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Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB
Brief Notes on RNTCP
For The PPM coordinators
(Draft Version)
Compiled based on Partnership Guidelines 2014, TOG-2016, Revised PMDT
Guidelines 2017, DBT schemes & Latest Govt Gadget notifications
By
Tuberculosis Health Action Learning Initiative (THALI) Project,
Kolkata, West Bengal
In association with
STDC & RNTCP Team, West Bengal
Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB
Common abbreviations used in RNTCP
ACF/ICF Active case findings/intensified case findings
ADR Adverse drug reaction
AE Adverse event
AFB Acid Fast bacilli
AIC Airborne infection control
AIDS Acquired Immune Deficiency Syndrome
ALT Alanine aminotransferase
Am Amikacin
Amx/Clv Amoxicillin/clavulanate
ART Anti-retroviral therapy
AST Aspartate aminotransferase
ATS American Thoracic Society
Bdq Bedaquiline
BPL Below poverty line
CAP Conditional Access Programme
CBNAAT Cartridge Based Nucleic Acid Amplification Test
CEM Cohort event monitoring
Cfz Clofazimine
Clr Clarithromycin
Cm Capreomycin
CMO Chief Medical Officer
CP Continuation phase
CPT Co-trimoxazole preventive therapy
Cs Cycloserine
CTD Central TB Division
CUP Compassionate Use Programme
C-DAC Centre for Development of Advanced Computing
C-DST Culture and Drug Susceptibility Test
CL-HIV Children living with HIV
DAIDS Division of AIDS
DBT Direct Beneficiary Transfer
DCGI Drugs Controller General of India
DDG Deputy Director General
DDS District drug store
DDR-TBC District DR-TB Centre
DG Director General
DGHS Directorate General of Health Services
Dlm Delamanid
DMC Designated microscopy centre
DOT Directly observed treatment
DRT Drug resistance testing
DR-TB Drug-resistant tuberculosis
DR-TBC Drug-Resistant Tuberculosis Centre
DSMC Drug Safety Monitoring Committee
DST Drug susceptibility testing
Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB
DTO District TB officer
DVDMS Drug & vaccine distribution management system
E Ethambutol
ECG Electrocardiogram
ECHO Extension of Community Health Care Outcomes
EP-TB Extra-pulmonary tuberculosis
EQA External quality assurance
Eto Ethionamide
EU European Union
FDA Food and Drug Administration
FEFO First expiry first out
FL-LPA First line-line probe assay
FO Field Officer
FQ Fluoroquinolone
GLC Green Light Committee
GFATM Global Fund for AIDS, Tuberculosis & Malaria
Gfx Gatifloxacin
GMSD General Medical Stores Depot
GoI Government of India
H Isoniazid
Hh High dose isoniazid
HRCT High resolution CT scan
ICH International Conference on Harmonization
ICT Information communication technology
ICMR Indian Council for Medical Research
IP Intensive phase
Ipm Imipenem
IPAQT Initiative for promoting affordable & quality TB test
IQC Internal Quality Control
IRL Intermediate reference laboratory
ISO International Standard Organization
Km Kanamycin
LC Liquid culture
LFT Liver function test
Lfx Levofloxacin
L J Lowenstein Jensen
LPA Line probe assay
LT Laboratory technician
LTFU Lost to follow up
Lzd Linezolid
MAC Mycobacterium avium complex
MDR-TB Multidrug-resistant TB
Mfx Moxifloxacin
Mfxh High dose Moxifloxacin
MGIT Mycobacteria growth indicator tube
MIS Management information system
MO Medical Officer
MoHFW Ministry of Health and Family Welfare
MO-DMC Medical Officer-designated microscopy centre
MO-PHI Medical Officer- peripheral health institute
Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB
MO-TC Medical Officer TB control
MOTT Mycobacterium other than tubercle bacilli
MoU Memorandum of understanding
Mpm Meropenem
MPR Mixed pattern resistance
MR Mono resistance
MSS Monthly stock statement
NAAT Nucleic Acid Amplification Test
NABL National accreditation board for laboratories
NDRS National Drug Resistance Survey
NDR-TBC Nodal DR-TB Centre
NGO Non-Government Organization
NGS Next-Generation Sequencing
NHPS National health protection scheme
NHM National Health Mission
NIRT National Institute for Research in Tuberculosis
NITRD National Institute for Tuberculosis and Respiratory Diseases
NRL National reference laboratory
NSP National strategic plan
NTI National TB institute
NTM Non-Tuberculous Mycobacterium
OBR Optimized background regimen
Ofx Ofloxacin
OPD Out Patient Department
PAS p-aminosalicylic acid
Pdx Pyridoxine
PDR Poly drug resistance
PHI Peripheral health institute
PK/PD Pharmacokinetic/pharmacodynamics
PL-HIV People living with HIV
PMDT Programmatic management of drug-resistant tuberculosis
PP Private Provider
PQC Product quality compliance
PSM Procurement and supply management
PT Previously treated
PTE Pre-treatment evaluation
Pto Protionamide
PvPI Pharmaco-vigilance programme of India
QA Quality assurance
QSE Quality System Elements
R Rifampicin
RNTCP Revised National Tuberculosis Control Programme
RR-TB Rifampicin-resistant tuberculosis
R&R Recording & reporting
RT-MERM Real time medication event reminder monitor device
S Streptomycin
SA Statistical Assistant
SAE Serious adverse event
SDG Sustainable Development Goals
SDS State drug store
Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB
SLD Second line anti-TB drugs
SLDST Second line drug susceptibility testing
SLI Second line injectable
SL-LPA Second line-line probe assay
SME Supervision, Monitoring & Evaluation
SoP Standard operating procedures
SPC Specimen Processing Control
STLS Senior TB Laboratory Supervisor
STO State TB Officer
STR Standardized treatment regimen
STS Senior treatment supervisor
TALFU Treatment after lost to follow up
TA Touch Agent
TAT Turn-around time
TB Tuberculosis
TBHV TB Health Visitor
THALI TB Health Action Learning Initiative
Thz Thioacetazone
ToR Terms of reference
Trd Terizidone
TU TB Unit
UDST Universal Drug Susceptibility Testing
ULN Upper limit of normal
UPT Urine pregnancy test
USAID United States Agency for International Development
USFDA United States Food & Drug Administration
WCO World Health Organization Country Office for India
WHO World Health Organization
WHP World Health Partners
XDR-TB Extensively-drug resistant TB
Z Pyrazinamide
Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB
District PPM coordinators training Agenda
Organized by STDC and TB Health Action Learning Initiative (THALI) Project, WB,
Venue: Conference Hall, STDC, Kolkata, WB
Time Session topics Facilitator/s
Day one (24/5/18)
10:00-10:30 Registration & Pre test
Dr Abhijit, SrMC,
THALI
10:30- 10:40 Self-introductions All
10:40- 11:00 Welcome address Director, STDC
11.00-11.10 Background, importance of the training
Dr Milan Kumar Dinda,
PD, THALI
11:10-11:20 Special address STO
11:20-11:30 Expectation from the participants
Dr S. Parthiban, DPD,
THALI
11:30-12:10
Epidemiology of TB, magnitude of the problem,
Evolution of TB program in India- RNTCP , DOTs
& NSP 2017-2025
Dr. Bipra, WHO
Consultant,
12:10-12:20 Tea break
12:20-1:00
TB Sign symptoms, Types of TB, Comorbidities,
Patient Pathway, & PSS
Dr S. Parthiban, DPD,
THALI
1.00-1.30
DST, UDST & TB Diagnostic algorithm & treatment
as per TOG-16
Dr. Sandeep Roy, MO-
STDC
1.30-2.00
Treatment of TB, FDC, Wt Bands & Treatment
Outcomes
Dr Bipra/Dr Dheeraj
WHO Consultant
2.00-2.45 Lunch
2.45- 3:30 DR-TB
Dr. Sandeep Roy, MO-
STDC
3.30- 4:00 Program Monitoring & Nikshay
Dy STO/ Dr Dheeraj,
WHO Consultant
4.00-4:10 Tea break
4:10-5:00
Private Public Mix- Definition, Objectives of PPM,
the structure of RNTCP and hierarchal position of a
PPM coordinator
State PPMC/ Dr S.
Parthiban, DPD, THALI
5.00-5.45 Role & Responsibilities of a PPM coordinator
Dy STO/ State PPM
coordinator
5:45-6:00 Summary of the day, Proposal for homework
Dr. Sandeep, MO-
STDC /D.STDC/Dy
STO
Overall Floor Arrangements : Dr Abhijit, Sr MC, THALI
Logistics: Mr. Debasis, Finance and Admin Associate, THALI,
Documentation: Ms. Rupasree, Sr Associate, THALI
Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB
Day Two (25/5/18)
10:00-
10:30 Recap, homework discussions
D.STDC/Dy STO/Dr
Sandeep Roy
10:30-
11:15 ACSM & ACF
State IEC consultant/
Isita
11:15-
11:45
Delivery of TB care in Private sector, TIPs to the PPM
coordinators ,
Dr S. Parthiban, DPD,
THALI/WHO
Consultant
11:45-
12:30
Importance of TB notification, How to notify TB,
Notification registers
Dr Abhijit, SrMC,
THALI/WHO
Consultant
12.30-
12.40 Tea break
12:40-1.15
Adherence monitoring in private sector & other
vulnerable groups; Public health action, 99 DOTs
solution
Dr S. Parthiban, DPD,
THALI/WHO
Consultant
12:45-1.15 DBT schemes, Nikshay Poshan Yojna
Dy STO / State PPM
coordinator/ Dr Dheeraj
Tumu, WHO
Consultant
1:15-1:45 Partnership- Definition, relevance & Process
Dy STO/ WHO
Consultant/ Dr Abhijit,
SrMC, THALI
1:45-2:30 Lunch
2.30-3:30
Linking the TB Patients to social schemes,
Coordination with other Health departments &
experience sharing on linking the beneficiaries to
social schemes in other sector
Isita Roy Chakrobarthy
CPA, THALI & Mr
Marine Mukherjee, AD,
CINI
3:30-4:15 Details of Partnership Schemes: Scheme I- ACSM
Isita Roy Chakrobarthy
CPA, THALI
/Consultant/State IEC
officer
4.15-4.30 Tea Break
4:30-5:15
Details of Partnership Schemes: Scheme II-
Diagnosis & Treatment
WHO/Dr Abhijit, Sr.
MC,THALI
5:15-5:45
Details of Partnership Schemes: Scheme III- TB &
Co-morbidities
Parthiban/ Dr Abhijit,
Sr. MC,THALI/WHO
Consultants
5:45-6:00 Summary of the day, Proposal for homework
STO/D.STDC/Dy STO
Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB
Day Three (26/5/18)
10.00-
10.30 Recap, homework discussions
D.STDC/Dy STO/
10.30-
11.30
Details of Partnership Schemes: Scheme IV-
Program Management
Dy STO/ WHO
Consultant/Dr Abhijit
SrMC, THALI
11.30-
12.15
Sensitization of PRIs, NGOs, PPs etc. Report writing by
the PPMC,
PD THALI /Isita Roy
Chakrobarthy CPA,
THALI/St IEC
Consultant/
12:15-
12:30 Tea break
12.30-1.45 Records, reports, different Tools, M&E
Dy STO / State PPM
coordinator/WHO/Vivek
1:45-2.30 Lunch
2.30-3:00
Leveraging Resources, Approaching the corporates-
CSRs, Medical Colleges, THALI/WHO
3.00-4:10 District Action Plan Group work & Presentation
Dist. PPMC & THALI
4:10-4:30 Post Test
Dr Abhijit, SrMC,
THALI
4.30-4.40 Tea break
4:40-:5.10
Question answers, Suggestions Recommendations &
Open discussion , Some common issues &
observation : Tips to the DPPMC
ALL
5.10-5:30
Recaps , Feedback from trainees & Take Home
messages
D STDC/State PPM
coordinator/THALI
5:30:-5.45 Distribution of Certificates
STO/STDC
Director/PD THALI/Dy
STO
5.45-5.50 Vote of Thanks & closing remarks
STO/D.STDC
Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB
CONTENTS Page No.
Pre & Post Test Questionnaire 1
Aim of the training & Module Overview 3
Basics of Tuberculosis 4
Magnitude of Tuberculosis in India 4
Classification of Tuberculosis 5
Signs & Symptoms of Tuberculosis 6
Presumptive TB: Case definitions 6
Comorbidities 7
National Tuberculosis Programme 7
What is DOTS? 7
National Strategic Plan of Govt of India 2017-2025 8
NSP Targets : Outcome Indicators 9
How to diagnose Tuberculosis? 9
Drug susceptibility test (DST) 9
Universal DST (UDST) 10
Diagnostic approaches & Algorithms (as per TOG-16) 10
Treatment of Tuberculosis 12
FDC weight Bands & schedules 14
Outcome definitions 16
Drug resistant TB 16
Causes of drug resistance & how to prevent resistance 17
Integrated DR TB algorithm 18
DR-TB Durg dosages 18
Operational guidelines on Revised PMDT 19
Program Monitoring; Nikshay & e-Nikshay 20
PPM: Definition & Objectives 21
Guidance Note for PPM coordinators 22
Health system structures & functions at Public Sector 23
Key personnel in RNTCP supervision 26
Terms of reference (TOR) for District PPM coordinators 27
ACSM 28
Active Case Findings 28
99 DOTs 31
DBT Scheme & Nikshay Poshan Yojna 32
Schedule for payment in Nikshay Poshon Yojna 33
Partnership: Definition & Relevance 34
TB notification & latest gadget notification 37
IPC 269 & 270: Laws against negligent act to spread infection 37
Delivery of TB Care services in Private sector 38
Partnership schemes under RNTCP 39
Sensitization of PRIs, NGOs, PPs etc. & Role of PPM coordinator 46
H1 register & other format to capture TB Patient information from Pharmacy 48
TB Notification reporting formats (Annexure I, II & III) 49
Utilization certificate format for the NGOs 51
Universal Lab referral form: Revised Annexure 15A 52
Post Test 55
1
Pre & Post Test Questionnaire
1. Which of the following information is INCORRECT
A. TB is a viral disease
B. Mainly Sexually transmitted
C. Genetic disease
D. Usually blood, urine or stool is tested as
a confirmatory test
E. All
2. Symptom of TB
A. Cough & Fever>2wk, weight loss
B. Dry cough, high blood pressure &
weight gain
C. Distended abdomen, hematemesis &
Melena
D. Convulsion & sudden numbness
E. ALL
3. Which is NOT TRUE regarding TB
A. All TB patient should be tested for HIV &
Diabetes Mellitus
B. TB prevalence is more at urban & peri-
urban area in comparison to Rural area
C. One third population having latent TB
infection
D. At birth BCG gives total protection
against Adult PTB
E. All
4. Not a recommended test for active TB diagnosis in
adult
A. X-ray
B. Sputum microscopy
C. Sputum culture
D. Gene xpert
E. Mountoux skin test
F.
5. TB bacillus cannot affect which organ
A. GIT
B. Gland
C. Bone
D. Uterus
E. All can be affected by TB
6. Problem in private sector TB treatment
A. Always bad quality medicine
B. Lack of notification & follow-up
C. Very few patient at Private sector so no
focus from Govt
D. Lack of medicine availability at Private
sector
E. All
7. Hurdles in TB elimination target
A. Emerging drug resistance
B. Lack of Community involvement &
awareness
C. Air pollution, smoking habit etc indirectly
aggravating the disease incidence
D. All
E. Only A & B
8. Regarding treatment supervision & follow up of a
PTB which is not true
A. Sputum test needed at end of IP & end
of CP
B. If no AFB at the end of CP then also
follow up sputum test at 12, 18 & 24 month
C. Sputum positivity after treatment can be
due to drug resistance
D. All are true
E. Only B & C is correct
9. Factors may leads to DRTB
A. Lack of notification & proper follow-up
B. Wrong dose/combination
C. Incomplete treatment
D. Infected from an already DRTB patient
E. All
10. Not a correct cough etiquette-
A. Handkerchief or tissue should be used
B. If not available then palm can be used
C. Arm/forearm can be used
D. TB patient should use face mask for at
least first two weeks of treatment
E. B & C
11. What should not be done during treatment with ATT
A. Consuming nutritious diet
B. Refrain from alcoholism
C. Using contraceptive
D. Stop ATT if dark colored urine
E. Complete the full course despite feeling
healthy after sometime
12. Responsibility of a District PPM coordinator-
A. Implementation of ACSM activities at
the district and sub-district level.
B. Coordinating with the medical college /
Corporate hospitals / teaching institutes /
schools for improved involvement in the
program.
C. Mapping and line listing of all stake
holders, identifying NGOs, Private providers
for partnerships and facilitating the process
of partnerships.
D. All
E. Option A &C
2
13. Not true regarding pediatric TB
A. Failure to gain weight & low grade fever
can be a symptom of TB
B. Sputum microscopy is the main
diagnostic modality for a two year old child
C. If mother/close care giver having active
TB then INH prophylaxis should be given to
children up to 6 years old
D. Malnourished child has got more risk for
contracting TB
E. All are True
14. Advantage of community involvement
A. Scope of getting more number of
presumptive case & thereby early detection
B. Community faith building
C. Gather knowledge about community felt
need & challenges
D. Scope to clear misconception /myths
about TB
E. All
15. Regarding NSP 2017-2025 target which of the
following is NOT TRUE –
A. Proportion of notified TB patients
receiving financial support through DBT
should be 50% by 2018 & 90% by 2021
B. Proportion of private providers paid
incentives/honorarium using DBT/PFMS
should be 50% by 2018 & 90% by 2021
C. Proportion of patients from private
sector who are provisioned or reimbursed
by the program for anti TB drugs should be
50% by 2018 & 90% by 2021
D. Catastrophic cost for affected families
due to TB should be 50% by 2020
E. ALL are TRUE
16. Who are NOT eligible for getting DBT?
A. All notified TB patients from Private
sector
B. Treatment supporters
C. Private providers who notify TB patient
D. All notified TB patients from Public
sector
E. All Private Labs who are diagnosing TB
using IGRA/TB Gold
17. Which of the following is NOT TRUE
A. For notifying a microbiologically
confirmed TB case a qualified doctor will get
500 INR & again after completion of
treatment 500 INR
B. Treatment supporter will get 1000 after
completion of treatment of a Cat-I patient
C. Family member/relative can also be act
as a treatment supporter after orientation
given by RNTCP
D. Chemist/Pharmacist can act as a
treatment supporter
E. All are true
18. Which is the mandate of Universal DST
A. All diagnosed TB patient should at least
know their Rif sensitivity status
B. All presumptive TB case should be
diagnosed through CBNAAT
C. All presumptive DR-TB case should be
diagnosed through Culture & LPA
D. All >15 yrs old case should go to
upfront CBNAAT
E. ALL
19. Which of the following scheme CAN NOT be
implemented at Private / NGO sector as per
RNTCP partnership guideline
A. Establishment of Private DMC
B. Establishment of Private DMC cum
Treatment center
C. Establishment of Private DRTB center
D. Establishment of Sputum collection &
transport mechanism
E. ALL can be implemented
20. Which is NOT true regarding 99DOTs
A. Priority should be given to the key
population like TB-HIV, Privately treated
patient & patients from Hard to reach area
B. Mobile with Internet connectivity is a
pre-requisite
C. More than one mobile no. can be tagged
with a patient
D. 99DOTS patients receive a series of
daily reminders (via SMS and automated
calls). Missed doses trigger SMS
notifications to care providers,
E. ALL are true
3
AIM OF the Document:
This document contains basic information about various aspects of tuberculosis and its control. It
includes exercises on various activities and skills which the PPM coordinator has to perform while
implementing the Revised National Tuberculosis Control Programme (RNTCP).
District PPM coordinator is generally a health management or paramedical staff with mobility, who will
assist DTO/STO to implement the partnership scheme at District/State level.
Besides the summary of RNTCP technical & operational guideline 2016 this module will highlight the
key points of Partnership guideline 2014. At the end of training the trainee will know what a PPM
partnership is, the mutual benefits of participating in the partnership, basic information on other
partners’ activities (increase in detection, new cases, improvement in referrals, etc). What is needed
to implement this. What is expected from a PPM coordinator? Why partnership is essential to achieve
the target of elimination of TB by the year of 2025.
PPM coordinators Training Overview
Description of
the thematic
areas
Epidemiology of Tuberculosis
Latest Diagnostic algorithm (TOG-16)
Basics of DOTs
Treatment of Cat-I & Cat-II
DRTB basics
Data monitoring, Nikshay
DBT schemes
99 DOTS
PPM- objectives
TOR of PPM coordinators
Different partnership schemes under RNTCP
Monitoring & Evaluation tools
Target Groups State & District PPM Coordinators
Allocated time 2 days or 3 Days (with field visit , group work & presentation by the participants)
Objectives
To build capacity of PPMCs on RNTCP program objectives, how to make
partnership with other departments & Private sector, how to evaluate the process
of PPM
Assessment
plan Pre & Post Test, Group work, Group presentation & open interactive session
Training flow -
Part by Part Model agenda attached separately
4
BASICS OF TUBERCULOSIS:
WHAT IS TUBERCULOSIS?
Tuberculosis (TB) is a highly infectious bacterial disease caused by Mycobacterium tuberculosis. TB
can affect any part of the body. When it affects the lungs it is called pulmonary TB. The commonest
form (80-85%) of TB is pulmonary TB.
TB in any other part of the body (i.e. other than lungs) is called extra pulmonary TB. TB affecting
Lung as well as any extra pulmonary site(s) is also classified as Pulmonary TB.
HOW DOES TUBERCULOSIS SPREAD?
TB germs usually spread through air. When a patient with pulmonary tuberculosis coughs or sneezes,
TB germs are spread in the air in the form of tiny droplets. When these droplets are inhaled by a
healthy person s/he gets infected with tuberculosis.
TB infection doesn’t always lead to the TB disease (active TB). Some factors like malnutrition, HIV-
AIDS & other immune-compromised state of body, uncontrolled diabetes, silicosis & other chronic
inflammatory lung disease act as a trigger factor for TB infection (Latent TB) to TB disease (Active
TB) conversion.
One sputum positive case, if not treated, can infect 10 -15 individuals in one year. Any infected
person will have an average of 10% lifetime risk of developing tuberculosis.
MAGNITUDE OF TUBERCULOSIS IN INDIA
According to WHO global TB report 2017 - In India everyday
• More than 7000 people develop TB disease
• More than 1200 people die due to TB (i.e. nearly one person dies every minute)
• It is estimated that in a year, about 211 TB cases are occurring in a population of 1 lakh
• Annually, about 28 lakh new cases of TB occur of which about 20 lakh are sputum positive
infectious cases
• About 3 lakh children drop out from the school because of their parents had tuberculosis
• More than 1 lakh women are rejected by their families because of stigma due to TB
• Due to its devastating health & economic effect the World Health Organization declared
Tuberculosis is a Global emergency in 1993
5
Classification
Pulmonary Tuberculosis (Lung TB)-
Tuberculosis affecting lung parenchyma with or without involvement of other anatomical site.
Microbiologically Confirmed
A patient with at least one of two samples of sputum found positive for Acid-Fast Bacilli (AFB) by
microscopy or by culture or by rapid molecular test (like CBNAAT) is known as a Microbiologically
Confirmed case. If AFB is identified through sputum smear microscopy it is called smear positive
pulmonary TB.
Smear-Positive Pulmonary TB is the most infectious form of Tuberculosis!
Clinically confirmed or Probable TB
Presumptive TB cases which are diagnosed as TB through various diagnostic modalities like Chest X
Ray, Histopathology (Biopsy), Cytopathology (Fine Needle Aspiration Cytology - FNAC),
Case (TB)
Site of
involvement
Pulmonary
Extra-
pulmonary
(e.g Gland TB,
Plural TB,
Milliary TB)
TB Tratment
History
New
Case
Previously
Treated Case
Drug
Susceptibility
Drug
Sensitive
Drug
Registant
Mono-resistant (MR)
(e.g-Isoniazid Resistant or H-Mono)
Poly-resistant (PR)
Multi-drug resistant (MDR)
Extensively drug registance (XDR)
Mixed resistance pattern
Microbilogically
Confirmed
Clinically
confirmed
6
Computerized Tomography Scan – CT), MRI, ADA, Mountoux etc., along with clinical correlation of
symptoms will be known as Clinically confirmed TB.
The program mentions that all clinically diagnosed cases should be attempted to get a Microbiological
confirmation by testing the sample using CBNAAT in all pulmonary cases and smear negative cases.
Extra-Pulmonary Tuberculosis (EP TB)
A patient with active tuberculosis of any part of the body other than the lungs is a case of extra-
pulmonary tuberculosis. Efforts must be made for all patients (adults, adolescents and children) with
presumptive EPTB, to test appropriate specimens from the presumed sites of involvement in order to
obtain microbiological confirmation preferably through CBNAAT.
WHEN SHOULD TUBERCULOSIS BE SUSPECTED?
Sign symptom of Tuberculosis
Generalized symptom (May
be seen in both PTB &
EPTB)
Symptom of Pulmonary
TB (PTB)
Symptom of Extra pulmonary TB
(EPTB)
Pulmonary TB
Extra Pulmonary TB
 Fever for two or more
weeks, especially
accompanied by night
sweats
 Loss of appetite
 Significant weight loss
 Weakness and fatigue
 Cough for two or more
weeks
 Chest pain,
 Shortness of breath
with/without wheezing
 Blood in sputum
(hemoptysis)
Depending on the site and extent of the
involvement--- e.g.
 Joint pain, stiffness – Joint TB
 Swelling in the glands- Gland TB
 Cold abscess/Tubercular
abscess/fracture—Bone TB
 Convulsion/altered sensorium/neck
stiffness--- Meningeal/neural TB
 Blockage of fallopian tube/infertility-
Genital TB
 Collection of fluid in abdomen
(ascites)- abdominal TB
(Liver/GIT/Peritoneal or other visceral
TB)
Case definition of Presumptive Pulmonary TB - (previously called TB suspects)
Adult -- Any person with symptoms and signs suggestive of TB including cough >2 weeks, fever >2
weeks, significant weight loss (5% or more loss in last 3 month), hemoptysis and/or any abnormality
in chest radiograph is called Presumptive TB. Prompt diagnostic evaluation must be made to rule out
active TB.
Children -- Children with persistent fever and /or cough >2 weeks, loss of weight /no weight gain for
last 3 months, and /or contact with pulmonary TB cases in last 2 years must be evaluated for TB.
Presumptive Extra Pulmonary TB
In case of extra-pulmonary TB, symptoms in addition to the above mentioned, depends on the organ
involved, for e.g.
7
• Lymph Node Tuberculosis – Swelling in the neck with or without discharging sinus.
• Tuberculous Meningitis - Headache, fever, drowsiness, mental confusion, neck rigidity.
• Spinal Tuberculosis – Back pain, fever and at times swelling of the backbone.
CB-NAAT (cartridge-based nucleic-acid amplification test) is the preferred diagnostic test in
Presumptive EPTB, commercially Called GenXpert Test)
Co-morbidities
Co-morbidities are certain clinical conditions which are more susceptible to TB infection AND/OR
more likely to develop active TB disease after infection AND/OR more likely to cause severe TB and
disseminated, extra-pulmonary TB AND/OR the TB Disease help progression of the condition. These
includes & not limited to HIV-AIDS, Diabetes, Cancer, Renal Failure, Hepatic disease, immune
compromised states, chronic lung disease, disease arises from substance abuse etc. Among these
HIV & Diabetes are two most important co-morbidities. Program is now following some of the basic
protocol, as mentioned below, to address the issue of co-morbidity.
 All diagnosed TB patient must be screened for HIV & Diabetes
 TB patients living with HIV infection should receive the daily regimen & FDCs wherever applicable
& available. Now Daily FDC is recommended for all TB patients
 Anti-retroviral therapy must be offered to all patients with HIV and TB as well as drug-resistant TB
who require second-line anti-TB drugs, irrespective of CD4 cell-count, as early as possible
following initiation of anti-TB treatment, Preferably after two weeks & within the first eight
weeks if CD4 count is >50 ! (ATT & ART to be given simultaneously / within 2 weeks if CD4
count is <50)
 Patients with TB and HIV infection should also receive Cotrimoxazole as prophylaxis for other
infections.
 People living with HIV (PLHIV) should be screened for TB using four symptom complexes (current
cough or fever or weight loss or night sweats) at HIV care settings and those with any of these
symptoms should be evaluated for ruling out active TB. All asymptomatic patients in whom active
TB is ruled out, Isoniazid Preventive Therapy (IPT) should be offered to them for six months or
longer.
NATIONAL TUBERCULOSIS PROGRAMME
The National Tuberculosis Programme (NTP) in India was being implemented since 1962 by
establishing District Tuberculosis Centres (DTCs), TB Clinics and TB Hospitals.
From its inception, the programme was integrated with the general health services and the service
delivery was through the primary health care infrastructure. The results of NTP were not encouraging.
The strategy of the NTP was reviewed in 1992. This led to the launching of the Revised National
Tuberculosis Control Programme (RNTCP) in 1997, planning to cover the entire country by 2005.
RNTCP is based on the internationally recommended strategy to control TB known as ‘DOTS’
(Directly Observed Treatment Short course)
WHAT IS DOTS?
DOTS is a systematic strategy which has five components-
• Political and administrative commitment. TB is the leading infectious cause of death among
adults. It kills more women than all causes associated with childbirth combined and leaves more
orphans than any other infectious disease. Since TB can be cured and the problem can be controlled,
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it warrants the topmost priority, which it has been accorded by the Government of India. This priority
must be continued and expanded at the state, district and local levels.
• Good quality diagnosis. Top quality microscopy allows health workers to see the tubercle bacilli
and is essential to identify the patients who need treatment the most.
• Good quality drugs. An uninterrupted supply of good quality anti-TB drugs must be available. In
RNTCP, a box of drugs for the entire treatment is earmarked for every patient registered, ensuring
the availability of the full course of treatment to the patient the moment s/he is registered for
treatment. Hence in DOTS, the treatment will never fail for lack of medicine.
• The right treatment, given in the right way. The RNTCP uses the best anti-TB medications
available. But unless treatment is made convenient for patients, it will fail. This is why the heart of the
DOTS programme is "Directly Observed Treatment" in which a health worker, or another trained
person who is not a family member, watches as the patient swallows the anti-TB medicines in their
presence.
• Systematic monitoring and accountability. The programme is accountable for the outcome of
every patient treated. The cure rate and other key indicators are monitored at every level of the health
system, and if any area is not meeting expectations, supervision is intensified. The RNTCP shifts the
responsibility for cure from the patient to the health system.
DOTS
� Makes the patient the VIP of the programme
� Places responsibility for patient’s cure on the health system, not on the patient
� Reduces risk to the community by preventing spread of TB
� The best method to ensure cure
� Empowers people with the disease and their communities through knowledge of the disease.
� It allows all parties to be held more accountable to each other, fostering mutual interaction and a
“positive partnership”.
� Develops in tandem with the set Standards for Tuberculosis Care to promote a “patient-centered”
approach, & adheres to the principles on health and human rights.
The NSP for TB elimination 2017 -2025
The NSP for TB elimination 2017–25 is a framework to guide the activities of all stakeholders
including the national and state governments, development partners, civil society organizations,
international agencies, research institutions, private sector, and many others whose work is relevant
to TB elimination in India.
Vision, Goals and Targets of NSP
The NSP proposes bold strategies with commensurate resources to rapidly decline TB in the country
by 2030 in line with the global End TB targets and Sustainable Development Goal’s to attain the
vision of a TB-free India.
VISION: TB-Free India with zero deaths, disease and poverty due to tuberculosis
GOAL: To achieve a rapid decline in burden of TB, morbidity and mortality while working towards
elimination of TB in India by 2025.
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HOW TO DIAGNOSE TUBERCULOSIS?
All patients (adults, adolescents, and children who are capable of producing sputum) with
presumptive pulmonary TB should undergo quality-assured sputum test for rapid diagnosis of TB
(with at least two samples, including one early morning sample for sputum smear for AFB) for
microbiological confirmation. Where available, chest X-ray should be used as a screening tool to
increase the sensitivity of the diagnostic algorithm.
CB-NAAT (cartridge-based nucleic-acid amplification test) is the preferred first diagnostic test in
children, PLHIV, previously treated case.
Sputum microscopy of at least two samples (preferably in the sequence of Spot-Morning) should be
done only at an RNTCP designated microscopy center (DMC) or other RNTCP accredited Lab. A
DMC is an identified sputum microscopy laboratory in a PHC, CHC or hospital for 1 lakh population
(in tribal areas – 50,000 population). It is equipped with a binocular microscope, trained lab technician
and is supervised by the Senior Tuberculosis Laboratory Supervisor (STLS) at regular intervals.
 Serological tests are banned and not recommended for diagnosing tuberculosis.
 TST and IGRA are not recommended for the diagnosis of active tuberculosis. Standardized TST
may be used as a complimentary test in children only (vide algorithm)
Drug susceptibility testing-DST
Drug susceptibility testing means testing to find out if a person has got drug resistant TB or not. That
includes finding out which drugs the TB bacteria in their body are sensitive & which are resistant. It is
essential that if a person might possibly have drug resistant TB, that this is discovered as soon as
possible, in order that the patient can be provided with effective TB treatment.
Different types of drug susceptibility tests
Outcome indicator : NSP 2017-2025 Baseline
(2015)
2020 2023 2025
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Drug susceptibility tests for TB are basically of two different types. One type of test is culture, which
involves looking at how the bacteria behave. For example, do the bacteria grow in the presence of
anti TB drugs?
Another type of test involves looking at genetic mutations (Molecular Test).
CBNAAT is now most widely used & preferred method for rapid molecular testing.
Universal drug susceptibility testing (U-DST)
The programme is committed to providing Universal Drug Susceptibility Testing (UDST) for all
diagnosed and notified TB patients. Depending upon resource availability, this service is
progressively being made available throughout the country. A range of rapid molecular tests are
available for UDST, such as Cartridge Based Nucleic Acid Amplification Test (CBNAAT) and Line
Probe Assay (LPA).
In the past, patients were offered DST based on their risk of developing drug resistance.
Over time, DST has been increasingly made available to the patient to lower levels of risk. Currently,
all diagnosed TB patients are routinely offered at least the R resistance test. The revised DRTB
algorithm (2017) also recommended upfront DRT (CBNAAT) for presumptive TB cases from selected
key population (PLHIV, <15 yrs., EPTB, Smear –ve but X-ray suggestive) for reliable and early
microbiological confirmation and in these patients, R resistance information is available as a
byproduct. There are several additional DST technologies in the development pipeline. These tests
will be made available progressively as they are endorsed for use by WHO. Recently, WHO endorsed
LPA for use for DST of FQ class and SLI class. Currently, LPA labs are in preparation for rolling out
this facility while DST on CBNAAT is offering more accurate and wider testing of resistance to R
which is also in various phases of development.
Approach to Presumptive TB Case & the Diagnostic Algorithms as per TOG-2016
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TREATMENT OF TUBERCULOSIS
 TB is curable
 To be cured of TB a patient must start treatment immediately after being diagnosed by a doctor
after microbiological confirmation.
 Patients must take their medicines regularly and complete the course of treatment.
 After 2 to 3 weeks, patient usually stops spreading the infection.
 Anti-TB drugs may have some common side effects. The side effect includes: vomiting, nausea,
loss of appetite, joint pain, orange/red urine, skin rash, weakness, giddiness
 These common side effects usually diminish as the body gets used to the medicines within 1-2
weeks. However, if they persist it is better to take advice from the doctor.
 If any serious side-effects appear, report these to the doctor but stopping the medication without
doctors advise could be even more dangerous.
The duration of treatment is usually 6 to 8 months. There are two phases in the treatment of
tuberculosis: the intensive phase (IP) of 2-3 months and the continuation phase (CP) of 4-5 months,
depending upon the category of treatment.
During IP, all doses are given under direct observation, Thereafter, sputum or other relevant sample
is examined and if found negative, the CP is started. If found positive then DST/CBNNAT is done & if
found drug sensitive then also CP is started. Prolongation of IP is no more recommended.
If found drug resistant then the patient is put on appropriate DRTB regimen.
At the end of CP also similar test is performed & action taken as per result of such tests &
evaluations.
Type of Treatments
It is very important that patients receive the correct TB treatment. This usually means that they must
receive the correct TB drugs, correct combination, correct duration & correct dosage (weight band).
Types of treatments are different for
different types of TB.
Treatment for new TB patients
All new TB patients in India should receive
an internationally accepted first line
treatment regimen (a regimen is the
prescribed course of treatment, in this case
the TB drugs) for new patients.
The initial intensive (IP) phase should
consist of eight weeks (2 month) of the drugs Isoniazid (H), Rifampicin (R), Pyrazinamide (Z) and
Ethambutol (E). The continuation phase (CP) should consist of the three drugs Isoniazid, Rifampicin
and Ethambutol given for another sixteen weeks (4 month). This is alternatively written as 2HREZ + 4
HRE. There may be need for extension of the continuation phase for another few weeks to few
months in some form of EPTB like bone or neural TB. Extension of IP phase is not recommended.
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Previously treated patients
With patients who have had treatment before, MDR-TB or R resistance must firstly be ruled out by a
quality assured test.
Then if the TB patient is a previously treated patient as defined above, they should then receive the
retreatment regime
(2HREZS+1HREZ) + 5HRE
containing first line drugs in a similar
way to new TB patients. The main
difference is the addition of
streptomycin to the intensive phase.
It is not usual to add one TB drug to a
failing regimen as this can encourage
the development of resistance. But it
may be considered that this is still
sensible guidance as MDR-TB and
rifampicin resistance will have
already been excluded. So it is
essential that this testing for
additional resistance is done.
However, the effect on the patients
could still be considerable. Streptomycin has to be painfully injected, and its common side effects
include a loss of hearing.
Daily Regimen:
Under the new daily drug regimen, TB patients will be given fixed dose combinations (FDCs) – three
or four drugs in specific dosages in a single pill – on a daily basis. The drugs will also be administered
in a more scientific manner, according to the patient’s weight. The biggest advantage for the patient
under the new regimen will be reduced pill burden, as instead of seven tablets, patients need
consume only 3-4 tablets, according to their weight band.
Fixed dose combinations
A fixed dose combination (FDC) is when two or more drugs are combined together in a single pill or
tablet.
Fixed dose combinations are helpful as they simplify getting TB drugs and the delivery of DOTS.
They may also increase adherence. Individually worked out drug dosing should be only used for
patients with toxicities or contraindications to one or more parts of the FDC.
Fixed dose combinations of four drugs (Isoniazid, Rifampicin, Pyrazinamide and Ethambutol) i.e.
4FDC (for adult), three drugs (Isoniazid, Rifampicin and Ethambutol) i.e. 3FDC for adult, three drugs
(Isoniazid, Rifampicin and Pyrazinamide) i.e. 3FDC for children and two drugs (Isoniazid and
Rifampicin) i.e 2 FDC (for children) is now available.
Patient wise boxes (PWB)
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The TB drugs for RNTCP patients are supplied in an individual patient wise box which contains the
entire course of treatment for the patient. In each patient wise
box there are two pouches. One is for the intensive phase and
the other is for the continuation phase.
The patient wise boxes are colour coded. Red boxes are for new
patients, sometimes referred to as category 1. Blue boxes are for
previously treated patients and are sometimes referred to as
category 2. For paediatric TB patients separate patient wise
boxes have been developed.
FDC weight bandings:-
Daily FDCs are given according to the weight of the patients. WHO recommended new weight
banding made TB treatment simpler more than ever
The following dosing table provides information on the number of daily tablets needed to reach the
proper dosing, based on the patient’s weight:
Figure 1: RNTCP Patient wise box (PWB) for children
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Treatment Outcome definitions (DSTB):
1. Cured: Microbiologically confirmed TB patients at the beginning of treatment who was smear or
culture negative at the end of the complete treatment.
Note: a microbiological positive report at diagnosis and microbiological negative report at end of
treatment are both required.
2. Treatment completed: A TB patient who completed treatment without evidence of failure or
clinical deterioration BUT with no record to show that the smear or culture results of biological
specimen in the last month of treatment was negative, either because test was not done or because
result is unavailable.
3. Failure: A TB patient whose biological specimen is positive by smear or culture at end of treatment
4. Lost to Follow-up: Patient whose treatment was interrupted for 1 consecutive month or more
5. Not Evaluated: Patient could not be tracked due migration/transfer out or some other cause OR
Patient has TB diagnosis withdrawn (by a qualified doctor) OR Patient's anti-TB treatment had to be
stopped for indefinite period due to life-threatening adverse reaction.
6. Treatment Regiment Changed: A TB patient was put on first line regimen, who has been
diagnosed as having DRTB and switched to drug resistant TB regimen prior to being declared as
failed.
7. Died: Patient who has died during the course of anti-TB treatment
Drug resistant TB in India – Categories, DOTs Plus (Now PMDT) , treatment
Drug resistant TB in India
Drug resistant TB has frequently been encountered in India and its presence has been known
virtually from the time anti TB drugs were introduced for the treatment of TB. If a person has drug
resistant TB it means that their illness will not respond to at least one of the first line TB drugs.
Traditionally, the view in India has been that drug resistant TB is not easily transmissible. So it was
believed that most drug resistant TB in India arose from the failure of people to take their anti TB
drugs properly, rather than from them becoming infected with an MDR TB strain. So a high quality
DOTS program, which includes supervising people taking their drugs should prevent the emergence
of resistance.
This belief was based largely on animal studies. It had then been found that drug resistant bacilli were
not less infectious. In fact people who contact with previously untreated patients had had a similar risk
of infection regardless of whether the bacilli were drug susceptible or drug resistant.
PMDT
DOTS-Plus refers to a DOTS service with additional elements for drug resistant TB.
In 2007 DOTS-Plus was launched for the management of drug resistant TB. By 2012 the DOTS-Plus
service (now referred to as the “Programmatic Management of Drug Resistant TB” ) had been
expanded across the whole country and by 2013 the service was available in all districts. By this time
it had though been decided to decentralize the DOTS Plus services. The services were to be totally
integrated into the main RNTCP services at local level.
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In addition, treatment categories I & II became the treatment regimens for new and previously treated
patients. Category III was phased out, and two new categories were introduced. These were
Category IV for patients requiring treatment for MDR TB, and category V for patients requiring
treatment for XDR TB. As per revised PMDT guideline 2017 these category concept has been
changed. The guideline has proposed total 12 regimens for the DRTB.
As per RNTCP 2016 data treatment success rate among notified DRTB was only 46% !!
Causes of drug-resistant tuberculosis
From a microbiological perspective, the resistance is caused by a genetic mutation that makes a drug
ineffective against the mutant bacilli. In clinical settings, an inadequate or poorly administered
treatment regimen allows drug-resistant mutants to become the dominant strain in a patient infected
with TB. Clinical characteristics of patients have also been recognized where appropriately
administered drugs have not achieved necessary drug levels to deal with all populations of
mycobacteria. From a programmatic perspective, weak TB services lead to delay in detection and
effective treatment of drug resistance and are unequipped to support patients to keep adherence to
treatment and prevent ongoing transmission.
Prevention of drug-resistance
The problem of DR-TB cannot be addressed completely by standalone systems for detection and
treatment of drug-resistance. Strong systems to detect successfully treat and ensure long term
disease-free status of TB patients, are required to prevent emergence of resistance. Thus, basic TB
diagnostic and treatment services should receive priority and systems for early detection and
treatment of drug-resistant forms of TB which should be integrated into existing TB services.
Improperly treated patients with resistant strains of TB will constitute a source of ongoing
transmission of resistant strains. Health care facilities and congregate settings lacking of proper
infection control measures as recommended by WHO contribute to maintain transmission. The
interruption of transmission and not only rapid detection and immediate enrolment on effective
regimens are therefore necessary to prevent the emergence of new DR-TB patients.
Measures to prevent incidence and transmission of TB are also effective in prevention of drug-
resistance. The framework for PMDT considers the following steps as most important to check the
menace of drug resistance-
Move to patient-centric care
Successful treatment and care can only result when patient preferences, values and needs are
satisfactorily addressed along with PMDT services. This includes ensuring that the diagnosis of DR-
TB is early, accurate and affordable; and the most effective treatment is delivered early and provided
in a manner that is easily accessible to the patient, affordable and socially acceptable. At the same
time it must ensure that the confidentiality and dignity of the patient is protected. It is the responsibility
of the health system to make sure that the patient is treated successfully within the society s/he
belongs to, enjoying all support which the community would otherwise provide to its members so that
the new chain of infection is arrested at source and the cured member enriches his/her material,
social and cultural assets. Prevention, management and mitigation of stigma and discrimination are
essential elements of a patient-centered care approach to TB management.
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When PMDT (erstwhile DOTS Plus) was first rolled-out in India in 2007-- failures after treatment with
Category I for new TB patients or Category 2 for previously treated TB patients only were considered
as presumptive MDR-TB patients. Later, patients remaining smear positive during any follow-up,
patients with history of previous TB treatment, TB-HIV, Treatment Non-responders and TB patients
who are close contacts of DR-TB were added to the presumptive list.
Most recently all diagnosed TB cases are to be considered as presumptive DRTB & should be offered
DRT (CBNAAT)
Decentralized DR-TB management
Previously, guidance was largely provided for centralized PMDT treatment initiation in inpatient
settings. This version provides guidance on both inpatient and outpatient based treatment initiation for
providing increased access to PMDT services. Inpatient-care for those who require it on medical
grounds and drug supply chain management have been decentralized down to the district level.
Every district should establish a District DR TB Center to be guided by District DR TB Committee for
decentralized DR-TB management.
Drug dosage and administration
The dosage of drugs would vary as per weight of the patients. Patients would be classified in weight
bands of <16 kg, 16-29 kg, 30-45 kg, 46-70 kg and >70kg. All drugs in the regimen are to be given on
a daily basis under observation. Injectable will be administered for six days/week (excluding
Sundays). All morning doses are to be supervised by the treatment supporter (can be Govt health
worker, CV or family member of the patient). After taking the morning doses on Saturday, next day’s
oral drugs would be given to the patient to be taken at home on Sunday. Empty blisters of medicines
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taken unsupervised in the evening and on Sundays are to be collected by treatment supporter. In
cases of drug intolerance – E, Cs and Na-PAS can be given in divided doses (twice a day).
The dosage for drugs used in various DR-TB regimens by weight bands that is in accordance to the
WHO recommended doses of anti- TB drugs for adults and pediatric patients.
Treatment support to DRTB Patient
Treatment support is the compendium of services provided to the patient enabling them to
successfully complete the treatment. These services include therapeutic, emotional, social and
financial support.
Integration with social scheme, counselling, adverse drug reaction monitoring , appropriate & timely
follow-up evaluation is the key to success.
Operational guidelines on revised PMDT
1) If RR-TB is detected, the patient is immediately referred for pre-treatment evaluation and
treatment initiation for DR-TB within 1 day of receipt of results. While the RR-TB patient is
undergoing pre-treatment evaluation, the Senior DR-TB TB-HIV Supervisor, STS and
TBHV should ensure an initial home visit to verify the address and meet the family
members. A Treatment supporter (who can either be a health care worker, community
worker/ volunteer or private practitioner) should be identified in consultation with the
patient. The Treatment centre can either be at the sub centre of the health system or in the
community. If a family member is identified as Treatment supporter, he should be trained to
give medication under supervision at the residence, under close monitoring by TBHV/STS.
The Treatment supporter should also be given training for drug administration, identification
of adverse effects during treatment, frequency of follow-up and record keeping. During IP,
appropriate arrangement for injections should be done.
2) The results of SL-LPA have to be made available to the districts within 5 days of specimen
submission for all samples that are smear positive at the CDST lab. For smear negative
samples the results will have to be made available within 15 - 30 days. The reason for
further delay if any has to be mentioned in 15 A by the CDST labs and that will be recorded
in the treatment card of patients. The LPA laboratory must report whether the specimen is
resistant to all SLIs (i.e., rrs mutation) or only Km (eis mutation). The results of LC DST are
expected to be available after 6-8 weeks of specimen submission.
3) Nikshay entry of cases found to have resistance in SL-LPA have to be mandatorily entered
on the same day at the CDST labs so that districts and DR TB sites can access that without
time lag and take further action.
4) NDR-TBCs by default will also act as DDR-TBCs. Such districts can have an additional
DDR-TBC if required for convenience to patients. All districts those who have not yet made
their DDR-TBC functional will have to make them so within 25th May, at least on OPD
basis and provide DDR TBC Ids to patients.
5) All RR-TB patients will be initiated on the shorter MDR-TB regimen as the 1st choice after
pre-treatment evaluation is completed excluding those who have history of intake of
Flourquinolone (FQ) and 2nd line injectable (SLI) more than 1 month. Pregnant women and
EPTB patients other than Pleural Effusion and Lymph node TB will also be excluded. The
DDR-TBC Committee can decide on a case-to-case basis, the need for admission for
DRTB patients for initiation of treatment. For majority of cases it is expected that SL-LPA
results will be available during the pre-treatment evaluation. For the remaining cases the
results will be available within 15 - 25 days. Based on results, if no additional resistance is
detected, the patient will be continued on the same short course regimen. Only those
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patients excluded from shorter course regimen will be put on conventional MDR regimen till
SL LPA results are available.
6) All patients (whether started or not started on short course / conventional regimen) with
additional resistance to FQ class or SLI class on SL-LPA would be assessed for eligibility
for newer drug containing regimen. Patients who have consented and are found to be
eligible (considering exclusion criteria and other parameters) would be initiated on
Bedaquilline (BDQ) containing the regimen while rest of the patients would be initiated on a
DST guided regimen and reclassified. All Medical Colleges who have NDR TBC and those
NDR TBCs who have an ECG machine will have to start assessing patients for BDQ
containing regimens as the first choice. At present the state level decision is to keep
patients started on BDQ admitted for at least 2 months.
7) All patients (whether started or not started on short course / conventional regimen) with
additional resistance to FQ class or SLI class on SL-LPA and cannot be started on BDQ
containing regimen has to be put on the DST guided regimen mentioned in the new
Guidelines on programmatic management of drug resistant TB in India, 2017 at the NDR
TBCs.
8) If a patient is resistant to both FQ and SLI on SL-LPA or to any of the drugs of the other
class, in LC-DST (results available after 6 to 8 weeks), the patient will be reclassified as
XDR-TB or mixed pattern resistant according to the new guidelines on page 65. All Medical
Colleges who have NDR TBC and those NDR TBCs who have an ECG machine will have
to start assessing patients for BDQ containing regimens for such patients as the first
choice. Otherwise DST guided regimens will be started. There is no scope to continue on
conventional MDR or XDR regimen any more.
9) Initiation of new drugs and DST guided regimen and any regimen change, will have to be
started at the NDR TBCs
Programme monitoring
Monitoring is the process of observing whether an activity or service is occurring as planned.
It implies systematic and purposeful observation, aiming to identify any diversion from the planned
course of action. It is a routine tracking of programme using input, process, output and outcome data
collected on a regular and ongoing basis. This helps identify the need for more formal evaluation of
activities and find timely solutions to the problems.
Monitoring in TB programmes is of paramount importance for ongoing programme planning and
implementation.
A good monitoring strategy moves beyond the widely used case detection and treatment outcome
indicators and applies the concept of input, process, output, outcome and impact indicators for
measurement of key programme activities.
Monitoring indicators: Various components of programme service delivery are fed in NIKSHAY
from where various input, process and outcome indicators are drawn for different levels of health
facilities. Analysis of these indicators will help in monitoring improvement in programme performance.
NIKSHAY
NIKSHAY is the web-based platform for the National Tuberculosis Programme Surveillance System.
It envisages establishing a state-of-art surveillance system with system utilization by
100% stakeholders, ensuring 100% notification of TB patients at diagnosis (microbiologically
confirmed and clinically diagnosed). The programme envisions enabling tracking of all registered TB
patients across TB elimination lifecycle, geographies, transfers and referrals.
The first step is to ensure complete the entry in all formats of R&R. Dashboard functions to track
activities and online monitoring indicators with graphical and geo-mapping displays in
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NIKSHAY/e-NIKSHAY is helpful in programme monitoring provided completeness of data entered is
ascertained. Primarily, the source of information for all monitoring indicators will be NIKSHAY.
e-NIKSHAY
In an attempt to reduce the TB burden in the country, it is envisaged that an ICT system such as e-
NIKSHAY could help with coordinated planning and action that is required at various levels. The goal
would
be to develop a common integrated platform as an open system to engage ecosystem stakeholders
towards effective, timely and quality assured diagnosis and effective treatment of TB. It would
essentially use a case-based approach to the TB lifecycle, enabling patient based tracking using
unique ID and monitoring allowing for stakeholder integration, as well as timely and accurate
reporting and real time decision support.
PUBLIC PRIVATE MIX (PPM)
A partnership between government and the private sector for the purpose of more effectively
providing services and infrastructure traditionally provided by the public sector.
It is widely recognized that a large proportion of TB patients seek care from private providers, mainly
outside the network of Revised National Tuberculosis Control Program (RNTCP). These include
private (for profit and not-for profit) providers and private healthcare institutions and they do not
usually follow the recommended DOTS strategy for management of TB, hence depriving patients of
quality management and treatment.
Objectives
To achieve the NSP targets (by implementing different Schemes/incentives & enablers).
Some of the notable targets of NSP are as below-
a) Proportion of notified TB patients receiving financial support through DBT should be 50% by 2018
& 90% by 2021
b) Proportion of private providers paid incentives/honorarium using DBT/PFMS should be 50% by
2018 & 90% by 2021
c) Proportion of patients from private sector who are provisioned or reimbursed by the program for
anti TB drugs should be 50% by 2018 & 90% by 2021
d) Proportion of treatment supporters paid incentives/honorarium using DBT/PFMS should be 80%
2018 & 100% by 2019
e) Proportion of patient provider support agency (PPSA) units established at the state & district
level- should be 80% by 2018 & 100% by 2019
And by all these it is targeted to achieve-
 Proportion of notified TB patients offered DST will be 80% by 2020 & 100% by 2025
 Proportion of notified patients initiated on treatment will be 90% by 2020
 Treatment success rate among notified DSTB will be 90% by 2020
 Treatment success rate among notified DRTB will be 65% by 2020 & 75% by 2025
 Catastrophic cost for affected families due to TB will be “0” by 2020
How to implement DOTS through PPM
Case management procedures should be followed by Private provider (PP) including:
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Identification of TB suspects.
Diagnosis of Pulmonary TB through sputum smears microcopy / molecular technique
Patients and their relatives should be educated about TB and treatment,
TB drugs should be provided free of cost to the patient from the local GP's clinic,
Directly observed treatment (DOT) should be arranged for the intensive phase in all new cases and
the whole of the re-treatment regimen
Lost to follow-up cases should be traced,
PPM organization in the district
TB care is integrated within Primary Health Care (PHC) services, so that continuing care is provided
close to the patient. The strengthening and maintenance of quality services are extremely important
involving all levels of healthcare facilities (both public and private) as well as community leaders such
as LHW, Imam, teacher and health staff.
The following are the recommended organizational arrangements of TB control at district level:
The Chief Medical Officer Health (CMOH) has overall technical and administrative responsibilities
for TB control activities in the district.
District TB officer (DTO) is the nodal point at a RNTCP District for TB program.
District PPM coordinator will work directly under the guidance & supervision of the DTO & will help
DTO for field level implementation of universal access to TB care & will maintain liaison with other
health & non-health depts./stakeholders
Monitoring and evaluation
A strategy for monitoring and evaluation of the PPM is advisable. Its purpose may be to:
· determine rate of referral, detection and notification by PPs
· monitor change in total case detection within a PPM area in order to determine if case detection
increases and/or reaches a specific target
· determine quality of case management by PPs and treatment outcome (in relation to targets and/or
in relation to quality and treatment outcome in public NTP facilities)
· monitor engagement and involvement of PPs
· monitor training and supervision activities within the PPM
· identify enabling and hindering factors for effective PPM
- Monitor the process of DBT
- Comparative study between different sectors
Data collection
The tools for PPM DOTS presented here could also function as data collection instruments for most
of the indicators listed in Table 2. A simple logbook for recording
PPM activities (meetings, educational activities, distribution of forms) will complement the data
collected through the use of forms. The use of such a logbook should start as soon as the planning of
the PPM starts. A routine for data retrieval and data management will have to be developed.
Questionnaires for PPs and RNTCP staff may be developed in order to obtain further information on
reported management, how forms have been used, and what experiences difference stakeholders
have had about PPM.
Guidance Note for PPM coordinators
Definition of Partner for Public Private Partnership:: Any registered entity which would include
NGOs, CBOs, federation of SHGs, Registered Medical Practitioners (Allopathic/AYUSH), clinics,
23
companies, nursing homes, hospitals, health care providers, individuals, organizations, bodies,
agencies etc. Registration should be under any of the Indian laws / Acts including but not limited to
Society Registration Act, Trust Act, Charitable Trust Act, Companies act, partnership firm,
Cooperatives Act etc
The PPP strategy is for reaching the unreached and also to reach patients even if they are
accessing private / other sector as RNTCP in this case would act as an enabler and not provider of
services.
The PPP seeks to form partnership in its true sense and thus the DTO and STO would provide an
enabling environment for the NGO/private partner adopting required flexibility and making sustained
efforts to provide Universal Access to TB care.
Designate a nodal person in state / district for coordination with NGOs-PPs/Private sector and
Central TB Division.
Ensure that NGOs are registered in DARPAN platform developed by National Informatics Centre
(NIC), the premier ICT Organisation of the Government of India under the aegis of Ministry of
Electronics & Information Technology (MeitY) , Government of India
(https://ngodarpan.gov.in/index.php/search/) while applying / forming partnership with NGOs.
Undertake assessment of gaps in health service delivery in RNTCP in different districts of your
state. Identify the geographical and functional gaps. The identified gaps would form the basis for
formation of partnership and this information may be displayed on your state website and office of
STOs/DTOs.
The cost of stamp paper (Rs.100) for signing the MOU to be borne by the SHS/ District Health
Society through its own budget.
Date of start of contract period to be decided mutually by the DTO & Partner on date of signing and
should be mentioned.
RNTCP to facilitate the process of development of annual work plan for the NGO/PP under
different partnership options.
RNTCP would monitor the performance of the PPP partner with outputs as agreed upon in the
annual workplan submitted by PPP partner.
Health System structure & functions for delivery of TB care
Delivery of TB care in the public sector
Healthcare is one of India's largest service sectors. Under the Indian Constitution, health is a state
subject. Each state has its own healthcare delivery system in which both public and private (for profit
as well as non-profit) actors operate.
The organization at the national level consists of the Union Ministry of Health and Family welfare
(MoHFW). In each State, the organization is under the State Department of Health and Family
Welfare that is headed by a State Minister and with a Secretariat under the charge of the Secretary/
Commissioner (Health and Family Welfare).
24
a) In 2005, NRHM was launched to provide accessible, affordable, accountable, effective and reliable
primary health care facilities, to the rural population, especially vulnerable groups. In addition, the
National Urban Health Mission (NUHM) was also launched to further strengthen urban health
structure and both NUHM and NRHM have been clubbed together under National Health Mission
(NHM) from 2013. The vision of NHM is “Attainment of Universal Access to Equitable, Affordable and
Quality health care services, accountable and responsive to people's needs, with effective inter-
sectoral convergent action to address the wider social determinants of health”.
b) NHM further aims to provide support to the existing national programmes of health and family
welfare including RCH-II, malaria, blindness control, iodine deficiency, filariasis, kala- azar,
tuberculosis, and leprosy and for integrated disease surveillance
c) RNTCP is one of the components under the National Health Mission which is a flagship scheme
under Govt. of India. The MoHFW follows equity-based approach to allocate funds under RNTCP to
various States. The overall allocation is made on the basis of population of the states, disease burden
and socio economic status. The financial management procedures for RNTCP are well established
and administered by the Finance Cell of the CTD. These procedures are documented in manuals and
guidelines available on the program's website.
I. Institutional arrangements: Overall responsibility for financial management of the program is with
the Central Tuberculosis Division (CTD), Directorate General of Health Services, Ministry of Health &
Family Welfare (DGHS) a part of the National Health Mission of the MoHFW. At state level these are
through state TB cell and at district level through state and district TB cell.
ii. Budget and release of funds: Program expenditures are budgeted in the Demand for Grants of
the MoHFW under the Disease flexi-pool funding arrangement under two separate budget lines for
Externally Aided Component (EAC) and General Component (GC).
iii. Funds flow: Funds flow for the program will remain within the existing financial management
systems of MoHFW, which operates through the centralized Pay of an Accounts Office. Funds are
being released to state in 2-3 instalments. All the states are required to submit the annual audit report
to CTD by 30th September.
National Level
Central TB Division (CTD) of Directorate General Health Services (DGHS) is the technical arm of the
Ministry of Health and Family Welfare (MoHFW). CTD, under the guidance of DGHS, manages the
National TB Control Programme for the entire country at the central level through a National
Programme manager, Deputy Director General TB (DDG TB). The financial and administrative control
of the Programme is managed by the Joint Secretary from the administrative arm of the MoHFW.
The CTD is supported by 6 national institutes: National Institute for Research in Tuberculosis (NIRT),
Chennai, National Tuberculosis Institute (NTI), Bangalore, National Institute of Tuberculosis and
Respiratory Diseases (NITRD), Delhi, National JALMA Institute, Agra, Regional Medical Research
Centre, Bhubaneshwar and BMHRC, Bhopal, and National Task Force of Medical Colleges. Various
committees of experts to guide the Programme at different levels on technical & policy matters are
there supporting Central TB Division.
State Level
The States have total ownership and accountability for the TB control in their state. State Health
Society or its equivalent under National Health Mission of the state manages the TB Control
Programme. A full-time State
Tuberculosis Officer (STO), trained at national level and based at the State TB Cell (STC), is
responsible for planning, training, supervising and monitoring the programme in all the districts of
their respective states. STO is administratively accountable to the State Government, technically
follows the instructions of the CTD, and coordinates with CTD and the districts and is assisted by
other technical& secretarial staff.
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State TB cell is being supported by State TB Training and Demonstration Centre (STDC) in many
states through its three units – a training unit, Supervision and monitoring unit and an Intermediate
Reference Laboratory (IRL) supporting an effective Quality Assurance system of the Sputum smear
microscopy network and lab services for PMDT (molecular DR testing and C&DST) in the State.
Each state also has one (1 for each 50 million populations at least) fully operational State Drug Store
(SDS). It is responsible for effective management of medicines and other logistics and ensuring
uninterrupted supply of good quality 1st & 2nd line anti-TB medicines for adults and pediatric
population.
District Level
The key level for the management of primary health care services is the district. The Chief Medical
Officer of Health (CMOH) / Chief District Medical Officer (CDMO) / Civil Surgeon or an equivalent
functionary in the district is responsible for all medical and public health activities including control of
TB. The District Tuberculosis Centre (DTC) is the nodal point for TB control activities in the district. A
full-time District Tuberculosis Officer (DTO), trained at national level & based at the DTC, is
responsible for planning, training, supervising and monitoring the Programme in the district. DTO is
assisted by other technical& secretarial staff. The primary role of the DTC is a managerial one.
Sub-District Level (Tuberculosis Unit Level)
Integrating the TB control Programme with the health system increases effectiveness and efficiency
of TB care and control. India's TB control Programme has been mainstreamed efficiently with
National Health Mission (NHM).
A major organizational change in RNTCP is the creation of a sub-district level (Tuberculosis Unit -
TU). The TU is the nodal point for TB control activities in the sub- district. TUs are based mainly in
NHM health blocks with the overall aim to align with NHM Block Programme Management Unit
(BPMU) for optimum resource utilization and appropriate monitoring. In urban areas the TUs have
been created based on a population of 1 per 2,00,000 (range 1.5 – 2.5 lakh).
The Tuberculosis unit (TU) consists of a designated Medical Officer-Tuberculosis Control (MO-TC),
as well as one fulltime supervisory staff - Senior Treatment Supervisor (STS). One Senior TB
Laboratory Supervisor (STLS) will continue to be in 5 lakh population and 1 TBHV per one lakh urban
population is there to support the urban TB control activities.
The Block Medical Officer also functions as a MO-TC who is trained in RNTCP at a state level
institution. MO-TC has the overall responsibility of management of TB Control Programme at the TU
and is expected to undertake supervisory visits for seven days in a month. The team of STS and
STLS are under the administrative supervision of the MO- TC and the DTO. The TU will have one
Microscopy Centre for every 100,000 population (50,000 in tribal, desert, remote and hilly regions)
referred to as the Designated Microscopy Centre (DMC). Microscopy Centres are also located in
Medical Colleges, Corporate hospitals, ESI, Railways, NGOs, private hospitals, etc.
Peripheral Health Institutions (PHIs)
For the purpose of RNTCP, a PHI is a health facility which is manned by at least a medical officer. At
this level, there are dispensaries, PHCs, CHCs, referral hospitals, major hospitals, specialty clinics or
hospitals (including other health facilities), TB hospitals, and Medical colleges within the respective
district. All health facilities in the private & NGO sectors participating in RNTCP are also considered
as PHIs by the programme. Some of these PHIs also function as
DMCs. PHIs undertake tuberculosis case-finding & treatment activities as a part of the general health
services. In situations where more than one MO is posted in any of the peripheral health centres, one
of them may be identified & entrusted with the responsibilities of the RNTCP.
The peripheral laboratories (Erstwhile DMC)
26
These are situated in the public sector like the dispensaries, PHCs, CHCs, referral hospitals, major
hospitals, specialty clinics / other sector hospitals / TB hospitals / Medical colleges and in the
private/NGO sectors. For establishment of microscopy centre in a lab, it must have adequate physical
infrastructure, Binocular microscope and a trained LT. These laboratories are covered under quality
assurance mechanisms
Some of the labs not having facility for sputum microscopy, function as a sputum collection centres,
and such facilities are also established in areas such as the tribal, hilly, desert and difficult to reach
areas of the country for improving the access to diagnostic services.
 Key personnel in RNTCP supervision
 STO- State Tuberculosis Officer
 DTO – District Tuberculosis Officer
 MO-DTC- Medical Officer- District Tuberculosis Center
 MOTC – Medical Officer–TB control
 MOIC – Medical Officer In-charge
 MOs – Medical Officers
 STS – Senior Treatment Supervisor
 CV- Community Volunteer
 STLS – Senior Tuberculosis Laboratory Supervisor
 LT – Lab Technician
 SA- Statistical Analyst
 NGO- Non-Govt Organization
 PP- Private Practitioner
 MPW- Multi Purpose Worker
 DEO- Data Entry Operator
 DP- DOTs Provider
RNTCP Structure
27
Terms of Reference (TOR) of District Private Public Mix Coordinator (DPPMC) under RNTCP
To assist the District TB officer (in co-ordination with State PPM coordinator) in field level
implementation of RNTCP & multi-sectoral coordination:
1. Implementation of PPM and ACSM activities at the district and sub-district level.
2. Assisting the DTO in mapping and line listing of all stake holders, identifying NGOs, Private
providers for partnerships and facilitating the process of partnerships.
3. Coordinating workshops / meetings for improving involvement of PPs & NGOs.
4. Collating the required information from NGOs / PPs / Partners to enable quality monitoring and
enhancing TB control activities.
5. Compiling necessary documents for disbursal of Grant in Aid to NGOs and PPs
6. Facilitating periodic review of partnerships with different stakeholders
7. Facilitate ACSM activities in coordination with the IEC officer and PPM partners.
8. Coordinating with the medical college / hospitals / teaching institutes / schools for improved
involvement in the program.
9. Coordinating with corporate / private hospitals for their involvement in the program.
10. Monitoring PPM activities of partners at field level on behalf of DTO
11. Prepare monthly and quarterly report of ACSM/PPM activities for DTO
12. Documentation of best practices of PPM partners for annual reports.
13. To facilitate change management with respect to use of ICT & Nikshay tools for concerned data
entry, validation & its use for public health action
14. Regular field visits & maintaining regular liaison with private provider, hospital, medical colleges,
CSO & other key stake holders.
15. Any other job assigned as per program need
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Advocacy Communication and Social Mobilization (ACSM)
There is an unmet need for improved advocacy, communication, and social mobilization (ACSM) to
support ongoing TB control efforts in most districts. Improved ACSM is expected to achieve the
following outcomes at community level:
 Mobilization of local political commitment and resources for TB
 Improved case detection and treatment adherence
 Empower people and communities affected by TB
 Reduced stigma and discrimination against persons and families affected by TB.
Active case Finding (ACF) activity
Active Case Finding (ACF) or Intensive case finding activity (ICF) is basically a provider initiated
activity with the primary objective of detecting TB cases early by active case finding in targeted
groups and to initiate treatment promptly. It can target people who anyway have sought health care
with or without symptoms or signs of TB and also people who do not seek care. Increased coverage
can be achieved by focusing on clinically, socially and occupationally vulnerable populations. It must
be remembered that ‘Screening’ is a dynamic process and the prioritization of vulnerable groups,
choice of screening approach and screening interval should be regularly reassessed by the
programme. Decisions on when and how to screen for TB, which vulnerable groups to prioritize and
29
which screening tool to use depend on the vulnerable group, the capacity of the health system, and
the availability of resources.
Prioritization of vulnerable groups for target:
Priority Urban area Rural area Tribal area
1 Slum Difficult to reach villages Difficult to reach villages &
hamlets
2 Prisons inmates Mine workers Villages with known higher
case load
3 Old Age homes Stone crusher workers Tribal school hostels
4 Construction site
workers
Populations groups with known
high malnutrition
Areas with known high
malnutrition
5 Refugee camps Populations known to drink raw
milk
Villages seeking care from
traditional healers
6 Night shelters Populations known to eat
uncooked meat
Populations known to drink
raw milk
7 NACO/SACS identified
HRG for HIV
NACO/SACS identified HRG for
HIV
Populations known to eat
uncooked meat
8 Homeless Weaving & Glass industrial
workers
Tribal areas with little
ventilated huts
9 Street children Cotton mill workers
10 Orphanages Unorganised labour
11 Homes for destitute Tea garden workers
12 Asylums Villages largely seeking care
from traditional healers
Activities by Community volunteer during ACF:
conducting household visit to target population,
Symptom screening of individuals,
ffering 2 sputum containers to all symptomatic person
xplain how to produce and collect sputum sample
Carry collected sputum sample to Designated Microscopy Center/Laboratories
Each ACF team (often called as Community Search Team-CST) will comprise of at least one health
worker from RNTCP (STS/STLS/TB-HV) + Community volunteer/ Partner Organization (NGO
outreach worker) + General health services (ANM/MPW/MPHS/ASHA/AWW/NUHM staff).
Generally 4-6 days has been allotted to screen around 800-1200 target group citizens (200-300
household) by each team. The DTO should decide on the team workload & team composition based
on available resources and population to be covered.
After household screening the target population eligible for sputum examination includes:
during last 6 months
30
-TB Treatment (previous / current)
House to House activity (HtH)
-t-h activity, micro plan with team day wise area maps should be used to visit all houses
systematically as per the micro plan. No house should be left unvisited.
inhabitants of the area are most likely to be available at their homes.
-to-house visits, teams should knock at the door and then enter each house.
their visit.
ermine correct
information, the team members have to go systematically and ask all the following questions in each
house:
by the number of ‘chullahs’ (kitchens).
or market place or school, visiting friends /relatives within the village or in other villages / cities, gone
out to their place of work, outside the house for any other reason?
detailed above. If household is not available screening may be done in the nearest health facility. The
members of the team should also enter details in the recording tool after every member of the family
is screened and mark every visited house as T/date or X/date with chalk or geru. Team members
should advise family regarding need & benefits of this campaign for TB patients and community. They
should try to address the queries and myths regarding disease and programme.
should thank the mukhiya/ head of the family and family
members as well for their cooperation and be doubly sure that all inhabitants of house have been
examined in the house.
he recording tool.
-to-
house search teams. Search teams must be specially trained to carry out search in these specific
situations .
31
Marking of houses by search teams:
T/date: When all persons staying in the house have been screened in this visit. This includes
persons visiting the house when the campaign is on.
X/date: All or some eligible inhabitants of the house were not screened for any reason (out of
house, locked door, refuse to share information etc)
EXAMPLES OF HOUSE MARKING
T-1 T-2 X - 3
---------- ------------ -----------
13/3/18 25/7/18 2/12/18
99DOTS Solution
99DOTS is a low-cost approach for monitoring and improving TB medication adherence. It can be
utilized either as a supplement to existing DOTS programs, or to enable remote observation of doses
administered by patients or their family members. Using 99DOTS, each anti-TB blister pack is
wrapped in a custom
envelope, which includes
hidden phone numbers that
are visible only when doses
are dispensed. After taking
daily medication, patients
make a free call to the hidden
phone number, yielding high
confidence that the dose was
“in-hand” and has been taken.
It is important to note that
99DOTS requires only a small
number of phone numbers. The numbers called by a patient may repeat over time; however, on each
blister pack, the numbers are arranged in an unpredictable sequence. As treatment progresses, the
sequence of numbers called is checked against the blister designs, thereby verifying that the patient
is taking medication as intended.
99DOTS patients receive a series of daily reminders (via SMS and automated calls). Missed doses
trigger SMS notifications to care providers, who follow up with personal, phone-based counseling.
Real-time adherence reports are also available on the web.
Compared to the current standard of care, 99DOTS offers three key benefits. First, it reduces
burden to the patients’: instead of traveling to a center for every dose, patients can provide
evidence of dosing from the comfort of their home. Second, it improves the efficiency of care
providers: instead of waiting weeks or months for adherence records to be digitized, supervisors can
view real-time adherence data for every patient and ensure prompt response to every missed dose.
Finally, 99DOTS enables differentiated care: instead of mandating that all patients receive frequent
counseling, adherent patients can proceed with less supervision, while limited program resources
are channelized to the cases that need the most attention.
Patient may register more than one phone number for 99 DOTS monitoring. Patients don’t need to
talk to anybody. Patients don’t need to answer any call. Timings of adherence call also depend on
32
patient’s free time. It’s toll free [minimum balance may be required to make an outgoing]. 99DOTs is
gaining popularity for all these flexibility & patient friendly designing!
Preference to be given to TB-HIV, Privately treated patient, patient living at migratory, tribal & hard to
reach areas!
DBT Scheme
Providing treatment enablers in the form of financial incentives and nutritional support can provide for
increased adherence and treatment success rates. To meet these twin objectives of adherence and
treatment support, the programme has launched a “Direct Benefits Transfer (DBT)” scheme to
financially aid TB patients.
There has been an increase in rural access to banking facilities over the years especially with the
recent push through PM “Jan-Dhan Yojana”. Subsequently DBT initiatives in social welfare schemes
have also shown promise, making it prudent that the program too adopts a similar approach towards
treatment enablers.
It is envisaged that this scheme will motivate all the beneficiaries to adhere the RNTCP guideline for a
better TB outcome. It is also envisaged to minimize the delay of incentive transfer, disparity, paper
worker, manual error etc.
A community health volunteer may help this DBT roll-out, if requested so, by collecting details of the
beneficiaries (when already available) or by facilitating to create Aadhar Card & Bank account (when
not available) of the beneficiaries.
Who are eligible for getting DBT?
As of now-
 All notified TB patients- for nutritional benefit
 Tribal Patient- Patients from the Notified Tribal Area only
 Treatment supporters & some other contractual staff
 Private providers who notify TB patient
Nutritional Support scheme to TB patients (Nikshay Poshan Yojana)
1. Scheme details / components:
Ministry of Health and Family Welfare, Government of India has announced the scheme for incentives
for nutritional support to TB patients. This scheme will be called “Nikshay Poshan Yojana”.
2. Beneficiary:
Each TB patient whether public or private sector notified must be notified on the Nikshay, platform.
3. Eligibility:
All TB patients notified on or after 1st April 2018 including all existing TB patients under treatment
who has at least two months of treatment remaining are eligible to receive incentives. The patient
must be registerednotified on the NIKSHAY portal.
4. Benefit:
33
Financial incentive of Rs.500/- per month for each notified TB patient for duration for which the patient
is on anti-TB treatment.
The scheme is registered under Direct Benefit Transfer. The incentives can be distributed in money
(only via DBT preferably through Aadhaar enabled bank accounts) or in-kind. The States has to take
the decision.
5. Start date: 1st April 2018
5. Funding: The scheme is a centrally sponsored scheme under National Health Mission (NHM).
7. Schedule of payment: Bi-monthly @1000 INR per transaction (500 x 2month)
34
Partnerships
Synergistic efforts of all stakeholders involved in TB control in India are the key towards realizing the
goal of “Universal access to TB care and treatment for all”. Revised National TB Control Programme
is working towards this goal with the basic philosophy that government is not the sole provider of
services for TB and optimum efforts should be made to utilize the resources in the private sector. In
this context an enabling environment should be created through regular interaction with partners
involved in TB control and promoting innovative TB control initiatives at district, state and national
level.
Definition
Partnership means an arrangement between any two or more entities; most often, government
owned entity on one side and a private sector entity on the other, for the provision of public assets
and/or public services, through investments being made and/or management being undertaken by the
private sector entity, for a specified period of time. Such arrangements may have options of receiving
performance linked incentives that conform (or are benchmarked) to specify and pre-determined
performance standards, measurable by the public entity or its representative.
This concept of partnership is much broader as compared to previous approaches of Public Private
Mix (PPM) under RNTCP which entailed strategies that link all entities within the private and public
sectors (including health providers in other governmental ministries) to the national TB programme for
DOTS expansion'. Involvement of all health care providers is necessary to achieve Universal access
to TB care.
Partnership Options
The National Guideline for Partnership was developed in 2014 on how different stakeholders can
supplement the efforts of the government for TB control in India. The National Guideline for
partnership consists of four thematic areas:
1. Advocacy Communication and Social Mobilisation (ACSM)
2. Diagnosis and treatment
3. TB & Co-morbidities
4. Programme Management
Health care providers in India
There is large number of health facilities run by public sector other than Ministry of Health & Family
Welfare under different ministries of centre / state governments as mentioned above. There are
corporate sector companies in the public sector like Coal India, SAIL etc. which run their own set ups.
Usually these facilities cater to a “captive population” who receive subsidized or free services from
said facilities.
35
Additionally ministries like defense, railways, home ministry etc. have their own medical services set
up and they have been involved at various levels under the RNTCP. The program had already
involved ESI, NTPC, Railways, CGHS, Coal, Prisons, Armed Forces, Mines and Port. Further there
are also health services offered by ITBP, BSF, CRPF, Assam Rifles, CISF and Ministry of Home,
apart from some local initiatives to involve these institutions.
There is integration of service delivery and reporting at the TU and district level with most of the
partners delivering health care through their own set up.
RNTCP has formed the National Technical Working Group on Public Private Mix to provide a forum
for dialogue, to ensure sustained attention on the issue, and guide innovation and learning. The group
provides guidance on technical aspects such as the inclusion of all internationally accepted regimens,
guidance on the scope and geographic distribution of initial projects, and policy requirements for
improved PPM. Institutional mechanisms to support the
States for effective contract management, hiring interface agencies to manage activities of engaging
private sector and other partnership-strengthening functions need to be developed.
RNTCP has proactively sought the involvement of NGOs in TB control activities. Using the
experiences gained from collaborations with NGOs and the private sector, the Central TB Division
has brought out the National Guideline for Partnership 2014 for engagement with all stakeholders.
However, RNTCP does not restrict to these guidelines alone and rather promote innovation for
reaching the goal of universal access to TB care. One example is flexibility as mentioned below.
Flexibility in budget for Partnership
Under this approach the states have been provided greater flexibility whereby they can utilize 30% of
their PPM budget for piloting new projects and innovations as per requirements of the state. The
states have been given the flexibility for utilization of 10% of their PPM projects for capacity building
and promotion of NGO-PP activities.
Process of Partnership
Before going into detail of each partnership option we need to understand the processes involved in
partnership formation which is crucial for the work of PPM Coordinators and Program Managers at
district and state level. The processes involved in partnership are:
The PPP strategy is for reaching the unreached and also to reach patients even if they are accessing
private / other sector as RNTCP in this case would act as an enabler and not provider of services.
Undertake assessment of gaps in health service delivery in RNTCP in different districts of your state.
Identify the geographical and functional gaps. The identified gaps would form the basis for formation
of partnership and this information may be displayed on your state website and office of STOs/DTOs.
NGOs and other partners must be involved for supplementing capacities in some key areas where
the formal health delivery system is unable to provide optimal services.
NGOs and other partners would be encouraged to work in unserved and underserved areas which
would be areas in hilly, tribal, desert regions or peri- urban areas and slums. The State and the
District Health Societies would have the flexibility to categorize unserved and underserved areas for
focused attention.
Private sector health care services are more concentrated in urban and peri- urban areas and
National Sample Surveys has consistently shown that vast majority of not only rich, but also poor
population do seek care from private sector. Attempts should be made to develop partnerships with
private sector, so that the goal of universal access can be achieved.
The process of renewal of MOU would be on the basis of performance as per the review and
quarterly reports submitted.
The updated list of approvals and collaborations must be maintained at the district and state level for
all partnership options. The updated list has to be updated in Nikshay.
The presence of these healthcare setups in the States/ districts needs to be prioritized and effective
communication channels and reporting mechanisms set up at the district and State levels.
36
Engagement of Professional Associations
Professional associations have a key role to play in TB control activities In India and any their
engagement and active involvement is important for stewardship in private sector engagement.
Organisations like IMA, Indian Academy of Paediatrics (IAP), Indian Nursing Association, Indian
association of medical microbiologists, Indian Public Health
Association etc. are key resources for dissemination of knowledge on diagnosis and treatment
guidelines in RNTCP and Standards for TB Care in India.
Pharmacist / Chemists involvement
RNTCP has signed MOU with Indian Pharmaceutical Association (IPA), All India Organization of
Chemists & Druggists (AIOCD), Pharmacy Council of India (PCI) and SEAR (South east Asia Region)
Pharm Forum representing World Health Organization (WHO) – International Pharmaceutical
Federation (FIP) Forum of National Associations in South East Asia for engaging pharmacists in
RNTCP for TB Care & Control in India. Pharmacists should be involved for early identification and
referral of presumptive TB cases for diagnosis, treatment supporter for TB patients, increasing
community awareness about TB and MDR-TB, patient education and counselling, promoting rational
use of Anti-TB drugs and contributing to preventing the emergence of drug resistance.
Laboratory involvement:
To reach all TB patients in India need to include dominant private sector and private laboratory is not
an exception.
Laboratories are engaged through partnership options under National guidelines of partnerships.
Additionally, to facilitate use and access to affordable and accurate tests endorsed by the World
Health Organization (WHO) and the Revised National TB Control Programme (RNTCP).
One of such mechanism is Initiative for Promoting Affordable, Quality TB Test (IPAQT). Under this
initiative, several private laboratories in India have agreed for not exceeding negotiated, ceiling prices
to patients, notifying the government of the cases diagnosed, promoting the use of these tests and
participating in external quality assurance
(EQA) and in exchange, they would get reagents at significantly reduced prices. In exchange for
offering lower prices, the manufacturers and distributors would receive greater and more predictable
volumes from the previously untapped private market.
Involvement of Medical colleges in RNTCP
To widen access and improving the quality of TB services, involvement of medical colleges and their
hospitals is of paramount importance.
The medical colleges in India have been involved under RNTCP in a structured task force mechanism
of National, Zonal and State level task forces in addition to the medical college core committee. The
main role of the NTF is to guide, provide leadership and advocacy for the RNTCP, recommend policy
suggestion regarding medical colleges' involvement in the RNTCP, coordinate with the Central TB
Division, and monitor the activities of the ZTF. ZTF facilitates the establishment & functioning of State
Task Forces (STF), coordinates between the national and STF, as well as between medical colleges
and the State/District TB Centres, and monitors the activities of STF.
STF facilitates establishment of Designated Microscopy Centres (DMCs) & Directly Observed
Treatment (DOT) centres, as well as other activities, in all the medical colleges in the respective
States. Core Committees, at the level of medical colleges facilitate inter-departmental coordination for
Programme implementation. Core committee meet every month. DMC and DOT Centres are
established in all government and private medical colleges and these are equipped with suitably
trained additional manpower in the form of Medical Officer (MO), laboratory technician (LT) and TB
health visitor (TBHV).
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18
Rntcp brief note for ppm coordinators final draft 21 05 18

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Rntcp brief note for ppm coordinators final draft 21 05 18

  • 1. Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB Brief Notes on RNTCP For The PPM coordinators (Draft Version) Compiled based on Partnership Guidelines 2014, TOG-2016, Revised PMDT Guidelines 2017, DBT schemes & Latest Govt Gadget notifications By Tuberculosis Health Action Learning Initiative (THALI) Project, Kolkata, West Bengal In association with STDC & RNTCP Team, West Bengal
  • 2. Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB Common abbreviations used in RNTCP ACF/ICF Active case findings/intensified case findings ADR Adverse drug reaction AE Adverse event AFB Acid Fast bacilli AIC Airborne infection control AIDS Acquired Immune Deficiency Syndrome ALT Alanine aminotransferase Am Amikacin Amx/Clv Amoxicillin/clavulanate ART Anti-retroviral therapy AST Aspartate aminotransferase ATS American Thoracic Society Bdq Bedaquiline BPL Below poverty line CAP Conditional Access Programme CBNAAT Cartridge Based Nucleic Acid Amplification Test CEM Cohort event monitoring Cfz Clofazimine Clr Clarithromycin Cm Capreomycin CMO Chief Medical Officer CP Continuation phase CPT Co-trimoxazole preventive therapy Cs Cycloserine CTD Central TB Division CUP Compassionate Use Programme C-DAC Centre for Development of Advanced Computing C-DST Culture and Drug Susceptibility Test CL-HIV Children living with HIV DAIDS Division of AIDS DBT Direct Beneficiary Transfer DCGI Drugs Controller General of India DDG Deputy Director General DDS District drug store DDR-TBC District DR-TB Centre DG Director General DGHS Directorate General of Health Services Dlm Delamanid DMC Designated microscopy centre DOT Directly observed treatment DRT Drug resistance testing DR-TB Drug-resistant tuberculosis DR-TBC Drug-Resistant Tuberculosis Centre DSMC Drug Safety Monitoring Committee DST Drug susceptibility testing
  • 3. Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB DTO District TB officer DVDMS Drug & vaccine distribution management system E Ethambutol ECG Electrocardiogram ECHO Extension of Community Health Care Outcomes EP-TB Extra-pulmonary tuberculosis EQA External quality assurance Eto Ethionamide EU European Union FDA Food and Drug Administration FEFO First expiry first out FL-LPA First line-line probe assay FO Field Officer FQ Fluoroquinolone GLC Green Light Committee GFATM Global Fund for AIDS, Tuberculosis & Malaria Gfx Gatifloxacin GMSD General Medical Stores Depot GoI Government of India H Isoniazid Hh High dose isoniazid HRCT High resolution CT scan ICH International Conference on Harmonization ICT Information communication technology ICMR Indian Council for Medical Research IP Intensive phase Ipm Imipenem IPAQT Initiative for promoting affordable & quality TB test IQC Internal Quality Control IRL Intermediate reference laboratory ISO International Standard Organization Km Kanamycin LC Liquid culture LFT Liver function test Lfx Levofloxacin L J Lowenstein Jensen LPA Line probe assay LT Laboratory technician LTFU Lost to follow up Lzd Linezolid MAC Mycobacterium avium complex MDR-TB Multidrug-resistant TB Mfx Moxifloxacin Mfxh High dose Moxifloxacin MGIT Mycobacteria growth indicator tube MIS Management information system MO Medical Officer MoHFW Ministry of Health and Family Welfare MO-DMC Medical Officer-designated microscopy centre MO-PHI Medical Officer- peripheral health institute
  • 4. Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB MO-TC Medical Officer TB control MOTT Mycobacterium other than tubercle bacilli MoU Memorandum of understanding Mpm Meropenem MPR Mixed pattern resistance MR Mono resistance MSS Monthly stock statement NAAT Nucleic Acid Amplification Test NABL National accreditation board for laboratories NDRS National Drug Resistance Survey NDR-TBC Nodal DR-TB Centre NGO Non-Government Organization NGS Next-Generation Sequencing NHPS National health protection scheme NHM National Health Mission NIRT National Institute for Research in Tuberculosis NITRD National Institute for Tuberculosis and Respiratory Diseases NRL National reference laboratory NSP National strategic plan NTI National TB institute NTM Non-Tuberculous Mycobacterium OBR Optimized background regimen Ofx Ofloxacin OPD Out Patient Department PAS p-aminosalicylic acid Pdx Pyridoxine PDR Poly drug resistance PHI Peripheral health institute PK/PD Pharmacokinetic/pharmacodynamics PL-HIV People living with HIV PMDT Programmatic management of drug-resistant tuberculosis PP Private Provider PQC Product quality compliance PSM Procurement and supply management PT Previously treated PTE Pre-treatment evaluation Pto Protionamide PvPI Pharmaco-vigilance programme of India QA Quality assurance QSE Quality System Elements R Rifampicin RNTCP Revised National Tuberculosis Control Programme RR-TB Rifampicin-resistant tuberculosis R&R Recording & reporting RT-MERM Real time medication event reminder monitor device S Streptomycin SA Statistical Assistant SAE Serious adverse event SDG Sustainable Development Goals SDS State drug store
  • 5. Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB SLD Second line anti-TB drugs SLDST Second line drug susceptibility testing SLI Second line injectable SL-LPA Second line-line probe assay SME Supervision, Monitoring & Evaluation SoP Standard operating procedures SPC Specimen Processing Control STLS Senior TB Laboratory Supervisor STO State TB Officer STR Standardized treatment regimen STS Senior treatment supervisor TALFU Treatment after lost to follow up TA Touch Agent TAT Turn-around time TB Tuberculosis TBHV TB Health Visitor THALI TB Health Action Learning Initiative Thz Thioacetazone ToR Terms of reference Trd Terizidone TU TB Unit UDST Universal Drug Susceptibility Testing ULN Upper limit of normal UPT Urine pregnancy test USAID United States Agency for International Development USFDA United States Food & Drug Administration WCO World Health Organization Country Office for India WHO World Health Organization WHP World Health Partners XDR-TB Extensively-drug resistant TB Z Pyrazinamide
  • 6. Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB District PPM coordinators training Agenda Organized by STDC and TB Health Action Learning Initiative (THALI) Project, WB, Venue: Conference Hall, STDC, Kolkata, WB Time Session topics Facilitator/s Day one (24/5/18) 10:00-10:30 Registration & Pre test Dr Abhijit, SrMC, THALI 10:30- 10:40 Self-introductions All 10:40- 11:00 Welcome address Director, STDC 11.00-11.10 Background, importance of the training Dr Milan Kumar Dinda, PD, THALI 11:10-11:20 Special address STO 11:20-11:30 Expectation from the participants Dr S. Parthiban, DPD, THALI 11:30-12:10 Epidemiology of TB, magnitude of the problem, Evolution of TB program in India- RNTCP , DOTs & NSP 2017-2025 Dr. Bipra, WHO Consultant, 12:10-12:20 Tea break 12:20-1:00 TB Sign symptoms, Types of TB, Comorbidities, Patient Pathway, & PSS Dr S. Parthiban, DPD, THALI 1.00-1.30 DST, UDST & TB Diagnostic algorithm & treatment as per TOG-16 Dr. Sandeep Roy, MO- STDC 1.30-2.00 Treatment of TB, FDC, Wt Bands & Treatment Outcomes Dr Bipra/Dr Dheeraj WHO Consultant 2.00-2.45 Lunch 2.45- 3:30 DR-TB Dr. Sandeep Roy, MO- STDC 3.30- 4:00 Program Monitoring & Nikshay Dy STO/ Dr Dheeraj, WHO Consultant 4.00-4:10 Tea break 4:10-5:00 Private Public Mix- Definition, Objectives of PPM, the structure of RNTCP and hierarchal position of a PPM coordinator State PPMC/ Dr S. Parthiban, DPD, THALI 5.00-5.45 Role & Responsibilities of a PPM coordinator Dy STO/ State PPM coordinator 5:45-6:00 Summary of the day, Proposal for homework Dr. Sandeep, MO- STDC /D.STDC/Dy STO Overall Floor Arrangements : Dr Abhijit, Sr MC, THALI Logistics: Mr. Debasis, Finance and Admin Associate, THALI, Documentation: Ms. Rupasree, Sr Associate, THALI
  • 7. Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB Day Two (25/5/18) 10:00- 10:30 Recap, homework discussions D.STDC/Dy STO/Dr Sandeep Roy 10:30- 11:15 ACSM & ACF State IEC consultant/ Isita 11:15- 11:45 Delivery of TB care in Private sector, TIPs to the PPM coordinators , Dr S. Parthiban, DPD, THALI/WHO Consultant 11:45- 12:30 Importance of TB notification, How to notify TB, Notification registers Dr Abhijit, SrMC, THALI/WHO Consultant 12.30- 12.40 Tea break 12:40-1.15 Adherence monitoring in private sector & other vulnerable groups; Public health action, 99 DOTs solution Dr S. Parthiban, DPD, THALI/WHO Consultant 12:45-1.15 DBT schemes, Nikshay Poshan Yojna Dy STO / State PPM coordinator/ Dr Dheeraj Tumu, WHO Consultant 1:15-1:45 Partnership- Definition, relevance & Process Dy STO/ WHO Consultant/ Dr Abhijit, SrMC, THALI 1:45-2:30 Lunch 2.30-3:30 Linking the TB Patients to social schemes, Coordination with other Health departments & experience sharing on linking the beneficiaries to social schemes in other sector Isita Roy Chakrobarthy CPA, THALI & Mr Marine Mukherjee, AD, CINI 3:30-4:15 Details of Partnership Schemes: Scheme I- ACSM Isita Roy Chakrobarthy CPA, THALI /Consultant/State IEC officer 4.15-4.30 Tea Break 4:30-5:15 Details of Partnership Schemes: Scheme II- Diagnosis & Treatment WHO/Dr Abhijit, Sr. MC,THALI 5:15-5:45 Details of Partnership Schemes: Scheme III- TB & Co-morbidities Parthiban/ Dr Abhijit, Sr. MC,THALI/WHO Consultants 5:45-6:00 Summary of the day, Proposal for homework STO/D.STDC/Dy STO
  • 8. Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB Day Three (26/5/18) 10.00- 10.30 Recap, homework discussions D.STDC/Dy STO/ 10.30- 11.30 Details of Partnership Schemes: Scheme IV- Program Management Dy STO/ WHO Consultant/Dr Abhijit SrMC, THALI 11.30- 12.15 Sensitization of PRIs, NGOs, PPs etc. Report writing by the PPMC, PD THALI /Isita Roy Chakrobarthy CPA, THALI/St IEC Consultant/ 12:15- 12:30 Tea break 12.30-1.45 Records, reports, different Tools, M&E Dy STO / State PPM coordinator/WHO/Vivek 1:45-2.30 Lunch 2.30-3:00 Leveraging Resources, Approaching the corporates- CSRs, Medical Colleges, THALI/WHO 3.00-4:10 District Action Plan Group work & Presentation Dist. PPMC & THALI 4:10-4:30 Post Test Dr Abhijit, SrMC, THALI 4.30-4.40 Tea break 4:40-:5.10 Question answers, Suggestions Recommendations & Open discussion , Some common issues & observation : Tips to the DPPMC ALL 5.10-5:30 Recaps , Feedback from trainees & Take Home messages D STDC/State PPM coordinator/THALI 5:30:-5.45 Distribution of Certificates STO/STDC Director/PD THALI/Dy STO 5.45-5.50 Vote of Thanks & closing remarks STO/D.STDC
  • 9. Brief notes on RNTCP for PPM coordinator-2018 - Draft version By THALI Project, WB CONTENTS Page No. Pre & Post Test Questionnaire 1 Aim of the training & Module Overview 3 Basics of Tuberculosis 4 Magnitude of Tuberculosis in India 4 Classification of Tuberculosis 5 Signs & Symptoms of Tuberculosis 6 Presumptive TB: Case definitions 6 Comorbidities 7 National Tuberculosis Programme 7 What is DOTS? 7 National Strategic Plan of Govt of India 2017-2025 8 NSP Targets : Outcome Indicators 9 How to diagnose Tuberculosis? 9 Drug susceptibility test (DST) 9 Universal DST (UDST) 10 Diagnostic approaches & Algorithms (as per TOG-16) 10 Treatment of Tuberculosis 12 FDC weight Bands & schedules 14 Outcome definitions 16 Drug resistant TB 16 Causes of drug resistance & how to prevent resistance 17 Integrated DR TB algorithm 18 DR-TB Durg dosages 18 Operational guidelines on Revised PMDT 19 Program Monitoring; Nikshay & e-Nikshay 20 PPM: Definition & Objectives 21 Guidance Note for PPM coordinators 22 Health system structures & functions at Public Sector 23 Key personnel in RNTCP supervision 26 Terms of reference (TOR) for District PPM coordinators 27 ACSM 28 Active Case Findings 28 99 DOTs 31 DBT Scheme & Nikshay Poshan Yojna 32 Schedule for payment in Nikshay Poshon Yojna 33 Partnership: Definition & Relevance 34 TB notification & latest gadget notification 37 IPC 269 & 270: Laws against negligent act to spread infection 37 Delivery of TB Care services in Private sector 38 Partnership schemes under RNTCP 39 Sensitization of PRIs, NGOs, PPs etc. & Role of PPM coordinator 46 H1 register & other format to capture TB Patient information from Pharmacy 48 TB Notification reporting formats (Annexure I, II & III) 49 Utilization certificate format for the NGOs 51 Universal Lab referral form: Revised Annexure 15A 52 Post Test 55
  • 10. 1 Pre & Post Test Questionnaire 1. Which of the following information is INCORRECT A. TB is a viral disease B. Mainly Sexually transmitted C. Genetic disease D. Usually blood, urine or stool is tested as a confirmatory test E. All 2. Symptom of TB A. Cough & Fever>2wk, weight loss B. Dry cough, high blood pressure & weight gain C. Distended abdomen, hematemesis & Melena D. Convulsion & sudden numbness E. ALL 3. Which is NOT TRUE regarding TB A. All TB patient should be tested for HIV & Diabetes Mellitus B. TB prevalence is more at urban & peri- urban area in comparison to Rural area C. One third population having latent TB infection D. At birth BCG gives total protection against Adult PTB E. All 4. Not a recommended test for active TB diagnosis in adult A. X-ray B. Sputum microscopy C. Sputum culture D. Gene xpert E. Mountoux skin test F. 5. TB bacillus cannot affect which organ A. GIT B. Gland C. Bone D. Uterus E. All can be affected by TB 6. Problem in private sector TB treatment A. Always bad quality medicine B. Lack of notification & follow-up C. Very few patient at Private sector so no focus from Govt D. Lack of medicine availability at Private sector E. All 7. Hurdles in TB elimination target A. Emerging drug resistance B. Lack of Community involvement & awareness C. Air pollution, smoking habit etc indirectly aggravating the disease incidence D. All E. Only A & B 8. Regarding treatment supervision & follow up of a PTB which is not true A. Sputum test needed at end of IP & end of CP B. If no AFB at the end of CP then also follow up sputum test at 12, 18 & 24 month C. Sputum positivity after treatment can be due to drug resistance D. All are true E. Only B & C is correct 9. Factors may leads to DRTB A. Lack of notification & proper follow-up B. Wrong dose/combination C. Incomplete treatment D. Infected from an already DRTB patient E. All 10. Not a correct cough etiquette- A. Handkerchief or tissue should be used B. If not available then palm can be used C. Arm/forearm can be used D. TB patient should use face mask for at least first two weeks of treatment E. B & C 11. What should not be done during treatment with ATT A. Consuming nutritious diet B. Refrain from alcoholism C. Using contraceptive D. Stop ATT if dark colored urine E. Complete the full course despite feeling healthy after sometime 12. Responsibility of a District PPM coordinator- A. Implementation of ACSM activities at the district and sub-district level. B. Coordinating with the medical college / Corporate hospitals / teaching institutes / schools for improved involvement in the program. C. Mapping and line listing of all stake holders, identifying NGOs, Private providers for partnerships and facilitating the process of partnerships. D. All E. Option A &C
  • 11. 2 13. Not true regarding pediatric TB A. Failure to gain weight & low grade fever can be a symptom of TB B. Sputum microscopy is the main diagnostic modality for a two year old child C. If mother/close care giver having active TB then INH prophylaxis should be given to children up to 6 years old D. Malnourished child has got more risk for contracting TB E. All are True 14. Advantage of community involvement A. Scope of getting more number of presumptive case & thereby early detection B. Community faith building C. Gather knowledge about community felt need & challenges D. Scope to clear misconception /myths about TB E. All 15. Regarding NSP 2017-2025 target which of the following is NOT TRUE – A. Proportion of notified TB patients receiving financial support through DBT should be 50% by 2018 & 90% by 2021 B. Proportion of private providers paid incentives/honorarium using DBT/PFMS should be 50% by 2018 & 90% by 2021 C. Proportion of patients from private sector who are provisioned or reimbursed by the program for anti TB drugs should be 50% by 2018 & 90% by 2021 D. Catastrophic cost for affected families due to TB should be 50% by 2020 E. ALL are TRUE 16. Who are NOT eligible for getting DBT? A. All notified TB patients from Private sector B. Treatment supporters C. Private providers who notify TB patient D. All notified TB patients from Public sector E. All Private Labs who are diagnosing TB using IGRA/TB Gold 17. Which of the following is NOT TRUE A. For notifying a microbiologically confirmed TB case a qualified doctor will get 500 INR & again after completion of treatment 500 INR B. Treatment supporter will get 1000 after completion of treatment of a Cat-I patient C. Family member/relative can also be act as a treatment supporter after orientation given by RNTCP D. Chemist/Pharmacist can act as a treatment supporter E. All are true 18. Which is the mandate of Universal DST A. All diagnosed TB patient should at least know their Rif sensitivity status B. All presumptive TB case should be diagnosed through CBNAAT C. All presumptive DR-TB case should be diagnosed through Culture & LPA D. All >15 yrs old case should go to upfront CBNAAT E. ALL 19. Which of the following scheme CAN NOT be implemented at Private / NGO sector as per RNTCP partnership guideline A. Establishment of Private DMC B. Establishment of Private DMC cum Treatment center C. Establishment of Private DRTB center D. Establishment of Sputum collection & transport mechanism E. ALL can be implemented 20. Which is NOT true regarding 99DOTs A. Priority should be given to the key population like TB-HIV, Privately treated patient & patients from Hard to reach area B. Mobile with Internet connectivity is a pre-requisite C. More than one mobile no. can be tagged with a patient D. 99DOTS patients receive a series of daily reminders (via SMS and automated calls). Missed doses trigger SMS notifications to care providers, E. ALL are true
  • 12. 3 AIM OF the Document: This document contains basic information about various aspects of tuberculosis and its control. It includes exercises on various activities and skills which the PPM coordinator has to perform while implementing the Revised National Tuberculosis Control Programme (RNTCP). District PPM coordinator is generally a health management or paramedical staff with mobility, who will assist DTO/STO to implement the partnership scheme at District/State level. Besides the summary of RNTCP technical & operational guideline 2016 this module will highlight the key points of Partnership guideline 2014. At the end of training the trainee will know what a PPM partnership is, the mutual benefits of participating in the partnership, basic information on other partners’ activities (increase in detection, new cases, improvement in referrals, etc). What is needed to implement this. What is expected from a PPM coordinator? Why partnership is essential to achieve the target of elimination of TB by the year of 2025. PPM coordinators Training Overview Description of the thematic areas Epidemiology of Tuberculosis Latest Diagnostic algorithm (TOG-16) Basics of DOTs Treatment of Cat-I & Cat-II DRTB basics Data monitoring, Nikshay DBT schemes 99 DOTS PPM- objectives TOR of PPM coordinators Different partnership schemes under RNTCP Monitoring & Evaluation tools Target Groups State & District PPM Coordinators Allocated time 2 days or 3 Days (with field visit , group work & presentation by the participants) Objectives To build capacity of PPMCs on RNTCP program objectives, how to make partnership with other departments & Private sector, how to evaluate the process of PPM Assessment plan Pre & Post Test, Group work, Group presentation & open interactive session Training flow - Part by Part Model agenda attached separately
  • 13. 4 BASICS OF TUBERCULOSIS: WHAT IS TUBERCULOSIS? Tuberculosis (TB) is a highly infectious bacterial disease caused by Mycobacterium tuberculosis. TB can affect any part of the body. When it affects the lungs it is called pulmonary TB. The commonest form (80-85%) of TB is pulmonary TB. TB in any other part of the body (i.e. other than lungs) is called extra pulmonary TB. TB affecting Lung as well as any extra pulmonary site(s) is also classified as Pulmonary TB. HOW DOES TUBERCULOSIS SPREAD? TB germs usually spread through air. When a patient with pulmonary tuberculosis coughs or sneezes, TB germs are spread in the air in the form of tiny droplets. When these droplets are inhaled by a healthy person s/he gets infected with tuberculosis. TB infection doesn’t always lead to the TB disease (active TB). Some factors like malnutrition, HIV- AIDS & other immune-compromised state of body, uncontrolled diabetes, silicosis & other chronic inflammatory lung disease act as a trigger factor for TB infection (Latent TB) to TB disease (Active TB) conversion. One sputum positive case, if not treated, can infect 10 -15 individuals in one year. Any infected person will have an average of 10% lifetime risk of developing tuberculosis. MAGNITUDE OF TUBERCULOSIS IN INDIA According to WHO global TB report 2017 - In India everyday • More than 7000 people develop TB disease • More than 1200 people die due to TB (i.e. nearly one person dies every minute) • It is estimated that in a year, about 211 TB cases are occurring in a population of 1 lakh • Annually, about 28 lakh new cases of TB occur of which about 20 lakh are sputum positive infectious cases • About 3 lakh children drop out from the school because of their parents had tuberculosis • More than 1 lakh women are rejected by their families because of stigma due to TB • Due to its devastating health & economic effect the World Health Organization declared Tuberculosis is a Global emergency in 1993
  • 14. 5 Classification Pulmonary Tuberculosis (Lung TB)- Tuberculosis affecting lung parenchyma with or without involvement of other anatomical site. Microbiologically Confirmed A patient with at least one of two samples of sputum found positive for Acid-Fast Bacilli (AFB) by microscopy or by culture or by rapid molecular test (like CBNAAT) is known as a Microbiologically Confirmed case. If AFB is identified through sputum smear microscopy it is called smear positive pulmonary TB. Smear-Positive Pulmonary TB is the most infectious form of Tuberculosis! Clinically confirmed or Probable TB Presumptive TB cases which are diagnosed as TB through various diagnostic modalities like Chest X Ray, Histopathology (Biopsy), Cytopathology (Fine Needle Aspiration Cytology - FNAC), Case (TB) Site of involvement Pulmonary Extra- pulmonary (e.g Gland TB, Plural TB, Milliary TB) TB Tratment History New Case Previously Treated Case Drug Susceptibility Drug Sensitive Drug Registant Mono-resistant (MR) (e.g-Isoniazid Resistant or H-Mono) Poly-resistant (PR) Multi-drug resistant (MDR) Extensively drug registance (XDR) Mixed resistance pattern Microbilogically Confirmed Clinically confirmed
  • 15. 6 Computerized Tomography Scan – CT), MRI, ADA, Mountoux etc., along with clinical correlation of symptoms will be known as Clinically confirmed TB. The program mentions that all clinically diagnosed cases should be attempted to get a Microbiological confirmation by testing the sample using CBNAAT in all pulmonary cases and smear negative cases. Extra-Pulmonary Tuberculosis (EP TB) A patient with active tuberculosis of any part of the body other than the lungs is a case of extra- pulmonary tuberculosis. Efforts must be made for all patients (adults, adolescents and children) with presumptive EPTB, to test appropriate specimens from the presumed sites of involvement in order to obtain microbiological confirmation preferably through CBNAAT. WHEN SHOULD TUBERCULOSIS BE SUSPECTED? Sign symptom of Tuberculosis Generalized symptom (May be seen in both PTB & EPTB) Symptom of Pulmonary TB (PTB) Symptom of Extra pulmonary TB (EPTB) Pulmonary TB Extra Pulmonary TB  Fever for two or more weeks, especially accompanied by night sweats  Loss of appetite  Significant weight loss  Weakness and fatigue  Cough for two or more weeks  Chest pain,  Shortness of breath with/without wheezing  Blood in sputum (hemoptysis) Depending on the site and extent of the involvement--- e.g.  Joint pain, stiffness – Joint TB  Swelling in the glands- Gland TB  Cold abscess/Tubercular abscess/fracture—Bone TB  Convulsion/altered sensorium/neck stiffness--- Meningeal/neural TB  Blockage of fallopian tube/infertility- Genital TB  Collection of fluid in abdomen (ascites)- abdominal TB (Liver/GIT/Peritoneal or other visceral TB) Case definition of Presumptive Pulmonary TB - (previously called TB suspects) Adult -- Any person with symptoms and signs suggestive of TB including cough >2 weeks, fever >2 weeks, significant weight loss (5% or more loss in last 3 month), hemoptysis and/or any abnormality in chest radiograph is called Presumptive TB. Prompt diagnostic evaluation must be made to rule out active TB. Children -- Children with persistent fever and /or cough >2 weeks, loss of weight /no weight gain for last 3 months, and /or contact with pulmonary TB cases in last 2 years must be evaluated for TB. Presumptive Extra Pulmonary TB In case of extra-pulmonary TB, symptoms in addition to the above mentioned, depends on the organ involved, for e.g.
  • 16. 7 • Lymph Node Tuberculosis – Swelling in the neck with or without discharging sinus. • Tuberculous Meningitis - Headache, fever, drowsiness, mental confusion, neck rigidity. • Spinal Tuberculosis – Back pain, fever and at times swelling of the backbone. CB-NAAT (cartridge-based nucleic-acid amplification test) is the preferred diagnostic test in Presumptive EPTB, commercially Called GenXpert Test) Co-morbidities Co-morbidities are certain clinical conditions which are more susceptible to TB infection AND/OR more likely to develop active TB disease after infection AND/OR more likely to cause severe TB and disseminated, extra-pulmonary TB AND/OR the TB Disease help progression of the condition. These includes & not limited to HIV-AIDS, Diabetes, Cancer, Renal Failure, Hepatic disease, immune compromised states, chronic lung disease, disease arises from substance abuse etc. Among these HIV & Diabetes are two most important co-morbidities. Program is now following some of the basic protocol, as mentioned below, to address the issue of co-morbidity.  All diagnosed TB patient must be screened for HIV & Diabetes  TB patients living with HIV infection should receive the daily regimen & FDCs wherever applicable & available. Now Daily FDC is recommended for all TB patients  Anti-retroviral therapy must be offered to all patients with HIV and TB as well as drug-resistant TB who require second-line anti-TB drugs, irrespective of CD4 cell-count, as early as possible following initiation of anti-TB treatment, Preferably after two weeks & within the first eight weeks if CD4 count is >50 ! (ATT & ART to be given simultaneously / within 2 weeks if CD4 count is <50)  Patients with TB and HIV infection should also receive Cotrimoxazole as prophylaxis for other infections.  People living with HIV (PLHIV) should be screened for TB using four symptom complexes (current cough or fever or weight loss or night sweats) at HIV care settings and those with any of these symptoms should be evaluated for ruling out active TB. All asymptomatic patients in whom active TB is ruled out, Isoniazid Preventive Therapy (IPT) should be offered to them for six months or longer. NATIONAL TUBERCULOSIS PROGRAMME The National Tuberculosis Programme (NTP) in India was being implemented since 1962 by establishing District Tuberculosis Centres (DTCs), TB Clinics and TB Hospitals. From its inception, the programme was integrated with the general health services and the service delivery was through the primary health care infrastructure. The results of NTP were not encouraging. The strategy of the NTP was reviewed in 1992. This led to the launching of the Revised National Tuberculosis Control Programme (RNTCP) in 1997, planning to cover the entire country by 2005. RNTCP is based on the internationally recommended strategy to control TB known as ‘DOTS’ (Directly Observed Treatment Short course) WHAT IS DOTS? DOTS is a systematic strategy which has five components- • Political and administrative commitment. TB is the leading infectious cause of death among adults. It kills more women than all causes associated with childbirth combined and leaves more orphans than any other infectious disease. Since TB can be cured and the problem can be controlled,
  • 17. 8 it warrants the topmost priority, which it has been accorded by the Government of India. This priority must be continued and expanded at the state, district and local levels. • Good quality diagnosis. Top quality microscopy allows health workers to see the tubercle bacilli and is essential to identify the patients who need treatment the most. • Good quality drugs. An uninterrupted supply of good quality anti-TB drugs must be available. In RNTCP, a box of drugs for the entire treatment is earmarked for every patient registered, ensuring the availability of the full course of treatment to the patient the moment s/he is registered for treatment. Hence in DOTS, the treatment will never fail for lack of medicine. • The right treatment, given in the right way. The RNTCP uses the best anti-TB medications available. But unless treatment is made convenient for patients, it will fail. This is why the heart of the DOTS programme is "Directly Observed Treatment" in which a health worker, or another trained person who is not a family member, watches as the patient swallows the anti-TB medicines in their presence. • Systematic monitoring and accountability. The programme is accountable for the outcome of every patient treated. The cure rate and other key indicators are monitored at every level of the health system, and if any area is not meeting expectations, supervision is intensified. The RNTCP shifts the responsibility for cure from the patient to the health system. DOTS � Makes the patient the VIP of the programme � Places responsibility for patient’s cure on the health system, not on the patient � Reduces risk to the community by preventing spread of TB � The best method to ensure cure � Empowers people with the disease and their communities through knowledge of the disease. � It allows all parties to be held more accountable to each other, fostering mutual interaction and a “positive partnership”. � Develops in tandem with the set Standards for Tuberculosis Care to promote a “patient-centered” approach, & adheres to the principles on health and human rights. The NSP for TB elimination 2017 -2025 The NSP for TB elimination 2017–25 is a framework to guide the activities of all stakeholders including the national and state governments, development partners, civil society organizations, international agencies, research institutions, private sector, and many others whose work is relevant to TB elimination in India. Vision, Goals and Targets of NSP The NSP proposes bold strategies with commensurate resources to rapidly decline TB in the country by 2030 in line with the global End TB targets and Sustainable Development Goal’s to attain the vision of a TB-free India. VISION: TB-Free India with zero deaths, disease and poverty due to tuberculosis GOAL: To achieve a rapid decline in burden of TB, morbidity and mortality while working towards elimination of TB in India by 2025.
  • 18. 9 HOW TO DIAGNOSE TUBERCULOSIS? All patients (adults, adolescents, and children who are capable of producing sputum) with presumptive pulmonary TB should undergo quality-assured sputum test for rapid diagnosis of TB (with at least two samples, including one early morning sample for sputum smear for AFB) for microbiological confirmation. Where available, chest X-ray should be used as a screening tool to increase the sensitivity of the diagnostic algorithm. CB-NAAT (cartridge-based nucleic-acid amplification test) is the preferred first diagnostic test in children, PLHIV, previously treated case. Sputum microscopy of at least two samples (preferably in the sequence of Spot-Morning) should be done only at an RNTCP designated microscopy center (DMC) or other RNTCP accredited Lab. A DMC is an identified sputum microscopy laboratory in a PHC, CHC or hospital for 1 lakh population (in tribal areas – 50,000 population). It is equipped with a binocular microscope, trained lab technician and is supervised by the Senior Tuberculosis Laboratory Supervisor (STLS) at regular intervals.  Serological tests are banned and not recommended for diagnosing tuberculosis.  TST and IGRA are not recommended for the diagnosis of active tuberculosis. Standardized TST may be used as a complimentary test in children only (vide algorithm) Drug susceptibility testing-DST Drug susceptibility testing means testing to find out if a person has got drug resistant TB or not. That includes finding out which drugs the TB bacteria in their body are sensitive & which are resistant. It is essential that if a person might possibly have drug resistant TB, that this is discovered as soon as possible, in order that the patient can be provided with effective TB treatment. Different types of drug susceptibility tests Outcome indicator : NSP 2017-2025 Baseline (2015) 2020 2023 2025
  • 19. 10 Drug susceptibility tests for TB are basically of two different types. One type of test is culture, which involves looking at how the bacteria behave. For example, do the bacteria grow in the presence of anti TB drugs? Another type of test involves looking at genetic mutations (Molecular Test). CBNAAT is now most widely used & preferred method for rapid molecular testing. Universal drug susceptibility testing (U-DST) The programme is committed to providing Universal Drug Susceptibility Testing (UDST) for all diagnosed and notified TB patients. Depending upon resource availability, this service is progressively being made available throughout the country. A range of rapid molecular tests are available for UDST, such as Cartridge Based Nucleic Acid Amplification Test (CBNAAT) and Line Probe Assay (LPA). In the past, patients were offered DST based on their risk of developing drug resistance. Over time, DST has been increasingly made available to the patient to lower levels of risk. Currently, all diagnosed TB patients are routinely offered at least the R resistance test. The revised DRTB algorithm (2017) also recommended upfront DRT (CBNAAT) for presumptive TB cases from selected key population (PLHIV, <15 yrs., EPTB, Smear –ve but X-ray suggestive) for reliable and early microbiological confirmation and in these patients, R resistance information is available as a byproduct. There are several additional DST technologies in the development pipeline. These tests will be made available progressively as they are endorsed for use by WHO. Recently, WHO endorsed LPA for use for DST of FQ class and SLI class. Currently, LPA labs are in preparation for rolling out this facility while DST on CBNAAT is offering more accurate and wider testing of resistance to R which is also in various phases of development. Approach to Presumptive TB Case & the Diagnostic Algorithms as per TOG-2016
  • 20. 11
  • 21. 12 TREATMENT OF TUBERCULOSIS  TB is curable  To be cured of TB a patient must start treatment immediately after being diagnosed by a doctor after microbiological confirmation.  Patients must take their medicines regularly and complete the course of treatment.  After 2 to 3 weeks, patient usually stops spreading the infection.  Anti-TB drugs may have some common side effects. The side effect includes: vomiting, nausea, loss of appetite, joint pain, orange/red urine, skin rash, weakness, giddiness  These common side effects usually diminish as the body gets used to the medicines within 1-2 weeks. However, if they persist it is better to take advice from the doctor.  If any serious side-effects appear, report these to the doctor but stopping the medication without doctors advise could be even more dangerous. The duration of treatment is usually 6 to 8 months. There are two phases in the treatment of tuberculosis: the intensive phase (IP) of 2-3 months and the continuation phase (CP) of 4-5 months, depending upon the category of treatment. During IP, all doses are given under direct observation, Thereafter, sputum or other relevant sample is examined and if found negative, the CP is started. If found positive then DST/CBNNAT is done & if found drug sensitive then also CP is started. Prolongation of IP is no more recommended. If found drug resistant then the patient is put on appropriate DRTB regimen. At the end of CP also similar test is performed & action taken as per result of such tests & evaluations. Type of Treatments It is very important that patients receive the correct TB treatment. This usually means that they must receive the correct TB drugs, correct combination, correct duration & correct dosage (weight band). Types of treatments are different for different types of TB. Treatment for new TB patients All new TB patients in India should receive an internationally accepted first line treatment regimen (a regimen is the prescribed course of treatment, in this case the TB drugs) for new patients. The initial intensive (IP) phase should consist of eight weeks (2 month) of the drugs Isoniazid (H), Rifampicin (R), Pyrazinamide (Z) and Ethambutol (E). The continuation phase (CP) should consist of the three drugs Isoniazid, Rifampicin and Ethambutol given for another sixteen weeks (4 month). This is alternatively written as 2HREZ + 4 HRE. There may be need for extension of the continuation phase for another few weeks to few months in some form of EPTB like bone or neural TB. Extension of IP phase is not recommended.
  • 22. 13 Previously treated patients With patients who have had treatment before, MDR-TB or R resistance must firstly be ruled out by a quality assured test. Then if the TB patient is a previously treated patient as defined above, they should then receive the retreatment regime (2HREZS+1HREZ) + 5HRE containing first line drugs in a similar way to new TB patients. The main difference is the addition of streptomycin to the intensive phase. It is not usual to add one TB drug to a failing regimen as this can encourage the development of resistance. But it may be considered that this is still sensible guidance as MDR-TB and rifampicin resistance will have already been excluded. So it is essential that this testing for additional resistance is done. However, the effect on the patients could still be considerable. Streptomycin has to be painfully injected, and its common side effects include a loss of hearing. Daily Regimen: Under the new daily drug regimen, TB patients will be given fixed dose combinations (FDCs) – three or four drugs in specific dosages in a single pill – on a daily basis. The drugs will also be administered in a more scientific manner, according to the patient’s weight. The biggest advantage for the patient under the new regimen will be reduced pill burden, as instead of seven tablets, patients need consume only 3-4 tablets, according to their weight band. Fixed dose combinations A fixed dose combination (FDC) is when two or more drugs are combined together in a single pill or tablet. Fixed dose combinations are helpful as they simplify getting TB drugs and the delivery of DOTS. They may also increase adherence. Individually worked out drug dosing should be only used for patients with toxicities or contraindications to one or more parts of the FDC. Fixed dose combinations of four drugs (Isoniazid, Rifampicin, Pyrazinamide and Ethambutol) i.e. 4FDC (for adult), three drugs (Isoniazid, Rifampicin and Ethambutol) i.e. 3FDC for adult, three drugs (Isoniazid, Rifampicin and Pyrazinamide) i.e. 3FDC for children and two drugs (Isoniazid and Rifampicin) i.e 2 FDC (for children) is now available. Patient wise boxes (PWB)
  • 23. 14 The TB drugs for RNTCP patients are supplied in an individual patient wise box which contains the entire course of treatment for the patient. In each patient wise box there are two pouches. One is for the intensive phase and the other is for the continuation phase. The patient wise boxes are colour coded. Red boxes are for new patients, sometimes referred to as category 1. Blue boxes are for previously treated patients and are sometimes referred to as category 2. For paediatric TB patients separate patient wise boxes have been developed. FDC weight bandings:- Daily FDCs are given according to the weight of the patients. WHO recommended new weight banding made TB treatment simpler more than ever The following dosing table provides information on the number of daily tablets needed to reach the proper dosing, based on the patient’s weight: Figure 1: RNTCP Patient wise box (PWB) for children
  • 24. 15
  • 25. 16 Treatment Outcome definitions (DSTB): 1. Cured: Microbiologically confirmed TB patients at the beginning of treatment who was smear or culture negative at the end of the complete treatment. Note: a microbiological positive report at diagnosis and microbiological negative report at end of treatment are both required. 2. Treatment completed: A TB patient who completed treatment without evidence of failure or clinical deterioration BUT with no record to show that the smear or culture results of biological specimen in the last month of treatment was negative, either because test was not done or because result is unavailable. 3. Failure: A TB patient whose biological specimen is positive by smear or culture at end of treatment 4. Lost to Follow-up: Patient whose treatment was interrupted for 1 consecutive month or more 5. Not Evaluated: Patient could not be tracked due migration/transfer out or some other cause OR Patient has TB diagnosis withdrawn (by a qualified doctor) OR Patient's anti-TB treatment had to be stopped for indefinite period due to life-threatening adverse reaction. 6. Treatment Regiment Changed: A TB patient was put on first line regimen, who has been diagnosed as having DRTB and switched to drug resistant TB regimen prior to being declared as failed. 7. Died: Patient who has died during the course of anti-TB treatment Drug resistant TB in India – Categories, DOTs Plus (Now PMDT) , treatment Drug resistant TB in India Drug resistant TB has frequently been encountered in India and its presence has been known virtually from the time anti TB drugs were introduced for the treatment of TB. If a person has drug resistant TB it means that their illness will not respond to at least one of the first line TB drugs. Traditionally, the view in India has been that drug resistant TB is not easily transmissible. So it was believed that most drug resistant TB in India arose from the failure of people to take their anti TB drugs properly, rather than from them becoming infected with an MDR TB strain. So a high quality DOTS program, which includes supervising people taking their drugs should prevent the emergence of resistance. This belief was based largely on animal studies. It had then been found that drug resistant bacilli were not less infectious. In fact people who contact with previously untreated patients had had a similar risk of infection regardless of whether the bacilli were drug susceptible or drug resistant. PMDT DOTS-Plus refers to a DOTS service with additional elements for drug resistant TB. In 2007 DOTS-Plus was launched for the management of drug resistant TB. By 2012 the DOTS-Plus service (now referred to as the “Programmatic Management of Drug Resistant TB” ) had been expanded across the whole country and by 2013 the service was available in all districts. By this time it had though been decided to decentralize the DOTS Plus services. The services were to be totally integrated into the main RNTCP services at local level.
  • 26. 17 In addition, treatment categories I & II became the treatment regimens for new and previously treated patients. Category III was phased out, and two new categories were introduced. These were Category IV for patients requiring treatment for MDR TB, and category V for patients requiring treatment for XDR TB. As per revised PMDT guideline 2017 these category concept has been changed. The guideline has proposed total 12 regimens for the DRTB. As per RNTCP 2016 data treatment success rate among notified DRTB was only 46% !! Causes of drug-resistant tuberculosis From a microbiological perspective, the resistance is caused by a genetic mutation that makes a drug ineffective against the mutant bacilli. In clinical settings, an inadequate or poorly administered treatment regimen allows drug-resistant mutants to become the dominant strain in a patient infected with TB. Clinical characteristics of patients have also been recognized where appropriately administered drugs have not achieved necessary drug levels to deal with all populations of mycobacteria. From a programmatic perspective, weak TB services lead to delay in detection and effective treatment of drug resistance and are unequipped to support patients to keep adherence to treatment and prevent ongoing transmission. Prevention of drug-resistance The problem of DR-TB cannot be addressed completely by standalone systems for detection and treatment of drug-resistance. Strong systems to detect successfully treat and ensure long term disease-free status of TB patients, are required to prevent emergence of resistance. Thus, basic TB diagnostic and treatment services should receive priority and systems for early detection and treatment of drug-resistant forms of TB which should be integrated into existing TB services. Improperly treated patients with resistant strains of TB will constitute a source of ongoing transmission of resistant strains. Health care facilities and congregate settings lacking of proper infection control measures as recommended by WHO contribute to maintain transmission. The interruption of transmission and not only rapid detection and immediate enrolment on effective regimens are therefore necessary to prevent the emergence of new DR-TB patients. Measures to prevent incidence and transmission of TB are also effective in prevention of drug- resistance. The framework for PMDT considers the following steps as most important to check the menace of drug resistance- Move to patient-centric care Successful treatment and care can only result when patient preferences, values and needs are satisfactorily addressed along with PMDT services. This includes ensuring that the diagnosis of DR- TB is early, accurate and affordable; and the most effective treatment is delivered early and provided in a manner that is easily accessible to the patient, affordable and socially acceptable. At the same time it must ensure that the confidentiality and dignity of the patient is protected. It is the responsibility of the health system to make sure that the patient is treated successfully within the society s/he belongs to, enjoying all support which the community would otherwise provide to its members so that the new chain of infection is arrested at source and the cured member enriches his/her material, social and cultural assets. Prevention, management and mitigation of stigma and discrimination are essential elements of a patient-centered care approach to TB management.
  • 27. 18 When PMDT (erstwhile DOTS Plus) was first rolled-out in India in 2007-- failures after treatment with Category I for new TB patients or Category 2 for previously treated TB patients only were considered as presumptive MDR-TB patients. Later, patients remaining smear positive during any follow-up, patients with history of previous TB treatment, TB-HIV, Treatment Non-responders and TB patients who are close contacts of DR-TB were added to the presumptive list. Most recently all diagnosed TB cases are to be considered as presumptive DRTB & should be offered DRT (CBNAAT) Decentralized DR-TB management Previously, guidance was largely provided for centralized PMDT treatment initiation in inpatient settings. This version provides guidance on both inpatient and outpatient based treatment initiation for providing increased access to PMDT services. Inpatient-care for those who require it on medical grounds and drug supply chain management have been decentralized down to the district level. Every district should establish a District DR TB Center to be guided by District DR TB Committee for decentralized DR-TB management. Drug dosage and administration The dosage of drugs would vary as per weight of the patients. Patients would be classified in weight bands of <16 kg, 16-29 kg, 30-45 kg, 46-70 kg and >70kg. All drugs in the regimen are to be given on a daily basis under observation. Injectable will be administered for six days/week (excluding Sundays). All morning doses are to be supervised by the treatment supporter (can be Govt health worker, CV or family member of the patient). After taking the morning doses on Saturday, next day’s oral drugs would be given to the patient to be taken at home on Sunday. Empty blisters of medicines
  • 28. 19 taken unsupervised in the evening and on Sundays are to be collected by treatment supporter. In cases of drug intolerance – E, Cs and Na-PAS can be given in divided doses (twice a day). The dosage for drugs used in various DR-TB regimens by weight bands that is in accordance to the WHO recommended doses of anti- TB drugs for adults and pediatric patients. Treatment support to DRTB Patient Treatment support is the compendium of services provided to the patient enabling them to successfully complete the treatment. These services include therapeutic, emotional, social and financial support. Integration with social scheme, counselling, adverse drug reaction monitoring , appropriate & timely follow-up evaluation is the key to success. Operational guidelines on revised PMDT 1) If RR-TB is detected, the patient is immediately referred for pre-treatment evaluation and treatment initiation for DR-TB within 1 day of receipt of results. While the RR-TB patient is undergoing pre-treatment evaluation, the Senior DR-TB TB-HIV Supervisor, STS and TBHV should ensure an initial home visit to verify the address and meet the family members. A Treatment supporter (who can either be a health care worker, community worker/ volunteer or private practitioner) should be identified in consultation with the patient. The Treatment centre can either be at the sub centre of the health system or in the community. If a family member is identified as Treatment supporter, he should be trained to give medication under supervision at the residence, under close monitoring by TBHV/STS. The Treatment supporter should also be given training for drug administration, identification of adverse effects during treatment, frequency of follow-up and record keeping. During IP, appropriate arrangement for injections should be done. 2) The results of SL-LPA have to be made available to the districts within 5 days of specimen submission for all samples that are smear positive at the CDST lab. For smear negative samples the results will have to be made available within 15 - 30 days. The reason for further delay if any has to be mentioned in 15 A by the CDST labs and that will be recorded in the treatment card of patients. The LPA laboratory must report whether the specimen is resistant to all SLIs (i.e., rrs mutation) or only Km (eis mutation). The results of LC DST are expected to be available after 6-8 weeks of specimen submission. 3) Nikshay entry of cases found to have resistance in SL-LPA have to be mandatorily entered on the same day at the CDST labs so that districts and DR TB sites can access that without time lag and take further action. 4) NDR-TBCs by default will also act as DDR-TBCs. Such districts can have an additional DDR-TBC if required for convenience to patients. All districts those who have not yet made their DDR-TBC functional will have to make them so within 25th May, at least on OPD basis and provide DDR TBC Ids to patients. 5) All RR-TB patients will be initiated on the shorter MDR-TB regimen as the 1st choice after pre-treatment evaluation is completed excluding those who have history of intake of Flourquinolone (FQ) and 2nd line injectable (SLI) more than 1 month. Pregnant women and EPTB patients other than Pleural Effusion and Lymph node TB will also be excluded. The DDR-TBC Committee can decide on a case-to-case basis, the need for admission for DRTB patients for initiation of treatment. For majority of cases it is expected that SL-LPA results will be available during the pre-treatment evaluation. For the remaining cases the results will be available within 15 - 25 days. Based on results, if no additional resistance is detected, the patient will be continued on the same short course regimen. Only those
  • 29. 20 patients excluded from shorter course regimen will be put on conventional MDR regimen till SL LPA results are available. 6) All patients (whether started or not started on short course / conventional regimen) with additional resistance to FQ class or SLI class on SL-LPA would be assessed for eligibility for newer drug containing regimen. Patients who have consented and are found to be eligible (considering exclusion criteria and other parameters) would be initiated on Bedaquilline (BDQ) containing the regimen while rest of the patients would be initiated on a DST guided regimen and reclassified. All Medical Colleges who have NDR TBC and those NDR TBCs who have an ECG machine will have to start assessing patients for BDQ containing regimens as the first choice. At present the state level decision is to keep patients started on BDQ admitted for at least 2 months. 7) All patients (whether started or not started on short course / conventional regimen) with additional resistance to FQ class or SLI class on SL-LPA and cannot be started on BDQ containing regimen has to be put on the DST guided regimen mentioned in the new Guidelines on programmatic management of drug resistant TB in India, 2017 at the NDR TBCs. 8) If a patient is resistant to both FQ and SLI on SL-LPA or to any of the drugs of the other class, in LC-DST (results available after 6 to 8 weeks), the patient will be reclassified as XDR-TB or mixed pattern resistant according to the new guidelines on page 65. All Medical Colleges who have NDR TBC and those NDR TBCs who have an ECG machine will have to start assessing patients for BDQ containing regimens for such patients as the first choice. Otherwise DST guided regimens will be started. There is no scope to continue on conventional MDR or XDR regimen any more. 9) Initiation of new drugs and DST guided regimen and any regimen change, will have to be started at the NDR TBCs Programme monitoring Monitoring is the process of observing whether an activity or service is occurring as planned. It implies systematic and purposeful observation, aiming to identify any diversion from the planned course of action. It is a routine tracking of programme using input, process, output and outcome data collected on a regular and ongoing basis. This helps identify the need for more formal evaluation of activities and find timely solutions to the problems. Monitoring in TB programmes is of paramount importance for ongoing programme planning and implementation. A good monitoring strategy moves beyond the widely used case detection and treatment outcome indicators and applies the concept of input, process, output, outcome and impact indicators for measurement of key programme activities. Monitoring indicators: Various components of programme service delivery are fed in NIKSHAY from where various input, process and outcome indicators are drawn for different levels of health facilities. Analysis of these indicators will help in monitoring improvement in programme performance. NIKSHAY NIKSHAY is the web-based platform for the National Tuberculosis Programme Surveillance System. It envisages establishing a state-of-art surveillance system with system utilization by 100% stakeholders, ensuring 100% notification of TB patients at diagnosis (microbiologically confirmed and clinically diagnosed). The programme envisions enabling tracking of all registered TB patients across TB elimination lifecycle, geographies, transfers and referrals. The first step is to ensure complete the entry in all formats of R&R. Dashboard functions to track activities and online monitoring indicators with graphical and geo-mapping displays in
  • 30. 21 NIKSHAY/e-NIKSHAY is helpful in programme monitoring provided completeness of data entered is ascertained. Primarily, the source of information for all monitoring indicators will be NIKSHAY. e-NIKSHAY In an attempt to reduce the TB burden in the country, it is envisaged that an ICT system such as e- NIKSHAY could help with coordinated planning and action that is required at various levels. The goal would be to develop a common integrated platform as an open system to engage ecosystem stakeholders towards effective, timely and quality assured diagnosis and effective treatment of TB. It would essentially use a case-based approach to the TB lifecycle, enabling patient based tracking using unique ID and monitoring allowing for stakeholder integration, as well as timely and accurate reporting and real time decision support. PUBLIC PRIVATE MIX (PPM) A partnership between government and the private sector for the purpose of more effectively providing services and infrastructure traditionally provided by the public sector. It is widely recognized that a large proportion of TB patients seek care from private providers, mainly outside the network of Revised National Tuberculosis Control Program (RNTCP). These include private (for profit and not-for profit) providers and private healthcare institutions and they do not usually follow the recommended DOTS strategy for management of TB, hence depriving patients of quality management and treatment. Objectives To achieve the NSP targets (by implementing different Schemes/incentives & enablers). Some of the notable targets of NSP are as below- a) Proportion of notified TB patients receiving financial support through DBT should be 50% by 2018 & 90% by 2021 b) Proportion of private providers paid incentives/honorarium using DBT/PFMS should be 50% by 2018 & 90% by 2021 c) Proportion of patients from private sector who are provisioned or reimbursed by the program for anti TB drugs should be 50% by 2018 & 90% by 2021 d) Proportion of treatment supporters paid incentives/honorarium using DBT/PFMS should be 80% 2018 & 100% by 2019 e) Proportion of patient provider support agency (PPSA) units established at the state & district level- should be 80% by 2018 & 100% by 2019 And by all these it is targeted to achieve-  Proportion of notified TB patients offered DST will be 80% by 2020 & 100% by 2025  Proportion of notified patients initiated on treatment will be 90% by 2020  Treatment success rate among notified DSTB will be 90% by 2020  Treatment success rate among notified DRTB will be 65% by 2020 & 75% by 2025  Catastrophic cost for affected families due to TB will be “0” by 2020 How to implement DOTS through PPM Case management procedures should be followed by Private provider (PP) including:
  • 31. 22 Identification of TB suspects. Diagnosis of Pulmonary TB through sputum smears microcopy / molecular technique Patients and their relatives should be educated about TB and treatment, TB drugs should be provided free of cost to the patient from the local GP's clinic, Directly observed treatment (DOT) should be arranged for the intensive phase in all new cases and the whole of the re-treatment regimen Lost to follow-up cases should be traced, PPM organization in the district TB care is integrated within Primary Health Care (PHC) services, so that continuing care is provided close to the patient. The strengthening and maintenance of quality services are extremely important involving all levels of healthcare facilities (both public and private) as well as community leaders such as LHW, Imam, teacher and health staff. The following are the recommended organizational arrangements of TB control at district level: The Chief Medical Officer Health (CMOH) has overall technical and administrative responsibilities for TB control activities in the district. District TB officer (DTO) is the nodal point at a RNTCP District for TB program. District PPM coordinator will work directly under the guidance & supervision of the DTO & will help DTO for field level implementation of universal access to TB care & will maintain liaison with other health & non-health depts./stakeholders Monitoring and evaluation A strategy for monitoring and evaluation of the PPM is advisable. Its purpose may be to: · determine rate of referral, detection and notification by PPs · monitor change in total case detection within a PPM area in order to determine if case detection increases and/or reaches a specific target · determine quality of case management by PPs and treatment outcome (in relation to targets and/or in relation to quality and treatment outcome in public NTP facilities) · monitor engagement and involvement of PPs · monitor training and supervision activities within the PPM · identify enabling and hindering factors for effective PPM - Monitor the process of DBT - Comparative study between different sectors Data collection The tools for PPM DOTS presented here could also function as data collection instruments for most of the indicators listed in Table 2. A simple logbook for recording PPM activities (meetings, educational activities, distribution of forms) will complement the data collected through the use of forms. The use of such a logbook should start as soon as the planning of the PPM starts. A routine for data retrieval and data management will have to be developed. Questionnaires for PPs and RNTCP staff may be developed in order to obtain further information on reported management, how forms have been used, and what experiences difference stakeholders have had about PPM. Guidance Note for PPM coordinators Definition of Partner for Public Private Partnership:: Any registered entity which would include NGOs, CBOs, federation of SHGs, Registered Medical Practitioners (Allopathic/AYUSH), clinics,
  • 32. 23 companies, nursing homes, hospitals, health care providers, individuals, organizations, bodies, agencies etc. Registration should be under any of the Indian laws / Acts including but not limited to Society Registration Act, Trust Act, Charitable Trust Act, Companies act, partnership firm, Cooperatives Act etc The PPP strategy is for reaching the unreached and also to reach patients even if they are accessing private / other sector as RNTCP in this case would act as an enabler and not provider of services. The PPP seeks to form partnership in its true sense and thus the DTO and STO would provide an enabling environment for the NGO/private partner adopting required flexibility and making sustained efforts to provide Universal Access to TB care. Designate a nodal person in state / district for coordination with NGOs-PPs/Private sector and Central TB Division. Ensure that NGOs are registered in DARPAN platform developed by National Informatics Centre (NIC), the premier ICT Organisation of the Government of India under the aegis of Ministry of Electronics & Information Technology (MeitY) , Government of India (https://ngodarpan.gov.in/index.php/search/) while applying / forming partnership with NGOs. Undertake assessment of gaps in health service delivery in RNTCP in different districts of your state. Identify the geographical and functional gaps. The identified gaps would form the basis for formation of partnership and this information may be displayed on your state website and office of STOs/DTOs. The cost of stamp paper (Rs.100) for signing the MOU to be borne by the SHS/ District Health Society through its own budget. Date of start of contract period to be decided mutually by the DTO & Partner on date of signing and should be mentioned. RNTCP to facilitate the process of development of annual work plan for the NGO/PP under different partnership options. RNTCP would monitor the performance of the PPP partner with outputs as agreed upon in the annual workplan submitted by PPP partner. Health System structure & functions for delivery of TB care Delivery of TB care in the public sector Healthcare is one of India's largest service sectors. Under the Indian Constitution, health is a state subject. Each state has its own healthcare delivery system in which both public and private (for profit as well as non-profit) actors operate. The organization at the national level consists of the Union Ministry of Health and Family welfare (MoHFW). In each State, the organization is under the State Department of Health and Family Welfare that is headed by a State Minister and with a Secretariat under the charge of the Secretary/ Commissioner (Health and Family Welfare).
  • 33. 24 a) In 2005, NRHM was launched to provide accessible, affordable, accountable, effective and reliable primary health care facilities, to the rural population, especially vulnerable groups. In addition, the National Urban Health Mission (NUHM) was also launched to further strengthen urban health structure and both NUHM and NRHM have been clubbed together under National Health Mission (NHM) from 2013. The vision of NHM is “Attainment of Universal Access to Equitable, Affordable and Quality health care services, accountable and responsive to people's needs, with effective inter- sectoral convergent action to address the wider social determinants of health”. b) NHM further aims to provide support to the existing national programmes of health and family welfare including RCH-II, malaria, blindness control, iodine deficiency, filariasis, kala- azar, tuberculosis, and leprosy and for integrated disease surveillance c) RNTCP is one of the components under the National Health Mission which is a flagship scheme under Govt. of India. The MoHFW follows equity-based approach to allocate funds under RNTCP to various States. The overall allocation is made on the basis of population of the states, disease burden and socio economic status. The financial management procedures for RNTCP are well established and administered by the Finance Cell of the CTD. These procedures are documented in manuals and guidelines available on the program's website. I. Institutional arrangements: Overall responsibility for financial management of the program is with the Central Tuberculosis Division (CTD), Directorate General of Health Services, Ministry of Health & Family Welfare (DGHS) a part of the National Health Mission of the MoHFW. At state level these are through state TB cell and at district level through state and district TB cell. ii. Budget and release of funds: Program expenditures are budgeted in the Demand for Grants of the MoHFW under the Disease flexi-pool funding arrangement under two separate budget lines for Externally Aided Component (EAC) and General Component (GC). iii. Funds flow: Funds flow for the program will remain within the existing financial management systems of MoHFW, which operates through the centralized Pay of an Accounts Office. Funds are being released to state in 2-3 instalments. All the states are required to submit the annual audit report to CTD by 30th September. National Level Central TB Division (CTD) of Directorate General Health Services (DGHS) is the technical arm of the Ministry of Health and Family Welfare (MoHFW). CTD, under the guidance of DGHS, manages the National TB Control Programme for the entire country at the central level through a National Programme manager, Deputy Director General TB (DDG TB). The financial and administrative control of the Programme is managed by the Joint Secretary from the administrative arm of the MoHFW. The CTD is supported by 6 national institutes: National Institute for Research in Tuberculosis (NIRT), Chennai, National Tuberculosis Institute (NTI), Bangalore, National Institute of Tuberculosis and Respiratory Diseases (NITRD), Delhi, National JALMA Institute, Agra, Regional Medical Research Centre, Bhubaneshwar and BMHRC, Bhopal, and National Task Force of Medical Colleges. Various committees of experts to guide the Programme at different levels on technical & policy matters are there supporting Central TB Division. State Level The States have total ownership and accountability for the TB control in their state. State Health Society or its equivalent under National Health Mission of the state manages the TB Control Programme. A full-time State Tuberculosis Officer (STO), trained at national level and based at the State TB Cell (STC), is responsible for planning, training, supervising and monitoring the programme in all the districts of their respective states. STO is administratively accountable to the State Government, technically follows the instructions of the CTD, and coordinates with CTD and the districts and is assisted by other technical& secretarial staff.
  • 34. 25 State TB cell is being supported by State TB Training and Demonstration Centre (STDC) in many states through its three units – a training unit, Supervision and monitoring unit and an Intermediate Reference Laboratory (IRL) supporting an effective Quality Assurance system of the Sputum smear microscopy network and lab services for PMDT (molecular DR testing and C&DST) in the State. Each state also has one (1 for each 50 million populations at least) fully operational State Drug Store (SDS). It is responsible for effective management of medicines and other logistics and ensuring uninterrupted supply of good quality 1st & 2nd line anti-TB medicines for adults and pediatric population. District Level The key level for the management of primary health care services is the district. The Chief Medical Officer of Health (CMOH) / Chief District Medical Officer (CDMO) / Civil Surgeon or an equivalent functionary in the district is responsible for all medical and public health activities including control of TB. The District Tuberculosis Centre (DTC) is the nodal point for TB control activities in the district. A full-time District Tuberculosis Officer (DTO), trained at national level & based at the DTC, is responsible for planning, training, supervising and monitoring the Programme in the district. DTO is assisted by other technical& secretarial staff. The primary role of the DTC is a managerial one. Sub-District Level (Tuberculosis Unit Level) Integrating the TB control Programme with the health system increases effectiveness and efficiency of TB care and control. India's TB control Programme has been mainstreamed efficiently with National Health Mission (NHM). A major organizational change in RNTCP is the creation of a sub-district level (Tuberculosis Unit - TU). The TU is the nodal point for TB control activities in the sub- district. TUs are based mainly in NHM health blocks with the overall aim to align with NHM Block Programme Management Unit (BPMU) for optimum resource utilization and appropriate monitoring. In urban areas the TUs have been created based on a population of 1 per 2,00,000 (range 1.5 – 2.5 lakh). The Tuberculosis unit (TU) consists of a designated Medical Officer-Tuberculosis Control (MO-TC), as well as one fulltime supervisory staff - Senior Treatment Supervisor (STS). One Senior TB Laboratory Supervisor (STLS) will continue to be in 5 lakh population and 1 TBHV per one lakh urban population is there to support the urban TB control activities. The Block Medical Officer also functions as a MO-TC who is trained in RNTCP at a state level institution. MO-TC has the overall responsibility of management of TB Control Programme at the TU and is expected to undertake supervisory visits for seven days in a month. The team of STS and STLS are under the administrative supervision of the MO- TC and the DTO. The TU will have one Microscopy Centre for every 100,000 population (50,000 in tribal, desert, remote and hilly regions) referred to as the Designated Microscopy Centre (DMC). Microscopy Centres are also located in Medical Colleges, Corporate hospitals, ESI, Railways, NGOs, private hospitals, etc. Peripheral Health Institutions (PHIs) For the purpose of RNTCP, a PHI is a health facility which is manned by at least a medical officer. At this level, there are dispensaries, PHCs, CHCs, referral hospitals, major hospitals, specialty clinics or hospitals (including other health facilities), TB hospitals, and Medical colleges within the respective district. All health facilities in the private & NGO sectors participating in RNTCP are also considered as PHIs by the programme. Some of these PHIs also function as DMCs. PHIs undertake tuberculosis case-finding & treatment activities as a part of the general health services. In situations where more than one MO is posted in any of the peripheral health centres, one of them may be identified & entrusted with the responsibilities of the RNTCP. The peripheral laboratories (Erstwhile DMC)
  • 35. 26 These are situated in the public sector like the dispensaries, PHCs, CHCs, referral hospitals, major hospitals, specialty clinics / other sector hospitals / TB hospitals / Medical colleges and in the private/NGO sectors. For establishment of microscopy centre in a lab, it must have adequate physical infrastructure, Binocular microscope and a trained LT. These laboratories are covered under quality assurance mechanisms Some of the labs not having facility for sputum microscopy, function as a sputum collection centres, and such facilities are also established in areas such as the tribal, hilly, desert and difficult to reach areas of the country for improving the access to diagnostic services.  Key personnel in RNTCP supervision  STO- State Tuberculosis Officer  DTO – District Tuberculosis Officer  MO-DTC- Medical Officer- District Tuberculosis Center  MOTC – Medical Officer–TB control  MOIC – Medical Officer In-charge  MOs – Medical Officers  STS – Senior Treatment Supervisor  CV- Community Volunteer  STLS – Senior Tuberculosis Laboratory Supervisor  LT – Lab Technician  SA- Statistical Analyst  NGO- Non-Govt Organization  PP- Private Practitioner  MPW- Multi Purpose Worker  DEO- Data Entry Operator  DP- DOTs Provider RNTCP Structure
  • 36. 27 Terms of Reference (TOR) of District Private Public Mix Coordinator (DPPMC) under RNTCP To assist the District TB officer (in co-ordination with State PPM coordinator) in field level implementation of RNTCP & multi-sectoral coordination: 1. Implementation of PPM and ACSM activities at the district and sub-district level. 2. Assisting the DTO in mapping and line listing of all stake holders, identifying NGOs, Private providers for partnerships and facilitating the process of partnerships. 3. Coordinating workshops / meetings for improving involvement of PPs & NGOs. 4. Collating the required information from NGOs / PPs / Partners to enable quality monitoring and enhancing TB control activities. 5. Compiling necessary documents for disbursal of Grant in Aid to NGOs and PPs 6. Facilitating periodic review of partnerships with different stakeholders 7. Facilitate ACSM activities in coordination with the IEC officer and PPM partners. 8. Coordinating with the medical college / hospitals / teaching institutes / schools for improved involvement in the program. 9. Coordinating with corporate / private hospitals for their involvement in the program. 10. Monitoring PPM activities of partners at field level on behalf of DTO 11. Prepare monthly and quarterly report of ACSM/PPM activities for DTO 12. Documentation of best practices of PPM partners for annual reports. 13. To facilitate change management with respect to use of ICT & Nikshay tools for concerned data entry, validation & its use for public health action 14. Regular field visits & maintaining regular liaison with private provider, hospital, medical colleges, CSO & other key stake holders. 15. Any other job assigned as per program need
  • 37. 28 Advocacy Communication and Social Mobilization (ACSM) There is an unmet need for improved advocacy, communication, and social mobilization (ACSM) to support ongoing TB control efforts in most districts. Improved ACSM is expected to achieve the following outcomes at community level:  Mobilization of local political commitment and resources for TB  Improved case detection and treatment adherence  Empower people and communities affected by TB  Reduced stigma and discrimination against persons and families affected by TB. Active case Finding (ACF) activity Active Case Finding (ACF) or Intensive case finding activity (ICF) is basically a provider initiated activity with the primary objective of detecting TB cases early by active case finding in targeted groups and to initiate treatment promptly. It can target people who anyway have sought health care with or without symptoms or signs of TB and also people who do not seek care. Increased coverage can be achieved by focusing on clinically, socially and occupationally vulnerable populations. It must be remembered that ‘Screening’ is a dynamic process and the prioritization of vulnerable groups, choice of screening approach and screening interval should be regularly reassessed by the programme. Decisions on when and how to screen for TB, which vulnerable groups to prioritize and
  • 38. 29 which screening tool to use depend on the vulnerable group, the capacity of the health system, and the availability of resources. Prioritization of vulnerable groups for target: Priority Urban area Rural area Tribal area 1 Slum Difficult to reach villages Difficult to reach villages & hamlets 2 Prisons inmates Mine workers Villages with known higher case load 3 Old Age homes Stone crusher workers Tribal school hostels 4 Construction site workers Populations groups with known high malnutrition Areas with known high malnutrition 5 Refugee camps Populations known to drink raw milk Villages seeking care from traditional healers 6 Night shelters Populations known to eat uncooked meat Populations known to drink raw milk 7 NACO/SACS identified HRG for HIV NACO/SACS identified HRG for HIV Populations known to eat uncooked meat 8 Homeless Weaving & Glass industrial workers Tribal areas with little ventilated huts 9 Street children Cotton mill workers 10 Orphanages Unorganised labour 11 Homes for destitute Tea garden workers 12 Asylums Villages largely seeking care from traditional healers Activities by Community volunteer during ACF: conducting household visit to target population, Symptom screening of individuals, ffering 2 sputum containers to all symptomatic person xplain how to produce and collect sputum sample Carry collected sputum sample to Designated Microscopy Center/Laboratories Each ACF team (often called as Community Search Team-CST) will comprise of at least one health worker from RNTCP (STS/STLS/TB-HV) + Community volunteer/ Partner Organization (NGO outreach worker) + General health services (ANM/MPW/MPHS/ASHA/AWW/NUHM staff). Generally 4-6 days has been allotted to screen around 800-1200 target group citizens (200-300 household) by each team. The DTO should decide on the team workload & team composition based on available resources and population to be covered. After household screening the target population eligible for sputum examination includes: during last 6 months
  • 39. 30 -TB Treatment (previous / current) House to House activity (HtH) -t-h activity, micro plan with team day wise area maps should be used to visit all houses systematically as per the micro plan. No house should be left unvisited. inhabitants of the area are most likely to be available at their homes. -to-house visits, teams should knock at the door and then enter each house. their visit. ermine correct information, the team members have to go systematically and ask all the following questions in each house: by the number of ‘chullahs’ (kitchens). or market place or school, visiting friends /relatives within the village or in other villages / cities, gone out to their place of work, outside the house for any other reason? detailed above. If household is not available screening may be done in the nearest health facility. The members of the team should also enter details in the recording tool after every member of the family is screened and mark every visited house as T/date or X/date with chalk or geru. Team members should advise family regarding need & benefits of this campaign for TB patients and community. They should try to address the queries and myths regarding disease and programme. should thank the mukhiya/ head of the family and family members as well for their cooperation and be doubly sure that all inhabitants of house have been examined in the house. he recording tool. -to- house search teams. Search teams must be specially trained to carry out search in these specific situations .
  • 40. 31 Marking of houses by search teams: T/date: When all persons staying in the house have been screened in this visit. This includes persons visiting the house when the campaign is on. X/date: All or some eligible inhabitants of the house were not screened for any reason (out of house, locked door, refuse to share information etc) EXAMPLES OF HOUSE MARKING T-1 T-2 X - 3 ---------- ------------ ----------- 13/3/18 25/7/18 2/12/18 99DOTS Solution 99DOTS is a low-cost approach for monitoring and improving TB medication adherence. It can be utilized either as a supplement to existing DOTS programs, or to enable remote observation of doses administered by patients or their family members. Using 99DOTS, each anti-TB blister pack is wrapped in a custom envelope, which includes hidden phone numbers that are visible only when doses are dispensed. After taking daily medication, patients make a free call to the hidden phone number, yielding high confidence that the dose was “in-hand” and has been taken. It is important to note that 99DOTS requires only a small number of phone numbers. The numbers called by a patient may repeat over time; however, on each blister pack, the numbers are arranged in an unpredictable sequence. As treatment progresses, the sequence of numbers called is checked against the blister designs, thereby verifying that the patient is taking medication as intended. 99DOTS patients receive a series of daily reminders (via SMS and automated calls). Missed doses trigger SMS notifications to care providers, who follow up with personal, phone-based counseling. Real-time adherence reports are also available on the web. Compared to the current standard of care, 99DOTS offers three key benefits. First, it reduces burden to the patients’: instead of traveling to a center for every dose, patients can provide evidence of dosing from the comfort of their home. Second, it improves the efficiency of care providers: instead of waiting weeks or months for adherence records to be digitized, supervisors can view real-time adherence data for every patient and ensure prompt response to every missed dose. Finally, 99DOTS enables differentiated care: instead of mandating that all patients receive frequent counseling, adherent patients can proceed with less supervision, while limited program resources are channelized to the cases that need the most attention. Patient may register more than one phone number for 99 DOTS monitoring. Patients don’t need to talk to anybody. Patients don’t need to answer any call. Timings of adherence call also depend on
  • 41. 32 patient’s free time. It’s toll free [minimum balance may be required to make an outgoing]. 99DOTs is gaining popularity for all these flexibility & patient friendly designing! Preference to be given to TB-HIV, Privately treated patient, patient living at migratory, tribal & hard to reach areas! DBT Scheme Providing treatment enablers in the form of financial incentives and nutritional support can provide for increased adherence and treatment success rates. To meet these twin objectives of adherence and treatment support, the programme has launched a “Direct Benefits Transfer (DBT)” scheme to financially aid TB patients. There has been an increase in rural access to banking facilities over the years especially with the recent push through PM “Jan-Dhan Yojana”. Subsequently DBT initiatives in social welfare schemes have also shown promise, making it prudent that the program too adopts a similar approach towards treatment enablers. It is envisaged that this scheme will motivate all the beneficiaries to adhere the RNTCP guideline for a better TB outcome. It is also envisaged to minimize the delay of incentive transfer, disparity, paper worker, manual error etc. A community health volunteer may help this DBT roll-out, if requested so, by collecting details of the beneficiaries (when already available) or by facilitating to create Aadhar Card & Bank account (when not available) of the beneficiaries. Who are eligible for getting DBT? As of now-  All notified TB patients- for nutritional benefit  Tribal Patient- Patients from the Notified Tribal Area only  Treatment supporters & some other contractual staff  Private providers who notify TB patient Nutritional Support scheme to TB patients (Nikshay Poshan Yojana) 1. Scheme details / components: Ministry of Health and Family Welfare, Government of India has announced the scheme for incentives for nutritional support to TB patients. This scheme will be called “Nikshay Poshan Yojana”. 2. Beneficiary: Each TB patient whether public or private sector notified must be notified on the Nikshay, platform. 3. Eligibility: All TB patients notified on or after 1st April 2018 including all existing TB patients under treatment who has at least two months of treatment remaining are eligible to receive incentives. The patient must be registerednotified on the NIKSHAY portal. 4. Benefit:
  • 42. 33 Financial incentive of Rs.500/- per month for each notified TB patient for duration for which the patient is on anti-TB treatment. The scheme is registered under Direct Benefit Transfer. The incentives can be distributed in money (only via DBT preferably through Aadhaar enabled bank accounts) or in-kind. The States has to take the decision. 5. Start date: 1st April 2018 5. Funding: The scheme is a centrally sponsored scheme under National Health Mission (NHM). 7. Schedule of payment: Bi-monthly @1000 INR per transaction (500 x 2month)
  • 43. 34 Partnerships Synergistic efforts of all stakeholders involved in TB control in India are the key towards realizing the goal of “Universal access to TB care and treatment for all”. Revised National TB Control Programme is working towards this goal with the basic philosophy that government is not the sole provider of services for TB and optimum efforts should be made to utilize the resources in the private sector. In this context an enabling environment should be created through regular interaction with partners involved in TB control and promoting innovative TB control initiatives at district, state and national level. Definition Partnership means an arrangement between any two or more entities; most often, government owned entity on one side and a private sector entity on the other, for the provision of public assets and/or public services, through investments being made and/or management being undertaken by the private sector entity, for a specified period of time. Such arrangements may have options of receiving performance linked incentives that conform (or are benchmarked) to specify and pre-determined performance standards, measurable by the public entity or its representative. This concept of partnership is much broader as compared to previous approaches of Public Private Mix (PPM) under RNTCP which entailed strategies that link all entities within the private and public sectors (including health providers in other governmental ministries) to the national TB programme for DOTS expansion'. Involvement of all health care providers is necessary to achieve Universal access to TB care. Partnership Options The National Guideline for Partnership was developed in 2014 on how different stakeholders can supplement the efforts of the government for TB control in India. The National Guideline for partnership consists of four thematic areas: 1. Advocacy Communication and Social Mobilisation (ACSM) 2. Diagnosis and treatment 3. TB & Co-morbidities 4. Programme Management Health care providers in India There is large number of health facilities run by public sector other than Ministry of Health & Family Welfare under different ministries of centre / state governments as mentioned above. There are corporate sector companies in the public sector like Coal India, SAIL etc. which run their own set ups. Usually these facilities cater to a “captive population” who receive subsidized or free services from said facilities.
  • 44. 35 Additionally ministries like defense, railways, home ministry etc. have their own medical services set up and they have been involved at various levels under the RNTCP. The program had already involved ESI, NTPC, Railways, CGHS, Coal, Prisons, Armed Forces, Mines and Port. Further there are also health services offered by ITBP, BSF, CRPF, Assam Rifles, CISF and Ministry of Home, apart from some local initiatives to involve these institutions. There is integration of service delivery and reporting at the TU and district level with most of the partners delivering health care through their own set up. RNTCP has formed the National Technical Working Group on Public Private Mix to provide a forum for dialogue, to ensure sustained attention on the issue, and guide innovation and learning. The group provides guidance on technical aspects such as the inclusion of all internationally accepted regimens, guidance on the scope and geographic distribution of initial projects, and policy requirements for improved PPM. Institutional mechanisms to support the States for effective contract management, hiring interface agencies to manage activities of engaging private sector and other partnership-strengthening functions need to be developed. RNTCP has proactively sought the involvement of NGOs in TB control activities. Using the experiences gained from collaborations with NGOs and the private sector, the Central TB Division has brought out the National Guideline for Partnership 2014 for engagement with all stakeholders. However, RNTCP does not restrict to these guidelines alone and rather promote innovation for reaching the goal of universal access to TB care. One example is flexibility as mentioned below. Flexibility in budget for Partnership Under this approach the states have been provided greater flexibility whereby they can utilize 30% of their PPM budget for piloting new projects and innovations as per requirements of the state. The states have been given the flexibility for utilization of 10% of their PPM projects for capacity building and promotion of NGO-PP activities. Process of Partnership Before going into detail of each partnership option we need to understand the processes involved in partnership formation which is crucial for the work of PPM Coordinators and Program Managers at district and state level. The processes involved in partnership are: The PPP strategy is for reaching the unreached and also to reach patients even if they are accessing private / other sector as RNTCP in this case would act as an enabler and not provider of services. Undertake assessment of gaps in health service delivery in RNTCP in different districts of your state. Identify the geographical and functional gaps. The identified gaps would form the basis for formation of partnership and this information may be displayed on your state website and office of STOs/DTOs. NGOs and other partners must be involved for supplementing capacities in some key areas where the formal health delivery system is unable to provide optimal services. NGOs and other partners would be encouraged to work in unserved and underserved areas which would be areas in hilly, tribal, desert regions or peri- urban areas and slums. The State and the District Health Societies would have the flexibility to categorize unserved and underserved areas for focused attention. Private sector health care services are more concentrated in urban and peri- urban areas and National Sample Surveys has consistently shown that vast majority of not only rich, but also poor population do seek care from private sector. Attempts should be made to develop partnerships with private sector, so that the goal of universal access can be achieved. The process of renewal of MOU would be on the basis of performance as per the review and quarterly reports submitted. The updated list of approvals and collaborations must be maintained at the district and state level for all partnership options. The updated list has to be updated in Nikshay. The presence of these healthcare setups in the States/ districts needs to be prioritized and effective communication channels and reporting mechanisms set up at the district and State levels.
  • 45. 36 Engagement of Professional Associations Professional associations have a key role to play in TB control activities In India and any their engagement and active involvement is important for stewardship in private sector engagement. Organisations like IMA, Indian Academy of Paediatrics (IAP), Indian Nursing Association, Indian association of medical microbiologists, Indian Public Health Association etc. are key resources for dissemination of knowledge on diagnosis and treatment guidelines in RNTCP and Standards for TB Care in India. Pharmacist / Chemists involvement RNTCP has signed MOU with Indian Pharmaceutical Association (IPA), All India Organization of Chemists & Druggists (AIOCD), Pharmacy Council of India (PCI) and SEAR (South east Asia Region) Pharm Forum representing World Health Organization (WHO) – International Pharmaceutical Federation (FIP) Forum of National Associations in South East Asia for engaging pharmacists in RNTCP for TB Care & Control in India. Pharmacists should be involved for early identification and referral of presumptive TB cases for diagnosis, treatment supporter for TB patients, increasing community awareness about TB and MDR-TB, patient education and counselling, promoting rational use of Anti-TB drugs and contributing to preventing the emergence of drug resistance. Laboratory involvement: To reach all TB patients in India need to include dominant private sector and private laboratory is not an exception. Laboratories are engaged through partnership options under National guidelines of partnerships. Additionally, to facilitate use and access to affordable and accurate tests endorsed by the World Health Organization (WHO) and the Revised National TB Control Programme (RNTCP). One of such mechanism is Initiative for Promoting Affordable, Quality TB Test (IPAQT). Under this initiative, several private laboratories in India have agreed for not exceeding negotiated, ceiling prices to patients, notifying the government of the cases diagnosed, promoting the use of these tests and participating in external quality assurance (EQA) and in exchange, they would get reagents at significantly reduced prices. In exchange for offering lower prices, the manufacturers and distributors would receive greater and more predictable volumes from the previously untapped private market. Involvement of Medical colleges in RNTCP To widen access and improving the quality of TB services, involvement of medical colleges and their hospitals is of paramount importance. The medical colleges in India have been involved under RNTCP in a structured task force mechanism of National, Zonal and State level task forces in addition to the medical college core committee. The main role of the NTF is to guide, provide leadership and advocacy for the RNTCP, recommend policy suggestion regarding medical colleges' involvement in the RNTCP, coordinate with the Central TB Division, and monitor the activities of the ZTF. ZTF facilitates the establishment & functioning of State Task Forces (STF), coordinates between the national and STF, as well as between medical colleges and the State/District TB Centres, and monitors the activities of STF. STF facilitates establishment of Designated Microscopy Centres (DMCs) & Directly Observed Treatment (DOT) centres, as well as other activities, in all the medical colleges in the respective States. Core Committees, at the level of medical colleges facilitate inter-departmental coordination for Programme implementation. Core committee meet every month. DMC and DOT Centres are established in all government and private medical colleges and these are equipped with suitably trained additional manpower in the form of Medical Officer (MO), laboratory technician (LT) and TB health visitor (TBHV).