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Revised National Tuberculosis Control Programme Revised National

Revised National Tuberculosis Control Programme


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

DEFINITIONS: THE REVISED NATIONAL TUBERCULOSIS


CONTROL PROGRAMME 5
DIAGNOSTIC ALGORITHM FOR PULMONARY TB 6
STAINING METHOD 7
Key steps in the preparation and staining of smears 7
Ziehl - Neelsen Staining Method 8
TREATMENT 9
ZONAL ARTIS AND ESTIMATED NSP CASES PER LAKH
POPULATION 9
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
DEFINITIONS: THE REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME
Case definitions Types of cases Treatment outcomes
Pulmonary Tuberculosis, Smear-Positive New Cured
TB in a patient with at least 2 initial sputum smear A TB patient who has never had treatment for Initially sputum smear-positive patient who has
examinations (direct smear microscopy) positive for tuberculosis or has taken anti-tuberculosis drugs for completed treatment and had negative sputum
AFB. less than one month. smears, on two occasions, one of which was at the
Or: TB in a patient with one sputum smear Relapse end of treatment
examination positive for AFB and radiographic A TB patient who was declared cured or treatment Treatment completed
abnormalities consistent with active pulmonary TB completed by a physician, but who reports back to Sputum smear-positive patient who has completed
as determined by the treating MO. the health service and is now found to be sputum treatment, with negative smears at the end of the
Or: TB in a patient with one sputum smear smear positive. intensive phase but none at the end of treatment.
specimen positive for AFB and culture positive for Transferred in Or: Sputum smear-negative TB patient who has
M.tuberculosis. A TB patient who has been received for treatment received a full course of treatment and has not
Pulmonary tuberculosis, Smear-negative into a Tuberculosis Unit, after starting treatment in become smear-positive during or at the end of
TB in a patient with symptoms suggestive of another unit where s/he has been registered. treatment.
TB with at least 3 sputum smear examinations Treatment after default Or: Extra-pulmonary TB patient who has received a
negative for AFB, and radiographic abnormalities A TB patient who received anti-tuberculosis full course of treatment and has not become smear-
consistent with active pulmonary TB as determined treatment for one month or more from any source positive during or at the end of treatment.
by the treating MO followed by a decision to treat and returns to treatment after having defaulted, Died
the patient with a full course of anti-tuberculosis i.e., not taken anti-TB drugs consecutively for two Patient who died during the course of treatment
therapy. months or more, and is found to be sputum smear regardless of cause
Or: Diagnosis based on positive culture but negative positive. Failure
AFB sputum smear examinations. Failure Any TB patient who is smear positive at 5 months
Extra Pulmonary tuberculosis Any TB patient who is smear positive at 5 months or more after starting treatment. Failure also
TB of any organ other than the lungs, such as or more after starting treatment. Failure also includes a patient who was treated with Category
the pleura (TB pleurisy), lymph nodes, intestines, includes a patient who was treated with Category III regimen but who becomes smear positive during
genitourinary tract, skin, joints and bones, meninges III regimen but who becomes smear positive during treatment.
of the brain, etc. treatment. Defaulted
Diagnosis should be based on culture-positive Chronic A patient who has not taken anti-TB drugs for
specimen from the extra-pulmonary site, histological, A TB patient who remains smear positive after 2 months or more consecutively after starting
radiological, or strong clinical evidence consistent completing a re-treatment regimen. treatment.
with active extra pulmonary TB followed by decision
Others Transferred out
of the treating MO to treat with a full course of anti-
TB therapy. TB patients who do not fit into the above mentioned A patient who has been transferred to another
types. Reasons for putting a patient in this type Tuberculosis Unit/District and his/her treatment
Pleurisy is classified as extra pulmonary TB.
must be specified. result (outcome) is not known.
A patient diagnosed with both sputum smear
positive pulmonary and extra pulmonary TB should
be classified as pulmonary TB.

RNTCP at a Glance
5
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

1 Positive Repeat 3 Sputum


Examinations

X-Ray Negative 2 or 3 Positives

Suggestive of TB Negative for TB Sputum Positive


TB (Anti-TB
Treatment)
X-Ray
Sputum Positive
TB (Anti-TB
Treatment)
Negative for TB Suggestive of TB

Non TB Sputum Smear


Negative TB
(Anti-TB Treatment)

6 RNTCP at a Glance
STAINING METHOD
Key steps in the preparation and staining of smears
Step 1
Break a broomstick Pick up the large, yellow purulent Spread evenly onto 2/3
into two portion of sputum Spread evenly of central portion of the
onto 2/3 of central portion of the numbered slide
numbered slide

Step 2 Step 3 Step 4


Air-dry the Fix the dry slide by heating Place the slides in Stain the slides
slide for 15–30 briefly 3–5 times for 3–4 serial order on the with 1% carbol
minutes seconds each time staining rack fuchsin

Step 5 Step 6 Step 7


Heat the slides Let the slides stand Rinse the slides Drain off
from underneath for 5 minutes with tap water excess water
until vapours rise

Step 8 Step 9
Decolourize with 25% sulphuric acid and Rinse away excess Drain off the
let it stand for 2–4 minutes (repeat, letting stain with tap water water
stand for 1–3 minutes, if necessary)

Step 10
Counterstain with 0.1% Gently rinse the slides with Examine the slides under
methylene blue and let tap water, drain the water the microscope examine
stand for 30 seconds off, and allow the slide to dry at least 100 fields.

RNTCP at a Glance 7
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 15–30 minutes.
4. Fix the slide by passing it over a flame 3–5 times for 3–4 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 2–4 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 1–3 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.

8 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
YES
previously
NO
NO YES
Is the patient
seriously ill?**

NO YES

CAT III 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, smear-
negative 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, 95
Punjab, Uttar Pradesh, Chandigarh, Delhi, Uttaranchal
East* Assam, Bihar, Manipur, Meghalaya, Mizoram, 75
Nagaland, Sikkim, Tripura, West Bengal, Andaman &
Nicobar, Arunachal Pradesh, Jharkhand
South* Andhra Pradesh, Karnataka, Kerala, Tamil Nadu, 75
Pondicherry, Lakshadweep
West Goa, Gujarat, Madhya Pradesh, Maharashtra, 80
Rajasthan, Dadra & Nagar Haveli, Daman & Diu,
Chhattisgarh
State specific Orissa 85

RNTCP at a Glance 9
TREATMENT CATEGORIES AND SPUTUM EXAMINATION SCHEDULE
TREATMENT REGIMEN SPUTUM EXAMINATIONS FOR PULMONARY TB
Category of Type of patient Regimen* Pre-treatment Test at If result Then
Treat ment sputum month is
(end IP)

New sputum smear-positive 2H3R3Z3E3 +


Start continuation phase, test sputum again at
4H3R3
– 2 months in CP (4 months) and at the end of
treatment (6 months)

2 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
Category I months)†
Seriously ill** sputum smear-negative Start continuation phase, test sputum again at

10 RNTCP at a Glance
Seriously ill** extra-pulmonary –
the end of treatment (6 months)
Continue Intensive phase for one more
– 2 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)†
Sputum smear-positive Relapse 2H3R3Z3E3S3 +
Start continuation phase, test sputum again at
Sputum smear-positive Failure 1H3R3Z3E3 +
5H3R3E3 – 2 months in CP (5 months) and at the end of
Sputum smear-positive Treatment after treatment (8 months)
default 3
Category II Others*** + 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)
New sputum smear-negative, 2H3R3Z3 +
Start continuation phase, test sputum again at
not seriously ill 4H3R3 2 –
the end of treatment (6 months)
Category III New extra-pulmonary, not seriously ill –
Re-register the patient and begin Category II
+
treatment†

* 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.
MEDICATION
Medication Dose (thrice a week)*** Number of pills in
combipack
Isonazid 600mg 2
Rifampicin 450mg* 1
Pyrazinamide 1500mg 2
Ethambutol 1200mg 2
Streptomycin 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 Duration (number of doses) Total
Intensive Phase (IP) Continuation Phase (CP)
Category I 8 weeks (24 doses) 18 weeks (54 doses) 26 weeks (78 doses)
Category II 12 weeks (36 doses) 22 weeks (66 doses) 34 weeks (102 doses)
Category III 8 weeks (24 doses) 18 weeks (54 doses) 26 weeks (78 doses)

Duration if sputum is positive at end of Intensive Phase*


Category Duration (number of doses) Total
Intensive Phase (IP) Continuation Phase (CP)
Category I 12 weeks (36 doses) 18 weeks (54 doses) 26 weeks (90 doses)
Category II 16 weeks (48 doses) 22 weeks (66 doses) 34 weeks (114doses)
* Cat I – at the end of 2 months Cat II – at the end of 3 months

Regimen for non-DOTS in RNTCP areas


Treatment Type of Patient Regimen
Non-DOTS Regimen 1 New smear-positive pulmonary Seriously ill 2 HSE + 10 HE
(ND 1) sputum smear-negative
Seriously ill extra-pulmonary
Non-DOTS Regimen 2 Smear-negative pulmonary, not seriously ill 12 HE
(ND 2) Extra-pulmonary, not seriously ill
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 Length of Do a Result of Outcome Re- Treatment
received interruption sputum sputum registration
before Smear Smear
interruption examination examination

Less than No __ __ __ Resume


2 months Treatment
and
Complete
All doses
Less than
1 month 2 months or Yes Neg __ __ Resume
more Treatment
Pos Default New Begin CAT I
afresh

Less than No __ __ __ Resume


2 months Treatment
and
Complete
All doses
More than Yes Neg __ __ Resume
More than
2 months Treatment
1 month
and
Complete
All doses
Pos Default Treatment Begin CAT II
After Treatment
Default afresh

12 RNTCP at a Glance
MANAGEMENT OF PATIENTS WHO INTERRUPT TREATMENT

Treatment for New smear-positive cases who interrupt treatment


(Category I)
Treatment Length of Do a Result of Outcome Re- Treatment
received interruption sputum sputum registration
before Smear Smear
interruption examination? examination
Less than Less than No __ __ __ Continue
1 month 2 weeks CAT I*

2-7 weeks No __ __ __ Start again on


CAT I**

8 weeks Yes Positive Default New Start again


or more on CAT I**
Negative __ __ Continue
CAT I*
1-2 months Less than No __ __ __ Continue
2 weeks CAT I*

More than 2-7 weeks Yes Positive __ __ 1 extra month


2 months of intensive
phase of
CAT I
8 weeks or Yes Negative __ __ Continue
more CAT I*

Positive Default Treatment Start on


After CAT II*
Default
Less than No Negative __ __ Continue
2 weeks CAT I*
__ __ __ Continue
CAT I*

2-7 weeks Yes Positive Default*** Other Start on


CAT II**
8 weeks or Negative __ __ Continue
more CAT I*
Yes Positive Default Treatment Start on
After CAT II**
Default
Negative __ __ 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 Length of Do a sputum Result of Outcome Re- Treatment


received interruption Smear sputum registration
before examination Smear
interruption examination

Less than No __ __ __ Continue CAT II*


2 weeks
2-7 weeks No __ __ __ Start again on
Less than CAT II**
1 month
8 weeks Yes Positive Default Treatment Start again on
or more After Default CAT II**
Negative __ __ Continue CAT II*
Less than No __ __ __ Continue CAT II*
2 weeks

2-7 weeks Yes Positive __ __ 1 extra month of


1-2 months intensive phase
of CAT II
8 weeks or Yes Negative __ __ Continue CAT II*
more Positive Default Treatment Start again on
After Default CAT II**
Less than No Negative __ __ Continue CAT II*
2 weeks
__ __ __ Continue CAT II*

2-7 weeks Yes Positive Default*** Other Start again on


More than CAT II**
2 months
8 weeks or Negative __ __ Continue CAT II*
more

Yes Positive Default Treatment Start again on


After Default CAT II

Negative __ __ 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 Negative 2 or 3 Positives

Suggestive of TB Negative for TB Sputum Positive


TB (Anti-TB
Treatment)
X-Ray +
Sputum Positive Mantoux
TB (Anti-TB
Treatment)
Negative for TB Suggestive of TB

Refer to Pediatrician Sputum Smear Negative TB


(Anti-TB Treatment)
Algorithm for Clinical Monitoring of Pediatric TB

Patient on treatment

Review at 2 months, Review at 2 months, non-


satisfactory response satisfactory response assessed
assessed by: by:
– improvement in symptoms – adherence to treatment
– no weight loss and or – weight loss
weight gain – 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 Sputum negative or not


available

Failure – Review diagnosis


– extend IP by 1 month

Category II
No improvement =
Pediatric non-responder

16 RNTCP at a Glance
Dosages for children
Drugs Dosage (Thrice a week)
Isonoazid 10-15mg/kg
Rifampicin 10mg/kg
Pyrazinamide 35mg/kg
Streptomycin 15mg/kg
Ethambutol 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 Any oral medication Reassure patient
upset 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
Reassure patient
Isoniazid (H) (Other
Itching If severe, stop all drugs and refer
drugs also)
patient to MO
Burning in the Give pyridoxine 100 mg/day until
Isoniazid (H)
hands and feet symptoms subside
If severe, refer patient for
Joint pains Pyrazinamide (Z)
Evaluation
STOP ethambutol, refer patient for
Impaired vision Ethambutol (E)
evaluation
Ringing in the STOP streptomycin, refer patient for
Streptomycin (S)
ears evaluation
STOP streptomycin, refer patient for
Loss of hearing Streptomycin (S)
evaluation
Dizziness and STOP streptomycin, refer patient for
Streptomycin (S)
loss of balance evaluation
Isoniazid (H)
STOP all drugs, refer patient for
Jaundice Rifampicin (R)
evaluation
Pyrazinamide (Z)

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 Management
Hospitalization • 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
Tuberculous • Fatal if untreated
meningitis • Patient should be referred to the hospital
• Total duration of treatment is 8–9 months. The continuation
phase should be given for 6–7 months
• Steroids should be given initially and gradually reduced over
6–8 weeks
Treatment of TB • Streptomycin should not be given; other drugs used in RNTCP
during pregnancy are safe
and postnatal • Breast feeding should continue regardless of the mother’s TB
period 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
Treatment in • Rifampicin, isoniazid and pyrazinamide can be safely given
patients with renal • Streptomycin and ethambutol, if given, should be closely
failure monitored with reduced dosage
Treatment in • Rifampicin decreases the efficiency of oral contraceptives;
women taking oral increase the dosage of the oral contraceptive or switch to
contraceptive pills another method of contraception
TB and HIV • 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 • 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 MDR–TB 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 If the patient is already


hospital belongs if the patient registered, do not re-register.
is not already registered On discharge send back to
treating PHI to continue and
complete treatment.

If the patient does not reside If the patient resides in the


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

20 RNTCP at a Glance
SUPERVISORY VISITS

Category of Methodology of supervision Number of supervisory visits


supervisor
Interview the MO-TC, MO I/C of Visit all TUs every month and
PHC-CHC, STS, STLS, LT and all DMCs every quarter. Visit all
DOT-provider, health personnel of CHCs and Block PHCs in the
other sectors (NGO, private etc.) district every quarter, one sub-
and the person in-charge of anti- centre from each Block PHC area
TB drug & consumable storage. and a proportion of treatment
observation centres every
Interact with community and
quarter. Conduct supervisory
local opinion leaders
DTO/MO visit at least 3-5 days a week.
Randomly interview patients and Visit at least three patients at
–DTC
community leaders. their homes per visit
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/ Visit all DMCs every month.
CHC/PHC. Visit all CHCs/BPHCs/ PHCs
and a proportion of treatment
Randomly interview patients and
observation centres at least
community leaders.
once every quarter. Conduct
Interact with community and supervisory visits 7days a
MO-TC local opinion leaders month. Visit at least three
Randomly check the microscopy patients at their homes per visit.
centre and treatment
observation centre; stock of
anti-tuberculosis drugs and
laboratory consumables.
Interview MPHS and MPWs at Visit all PHIs at least once
the PHC sub-centre. every month and all treatment
observation centres once every
Inspect records, Tuberculosis
quarter. Visit all new sputum
STS Treatment Cards and
positive patients at their home
Tuberculosis Laboratory Register.
within one month of treatment
Randomly interview patients. initiation. Conduct supervisory
visits at least 5 days a week.
Inspect all microscopy centres Visit all microscopy centres in
and laboratory records. the jurisdiction of the TU at least
STLS once a month. Visit all sputum
collection centres at least once
a month.

RNTCP at a Glance 21
SUMMARY OF KEY INDICATORS AND POSSIBLE CORRECTIVE ACTIONS
Case Finding Indicators and possible responses to problems
Quarterly Report Indicator Possible Actions
Expected: New smear- Annualized Ensure that every TB suspect in all peripheral health facilities undergo sputum smear examination (in at
positive cases case registered number of least 2% of new adult outpatients).
detection of ≥ 70% new smear-positive Ensure that 3 sputum smear examinations are done for TB suspects.
cases is <50% 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.

22 RNTCP at a Glance
Annualized Ensure that no active case-finding is being done in any area.
registered number of Ensure that sputum smear microscopy is accurate.
new smear-positive Ensure review of slides of smear-positive patients.
cases is >100% 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.
Expected: Re-treatment Re-treatment cases Ensure that accurate history taking is done at all levels. Patients must be asked carefully about any
smear-positive cases are <20% of all prior treatment taken for TB from any source. It should be explained to patients that only if they provide
are about 30% of all smear -positive cases accurate information can the most effective treatment be given.
smear-positive cases in Make sure that definitions are applied correctly. Any smear-positive patient treated in the past for more
initial years of RNTCP than one month and has defaulted for more than two months, should receive the re-treatment (Category
implementation II) regimen
Re-treatment cases Ensure that active case-finding is not being resorted to. With active case-finding, many ‘old’ TB cases are
are >40% of all reported.
smear-positive cases 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).
Expected: 50% of all new Among new Ensure that over-diagnosis of sputum smear-negative patients is not happening due to over reliance on
pulmonary cases will be pulmonary cases, radiography. No patient should begin treatment without the mandatory three sputum smear examinations.
smear-positive proportion of smear- Ensure that 3 sputum smears are examined for all TB suspects.
positive is <45% 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.
Expected: Not more than Proportion of smear- Ensure that only seriously ill patients are given Category I treatment. Non-seriously ill New smear-negative
20% of smear-negative and negative or extra- patients should receive Category III treatment.
extra-pulmonary patients pulmonary seriously Ensure that sputum microscopy is done correctly. Arrange review of slides of smear-negative patients
are considered seriously ill ill patients given placed on treatment.
and placed under Category Category I regimen is
I >25%
Sputum Conversion Indicators and possible responses to problems
Quarterly Report Indicator Possible Actions
Expected: Less than 85% of Ensure that Medical Officers, treatment supervisors, and all other staff involved in the
Conversion rate is >90% of New smear-positive programme at peripheral centres understand the importance of follow-up sputum examinations.
new smear-positive patients at 3 patients are documented Follow-up sputum examinations are the best measure of patient response to treatment.
months to become sputum smear- Conversion of sputum at the end of IP increases patient confidence and is critical to
negative at 3 months 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.

RNTCP at a Glance 23
Result of Treatment Indicators and possible solution to problems
Quarterly Report Indicator Possible Actions
Expected: Cure rate Cure rate of Visit centres with low cure rates to discuss with patients and staff the reasons for low cure rate and
for new smear-positive new smear-positive possible solutions.
cases is ≥85% patients Ensure that accurate history-taking takes place at all levels. Patients must be asked carefully about any prior
is <80% 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.

24 RNTCP at a Glance
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 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.
Ensure that health workers are dispensing medication properly as per technical guidelines.
Ensure that follow-up sputum smear examinations are done according to guidelines.
Cure rate of new Check for the accuracy of the report. Make sure that Result of Treatments are correctly recorded and
smear- positive CAT I reported. All diagnosed smear-positive patients started on treatment should be registered.
patients is >95%
Expected: Not more Proportion of new Ensure that follow-up sputum examinations are done as per policy. Carefully track this at all treatment units.
than 3% of new smear- smear- positive Sensitize the Medical Officers and other health staff about the importance of follow-up sputum
positive patients are patients who are examinations.
given the classified as having
‘completed’ treatment Locate patients who have recently completed treatment and obtain sputum samples for examination.
is >5% Carefully review the patient data for accuracy and to ensure that treatment is being given under direct
observation as per policy.
Expected: Not more Proportion of new Ensure that every dose of medication is observed during the intensive phase of treatment, and at least one
than 4% of new smear- smear- dose per week in the continuation phase. Observation sites should be convenient to the patient.
positive patients die positive patients who Review information on patients who died to determine reasons.
during treatment
die during treatment is If patients are presenting for treatment when already moribund, consider ways and means to encourage
>5% more prompt referral and diagnosis so that patients can be treated earlier in the course of their TB illness.
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.
Expected: Proportion of new Ensure that accurate history-taking is done at all levels. Patients must be asked carefully about prior
Failure: Not more than smear-positive patients treatment for tuberculosis from any source. It should be explained to patients that only if they provide
4% of new smear- who fail treatment is accurate information can the most effective treatment be given. If previously treated patients are not given
positive patients the re-treatment regimen, they may not respond well to treatment.
>5%
continue to be smear- Make sure that definitions are applied correctly. Any smear-positive patient treated for more than one month
positive at 5 months or in the past, with default of more than two months, should receive the re-treatment (Category II) regimen.
later from the start of Ensure that every dose of medication is observed during the intensive phase of treatment and at least one
treatment 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.
Ensure that health workers are dispensing medication properly as per technical guidelines.
Ensure that drugs are of acceptable quality, stored in appropriate conditions and are used before the expiry
period.
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.
Expected Default rate of smear- Visit centres which have reported the highest default rates and interview staff and patients to determine the
Default rate is <5% positive Category I 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.
patients is >8%
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.
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 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.
Transfer out can be a way of disguising default. Patients should be categorized as ‘Transferred out’ only if
Expected: Proportion of patients they have been given a Transfer Form to be taken to the facility where they are transferred to.

Transferred out is <3% who are ‘Transferred Ensure the receipt of results of follow up sputum examinations and treatment

out’ is >5%

RNTCP at a Glance 25
New Indicators
Indicators Formula Comments
% new smear positive out of Nos. of NSP cases registered in the quarter / Total Nos. of new pulmonary (NSP+NSN) cases Expected value is 50%.
total new pulmonary cases registered in the same quarter X 100
% of new extra pulmonary Nos. of new extrapulmonary cases registered / Nos. of new cases registered (NSP+NSN+new Expected value is 10-
cases out of all new cases extra pulmonary) X 100 15%
% of retreatment cases out of Total Nos. of smear positive retreatment cases (Relapse, Failure, Treatment after default, Others)
all smear positive cases registered / Total Nos. of smear positive cases (new smear positive pulmonary cases + smear
positive retreatment cases) X 100
% of pediatric cases out of all Total Nos. of new pediatric cases registered (new smear positive pulmonary pediatric cases + new

26 RNTCP at a Glance
new cases smear negative pulmonary pediatric cases + new extra pulmonary pediatric cases) / Total Nos. of
new cases registered (NSP+NSN+ new extrapulmonary) X 100
% smear positive patients Nos. of sputum positive patients put on RNTCP DOTS during the quarter in the district / (Nos. Expected value > 95%
living in the district placed on of sputum positive patients diagnosed during the respective quarter – Nos. of sputum positive
DOTS patients referred for treatment outside the district) X 100
% of smear positive patients Nos. of sputum positive patients put on RNTCP Non-DOTS during the quarter in the district / (Nos. Expected value less than
placed on Non-DOTS treatment of sputum positive patients diagnosed during the respective quarter – Nos. of sputum positive 5%
regimen patients referred for treatment outside the district) X 100
% of initial defaulters 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
% of new smear positive cases Nos. of sputum positive patients diagnosed started on treatment with in 7 days of diagnosis / Total Data obtained from TB
started on RNTCP DOTS within Nos. of sputum positive patients diagnosed X 100 register
7 days of diagnosis
% of new smear positive cases Nos. of sputum positive patients diagnosed and started on treatment under RNTCP, who are Data obtained from TB
registered within one month of registered within 1 month of diagnosis / Total Nos. of sputum positive patients diagnosed X 100 register
diagnosis
% of interviewed new smear Nos. of interviewed NSP cases who received DOT as per guidelines (>21/24 doses)/ Total Nos. of Data obtained from
positive cases who received NSP cases interviewed X 100 Patients interviews during
DOT during Intensive Phase as supervisory field visits
per guidelines
% of cured NSP cases having Nos. of NSP cases registered during the quarter having an outcome cured, who had their end of Data obtained from TB
end of treatment follow-up treatment sputum examined within 7 days of last dose/ Total Nos. of NSP cases registered during register
sputum done within 7 days of the respective quarter with treatment outcome as cured X 100
last dose
NSP- New Smear Positive; NSN- New Smear Negative
RNTCP at a Glance 27
Due dates for reports from Tuberculosis Units to
DTC in the year 2006
Due On Quarterly Report on Period Covered
Case Finding 1 October – 31 December 2005
Programme Management 1 October – 31 December 2005
7 January 2006
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
7 April 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
7 July 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
7 October 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

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