RNTCP orientation lecture (Updated) delivered on 03/08/2015.

1. RNTCP
Dr. Gyanshankar Mishra
MD (Pulmonary Medicine) DNB(Respiratory Diseases)
Assistant Professor
Dept. of Pulmonary Medicine, GMC Nagpur

2. In our country…

3. Why is orientation to TB care important to us?

6. RNTCP
Treatment
o Objectives of TB treatment
o Basis of TB treatment
o Case definitions
o Treatment regimens
o Special situations
o Directly Observed Treatment (DOT)
o Monitoring of patients
o Treatment outcome
o Advanced categories under RNTCP – CAT IV & CAT V

7. o The objectives of RNTCP are to achieve
and maintain a cure rate of at least 85%
among new sputum smear-positive
cases and to achieve and maintain
detection of atleast 70% of such cases in
the population.

8. Basis of TB treatment
o Intermittent (thrice weekly) treatment
regimens
o Treatment given under direct observation
o Standardized treatment regimens in two
categories
o Regimen decided by MO on basis of
o Sputum smear results
o History of previous anti-TB treatment

9. 1.Political
and
administra
tive
commitme
nt
2.Good
quality
diagnosis,
primarily
by sputum
smear
microscop
y
3.Uninterr
upted
supply of
good
quality
drugs
4.Directly
observed
treatment
(DOT)
5.Systemat
ic
monitoring
and
accountabi
lity
Components of DOTS

10. o A pulmonary TB suspect is defined as:
An individual having cough of 2 weeks or more
Contacts of smear-positive TB patients having cough of any duration
Suspected/confirmed extra-pulmonary TB having cough of any duration
HIV positive patient having cough of any duration

12. Sputum AFB smear Lab referral form

13. o Pulmonary Tuberculosis, Smear-Positive
o TB in a patient with atleast one smear-positive
for AFB out of the two initial sputum smear
examination by direct microscopy
o Pulmonary Tuberculosis, Smear Negative
o A patient with symptoms suggestive of TB with
two smear examination negative for AFB, with
evidence of pulmonary TB by microbiological
methods (culture positive or by other
approved molecular methods) or Chest Xray is
classified as having smear negative pulmonary
tuberculosis

14. o Extra Pulmonary Tuberculosis
o Tuberculosis in any organ other than lungs
(eg. pleura, lymph nodes, intestine, genitor-
urinary tract, joint and bones, meninges of
the brain etc).
o The diagnosis should be based on strong
clinical evidence with the following
investigations
o Smear/Culture from extrapulmonary sites
o Histopathological examination or
o Radiological examination or
o Biochemical and cytological examination
including FNAC

15. Case definitions
o NEW
o A TB patient who has never had treatment
for TB or has taken anti-tuberculosis drugs
for less than one month
o RELAPSE
o 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.

16. Case definitions (contd)
o TRANSFERRED IN
o 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.
o TREATMENT AFTER DEFAULT
o 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.

17. Case definitions (contd)
o FAILURE
o Any TB patient who is smear positive at 5
months or more after starting treatment.
o CHRONIC
o A TB patient who remains smear-positive
after completing a re-treatment regimen but
has not been initiated on MDR TB treatment
o OTHERS
o TB patients who do not fit into the above
mentioned types. Reasons for putting a
patient in this type must be specified

18. Which bacilli are acted upon by the ATT drugs?

19. Treatment Regimens
Category of
Treatment
Type of Patient Regimen*
Category I All new pulmonary (smear-positive and
negative), extra pulmonary and ‘others’ TB patients.
2H3R3Z3E3+
4H3R3
Category II TB patients who have had more than one month
anti-tuberculosis treatment previously
Relapse , Failure, Treatment After Default ,Others
2H3R3Z3E3S3 +
1H3R3Z3E3 + 5H3R3E3

20. Basis for Regimens
CAT I: New sputum smear Positive patients,
high bacillary population, chances for
naturally occurring resistant mutants
higher,therefore 4 drugs in intensive phase
CAT II: Because of previous treatment,
chances of harboring resistant bacilli
are higher; hence 5 drugs in IP and total
duration of treatment is 8 months.In
continuation phase lower bacterial
population;hence less chance of resistant
organisms, therefore 3 drugs are enough.

21. Regimen for Non-DOTS treatment in RNTCP Areas
o Self administered non
rifampicin containing regimen
o Needed in few cases of
adverse reaction to rifampicin
and pyrazinamide
o Upto a maximum of 1% of
patients may get Non-DOTS
treatment in an RNTCP area.
o Tuberculosis treatment card
to be filled for these patients
as well

22. Regimen for Non-DOTS treatment in RNTCP Areas
Treatment Regimen
Non-DOTS Regimen 2HSE+10 HE

23. DOTS in the context of HIV
DOTS can:
o Prolong and improve the quality of life.
o Prevent emergence of MDRTB.
o Stop the spread of TB.
o Reverse the trend of MDRTB.
o In the context of HIV, failure to use DOTS
can result in - rapid spread of disease -
tripling of cases - increased drug resistance.

24. Special situations
o Hospitalization
o general policy is treatment on ambulatory
basis.
o Indoor treatment adviced if general
condition of patient is serious
o Pneumothorax
o Massive haemoptysis
o Large pleural effusion
o Treatment with prolongation pouches
supplied by DTO of the district in which
hospital is situated.

25. Special Situations (contd)
o Pregnancy and post natal period
o Streptomycin not to be given. Other drugs in
RNTCP are safe
o Breast feeding should continue
o Chemoprophylaxis for baby if mother is smear
positive
o Renal failure
o Rifampicin, isoniazid and pyrazinamide can be
given
o Streptomycin and ethambutol require close
monitoring

26. Directly observed
treatment (DOT) is
one element of the
DOTS strategy
An observer watches
and helps the patient
swallow the tablets
Direct observation
ensures treatment for
the entire course
• with the right drugs
• in the right doses
• at the right
intervals
Directly Observed Treatment

27. DOTS Strategy
A strategy to ensure treatment completion in
which
o Treatment observer (DOT provider) must be
accessible and acceptable to the patient and
accountable to the health system
o DOT provider administers the drugs in
intensive phase.
o Ensures that the patient takes medicines
correctly in continuation phase.
o Provides the necessary information and
encouragement for completion of treatment.

28. A suitable DOT provider and DOT center is selected in
consultation with patient
Tuberculosis Treatment Card is accurately and
completely filled after initial home visit
Initial counseling at the health facility and at patients
home is important to achieve treatment compliance
Ensure that treatment is being directly observed for
all doses of the intensive phase and the first of the
thrice weekly dose in the continuation phase
Drug administration

29. Drug doses in RNTCP

30. Remember the correct doses of anti TB Drugs!

31. Why are correct doses important?
Ref: Mishra G, Mulani J. Tuberculosis Prescription Practices In Private And
Public Sector In India. NJIRM. 2013; 4(2): 71-78.

32. Why are correct doses important?
Ref: Mishra G, Mulani J. Tuberculosis Prescription Practices In Private And
Public Sector In India. NJIRM. 2013; 4(2): 71-78.

33. Pediatric weight bands

34. Streptomycin injections should be
given
• After oral drugs are administered
• With disposable syringes and
needles
• First dose after sensitivity testing
Chemoprophylaxis to be given to
children (under 6 years of age) of
smear-positive patients
Patients missing doses should be
traced and put back on treatment
• Within one day in intensive phase
• Within one week in continuation
phase
Drug administration(contd)

35. Monitoring of Treatment
o Follow up sputum
microscopy determines
o Conversion rate
o Cure rate
o Sputum smear microscopy
schedule
o Initial sputum examination
o End of Intensive phase of
treatment
o 2 months into Continuation
phase of treatment
o End of treatment

36. Cat.
of Rx
Pre–Rx
Sputum
Test at
month
If:
result
Then
Cat–1
+ 2 - C.P. – Sputum at 4 & 6 m
+ I.P. for 1month, Sp. At 3, 5 & 7
- 2
- C.P. Sputum at 6 months
+ I.P. for 1 month, SP. at 3, 5 & 7
Cat–II + 3 - C.P. Sputum at 5 & months
+ I.P. for 1 month, Sp. at 4, 6 & 9
Schedule of follow-up sputum smear
examination

37. 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.
• 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.
• Extra-pulmonary TB patient who has received a full course of treatment and
has not become smear-positive during or at the end of treatment
Treatment Outcomes

38. Treatment Outcomes
o DIED
o Patient who died
during the course of
treatment regardless
of cause
o FAILURE
o Any TB patient who is
smear positive at 5
months or more after
starting treatment.

39. 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

40. DRUG RESISTANT TB

41. Drug resistant TB

42. We need to screen drug resistant suspects
Why?
Previously when drug resistant suspects were not screened under the
programme then drug resistant TB cases were left undiagnosed in the
programme!

43. For all practical purposes, all
retreatment cases, HIV-TB cases, TB
cases who are contacts of known MDR
TB case and new cases which are
smear-positive at two months or later
can be suspected to have MDR-TB.
Who are MDR TB Suspects?

44. Advanced RNTCP Regimes
Drug Resistant TB (PMDT)
o MDR TB – Resistant to
INH & Rifampicin

45. CAT IV – MDR TB
INITIAL INTENSIVE PHASE : 6- 9 months
o Inj. Kanamycin
o Tab Ethionamide
o Tab Ofloxacin
o Tab. Pyrazinamide
o Tab. Ethambutol
o Cap Cycloserine
CONTINUATION PHASE : 18 months
o Tab Ethionamide
o Tab Ofloxacin
o Tab Ethambutol
o Cap Cycloserine

46. CAT V- XDR TB
o XDR TB- MDR TB+ Resistant to Second
line injectable Anti TB drug &
Fluroquinolone

47. CAT V- XDR TB
The Intensive Phase (6-12 months) will
consist of 7 drugs Capreomycin (Cm),
PAS, Moxifloxacin (Mfx), High dose-
INH, Clofazimine, Linezolid, and
Amoxyclav
The Continuation Phase (18 months) will
consist of 6 drugs –
PAS, Moxifloxacin (Mfx), High dose-INH,
Clofazimine, Linezolid, and Amoxyclav

49. Some practical points
o 1. TB is a notifiable disease.
o 2. If you not sure of individualized treatment regime, please do
not start it. Instead you may register the patient under RNTCP.
o 3. Do not start a fluroquinolone to a TB suspect.
o 4.Please do simple sputum microscopy for afb smear for all TB
suspects, rather than directly starting from higher investigations
like CT scan.
o 5. Serological TB tests are banned in India eg. TB IgG and TB
IgM.
o 6. Screen for drug resistant suspects.
o 6. Do not even attempt to treat drug resistant TB, in absence of
requisite training. Refer to specialist/ RNTCP /PMDT.