2. Revised National Tuberculosis Control
Program(RNTCP)
Goal
1. to decrease the mortality and morbidity
2. To cut down the chain of transmission of infection.
Until TB ceases to be a public health problem
Objectives
To achieve and maintain:
1. Cure rate of at least 90% among newly detected
smear positive (infectious) pulmonary TB cases
2. Case detection of at least 85% of the expected new
smear positive PTB cases in the community.
3. Implementation
Case finding- by passive surveillance on patient
with symptoms of
1. Persistent cough for 2weeks or more
2. Haemoptysis
3. Night sweats
4. Evening rise of temperature
5. Chest pain
In lab:
1. Sputum collection for diagnosis
2. Radiography
3. tuberculin test
4.
5. DOTS
Directly Observed Treatment Short Course
Tuberculosis control strategy recommended by the World Health Organisation as the strategy
that ensures cure of TB
6. Directly Observed Treatment Short Course
⢠Directly observed treatment (DOTS)
is one element of the DOTS strategy
⢠An observer watches and help 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
8. Directly Observed Treatment Short Course
Phases
1. Intensive phase(IP):
⢠Intensive phase is of 2-3 months duration
⢠Patient swallow medicine under the
observation of the health worker during IP
⢠Medicine are taken 3 times a week on
alternative days
⢠If the sputum is negative for bacteria after
IP, continuation phase is started
9. Directly Observed Treatment Short Course
2. Continuation phase
⢠This phase is of 4 to 5 month duration
⢠The patient is provided with a weekly blister
pack to take home
⢠The medicines from the blister pack are taken
on alternate days, three time a week and in the
remaining days, vitamin tablets are taken
⢠The first dose of the weekly blister pack is
taken under direct observation of the health
worker
⢠Empty blister packs are collected to ensure that
the medicines are taken at home by the
patient
10. H: Isoniazid(300mg) R: Rifampicin(600mg) Z: Pyrazinamide(1500mg)
E: Ethambutol(1000mg) S: Streptomycin(1000mg)
⢠Patient who weight 60 kg or more receive additional rifampicin 150 mg
⢠Patient who are more than 50 years old receive Streptomycin 500 mg
⢠Patient who weight less than 30 kg receive drugs as per paediatric weight band
boxes according to body weight.
11. Drug Resistant TB
1. Multiple drug resistant TB(MDR-TB)
An MDR-TB suspect who is sputum culture positive and whose TB is
due to Mycobacterium tuberculosis that are resistant in vitro to as least
Isoniazid and Rifampicin.
2. Extensively drug resistant TB(XDR-TB)
Subset of MDR-TB where the bacilli, in addition to being resistant to R
and H, are also resistant to any fluoroquinolones and any one of the
second line injectable drug(namely kanamycin, capreomycin, or
amikacin)
12. Directly Observed Treatment Short Course
For MDR-TB
For 6-9 months of the intensive
phase
â˘Kanamycin
â˘Ethionamide
â˘Ethambutol
â˘Ofloxacin
â˘Pyrazinamide
â˘Cyclomerize
Standard treatment regimen
6 drugs
13. Directly Observed Treatment Short Course
For MDR-TB
Continuation phase
4 drugs
⢠Ofloxacin
⢠Ethionamide
⢠Ethambutol
⢠Cyclomerize
For 18 months
14. National tuberculosis elimination
program(NTEP)
1. To achieve 90% notification rate for all cases
2. To achieve 90% success rate for all new and 85% for re-treatment
cases
3. To significantly improve the successful outcomes of treatment of
DR-TB cases
4. To achieve decreased morbidity and mortality of HIV-associated TB
5. To improve outcome of TB care in the private sector.
15.
16. Changes proposed by NTEP
⢠Daily regimen
⢠Fixed dose combination(FDC)
⢠Weight band
⢠Ethambutol in Cat-I CP
⢠No extension of IP
⢠No Cat-II
17. Why daily regimen?
Relapse rates
⢠Relapse rates are high â more than many high burden countries, over
a period time, in all states
⢠Relapse rates high with treatment interruption but not significantly
different in patients without treatment interruption
⢠Relapse rates are high among NSP TB patients in area with no private
sector presence
⢠Relapse rates are higher with intermittent regimen
18. Why fixed dose combinations (FDC)?
Potential Advantages
⢠Simplicity of treatment
⢠Increased patient acceptance
⢠Fewer tablets to swallow
⢠Prevents âconcealedâ irregularity
⢠Increased health worker
compliance
⢠Fewer tablets to handle, hence
quicker supervision of DOT
⢠Easier drug management
⢠Reduced use of monotherapy
⢠Lower risk of misuse of single
drugs
⢠Lower risk of emergence of drug
resistance
⢠Easier to adjust dosages by body
weight
19. Why Three Drugs (Ethambutol) in
continuation phase (CP) ?
INH resistance
⢠Pre-treatment INH resistance is high (>10%)
⢠Pre-treatment INH resistance lead to amplification of resistance
(acquired rifampicin resistance), leading to MDR
20. Pre-treatment INH resistance
Findings
⢠Out of 227 TB patients, there were a total of 19 (8.4%) bacteriological failures
during treatment. ( 8 in 6 Months regimen and 11 in 9 Months regimen).
⢠All of them had acquired Rifampicin resistance.
⢠9 (47%) of these patients had isolates with initial isoniazid resistance
Swaminathan S et al. 2010, EfďŹcacy of a 6-month versus 9-month Intermittent Treatment Regimen in HIV-infected Patients
with Tuberculosis. A Randomized Clinical Trial. AJRCCM, VOL 181 Pre-treatment INH resistance
HIV-positive patients with pulmonary TB are at higher risk of acquired rifampicin resistance,
when failing a three times weekly short-course intermittent regimen, irrespective of length of
treatment (6 month or 9 month duration)
21. Pre-treatment INH resistance
⢠Patients with pre-treatment isoniazid resistance were 22 times more
likely to acquire drug resistance than patients who started treatment
with drug-susceptible disease. (Menzies D, etal.PLoS Med. 2009; 6(9): e1000146.)
⢠INH resistance in retreatment cases: 47%- 87% ( Paramsivan . 2004)
Ethambutol in continuation phase could protect Rifampicin and
prevent emergence of MDR in patient with Pre-treatment INH resistance
22. WHY WEIGHT BAND ?
⢠RNTCP regimen & body weight of Indian patients
⢠In RNTCP regimens for adults
⢠< 30 kg
⢠30-60 kg
⢠> 60 kg
⢠Dose of INH is inappropriately high for those in the band of 30-40 kg.
⢠Drug toxicity related to INH in underweight patients is possibly one of
the reasons for adverse effects and default.
23. No extension of IP
⢠For new TB cases the treatment in intensive phase will be of 8 weeks.
⢠There will be no need for extension of IP.
⢠Only PZA will be stopped in the CP phase.
⢠Other 3 drugs will be continued for another 16 weeks as daily
dosages.
25. ⢠The CP in both new and previously treated cases may be extended by
12-24 weeks in certain forms of TB like CNS TB, Skeletal TB,
Disseminated TB etc. Based on clinical decision of the treating
physician. Extension beyond 12 weeks should only be on
recommendation of expert of the concerned field; loose drugs would
be need as substitution in case of adverse drug reaction or with co-
morbidity condition.
26. The revised weight band for standard first line
regimen for TB in adults is as given below:
Weight category
(2019)
Number of tablets(FDC)
Intensive phase -4FDC(HRZE)
75/150/400/275
Continuation phase -3FDC(HRE)
75/150/275
25-34 2 2
35-49 3 3
50-64 4 4
65-75 5 5
>75 Kg* 6 6
Patients >75 Kg may receive 5 tablets/day if they do not tolerate this dose
32. How can the patient data be accessed ?
⢠Web dashboard (www.99dots.org)
⢠Every center will be given their own login ID and password to access their
patients
⢠Different logins for ART center, DTC(district TB center) and Field staff (with
limited permissions)
SMS alert for staff abd treatment supports to take immediate action in case of
defalt.
33. Nikshay
⢠Integrated system for TB patient management and care in India
⢠Real-time, case-based, web-based surveillance tool
⢠Unified interface for public and private sector health care provider
⢠Webpage: https://NIkshay.in
⢠Android app
34. Reactions to Drug Therapy
Isoniazid
⢠Asymptomatic elevation in liver enzymes, rare peripheral
neurotoxicity, hepatitis that may, rarely, be fatal
⢠CNS effects (dysarthria, irritability, seizures, dysphoria, diminished
concentration)
⢠lupus-like syndrome, hypersensitivity reactions, and monoamine
poisoning (rarely occurring with consumption of some wines and
cheeses)
⢠Patients with pre-existing liver disease should be monitored closely.
35. Reactions to Drug Therapy
Ethambutol
⢠Retrobulbar optic neuritis with decreased visual acuity and decreased
red-green discrimination in one or both eyes (occurs rarely with daily
doses of 15 mg/kg/day)
⢠Peripheral neuritis and cutaneous reactions
⢠Patients should have baseline visual acuity and color discrimination
(Ishihara test) testing as well as monthly monitoring
36. Reactions to Drug Therapy
Pyrazinamide
⢠hepatotoxicity, GI symptoms, non-gouty-polyarthralgia, asymptomatic
hyperuricemia, acute gouty arthritis
⢠Any anti-TB drug may cause rash.
Rifampin
⢠pruritus with or without rash, GI adverse effects, flu-like symptoms,
hepatotoxicity, rare severe immunologic reactions, orange
discoloration of body fluids
⢠drug interactions with hormonal contraceptives, methadone, warfarin
37. Role of nurse
⢠Administer ordered antibiotics and antitubercular agents.
⢠Isolate the infectious patient in a quiet, properly ventilated room and
maintain TB precautions.
⢠Place a covered trash can nearby, or tape a waxed bag to the bedside
for used tissues.
⢠Tell the patient to wear a mask when outside his room.
⢠Make sure the patient gets plenty of rest.
38. Role of nurse
⢠well-balanced, high-calorie foods, preferably in small, frequent meals
to conserve energy.
⢠Record the patient's weight weekly.
⢠Watch for adverse reactions to the medications.
⢠Administer isoniazid with food. To prevent or treat peripheral neuritis,
give pyridoxine (vitamin B6) as ordered.
⢠If the patient receives ethambutol, Check the patient's vision monthly,
and give this medication with food.
39. Role of nurse
⢠Rifampin, Monitor liver and kidney function tests throughout therapy.
⢠Perform chest physiotherapy, including postural drainage and chest
percussion, several times per day.
⢠Give the patient supportive care
40. Community and home considerations
⢠Improve ventilation in the home by opening windows in room of
affected person, and keeping bedroom door closed as much as
possible.
⢠Instruct patient to cover mouth with fresh tissue when coughing or
sneezing and to dispose of tissues promptly in plastic bags.
⢠Discuss TB testing of people residing with patient.
⢠Investigate factors that may affect compliance with follow-up and
treatment.
⢠Report new cases of TB to public health department for screening of
close contacts and monitoring
41. Patient teaching
⢠coughing and deep-breathing exercises.
⢠Teach the patient the adverse effects of his medication, and tell him
to report them immediately.
⢠Stress the importance of faithfully following long-term treatment
⢠Advise anyone exposed to an infected patient to receive tuberculin
tests and, if a positive reaction occurs, chest X-rays and prophylactic
isoniazid.
42. Patient teaching
⢠Rifampin, urine appear orange; reassure him that this effect is
harmless.
⢠oral contraceptives are less effective while taking rifampin.
⢠medical assessment required if: increased cough, hemoptysis,
unexplained weight loss, fever, and night sweats.
⢠Eat high-calorie, high-protein, balanced meals.
⢠Emphasize the importance of scheduling and keeping follow-up
appointments
Editor's Notes
Phase 1 :1997
Phase 2: 2005
NSP-non sputum positive
Follow up by 6, 12, 18, 24 months
Lupus like symptoms: fever, fatigue, rash, join pain
Retrobulber: behind the eye ball
Peripheral neuritis: weakness, numbness and pain (affect peripheral nerves)