CLINICAL POLICIES AND PROTOCOLS

270 Pages·2008·2.64 MB·English

4th Edition March 2008
CLINICAL POLICIES
AND PROTOCOLS
Bureau of Tuberculosis Control
New York City Department of Health and Mental Hygiene
Abbreviations
AAP AmericanAcademyofPediatrics MAC mycobacteriumaviumcomplex
ACH airchangesperhour MAI mycobacteriumaviumintracellulare
AFB acid-fastbacilli M.bovis mycobacteriumbovis
AII airborneinfectionisolation MDRTB multidrug-resistanttuberculosis
ALT alaninetransaminase MGIT MycobacterialGrowthIndicatorTube
AMA againstmedicaladvice MIRU mycobacterialinterspersal
ANA antinuclearantibody repetitiveunits
ATS AmericanThoracicSociety MOTT mycobacteriumotherthan
tuberculosis,NTM
BCG BacilleCalmette-Guérin
MMR measles,mumpsand/orrubella
BP basepairs
MRI magneticresonanceimaging
BTBC BureauofTuberculosisControl
M.tb mycobacteriumtuberculosis
CBC completebloodcount
MTD MycobacteriumTuberculosisDirect®
CDC CentersforDiseaseControl
andPrevention NAA nucleicacidamplification
CDC/DGMQ CDCDivisionofGlobalMigration NIOSH NationalInstituteforOccupational
andQuarantine SafetyandHealth
CFM cubicfeetperminute NJMRC NationalJewishMedicaland
ResearchCenter
CFP-10 culturefiltrateprotein-10
NNRTIs non-nucleosidereversetranscriptase
CI contactinvestigation
inhibitors
CNS centralnervoussystem
NTM nontuberculosismycobacterium,MOTT
CSF cerebrospinalfluid
NYCDOHMH NewYorkCityDepartmentofHealth
CT computedtomography
andMentalHygiene
CXR chestX-ray
NYPHL NewYorkCityBureauofPublic
DOS DepartmentofState HealthLaboratories
DOT directlyobservedtherapy PCR polymerasechainreaction
DR directrepeat PHA publichealthadvisor
DRTB drugresistanttuberculosis PHI protectedhealthinformation
ECLRS ElectronicClinicalLaboratory PIs proteaseinhibitors
ReportingSystem
PPD purifiedproteinderivative
EDN ElectronicDiseaseNotification
QFT-G QuantiFERON©-TBGold
EDTA ethylenediaminetetraaceticacid
RFLP restrictionfragmentlength
ELISA enzyme-linkedimmunosorbentassay polymorphism
ESAT-6 EarlySecretoryAntigenicTarget-6 RTS returntosupervision
FP false-positive SDN SecureDataNetwork
HAART highlyactiveantiretroviraltherapy SLE systemiclupuserythematosus
HEPA high-efficiencyparticulateair SPC singlepositiveculture
HHS U.S.DepartmentofHealthandHuman SSRIs selectiveserotoninreuptakeinhibitors
Services
SST serumseparatortubes
HIPAA TheHealthInsurancePortabilityand
TB tuberculosis
AccountabilityActof1966
TDM therapeuticdrugmonitoring
HIV HumanImmunodeficiencyVirus
TI TechnicalInstructionsforMedical
IDPL InfectiousDiseasesPharmacokinetics
ExaminationofAliens
Laboratory
TST tuberculinskintest
IDSA InfectiousDiseasesSocietyofAmerica
TTBI testfortuberculosisinfection
INA ImmigrationandNaturalizationAct
UGVI ultravioletgermicidalirradiation
IND investigationalnewdrug
ULN upperlimitsnormal
IFN-g interferon-gamma
URF UniversalReportingForm
IRIS immunereconstitutionsyndrome
USCIS UnitedStatesCitizenshipand
IRU ImmigrationandRefugeeUnit
ImmigrationServices
LFTs liverfunctiontests
WHO WorldHealthOrganization
LTBI latenttuberculosisinfection
XDRTB extremelydrugresistanttuberculosis
Clinical Policies and Protocols
Bureau of Tuberculosis Control
New York City Department of Health and Mental Hygiene
4th Edition March 2008
Content:
Sonal S. Munsiff, MD
Diana Nilsen, MD, RN
Paula I. Fujiwara, MD, MPH
Editorial:
Cortnie Lowe, MFA, Executive Editor, Bureau of Communications
Lise Millay Stevens, MA, Deputy Director, Editor
Melissa Burdick Harmon, MA, Senior Editor
Additional Contributions:
Joseph Burzynski, MD, MPH
Marie Dorsinville, RN, MPH
Cynthia Driver, RN, DrPH
Chrispin Kambili, MD
Liza King, MPH
Ann Winters, MD
WethanktheadministrativestaffattheBTBCExecutiveOffice,especially
JasmineHyltonforherextensiveadministrativeassistance,andalltheBTBCand
non-BTBCphysiciansandstaffwhoreadthemanuscriptandofferedcomments.
www.nyc.gov/health/tb
Table of Contents
Section I. Section II.
Introduction to the 4th Edition Initial Evaluation of
Suspected Tuberculosis
Director’sStatement...............................................11
PathogenesisofTuberculosis...............................25
Aboutthe4thEdition...............................................12
Transmission,infectionandproliferation....25
The2003nationalguidelines..............................12
Hostimmuneresponse...................................25
Rifapentine.......................................................12
Inflammation,necrosisand
Useoffluoroquinolones
cavityformation...............................................25
inthetreatmentoftuberculosis ..................13
BTBCguidelinesvs. PhysicalEvaluationofAdultsandChildren.......26
ATS/CDC/IDSAguidelines.............................13
RadiographicEvaluation........................................27
Treatmentofpatientswhoareco-infected
withtuberculosisandHIV...............................14 MicrobiologicEvaluation......................................27
Hospitalizationanddischargeguidelines....14 Specimencollection........................................27
Targetedtestingand Nucleicacidamplification............................30
latenttuberculosisinfection.........................15 Culture................................................................31
Keysources........................................................15 Speciesidentification.....................................32
Appendices........................................................15 Drugsusceptibilitytesting............................32
TuberculosisSurveillanceandEpidemiology.......15 Genotyping........................................................34
Surveillance.........................................................15 False-positiveresults......................................35
Objectivesoffalse-positive
Tuberculosisepidemiology
M.tbspecimeninvestigations......................35
inNewYorkCity..............................................16
Methodsusedtoidentify
ConfidentialityandHealthInsurancePortability
false-positiveM.tbcultures..........................35
andAccountabilityActRegulations....................16
Interpretingresultsofthe
Lawsgoverningconfidentiality....................16
false-positiveinvestigation............................36
HIPAAprivacyrule..........................................17
OtherLaboratoryTests............................................36
Talkingtotuberculosispatients
andcontacts......................................................18 ClassificationofSuspected
TuberculosisPatients.............................................36
Exceptionstoconfidentialityrules..............18
TuberculosisinChildhood.....................................37
MissionStatement..................................................20
Medicalevaluation..........................................37
KeySources.............................................................21
ChestX-rayinchildren..................................37
Congenitalandneonataltuberculosis......38
Evaluatingneonatesfortuberculosis.........38
BacilleCalmette-Guérinvaccination.........38
KeySources.............................................................40
NewYorkCityDepartmentofHealthandMentalHygiene 1
Table of Contents
Section III. RegimensforPatients
Treatment of Pulmonary Tuberculosis withChronicRenalFailure....................................60
RegimensforPatientswithLiverDisease..........61
RegimensforTreatmentof
Drug-SusceptibleTuberculosis............................43 TheUseofPyridoxine(VitaminB )
6
Standardregimen.............................................43 inTuberculosisTreatment......................................62
Lengthoftreatment ..........................................43 Anti-TuberculosisDrugsandMeals....................62
IntermittentRegimens............................................44 DirectlyObservedTherapy....................................63
Rifapentine...............................................................46 Protocolforproviding
directlyobservedtherapy..............................63
Patientselection...............................................46
Priorityofpatientsfor
Treatmentlength..............................................48
directlyobservedtherapy..............................64
Dosing.................................................................48
Monitoring..........................................................48 DeterminationofTreatmentCompletion..............64
Adversereactions............................................48 Interruptedorincompletetreatment...........65
Useinpregnantand Renewaloftuberculosistreatment.............65
breast-feedingwomen....................................48
Continuationoflapsedtreatment...............65
Useinchildren..................................................48
Protocolsforreinstitutingtreatment...........65
Druginteractions.............................................48
Treatmentfailure..............................................67
TreatmentofCo-existentTuberculosisandHIV....49
Treatmentofcoexistenttuberculosis
Antiretroviraldrugsandrifamycins...........49 anddisseminatedMycobacterium
avium-intracellulare.......................................67
Treatmentoptions............................................52
Generalconsiderations..................................52 KeySources.............................................................68
Immunereconstitution
inflammatorysyndrome.................................56
Section IV.
RegimensforPregnantWomen............................56 Evaluation and Treatment of
Standardregimenforpregnantwomen.......57 Extrapulmonary Tuberculosis
Lengthoftreatment.........................................57
LymphaticTuberculosis..........................................72
Regimen for pregnant women
Diagnosis...........................................................72
suspected or known to have tuberculosis
resistant to isoniazid and rifampin Treatment...........................................................72
(MDRTB)..............................................................58 PleuralTuberculosis...............................................72
Anti-tuberculosismedications
Diagnosis...........................................................73
inbreast-feedingwomen...............................58
Treatment...........................................................73
RegimensforChildren............................................59
PericardialTuberculosis........................................73
Standardregimen............................................59
Diagnosis...........................................................73
Lengthoftreatmentregardless
Treatment...........................................................73
ofcultureresults...............................................60
Adverseeventsinchildren............................60
2 TuberculosisClinicalPoliciesandProtocols,4thEdition
Table of Contents
CentralNervousSystemTuberculosis.................73 SuggestedRegimensforSpecific
DrugResistancePatterns......................................85
Diagnosisofmeningealtuberculosis.........73
Isoniazidresistance.........................................87
Treatmentofmeningealtuberculosis.........74
(withorwithoutstreptomycinresistance)
Tuberculoma......................................................75
Isoniazidandethambutolresistance.........87
DisseminatedTuberculosis...................................75
(withorwithoutstreptomycinresistance)
Diagnosis...........................................................76
Rifampinresistance........................................87
Treatment...........................................................76 (withorwithoutstreptomycinresistance)
SkeletalTuberculosis.............................................76 Isoniazidandrifampinresistance...............88
(withorwithoutstreptomycinresistance)
Diagnosis...........................................................76
Isoniazid,rifampinand
Treatment...........................................................76
ethambutolresistance ...................................89
GenitourinaryTuberculosis...................................76
(withorwithoutstreptomycinresistance)
Diagnosis...........................................................76
Isoniazid,rifampin
Treatment...........................................................76 andpyrazinamideresistance.......................89
(withorwithoutstreptomycinresistance)
GastrointestinalTuberculosis...............................77
Isoniazid,rifampin,pyrazinamide
Diagnosis...........................................................77
andethambutolresistance............................90
Treatment...........................................................77 (withorwithoutstreptomycinresistance)
PeritonealTuberculosis.........................................77 Isoniazid,rifampin,ethambutol,
Diagnosis...........................................................77 streptomycin,kanamycin,ethionamide
andrifabutinresistance(“StrainW”).........90
Treatment...........................................................77
Isoniazid, rifampin, ethambutol,
CutaneousTuberculosis.........................................77
streptomycin, fluoroquinolone
Diagnosis...........................................................78
resistance(withorwithoutpyrazinamide
Treatment...........................................................78 orseveralinjectableagents).........................91
DiseaseDuetoIntravesicalBacille
UseofNewerFluoroquinolones
Calmette-GuérinforBladderCancer.....................78
forTreatingTuberculosis.......................................91
Diagnosis...........................................................78
ToxicitiesofFluoroquinolones..............................92
Treatment...........................................................78
Photosensitivityandcardiotoxicity.............92
KeySources.............................................................80
Tendinopathy/tendonitis................................92
Hypoglycemiaandhyperglycemia.............93
Section V.
Long-termuseoffluoroquinolones..............93
TreatmentofDrug-ResistantTuberculosis
Moxifloxacin......................................................93
PrinciplesofTreatingDrug-Resistant Linezolid....................................................................94
Tuberculosis.............................................................83
Clofazamine..............................................................95
Treatmentprinciples.......................................83
MonitoringandPost-TreatmentEvaluation........95
Monitoringprinciples......................................84
SurgeryforPulmonaryTuberculosis....................95
Principlesforselecteddrugs........................85
NewYorkCityDepartmentofHealthandMentalHygiene 3
Table of Contents
Indicationsforsurgery....................................96 KeySources...........................................................118
Protocolforsurgeryreferral..........................96
KeySources.............................................................97 Section VII.
Infection Control
Section VI.
GuidelinesforHospitalAdmissionand
Clinical Monitoring and Follow-up OutpatientManagementofPatientswith
for Tuberculosis Treatment SuspectedorConfirmedTuberculosis...............121
Whentoadmitapatientwith
MonthlyClinicalEvaluation................................101
suspectedorconfirmedtuberculosis........121
Physicianassessment...................................101
Whennottoadmitapatientwith
Nurseassessment..........................................105 suspectedorconfirmedtuberculosis........122
ManagementofAdverseReactions...................106 AirborneInfectionIsolation................................122
Dermatitis.........................................................106 Initiatingairborneinfectionisolation......122
Hepatitis...........................................................107 Dischargefromairborne
Gastritis............................................................110 infectionisolation..........................................124
Peripheralneuropathy..................................110 Transfertoanonairborne
isolationarea..................................................124
Jointmanifestations......................................111
Influenceofnucleicacidamplification
Renalmanifestations....................................111
onairborneinfectionisolation...................125
Hematologicmanifestations.......................111
GuidelinesforReturningSuspectedor
Visualmanifestations...................................112
KnownTuberculosisPatientstoHome..............125
Audiovestibularmanifestations................112
Patientswhocanbedischarged
Drugdesensitization.....................................113
fromthehospital............................................125
Paradoxicalreactions,non-HIVrelated...113
Patientswhoshouldnotbedischarged
Reportingadverseevents............................114 fromthehospitalwhilestillAFBsmear
positiveormovedtoanonairborne
Gradesoftoxicity...........................................114
isolationroom.................................................126
ReclassificationofPatients
DischargeofanAFBsmear-negative
SuspectedofHavingTuberculosis.....................114 individualdirectlyfromthehospital
(suspectednon-MDRTB)................................126
CaseClosingand
End-of-TreatmentEvaluation...............................115 Dischargeofanindividualwith
knownorsuspectedMDRTB........................126
Post-TreatmentEvaluation...................................115
GuidelinesforReturningPatientstoWork,
Candidatesandproceduresfor
post-treatmentevaluation............................115 SchoolorOtherCongregateSettings................127
Specialconsiderations SputumAFBsmear-positivepatients
forpatientswhoareHIVpositive..............117 knownorlikelytohavedrug-susceptible
tuberculosis.....................................................127
Theuseofisoniazidafter
completionoftuberculosistreatment.......117
4 TuberculosisClinicalPoliciesandProtocols,4thEdition
Table of Contents
SputumAFBsmear-negativepatients Theinitialinterview......................................139
knownorlikelytohavedrug-susceptible
EnsuringEffectiveCaseManagement...............139
tuberculosis.....................................................127
Casemanagerinitialinterviewtopics....141
Patientsknownorlikelytohave
multidrug-resistanttuberculosis...............129 EnsuringAdherence.............................................142
HomeIsolation.......................................................129 Commonproblemswith,andearly
indicatorsof,pooradherence.....................142
InfectionControlIssuesinPregnancy
andthePeripartumPeriod...................................130 Return-to-SupervisionActivities........................143
Pregnantwomenwithlatent Follow-upforpatientswithtuberculosis
tuberculosisinfection....................................130 whohavemissedvisitsandforsuspected
casesnotondirectlyobservedtherapy......143
InfectionControlinChestCenters.....................131
Follow-uponmisseddirectly
Triage................................................................131 observedtherapyvisits..................................143
Temporaryisolation......................................131 Prioritizingpatientsforfurther
Masksandparticulaterespirators............131 returntosupervision.....................................143
SputumInduction..................................................132 CohortReview.......................................................143
Staffinvolvedinsputuminduction...........132 Prioritizationforlocating
nonadherentpatients.....................................144
Equipment........................................................132
Nonadherentpatientswhoshouldbe
Preparingequipmentand
referredfordetention......................................145
thesputuminductionroom..........................132
RegulatoryInterventionOptions.........................145
Preparingthepatient....................................133
Commissioner’sorders.................................145
Roleofchestcenterstaffduring
theinductionprocedure...............................133 Tuberculosis-relatedregulatory
interventionssectionsofthecurrent
Handlingofthespecimen............................133
HealthCode.....................................................147
Careofequipment
Proceduresforinfectiousor
andareabetweenuses................................133
potentiallyinfectiouspatients
Careofroomandnebulizer
whowanttoleavethehospital..................148
attheendoftheday......................................134
Documentation................................................134 KeySources...........................................................149
KeySources...........................................................135
Section IX.
Contact Evaluation and
Section VIII.
Public Health Management
Case Management of Suspected
Cases and Patients with Tuberculosis ImportanceofContactEvaluation......................153
in the Field and Clinic Definitions........................................................153
InitialCaseManagement.....................................139 Confidentiality................................................155
Objectivesofcasemanagement................139
NewYorkCityDepartmentofHealthandMentalHygiene 5
Table of Contents
EpidemiologicalAssessment Section X.
ofTransmission......................................................155 Testing for Latent
PrioritiesforContactInvestigation....................155 Tuberculosis Infection
CalculatingtheInfectiousPeriod.......................161 CandidatesforTesting
forLatentTuberculosisInfection........................173
AssessingRiskofTransmission.........................161
Prioritiesfortesting.......................................173
EvaluationandManagementofContacts.........161
Testingpregnantwomen.............................176
Symptomreview.............................................161
Guidelinesfortesting
HIVscreeningandtesting...........................162
specifichigh-riskgroups..............................176
Initialtestfortuberculosisinfection
AdministeringtheTuberculinSkinTest............178
andfollow-up..................................................162
Preparation......................................................178
Medicalevaluation
andchestradiograph....................................163 Injection............................................................178
Repeattestfortuberculosisinfection Post-injection...................................................178
andfollow-up..................................................163
ReadingtheTuberculinSkinTestReaction......179
Contactevaluationforpatientswhose
culturesconvertbacktopositive...............164 Interpretationofthe
TuberculinSkinTestReaction............................179
SpecialConsiderationsfor
InfantandChildContacts.....................................164 InterpretationoftheTuberculin
SkinTestinBacilleCalmette-Guérin-
Initialtestfortuberculosisinfection
VaccinatedIndividuals.........................................179
andchestX-rayforinfantsandchildren...164
Repeattestfortuberculosisinfection RoleofAnergyTesting.........................................182
andchestX-rayforinfantsandchildren...165
Two-StepTuberculinSkinTesting......................182
ContactInvestigationforSmear-Negative, Background......................................................182
Culture-PendingCases.........................................165
Candidatesandprocedure
ExpandingaContactInvestigation.....................165 for2-steptesting.............................................183
AirlineExposures..................................................167 Blood-BasedTestsforTuberculosisInfection:
TheQuantiFERON®-GoldTest..............................183
SourceCaseInvestigationfor
AdvantagesoftheQFT-Gtest....................183
PediatricTuberculosisCases..............................167
LimitationsoftheQFT-Gtest......................184
CaseManagementandTreatmentofContacts
Eligibilityandinterpretationof
withLatentTuberculosisInfection.....................169
theresultsoftheQFT-Gtest.......................184
Responsibilitiesofthecasemanager......169
CostsandbenefitsoftheQFT-Gtest........184
Returntosupervisionprocedures
Futureblood-basedassays.........................184
forcontactsbeingtreatedforlatent
tuberculosisinfection....................................169
KeySources...........................................................185
KeySources...........................................................170
6 TuberculosisClinicalPoliciesandProtocols,4thEdition
Table of Contents
Section XI. Regimensforwomenwhobecome
LatentTuberculosisInfection:Evaluation, pregnantwhiletakingtreatment
forlatenttuberculosisinfection.................200
Treatment, Monitoring and Follow-up
Regimensforindividualswithradiographic
ClinicalEvaluation................................................189 evidenceofold,healedtuberculosis
(ClassesIVandV)..........................................200
Medicalhistoryand
physicalexamination...................................189
Treatmentofclosecontactswithaprior
ChestX-ray......................................................189 positivetestfortuberculosisinfection........202
PatientchestX-rayclassifications............189
CaseManagementofPatientswithLatent
Laboratorytestsforindividualsbeing TuberculosisInfection .........................................202
consideredforlatenttuberculosis
MonitoringPatientsDuringTreatment..............202
infectiontreatment........................................190
CandidatesforTreatmentfor Howproviderscanassessand
promoteadherence........................................203
LatentTuberculosisInfection..............................192
Individualswhomayhave EnsuringAdherenceDuringTreatment..............203
beenrecentlyinfected..................................192
ManagingInterruptionsinTreatment................203
Patientswithclinicalconditionsassociated
CompletingTreatment...........................................205
withprogressionfromlatenttuberculosis
toactivetuberculosis....................................192 Follow-upforPatientsWhoHaveCompleted
Personswithimmunosuppressive Treatment................................................................205
conditionsorwhoarebeingtreated
KeySources...........................................................206
withimmunosuppressiveagents...............192
Contactswhoshouldstarttreatment
Appendices
regardlessoftuberculinskin
testreaction.....................................................193
AppendixI-A
Pregnantwomenascandidatesfor
DosagesforPrimaryMedications
latenttuberculosisinfectiontreatment....193
UsedintheTreatmentofTuberculosis.....208
Childrenascandidatesforlatent
AppendixI-B
tuberculosisinfectiontreatment................193
DosagesforReserveMedications
LatentTuberculosisInfection UsedintheTreatmentofTuberculosis.....210
TreatmentRegimens.............................................195
AppendixI-C
Standardregimen:isoniazid.......................195
TheUseofAntituberculosisDrugsDuring
Alternativeregimen:rifampin....................195 Pregnancy,Breastfeeding,Tuberculosis
Meningitis,andRenalandHepatic
Rifampinandpyrazinamide.......................198
Failure..................................................................211
Alternativeregimensforcontactsof
AppendixI-D
personswithisoniazid-andrifampin-
resistanttuberculosis(multidrug- LateComplicationsofTreated
resistantcontacts).........................................198 PulmonaryTuberculosis...............................212
NewYorkCityDepartmentofHealthandMentalHygiene 7