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Private Sector Sensitization.pptx
1. National TB Elimination Programme
Private Sector Sensitization Program
in collaboration with IMA
-Dr Sandip Roy
Sr MO, STDC
GOWB
2. TB Epidemiology –India 2019-2021
Source: WHO Global TB Report 2020, 2021 & 2022
Parameters 2019 2020 2021
Estimated TB incidence 26,40,000 25,90,000 29,50,000
Incidence per 100 000
population 193 188 210
HIV-positive TB incidence 71,000 53000 54000
HIV-negative TB mortality 4,35,500 4,93,000 4,94,000
HIV-positive TB mortality 9500 11000 11000
Total TB Deaths 4,45,000 5,04,000 5,05,000
TB case fatality ratio
(estimated
mortality/estimated
incidence) 17% 20% 17%
Total cases notified 2391022 18,12,643 21,16,976
3. TB BURDEN – COMPARISON WITH OTHER
DISEASES
Tuberculosis is (India)-
• Leading cause of death among communicable diseases- as a single
infectious agent
• 5th leading cause of death among all diseases
Diarrheal
diseases
Tuberculosis
Typhoid
and
paratyphoid
Encephalitis
HIV/AIDS
Maternal
disorders
Meningitis
Malaria
0
200
400
600
800
1000
1200
1400
1600
1800
DALY
per
100000
Deaths attributed to disease
Source: IHME, Global disease burden
4. COMPARISON OF ANNUAL MORTALITY OF INFECTIOUS
DISEASES IN INDIA:
1.MALARIA (2020), 2. DENGUE (2019), 3. HIV (2020) , 4. COVID (2021) & 5.TB (2021)
Data Sources:
1. NVBDCP Report: Countrywide
Epidemiological Situation (1995 –
2020)
2. NVBDCP report: Dengue Cases
and Deaths in the Country since
2015
3. NACO INDIA HIV ESTIMATES
2020
4. India Coronavirus COVID-19
Deaths
(https://tradingeconomics.com/indi
a/coronavirus-deaths)
5. WHO Global TB Report 2022
Malaria, 93
Dengue, 166
HIV,51000
COVID, 32000
TB, 494000
5. GAP BETWEEN ESTIMATES AND NOTIFICATION-
INDIA (NUMBERS IN LAKHS)
28.40 27.90 27.40 26.90
26.40 25.9
29.5
16.67 17.64 17.87
19.94
23.90
18.1
21.2
10.00
15.00
20.00
25.00
30.00
35.00
2015 2016 2017 2018 2019 2020 2021
WHO estimated incident TB cases
GAP
Two significant
causes of the
GAP—
Case presented
with symptom
but remain
undiagnosed
Diagnosed but
NOT notified
Gap has increased in huge proportion due to COVID in 2020
6. PROPORTION OF DRUG SALES IN PRIVATE AND CONSUMPTION IN NTEP-
VS
PROPORTION OF PRIVATE NOTIFICATION
1 1 1 1 1 1
0.8
0.9
0.7
0.5
0.4
0.5
0.02
0.06
0.12
0.18
0.30 0.28
0
0.2
0.4
0.6
0.8
1
1.2
2015 2016 2017 2018 2019 2020
Public Drug Consumption Private Drug Sale Private Notification
IQVIA data- Calculated from Drug sales in private and consumption in NTEP. Notification
We are still missing Notifications from
Private
9. THE STATE STRATEGIC PLAN FOR TUBERCULOSIS ELIMINATION
2020 – 2025
Treat
Prevent
Build
Detect
Find all TB cases
through quality
assured Diagnostics
with an emphasis on
reaching every TB
patient in the private
sector
Treat all TB cases with
high quality anti TB
drugs
Prevent the emergence
of TB in susceptible
populations and stop
catastrophic
expenditure due to TB
Build & strengthen
supportive systems
including enabling
policies, empowered
institutions & human
resources
10. 100% Notification from the entire
Private Sector
Registration in TB Surveillance
portal (Nikshay)
Notification can be done in 3 ways—
A) Using registered ID in Nikshay directly
B) Through Patient Provider Support
Agencies
C) Inform District TB officer in prescribed
format
Use Molecular Diagnostic
Technology. Establish
Microbiological confirmation
All TB cases has to undergo Drug
Susceptibility testing
Nikshay records all events of a TB
patient, hence has to be updated
real time regularly)
Scale up of
Technology
Govt Sector-
WB
2021
Microscopy 1029
Rapid Molecular
Test
276
Culture lab
(for drug resistance
test)
5
GAP--
• Quantum of TB Diagnostic
modalities present in Private is
Unknown. Urgent need to line
list ALL PRIVATE HEALTH
FACILITIES along with the
technologies used for
diagnosing TB
• Quantum of presumptive case
identified/examined not
recorded/shared. So
D
E
T
E
C
T
11. When we suspect TB?
Presumptive TB : Sign & symptoms of Pulmonary TB in adult
1. Cough for 2 weeks or more
2. Any Chest X-ray abnormality
3. Fever for 2 weeks or more
4. Significant weight loss (>5% wt. loss in last 3 month)
5. Blood in sputum
6. Abnormal night sweat
Any one of the above qualify for TB testing
Presumptive TB : Sign & symptoms of TB in Children (<15
years)
1. H/o Cough or fever for 14 days or abnormal chest X-ray or hemoptysis or weight loss or no
weight gain
2. H/o contact with active TB within two years in case of under six years
• For extra-pulmonary TB- symptoms depend on organ affected
• Socially and clinically vulnerable populations needs to be screened for TB at
regular intervals
• In case of PLHIV , cough for any duration qualify for TB testing
In a Health
Facility
around 3-5%
of total OPD
footfall is
referred for
TB testing
12. Follow STANDARDISED Treatment
Protocol for Drug Sensitive and
Drug Resistant TB cases
Use 2nd line Anti TB Drugs like
Linezolid, Kanamycin only for
Microbiologically confirmed Drug
Resistant TB cases
Use injection free regimens with
latest Anti TB drugs
Store NTEP drugs in Private
Pharmacies for periodic
dispensation to private TB patients
Use IT based adherence technology
to monitor compliance
Sustain treatment success rate of
95% and more
T
R
E
A
T
STOP
empirical
treatmen
t/ Trial
ATD
16. Regimen class Intensive phase
Continuation
phase
H mono/poly DR TB (R resistance not detected and H resistance)
All oral H mono-poly
DR TB regimen
(6) Lfx R E Z
MDR/RR TB
Shorter Oral MDR TB
regimen
(4-6) BDQ(6) Lxf Eto Cfz Z Hh E (5) Lxf Cfz Z E
All oral longer MDR TB
regimen
(18-20) Bdq(6) Lfx Lzd# Cfz Cs
Treatment regimens for DRTB
17. Providers/Programmes:
•Inadequate regimens
Drugs:
•Inadequate supply
•Poor quality
•Wrong use
Patients:
•Inadequate drug
intake
• Unsupervised treatment
• Absence of guidelines or
inappropriate guidelines
• Non-compliance with
guidelines
• Inadequate training of
health staff
• No monitoring of
treatment
• Poorly organized or
funded TB control
programmes
•Non-availability of
certain drugs (stock-
outs or delivery
disruptions)
• Poor quality
• Poor storage
conditions
• Wrong dosages or
combination
• Indiscriminate use
of antibiotics
•Unobserved treatment
(Poor
DOT)
• Poor adherence
• Lack of information
• Non-availability of free
drugs
• Adverse drug reactions
• Social & economic barriers
• Malabsorption
• Substance abuse
disorders
• Microbial: As a result of genetic mutation
•Essentially drug resistance is a man-made phenomenon
19. DOSAGE DISPARITY
Daily dosage according to Standards of TB
Care in NTEP are—
FDCs are prepared in such a way that they
can cater to all age groups. Even
paediatric formulations are present.
Weight
band
Number of tablets
Intensive phase Continuation
phase
HRZE HRE
75/150/400/275
mg
75/150/275 mg
25-39
kg
2 2
40-54
kg
3 3
55-69
kg
4 4
≥70 5 5
20.
21. Sustain COVID
appropriate behavior
Contact Tracing & TB
Preventive Treatment for
all contacts of TB
patients– GAME CHANGER
TB preventive
treatment after testing
for TB infection among
clinically vulnerable
Airborne Infection
Control in Health
Facilities
Contact tracing and
screening of all
household contacts and
TB Preventive Treatment
P
R
E
V
E
N
T
Clinical risk groups-
Patients on anti-TNF treatment
Receiving dialysis
Preparing for organ or hematological
transplantation
Those with silicosis
On immune suppressants
Patients with cancer
Having HIV infection
Cross
23. Burden of TB
• India has the highest estimated burden of tuberculosis infection (TBI) globally,
o with nearly 35-40 crore Indian population having TBI, of which 26 lakh (18-36 lakh) are estimated
to develop tuberculosis (TB) disease annually
• 5–10% of those infected will develop TB disease over the course of their lives, usually within
the first 2 years after initial infection
• 75% of people who develop TB disease after contact with a patient of active TB are
estimated to do so within one year of TB diagnosis of the index patient and 97% within two
years.
• Risk of developing TB disease after TPT decreases by approximately 60% and the reduction
can be up to 90% among people living with HIV (PLHIV).
• Epidemiological modelling studies show that effective implementation of TPT alone in
South-East Asia (SEA) region would result in an annual TB incidence decline of 8.3% (7-10)
(current annual decline rate is only 2%).
23
24. Study published in July 2020 from India
• Sample size: 1051 household contact
• 71% household contacts of pulmonary TB (PTB) patients had baseline TBI* (tuberculin skin
test [TST] ≥ 5 mm or Quantiferon®- Gold-in-Tube [QGIT] ≥ 0.35 IU/ml).
• Overall, 2% HHC developed incident TB disease (12 cases/1000 person-years, 95%CI: 8–19)
o HIV infection (aIRR = 29.08, 95% CI: 2.38–355.77, p = 0.01) and undernutrition (aIRR = 6.16, 95%
CI: 1.89–20.03, p = 0.003) were independently associated with incident TB disease while
o age, diabetes mellitus, smoking, alcohol, and baseline TBI, regardless of TST (≥ 5 mm, ≥ 10 mm,
≥ 6 mm increase) or QGIT (≥ 0.35 IU/ml, ≥ 0.7 IU/ml) cut-offs were not associated.
o Source: Paradkar M, Padmapriyadarsini C, Jain D, Shivakumar SVBY, Thiruvengadam K, Gupte AN, et al. (2020) Tuberculosis preventive
treatment should be considered for all household contacts of pulmonary tuberculosis patients in India. PLoS ONE 15(7): e0236743.
https://doi.org/10.1371/journal.pone.0236743
24
*Justification for treat only policy in India
25. Target population and strategy
a. Expanded eligible
group including
children >5 years,
adolescents and adult
HHC of pulmonary*
TB patients notified
in Nikshay from
public and private
sector
(*bacteriologically
confirmed pulmonary
TB patients will be
prioritized for
enumeration of the
target population)
b. other risk groups
25
Target population Strategy
People living with HIV (+ ART)
o Adults and children >12 months
o Infants <12 months with HIV in contact with active TB
HHC below 5 years of pulmonary* TB patients
TPT to all after ruling out
active TB disease
HHC 5 years and above of pulmonary* TB patients#
TPT among TBI positive# after
ruling out TB disease
#Chest X Ray (CXR) and TBI testing would be offered wherever available, but TPT must not
be deferred in their absence
Target population Strategy
Individuals who are:
• on immunosuppressive therapy
• having silicosis
• on anti-TNF treatment
• on dialysis
• preparing for organ or hematologic transplantation
TPT after ruling out TB
disease among TBI positive
26. Tests for TB infection
• Currently recommended and available tests for TBI-
1. Tuberculin Skin Test (TST) and
2. Interferon- Gamma Release Assay (IGRA)
• TST detects reaction to purified protein derivative (PPD) of mycobacterium
• IGRAs measure amount of interferon-gamma released in vitro by white blood cells
when mixed with M. tuberculosis antigens or the number of T-lymphocytes
producing interferon-gamma.
• A diagnosis of TBI needs to be complemented by a negative test outcome for TB
disease, through clinical evaluation, chest radiography and examination of sputum or
another suitable specimen if symptomatic, as per NTEP diagnostic algorithm.
26
Both tests measure immune sensitization
(type IV or delayed-type II hypersensitivity)
to mycobacterial protein antigens that
occurs following infection by M.tb
27. Comparison between TST and IGRA test
• A positive test result by either of the two methods available is not by itself a reliable indicator that
the person will progress to TB disease as the possibility of false positive results cannot be ruled out.
• Conversely, a negative test result does not rule out TBI, given the possibility of a false-negative test
result among at-risk groups, such as young children or among those recently infected.
27
TST IGRA
Specificity Low in BCG vaccinated High also in BCG vaccinated
Sensitivity High High
Ease of use Field friendly, complex test interpretation Require labs and infrastructure
Cost of test Low High
Manufacturing Complex old product Complex, multiple components*
Children Affected by young age Affected by young age
PLHIV
Requires info on HIV status for correct
interpretation
Affected by HIV and low CD4 count
28. Algorithm for TB screening and TPT
28
NO
Defer preventive
treatment
YES
Give preventive treatment5
NO
NO
<5 years
TST or IGRA
Symptomatic?2
Investigate for active TB
Follow-up for active TB as necessary, even for patients who have completed preventive treatment
YES
Abnormal
YES
Positive or unavailable Negative
Preventive treatment
contraindicated?4
No active TB
Normal or
unavailable
5 years +
CXR6
Any symptom1 of
current cough or fever or weight loss or
night sweats
Household contact
HIV positive Other risk group 3
29. Contraindications of TPT
• Active TB disease (absolute)
• Acute or chronic hepatitis
• Concurrent use of other hepatotoxic medications (such as
nevirapine)
• Regular and heavy alcohol consumption
• Signs and symptoms of peripheral neuropathy like
persistent tingling, numbness and burning sensation in the
limbs
• Allergy or known hypersensitivity to any drugs being
considered for TPT
29
• Pregnancy or a
previous history of
TB are not
contraindications for
TPT; and
• Contact with drug
resistant TB (DR-TB)
cases have been
dealt with in detail
later in the
corresponding
chapter.
30. TB Preventive Treatment
a. Expanded eligible
group including
children >5 years,
adolescents and adult
HHC of pulmonary*
TB patients notified in
Nikshay from public
and private sector
(*bacteriologically
confirmed pulmonary
TB patients will be
prioritized for
enumeration of the
target population)
b. other risk groups
30
Target population TPT Regimen
• People living with HIV (+ ART)
o Adults and children >12 months
o Infants <12 months with HIV in contact
with active TB
• HHC below 5 years of pulmonary* TB
patients
• 6-months daily isoniazid (6H)
• 3-month weekly Isoniazid and
Rifapentine (3HP) in persons
older than 2 years
• HHC 5 years and above of pulmonary* TB
patients#
• 3-month weekly Isoniazid and
Rifapentine (3HP)
• 6-months daily isoniazid (6H)
• Children/adult on immunosuppressive
therapy, silicosis, anti-TNF treatment,
dialysis, transplantation
• 3-month weekly Isoniazid and
Rifapentine (3HP)
• 6-months daily isoniazid (6H)
31. Comparison of TPT options
6H 3HP
Medicines Isoniazid Isoniazid + rifapentine
Duration (months) 6 3
Interval Daily Weekly
Doses 182 12
Pill burden per dose
(total no. of pills for
an average adult)
1 (182 pills)
9 pills with loose drugs (108 pills)
3 pills of FDC (36 pills)
Pregnant women Safe for use Not known
Interaction with
ART
No restriction
Contraindicated:
All PIs, NVP/NNRTIs, TAF
Use: TDF, EFV (600 mg), DTG, RAL (without dose
adjustment)
Toxicity
Hepatotoxicity (more), peripheral neuropathy,
rash, gastrointestinal (GI) upset
Flu-like syndrome, hypersensitivity reactions, GI
upset, orange dis-coloration of body fluids, rash,
hepatotoxicity (less)
Absorption
Best absorbed on an empty stomach; up to 50%
reduction in peak concentration with a fatty meal
Oral rifapentine bioavailability is 70% (not HP);
peak concentration increased if given with a meal
31
32. Dosage of 6H regimen
Regimen Dose by age and weight band
6 months of daily
Isoniazid
Monotherapy (6H)
Age 10 years & older: 5 mg/kg/dayd
Age <10 years: 10 mg/kg/day (range, 7–15 mg)
d Maximum dose of H if given daily would be 300 mg/day
32
34. Role of pyridoxine and its availability
• Peripheral neuropathy secondary to a deficiency of vitamin B6 (pyridoxine)
o commonly during TB treatment and infrequently with standard doses of H for
TPT
o recognized as symmetrical numbness and tingling of the extremities
o usually easily reversible upon withdrawal of H and giving high-dose pyridoxine
therapeutic dose (100–200mg/day).
• Dose: 10 mg/day in children and 25 mg/day in adults. 50 mg/day in adult PLHIV.
• TPT should not be withheld if pyridoxine is not available. Alternatively, the multi-
vitamin/B-complex formulations with the requisite prophylactic dose of pyridoxin
available within the general health system may be considered.
• If pyridoxine/multi-vitamins/B-complex are in short supply, then restricted to those
at highest risk, like severely malnourished and people with problem alcohol use.
• Close monitoring for peripheral neuropathy during treatment would be important
to start treatment early
34
Recommended
group for pyridoxine
prophylaxis when
on Isoniazid based
regimen:
• malnutrition,
• chronic alcohol
dependence,
• HIV infection,
• renal failure
• diabetes,
• pregnant or
breastfeeding
35. Policy recommendation of
TPT in DR-TB contacts in India
• Preventive treatment among HHC of MDR-TB index patients (in whom FQ
resistance has been ruled out) and among HHC of H resistant index patients (in
whom R resistance has been ruled out), the target population, using 6Lfx and
4R respectively to be introduced in a phased manner for all age groups to gain
programmatic experience to guide future expansion while awaiting results of
ongoing studies.
• This recommendation may be considered for children given their special needs
pan-India.
35
36. TPT regimen and dosages for
Contacts of DR-TB index patients
36
Regimen Dose by age and weight band
Six months of daily levofloxacin (6Lfx) for
contacts of R resistant FQ sensitive
patients#
Age > 14 years, by body weight: < 45 kg, 750 mg/day; ≥ 45 kg, 1g/day
Age < 15 years (range approx. 15–20 mg/kg/day), by body weight:
5–9 kg: 150 mg/day
10–15 kg: 200–300mg/day
16–23 kg: 300–400mg/day
24–34 kg: 500–750mg/day
Four months of rifampicin daily (4R) for
contacts of H resistant R sensitive
patients*
Age 10 years & older: 10 mg/kg/day@
Age <10 years: 15 mg/kg/day (range, 10–20 mg)
# Lfx 100 mg dispersible tablets available for children. Children receiving 6Lfx should be watched for joint abnormalities.
* In children from 0-14 years, 4R should only be used after ruling out active TB in limited geographies/populations for
evidence generation to guide future scale up for country wide implementation.
@ Maximum dose of R would be 600 mg/day.
Note: 6H can be considered as the TPT regimen option for contacts of index patients with RR-TB with FQ and H sensitive,
after ruling out active TB in them.
37. Treatment outcome – Treatment Completion
37
TB preventive treatment completion
Total
duration
in
months
Expected
number
of doses
80% of
recommended
doses (days)
Extended time
for treatment
completion
(days)
(treatment
duration +33%
additional time)
6H (daily) 6 180 144 239
3HP
(weekly)
3 12 11* 120
6Lfx (daily) 6 180 144 239
4R (daily) 4 120 96 160
* 90% of recommended number of doses
Treatment completion: A person
initiated on TPT who completed at
least:
• 80% of recommended dose
(144/180) consumed within 133% of
planned TPT duration (239 days) for
6H or 6Lfx or
• 90% of recommended dose (11/12)
consumed within 133% of planned
TPT duration (120 days) for 3HP or
• 80% of recommended dose (96/120)
consumed within 133% of planned
TPT duration (160 days) for 4R
38. Treatment outcomes- other definitions
38
Treatment failed A person initiated on TPT who developed active TB disease any time
while on TPT course
Died A person initiated on TPT who died for any reason while on TPT course
Lost to follow-up TPT interrupted by person for eight consecutive weeks (2 months) or
more for 6H or 6Lfx, four consecutive weeks (1 month) or more for 3HP
or 4R
TPT discontinuation
due to toxicity
A person whose TPT is permanently discontinued by the doctor due to
adverse events or drug–drug interactions
Not evaluated Such as records lost, transfer to another health facility without record of
TPT completion
39. Emergence of drug resistant following TPT
• Currently there is no evidence of significant association between development
of resistance to H or R with use of these drugs for TPT.
• TB disease must be ruled out before TPT is initiated,
• Regular (at least monthly) follow-up to rule out development of active TB
disease.
39
40. Display Information material on TB in
Hospital premise
Strengthening workforce in the
hospital for TB awareness and
counselling among staff and patients,
Notification techniques
Formation of Private Hospitals
Consortium for TB elimination.
Member of State TB Forum
Apply for NTEP certification for TB
diagnosis and Drug susceptibility
testing. Join IPAQT labs
Establish dedicated DR-TB, Pediatric
TB wards / ICU
Avail Partnership Options Or
apply CSR
Mobilize Brand Ambassador for TB,
Organize High Visibility Event,
Support Mass Media Activity, Social
Media Campaign, Community
B
U
I
L
D
Plenty of
Partnership
options available
Invest to Eliminate TB
Make India TB Free by
2025
#TBHaregaDeshJeetega
41. WHY NOTIFICATION?
PUBLIC HEALTH ACTIONS FOR THE NOTIFIED TB PATIENTS !
Components—
1. Patient home visit as per convenience of patient
2. Counselling of patient and family members
3. Treatment adherence and follow up support to ensure
treatment completion
4. Contact tracing -- Symptoms screening -- Evaluation of TB
symptomatics
5. Offering TB preventive treatment to all contacts after ruling
out TB
6. Offering HIV counselling and testing
7. Offering Diabetes testing
42. BENEFITS AVAILABLE TO A NOTIFIED TB PATIENT PUBLIC AND
PRIVATE-
ROAD TOWARDS ZERO CATASTROPHIC COST
Rs 500 per month as nutrition benefit- Nikshay Poshan Yojana
Travel reimbursement for DR TB and TB-HIV patients
Linkages with social welfare schemes of Government
Free Diagnosis and Treatment at Govt Health Facilities.
INCENTIVE TO PRIVATE PROVIDERS & TREATMENT
SUPPORTERS
Private Providers Treatment Supporters
Beneficiary
All types of Private providers.
Private provider who notifies
the earliest
Anyone who helps a patient
complete treatment
Benefits
500 for notifying, 500 for
declaring outcome
1000 for DS TB, 5000 for DR
TB
Mode Payment is made through direct bank transfer
43. GAZETTE ON TB NOTIFICATION
Mandatory Notification and Public Health Actions of TB patients
Private Clinics---Hospitals---Laboratories--- Chemists
Latest version of the Gazette dated 19th
March 2018 has the following provision—
Failure to take the mandated steps may attract
the provisions of Sections 269 and 270 of
the Indian Penal Code (IPC)
45. PUBLIC VS PRIVATE- KEY INDICATORS: WEST BENGAL (1Q22-3Q22)
Indicators Public (%) Private (%)
Microbiological confirmation 79 54
HIV status known 96 88
Drug Susceptibility testing offered 68 40
Proportion of Treatment Days monitored (DOT) 28 14
Proportion of HHC initiated with TPT 36 20
Treatment Success Rate (2021) 82 72
Beneficiaries paid under NPY (at least once) 62 52
Status of Treatment Adherence? TB Preventive Treatment?
Are we missing DRTB Patients from the Private Sector?
46. FEW ENCOURAGING INDICATORS AT PRIVATE SECTOR: WEST BENGAL (1Q22-
3Q22)
Type of
HF
Pediatric TB (0-
14 Yrs)
% (national
average =6%)
Adult cases
(>14 yrs) %
Public 1649 2.74% 58574 97.26%
Private 835 4.65% 17130 95.35%
Grand
Total 2484 3.18% 75704 96.82%
Gender %
Type of
HF Female Male
Trans-
gender
Female (national
average = 35%) Male Transgender
Public 18369 41839 15 30.50% 69.47% 0.02%
Private 7346 10617 2 40.89% 59.10% 0.01%
Grand
Total 25715 52456 17 32.89% 67.09% 0.02%