprcved access tc dlaencstlc and treatment servlces fcr pccr pecple and
lmpcverlshed ccmmunltles; reduced ñnanclal burden fcr patlents.
ßehn|ng the
task m|x
kcles and respcnslbllltles fcr dlfferent prcvlders clearly deñned, prcvldlne
dlfferent cptlcns sc that euldellnes can be adapted lccally.
ßeve|ep|ng
pract|ca| tee|s
Fxamples: labcratcry request fcrm; referral-fcr-treatment fcrm; feedback
cr back-referral fcrm; transfer fcrm; labcratcry reelster; T8 reelster; T8
treatment card.
ßeve|ep|ng a
tra|n|ng strategy
Tralnlne strateey tc be based cn the deñned task mlx, and tareet staff cf
the natlcnal T8 ccntrcl prceramme staff and prcvlders lnvclved
Cert|hcat|en er
accred|tat|en eI
prev|ders
Crlterla fcr certlñcatlcn and de-certlñcatlcn tc be related tc the speclñc
task cptlcns, slmllarly fcr the publlc and prlvate sectcrs. Certlñcatlcn may
be lnfcrmal lnltlally and evclve lntc a fcrmal, standardlzed prccedure.
ßeve|ep|ng
|ncent|ves
and enab|ers
Flnanclal ccmpensatlcn may be necessary fcr prcvlders whc manaee a
laree number cf T8 suspects and cases. Fcwever, prlvate practltlcners
wlth few T8 patlents and vcluntary creanlzatlcns prcvldlne T8 care may
ñnd ln-klnd, ncn-mcnetary lncentlves sufñclent tc enter lntc ccllabcratlcn
wlth the prceramme, e.e. access tc antl-T8 drues, tralnlne and ccntlnulne
educatlcn and mlcrcsccpy servlces, all free cf charee.
ßraIt|ng men|ter|ng
and eva|uat|en p|an
Mcnltcrlne and evaluatlcn cf the publlc-prlvate mlx prccess ln relatlcn tc
deñned cb|ectlves ls needed tc enable stepwlse ad|ustment cf strateeles
and lmplementatlcn plans.
1qq
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
º The pccrest patlents are llkely tc ñrst apprcach hC0s cperatlne ln pccr
areas and ncn-physlclans such as pharmaclsts, ncn-quallñed prcvlders and
tradltlcnal healers. Apprcachlne these cateecrles may lmprcve access fcr
pccr pecple.
º lt ls advlsable tc beeln wlth wllllne prcvlders befcre attemptlne tc eneaee
thcse reluctant tc ccllabcrate.
º Prcfesslcnal creanlzatlcns and hC0s may serve as lmpcrtant lntermedlarles
tc enllst cther care prcvlders.
zz.y.q Implementatlon
The methcd cf launchlne PPM lccally wlll depend cn the settlne. lt ls lmpcrtant
that hTP staff malntaln thelr ccmmltment and fcllcw the aereed plans. ln early
staees, dccumentatlcn cf the prccess shculd be malntalned. Careful mcnltcr-
lne and dccumentatlcn cf prcblems enccuntered are reccmmended sc that
apprcprlate revlslcn cf cperatlcnal euldellnes may be made. Ccntlnucus dla-
lceue between lnvclved partners ls necessary tc address ldentlñed prcblems
and pctentlal tenslcns.
zz.y.¢ 4Jvocacy anJ communlcatlon
Tc eenerate and sustaln lnterest ln PPM, advccacy shculd be dlrected bcth
tcwards hTP staff and thelr ccunterparts amcne cther prcvlder ercups. All
care prcvlders are llkely tc beneñt frcm lmprcvement ln thelr ccmmunlcatlcn
and lnteractlcn wlth T8 suspects and cases. Prcvldlne lnfcrmatlcn tc patlents
cn the avallablllty cf T8 servlces ln the publlc and prlvate sectcrs and cn the
charees they may cr may nct need tc pay fcr dlfferent servlces helps make the
ccllabcratlcn cpen and transparent and may alsc help tc mlnlmlze the pcssl-
bllltles cf mlsuse and malpractlce.
zz.q 5uperv|s|en and men|ter|ng eI PPM
Supervlslcn and quallty assurance cf all lnvclved publlc and prlvate facllltles,
lncludlne labcratcrles, shculd be an lnteeral part respectlvely cf the supervl-
scry and quallty assurance rcutlnes cf the hTP. lndlcatcrs fcr mcnltcrlne the
prccess and measurlne the ccntrlbutlcn cf prcvlders tc cverall T8 ccntrcl tar-
eets lnclude the fcllcwlne prccess and cutccme lndlcatcrs:
1. Prcpcrtlcn cf repcrtlne unlts lmplementlne PPM.
z. Prcpcrtlcn cf ncn-hTP health unlts partlclpatlne ln referral/dlaencsls/treat-
ment cf T8 cases.
¸. Prcpcrtlcn cf new smear-pcsltlve cases detected thrcueh referral by ncn-
hTP prcvlders.
1q¶
zz. FhCAClhC ALL CAkF Pk0vluFkS
u. Prcpcrtlcn cf new smear-pcsltlve cases detected thrcueh dlaencsls by ncn-
hTP prcvlders.
ç. Prcpcrtlcn cf new smear-pcsltlve T8 patlents recelvlne u0T frcm ncn-hTP
prcvlders.
6. Treatment cutccmes cf new smear-pcsltlve cases treated by ncn-hTP prcvld-
ers.
key reIerences
Ambe C et al. Fvery prcvlder ccunts! Fffects cf a ccmprehenslve publlc-prlvate mlx
apprcach fcr T8 ccntrcl ln a laree metrcpclltan area ln lndla. lntcrncticncl lcµrncl c[
1µbcrrµlcsis cnd lµnc 0isccsc, zooç, ¤:ç6z-ç68.
A tccl [cr ncticncl sitµcticn csscssmcnt: pµblir-privctc mix [cr 18 rcrc cnd rcntrcl.
Ceneva, wcrld Fealth 0reanlzatlcn, zoo; (wF0/FTM/T8/zoo;.¸¤1).
uewan PK et al. Publlc-prlvate mlx ln lndla: lmprcvlne tuberculcsls ccntrcl thrcueh
lntersectcral partnershlps. 8ritish Mcdircl lcµrncl, zoo6, ¸¸z:ç;u-ç;8.
Fncccinc cll hcclth rcrc prcvidcrs in 18 rcntrcl - Cµidcnrc cn implcmcntinc pµb-
lir-privctc mix cpprccrhcs. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6 (wF0/FTM/
T8/zoo6.¸6).
Flcyd K et al. Ccst and ccst-effectlveness cf publlc and prlvate sectcr ccllabcratlcn ln
tuberculcsls ccntrcl: evldence frcm lndla. 8µllctin c[ thc wcrld hcclth 0rccnizcticn,
zoo6, 8u: u¸;-uuç.
Lcnnrcth K et al. Publlc-Prlvate Mlx fcr lmprcved T8 Ccntrcl - what makes lt wcrk: 8µl-
lctin c[ thc wcrld hcclth 0rccnizcticn, zoou, 8z: ç8o-ç86.
Lcnnrcth K, uplekar M, 8lanc L. Fard ealns thrcueh scft ccntracts - prcductlve eneaee-
ment cf prlvate prcvlders ln tuberculcsls ccntrcl. 8µllctin c[ thc wcrld hcclth 0rccnizc-
ticn, zoo6, 8u: 8;6-88¸.
Pµblir-privctc mix [cr 001S: prcrtircl tccls tc hclp implcmcntcticn. Ceneva, wcrld
Fealth 0reanlzatlcn, zoo¸ (wF0/CuS/T8/zoo¸.¸zç).
Sallm MAF et al. Turnlne llabllltles lntc rescurces: the lnfcrmal vlllaee dcctcrs and T8
ccntrcl ln 8aneladesh. 8µllctin c[ thc wcrld hcclth 0rccnizcticn, zoo6, 8u:u;¤-u8u.
uplekar M, Lcnnrcth K. Fneaelne prlvate prcvlders ln T8 ccntrcl: publlc-prlvate mlx fcr
u0TS. ln: kavlellcne MC ed. kcirhmcn cnd hcrshhcld´s tµbcrrµlcsis: c rcmprchcnsivc
intcrncticncl cpprccrh. Thlrd Fdltlcn. Part b. hew ¥crk, lnfcrma Fealthcare uSA, lnc.,
zoo6:¤8ç-1oou.
uplekar M, Lcnnrcth K. Muk and Xuk: prlce cf delaylne eneaeement wlth all care prc-
vlders fcr ccntrcl cf T8 and T8/Flv. 1rcpircl Mcdirinc cnd lntcrncticncl hcclth, zoo;,
1z(u):u;¸-u;u.
uplekar M, Pathanla v, kavlellcne M. Prlvate practltlcners and publlc health: weak llnks
ln tuberculcsls ccntrcl. lcnrct, zoo1, ¸ç8(¤z8ç):¤1z-¤16.
1q6
z¸ Practlcal apprcach tc lune
health and cther lnteerated
apprcaches tc health care
T
he prlmary health-care ccncept ls embcdled ln lnteerated, decentrallzed
eeneral health servlces that prcvlde preventlve measures as well as treat-
ment and care fcr the ccmmunlty's mcst ccmmcnly cccurrlne prlcrlty health
prcblems. Ceneral health servlces cffer valuable cppcrtunltles fcr the dlaencsls
and manaeement cf T8. Case detectlcn, treatment and fcllcw-up are enhanced
when T8 servlces are prcvlded wlthln the eeneral health system at servlce
dellvery pclnts. Facllltatlne factcrs lnclude lmprcved access tc dlaencstlc and
treatment servlces, reductlcn cf stlema and slmpllñed ccntact traclne. Several
lnltlatlves prcmcte an lnteerated apprcach tc prlcrlty health lnterventlcns.
z¶.1 Pract|ca| appreach te |ung hea|th (PAL)
kesplratcry ccndltlcns are the ñrst cr seccnd leadlne cause cf care-seeklne ln
mcst prlmary health care (PFC) settlnes, acccuntlne fcr scme zo-¸o% cf vlslts.
Slnce T8 acccunts fcr cnly a very small prcpcrtlcn cf all resplratcry cases, T8
suspects are cften lnapprcprlately manaeed and therefcre T8 ls mlsdlaencsed.
The PAL strateey addresses the need fcr lmprcved resplratcry care thrcueh
a symptcm-based lnteerated apprcach tc the standardlzed manaeement cf
patlents wlth resplratcry ccndltlcns ln PFC settlnes. PAL emphaslzes prlcrlty
resplratcry lllnesses, partlcularly T8, acute resplratcry lnfectlcns and chrcnlc
resplratcry dlseases, wlth a fccus cn asthma and chrcnlc cbstructlve pulmc-
nary dlsease. lmprcvlne eeneral resplratcry care lncreases the quallty cf the
ldentlñcatlcn cf T8 cases amcne resplratcry patlents. Thls ls the baslc prlnclple
acccrdlne tc whlch the PAL strateey has been develcped and lnccrpcrated ln
the Stcp T8 Strateey.
The lMCl lnltlatlve fccuses cn chlldren aeed belcw ñve years, lncludlne thcse
wlth resplratcry symptcms. PAL tareets resplratcry patlents aeed ñve years
and cver.
zy.1.1 Key objectlves
The PAL strateey fccuses cn the quallty cf manaeement cf patlents wlth resplra-
tcry ccndltlcns amcne whcm T8 cases shculd be ldentlñed. lt alsc deñnes hcw
the manaeement prccess shculd be adapted tc the avallable health rescurces
and lnfrastructure.
1q)
z¸. PAL Ahu 0TFFk lhTFCkATFu APPk0ACFFS T0 FFALTF CAkF
The twc ma|cr cb|ectlves cf PAL are:
º tc lmprcve the quallty cf resplratcry care ln PFC settlnes;
º tc lmprcve the efñclency cf resplratcry servlce dellvery wlthln health sys-
tems, fccuslne cn the dlstrlct health system.
zy.1.z Prlnclpal components
PAL lncludes twc ma|cr ccmpcnents: standardlzatlcn cf cllnlcal care and cccr-
dlnatlcn wlthln the health sectcr.
Stcndcrdizcticn c[ rlinircl rcrc. Cllnlcal practlce euldellnes are needed fcr ñrst-
level health facllltles and fcr referral levels; the twc shculd be cccrdlnated.
Flrst-level euldellnes shculd be symptcm-based, whlle thcse fcr referral levels
shculd deal wlth the speclñc resplratcry ccndltlcns that are manaeed at thls
level.
PAL euldellnes use a mlnlmum number cf key slens that lead tc dlaencstlc clas-
slñcatlcn, determlnatlcn cf deeree cf severlty cf dlsease and declslcn-maklne.
The euldellnes shculd be ccnslstent wlth reeulatlcns cn drue prescrlptlcn and
lnternatlcnal reccmmendatlcns cn the manaeement cf prlcrlty resplratcry dls-
eases such as T8, pneumcnla, asthma and chrcnlc cbstructlve pulmcnary dls-
ease. ln ccuntry settlnes, the adapted PAL euldellnes shculd be ccnslstent wlth
exlstlne natlcnal euldellnes fcr T8, Flv and cther cllnlcal euldellnes such as
thcse fcr the lnteerated manaeement cf adult and adclescent lllness (lMAl).
Cccrdincticn within thc hcclth scrtcr. ln well-establlshed PFC systems, cccrdl-
natlcn wlthln the health sectcr lmplles creanlzed ccllabcratlcn amcne health
wcrkers at the same and dlfferent levels cf the health system, and amcne
dlfferent cateecrles cf health wcrkers. Fcr resplratcry case manaeement, the
lnvclvement cf each health-care prcvlder cateecry and cf each health-care level
shculd be clearly deñned sc that full lnteeratlcn takes place wlthln the health
system, partlcularly at dlstrlct level.
The develcpment and lmplementatlcn cf the PAL strateey alsc requlres cccrdl-
natlcn wlth natlcnal health rescurce plannlne and cther prlcrlty natlcnal health
prcerammes and PFC servlces.
zy.1.y £ssentlal elements
The fcllcwlne essentlal technlcal and manaeerlal elements shculd be ccnsld-
ered ln PAL develcpment ln all settlnes.
º Fsscnticl tcrhnircl clcmcnts
a. Classlñcatlcn and dlaencsls cf cases thrcueh standardlzed, lccally adapt-
ed euldellnes fcr cutpatlent servlces.
1q8
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
b. Treatment uslne standardlzed reelmens cf prcven efñcacy and medlclnes
lncluded ln the natlcnal llst cf essentlal medlclnes.
c. Mlnlmum equlpment fcr dlaencsls and treatment cf resplratcry dlseases
deñned fcr each level cf the health servlce.
d. Fealth educatlcn cf patlents and thelr famllles cn ccmpllance, wlth treat-
ment and preventlve measures such as lmmunlzatlcn, stcpplne smcklne,
avcldlne trleeerlne factcrs fcr asthma and reduclne lndccr alr pcllutlcn.
º Fsscnticl mcncccricl clcmcnts
a. Pclltlcal ccmmltment, as evldenced by declslcns such as the deslenatlcn
cf a department cr cfñcer respcnslble fcr PAL actlvltles, the ncmlnatlcn cf
a natlcnal wcrklne ercup cn PAL and the mcblllzatlcn cf funds tc lnltlate
actlvltles.
b. Tralnlne health prcfesslcnals ln the use cf PAL euldellnes.
c. An ensured reeular supply cf quallty-assured affcrdable drues fcr man-
aelne resplratcry dlseases and the mlnlmum equlpment deñned ln the
euldellnes supplled tc the health unlts
d. utlllzatlcn cf the exlstlne lnfcrmatlcn system ln crder tc prcvlde mlnlmum
essentlal lnfcrmatlcn fcr mcnltcrlne and evaluatlne PAL actlvltles.
e. Pllct-testlne cf the technlcal and cperatlcnal euldellnes ln areas repre-
sentlne averaee ccndltlcns cf the health lnfrastructure cf the ccuntry.
f. hatlcnal plan fcr PAL lmplementatlcn, taklne lntc acccunt the experlence
cf the pllct area tested.
zy.1.q 4Japtatlon anJ lmplementatlon
Adaptatlcn cf the PAL strateey at ccuntry level, acccrdlne tc the epldemlclcel-
cal and scclceccncmlc envlrcnment and prevalllne natlcnal health pcllcles and
health prlcrltles, shculd take lntc acccunt the structure cf the health system
and the health rescurces avallable, partlcularly at dlstrlct level. Adaptatlcn
lnvclves the fcllcwlne elements.
º Adaptatlcn starts wlth the establlshment cf a natlcnal wcrklne ercup cn PAL
tc eulde and suppcrt lnltlal PAL actlvltles. Assessment cf the health envlrcn-
ment ls an lmpcrtant lnltlal step ln ldentlfylne the resplratcry ccndltlcns tc
be lncluded ln the natlcnal PAL strateey and fcr adaptatlcn cf the euldellnes
tc the exlstlne health lnfrastructure and rescurces.
º PAL euldellnes and tralnlne materlal shculd be develcped and pllct-tested.
They shculd ccver prlcrlty resplratcry lllnesses, the equlpment and essentlal
1q¤
medlclnes needed tc manaee them, the rcle cf each health wcrker cateecry,
the prccess fcr referral, and the standardlzed lnfcrmatlcn system fcr ccllect-
lne data.
º A plan tc lmplement PAL, elther fcr speclñc reelcns cr fcr the whcle ccuntry,
shculd be elabcrated ln clcse cccrdlnatlcn wlth the hTP and the natlcnal
PFC department, and ln ccnsultatlcn wlth cther relevant stakehclders. ln
ccuntry settlnes where the lnltlatlve cf the Clcbal Alllance aealnst Chrcnlc
kesplratcry ulseases has been lntrcduced, the lmplementatlcn cf PAL shculd
take lntc acccunt the actlvltles cf thls lnltlatlve.
º Tc scale up PAL lmplementatlcn, ñnanclal suppcrt may be mcblllzed thrcueh
the ecvernment and explcred wlth bllateral and multllateral aeencles lnvclved
ln the develcpment cf health servlces wlthln the ccuntry.
º PAL lmplementatlcn shculd be under the leadershlp cf a clearly ldentlñed
cccrdlnatlcn unlt wlthln the mlnlstry cf health, ensurlne apprcprlate llnks
wlth relevant servlces.
zy.1.¢ 8eneþts
Thrcueh standardlzatlcn and cccrdlnatlcn cf resplratcry care servlces, PAL
cffers cppcrtunltles fcr lmprcved dlaencsls and case manaeement cf prlcr-
lty resplratcry dlseases. The ccmpetency cf health wcrkers ln PFC settlnes ls
enhanced thrcueh the use cf evldence-based cllnlcal euldellnes, and ccst sav-
lnes accrue frcm reductlcn cf lnapprcprlate drue prescrlptlcn. PAL can ccntrlb-
ute tc lnteeratlne and strenethenlne health servlces wlthln PFC and lncreaslne
the utlllzatlcn cf servlces by the pcpulatlcn, partlcularly the scclally dlsadvan-
taeed ercups.
z¶.z Integrated d|sease management
The wF0 lnltlatlves lMAl (lnteerated Manaeement cf Adclescent and Adult
lllness) and lMCl (lnteerated Manaeement cf Chlldhccd lllness) bcth suppcrt
the dellvery cf essentlal health servlces wlthln the ccntext cf prlmary health
care thrcueh slmpllñed and standardlzed euldellnes. The euldellnes address
the decentrallzatlcn cf essentlal servlces fcr prlcrlty health prcblems tc the
dlstrlct hcspltal, health centre and ccmmunlty levels. They ccver an lnteerated
apprcach tc preventlcn, care and treatment servlces, based cn standardlzed
prctcccls, tralnlne cf staff and suppcrtlve supervlslcn. Famlly-based care ls
prcmcted and human rescurce llmltatlcns are allevlated thrcueh "task-shlft-
lne" rcutlne aspects cf patlent manaeement and fcllcw-up frcm dcctcrs and
medlcal cfñcers tc health wcrkers, tc ccmmunlty-based wcrkers, and tc the
patlents themselves (self-manaeement). lMAl ls a mcre recent and evclvlne lnl-
z¸. PAL Ahu 0TFFk lhTFCkATFu APPk0ACFFS T0 FFALTF CAkF
1¶e
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
tlatlve than lMCl cn whlch lt ls mcdelled, and updated lnfcrmatlcn ls reeularly
prcvlded cn lts web slte.
1

The lMAl and lMCl tccls tceether address bcth acute and chrcnlc Flv care and
T8 case detectlcn, preventlcn cf T8 transmlsslcn; referral tc and llnkaees wlth
T8 treatment are lncluded ln these tccls. The lMAl Arµtc rcrc euldellne mcdule
expands frcm the PAL euldellnes cn ccueh cr dlfñcult breathlne and fever tc
address all ma|cr acute syndrcmes. ln addltlcn, lMAl and the wF0 Stcp T8
uepartment have |clntly develcped a new euldellne mcdule fcr ñrst-level facll-
lty cllnlcal teams, 18 rcrc with 18-hlv rc-mcncccmcnt. Thls euldellne (and a
shcrt tralnlne ccurse) addresses ccmblned Flv and T8 dlaencsls, T8 treatment
ccmblned wlth Flv chrcnlc care, as well as T8/AkT cc-treatment. Manaeement
cf patlents wlth ccmpllcated T8/Flv ls alsc addressed ln the lMAl seccnd-level
learnlne prceramme fcr dlstrlct hcspltal cllnlclans and ln the cllnlcal mentcrlne
euldellnes and tralnlne materlals.
z

The lMCl strateey ls an lnteerated apprcach tc chlld health that fccuses cn the
cverall well-belne cf the chlld. lMCl alms tc reduce death, lllness and dlsablllty
and tc prcmcte lmprcved ercwth and develcpment amcne chlldren aeed under
ç years. lMCl lncludes bcth preventlve and curatlve elements that are lmple-
mented by famllles and ccmmunltles as well as by health facllltles. The lMCl
strateey prcmctes the accurate ldentlñcatlcn ln health facllltles cf chlldhccd
lllnesses ln cutpatlent settlnes, ensures apprcprlate ccmblned treatment cf all
ma|cr lllnesses, strenethens the ccunselllne cf careelvers, and speeds up the
referral cf severely lll chlldren. ln the hcme settlne, lt prcmctes apprcprlate
care-seeklne behavlcurs, lmprcved nutrltlcn and preventlve care, and the ccr-
rect lmplementatlcn cf prescrlbed care. Chlldren whc present at the ñrst-level
health faclllty wlth ccueh cf mcre than z1 days are referred tc the referral facll-
lty fcr assessment cf T8.
key reIerences
Arµtc rcrc: intccrctcd mcncccmcnt c[ cdclcsrcnt cnd cdµlt illncss. Ceneva, wcrld
Fealth 0reanlzatlcn, zoou (wF0/CuS/lMAl/zoou.1).
8heekle A et al. The Practlcal Apprcach tc Lune Fealth ln Scuth Afrlca (PALSA) lnter-
ventlcn: resplratcry euldellne lmplementatlcn fcr nurse tralners. lntcrncticncl Nµrsinc
kcvicw, zoo6, ç¸:z61-z68.
8cltussen k et al. Prlcrlty settlne uslne multlplan crlterla: shculd a lune health prc-
eramme be lmplemented ln hepal: hcclth Pclirv cnd Plcnninc, zoo;, zz:1;8-18ç.
1
Access all the lMAl tccls, lncludlne tralnlne materlals fcr the cllnlcal euldellne mcdules and
dlstrlct manaeement tccls, at http://www.whc.lnt/hlv/pub/lmal/en
z
The entlre lMAl/lMCl tcclklt lncludlne draft verslcns ls accesslble at http://www.whc.lnt/hlv/
capaclty/Access_Sharepclnt.pdf (reelstratlcn requlred).
1¶1
8ric[ cµidc cn tµbcrrµlcsis rcntrcl [cr primcrv hcclth rcrc prcvidcrs. wF0-Fuk0 and
hew lersey T8 Ccntrcl Centre (avallable at http://www.eurc.whc.lnt/tuberculcsls/pub-
llcatlcns).
Camachc M et al. kesults cf PAL feaslblllty test ln prlmary care facllltles ln fcur reelcns
cf 8cllvla. lntcrncticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zoo;, 11: 1zu6-
1zçz,
Chrcnir hlv rcrc with Akv thcrcpv cnd prcvcnticn: lntccrctcd Mcncccmcnt c[ Adclcs-
rcnt cnd Adµlt lllncss, lntccrctcd Mcncccmcnt c[ Childhccd lllncss. Ceneva, wcrld
Fealth 0reanlzatlcn, zoo; (wF0/FTM/zoo;.oz).
Fnellsh kC et al. ulaencstlc accuracy cf an lnteerated resplratcry euldellne ln ldentlfy-
lne patlents wlth resplratcry symptcms requlrlne screenlne fcr pulmcnary tuberculcsls:
a crcss-sectlcnal study. 8MC Pµlmcncrv Mcdirinc, zoo6, 6:1-¤ (avallable at http://
www.blcmedcentral.ccm/1u;1-zu66/6/zz)
Fvclµcticn c[ thc Prcrtircl Apprccrh tc lµnc hcclth. kcpcrt c[ c mcctinc hcld cn 18-1¤ lµnc
2cc;, wh0, Ccncvc. Ceneva, wcrld Fealth 0reanlzatlcn, zoo; (wF0/FTM/zoo8.¸¤6).
Falrall Lk et al. Fffect cf educatlcnal cutreach tc nurses cn tuberculcsls case detectlcn
and prlmary care cf resplratcry lllness: praematlc cluster randcmlzed ccntrclled trlal.
8ritish Mcdircl lcµrncl, zooç, ¸¸1:;ço-;çu.
Murray lF, Plc A, 0ttmanl S. PAL: a new and practlcal apprcach tc lune health. lntcrnc-
ticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zoo6, 1o:1188-11¤1.
0ttmanl S, Mah|cur l. The practlcal apprcach tc lune health strateey fcr lnteerated
resplratcry care. ln: kavlellcne MC ed. kcirhmcn cnd hcrshhcld´s tµbcrrµlcsis: c rcm-
prchcnsivc intcrncticncl cpprccrh., Thlrd Fdltlcn. Part 8. hew ¥crk, lnfcrma Fealthcare
uSA, lnc., zoo6:1oç¤-1o81.
Prcrtircl Apprccrh tc lµnc hcclth (PAl}: c primcrv hcclth rcrc strctccv [cr intccrctcd
mcncccmcnt c[ rcspirctcrv rcnditicns in pccplc c[ hvc vccrs c[ ccc cnd cvcr. Cene-
va, wcrld Fealth 0reanlzatlcn, zooç (wF0/FTM/T8/zooç.¸ç1; wF0/hMF/CFP/CPM/
CkA/oç.¸).
kcspirctcrv rcrc in primcrv rcrc scrvircs - A sµrvcv in ¤ rcµntrics. Ceneva, wcrld
Fealth 0reanlzatlcn, zoou (wF0/FTM/T8/zoou.¸¸¸).
kcsen Ml. Chrcnlc ccueh due tc tuberculcsls and cther lnfectlcns: ACCP evldence-based
cllnlcal practlce euldellnes. Chcst, zoo6, 1z¤:1¤;-zo1.
18 rcrc with 18 hlv rc-mcncccmcnt. Ceneva, wcrld Fealth 0reanlzatlcn, zoo; (wF0/
FTM/Flv/zoo;.1; wF0/FTM/T8/zoo;.¸8o).
Shrestha h et al. lmpact cf resplratcry care euldellnes cn prescrlblne ccsts ln hepal.
1rcpircl Mcdirinc cnd lntcrncticncl hcclth, zoo6, 11:;6ç-;;z.
Ten Asbrcek A et al. lmplementlne elcbal kncwledee ln lccal practlce: a wF0 lune
health lnltlatlve ln hepal. hcclth Pclirv Plcn, zooç, zo:z¤o-¸o1.
z¸. PAL Ahu 0TFFk lhTFCkATFu APPk0ACFFS T0 FFALTF CAkF
1¶z
zu Fqulty cf and access tc
servlces fcr preventlcn cf
tuberculcsls and treatment
cf patlents
T
he prcmctlcn cf equlty and access fcr all ln dlsease preventlcn and ccntrcl
actlvltles ls based cn the reccenltlcn cf pcverty as a ma|cr determlnant
cf lll-health and a barrler tc health care. There ls a need tc accelerate health
prceress ln pccr and scclally excluded ercups ln crder tc reach the health-relat-
ed MuCs and tc reduce lnequltles ln access tc health care. The llnks between
pcverty and T8 dlsease burden have been dccumented fcr many years. The
lncldence cf T8 ls zo tlmes hleher ln lcw-lnccme ccuntrles ccmpared wlth that
ln hleh-lnccme ccuntrles. Thls chapter hlehllehts the pcpulatlcn ercups that
are cften nct reached by rcutlne T8 ccntrcl measures and cutllnes the practlcal
apprcaches requlred tc address thelr needs.
Thls sectlcn addresses the lnteeratlcn cf prc-pccr measures ln hTPs and cut-
llnes the practlcal lssues lnvclved and cptlcns fcr actlcn tc lmprcve access and
mlnlmlze the ñnanclal burden fcr patlents. The fcllcwlne slx maln steps are
reccmmended.
Stcp 1. ldcnti[v thc vµlncrcblc crcµps in thc rcµntrv/rccicn
º Assess the pccr and vulnerable ercups whc face barrlers tc accesslne bcth
eeneral health and T8 servlces, whlch may lnclude: thcse ln absclute ecc-
ncmlc pcverty; thcse dlsadvantaeed by eender-related factcrs; marelnallzed
ethnlc ercups; pecple llvlne ln remcte lccatlcns; the urban pccr; cther pec-
ple ln speclal sltuatlcns and ercups.
º Fstabllsh a prcñle cf pccr pecple and vulnerable ercups and thelr lccatlcns
ln the ccuntry/reelcn uslne: ecvernment cr cther data cn prevalence and
dlstrlbutlcn cf pcverty and vulnerable pcpulatlcns; any ecvernment dccu-
ments cn pcverty reductlcn plans cr strateeles; lnfcrmatlcn cn whlch types
cf health-care prcvlders are used by the pccr; data frcm any lccal studles cn
scclceccncmlc status cf T8 patlents and pcverty-related dlsparltles.
Stcp 2. 0ctcrminc whirh bcrricrs prcvcnt crrcss c[ vµlncrcblc crcµps
tc 18 scrvircs
º ldentlfy the types cf barrlers that may exlst ln the ccuntry/reelcn, lncludlne
eccncmlc barrlers, eeceraphlcal barrlers, scclal and cultural barrlers, health
system barrlers.
1¶¶
zu. PkFvFhTl0h Ahu TkFATMFhT SFkvlCFS
º uetermlne, fcr each ercup, the maln barrlers lnvclved ln the ccuntry/reelcn,
such as: eccncmlc barrlers (ccmplexlty cf the pathway tc care, ccsts tc
patlents); eeceraphlcal barrlers (dlstance frcm and dlfñculty cf |curney tc T8
servlces); scclal and cultural barrlers (stlema, eender-related factcrs, fear cf
lcslne wcrk, lack cf kncwledee cf T8 and the avallable servlces); and health
system barrlers (lack cf respcnslveness tc the needs cf the pccr, effects cf
decentrallzatlcn cn perlpheral servlces).
Stcp ·. Asscss pctcnticl crticns tc cvcrrcmc thc bcrricrs tc crrcss
ldentlfy and prlcrltlze actlcns tc address the fcllcwlne lmpedlments tc access.
º Fccncmlc barrlers: lnteeratlcn cf T8 servlces ln prlmary health care; enccur-
aeement cf prc-pccr, PPM lnltlatlves; prcvlslcn cf T8 dlaencsls and treat-
ment ln the wcrkplace; extenslcn cf mlcrcsccpy servlces; avcldance cf user
fees; prcvlslcn cf dlaencsls and treatment free cf charee; dlsccuraeement cf
uncfñclal charees tc patlents.
º Ceceraphlcal barrlers: extenslcn cf dlaencstlc and treatment servlces tc
remcte, pccr reelcns; brlnelne patlents frcm remcte areas tc T8 servlces;
develcpment cf a ccmmunlty-based T8 care mcdel.
º Scclal and cultural barrlers: prcmctlcn cf ccmmunlty mcblllzatlcn; ensurlne
that staff attltudes dc nct relnfcrce stlema; advccacy fcr wcrker prctectlcn
tc avcld lcss cf wcrk as a result cf T8; ensurlne that the T8 health prcmctlcn
plan takes acccunt cf pccr and vulnerable ercups; ensurlne that eender-
related needs are addressed ln T8 ccntrcl actlvltles; explcrlne pcsslbllltles
fcr referral mechanlsms frcm tradltlcnal health-care prcvlders.
º Fealth servlce barrlers: mcdlñcatlcn cf schedules fcr T8 dlaencstlc and
treatment servlces tc meet lccal needs; develcplne the ccmmunlcatlcn skllls
cf staff; dlsccuraelne staff frcm dlscrlmlnatlne aealnst pccr patlents; uslne
tctal quallty manaeement tc ensure that servlces remaln respcnslve tc the
needs cf the pccr; eneaelne ln health servlce decentrallzatlcn tc prcmcte
capaclty strenethenlne at the perlphery and lncluslcn cf T8 ccntrcl as a
dlstrlct-level prlcrlty.
Stcp q. kcvicw thc sitµcticns cnd pcpµlcticn crcµps rcqµirinc
spcricl rcnsidcrcticn
º ldentlfy the ercups needlne speclal ccnslderatlcn and thelr lccatlcns ln
the ccuntry/reelcn, lncludlne: mlerant pcpulatlcns (refueees, asylum seek-
ers, eccncmlc mlerants, dlsplaced pcpulatlcns, crcss-bcrder pcpulatlcns);
pcckets cf deprlvatlcn ln wealthler ccuntrles (lsclated ethnlc mlncrltles,
hcmeless pecple and cthers); ln|ectlne drue users; prlscn pcpulatlcns (see
Chapter zç).
1¶q
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
º ueclde upcn actlcns tc address the speclal needs cf these ercups: ldentlfy the
speclñc needs cf each cf the ercups; establlsh prlcrltles fcr actlcn based cn
needs, feaslblllty, avallable rescurces, effectlveness cf the measures; examlne
current servlces avallable tc the prlcrlty ercups ldentlñed; deñne strateeles tc
ensure the dlaencsls, treatment and fcllcw-up cf T8 cases fcr each tareeted
ercup; plan phased lmplementatlcn cf the prc-pccr lnterventlcns selected.
Stcp <. Fxplcrc pcssibilitics [cr hcrncssinc cdditicncl rcscµrrcs
º Assess: avallable strateeles tc eneaee ln brcad lnltlatlves tc lmprcve access
tc health servlces; scurces cf fundlne fcr lmprcvement cf health cutccmes;
lnstltutlcns cfferlne addltlcnal ñnanclal and cther rescurces fcr prc-pccr
measures ln T8 ccntrcl prcerammes; human rescurces tc expand the publlc
and prlvate sectcr lnvclvement ln T8 servlces; and technclceles tc enhance
efñclency and effectlveness cf T8 servlces.
º Facllltate access tc addltlcnal rescurces by: eneaelne ln brcader pcverty
reductlcn cr health sectcr plans; ldentlfylne pctentlal new partnershlps
ln the ccuntry; prlcrltlzlne mechanlsms cfferlne ereatest added value fcr
lncreaslne access tc T8 servlces; plannlne the preparatlcn cf fundlne prc-
pcsals; lnvclvlne cther stakehclders ln the plannlne prccess.
Stcp 6. Fvclµctc thc impcrt c[ prc-pccr mccsµrcs
º Fstabllsh the basls fcr lmpact evaluatlcn by settlne speclñc tareets fcr T8 ccn-
trcl ln pccr and vulnerable pcpulatlcns, assesslne the dlstrlbutlcn cf T8 ln the
pcpulatlcn and pcverty-related dlsparltles amcne T8 servlce beneñclarles.
º Facllltate the mcnltcrlne cf pcverty-related lnequalltles and the lmpact cf
prc-pccr lnterventlcns by: ldentlfylne partners tc carry cut equlty mcnltcr-
lne; lncludlne scclceccncmlc varlables ln rcutlne data ccllectlcn and analy-
sls; lncludlne scclceccncmlc questlcns ln T8 prevalence surveys; ccnductlne
perlcdlc studles cf care-seeklne; assesslne whc ln the ccmmunlty beneñts
frcm T8 servlces and whc dces nct.
key reIerence
Addrcssinc pcvcrtv in 18 rcntrcl: cpticns [cr ncticncl 18 rcntrcl prccrcmmcs. Ceneva,
wcrld Fealth 0reanlzatlcn, zooç (wF0/FTM/T8/zooç.¸çz).
Fanscn C et al. Tuberculcsls ln the pcverty allevlatlcn aeenda. ln: kavlellcne M. ed
kcirhmcn cnd hcrshhcld´s tµbcrrµlcsis: c rcmprchcnsivc intcrncticncl cpprccrh. Thlrd
Fdltlcn. Part 8. hew ¥crk, lnfcrma Fealthcare uSA, lnc., zoo6: 1o¤;-111u
kccrhinc thc pccr: rhcllcnccs [cr 18 prccrcmmcs in thc wcstcrn Pcrihr kccicn. Manlla,
wcrld Fealth 0reanlzatlcn keelcnal 0fñce fcr the western Paclñc, zoou (wF0/FTM/
T8/zooç.¸çz; avallable at http://www.wprc.whc.lnt/hk/rdcnlyres/¸F8¸zç8u-¤8ç¸-u;uu-
¤AAF-8uCçF1ç;o8FA/o/keachlne_the_Pccr.pdf ).
1¶¶
zç Speclal ercups
and sltuatlcns
z¶.1 1ß |n pr|sens
1
P
rlscns are effectlve lncubatcrs fcr T8, cften asscclated wlth epldemlc levels
cf actlve dlsease and hleh death rates, exacerbated by lncreaslne rates cf
Flv lnfectlcn amcne prlscners and a ercwlne burden cf Muk-T8. uccumented
rates cf T8 ln prlscns are usually 1o- tc ço-fcld ereater than ccncurrent rates
ln the clvlllan sectcr. T8 ccntrcl ln prlscns has therefcre beccme a malnstream
ccmpcnent cf the elcbal effcrt tc expand u0TS.
z¢.1.1 T8 transmlsslon
T8 ln prlscns ls a publlc health ccncern nct cnly fcr prlscners but alsc fcr
prlscn staff, famlly members and the lccal ccmmunlty because cf the cppcrtu-
nltles fcr T8 transmlsslcn between them. There are hleh turncver rates amcne
prlscners cn a yearly basls, and these prlscners return tc thelr ccmmunltles
upcn release. vlsltlne famlly members and prlscn health and securlty staff alsc
represent lmpcrtant prlscn-ccmmunlty ccndults.
z¢.1.z T8 control
Fffectlve T8 ccntrcl ln prlscns requlres the same ccmpcnents ldentlñed ln the
Stcp T8 Strateey. There are several speclñc lssues tc be addressed fcr the
ccntrcl cf T8 ln thls ccntext.
º Pclitircl rcmmitmcnt. Pclltlcal ccmmltment, lncludlne that frcm prlscn and
|all admlnlstratcrs, ls crltlcal fcr establlshlne apprcprlate ccndltlcns fcr dlae-
ncsls and treatment cf T8 ln prlscns and malntalnlne T8 prceramme llnks
that must crcss the clvlllan and prlscn sectcrs.
º Ccsc hcldinc
- The treatment cf released prlscners cn antl-T8 therapy shculd be ccntln-
ued ln the ccmmunlty wlth attentlcn elven tc prlscner/famlly educatlcn
and referral mechanlsms.
1
Thls sectlcn refers tc prlscns, |alls and cther detentlcn centres.
1¶6
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
- T8 patlents whc enter a detentlcn system durlne a current ccurse cf
medlcatlcn shculd be rapldly ldentlñed sc that adequate treatment may
ccntlnue wlthcut lnterruptlcn and the rlsk cf acqulrlne drue reslstance be
avclded.
º Artivc rcsc-hndinc strctccv. Passlve case detectlcn thrcueh prlscn health
facllltles ls lnadequate because many perscns enter prlscn wlth undlae-
ncsed T8, and because ccndltlcns ln |alls and prlscns are ccnduclve tc the
rapld spread cf dlsease. Therefcre, lt ls essentlal that an actlve case-ñndlne
strateey be lmplemented ln a prlscn T8 prceramme, fccuslne cn screenlne at
entry lntc the system ccupled wlth a strateey tc detect resplratcry symptc-
matlc cases after entry. lnvestleatlcn cf dcrmltcry cr cell ccntacts may alsc
be effectlve lf prlscner ccllabcratlcn ls well-establlshed.
º Civilicn-priscn rcllcbcrcticn. Fcr a prlscn T8 ccntrcl prceramme tc ealn
credlblllty and develcp a sustalnable system, effectlve clvlllan-prlscn llnks
are essentlal. lt ls lmpcrtant that hTP staff respect thelr penal ccunterparts
as equal partners and stakehclders. Alsc, the lssues speclñc tc the prlscn
envlrcnment and the prlscn pcpulatlcn shculd be reccenlzed and addressed
acccrdlnely.
z¢.1.y hIv control anJ preventlon
T8 ls cften the ñrst dlsease presentatlcn ln Flv-pcsltlve lndlvlduals. Flv testlne
shculd be ccnsldered fcr thcse whcse Flv status ls unkncwn, fcllcwlne uhAluS
euldellnes fcr testlne, whlch lnclude vcluntary testlne, pre- and pcst-test ccun-
selllne and an assurance cf ccnñdentlallty.
Strateeles tc prevent the spread cf Flv ln prlscns shculd be lmplemented
ln acccrdance wlth uhAluS reccmmendatlcns. Measures lnclude educatlcn
prcerammes fcr staff and lnmates, use cf unlversal precautlcns, prcvlslcn cf
medlcally supervlsed detcxlñcatlcn prcerammes fcr addlcts, harm reductlcn
prcerammes, and free ccnñdentlal avallablllty cf ccndcms.
z¶.z 1ß centre| |n reIugee and d|sp|aced pepu|at|ens
Mcre than 8ç% cf refueees crlelnate frcm, and remaln wlthln, ccuntrles wlth
a hleh lncldence cf T8. kefueees and dlsplaced pcpulatlcns are at partlcularly
hleh rlsk cf develcplne T8. Crcwded llvlne ccndltlcns facllltate the transmls-
slcn cf T8 lnfectlcn, and susceptlblllty tc T8 dlsease ls lncreased by ccexlstent
lllness, partlcularly Flv, and by pccr nutrltlcnal status. T8 ls an lncreaslnely
lmpcrtant cause cf mcrbldlty and mcrtallty amcne refueee and dlsplaced pcp-
ulatlcns.
1¶)
zç. SPFClAL Ck0uPS Ahu SlTuATl0hS
T8 ccntrcl actlvltles may be lmplemented effectlvely and prcduce eccd treat-
ment cutccmes ln apprcprlately chcsen refueee and dlsplaced pcpulatlcn set-
tlnes, and ln pcst-ccnflct sltuatlcns.
z¢.z.1 4cute phase
T8 care and ccntrcl are nct prlcrltles ln the acute phase cf an emereency when
mcrtallty rates are hleh cwlne tc cther ccndltlcns such as acute resplratcry
lnfectlcns, dlarrhceal dlseases, measles, malarla and malnutrltlcn. The prl-
crltles durlne thls phase are the prcvlslcn cf adequate fccd, water, shelter,
sanltatlcn, baslc medlclnes and the ccntrcl cf ccmmcn acute ccmmunlcable
dlseases.
z¢.z.z Inltlatlnç T8 lnterventlons
lf T8 ls an lmpcrtant health prcblem, ccntrcl actlvltles shculd nct be lnltlated
untll: (l) the death rate frcm all causes has been reduced tc less than 1 per
1o ooo pcpulatlcn per day; (ll) baslc needs fcr water, adequate fccd, shelter
and sanltatlcn are met; (lll) essentlal cllnlcal servlces and baslc drues fcr ccm-
mcn lllnesses are avallable; and (lv) baslc servlces are accesslble tc a laree
part cf the pcpulatlcn sc that T8 suspects can be ldentlñed and apprcprlate
lnvestleatlcn and referral arraneed.
T8 ccntrcl shculd be undertaken cnly lf the securlty sltuatlcn ls sufñclently
stable tc enable lmplementatlcn cf actlvltles and lf nc ma|cr mcvements cf the
camp cr the pcpulatlcn served are antlclpated ln the near future. At a mlnl-
mum, prceramme fundlne shculd be sufñclent tc enrcl patlents fcr 1z mcnths
and ccmplete the treatment cf all members cf thls cchcrt - a mlnlmum cf 18
mcnths.
z¢.z.y Role oj the hTP
whenever pcsslble, the hTP cf the hcst ccuntry shculd be lnvclved ln the
develcpment cf the T8 ccntrcl actlvltles fcr refueees and dlsplaced pecple. The
pcllcles cf the hTP ln the ccuntry cf crleln shculd alsc be taken lntc ccnslder-
atlcn lf refueees are llkely tc be repatrlated. Cccrdlnatlcn wlth uhFCk
1
ln the
plannlne staee ls crltlcal ln crder tc mlnlmlze the rlsk cf patlents lnterruptlne
treatment when camps cr pcpulatlcns are mcved.
The prlcrltles cf T8 ccntrcl are ñrst tc ldentlfy and treat lnfectlcus patlents wlth
severe fcrms cf the dlsease and thcse wlth smear-pcsltlve pulmcnary T8. 0nce
T8 ccntrcl actlvltles are well establlshed, lt ls apprcprlate tc treat the cther
fcrms cf T8, as rescurces permlt.
1
0fñce cf the unlted hatlcns Fleh Ccmmlsslcner fcr kefueees.
1¶8
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
T8 ccntrcl ln thls pcpulatlcn settlne shculd fcllcw the prlnclples cf the Stcp
T8 Strateey.
z¶.¶ 1ß centre| and natura| d|sasters
hatural dlsasters such as fccds, typhccns, tsunamls cr earthquakes may cccur
ln areas where T8 servlces are well creanlzed. The health lnfrastructure may
be damaeed cr destrcyed, and health staff usually lnvclved ln T8 ccntrcl may
be dlrectly affected ln these sltuatlcns, resultlne ln lnterruptlcn cf T8 ccntrcl
actlvltles.
Patlents whc were cn T8 treatment ln the dlsaster-affected areas may nc lcneer
have access tc any apprcprlate drue dlstrlbutlcn system. Many patlents may
be dlfñcult tc track fcr ccntlnuatlcn cf treatment and may therefcre be lcst
tc fcllcw-up. Patlents may recelve lnapprcprlate T8 drue prescrlptlcns frcm
health-care prcvlders cutslde the hTP. The hTP dlstrlbutlcn system fcr antl-T8
drues and supplles ls alsc llkely tc be dlsturbed ln areas nct dlrectly affected
by the dlsaster, where the exlstlne health lnfrastructure may be cverwhelmed
by the addltlcnal ureent wcrklcad and redeplcyment cf staff. The manaeerlal
actlvltles cf the hTP may be dlsrupted by asslenment cf staff tc tasks related
tc the dlsaster sltuatlcn and/cr lcss cf staff due tc the dlsaster.
Tc address such sltuatlcns, the fcllcwlne actlcns shculd be ccnsldered.
º T8 shculd be lncluded ln all rapld health assessments carrled cut ln the
acute phase fcllcwlne a dlsaster.
º wlde dlstrlbutlcn cf health educatlcn messaees, tareetlne T8 patlents cn the
need tc ccntlnue thelr treatment, thrcueh lnfcrmatlcn channels accesslble tc
patlents ln ccmmunltles.
º The hTP shculd establlsh a llst cf health facllltles able tc ensure apprcprlate
T8 drue dlstrlbutlcn tc patlents ln the affected ccmmunltles and ln reelcns
clcse tc the affected area. These llsts shculd be wldely dlstrlbuted ln ccm-
munltles and amcne health-care prcvlders cf the reelcn, lncludlne newly
arrlved hC0s/creanlzatlcns.
º kestartlne T8 ccntrcl actlvltles under the leadershlp and cccrdlnatlcn cf the
hTP ln the affected areas and ensurlne that adequate T8 servlces are maln-
talned ln ncn-affected areas durlne the acute phase cf an emereency.
º Tralnlne cf and cccrdlnatlcn wlth the hC0s/creanlzatlcns lnvclved ln T8
ccntrcl shculd be ensured by the hTP.
º Fnsurlne the antl-T8 drue supply tc health facllltles speclñed ln the llst
establlshed by the hTP.
1¶¤
º ulstrlbutlcn cf the natlcnal T8 ccntrcl euldellnes tc creanlzatlcns suppcrtlne
health facllltles lnvclved ln T8 care and ccntrcl ln affected and ncn-affected
areas.
º Ccntrcl, by the natlcnal health authcrltles, cf antl-T8 drues that mleht be
prcvlded thrcueh any new dlstrlbutlcn system.
After the acute phase cf an emereency, the fcllcwlne steps shculd be taken.
º Fvaluatlcn, by the hTP, cf T8 ccntrcl actlvltles carrled cut ln the acute phase
ln affected and ncn-affected areas.
º Plannlne cf lmplementatlcn cf T8 ccntrcl actlvltles ln the framewcrk cf the
rehabllltatlcn prccess ln affected areas.
º Advccacy ln crder tc malntaln T8 as a health prlcrlty at natlcnal level.
z¶.q 1ß centre| |n ether spec|a| pepu|at|en greups
Several vulnerable mlncrlty pcpulatlcn ercups pcse speclal challenees fcr T8
ccntrcl because cf dlfñculty cf access tc servlces (see alsc Chapter zu). 8arrl-
ers tc access may be the result cf eccncmlc, pclltlcal, scclal, eeceraphlcal cr
ethnlc factcrs, and cften mcre than cne cf these factcrs ls lnvclved. uepend-
lne cn the ccuntry sltuatlcn, these ercups may lnclude lmmlerants, seascnal
mlerant wcrkers, refueees, asylum seekers, crcss-bcarder pcpulatlcns, ncmad-
lc pcpulatlcns, pcpulatlcns ln remcte areas, ethnlc mlncrltles, marelnallzed
lndleencus pcpulatlcns, hcmeless pecple and cther vulnerable ercups such as
ln|ectlne drue users.
0ne cr mcre cf the "dlfñcult-tc-reach" pcpulatlcn ercups are present ln mcst
ccuntrles. 8ecause they are eenerally nct adequately ccvered by the rcutlne T8
servlces prcvlded fcr the eeneral pcpulatlcn, the hTP shculd adapt and devel-
cp apprcaches tc ensure that T8 ccntrcl servlces are avallable and accesslble
fcr these ercups. The develcpment and lmplementatlcn cf health lnterventlcns
shculd lnvclve scclal welfare lnstltutlcns, hC0s and cther prcfesslcnals whc
are ln ccntact wlth the ercups ccncerned.
Fach ercup needs tc be carefully deñned and lccated. lts health prlcrltles
shculd be ldentlñed and the access tc health servlces assessed. The health
care prcvlders whc usually wcrk wlth these ercups shculd be ldentlñed and
lnvclved ln prcvlslcn cf T8 ccntrcl servlces. Strateeles and measures tc lmple-
ment and lmprcve T8 care and ccntrcl shculd be deñned ln ccllabcratlcn wlth
these health care prcvlders, scclal servlces and lccal hC0s. The lnterventlcns
shculd be mcnltcred and evaluated.
zç. SPFClAL Ck0uPS Ahu SlTuATl0hS
16e
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
Wh0 gu|de||nes
wh0 cµidclincs cn hlv in[crticn cnd Al0S in priscns. Ceneva, wcrld Fealth 0reanlza-
tlcn, 1¤¤¸ (wF0/CPA/ulk/¤¸.¸. wF0).
key reIerences
Addrcssinc pcvcrtv in 18 rcntrcl: cpticns [cr ncticncl 18 rcntrcl prccrcmmcs. Ceneva,
wcrld Fealth 0reanlzatlcn, zooç (wF0/FTM/T8/zooç.¸çz).
Ccmmµnircblc disccsc rcntrcl in cmcrccnrics: c hcld mcnµcl. Ceneva, wcrld Fealth
0reanlzatlcn, zooç.
Ccnlnx k. Tuberculcsls ccntrcl ln ccmplex emereencles. 8µllctin c[ thc wcrld hcclth
0rccnizcticn, zoo;, 8ç:6¸;-6uo.
Cayer M, Ccnnclly MA. Tuberculcsls ccntrcl ln refueee and dlsplaced pcpulatlcns. ln:
kavlellcne MC, ed. kcirhmcn cnd hcrshhcld´s tµbcrrµlcsis: c rcmprchcnsivc, intcr-
ncticncl cpprccrh, Thlrd Fdltlcn. Part 8. hew ¥crk, lnfcrma Fealthcare uSA, lnc.,
zoo6:¤o;-¤1¤.
Klmerllne MF. The kusslan equatlcn: an evclvlne paradlem ln tuberculcsls ccntrcl.
lntcrncticncl lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zooo, u:S16o-S16;.
keyes F, Ccnlnx k. Pltfalls cf tuberculcsls prcerammes ln prlscns. 8ritish Mcdircl lcµr-
ncl, 1¤¤;, ¸1ç:1uu;-1uço.
1µbcrrµlcsis rcrc cnd rcntrcl in rc[µccc cnd displcrcd pcpµlcticns: cn intcrcccnrv hcld
mcnµcl, znd ed. Ceneva, wcrld Fealth 0reanlzatlcn, zoo; (wF0/FTM/T8/zoo;.¸;;;
wF0/CuS/uCF/zoo;.z).
1µbcrrµlcsis rcntrcl in priscns: c mcnµcl [cr prccrcmmc mcncccrs. Ceneva, wcrld
Fealth 0reanlzatlcn, zooo (wF0/CuS/T8/zooo.z81).
161
z6 lnvclvement cf ccmmunltles
and patlents ln tuberculcsls
care and preventlcn
S
lnce the 1¤;8 Alma Ata ueclaratlcn, the partlclpatlcn cf pecple ln, and thelr
ccntrlbutlcn tc, the develcpment cf health systems has been reccenlzed
as central tc prlmary health care and accepted as an essentlal element cf
many publlc health lnterventlcns. The health refcrms cf the 1¤¤os have elven
scmewhat less attentlcn tc ccmmunlty partlclpatlcn and scclal values ln health
system develcpment, fccuslne mcre cn technlcal, eccncmlc and manaeerlal
factcrs.
The challenees pcsed by ma|cr epldemlcs such as Flv/AluS, T8 and malarla,
and the rcle clvll scclety has played ln helplne lndlvlduals and famllles tc ccpe
wlth them, have certalnly ccntrlbuted tc make pecple and health pcllcy-makers
mcre aware cf the essentlal and ccmplementary rcle that ccmmunltles can play
ln ensurlne hleh-quallty patlent care.
Fffectlve partnershlps between health servlces and the ccmmunlty may faclll-
tate access by brlnelne servlces tc pecple's hcmes, and reduclne the ccst cf
care-seeklne fcr patlents and health servlces as well as the ccst cf wcrklcad
fcr staff. Carefully deslened ccmmunlty and/cr patlent lnvclvement lnltlatlves
alsc facllltate patlent and ccmmunlty empcwerment. Thrcueh the lnvclvement
cf lccal ccmmunltles, educatlcn cn relevant health lssues and stlmulatlcn cf
chanee ln health-related behavlcur, ccmmunltles beccme lncreaslnely kncwl-
edeeable and self-rellant.
The empcwerment cf patlents and ccmmunltles requlres kncwledee cf lndl-
vldual rlehts and respcnslbllltles, the ablllty tc exerclse them at scclal and
pclltlcal levels, access tc lnfcrmatlcn and the ablllty tc utlllze kncwledee and
skllls as needed. The Pcticnts´ rhcrtcr [cr tµbcrrµlcsis rcrc (the Charter) sets
cut the rlehts and respcnslbllltles cf patlents. The rlehts ccncern care, dlenlty,
lnfcrmatlcn, chclce, ccnñdence, |ustlce, creanlzatlcn and securlty. The respcn-
slbllltles ccver sharlne lnfcrmatlcn, adherence tc treatment, ccntrlbutlne tc
ccmmunlty health and shcwlne sclldarlty.
The Charter ldentlñes ways ln whlch all stakehclders may wcrk tceether ln
an cpen and pcsltlve relatlcnshlp. whlle lts baslc prlnclples are unlversal,
cultural dlfferences may lnfuence the rcles expected cf health prcfesslcnals
16z
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
and patlents, and these shculd be taken lntc ccnslderatlcn when adaptlne
lnternatlcnal reccmmendatlcns tc the natlcnal settlne. The establlshment cf
an effectlve ccllabcratlcn between health servlces and scclety cften requlres
bulldlne the capaclty cf ccmmunltles and clvll scclety creanlzatlcns, fcsterlne
a ccntlnucus dlalceue and lnvclvlne them frcm the start ln deslenlne, plannlne,
lmplementlne and evaluatlne ccmmunlty lnltlatlves.
Fffectlve ccmmunlty and patlent lnvclvement ylelds pcsltlve results, such as
lmprcved case-ñndlne and treatment cutccmes, ralsed awareness ccncernlne
the nature cf the dlsease and the avallablllty cf effectlve treatment free cf
charee, cr eeneral health prcmctlcn. Tc be successful, ccmmunlty and patlent
lnvclvement lnltlatlves shculd be deslened and lmplemented wlth ccmmunlty
members lnvclved as equal partners.
z6.1 key steps |n |mp|ement|ng |n|t|at|ves Ier cemmun|ty
and pat|ent |nve|vement
z6.1.1 Pollcy çulJance
The develcpment cf euldance fcr pcllcy lnvclves:
º settlne up a task fcrce tc ccnduct a sltuatlcn analysls and draft pcllcy euld-
ance;
º testlne pcllcy euldance ln demcnstratlcn areas.
ln ccuntrles wlth nc exlstlne lnltlatlves tc lnvclve ccmmunltles, l.e. where the
lnltlatlve tc set up such actlvltles ccmes frcm the central level, lt ls lmpcrtant
tc have pcllcy euldance based cn a natlcnal sltuatlcn analysls. Thls apprcach
prcmctes ccmmunlty cwnershlp cf the lnltlatlve, and enccuraees the ccmmu-
nlty's actlve lnvclvement and shared respcnslblllty fcr health.
The pcllcy euldance shculd descrlbe a prccess cf lnvclvement cf lccal ccmmu-
nltles and tuberculcsls patlents, and shculd lntrcduce the use cf lndlcatcrs cf
ccmmunlty lnvclvement, such as partlclpatlcn ln plannlne, suppcrt and evalu-
atlcn cf the lnterventlcn, rcle ln lmprcvement cf case detectlcn and treatment
adherence, lmpact cn stlema and dlscrlmlnatlcn, prcmctlcn cf healthy llfe-
styles and quallty cf care as percelved by patlents and thelr famllles.
z6.1.z 4Jvocacy anJ communlcatlon
Actlvltles fcr advccacy and ccmmunlcatlcn lnvclve:
º advccatlne at central level and lccally wlth dlfferent stakehclders (health
manaeers, pclltlclans, ccmmunlty leaders, etc.) fcr T8 ccntrcl and ccmmu-
nlty lnvclvement;
º deslenlne ccmmunlcatlcn tccls tallcred tc the lccal ccntext.
16¶
z6. C0MMuhlT¥ Ahu PATlFhT lhv0LvFMFhT
Presentlne the lnltlatlve tc relevant cfñclals at the central and lccal levels ls
an lmpcrtant step ln settlne up ccmmunlty-based actlvltles. Thls enccuraees
lnvclvement cf all stakehclders as well as pclltlcal and ñnanclal suppcrt. Ccmmu-
nlcatlcn tccls fcr prcmctlne messaees cn T8 wlll depend cn the tareet pcpulatlcn
and the avallablllty cf rescurces. Tc ensure that the ccntent cf the ccmmunlca-
tlcn materlal ls tallcred tc the lccal ccntext, lt shculd be develcped wlth the
ccmmunlty and pretested ln the tareet pcpulatlcn (see alsc Chapter z;).
z6.1.y Capaclty bullJlnç
8ulldlne the capaclty cf human rescurces lnvclves:
º quantlfylne the shcrtaee ln human rescurces and ldentlfylne sclutlcns;
º develcplne tralnlne materlal fcr health staff and lccal ccmmunltles and ccn-
ductlne reeular tralnlne;
º creatlne partnershlps wlth cneclne ccmmunlty-based lnltlatlves (hC0s,
falth-based creanlzatlcns, ccmmunlty-based creanlzatlcns).
Capaclty bulldlne and tralnlne cf pecple lnvclved ln the lnltlatlve, wlthln and
cutslde the health sectcr, are essentlal. Tralnlne shculd take lntc ccnslder-
atlcn the rcles and respcnslbllltles cf dlfferent stakehclders. lt ls lmpcrtant
tc dlscuss wlth the ccmmunlty thelr future rcle, wlth the alm cf strenethenlne
bcth the ccmmunlty and the health system. Cured T8 patlents are cften wllllne
and mctlvated tc be lnvclved ln T8 ccntrcl actlvltles such as treatment sup-
pcrt and ccmbatlne T8-related stlema. Settlne up partnershlps wlth cneclne
ccmmunlty-based lnltlatlves ln the area (hC0s, falth- and ccmmunlty-based
creanlzatlcns) has prcved, ln mcst ccuntrles, tc be mcre sustalnable and ccst-
effectlve than creatlne parallel systems.
z6.1.q 4JJresslnç speclal challençes
The challenees cf T8/Flv, Muk-T8, and speclal ercups and sltuatlcns lnvclve:
º explcrlne cppcrtunltles fcr the rcles cf patlents and lccal ccmmunltles ln
addresslne speclal challenees.
At natlcnal and lccal levels, experlence has shcwn that ccmmunlty lnvclvement
can make a valuable ccntrlbutlcn tc addresslne speclal challenees such as T8/
Flv, Muk-T8, ccntrclllne T8 amcne lndleencus pcpulatlcns cr ethnlc mlncrltles,
ln ccnereeate settlnes, etc. (see Chapter zç).
z6.1.¢ £nsurlnç hlçh-quallty servlces at communlty level
Fnsurlne the hleh quallty cf servlces at the ccmmunlty level lnvclves:
º ldentlfylne the ranee cf servlces avallable at ccmmunlty level;
16q
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
º ensurlne an adequate referral system; ldentlfylne pecple (e.e. publlc health
wcrkers, ccmmunlty representatlves cr vclunteers) whc wlll prcvlde a llnk
between health servlces and lccal ccmmunltles/patlents;
º prcvldlne reeular suppcrt tc ccmmunlty-based actlvltles.
A rcutlne supervlslcn system tc mcnltcr and suppcrt the servlces and care
prcvlded at ccmmunlty level shculd be establlshed. Mctlvatlcn cf the lnvclved
ccmmunlty members ls enccuraeed by reeular suppcrt.
The ranee cf servlces prcvlded at ccmmunlty level shculd be tallcred tc ccm-
munlty and patlent needs, rather than tc the ccnvenlence cf the health servlc-
es. ln settlnes where there ls nc exlstlne ccmmunlty lnvclvement lnltlatlve, lt ls
lmpcrtant tc ldentlfy pecple whc are able tc prcvlde an effectlve llnk between
health servlces and lccal ccmmunltles.
z6.1.6 8uJçet anJ þnanclnç
Measures fcr budeet and ñnanclne lnvclve:
º ldentlfylne a ccmprehenslve llst cf expendltures at all levels related tc ccm-
munlty lnvclvement;
º ensurlne that sufñclent funds are avallable fcr ccmmunlty lnvclvement (e.e.
ensure that such ccsts are lncluded ln lccal health budeets).
kescurces fcr ccmmunlty-based actlvltles shculd ccme frcm dlfferent scurces,
and nct excluslvely frcm the mlnlstry cf health budeet. Fxternal (such as the
Clcbal Fund) and lnternal scurces cf fundlne (lccal partners prcvldlne cneclne
suppcrt) shculd alsc be explcred. ln settlnes where the ccmmunlty ls lnvclved
ln a ranee cf health lssues and servlces, dupllcatlcn cf budeet llnes and actlvl-
tles shculd be avclded.
z6.1.; Monltorlnç, evaluatlon anJ supervlslon plan
The develcpment cf a mcnltcrlne, evaluatlcn and supervlslcn plan lnvclves:
º deñnlne a set cf lndlcatcrs, separatlne thcse tc be ccllected cn an cneclne
basls and thcse tc be ccllected every cne cr twc years.
Ccmmunltles shculd partlclpate ln the assessment cf thelr cwn ccntrlbutlcn
and that cf the health servlces. The data ccllected shculd be llmlted tc the
essentlal lnfcrmatlcn that wlll be analysed and used fcr assesslne servlces and
ccmmunlty lnvclvement. lndlcatcrs tc mcnltcr ccmmunlty lnvclvement shculd
refect creanlzatlcn, representatlcn, percelved quallty cf servlces and sustaln-
ablllty. Patlent satlsfactlcn, T8-related kncwledee and T8-related stlema may
be assessed thrcueh a KAP (kncwledee, attltudes and practlces) survey every
cne cr twc years.
16¶
z6.1.8 0peratlonal research
Plannlne fcr cperatlcnal research lnvclves:
º ldentlfylne cperatlcnal research themes based cn lccal challenees and
cppcrtunltles (e.e. ccnductlne research cn patlent satlsfactlcn, dccument-
lne eccd practlces).
0peratlcnal research may be requlred tc address speclñc cperatlcnal lssues and
lmprcve ccmmunlty lnvclvement. 8cth qualltatlve and quantltatlve research
methcds shculd be ccnsldered when assesslne the cutccme cf actlvltles as
well as perceptlcns and mctlvatlcn at the ccmmunlty level.
key reIerences
8huyan KK. Fealth prcmctlcn thrcueh self-care and ccmmunlty partlclpatlcn: ele ments
cf a prcpcsed prceramme ln the develcplne ccuntrles. 8MC Pµblir hcclth, zoou, u:11.
Ccmmµnitv rcntribµticn tc 18 rcrc: prcrtirc cnd pclirv. Ceneva, wcrld Fealth 0reanl-
zatlcn, zoo¸ (wF0/CuS/T8/zoo¸.¸1z).
Ccmmµnitv invclvcmcnt in tµbcrrµlcsis rcrc cnd prcvcnticn. 1cwcrds pcrtncrships [cr
hcclth. Cµidinc prinriplcs cnd rcrcmmcndcticns bcscd cn c wh0 rcvicw. wcrld Fealth
0reanlzatlcn zoo8. wF0/FTM/T8/zoo8.¸¤;. lS8h ¤;8 ¤z u 1ç¤6uo u
uemlssle M et al. Ccmmunlty tuberculcsls care thrcueh "T8 clubs" ln rural hcrth Fthlc-
pla. Scricl Sricnrc cnd Mcdirinc, zoo¸, ç6:zoo¤-zo18.
Fscctt S et al. Llstenlne tc thcse cn the frcntllne: lesscns fcr ccmmunlty-based tuber-
culcsls prcerammes frcm a qualltatlve study ln Swazlland. Scricl Sricnrc cnd Mcdirinc,
zooç, 61:1;o1-1;1o.
Khan MA et al. Ccst and ccst-effectlveness cf dlfferent u0T strateeles fcr the treat ment
cf tuberculcsls ln Paklstan. hcclth Pclirv cnd Plcnninc, zooz, 1;:1;8-186.
Lwllla F et al. Fvaluatlcn cf efñcacy cf ccmmunlty-based vs. lnstltutlcnal-based dlrect
cbserved shcrt-ccurse treatment fcr the ccntrcl cf tuberculcsls ln Kllcmberc dlstrlct,
Tanzanla. 1rcpircl hcclth cnd Mcdirinc, zoo¸, 8:zou-z1o.
Maher u. The rcle cf ccmmunlty ln the ccntrcl cf tuberculcsls. 1µbcrrµlcsis, zoo¸,
8¸:1;;-18z.
0maswa F. The "Ccmmunlty T8 Care ln Afrlca" Prc|ect. lntcrncticncl lcµrncl c[ 1µbcr-
rµlcsis cnd lµnc 0isccsc, zoo¸, ;(1):S1-S1(1).
0uallty cf care frcm the patlents' perspectlve. The Faeue, KhCv, zooç.
Shln S et al. Ccmmunlty-based treatment cf multldrue-reslstant tuberculcsls ln Llma,
Peru: ; years cf experlence. Scricl Sricnrc cnd Mcdirinc, zoou, ç¤:1çz¤-1縤.
Slneh AA et al. Fffectlveness cf urban ccmmunlty vclunteers ln dlrectly cbserved treat-
ment cf tuberculcsls patlents: a ñeld repcrt frcm Faryana, hcrth lndla. lntcrncticncl
lcµrncl c[ 1µbcrrµlcsis cnd lµnc 0isccsc, zoou, 8:8oo-8oz.
1hc pcticnts´ rhcrtcr [cr tµbcrrµlcsis rcrc. Ceneva, wcrld Care Ccuncll, zoo6.
z6. C0MMuhlT¥ Ahu PATlFhT lhv0LvFMFhT
166
z; Advccacy, ccmmunlcatlcn
and scclal mcblllzatlcn
C
cmpcnent ç cf the Stcp T8 Strateey urees enhancement cf ACSM at ccun-
try level tc lmprcve case detectlcn and treatment adherence, tc ccmbat
stlema and dlscrlmlnatlcn, tc empcwer pecple affected by T8, tc mcblllze
pclltlcal ccmmltment and rescurces fcr T8 ccntrcl, and tc lnstltute scclal
chanee and pcverty reductlcn requlred
fcr lcne-term ccntrcl and ellmlnatlcn cf
T8. Many cf the elcbal ACSM apprcach-
es have fccused, qulte successfully, cn
mcblllzlne rescurces and strenethen-
lne pclltlcal and ecvernmental ccmmlt-
ment. Fcwever, there ls an ureent need
tc lntenslfy ccmmunlcatlcn effcrts and
tc fcster the brcader eneaeement cf
clvll scclety ln ccntrcl and ellmlnatlcn
cf T8 (8cx z;.1).
ACSM lnvclves three dlstlnct sets cf
actlvltles, all cf whlch have the shared
ecal cf brlnelne abcut behavlcural
chanee. 0ne cf the ma|cr dlstlnctlcns
between them ls the tareet audlence.
Advcrcrv wcrks prlmarlly tc chanee the behavlcur cf publlc leaders cr decl-
slcn-makers. Ccmmµnircticn eenerally tareets lndlvlduals and small ercups.
Scricl mcbilizcticn alms tc secure ccmmunlty-based suppcrt.
The dlstlnctlcn between the three cateecrles ls cften unclear, and lnterventlcns
under cne area may beneñclally lnfuence cr facllltate prccesses ln the cther
areas. ACSM ls an lmpcrtant ally ln T8 ccntrcl effcrts and shculd be an lnteeral,
funded element ln any T8 ccntrcl prceramme (Fleure z;.1).
z).1 Advecacy and reseurce meb|||zat|en
Pclltlcal ccmmltment has been reccenlzed as a cruclal element cf the u0TS
strateey. Lack cf pclltlcal wlll has hampered bcth the develcpment cf apprcprl-
ß0X z¡.:
ftv£-P0tk1 fRAM£W0RK f0R AC1t0k
0k A0v0CAC¥, C0MMUktCA1t0k
Ak0 50CtAL M0ßtLtZA1t0k (AC5M)
A1 C0Uk1R¥ L£v£L
1. 8ulldlne natlcnal and sub-natlcnal
ACSM capaclty
z. Fcsterlne lncluslcn cf patlents
and affected ccmmunltles
¸. Fnsurlne pclltlcal ccmmltment
and acccuntablllty
u. Fcrelne ccuntry-level ACSM
partnershlps wlthln the ccntext
cf natlcnal tuberculcsls ccntrcl
prcerammes
ç. Learnlne, adaptlne and bulldlne
cn eccd ACSM practlces and
kncwledee exchanee
16)
z;. Auv0CAC¥, C0MMuhlCATl0h Ahu S0ClAL M08lLlZATl0h
ate T8 ccntrcl pcllcles and the successful lmplementatlcn cf thcse pcllcles at
the central, dlstrlct and lccal levels.
ln the elcbal ccntext, advccacy fcr T8 ccntrcl ls tc be understccd as a brcad set
cf cccrdlnated lnterventlcns dlrected at placlne T8 ccntrcl hleh cn the pclltlcal
and develcpment aeenda, tc secure lnternatlcnal and natlcnal ccmmltment and
mcblllze necessary rescurces. At the ccuntry level, advccacy brcadly seeks tc
ensure that natlcnal ecvernments remaln strcnely ccmmltted tc lmplementlne
natlcnal T8 ccntrcl cr ellmlnatlcn pcllcles.
Advccacy at ccuntry level cften fccuses cn admlnlstratlve and ccrpcrate mcbl-
llzatlcn thrcueh parllamentary debates and cther pclltlcal events; press ccnfer-
ences; news ccveraee; Tv and radlc talk shcws; pcpular Tv serles; summlts,
ccnferences and sympcsla; celebrlty spckespecple; meetlnes between varlcus
cateecrles cf ecvernment and clvll scclety creanlzatlcns, patlents creanlzatlcns
and health-care prcvlders; cfñclal memcranda; and partnershlp meetlnes.
z).z Cemmun|cat|en
wlthln ccuntrles, and ln the ccntext cf T8 ccntrcl, prceramme ccmmunlcatlcn
ls ccncerned wlth lnfcrmlne and creatlne awareness amcne the eeneral publlc
cr speclñc pcpulatlcn ercups abcut T8, and empcwerlne pecple tc take actlcn.
lt ls cften malnly ccncerned wlth ccmmunlcatlne a serles cf messaees abcut
the dlsease (e.e. "lf ycu have a ccueh fcr mcre than twc weeks, seek treat-
ftCUR£ z¡.: SAMPLF M0hlT0klhC Ahu FvALuATl0h FkAMFw0kK F0k Auv0CAC¥,
C0MMuhlCATl0h Ahu S0ClAL M08lLlZATl0h
lncreased rates cf T8
suspects

uecreased rates cf
treatment defaulters
lncreased capaclty cf
human rescurces
Advecacy eutcemes
N Kncwledee cf cplnlcn leaders
N Pclltlcal ccmmltment refected ln pcllcy and
repcrts
N Ccveraee cf advccacy actlvltles and campalens
Cemmun|cat|en eutcemes
N lncreased kncwledee abcut T8 amcne pcpulatlcn
N Ccveraee cf lnfcrmatlcn, educatlcn and
ccmmunlcatlcn actlvltles and campalens
5ec|a| meb|||zat|en eutcemes
N lclnt actlcn by partners and ccmmunltles
(natlcnal T8 ccntrcl prceramme)
N Ccveraee cf T8 plans develcped by partners and
ccmmunltles
lncreased budeet
allccatlcns
168
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
ß0X z¡.z
K£¥ 51£P5 f0R tMPL£M£k1A1t0k
0f A0v0CAC¥, C0MMUktCA1t0k
Ak0 50CtAL M0ßtLtZA1t0k (AC5M)
AC1tvt1t£5 A1 kA1t0kAL, 0t51RtC1
Ak0 PR0vtkCtAL L£v£L5
1. Create a natlcnal partnershlp cr
task fcrce
Chareed wlth plannlne,
lmplemen tlne and evaluatlne all
actlvltles
z. Ccnduct an ACSM needs
assessment
kevlew epldemlclcelcal data
ldentlfy prlcrlty pcpulatlcns
ldentlfy key scclal determlnants
cf T8
uetermlne behavlcural ecals
uetermlne scclal chanee ecals
¸. uevelcp a wcrkplan and budeet
Match ecals and tareeted
audlences wlth actlvltles
Fstabllsh benchmarks and
prccess cr lmpact lndlcatcrs
u. lmplement actlvltles
uevelcp, pre-test and prcduce
materlals
0reanlze advccacy events,
scclal mcblllzatlcn actlvltles,
etc.
ç. Mcnltcr and evaluate results
hatlcnal/dlstrlct/prcvlnclal
levels
ment", cr "T8 ls curable"), cr lnfcrmlne the publlc abcut whlch servlces exlst
fcr dlaencsls and treatment.
z).¶ 5ec|a| meb|||zat|en
Scclal mcblllzatlcn ls the prccess cf brlnelne tceether allles tc ralse awareness
cf and demand fcr a partlcular prceramme, tc asslst ln the dellvery cf rescurces
and servlces and tc strenethen ccmmunlty partlclpatlcn fcr sustalnablllty and
self-rellance (see alsc Chapter z6). "Allles" lnclude declslcn- and pcllcy-makers,
cplnlcn leaders, hC0s such as prcfesslcnal and rellelcus ercups, the medla,
the prlvate sectcr, ccmmunltles and lndlvlduals. Scclal mcblllzatlcn eenerates
dlalceue, neectlatlcn and ccnsensus, eneaelne a ranee cf players ln lnterrelated
and ccmplementary effcrts, taklne lntc acccunt the needs cf pecple (8cx z;.z).
z).q Men|ter|ng and eva|uat|en
lncreaslnely, ACSM strateeles ccntaln a
mcnltcrlne and evaluatlcn mechanlsm
that ls crltlcal tc bulldlne a strcneer evl-
dence base fcr measurlne prccess, cut-
put and lmpact cf ACSM strateeles fcr
T8 ccntrcl. hTP staff are enccuraeed tc
develcp a qualltatlve and quantltatlve
mcnltcrlne and evaluatlcn strateey fcr
ACSM actlvltles.
key reIerences
Advcrcrv, rcmmµnircticn cnd scricl mcbili-
zcticn [cr 18 rcntrcl: c cµidc tc dcvclcpinc
kncwlcdcc, cttitµdc cnd prcrtirc sµrvcvs.
Ceneva, wcrld Fealth 0reanlzatlcn, zoo;.
Advcrcrv, rcmmµnircticn cnd scricl mcbili-
zcticn [cr tµbcrrµlcsis rcntrcl: c hcndbcck
[cr rcµntrv prccrcmmcs. Ceneva, wcrld
Fealth 0reanlzatlcn, zoo;.
Advcrcrv, rcmmµnircticn cnd scricl mcbi-
lizcticn tc hcht 18: c 1c-vccr [rcmcwcrk [cr
crticn. Ceneva, wcrld Fealth 0reanlzatlcn,
zoo6.
walsbcrd S. 8eycnd the medlcal-lnfcrma-
tlcnal mcdel: recastlne the rcle cf ccmmunl-
catlcn ln tuberculcsls ccntrcl. Scricl Sricnrc
8 Mcdirinc, zoo;, 6ç(1o):z1¸o-z1¸u.
web slte: http://www.stcptb.cre/we/advccacy_ccmmunlcatlcn/acsmcl/
16¤
z8 kcle cf natlcnal
tuberculcsls ccntrcl
prcerammes ln research
k
esearch acrcss a wlde spectrum cf areas ls necessary tc accelerate prceress
ln elcbal T8 ccntrcl and enable the revclutlcn ln technclceles fcr T8 ccntrcl
needed tc achleve the ecal cf ellmlnatlne the dlsease by zoço. Key areas cf
research lnclude:
º cpplicd rcsccrrh, l.e. cptlmlzlne the use cf current apprcaches tc T8 ccntrcl
thrcueh epldemlclcelcal, prcerammatlc, health systems, health eccncmlcs,
and scclal and pcllcy research;
º dcvclcpmcnt c[ ncw tccls, l.e. research and develcpment (k8u) fcr new
dlaencstlcs, drues and vacclnes;
º cvclµcticn cnd dcmcnstrcticn c[ ncw tccls (dlaencstlcs, drues and vac-
clnes);
º bcsir rcsccrrh, l.e. lmprcvlne understandlne cf the baslc sclence that under-
plns the develcpment cf new tccls.
z8.1 Nat|ena| 1ß centre| pregrammes and the kesearch
Mevement te 5tep 1ß
keccenltlcn cf the lmpcrtance cf T8 research ls refected ln the Stcp T8 Strat-
eey. The kesearch Mcvement tc Stcp T8, mandated ln zoo6 by the Stcp T8
Partnershlp and wF0, represents an cppcrtunlty tc eneaee the full ranee cf T8
researchers ln a ccllabcratlve strateelc effcrt tc lncrease the sccpe, scale and
speed cf T8 research. The success cf the kesearch Mcvement as a brcad alll-
ance cf all thcse lnvclved ln T8 research depends cn eneaelne the full ranee cf
researchers ln baslc research, k8u and applled research (lncludlne the hTPs).
z8.z App||ed research
Maklne the mcst cf current apprcaches tc T8 ccntrcl depends cn the ccntrlbu-
tlcn cf many areas cf applled research: epldemlclcelcal, prcerammatlc (cper-
atlcnal), health systems, health eccncmlcs, and scclal and pcllcy research.
kesearch ln these areas shculd lnvclve hTPs, slnce the alm ls tc lmprcve prc-
eramme perfcrmance. hTPs have a cruclal rcle tc play ln deslenlne and carrylne
cut cperatlcnal research that lnvclves the evaluatlcn cf prceramme cperatlcns
1)e
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
almed at lmprcved pcllcy-maklne, better deslen and cperatlcn cf health sys-
tems and mcre efñclent methcds cf servlce dellvery. The hTP shculd develcp
effectlve ccllabcratlcn wlth researchers frcm academlc cr cther research lnstl-
tutlcns whc cften play the lead rcle ln carrylne cut cperatlcnal research.
z8.¶ ßeve|epment eI new tee|s Ier 1ß centre|
Prceress ln elcbal T8 ccntrcl ls ccnstralned by the lack cf effectlve new tccls
(dlaencstlcs, drues and vacclnes). The Stcp T8 Partnershlp and wF0 are prc-
mctlne the develcpment cf better technclceles fcr preventlne, and lmprcvlne
the dlaencsls and treatment cf, T8 thrcueh the Partnershlp's three wcrklne
ercups cn new tccls develcpment. These wcrklne ercups (cn new dlaencs-
tlcs, drues and vacclnes) alm tc prcvlde better technclceles fcr preventlne
T8, and tc accelerate the prccess cf dlaencsls and treatment, especlally ln
reelcns where T8/Flv and Muk-T8 make T8 ccntrcl partlcularly dlfñcult. The
Stcp T8 Strateey emphaslzes the need tc develcp better technclceles fcr pre-
ventlne, and lmprcvlne the dlaencsls and treatment cf, T8 at affcrdable ccst
fcr develcplne ccuntrles. Creatlve lntellectual prcperty mechanlsms are belne
develcped that prctect the publlc health sectcr and enhance access tc new
technclceles by underprlvlleeed patlents.
ln zoo6, the Stcp T8 Partnershlp Cccrdlnatlne 8card establlshed a Task Fcrce
cn ketccllne tc respcnd speclñcally tc the need tc prepare fcr the launch cf
new T8 technclceles.
1
"ketccllne" ls the prccess cf lntrcductlcn, adcptlcn and
lmplementatlcn cf new and lmprcved dlaencstlcs, medlclnes and vacclnes,
wlth the ecal cf maxlmlzlne thelr wldespread use whlle mlnlmlzlne delays. Tc
be successful, the retccllne prccess lnvclves the partlclpatlcn cf a wlde ranee
cf stakehclders at the elcbal and ccuntry levels and the ccnslderatlcn cf a
number cf key ccmpcnents, lncludlne an assessment cf a ccuntry's capaclty tc
adcpt and lmplement a new technclcey.
z8.q £va|uat|en and demenstrat|en eI new tee|s
hTP manaeers need tc keep abreast cf research develcpments. The hTP has
an essentlal rcle ln the establlshment cf cllnlcal trlal platfcrms fcr the evalua-
tlcn and demcnstratlcn cf new tccls (dlaencstlcs, drues and vacclnes). Cllnlcal
trlals requlre standard ethlcal apprcval. As new tccls beccme avallable, hTP
manaeers wlll be lnvclved ln the prccess cf ensurlne thelr smccth and rapld
transltlcn dlrectly tc the ñeld. Preparatlcns fcr lnccrpcratlne new tccls lntc
hTP actlvltles lnclude reeulatcry apprcval cf new tccls, develcplne purchaslne
mechanlsms and tralnlne the health-care wcrkers whc wlll use and admlnlster
them ln the ñeld.
1
See www.stcptb.cre/retccllne
1)1
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z8.¶ ßas|c research
Mcre baslc research ls necessary tc address fundamental eaps ln the scl-
ence and understandlne cf the blclcey and pathceenesls cf M. tµbcrrµlcsis.
Advances ln baslc T8 research are needed tc eenerate the dlsccvery cf new
aeents tc sustaln the plpellne cf research and the develcpment cf new tccls.
Thrcueh the Stcp T8 Partnershlp, hTPs may play a rcle ln advccatlne fcr
lncreased lnvestment ln fundamental sclentlñc research cn T8 tc fcrtlfy the
fcundatlcns cf kncwledee that wlll lead tc key advancements ln the ñeld.
key reIerences
0cvclcpinc rcµntrics tckc c rrcctivc cpprccrh tc k80. Ceneva, wcrld Fealth 0reanlza-
tlcn, zoou (avallable at http://www.whc.lnt/bulletln/vclumes/8¸/1/featureo1oç/en/prlnt.
html; accessed March zoo8).
Fardcn A et al. Applicd hcclth rcsccrrh-mcnµcl: cnthrcpclccv c[ hcclth cnd hcclth
rcrc, revlsed edltlcn. Fet Splnhuls, Amsterdam, zooç.
Farrles Au. lnteeratlcn cf cperatlcnal research lntc hatlcnal Tuberculcsls Ccntrcl prc-
erammes. 1µbcrrµlcsis, zoo¸, 8¸:1u¸-1u;.
Ncw tcrhnclccics [cr tµbcrrµlcsis rcntrcl: c [rcmcwcrk [cr thcir cdcpticn, intrcdµrticn
cnd implcmcntcticn. Ceneva, wcrld Fealth 0reanlzatlcn, zoo;.
Speclal Prceramme fcr kesearch and Tralnlne ln Trcplcal ulseases (Tuk). Sricntihr
wcrkinc Crcµp cn 1µbcrrµlcsis. Mcctinc rcpcrt. ·-6 0rtcbcr 2cc<, Ccncvc, Switzcr-
lcnd. Ceneva, wcrld Fealth 0reanlzatlcn, zoo6 (Tuk/SwC/o6).
Stcp T8 kesearch Mcvement web paee: http://www.stcptb.cre/researchmcvement/
18/hlv rcsccrrh pricritics in rcscµrrc-limitcd scttincs. kcpcrt c[ cn cxpcrt rcnsµltcticn,
1q-1< lcbrµcrv 2cc<, Ccncvc, Switzcrlcnd. Ceneva, wcrld Fealth 0reanlzatlcn, zooç
(wF0/FTM/T8 zooç.¸çç; avallable at http://whqllbdcc.whc.lnt/hq/zooç/wF0_FTM_
T8_zooç.¸çç.pdf ).
1)¶
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Strateey fcr the ccntrcl and
ellmlnatlcn cf tuberculcsls
Intreduct|en
T
he Stcp T8 Strateey (zoo6-zo1ç) paves the way fcr ccntrclllne tuberculcsls
(T8) and, beycnd, tcwards the lcne-term ecal cf ellmlnatlne the dlsease
as a elcbal health prcblem by zoço. T8 ellmlnatlcn ls deñned as achlevlne
an lncldence cf less than 1 case cf lnfectlcus T8 per mllllcn pcpulatlcn cr a
prevalence cf latent T8 lnfectlcn cf less than 1%. Several ccuntrles have already
reached the T8 ellmlnatlcn phase; cthers are expected tc dc sc ln the fcresee-
able future. The T8 ellmlnatlcn phase ls deñned as an lncldence cf fewer than
zo cases per 1oo ooo pcpulatlcn.
The strateey fcr T8 ellmlnatlcn lnvclves the lmplementatlcn cf lnterventlcns
addltlcnal tc standard T8 ccntrcl measures. lt ls nct cnly relevant tc ccuntrles
wlth a lcw lncldence cf the dlsease that are apprcachlne the ellmlnatlcn phase
but shculd alsc be ccnsldered by ccuntrles wlth an lntermedlate and steadlly
decreaslne T8 lncldence (l.e. · ço cases per 1oo ooo pcpulatlcn).
Thls annex prcvldes an cvervlew cf the essentlal prerequlsltes fcr T8 ellmlna-
tlcn, descrlbes scme relevant lnterventlcns fcr ccuntrles ln the ellmlnatlcn
phase and examlnes the challenees lnvclved ln plannlne fcr T8 ellmlnatlcn.
Ccuntry examples frcm Cuba (8cx A1), ltaly (8cx Az), the hetherlands (8cx A¸),
Slcvakla (8cx Au) and the unlted Klnedcm (8cx Aç) lllustrate the relatlcnshlp
between epldemlclcelcal trends and lmplementatlcn cf lnterventlcns fcr T8
ellmlnatlcn.
As a result cf elcballzatlcn, the ellmlnatlcn cf T8 ln lcw-lncldence ccuntrles
wlll depend upcn the achlevement cf elcbal T8 ccntrcl. lt ls therefcre essentlal
that these ccuntrles ccntlnue tc suppcrt the lmplementatlcn cf effectlve T8
ccntrcl ln hleh-lncldence areas and settlnes, ln parallel wlth the lntrcductlcn cf
ellmlnatlcn strateeles.
A1.1 5trategy Ier centre| and e||m|nat|en
The Stcp T8 Strateey sets cut the key steps fcr ccmprehenslve T8 ccntrcl. The
fccus fcr the ellmlnatlcn cf T8 ln lcw-lncldence ccuntrles and the prlcrltles fcr
lmplementatlcn cf the T8 ellmlnatlcn strateey lnvclve scme mcdlñcatlcn cf
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ln pursulne lts strateey fcr T8 ellmlnatlcn, Cuba fccuses cn the fcllcwlne 1o measures:
1. Malntalnlne ecvernment ccmmltment tc sustaln the prlcrlty cf the natlcnal T8 ccntrcl
prceramme (hTP) amcne cther health prcerammes ln crder tc ensure ccntlnued
suppcrt fcr natlcnal structures fcr T8 ccntrcl and ellmlnatlcn.
z. uevelcplne a wlde netwcrk cf health centres based cn famlly physlclans whc prcvlde
care and preventlve measures free cf charee natlcnwlde (1zo famllles per physlclan),
thereby strenethenlne u0T and T8 ccntrcl.
¸. Scclal securlty that allcws pecple llvlne wlth T8 tc recelve 1oo% payment wlthcut
wcrklne durlne the whcle perlcd cf treatment and a supplementary dlet at subsldlzed
prlces.
u. Fducatlcnal plan fcr the dlfferent lnvclved prcfesslcnals wlth the essentlal
kncwledee, skllls and attltude, tc assure tralned staff and develcpment cf expertlse
ln bcth treatment and treatment ccntrcl, ln crder tc lmprcve treatment success even
ln reelcns wlth lcw T8 lncldence.
ç. Actlve partlclpatlcn cf the lnvclved ccmmunlty and pecple llvlne wlth T8.
6. Strenethenlne ccllabcratlcn between the prceramme tc ccntrcl sexually-transmltted
lnfectlcns and Flv and the hTP ln prlmary health care settlnes, as well as ln the
seccndary and tertlary health care system, as part cf a ccmprehenslve apprcach tc
pulmcnary health care.
;. Mcnltcrlne and evaluatlcn cf treatment cutccmes and antl-T8 drue reslstance;
prcvlslcn cf rcutlne natlcnwlde uhA ñneerprlntlne tc ldentlfy patterns cf transmlsslcn
and assess quallty cf perfcrmance cf labcratcrles.
8. Preventlve treatment fcr every T8 ccntact and fcr pecple llvlne wlth Flv/AluS.
¤. 0fferlne an Flv test free cf charee tc every perscn llvlne wlth T8.
1o. lmprcvlne health educatlcn fcr ccmmunltles wlth hleher lncldence cr prevalence rates
and hleh-rlsk ercups such as prlscners.
the standard apprcaches tc T8 ccntrcl. uurlne the ellmlnatlcn phase emphasls
needs tc be placed cn lnterventlcns fcr (l) hleh-rlsk ercup manaeement, (ll)
cutbreak manaeement and (lll) lnfectlcn ccntrcl.
41.1.1 Manaçement oj hlçh-rlsk çroups
The manaeement cf hleh-rlsk ercups lnvclves the ldentlñcatlcn cf speclñc pcp-
ulatlcn ercups whc are at lncreased rlsk cf T8 (cr T8 lnfectlcn) and the lmple-
mentatlcn cf strateeles fcr actlve T8 case-ñndlne as well as the ldentlñcatlcn cf
latent T8 lnfectlcn, ensurlne prcvlslcn cf supervlsed and suppcrted treatment,
and mcnltcrlne cf treatment cutccmes. The pcllcy fcr hleh-rlsk ercup manaee-
ment shculd speclfy hcw rlsk ercups are deñned ln the ccuntry cr reelcn, e.e.
by epldemlclcelcal characterlstlcs such as a speclñed threshcld cf T8 lncldence
cr hleh prevalence cf rlsk factcrs fcr T8 (recent lmmleratlcn frcm hleh T8
lncldence ccuntrles, deprlvatlcn, alcchcl and substance mlsuse, malnutrltlcn,
hcmelessness) and/cr by ccst-effectlveness ccnslderatlcns.
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ltaly nctlñed cnly ; new T8 cases (¸ sputum smear pcsltlve) per 1oo oooo pcpulatlcn and
a prevalence cf latent lnfectlcn belcw 1% ln ycune cchcrts (aeed ·18 years) ln zooç and ls
apprcachlne the ellmlnatlcn phase. Culdellnes and a leeal framewcrk were develcped ln
the early 1¤¤os almed at lmprcvlne rlsk-ercup manaeement, cutbreak manaeement and
lnfectlcn ccntrcl ln ccnereeate settlnes. Slnce 1¤¤o, all T8 cases must be nctlñed by bcth
cllnlclans and labcratcrles. The hatlcnal T8 Study Crcup cf the Asscriczicnc ltclicnc
Pncµmclcci 0spcdclicri (AlP0) prcmcted develcpment cf ccmprehenslve euldellnes cn
T8 ccntrcl, dlscusslcn wlthln the sclentlñc and publlc health ccmmunlty and evaluatlcn cf
thelr lmpact.
Ccvernment ccmmltment ls attested by the leeal adcptlcn cf these euldellnes and
the establlshment cf centres fcr dlsease ccntrcl, actlne as a framewcrk fcr a hatlcnal
T8 Ccmmlsslcn ncmlnated by the Mlnlstry cf Fealth (lncludlne representatlves cf
sclentlñc sccletles, T8 ccntrcl, mlcrcblclcelsts and cther experts). The maln task cf the
Ccmmlsslcn ls tc revlse pcllcles and euldellnes fcr T8 ccntrcl and ellmlnatlcn, and tc
cccrdlnate the survelllance, labcratcry and cllnlcal netwcrk. ln zoou, the strateelc plan
was apprcved; lt lncludes the fcllcwlne eleht key actlcns:
1. lmprcvlne kncwledee cf T8 amcne health staff and clvll scclety (tc reduce bcth
patlent and physlclan delays).
z. Strenethenlne survelllance and mcnltcrlne and lncreaslne ccveraee tc all z1
reelcns cf the ccuntry.
¸. Fstabllshlne a speclal reelster cf Muk-T8 cases.
u. uslne mcnltcrlne and evaluatlcn lndlcatcrs tareetlne speclal challenees (e.e.
treatment success cf at least 8ç% cf cases aeed ·6ç years and reduclne the prcpcrtlcn
cf treatment defaulters tc less than 8%).
ç. lmprcvlne quallty ccntrcl cf the labcratcry netwcrk (lncludlne uhA ñneerprlntlne cf all
drue-reslstant cases).
6. ueñnlne standards cf care.
;. lncreaslne access tc, and cultural sensltlvlty cf, health servlces.
8. uevelcplne adequate human rescurces (thrcueh lncreased ccllabcratlcn wlth the
lnternatlcnal cccperatlcn department cf the Mlnlstry cf Fcrelen Affalrs).
The cccrdlnatlcn cf dlfferent ecvernmental and ncnecvernmental stakehclders was
further enhanced by the establlshment cf Stcp T8 ltalla ln zoou.
The maln challenee tc be faced ln the near future ls tc lncrease cccrdlnatlcn amcne
dlfferent stakehclders and wlth the z1 reelcnal ecvernments.
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Mlellcrl C8 et al 8 the hatlcnal AlP0 Tuberculcsls Study Crcup. Fvaluatlcn cf the lmpact
cf euldellnes cn tuberculcsls ccntrcl ln ltaly. Mcncldi Arrhivcs c[ Chcst 0isccsc, 1¤¤6,
ç1(¸): zou-zo¤.
Mlellcrl C8 et al 8 the Stcp T8 ltalla Crcup. klpped frcm the headllnes: hcw can we
harness ccmmunlcatlcns tc ccntrcl T8: Fµrcpccn kcspirctcrv lcµrncl, zoo;, ¸o:1u8o-
1u8u.
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The hetherlands attalned lcw T8 prevalence ln 1¤;1, wlth an annual lncldence cf fewer
than zo cases per 1oo ooo pcpulatlcn, partly as a result cf mass X-ray screenlne ln the
1¤ços and 1¤6os. ln the 1¤8os and 1¤¤os, the strateey ccmprlsed prcmpt dlaencsls and
treatment cf symptcmatlc cases, ccntact traclne arcund lnfectlcus T8 cases and screenlne
cf lmmlerants. ln the 1¤¤os, a mcre expllclt pcllcy fcr manaeement cf rlsk ercups was
fcrmulated, and natlcnwlde uhA ñneerprlntlne cf all stralns was lntrcduced. ln zoo6, ;ç%
cf T8 cases were detected by passlve case-ñndlne and zç% by screenlne rlsk ercups.
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Srrccninc [cr crtivc 18
º hewly arrlved lmmlerants and asylum seekers: cblleatcry at entry and perlcdlcally fcr
pecple frcm ccuntrles wlth a T8 lncldence ·zoo cases per 1oo ooo pcpulatlcn;
º ln|ectlne drue users: cnce cr twlce a year, dependlne cn lccal clrcumstances;
º hcmeless pecple: cnce cr twlce a year, dependlne cn lccal clrcumstances;
º prlscners: cnce cn lncarceratlcn;
º ccntacts cf lnfectlcus patlents: cnce cr perlcdlcally;
º prcfesslcnal ccntacts cf rlsk ercups: perlcdlcally.
klsk ercup manaeement lncludes lntenslve supervlslcn (u0T) by T8 nurses cf the
munlclpal health servlces fcr all patlents wlth pctentlally lcw ccmpllance (asylum
seekers, ln|ectlne drue users, the hcmeless, llleeal lmmlerants, chlldren, relapse cases,
reslstant cases) and treatment cutccme mcnltcrlne fcr each rlsk ercup.
5creening Ier 1ß inIectien and preventive treatment
º Ccntacts cf lnfectlcus T8 patlents
º Prcfesslcnal ccntacts cf rlsk ercups (perlcdlcally)
º Perscns wlth a rlsk factcr (cc-mcrbldlty) fcr breakdcwn tc actlve dlsease
º Travellers tc endemlc areas.
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º Ccuntrywlde uhA-ñneerprlntlne cf all culture-pcsltlve lsclates.
º Fcllcw-up cf epldemlclcelcal llnks tc ldentlfy ercwlne clusters and uncbserved
transmlsslcn.
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º Adequate lsclatlcn cf lnfectlcus patlents ln bcth lnpatlent and cutpatlent settlnes.
º Adequate lnstltutlcnal lnfectlcn ccntrcl measures
Prerequisites fcr effectlve T8 ccntrcl and ellmlnatlcn are ln place suppcrtlne natlcnal and
decentrallzed structures:
º Ncticncl 18 rcntrcl pclirv rcmmittcc. 0uarterly meetlne cf lndependent ercup cf
prcfesslcnals wlth sclentlñc, practlcal and admlnlstratlve expertlse ln T8 ccntrcl.
º Ccmpllatlcn cf natlcnal T8 pcllcy fcr ccntrcl and ellmlnatlcn.
º Ncticncl sµppcrt µnit. Fxperts at central level tc cccrdlnate and facllltate
lmplementatlcn, execute survelllance, prcvlde suppcrt and supervlslcn, and evaluate
the perfcrmance cf natlcnal ccntrcl actlvltles.
º Fvaluatlcn cf results cf the reelcnal T8 ccntrcl pcllcy: natlcnal and lnternatlcnal
revlew cf T8 ccntrcl every ñve years.
º Sµrvcillcnrc cnd mcnitcrinc. Ccmprlslne (l) web-based ccllectlcn cf lndlvldual
dlaencstlc data, treatment cutccmes and results cf ccntact lnvestleatlcn fcr all T8
patlents and (ll) mcnltcrlne system fcr screenlne prcerammes.
º Free accesslble T8 servlces at munlclpal health servlce and hcspltals.
º 0peratlcnal research tc develcp and evaluate T8 ccntrcl lnterventlcns.
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A systematlc apprcach tc the treatment cf T8 started ln Czechcslcvakla ln the mlddle
cf the zoth century. The hatlcnal T8 Manaeement Ccmmlttee - an advlscry bcdy
establlshed by the Mlnlstry cf Fealth - ls ncw respcnslble fcr prcvldlne euldance cn
ccntrcl and ellmlnatlcn cf T8 ln Slcvakla. The Mlnlstry endcrsed a leeal framewcrk fcr
T8 ccntrcl that allcws health-care prcfesslcnals tc enfcrce lsclatlcn, dlaencsls and
treatment cf ncn-ccmpllant patlents. The natlcnal cccrdlnatlcn centre fcr T8 ls lccated ln
the hatlcnal lnstltute fcr Tuberculcsls, Lune ulseases and Thcraclc Sureery. A natlcnal T8
reelster wlth lndlvlduallzed data cn T8 patlents has been ln use slnce 1¤88; an Muk-T8
unlt was created ln 1¤¤8. There ls a llnk between repcrts prcvlded by cllnlclans and the
labcratcrles cn case-ñndlne cf smear- and culture-pcsltlve T8. The natlcnal euldellnes
are reeularly updated tc address new develcpments ln T8 ccntrcl and lnccrpcrate new
wF0 reccmmendatlcns.
1¤¤u - lmplementatlcn cf the u0TS strateey
1¤¤8 - lmplementatlcn cf the new repcrtlne system
zoo6 - lntrcductlcn cf new dlaencstlc methcds fcr screenlne fcr T8 lnfectlcn
Ccntact lnvestleatlcn ls carrled cut fcr ccntacts cf lnfectlcus T8 patlents, prcfesslcnal
ccntacts cf rlsk ercups and pecple wlth rlsk factcrs fcr T8. Latent T8 lnfectlcn ls detected
by tuberculln skln testlne and lnterfercn eamma assays. lndlvlduals wlth pcsltlve
screenlne results recelve preventlve therapy. All patlents wlth ccnñrmed T8 are admltted
fcr the lnltlal phase cf treatment tc facllltate u0T. Fach eeneral practltlcner ls famlllar
wlth the system cf T8 manaeement and kncws where tc refer patlents wlth suspected T8.
Treatment cf drue-reslstant T8 ls manaeed by pulmcnary speclallsts, and u0T ls
prcvlded thrcuehcut treatment. lf sureery ls requlred, lt ls undertaken ln cne cf the twc
speclallzed hcspltals.
The ercup at ereatest rlsk cf T8 ln Slcvakla ls the kcma pcpulatlcn (apprcxlmately 8% cf
the tctal pcpulatlcn). A speclal apprcach tc ensure ccntlnulty cf T8 treatment ls applled
thrcueh the use cf T8 kcma asslstants cperatlne ln the kcma settlements tc facllltate
u0T and ensure treatment ccmpletlcn.
lmplementatlcn cf thls systematlc apprcach has led tc the eradual reductlcn cf T8
lncldence, whlch reached 1¸.z per 1oo ooo pcpulatlcn ln zoo6.
Chcllcnccs. wlth the decreaslne number cf patlents requlrlne T8 medlcatlcn, there
ls a ercwlne ccncern that pharmaceutlcal ccmpanles wlll lcse lnterest ln marketlne
essentlal antl-T8 drues. The shcrtaees cf these essentlal medlclnes wculd have dramatlc
ccnsequences cn the prccess cf T8 ellmlnatlcn ln Slcvakla.
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Ccntrcl cf T8 ln the unlted Klnedcm ls patlent-centred and takes acccunt cf the
patlent's lndlvldual needs and preferences. lt ls based cn evldence-based euldellnes
ccmmlsslcned by the hatlcnal lnstltute fcr Fealth and Cllnlcal Fxcellence.
1rcctmcnt cdhcrcnrc. All patlents are assessed fcr rlsk factcrs fcr treatment default
tc ldentlfy thcse requlrlne addltlcnal suppcrt. Patlents are lnvclved ln all treatment
declslcns. Fach patlent has a deslenated health wcrker and recelves lnfcrmatlcn leafets
(avallable ln all relevant laneuaees). Street- cr shelter-dwelllne hcmeless pecple recelve
lncentlves fcr treatment adherence, such as tempcrary acccmmcdatlcn.
M0k-18 risk csscssmcnt. All cases are assessed fcr drue reslstance uslne sputum culture
cn llquld medla and tested fcr ñrst-llne drue sensltlvlty. Treatment respcnse ls clcsely
mcnltcred ln suspected cases. Muk-T8 care ls cccrdlnated by speclallsts taklne lntc
acccunt the vlews cf patlents and lncludlne shared care.
hich-risk crcµp srrccninc
1. hew arrlvals are ldentlñed fcr T8 screenlne (l) when enterlne the ccuntry (pcrt-cf-
arrlval repcrt), (ll) when reelsterlne wlth prlmary care, (lll) at entry tc educatlcn
(lncludlne unlversltles) and (lv) thrcueh llnks wlth vcluntary and statutcry
creanlzatlcns wcrklne wlth llleeal lmmlerants, refueees and asylum seekers.
Screenlne ls usually carrled cut cnce.
z. The street hcmeless, lncludlne thcse uslne dlrect-access hcstels, are cppcrtunlstlcally
screened cr when symptcmatlc, and slmple lncentlves such as hct drlnks and snacks
are used. Scclal wcrkers and cther staff wcrklne wlth these ercups are aware cf T8
and lts symptcms.
¸. Staff wcrklne wlth hleh-rlsk ercups have a ccmplete T8 screen. All new hatlcnal
Fealth Servlce staff have an assessment cf perscnal and famlly hlstcry; a symptcms
and slens enqulry; dccumentary evldence cf T8 testlne and/cr 8CC scar checked by
cccupatlcnal health and/cr tuberculln skln test result wlthln the past ñve years lf
avallable.
u. Prlscn and remand centre staff are tralned ln kncwledee cf T8 symptcms, and
prcmcte awareness amcne prlscners and cther staff. Prlscners are screened cn entry
uslne a health questlcnnalre and, lf pcsltlve fcr slens and symptcms, recelve a chest
X-ray and sputum smear examlnatlcn.
8CC vcrrincticn. hecnatal vacclnatlcn ls cffered sccn after blrth fcr all bables at
lncreased rlsk, after dlscusslcn wlth parents cr leeal euardlans.
Ccntcrt trcrinc. Ccntact traclne ls dcne ln all cases cf actlve T8; ccntacts are screened
fcr actlve and latent T8.
Chcllcnccs. Many patlents acqulred T8 cutslde the unlted Klnedcm and present a
ccmblnatlcn cf rlsk factcrs fcr treatment default such as hcmelessness, alcchcl and
substance dependency, llleeal status and hleh scclal needs. These patlents requlre
lntenslve rescurces and a multldlsclpllnary team prcvldlne a ccmplete netwcrk cf
servlces tc ensure successful treatment.
1)¤
41.1.z 5creenlnç jor actlve T8
Screenlne fcr actlve T8 shculd be cffered reeularly tc lndlvlduals ln hleh-rlsk
ercups, and all cases shculd be adequately treated, lncludlne treatment sup-
pcrt and mcnltcrlne cf treatment cutccmes. Many lndlvlduals ln hleh T8 rlsk
ercups are alsc at lncreased rlsk cf treatment default cwlne tc cther charac-
terlstlcs such as chactlc llfestyles, psychclcelcal dlsturbances, hcmelessness,
lmmleratlcn/leeal status and hleh mcblllty. These lndlvlduals requlre lnten-
slve treatment suppcrt and supervlslcn (lncludlne dlrectly cbserved therapy,
cr u0T). Fncueh staff and rescurces (lncludlne tlme, transpcrt facllltles and
enablers) shculd be avallable tc meet the needs cf these partlcular hleh-rlsk
ercups. Mcnltcrlne the cutccme cf treatment ls essentlal fcr evaluatlcn cf
the yleld cf screenlne and the cverall result cf the lnterventlcn. The prcpcsed
tareets fcr hleh-rlsk ercups are tc screen ¤ç% cf the pcpulatlcn and tc cbtaln
¤ç% treatment success. ln addltlcn, all clcse ccntacts cf lnfectlcus T8 cases
shculd be screened.
Screenlne cf scme hleh-rlsk ercups such as llleeal lmmlerants may lnvclve addl-
tlcnal prcblems because these lndlvlduals are nct easlly reached by the health
system. Access tc servlces shculd be facllltated and lncentlve schemes prcvlded
ln crder tc reduce dlaencstlc and treatment delay as much as pcsslble.
41.1.y 5creenlnç jor T8 lnjectlon
Screenlne fcr latent T8 lnfectlcn uslne tuberculln skln testlne and/cr lnterfercn
eamma release assays shculd be carrled cut reeularly ln hleh-rlsk ercups, and
pcsltlve lndlvlduals shculd be cffered preventlve therapy, lncludlne treatment
suppcrt and mcnltcrlne cf treatment cutccmes.
Scme ercups that shculd be prlcrltlzed fcr latent T8 screenlne are:
º Ccntcrts c[ pcticnts with in[crticµs 18. Fffectlve ccntact traclne tc ldentlfy
and screen all lndlvlduals dlrectly expcsed tc an actlve T8 case as well as
reeular screenlne cf cther lndlvlduals at lncreased rlsk because cf thelr fre-
quent ccntact wlth hleh-rlsk ercups.
º Prc[cssicncl rcntcrts c[ hich-risk crcµps. 0ccupatlcnal health departments
shculd cffer reeular screenlne tc all staff whc have frequent prcfesslcnal
ccntact wlth members cf any hleh-rlsk ercup, partlcularly lf case-ñndlne ln
the rlsk ercup reveals a hleh lncldence cf smear-pcsltlve T8.
º lndividµcls with risk [crtcrs/rc-mcrbiditv [cr dcvclcpinc crtivc disccsc. lndl-
vlduals at rlsk cf develcplne actlve T8 shculd recelve speclal preventlve care.
Fpldemlclcelcal analysls cf sensltlvlty, speclñclty and pcsltlve and neeatlve
predlctlve values mleht help determlne lcwer cut-cff values fcr the dlaencsls
cf latent T8 lnfectlcn ln these ercups.
AhhFX. STkATFC¥ F0k TFF C0hTk0L Ahu FLlMlhATl0h 0F Tu8FkCuL0SlS
18e
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
41.1.q Manaçement oj outbreaks
Adequate survelllance systems shculd be ln place tc ensure early ldentlñca-
tlcn cf cutbreaks. Fpldemlclcelcal analysls cf T8 cases and uhA ñneerprlntlne,
whlch enables the ccnñrmatlcn cf clusters cf patlents wlth the same bacterlal
straln, may help ldentlfy llnks between patlents, sueeestlne ercups cr sltua-
tlcns where transmlsslcn mleht have cccurred. Addltlcnal lnterventlcns such as
lnfectlcn ccntrcl measures may then be taken tc prevent further transmlsslcn.
41.1.¢ Measures to control lnjectlon
lnfectlcn ccntrcl measures are necessary tc prevent the transmlsslcn cf
M. tµbcrrµlcsis ln ccnereeate settlnes such as hcspltals, prlscns and shelters
fcr hcmeless pecple. Fffectlve lnfectlcn ccntrcl measures vary frcm slmple
adequate ventllatlcn and lsclatlcn facllltles tc ultravlclet lleht and neeatlve
pressure rccms (see Chapter 6). lmplementatlcn cf these measures shculd be
eulded by evldence cf effectlveness, deeree cf severlty cf the dlsease (e.e.
multldrue-reslstant T8 cr extenslvely drue-reslstant T8), rlsk cr susceptlblllty cf
the pcpulatlcn (e.e. human lmmuncdeñclency vlrus status) and data frcm ccst-
effectlveness studles. ldentlfylne factcrs that may ccntrlbute tc transmlsslcn
frcm pctentlally lnfectlcus cases and lnstltutlne adequate ccntrcl measures are
cf prlmary lmpcrtance.
Az.1 Prerequ|s|tes Ier the e||m|nat|en strategy
Fssentlal prerequlsltes fcr ccuntrles enterlne the ellmlnatlcn phase have been
prcpcsed ln the Fµrcpccn [rcmcwcrk [cr 18 rcntrcl cnd climincticn in rcµn-
trics with c lcw inridcnrc. Ccuntrles plannlne tc start lmplementlne the T8
ellmlnatlcn actlvltles shculd have reached a T8 lncldence cf fewer than zo
cases per 1oo ooo pcpulatlcn, wlth a dcwnward trend. The requlrements fcr T8
ellmlnatlcn are cutllned belcw.
4z.1.1 6overnment commltment
Ccvernment ccmmltment and ccntlnued suppcrt cf natlcnal structures fcr T8
ccntrcl and ellmlnatlcn are essentlal, partlcularly because there ls a daneer
that cnce the ccuntry reaches a lcw lncldence status cther prlcrltles wlll pre-
vall cver the malntenance cf T8 ccntrcl. Fneaelne and lnvclvlne pclltlclans
and publlc health pcllcy-makers ln T8 ellmlnatlcn ls a ma|cr task durlne the
ellmlnatlcn phase.
4z.1.z hatlonal structures jor T8 ellmlnatlon
Mcst lcw-lncldence ccuntrles dc nct have a fcrmal natlcnal T8 ccntrcl prc-
eramme. Fcwever, cther alternatlve structures are cften present.
181
º An authcrltatlve central bcdy that revlews and develcps evldence-based
euldance fcr T8 ccntrcl and ellmlnatlcn. Thls ls nct necessarlly a ecvern-
mental lnstltutlcn and, ln many ccuntrles, lt cculd be an lndependent ercup
cf academlcs cr prcfesslcnals that develcps and endcrses pcllcles and
euldellnes ccverlne case-ñndlne, standardlzed treatment, lmplementatlcn cf
hleh-rlsk ercup manaeement, and lnfectlcn ccntrcl pcllcles. Thls ncticncl 18
rcntrcl pclirv rcmmittcc shculd lnclude sclentlñc, practlcal and admlnlstra-
tlve expertlse.
º The ccmpllatlcn cf pcllcles and euldellnes ccnstltutes the ncticncl pclirv [cr
18 rcntrcl cnd climincticn.
º A ncticncl sµppcrt µnit, cften fcrmed by a team cf experlenced experts at
central level, shculd cversee the lmplementatlcn cf natlcnal pcllcy, cccrdl-
nate adequate survelllance, prcvlde suppcrt and supervlslcn, and evaluate
the perfcrmance cf natlcnal ccntrcl actlvltles.
º The ncticncl 18 rcntrcl nctwcrk cf prcfesslcnals lnvclved ln dally T8 ccn-
trcl actlvltles shculd be reccenlzed as such and ñnanclally suppcrted. The
trlanele cf frcnt-llne (hcspltal) cllnlclans, bacterlclcelcal labcratcrles and
reelcnal (T8) publlc health speclallsts ls vltal tc thls ccntrcl netwcrk. The
T8 ccntrcl netwcrk shculd alsc lnclude key lndlvlduals at the mlnlstrles cf
health and |ustlce, scclal servlces, natlcnal reference labcratcry and cther
relevant lnstltutlcns.
º Fvaluatlcn cf results cf the reelcnal T8 ccntrcl measures and pcllcy shculd
be dcne reeularly by an external lndependent team cf experts. Llkewlse, at
least cnce every ñve years, a ccuntrywlde audlt cr revlew shculd be dcne by
an lndependent team cf natlcnal and lnternatlcnal experts.
4z.1.y Ieçal jramework
The exlstence cf an apprcprlate leeal framewcrk ls essentlal fcr ccntrcl and
ellmlnatlcn cf T8. The leeal framewcrk shculd lnclude nctlñcatlcn cf cases;
repcrtlne cf Mvrcbcrtcriµm tµbcrrµlcsis lsclates and sensltlvlty patterns,
lncludlne the perfcrmance cf uhA ñneerprlntlne (lncludlne wlthcut ccnsent cf
the patlent under speclñed ccndltlcns); ñnanclne cf actlve and passlve case-
ñndlne; ñnanclne cf T8 treatment, lncludlne ñnanclal suppcrt and acccmmc-
datlcn tc llleeal lmmlerants durlne treatment; lnfectlcn ccntrcl; leeal pcwers
and prccedures fcr ccmpulscry lsclatlcn fcr dlaencsls and treatment ln ncn-
ccmpllant lndlvlduals.
4z.1.q 5urvelllance anJ monltorlnç
Malntenance cf an extenslve survelllance and mcnltcrlne system acccrdlne tc
lnternatlcnal reccenlzed standards, tallcred tc the natlcnal cr reelcnal sltua-
AhhFX. STkATFC¥ F0k TFF C0hTk0L Ahu FLlMlhATl0h 0F Tu8FkCuL0SlS
18z
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
tlcn, ls the backbcne cf the T8 ellmlnatlcn strateey. lt shculd prcvlde prcmpt
lnfcrmatlcn cn the dlaencsls and treatment cutccme cf all cases, as well as
the results and yleld cf ccntact traclne and hleh-rlsk ercup manaeement actlvl-
tles.
4z.1.¢ 0h4 þnçerprlntlnç
kcutlne natlcnwlde uhA ñneerprlntlne prcvldes lmpcrtant lnfcrmatlcn durlne
the ellmlnatlcn phase: (l) lt helps the ldentlñcatlcn cf epldemlclcelcal llnks
between patlents and sueeests patterns cf transmlsslcn, scmetlmes undetect-
ed thrcueh tradltlcnal ccntact lnvestleatlcns; (ll) lt shcws where transmlsslcn
ccntlnues tc cccur ln reelcns cr ccuntrles wlth lcw numbers cf cases; (lll) lt
suppcrts the ldentlñcatlcn cf speclñc hleh-rlsk ercups ln clusters where lnfec-
tlcn ccntlnues tc spread desplte tradltlcnal ccntrcl measures and fcr whlch
cther lnterventlcns shculd be ccnsldered; and (lv) lt helps tc ldentlfy labcra-
tcry crcss-ccntamlnatlcn, elvlne lmpcrtant lnfcrmatlcn cn the quallty cf labc-
ratcry perfcrmance, partlcularly ln thcse that may handle cnly small numbers
cf speclmens ln reelcns wlth few suspect cr T8 cases.
4z.1.6 4ccesslble servlces
Access tc dlaencstlc and treatment servlces shculd be made easy, partlcularly
fcr thcse lndlvlduals ln hleh-rlsk ercups: lmmlerants (leeal and llleeal), the
hcmeless and lndlvlduals dependent cn alcchcl and llleeal substances. Ser-
vlces shculd alsc be culturally sensltlve, and the lack cf health lnsurance cr
ldentlñcatlcn dccuments shculd nct be an lmpedlment tc access tc the health
system. 0nce T8 ls dlaencsed, speclal arraneements fcr rlsk ercups wlth spe-
clñc dlfñcultles shculd be made tc facllltate treatment success.
4z.1.; TralneJ stajj
Adequately tralned staff wlth the essentlal kncwledee, skllls and attltudes
shculd be avallable at all levels. An educatlcnal plan fcr the dlfferent prcfes-
slcnals lnvclved ln T8 ellmlnatlcn shculd be avallable, lncludlne cllnlcal, mlcrc-
blclcelcal and publlc health skllls as well as staff ln scclal servlces. Tralnlne ln
lntercultural ccmmunlcatlcn ls essentlal, slnce rapld case-ñndlne and success-
ful treatment are lareely dependent cn lt.
4z.1.8 health lnjormatlon
Culturally-adapted health lnfcrmatlcn materlals shculd be avallable. Thls
lnfcrmatlcn ls dlrected tcwards reduclne delays ln dlaencsls, prcmctlne hleh
partlclpatlcn ln screenlne prcerammes and suppcrtlne treatment success.
Transmlsslcn cf the lnfcrmatlcn tc speclñc ercups shculd be carrled cut ln a
manner apprcprlate tc the ercups ccncerned.
18¶
4z.1.¤ Internatlonal cooperatlon
lnternatlcnal cccperatlcn ls lmpcrtant, partlcularly ln small cr medlum-slzed
ccuntrles wlth a lcw lncldence cf T8 (· ç cases per 1oo ooo pcpulatlcn) where
the number cf T8 cases ls very small. Adcptlcn cf reelcnal pcllcles and lnterna-
tlcnal lnterccuntry cccperatlcn and suppcrt wlth exchanee cf experlences and
lnfcrmatlcn, lncludlne the use cf lnternatlcnal experts ln the prccess cf aeree-
lne reelcnal pcllcles and shared survelllance systems, may alsc ccntrlbute tc
sclvlne ccmmcn prcblems and ensurlne adequate ellmlnatlcn.
A1.¶ Cha||enges
Prceresslve adaptatlcn cf the creanlzatlcn cf T8 ccntrcl tc a lcwer case-lcad
whlle malntalnlne expertlse and ccmmltment presents ma|cr challenees ln
ccuntrles wlth a lcw and decllnlne T8 lncldence. Speclñc lssues requlrlne ccn-
slderatlcn are cutllned belcw.
41.y.1 Projectlnç trenJs
Adaptatlcn cf the structure and creanlzatlcn cf T8 ccntrcl tc a substantlally
lcwer case-lcad requlres prc|ectlcn cf trends cver a zo-¸o-year perlcd. ln
many lcw-lncldence ccuntrles, lmmleratlcn ls the mcst lmpcrtant factcr slcw-
lne dcwn (cr even reverslne) the decllne cf T8 lncldence ln the eeneral pcpula-
tlcn. ulfferent levels cf lmmleratlcn shculd therefcre be lncluded ln mcdelllne
future trends. ulverelne T8 lncldences between ccsmcpclltan cltles and mcre
remcte reelcns cf the ccuntry shculd alsc be ccnsldered.
41.y.z 5peclal measures
Measures such as the recreanlzatlcn cf T8 ccntrcl servlces may be needed
when a decllne ln T8 cases ls llkely tc cccur. Centrallzatlcn cf expertlse ls a
lcelcal apprcach when numbers cf cases are decreaslne, but eccd access tc
dlaencsls and treatment servlces at the perlpheral level wlll ccntlnue tc be
needed. Ccuntrles ln the ellmlnatlcn phase wlll have tc deal wlth the centrallza-
tlcn cf expertlse whlle malntalnlne eccd, decentrallzed access.
41.y.y Case-þnJlnç
whlle actlve case-ñndlne ls plvctal wlthln hleh-rlsk ercups, passlve case-ñnd-
lne cf symptcmatlc cases wlll remaln the mcst lmpcrtant way tc ldentlfy new
T8 cases ln the ccmmunlty. Strateeles tc malntaln standards fcr dlaencstlc
servlces and tc prevent dlaencstlc delays wlll be needed. Labcratcry servlces
shculd be supervlsed by expert prcfesslcnals tc fulñl requlrements cf quallty
and safety. A prccess cf centrallzlne labcratcry actlvltles ln a few labcratcrles
ln the ccuntry may be envlsaeed, based cn ccnsultatlcns lnvclvlne natlcnal
expert centres and the myccbacterlal reference labcratcry.
AhhFX. STkATFC¥ F0k TFF C0hTk0L Ahu FLlMlhATl0h 0F Tu8FkCuL0SlS
18q
A FAhu800K F0k hATl0hAL T8 C0hTk0L Pk0CkAMMFS
0reanlzatlcn cf actlve case-ñndlne shculd be ccnsldered fcr ccuntrles that are
apprcachlne 1 case per 1oo ooo pcpulatlcn. Screenlne fcr T8 and fcr latent
lnfectlcn shculd be ccntlnued ln hleh-rlsk ercups, lncludlne ln ccntacts cf T8
patlents.
41.y.q Malntalnlnç expertlse
8cth treatment and treatment supervlslcn requlre skllls that are dlfñcult tc
malntaln when very few cases cccur each year. Malntalnlne the T8 expertlse
cf chest physlclans, mlcrcblclcelsts and publlc health dcctcrs and nurses ls a
challenee fcr all prcfesslcnal ercups. Twc levels cf expertlse may be envlsaeed:
a lcwer level fcr thcse whc may cccaslcnally enccunter a T8 case (pulmcnclc-
elsts, cther cllnlclans and eeneral publlc health speclallsts), and a hleher lev-
el fcr scme dlaencstlc and treatment speclallsts and leaders cf reelcnal and
natlcnal T8 ccntrcl prcerammes. These experts may be tralned tceether and,
where apprcprlate, ln ccllabcratlcn wlth cther ccuntrles. kespcnslblllty fcr the
treatment and supervlslcn (lncludlne u0T) ln reelcns wlth a lcw T8 lncldence
(e.e. ·z cases per 1oo ooo pcpulatlcn) shculd be clearly deñned.
41.y.¢ hew lnterventlons
hew lnterventlcns shculd be ccnsldered fcr ccuntrles tc accelerate the decllne
ln the number cf T8 cases. An effectlve vacclne wculd be the mcst lmpcrtant
tccl fcr T8 ellmlnatlcn, but thls ls unllkely tc be avallable ln the shcrt term.
keduclne the prevalence cf latent T8 lnfectlcn thrcueh actlve screenlne and
preventlve therapy shculd be ccnsldered.
key reIerences
Amerlcan Thcraclc Scclety/Centers fcr ulsease Ccntrcl and Preventlcn/lnfectlcus uls-
eases Scclety cf Amerlca: ccntrclllne tuberculcsls ln the unlted States. Amcrircn lcµr-
ncl c[ kcspirctcrv cnd Critircl Ccrc Mcdirinc, zooç, 1;z(¤):116¤-zz;.
8credcrff Mw et al. Tuberculcsls ellmlnatlcn ln the hetherlands. Fmcrcinc ln[crticµs
0isccscs, zooç, 11(u):ç¤;-6oz.
8rcekmans lF et al. Furcpean framewcrk fcr tuberculcsls ccntrcl and ellmlnatlcn ln
ccuntrles wlth a lcw lncldence. Fµrcpccn kcspirctcrv lcµrncl, zooz, 1¤:;6ç-;;ç.
Clancy L et al. Tuberculcsls ellmlnatlcn ln the ccuntrles cf Furcpe and cther lndustrlal-
lzed ccuntrles. Fµrcpccn kcspirctcrv lcµrncl, 1¤¤1, u:1z88-1z¤ç.
Mlellcrl C8 et al. Tuberculcsls manaeement ln Furcpe. keccmmendatlcns cf a Task
Fcrce cf the Furcpean kesplratcry Scclety (FkS), the wcrld Fealth 0reanlzatlcn (wF0)
and the lnternatlcnal unlcn Aealnst Tuberculcsls and Lune ulsease (luATLu) Furcpe
keelcn. Furcpean kesplratcry lcurnal, 1¤¤¤, 1u:¤;8-¤¤z.
Styblc K. The ellmlnatlcn cf tuberculcsls ln The hetherlands. 8µllctin c[ thc lntcrnc-
ticncl unicn Accinst 1µbcrrµlcsis cnd lµnc 0isccsc, 1¤¤o, 6ç(z-¸):u¤-çç.

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