ISTC

International Standards for Tuberculosis Care

Pediatrics perspective

Ikatan Dokter Anak Indonesia

02/19/17 Indonesian Pediatric Society 1

 Background

02/19/17 2
TB, strong & robust
Nature of the bacilli
Very complex & special pathogenesis
Very effective & efficient transmission
Difficult diagnosis, especially in children
Multiple drug, no new drugs
Drug side effects
Long term therapy
No effective prevention - immunization
Sub-standard management
MDR, XDR, HIV, etc
Not medical problem only

World TB problem
Case findings OK
TB treatments
OK
TB still a global
problem!?
something wrong!

need more than just

findings & treating the
case
DOTS!
02/19/17 4
DOTS
early 1990, WHO & IUATLD
developed a strategy to combat
world TB problem DOTS!
(Directly Observe Treatment
Short-course)

proven as a cost effective strategy

based on: many studies, clinical

trial, best practices, & program
implementation for more than 2
decades
02/19/17 5
 02/19/17 6
02/19/17 6
 DOTS
strategy Pediatric
TB

National TB Program
(NTP)

Adult patient oriented

02/19/17 7
 02/19/17 8
02/19/17 8
Commitment (political will)
From all & every stakeholders involved
President & all government leader and staffs
Minister of Health & all staffs of Dept of Health
Hospital directors
All doctors involved: Pulmonologist, Internist,
Pediatrician, General Physician,
All medical staffs involved
And others

02/19/17 9
TB management in
Indonesia
Healthcare provider

Government Private
,
Governme Private Private
PH nt hospital hospita clinic
C l
BKPM Specialist, GP &
RSP
assisted by GP Specialis
GP t
Pulm
10
 TB management guideline
Healthcare provider

Government Private
,
Governme Private Private
PH nt hospital hospita clinic
C l
BKPM Specialist, GP &
RSP
DOTS assisted by PDPI,
Guidelines: GP PAPDI,
Specialis
GP
strategy IDAI: PNTA t
Pulm
11
02/19/17 12
Basic principal in TB
management
a diagnosis should be established
promptly and accurately;
standardized treatment regimens of
proven efficacy should be used, with
appropriate treatment support and
supervision;
the response to treatment should be
monitored;
the essential public health
responsibilities must be carried out.
02/19/17
ISTC, 13
2006
 TB management in
Indonesia
Healthcare provider

Government Private
,
Governme Private Private
PH nt hospital hospita clinic
C l
BKPM Specialist, GP &
RSP
DOTS assisted by PDPI,
GP PAPDI,
Sub-standard
Guidelines: Specialis
GP
strategy IDAI: PNTA t
Pulm management 14
Sub-standard TB care
impact
mis-diagnosis (over / under) and mis-
treatment (over / under),
many severe pediatric TB cases
poor patient outcomes,
continued infectiousness with
transmission of M. tuberculosis to family
& other community members,
generation & propagation of drug
resistance (MDR, XDR)

02/19/17
ISTC, 15
2006
 ISTC

02/19/17 16
International Standards

02/19/17 17
ISTC
NOT replace guideline but as
complementary
Guideline HOW to manage
Standards WHAT should be done
Standards do not provide specific
guidance on disease management
but, present set of principles that can
be applied in nearly all situations.

02/19/17
ISTC, 18
2006
 Purpose
to describe a widely accepted level of
care that all practitioners, public and
private, should seek to achieve in
managing patients who have, or are
ISTC,
suspected of having, tuberculosis. 2006
ISTC UUD

gln PDPI gln PNTA PAPDI gln UU

DOTS gln PP
gln Perpu
Perda
02/19/17 19
 TB management in
Indonesia
Healthcare provider

Government Private
,
Governme Private Private
PH nt hospital hospita clinic
C
ISTC
l
BKPM Specialist, GP &
RSP
DOTS assisted by PDPI,
GP PAPDI,
Sub-standard
Guidelines: Specialis
GP
strategy IDAI: PNTA t
Pulm management 20
Original ISTC 1st ed 2006
ISTC: 17 standards

Diagnosis 6 standards

Treatment 9 standards

Public Health 2 standards

02/19/17
ISTC, 21
2006
02/19/17 22
 ISTC
in Indonesia

02/19/17 23
ISTC in Indonesia
ISTC launched at 24 March 2006,
spreaded to all countries
5 pilot project countries: India,
Indonesia, Kenya, Mexico and Tanzania
Indonesia: PDPI IDI, special task force
A long & winding road process
Many meetings, discussions, arguments,
even fightings

02/19/17 24
ISTC application in
Indonesia
Original ISTC

standard not fully match

legal implication IDAI & others

disclaimer addendums

Indonesia ISTC
02/19/17 25
Indonesia ISTC
disclaimer

Diagnosis 6 standards

Treatment 9 standards

Public health 2 standards

addendum
02/19/17 26
Wewanti (disclaimer)
ISTC telah disepakati Meskipun demikian,
mengingat keterbatasan dalam hal prasarana,
sarana, & letak geografis serta belum
meratanya SDM dan masih terdapat penyulit
penyakit selain TB pada pasien tsb, maka
dalam pelaksanaannya, ISTC dapat
disesuaikan dengan si-kon yang ada demi
kepentingan pasien.

Addendum
Standard 1:

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Indonesian endorsement

02/19/17 28
ISTC 2nd edition 2009
Indonesia ISTC 2nd ed
disclaimer

Diagnosis 6 standards

Treatment 7 standards
HIV & other 4 standards
Public health 4 standards

addendum
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 ISTC
pediatric
consideration

02/19/17 31
Standards for Diagnosis
pediatric considerations

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 02/19/17 33
02/19/17 33
ISTC Standard 1
All persons with otherwise unexplained
productive cough lasting two-three weeks or
more should be evaluated for tuberculosis.

Addendum: for children, cough is NOT the

main TB symptom, the other entries:
o weight loss or FTT in two last months
o fever >2 weeks with unexplained causes
o exposed to adult with active TB

02/19/17
ISTC 2nd 2009 34
ISTC Standard 3
For all patients (adults, adolescents, and
children) suspected of having
extrapulmonary tuberculosis,
appropriate specimens

Addendum: examination for pulmonary

TB also should be done i.e. sputum
examination in capable patient, TST in
children, and CXR

02/19/17
ISTC 2nd 2009 35
ISTC Standard 4
All persons with chest radiographic
findings suggestive of TB should have
sputum specimens submitted for
microbiological examination.

Addendum: for children, usually they

can not expectorate the sputum, so
sputium examination only if possible;
and TST should be done.

02/19/17 36
ISTC Standard 6
The diagnosis of intra-thoracic TB in
symptomatic children with negative sputum
smears should be based on the finding
of chest radiograph or evidence of TB
infection (positive TST or IGRA) ..

NO WAY!
Addendum: for children, the first and
most important diagnostic tools is
Tuberculin skin test, NOT the chest
radiograph (the priority should be changed)
02/19/17
ISTC 2nd 2009 37
TB diagnosis in Indonesia

suspect TB cases

Adult Pediatric

CX Microscopi
CXR Mantou
c x test
R examinatio
YES! n
YES/NO? YES OR/OR?

02/19/17 38
 Ped TB diagnosis in
Indonesia
Healthcare provider

Government Private
,
Governt Privat Privat
PH hospital e e
C hospit clinic
BKPM Specialist, al GP &
RSP
assisted by GP Speciali
DOTS
GP Guidelines: PDPI, PAPDI,
st
Pulm
strategy IDAI: PNTA
39
 02/19/17 40
02/19/17 40
Under-diagnosis in PHC
NTP guideline only for adult patient
DOTS 2nd element: microscope
examination! TST is not mentioned,
let alone provided
HCW worker only familiar with TB
management for adult patient
HCW question: children can contract TB ???
HCW have no confidence to diagnosed TB
in children
No sputum, no TB!
Two extreme conditions
Private
PHC practice

Under- Over3 -
diagnosis diagnosis

Adult NO
guideline
DOTS
Indonesian irony
Low social economy High social economy
Public service Private practice

Malnutrition Obesity

Pneumonia: Pneumonia:
Under-diagnosis, Over-diagnosis,
under-treatment over-treatment

Pediatric TB: Pediatric TB:

Under-diagnosis, Over-diagnosis,
under-treatment over-treatment
IDAI Ped TB scoring system
 Notes for IDAI scoring
system
Diagnosis by doctor
BW assessement at present
Fever & cough no respons to standard tx
CXR is NOT a main diagnostic tool in children
All accelerated BCG reaction should be
evaluated with scoring system
TB diagnosis if total score >6
Score 4 in under5 child or strong suspicion,
refered to hospital
INH prophylaxis for AFB(+) contact
with score <5

02/19/17 45
Standards for Treatment
pediatric considerations

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 02/19/17 47
02/19/17 47
ISTC Standard 8
All patients (incl those with HIV
infection) ..... regimen using drugs of known
bioavailability. The initial phase should
consist of two months of isoniazid,
rifampicin, pyrazinamide, and
ethambutol.

Addendum: for children, the initial phase

can consist of three drugs: H, R, and Z. For
severe TB, 4 5 drugs are given with longer
maintenance phase (9-12 months)
02/19/17
ISTC 2nd 2009 48
 Ped TB therapy regimen
2 mo 6 mo 9 mo 12mo

INH
RMP
PZA

ETB
SM

PREDNISON
DOTS !

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 02/19/17 50
02/19/17 50
 TB drugs & pharmaceutical
formulation

isoniazid (H) monosubstanc

e
rifampicin (R)
combi-packs
pyrazinamide
(Z)
ethambutol (E) fixed dose
comb
02/19/17 51
Combipack drugs
two or more separate drugs put in one
pack

02/19/17 52
Pediatric combipack

02/19/17 53
FDC with IDAI formulation

02/19/17 54
IDAI FDC (H50R75Z150 &
H50R75)

Note: BW < 5kg should be referred and need tailored dosing

02/19/17 55
Ped FDC & ped
combipack

Note: BW < 5kg should be referred and need tailored dosing

02/19/17 56
ISTC Standard 10
Response to therapy In patients with
extrapulmonary TB and in children, the
response to treatment is best
assessed clinically.

agree!
Addendum: response to therapy in
miliary TB, TB pleural effusion, and smear
negative TB can be monitored with CXR
02/19/17
ISTC 2nd 2009 57
 Standards for HIV &
other comorbid
pediatric considerations

02/19/17 58
ISTC Standard 16
Persons with HIV infection who, after
careful evaluation, do not have active TB
should be treated for presumed latent TB
infection (LTBI) with isoniazid for 6-9
months.

Addendum: IPT (isoniazid preventive

therapy) or INH prophylaxis for LTBI in
HIV patient is not an NTP policy yet

02/19/17
ISTC 2nd 2009 59
 Standards for Public
Health
pediatric considerations

02/19/17 60
ISTC Standard 18
All providers of care for patients with TB should
ensure that persons who are in close contact
with patients who have infectious TB are
evaluated & managed in line with
international recommendations.
o
o Children aged <5 years
o
agree!
Addendum: all practioners treating ped TB
patients, should trace the source (index
case)

02/19/17 61
ISTC Standard 19
Children <5 years of age and persons of
any age with HIV infection who are close
contacts of an infectious index patient and
who, after careful evaluation, do not have
active TB, should be treated for presumed
LTBI with isoniazid.

Addendum: IPT for patients (underfive &

HIV) who are close contact is undergoing
implementation trial program

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 02/19/17 63
02/19/17 63
ISTC Standard 21
All providers must report both new and
retreatment TB cases and their
treatment outcomes to local public
health authorities, in conformance
with applicable legal requirements and
policies.

Note: legal implication, addressed in

disclaimer

02/19/17 64
Recording & reporting of
TB
Another

VERY BIG
challenge
02/19/17 65
 ISTC advocation in
Indonesia
National ToT
Partcp: Province

Province ToT Province ToT

Partcp: District Partcp: District

Distric training Distric training Distric training

Partcp: doctors Partcp: doctors Partcp: doctors

02/19/17 66
Summary
TB is a very-very old human disease
Very difficult to manage, re-emergence
All medical profession are involved
DOTS strategy, many guidelines
Sub-standard care cases
ISTC guard us back to the right track
ISTC shold be known & implemented by
all TB healthcare providers including
pediatrician

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 Thank
02/19/17
you 68