Directly observed Treatment short course

(DOTS)
Reach the
Unreached

History of antituberculous
drugs
Bedaquiline
(2012)

TB Burden in India
Incidence: 2.2 million new TB cases annually 176 cases
per 100,000 population
Prevalence: 2.8 million cases - 230 cases per 100,000
population
Deaths: About 270,000 deaths each year - 22 deaths per
100,000 population
Approximately 5% of TB patients estimated to be HIV +ve
DR-TB (Drug resistant-TB)
2.2% in New cases and
15% in previously treated cases
Indian J Tuberc 2014; 61: 30 - 34

Evolution of TB Control in
India

1950s-60s
Important TB research at TRC and
NTI
1962
National TB Programme (NTP)
1992

Programme Review
only 30% of patients diagnosed;
of these, only 30% treated successfully

1993
1998

RNTCP pilot began

2001
2004

450 million population covered

2006

Entire country covered by RNTCP

RNTCP scale-up
>80% of country covered

NTF Presentations for RNTCP

th

Goals and objectives of

RNTCP
Goal
Decrease mortality and morbidity due to TB
and cut transmission of infection until TB
ceases to be a major public health problem in
India.

Objectives:
Achieve and maintain cure rate of at least 85%
in new sputum positive pulmonary TB patients.
Achieve and maintain detection of at least
70% of such cases.

WHO STOP-TB Strategy,

2006
1. Pursue high-quality DOTS expansion and
enhancement
2. Address TB-HIV, MDR-TB, and the needs of
poor and vulnerable populations
3. Contribute to health system strengthening
based on primary health care
4. Engage all care providers
5. Empower people with TB, and communities
through partnership
6. Enable and promote research

Components of DOTS
Political and administrative
commitment
Good quality diagnosis, primarily by
sputum smear microscopy
Uninterrupted supply of good quality
drugs
Supervised treatment to ensure the
right treatment
Systematic monitoring and
accountability

Short course chemotherapy

Intensive phase - objective is to achieve rapid
killing of actively multiplying bacteria
Continuation Phase - objective is to ensure
elimination of persisters which are responsible
for relapses

Intermittent regimens- lag

period
After a culture is exposed to certain drugs for
some time, it takes several days before new
growth occurs
No need to maintain blood levels of drugs for
24 hours

Identification of pulmonary TB suspects

Individual having cough of 2 weeks or more

Contacts of smear-positive TB patients having cough of

any duration
Suspected/conrmed extra-pulmonary TB having cough
of any duration
HIV positive patient having cough of any duration

Treatment

Case definitions
New case
A TB patient who has never had treatment for TB
or has taken anti-TB drugs for less than one month

Relapse
A TB patient who was declared cured or treatment
completed by a physician and who reports back to
the health facility and is now found to be sputum
smear-positive

Case definitions
Treatment failure
Any TB patient who is smear-positive at 5 months or
more after initiation of treatment.

Defaulter / Lost to follow up

A patient, who has received treatment for TB for a
month or more from any source and returns for
treatment after having defaulted i.e., not taken anti-TB
drugs consecutively for two months or more and found
to be smear-positive

Case definitions
Chronic : A patient who remains
smear-positive after completing
regimen for previously treated but not
initiated on MDR-TB treatment
Others- A patient who does not fit into
the any of the types mentioned above.
The reasons for labeling a patient
under this type must be specified in
the Treatment card and TB Register

Treatment Regimens

Drug dosages for adults in blister packs

Patient wise Drug Boxes

Red - New
Blue - Previously
treated

Patient wise Drug Boxes

New cases - 78 doses

Previously treated cases - 102 doses

CASE DEFINITIONS
Cured
A pulmonary TB patient with bacteriologically confirmed
TB at the beginning of treatment who was smear- or
culture-negative in the last month of treatment and on at
least one previous occasion.
Completed treatment
A TB patient who completed treatment without evidence
of failure but with no record to show that sputum smear or
culture results in the last month of treatment and on at least
one previous occasion were negative, either because tests
were not done or because results are unavailable

CASE DEFINITIONS

Died
A patient who died from any cause during
treatment.

Failed
A TB patient whose sputum smear or culture is
positive at month 5 or later during treatment

Successfully treated
A patient who was cured or who completed
treatment.

CASE DEFINITIONS

Not evaluated
A TB patient for whom no treatment outcome is
assigned. This includes cases transferred out to
another treatment unit as well as cases for whom
the treatment outcome is unknown to the reporting
unit.

WHY DOTS ?

Prevent patients from interrupting treatment

Ensures - right drugs, right doses, right duration
Intensive phase - all doses are given to the patients
under direct observation
Continuation phase - first dose of the week under
direct observation

Treatment related information

Role of rest, special diet and isolation
Cough hygiene and sputum disposal
Provision of transfer facility to other TU / state during
treatment
Referral for HIV counselling and testing
Adherence to follow-up schedules

Treatment related information

Treatment related information

Patient protected from both passive and active smoking.

Patient should refrain from alcohol as it would increase the

chances of patient developing hepatitis (jaundice),

irregularity in drug intake and adverse treatment outcome.
Screening symptomatic contacts and children below 6 year

Patients who interrupt treatment

Responsibility of curing the patient lies with the
program and not the patient
Home visit should be made by the DOTS provider,
not later than the day after the patient was due to
come for treatment in IP and within a week of missed
dose in CP
Efforts to be made to convince the patient to restart
the treatment
Concerned supervisory staff at sub-district level (TU)
should be informed, if efforts by DOT provider prove
to be futile

Follow up sputum examinations

Done at
End of Intensive phase
End of extended Intensive phase (if
applicable)
Two months into Continuation phase
End of treatment

Two sputum samples are to be collected.

IMPACT OF DOTS
Tuberculosis incidence per lakh population has
reduced from 216 in year 1990 to 176 in 2012.
Tuberculosis prevalence per lakh population
reduced from 465 in year 1990 to 230 in 2012.
In absolute numbers, prevalence has reduced
from 40 lakhs to 28 lakhs annually.
Tuberculosis mortality per lakh population has
reduced from 38 in year 1990 to 22 in 2012.
In absolute numbers, morality due to TB has
reduced from 3.3 lakhs to 2.7 lakhs annually

Limitations
High level of relapse 11 % observed with
DOTS
Thomas A et al Int J Tuberc Lung Dis

Areas of H resistance and HIV co-infection

higher relapse rates observed
GS Azhar DOTS for TB relapse in India

CHALLENGES
Insufficient public sector Drug Resistant TB diagnosis
and treatment
Poor quality of diagnosis in private sector
Lack of information about patients diagnosed in
private sector
ATT drugs available without prescription and its
irrational use

SPECIAL SITUATIONS
Hospitalization
Treated with RNTCP regimens supplied by DTO
On discharge can be given a maximum of 3 doses
Registered under the local TU in which indoor
facility is located
On discharge is transferred out for continuing
treatment

SPECIAL SITUATIONS
Pregnancy
Streptomycin not given
Breast feeding should continue
Advise her to cover mouth if she is smear positive
Chemoprophylaxis is recommended for baby if
mother is sputum positive

SPECIAL SITUATIONS
Renal failure
Rifampicin, isoniazid and pyrazinamide safe
Streptomycin and Ethambutol closely monitored
with reduced dosage

Women on OCPs
Switch to another method of contraception

EXTRA PULMONARY TBTB

10 to 15 % of all new cases
Out of them 75 % have lymph node or pleural TB
DOTS regimen of six to nine months recommended
HRZS in place of HRZE in TB meningitis
Steroids useful in TB meningitis and pericardial TB

STCI-2014
Chest X-Ray should be used as a
screening tool to increase the sensitivity
of the diagnostic algorithm
TST and IGRA are not recommended
for the diagnosis of active tuberculosis.
CB-NAAT (cartridge-based nucleic-acid
amplification test) is the preferred first
diagnostic test in children and PLHIV.

STCI-2014
Presumptive TB patients without
microbiological confirmation but with strong
clinical and other may be diagnosed as
Probable TB and should be treated.
The continuation phase should consist of
three drugs (HRE) given for at least four
months
The duration of continuation phase may be
extended by three to six months in special
situations

STCI-2014
All patients should be given daily
regimen under direct observation
Follow up sputum microscopy at
completion of intensive phase and
completetion of Rx
Extension of intensive phase not
recommended
Offer DST if sputum positive on
follow-up
Long term follow up