You are on page 1of 28

National

National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National
National

Revised National Tuberculosis Control Programme

Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised

Tuberculosis Control Programme Revised National


Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Central TBProgramme
Division
Tuberculosis Control
Revised National
Directorate General of Health Services
Tuberculosis
Programme
MinistryControl
of Health and
Family Welfare Revised National
Tuberculosis
Programme
NirmanControl
Bhavan, New
Delhi - 110 011 Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National
Tuberculosis Control Programme Revised National

RNTCP
at a

GLANCE

CONTENTS
DEFINITIONS: THE REVISED NATIONAL TUBERCULOSIS
CONTROL PROGRAMME

DIAGNOSTIC ALGORITHM FOR PULMONARY TB

STAINING METHOD

Key steps in the preparation and staining of smears

Ziehl - Neelsen Staining Method

TREATMENT

ZONAL ARTIS AND ESTIMATED NSP CASES PER LAKH


POPULATION

TREATMENT CATEGORIES AND SPUTUM EXAMINATION


SCHEDULE

10

MANAGEMENT OF PATIENTS WHO INTERRUPT TREATMENT

12

TREATMENT OF CHILDREN

15

Algorithm for clinical monitoring of Pediatric TB

16

Chemoprophylaxis for Children

17

SYMPTOM-BASED APPROACH TO EVALUATION OF POSSIBLE SIDE


EFFECTS OF ANTI-TB DRUGS USED IN RNTCP
18
MANAGEMENT OF TB PATIENTS ON DOT IN SPECIAL
SITUATIONS

19

HOSPITALIZATION OF TB PATIENTS

20

SUPERVISORY VISITS

21

SUMMARY OF KEY INDICATORS AND POSSIBLE CORRECTIVE


ACTIONS

22

NEW INDICATORS

26

RNTCP at a Glance

Types of cases
New
A TB patient who has never had treatment for
tuberculosis or has taken anti-tuberculosis drugs for
less than one month.
Relapse
A TB patient who was declared cured or treatment
completed by a physician, but who reports back to
the health service and is now found to be sputum
smear positive.
Transferred in
A TB patient who has been received for treatment
into a Tuberculosis Unit, after starting treatment in
another unit where s/he has been registered.
Treatment after default
A TB patient who received anti-tuberculosis
treatment for one month or more from any source
and returns to treatment after having defaulted,
i.e., not taken anti-TB drugs consecutively for two
months or more, and is found to be sputum smear
positive.
Failure
Any TB patient who is smear positive at 5 months
or more after starting treatment. Failure also
includes a patient who was treated with Category
III regimen but who becomes smear positive during
treatment.
Chronic
A TB patient who remains smear positive after
completing a re-treatment regimen.
Others
TB patients who do not fit into the above mentioned
types. Reasons for putting a patient in this type
must be specified.

Case definitions

Pulmonary Tuberculosis, Smear-Positive


TB in a patient with at least 2 initial sputum smear
examinations (direct smear microscopy) positive for
AFB.
Or: TB in a patient with one sputum smear
examination positive for AFB and radiographic
abnormalities consistent with active pulmonary TB
as determined by the treating MO.
Or: TB in a patient with one sputum smear
specimen positive for AFB and culture positive for
M.tuberculosis.
Pulmonary tuberculosis, Smear-negative
TB in a patient with symptoms suggestive of
TB with at least 3 sputum smear examinations
negative for AFB, and radiographic abnormalities
consistent with active pulmonary TB as determined
by the treating MO followed by a decision to treat
the patient with a full course of anti-tuberculosis
therapy.
Or: Diagnosis based on positive culture but negative
AFB sputum smear examinations.
Extra Pulmonary tuberculosis
TB of any organ other than the lungs, such as
the pleura (TB pleurisy), lymph nodes, intestines,
genitourinary tract, skin, joints and bones, meninges
of the brain, etc.
Diagnosis should be based on culture-positive
specimen from the extra-pulmonary site, histological,
radiological, or strong clinical evidence consistent
with active extra pulmonary TB followed by decision
of the treating MO to treat with a full course of antiTB therapy.
Pleurisy is classified as extra pulmonary TB.
A patient diagnosed with both sputum smear
positive pulmonary and extra pulmonary TB should
be classified as pulmonary TB.

Cured
Initially sputum smear-positive patient who has
completed treatment and had negative sputum
smears, on two occasions, one of which was at the
end of treatment
Treatment completed
Sputum smear-positive patient who has completed
treatment, with negative smears at the end of the
intensive phase but none at the end of treatment.
Or: Sputum smear-negative TB patient who has
received a full course of treatment and has not
become smear-positive during or at the end of
treatment.
Or: Extra-pulmonary TB patient who has received a
full course of treatment and has not become smearpositive during or at the end of treatment.
Died
Patient who died during the course of treatment
regardless of cause
Failure
Any TB patient who is smear positive at 5 months
or more after starting treatment. Failure also
includes a patient who was treated with Category
III regimen but who becomes smear positive during
treatment.
Defaulted
A patient who has not taken anti-TB drugs for
2 months or more consecutively after starting
treatment.
Transferred out
A patient who has been transferred to another
Tuberculosis Unit/District and his/her treatment
result (outcome) is not known.

Treatment outcomes

DEFINITIONS: THE REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME

DIAGNOSTIC ALGORITHM FOR PULMONARY TB


COUGH FOR 3 WEEKS OR MORE

3 Sputum smears

2 or 3 Positives

3 Negatives
Antibiotics 10-14 days
Cough Persists
Repeat 3 Sputum
Examinations

1 Positive

X-Ray

Negative

Sputum Positive
TB (Anti-TB
Treatment)

Negative for TB

Suggestive of TB

X-Ray

Sputum Positive
TB (Anti-TB
Treatment)

Negative for TB

Non TB

2 or 3 Positives

RNTCP at a Glance

Suggestive of TB

Sputum Smear
Negative TB
(Anti-TB Treatment)

STAINING METHOD
Key steps in the preparation and staining of smears
Step 1
Break a broomstick
into two

Pick up the large, yellow purulent


portion of sputum Spread evenly
onto 2/3 of central portion of the
numbered slide

Step 2
Air-dry the
slide for 1530
minutes

Step 4

Step 3
Fix the dry slide by heating
briefly 35 times for 34
seconds each time

Step 5
Heat the slides
from underneath
until vapours rise

Spread evenly onto 2/3


of central portion of the
numbered slide

Place the slides in


serial order on the
staining rack

Stain the slides


with 1% carbol
fuchsin

Step 7

Step 6
Let the slides stand
for 5 minutes

Rinse the slides


with tap water

Step 8

Drain off
excess water

Step 9

Decolourize with 25% sulphuric acid and


let it stand for 24 minutes (repeat, letting
stand for 13 minutes, if necessary)

Rinse away excess


stain with tap water

Drain off the


water

Step 10
Counterstain with 0.1%
methylene blue and let
stand for 30 seconds

Gently rinse the slides with


tap water, drain the water
off, and allow the slide to dry

Examine the slides under


the microscope examine
at least 100 fields.

RNTCP at a Glance

Ziehl - Neelsen Staining Method


1. Select a new unscratched slide and label the slide with the Laboratory Serial
Number with a diamond marking pencil.
2. Make a smear from yellow purulent portion of the sputum using a broom stick. A
good smear is spread evenly, 2 cms x 3 cms in size and is neither too thick nor
too thin. The optimum thickness of the smear can be assessed by placing the
smear on a printed matter. The print should be readable through the smear. Smear
preparation should be done near a flame. This is required, as six inches around the
flame is considered as a sterile zone which coagulates the aerosol raised during
smear preparation.
3. Allow the slide to air dry for 1530 minutes.
4. Fix the slide by passing it over a flame 35 times for 34 seconds each time.
5. Pour 1% filtered carbol fuchsin to cover the entire slide.
6. Gently heat the slide with carbol fuchsin on it, until vapours rise. Do not boil.
7. Leave carbol fuchsin on the slide for 5 minutes.
8. Gently rinse the slide with tap water until all free carbol fuchsin stain is washed
away. At this point, the smear on the slide looks red in colour.
9. Pour 25% sulphuric acid onto the slide.
10. Let the slide stand for 24 minutes.
11. Rinse gently with tap water. Tilt the slide to drain off the water.
12. A properly decolourised slide will appear light pink in color .If the slide is still red,
reapply sulphuric acid for 13 minutes and rinse gently with tap water. Wipe the
back of the slide clean with a swab dipped in sulphuric acid,
13. Pour 0.1% methylene blue onto the slide.
14. Leave methylene blue on the slide for 30 seconds.
15. Rinse gently with tap water.
16. Allow the slide to dry.
17. Examine the slide under the microscope using x 40 lens to select the suitable area
and then examine under x100 lens using a drop of immersion oil.
18. Record the results in the Laboratory Form and the Laboratory Register.
If the slide has:

Result

Grading

No. of fields to be examined

More than 10 AFB per oil immersion field

Pos

3+

20

1-10 AFB per oil immersion field

Pos

2+

50

10-99 AFB per 100 oil immersion fields

Pos

1+

100

1-9 AFB per 100 oil immersion fields

Pos

Scanty-B*

100

No AFB in 100 oil immersion fields

Neg

100

*Record actual number of bacilli seen in 100 fields e.g. Scanty 4

19. Invert the slides on tissue paper till the immersion oil is completely absorbed.
Do not use xylene for cleaning the slides, as it may give false results at repeat
examination after storage.
20. Store all positive and negative slides serially in the same slide-box until instructed
by the supervisor.
21. Disinfect all contaminated material before discarding.

RNTCP at a Glance

TREATMENT
Is the patient sputum-smear positive*
NO

YES

Does the patient have TB?

Has the patient been treated


for TB for one month or more
previously

YES
NO

NO

Is the patient
seriously ill?**
NO
CAT III

YES

YES
CAT I

CAT II

No Anti-TB
treatment
*

Patients with extra-pulmonary TB should receive Category III treatment unless they are seriously ill, in
which case they should receive Category I treatment.
** Examples of seriously ill patients are those suffering from meningitis, disseminated TB, tuberculous
pericarditis, peritonitis, bilateral or extensive pleurisy, spinal TB with neurological complications, smearnegative pulmonary TB with extensive parenchymal involvement, intestinal, genito-urinary TB and
co-infection with HIV. All forms of pediatric smear negative TB except primary complex and pediatric
extrapulmonary TB except lymph node TB and unilateral pleural effusion.

ZONAL ANNUAL RISK OF TUBERCULOUS INFECTION (ARTI)


AND ESTIMATED NSP CASES PER LAKH POPULATION
Zone

States/Union Territories

Estimated NSP cases


per lakh population

North

Haryana, Himachal Pradesh, Jammu & Kashmir,


Punjab, Uttar Pradesh, Chandigarh, Delhi, Uttaranchal

95

East*

Assam, Bihar, Manipur, Meghalaya, Mizoram,


Nagaland, Sikkim, Tripura, West Bengal, Andaman &
Nicobar, Arunachal Pradesh, Jharkhand

75

South*

Andhra Pradesh, Karnataka, Kerala, Tamil Nadu,


Pondicherry, Lakshadweep

75

West

Goa, Gujarat, Madhya Pradesh, Maharashtra,


Rajasthan, Dadra & Nagar Haveli, Daman & Diu,
Chhattisgarh

80

State specific

Orissa

85

RNTCP at a Glance

10 RNTCP at a Glance

New extra-pulmonary, not seriously ill

New sputum smear-negative,


not seriously ill

Sputum smear-positive Relapse


Sputum smear-positive Failure
Sputum smear-positive Treatment after
default
Others***

Seriously ill** sputum smear-negative


Seriously ill** extra-pulmonary

New sputum smear-positive

2H3R3Z3 +
4H3R3

2H3R3Z3E3S3 +
1H3R3Z3E3 +
5H3R3E3

2H3R3Z3E3 +
4H3R3

Regimen*

Pre-treatment
sputum

Re-register the patient and begin Category II


treatment

Start continuation phase, test sputum again at


the end of treatment (6 months)

Start continuation phase, test sputum again at


2 months in CP (5 months) and at the end of
treatment (8 months)

Continue Intensive phase for one more


month, test sputum again at end of extended
IP (3 months), and then at 2 months in CP
(5 months) and at the end of treatment (7
months)

Start continuation phase, test sputum again at


the end of treatment (6 months)

Continue Intensive phase for one more


month, test sputum again at end of extended
IP (3 months), and then at 2 months in CP
(5 months) and at the end of treatment (7
months)

Start continuation phase, test sputum again at


2 months in CP (4 months) and at the end of
treatment (6 months)

Continue Intensive phase for one more


month, test sputum again at end of extended
IP (4 months), and then at 2 months in CP
(6 months) and at the end of treatment (9
months)

SPUTUM EXAMINATIONS FOR PULMONARY TB


Test at
If result
Then
month
is
(end IP)

The number before the letters refers to the number of months of treatment. The subscript after the letters refers to the number of doses per week. The dosage strengths are as
follows: H: Isoniazid (600 mg), R: Rifampicin (450 mg), Z: Pyrazinamide (1500 mg), E: Ethambutol (1200 mg), S: Streptomycin (750 mg). Patients who weigh 60 kg or more
receive additional rifampicin 150 mg. Patients who are more than 50 years old receive streptomycin 500 mg. Patients who weigh less than 30 kg, receive drugs as per body
weight. Patients in Categories I and II who have a positive sputum smear at the end of the initial intensive phase receive an additional month of intensive phase treatment.
** Seriously ill also includes, any patient, pulmonary or extra-pulmonary who is HIV positive and declares his sero-status to the categorizing/ treating medical officer. For the purpose
of categorization, HIV testing should not be done
*** In rare and exceptional cases, patients who are sputum smear-negative or who have extra-pulmonary disease can have Relapse or Failure. This diagnosis in all such cases should
always be made by an MO and should be supported by culture or histological evidence of current, active TB. In these cases, the patient should be categorized as Others and
given Category II treatment.

Any patient treated with Category I who has a positive smear at 5 months or later should be considered a Failure and started on Category II treatment afresh. Any patient on
Category III who has a positive smear anytime during the treatment is also considered as Failure and started on Category II treatment.

Category III

Category II

Category I

Category of
Treat ment

TREATMENT CATEGORIES AND SPUTUM EXAMINATION SCHEDULE

TREATMENT REGIMEN
Type of patient

MEDICATION
Medication

Dose (thrice a week)***

Isonazid
Rifampicin
Pyrazinamide
Ethambutol
Streptomycin

Number of pills in
combipack
2
1
2
2
-

600mg
450mg*
1500mg
1200mg
0.75g**

*
Patients who weigh 60kg or more at the start of treatment are given an extra 150mg dose of rifampicin
** Patients over 50 years of age and those who weigh less than 30 kg are given 0.5g of streptomycin.
*** Adult patients who weigh less than 30kg receive drugs in patient-wise boxes from the weight band
suggested for pediatric patients

Phases and duration of treatment


Category
Category I
Category II
Category III

Duration (number of doses)


Intensive Phase (IP)
Continuation Phase (CP)
8 weeks (24 doses)
18 weeks (54 doses)
12 weeks (36 doses)
22 weeks (66 doses)
8 weeks (24 doses)
18 weeks (54 doses)

Total
26 weeks (78 doses)
34 weeks (102 doses)
26 weeks (78 doses)

Duration if sputum is positive at end of Intensive Phase*


Category
Category I
Category II

Duration (number of doses)


Intensive Phase (IP)
Continuation Phase (CP)
12 weeks (36 doses)
18 weeks (54 doses)
16 weeks (48 doses)
22 weeks (66 doses)

* Cat I at the end of 2 months

Total
26 weeks (90 doses)
34 weeks (114doses)

Cat II at the end of 3 months

Regimen for non-DOTS in RNTCP areas


Treatment
Non-DOTS Regimen 1
(ND 1)
Non-DOTS Regimen 2
(ND 2)

Type of Patient
New smear-positive pulmonary Seriously ill
sputum smear-negative
Seriously ill extra-pulmonary
Smear-negative pulmonary, not seriously ill
Extra-pulmonary, not seriously ill

Regimen
2 HSE + 10 HE

12 HE

In RNTCP areas, less then 5% of patients may get Non-DOTS Treatment

RNTCP at a Glance 11

MANAGEMENT OF PATIENTS WHO INTERRUPT TREATMENT


Management of patients who were smear-negative at diagnosis and
who interrupt treatment
Treatment
received
before
interruption

Less than
1 month

More than
1 month

Length of
interruption

Do a
sputum
Smear
examination

Result of
Outcome
sputum
Smear
examination

Reregistration

Treatment

Less than
2 months

No

__

__

__

Resume
Treatment
and
Complete
All doses

2 months or
more

Yes

Neg

__

__

Resume
Treatment

Pos

Default

New

Begin CAT I
afresh

Less than
2 months

No

__

__

__

Resume
Treatment
and
Complete
All doses

More than
2 months

Yes

Neg

__

__

Resume
Treatment
and
Complete
All doses

Pos

Default

Treatment
After
Default

Begin CAT II
Treatment
afresh

12 RNTCP at a Glance

MANAGEMENT OF PATIENTS WHO INTERRUPT TREATMENT


Treatment for New smear-positive cases who interrupt treatment
(Category I)
Treatment
received
before
interruption

Length of
interruption

Do a
sputum
Smear
examination?

Result of
Outcome
sputum
Smear
examination

ReTreatment
registration

Less than
1 month

Less than
2 weeks

No

__

__

__

Continue
CAT I*

2-7 weeks

No

__

__

__

Start again on
CAT I**

8 weeks
or more

Yes

Positive

Default

New

Start again
on CAT I**

Negative

__

__

Continue
CAT I*
Continue
CAT I*

1-2 months

Less than
2 weeks

No

__

__

__

More than
2 months

2-7 weeks

Yes

Positive

__

__

8 weeks or
more

Yes

Negative

__

__

Positive

Default

Start on
CAT II*

Negative

__

Treatment
After
Default
__

__

__

__

Continue
CAT I*

Positive

Default***

Other

Negative

__

__

Start on
CAT II**
Continue
CAT I*

Positive

Default

Negative

__

Treatment
After
Default
__

Less than
2 weeks

2-7 weeks

No

Yes

8 weeks or
more
Yes

1 extra month
of intensive
phase of
CAT I
Continue
CAT I*

Continue
CAT I*

Start on
CAT II**
Continue
CAT I*

A patient must complete all 24 doses of the initial intensive phase. For example, if a patient has to continue
his previous treatment and he took 1 month of treatment (12 doses) before interrupting. He will have to take 1
more month (12 doses) of the intensive phase treatment. The patient will then start the continuation phase of
treatment.
** A patient who must start again will restart treatment from the beginning.
*** Although this patient does not strictly fit the definition of default. Default most closely describes the outcome of
this patient. although at re-registration the patient should be categorized as Other.
*

RNTCP at a Glance 13

MANAGEMENT OF PATIENTS WHO INTERRUPT TREATMENT


Treatment for smear-positive retreatment cases who interrupt treatment
(Category II)
Treatment
received
before
interruption

Less than
1 month

Length of
interruption

Do a sputum
Smear
examination

Result of
sputum
Smear
examination

Outcome

Reregistration

Treatment

Less than
2 weeks

No

__

__

__

Continue CAT II*

2-7 weeks

No

__

__

__

Start again on
CAT II**

8 weeks
or more

Yes

Positive

Default

Treatment
Start again on
After Default CAT II**

Negative

__

__

Continue CAT II*

Less than
2 weeks

No

__

__

__

Continue CAT II*

2-7 weeks

Yes

Positive

__

__

8 weeks or
more

Yes

Negative

__

__

1 extra month of
intensive phase
of CAT II
Continue CAT II*

Positive

Default

Less than
2 weeks

No

Negative

__

Treatment
Start again on
After Default CAT II**
__
Continue CAT II*

__

__

__

Continue CAT II*

Positive

Default***

Other

Start again on
CAT II**

Negative

__

__

Continue CAT II*

Positive

Default

Treatment
Start again on
After Default CAT II

Negative

__

__

1-2 months

2-7 weeks
More than
2 months

Yes

8 weeks or
more
Yes

Continue CAT II*

*
A patient must complete all 36 doses of the initial intensive phase.
** A patient who must start again will restart treatment from the beginning.
*** Although this patient does not strictly fit the definition of default. Default most closely describes the outcome of this
patient, although at re-registration the patient should be categorized as Other.

14 RNTCP at a Glance

TREATMENT OF CHILDREN
Diagnostic Algorithm for Pediatric Pulmonary TB
Pulmonary TB Suspect

Fever and/or cough 3 weeks

Loss of wt/ No wt. gain

History of contact with suspected or diagnosed case of active TB

Is expectoration present?
If no, refer to Pediatrician
If yes, examine 3 sputum
2 or 3 Positives

3 Negatives
Antibiotics 10-14 days

Cough Persists
Repeat 3 Sputum
Examinations
1 Positive
X-Ray

Suggestive of TB

Negative

2 or 3 Positives

Sputum Positive
TB (Anti-TB
Treatment)

Negative for TB
X-Ray +
Mantoux

Sputum Positive
TB (Anti-TB
Treatment)

Negative for TB

Refer to Pediatrician

Suggestive of TB

Sputum Smear Negative TB


(Anti-TB Treatment)

Algorithm for Clinical Monitoring of Pediatric TB


Patient on treatment

Review at 2 months,
satisfactory response
assessed by:
improvement in symptoms
no weight loss and or
weight gain

Review at 2 months, nonsatisfactory response assessed


by:
adherence to treatment
weight loss
worsening of symptoms

Follow up clinically

Refer to Pediatrician/TB
specialist for assessment
(consider sputum examination)

Clinical assessment and


X-ray at completion of
treatment

Sputum positive

Failure

Category II

16 RNTCP at a Glance

Sputum negative or not


available
Review diagnosis
extend IP by 1 month
No improvement =
Pediatric non-responder

Dosages for children


Drugs
Isonoazid
Rifampicin
Pyrazinamide
Streptomycin
Ethambutol

Dosage (Thrice a week)


10-15mg/kg
10mg/kg
35mg/kg
15mg/kg
30mg/kg

Chemoprophylaxis for Children


Household contacts of smear-positive TB cases, especially those below 6
years of age, must be screened for symptoms of tuberculosis. In case of
symptoms being present, the diagnostic algorithm for pediatric TB should be
followed and the child should be given a full course of anti TB treatment if
s/he is diagnosed as a TB case.
For asymptomatic children and those who are not found to be suffering
from TB, chemoprophylaxis with isoniazid (5 mg per kg body wt) should be
administered daily for a period of six months.
This is regardless of the BCG vaccination status.

RNTCP at a Glance 17

SYMPTOM-BASED APPROACH TO EVALUATION OF POSSIBLE


SIDE EFFECTS OF ANTI-TB DRUGS USED IN RNTCP
Symptom

Drug (abbreviation)

Action to be taken

Gastrointestinal
upset

Any oral medication

Reassure patient
Give drugs with less water
Give drugs over a longer period of
time (e.g. 20 minutes)
Do not give drugs on empty stomach
If the above fails, give antiemetic if
appropriate

Itching

Isoniazid (H) (Other


drugs also)

Reassure patient
If severe, stop all drugs and refer
patient to MO

Burning in the
hands and feet

Isoniazid (H)

Give pyridoxine 100 mg/day until


symptoms subside

Joint pains

Pyrazinamide (Z)

If severe, refer patient for


Evaluation

Impaired vision

Ethambutol (E)

STOP ethambutol, refer patient for


evaluation

Ringing in the
ears

Streptomycin (S)

STOP streptomycin, refer patient for


evaluation

Loss of hearing

Streptomycin (S)

STOP streptomycin, refer patient for


evaluation

Dizziness and
loss of balance

Streptomycin (S)

STOP streptomycin, refer patient for


evaluation

Jaundice

Isoniazid (H)
Rifampicin (R)
Pyrazinamide (Z)

STOP all drugs, refer patient for


evaluation

In cases of jaundice, all anti-TB drugs should be stopped


immediately and the patient referred for evaluation.

18 RNTCP at a Glance

MANAGEMENT OF TB PATIENTS ON DOT IN SPECIAL SITUATIONS


Situation
Hospitalization

Tuberculous
meningitis

Treatment of TB
during pregnancy
and postnatal
period

Treatment in
patients with renal
failure
Treatment in
women taking oral
contraceptive pills
TB and HIV

MDR TB

Management
Only extremely ill patients need hospitalization during the
treatment
Patients with significant haemoptysis, pneumothorax or large
accumulation of pleural fluid leading to breathlessness need to
be hospitalized
Flow chart for hospitalized patients is given on next page
Fatal if untreated
Patient should be referred to the hospital
Total duration of treatment is 89 months. The continuation
phase should be given for 67 months
Steroids should be given initially and gradually reduced over
68 weeks
Streptomycin should not be given; other drugs used in RNTCP
are safe
Breast feeding should continue regardless of the mothers TB
status
Advise the mother to cover her mouth, if she is smear-positive,
while breastfeeding the baby
Chemoprophylaxis for the baby is advisable if mother is sputum
smear-positive
Rifampicin, isoniazid and pyrazinamide can be safely given
Streptomycin and ethambutol, if given, should be closely
monitored with reduced dosage
Rifampicin decreases the efficiency of oral contraceptives;
increase the dosage of the oral contraceptive or switch to
another method of contraception
Anti-TB Treatment is same for HIV-infected people as it is for
HIV negative TB patients
DOT assumes greater importance for HIV infected patients
All new TB cases who are known to be HIV positive based
on voluntary sharing of results and/or history of anti-retroviral
therapy are considered to be seriously ill
Patients with TB-HIV should complete their TB treatment prior
to beginning ART (if not already on ART). If patient is already
on ART, it should be modified to be rifampicin-friendly
MDR-TB is drug resistant TB caused due to bacilli resistant to
Isoniazid and Rifampicin, with or without resistance to other
anti TB drugs.
Management of MDR TB is very complex
Prevention of MDRTB rather than its treatment is the priority
under RNTCP

RNTCP at a Glance 19

HOSPITALIZATION OF TB PATIENTS
Some TB patients may need hospitalization during their illness. All indoor
patients are to be treated with RNTCP regimens. The treatment is given using
prolongation pouches which will be supplied by District TB Officer through
the STS of that TU. On discharge, patients may be given a maximum of three
doses (1 week drug supply) to cover the intervening period prior to their
continuation of treatment at their respective DOT Centre, which may/not be
in the same district, hence ensuring no interruption in treatment. All indoor
patients treated under RNTCP, should be registered under the local TU in
which the hospital is located.

Management of Hospitalized patients


Patient is admittted with tuberculosis for indications
like significant haemoptysis, pneumothorax or large
accumulation of pleural fluid leading to breathlessnes

Attending physician prescribes RNTCP regimen using


prolongation pouches

Inform DOT centre of that hospital

Register in the TU, where the


hospital belongs if the patient
is not already registered

If the patient does not reside


in the same TU, on discharge
transfer out to PHI/TU nearest to
his/her residence, to continue and
complete treatment

20 RNTCP at a Glance

If the patient is already


registered, do not re-register.
On discharge send back to
treating PHI to continue and
complete treatment.
If the patient resides in the
same TU, on discharge send
to the PHI nearest to his/her
residence to continue and
complete treatment

SUPERVISORY VISITS
Category of
supervisor

DTO/MO
DTC

Methodology of supervision

Number of supervisory visits

Interview the MO-TC, MO I/C of


PHC-CHC, STS, STLS, LT and
DOT-provider, health personnel of
other sectors (NGO, private etc.)
and the person in-charge of antiTB drug & consumable storage.

Visit all TUs every month and


all DMCs every quarter. Visit all
CHCs and Block PHCs in the
district every quarter, one subcentre from each Block PHC area
and a proportion of treatment
observation centres every
quarter. Conduct supervisory
visit at least 3-5 days a week.
Visit at least three patients at
their homes per visit

Interact with community and


local opinion leaders
Randomly interview patients and
community leaders.
Inspect records of the TU,
PHC and CHC, and stock of
anti-TB drugs and laboratory
consumables.
Randomly check the microscopy
centre and treatment observation
centres.
Interview the MO I/C BPHC/
CHC/PHC.
Randomly interview patients and
community leaders.

MO-TC

Interact with community and


local opinion leaders
Randomly check the microscopy
centre and treatment
observation centre; stock of
anti-tuberculosis drugs and
laboratory consumables.
Interview MPHS and MPWs at
the PHC sub-centre.

STS

Inspect records, Tuberculosis


Treatment Cards and
Tuberculosis Laboratory Register.
Randomly interview patients.

STLS

Inspect all microscopy centres


and laboratory records.

Visit all DMCs every month.


Visit all CHCs/BPHCs/ PHCs
and a proportion of treatment
observation centres at least
once every quarter. Conduct
supervisory visits 7days a
month. Visit at least three
patients at their homes per visit.

Visit all PHIs at least once


every month and all treatment
observation centres once every
quarter. Visit all new sputum
positive patients at their home
within one month of treatment
initiation. Conduct supervisory
visits at least 5 days a week.
Visit all microscopy centres in
the jurisdiction of the TU at least
once a month. Visit all sputum
collection centres at least once
a month.

RNTCP at a Glance 21

22 RNTCP at a Glance
Among new
pulmonary cases,
proportion of smearpositive is <45%

Proportion of smearnegative or extrapulmonary seriously


ill patients given
Category I regimen is
>25%

Expected: Not more than


20% of smear-negative and
extra-pulmonary patients
are considered seriously ill
and placed under Category
I

Re-treatment cases
are >40% of all
smear-positive cases

Ensure that accurate history taking is done at all levels. Patients must be asked carefully about any
prior treatment taken for TB from any source. It should be explained to patients that only if they provide
accurate information can the most effective treatment be given.
Make sure that definitions are applied correctly. Any smear-positive patient treated in the past for more
than one month and has defaulted for more than two months, should receive the re-treatment (Category
II) regimen
Ensure that active case-finding is not being resorted to. With active case-finding, many old TB cases are
reported.
Ensure that history-taking is accurate and definitions are being correctly applied.
Ensure that new symptomatic patients undergo three sputum smear examinations for acid-fast bacilli
(AFB).
Ensure that over-diagnosis of sputum smear-negative patients is not happening due to over reliance on
radiography. No patient should begin treatment without the mandatory three sputum smear examinations.
Ensure that 3 sputum smears are examined for all TB suspects.
Ensure that repeat sputum smear examinations are done for patients who continue to have symptoms
after a course of antibiotics.
Ensure that sputum smear microscopy is done correctly. Review slides of smear negative patients placed
on treatment.
Ensure that only seriously ill patients are given Category I treatment. Non-seriously ill New smear-negative
patients should receive Category III treatment.
Ensure that sputum microscopy is done correctly. Arrange review of slides of smear-negative patients
placed on treatment.

Ensure that no active case-finding is being done in any area.


Ensure that sputum smear microscopy is accurate.
Ensure review of slides of smear-positive patients.
Ensure that only patients who reside in the area are started on treatment, and non-resident patients are
referred for treatment to health facilities in the areas that they reside in.

Annualized
registered number of
new smear-positive
cases is >100%
Re-treatment cases
are <20% of all
smear -positive cases

Possible Actions
Ensure that every TB suspect in all peripheral health facilities undergo sputum smear examination (in at
least 2% of new adult outpatients).
Ensure that 3 sputum smear examinations are done for TB suspects.
Ensure that sputum smear microscopy is done correctly (5%15% positivity is expected among patients
examined for diagnosis). Intensify review of slides read as smear-negative, particularly those of patients
placed on treatment.
Ensure that all smear-positives in the Laboratory Register are started on treatment and registered in the
TB Register.
Ensure that sputum smear microscopy is accessible to patients, and the laboratory technician is trained.

Case Finding Indicators and possible responses to problems


Indicator
Annualized
registered number of
new smear-positive
cases is <50%

Expected: 50% of all new


pulmonary cases will be
smear-positive

Expected: Re-treatment
smear-positive cases
are about 30% of all
smear-positive cases in
initial years of RNTCP
implementation

Quarterly Report
Expected: New smearpositive cases case
detection of 70%

SUMMARY OF KEY INDICATORS AND POSSIBLE CORRECTIVE ACTIONS

RNTCP at a Glance 23

Indicator
Less than 85% of
New smear-positive
patients are documented
to become sputum smearnegative at 3 months

Quarterly Report

Expected:
Conversion rate is >90% of
new smear-positive patients at 3
months

Ensure that Medical Officers, treatment supervisors, and all other staff involved in the
programme at peripheral centres understand the importance of follow-up sputum examinations.
Follow-up sputum examinations are the best measure of patient response to treatment.
Conversion of sputum at the end of IP increases patient confidence and is critical to
programme evaluation.
Visit all centres with low sputum conversion rate and resolve any problem with the help of the
staff.
Make sure default rates in the first two months are <5%, and the number of patients who die
or transferred out are minimized.
Ensure that accurate history-taking takes place at all levels. Patients must be asked carefully
about any prior treatment for TB from any source. It should be explained to patients that only
if they provide accurate information can effective treatment be given. If previously treated
patients are not placed on the re-treatment regimen, they may not respond well to treatment.
Make sure that definitions are applied correctly. Any smear-positive patient treated for more
than one month in the past and with a default of more than two months, should receive the
re-treatment (Category II) regimen.
Ensure that sputum microscopy is accurate. Ensure review of slides of patients who remained
smear positive at the end of the intensive phase.
Ensure that every dose of medication is observed during the intensive phase of treatment.
Observation sites should be convenient to the patient. The quality of DOTS should be checked
at the time of supervision, including checking of entries in the Treatment Cards with the drugs
available in patient-wise boxes.

Possible Actions

Sputum Conversion Indicators and possible responses to problems

24 RNTCP at a Glance
Cure rate of

Expected: Cure rate


for new smear-positive
cases is 85%

Review information on patients who died to determine reasons.


If patients are presenting for treatment when already moribund, consider ways and means to encourage
more prompt referral and diagnosis so that patients can be treated earlier in the course of their TB illness.

positive patients who


die during treatment is
>5%

Ensure that every dose of medication is observed during the intensive phase of treatment, and at least one
dose per week in the continuation phase. Observation sites should be convenient to the patient.

Proportion of new
smear-

Expected: Not more


than 4% of new smearpositive patients die
during treatment

In-spite of all the above, if the death rate is still more than 5%, consider evaluation of the prevalence of HIV
infection among TB patients, to be done strictly as per policy with safeguards of confidentiality.

Carefully review the patient data for accuracy and to ensure that treatment is being given under direct
observation as per policy.

Locate patients who have recently completed treatment and obtain sputum samples for examination.

Sensitize the Medical Officers and other health staff about the importance of follow-up sputum
examinations.

Ensure that follow-up sputum examinations are done as per policy. Carefully track this at all treatment units.

Proportion of new
smear- positive
patients who are
classified as having
completed treatment
is >5%

Check for the accuracy of the report. Make sure that Result of Treatments are correctly recorded and
reported. All diagnosed smear-positive patients started on treatment should be registered.

Ensure that follow-up sputum smear examinations are done according to guidelines.

Ensure that health workers are dispensing medication properly as per technical guidelines.

Ensure that every dose of medication is observed during the intensive phase of treatment, and at least one
dose per week in the continuation phase. Ensure return of empty blister packs during weekly collection of
drugs. Observation sites should be convenient for the patient.

Make sure that definitions are applied correctly. Any smear-positive patient treated for more than one month
in the past, with default of more than two months, should receive the re-treatment (Category II) regimen.

Ensure that accurate history-taking takes place at all levels. Patients must be asked carefully about any prior
treatment for tuberculosis taken from any source. It should be explained to patients that only if they provide
accurate information can the most effective treatment be given. If previously treated patients are not given
the re-treatment regimen, they may not respond well to treatment.

Visit centres with low cure rates to discuss with patients and staff the reasons for low cure rate and
possible solutions.

Possible Actions

Expected: Not more


than 3% of new smearpositive patients are
given the

Cure rate of new


smear- positive CAT I
patients is >95%

is <80%

new smear-positive
patients

Indicator

Quarterly Report

Result of Treatment Indicators and possible solution to problems

RNTCP at a Glance 25

positive Category I

who are Transferred

Transferred out is <3%


out is >5%

Proportion of patients

Expected:

patients is >8%

Default rate of smear-

Default rate is <5%

>5%

who fail treatment is

Proportion of new
smear-positive patients

Expected

Failure: Not more than


4% of new smearpositive patients
continue to be smearpositive at 5 months or
later from the start of
treatment

Expected:

Ensure the receipt of results of follow up sputum examinations and treatment

Transfer out can be a way of disguising default. Patients should be categorized as Transferred out only if
they have been given a Transfer Form to be taken to the facility where they are transferred to.

Ensure that directly observed treatment is given to patients in the intensive phase and at least one dose per
week is directly observed during the continuation phase.

During the visit to the house for verification of address, note the name and address of a person who can be
contacted in the event the patient defaults.

Ensure that patient history is carefully ascertained, including the address. A visit to patients home should
be made to verify address and landmarks near the house should be recorded in the Treatment Card. Services
should be convenient to the patient in terms of distance, time and staff attitudes.

Visit centres which have reported the highest default rates and interview staff and patients to determine the
efforts made to retrieve patients, the reasons for default and possible solutions. Make sure that centres are
aware of their default rate so that they can take steps to reduce it.

In-spite of all the above, if the failure rate remains higher than 5%, consider evaluation of the level of primary
drug resistance in the community.

Ensure that drugs are of acceptable quality, stored in appropriate conditions and are used before the expiry
period.

Ensure that health workers are dispensing medication properly as per technical guidelines.

Ensure that every dose of medication is observed during the intensive phase of treatment and at least one
dose per week in the continuation phase. Ensure return of empty blister packs during weekly collection of
drugs in the continuation phase. Observation sites should be convenient to the patient.

Make sure that definitions are applied correctly. Any smear-positive patient treated for more than one month
in the past, with default of more than two months, should receive the re-treatment (Category II) regimen.

Ensure that accurate history-taking is done at all levels. Patients must be asked carefully about prior
treatment for tuberculosis from any source. It should be explained to patients that only if they provide
accurate information can the most effective treatment be given. If previously treated patients are not given
the re-treatment regimen, they may not respond well to treatment.

26 RNTCP at a Glance
Nos. of NSP cases registered in the quarter / Total Nos. of new pulmonary (NSP+NSN) cases
registered in the same quarter X 100
Nos. of new extrapulmonary cases registered / Nos. of new cases registered (NSP+NSN+new
extra pulmonary) X 100
Total Nos. of smear positive retreatment cases (Relapse, Failure, Treatment after default, Others)
registered / Total Nos. of smear positive cases (new smear positive pulmonary cases + smear
positive retreatment cases) X 100
Total Nos. of new pediatric cases registered (new smear positive pulmonary pediatric cases + new
smear negative pulmonary pediatric cases + new extra pulmonary pediatric cases) / Total Nos. of
new cases registered (NSP+NSN+ new extrapulmonary) X 100
Nos. of sputum positive patients put on RNTCP DOTS during the quarter in the district / (Nos.
of sputum positive patients diagnosed during the respective quarter Nos. of sputum positive
patients referred for treatment outside the district) X 100
Nos. of sputum positive patients put on RNTCP Non-DOTS during the quarter in the district / (Nos.
of sputum positive patients diagnosed during the respective quarter Nos. of sputum positive
patients referred for treatment outside the district) X 100
Nos. of sputum positive patients diagnosed who are neither put on RNTCP DOTS or RNTCP
Non-DOTS in the district, or referred for treatment outside the district / (Nos. of sputum positive
patients diagnosed during the respective quarter Nos. of sputum positive patients referred for
treatment outside the district) X 100
Nos. of sputum positive patients diagnosed started on treatment with in 7 days of diagnosis / Total
Nos. of sputum positive patients diagnosed X 100
Nos. of sputum positive patients diagnosed and started on treatment under RNTCP, who are
registered within 1 month of diagnosis / Total Nos. of sputum positive patients diagnosed X 100
Nos. of interviewed NSP cases who received DOT as per guidelines (>21/24 doses)/ Total Nos. of
NSP cases interviewed X 100

Nos. of NSP cases registered during the quarter having an outcome cured, who had their end of
treatment sputum examined within 7 days of last dose/ Total Nos. of NSP cases registered during
the respective quarter with treatment outcome as cured X 100

% new smear positive out of


total new pulmonary cases

% of new extra pulmonary


cases out of all new cases

% of retreatment cases out of


all smear positive cases

% of pediatric cases out of all


new cases

% smear positive patients


living in the district placed on
DOTS

% of smear positive patients


placed on Non-DOTS treatment
regimen

% of initial defaulters

% of new smear positive cases


started on RNTCP DOTS within
7 days of diagnosis

% of new smear positive cases


registered within one month of
diagnosis

% of interviewed new smear


positive cases who received
DOT during Intensive Phase as
per guidelines

% of cured NSP cases having


end of treatment follow-up
sputum done within 7 days of
last dose

NSP- New Smear Positive; NSN- New Smear Negative

Formula

Indicators

New Indicators

Data obtained from TB


register

Data obtained from


Patients interviews during
supervisory field visits

Data obtained from TB


register

Data obtained from TB


register

Expected value less than


5%

Expected value > 95%

Expected value is 1015%

Expected value is 50%.

Comments

RNTCP at a Glance 27

Due dates for reports from Tuberculosis Units to


DTC in the year 2006
Due On

7 January 2006

7 April 2006

7 July 2006

7 October 2006

Quarterly Report on

Period Covered

Case Finding

1 October 31 December 2005

Programme Management

1 October 31 December 2005

Sputum Conversion

1 July 30 September 2005

Results of Treatment

1 October 31 December 2004

Case Finding

1 January 31 March 2006

Programme Management

1 January 31 March 2006

Sputum Conversion

1 October 31 December 2005

Results of Treatment

1 January 31 March 2005

Case Finding

1 April 30 June 2006

Programme Management

1 April 30 June 2006

Sputum Conversion

1 January 31 March 2006

Results of Treatment

1 April 30 June 2005

Case Finding

1 July 30 September 2006

Programme Management

1 July 30 September 2006

Sputum Conversion

1 April 30 June 2006

Results of Treatment

1 July 30 September 2005

The District TB Officer is to retain one copy of records and send the quarterly reports to the state TB Officer.

All reports to reach Central TB Division by the 24th of the month. Reports to be sent to
quarterlyreports@tbcindia.org

You might also like