Revised National Tuberculosis Control Program- Dr. Atul MD, PGIMER

A brief discussion on RNTCP with a concise discussion on National strategic policy for TB

1. Revised National Tuberculosis Control Programme Presenter – Dr. Atul Gupta Moderator – Dr. J.S. Thakur

2. Outline Of Presentation Introduction Burden of disease Evolution of TB control in India National Tuberculosis Programme Revised National Tuberculosis Control Programme ( RNTCP) Paradigm Shift in Tuberculosis Control National Strategic Plan (NSP) 2017-25 Status in Punjab and Chandigarh Challenges

3. Introduction Tuberculosis is one of the leading causes of mortality in India- killing - 2 persons every three minute, nearly 1,000 every day . Tuberculosis (TB) is a contagious disease caused by Mycobacterium tuberculosis. Left untreated, each person with infectious pulmonary TB will infect an average of between 10 and 15 people every year. Emergence of Multi Drug Resistance and co-infection with HIV has weakened the battle against the disease. Source- The global tuberculosis situation and the new control strategy  of the World Health Organization

4. Brief History of Tuberculosis Robert Koch: - 1882 : Isolated and cultured M. Tuberculosis (24th March) - 1890: Developed staining methods used to identify the bacteria - 1905: Received Nobel Prize Kumar P. Journey of tuberculosis control movement in India: National tuberculosis programme to revised national tuberculosis control programme . Indian J tuberc . 2005;52:63-71.

5. Burden of Disease Indicator India Global statistics Incidence of TB (including HIV) 27,90,000 1,04,00,000 Mortality due to TB (Excluding HIV) 4,23,000 13,00,000 Incidence of MDRTB / RR 1,47,000 6,01,000 Incidence of HIV-TB 87,000 10,30,000 Mortality due to HIV-TB co-morbidity 12,000 3,74,000

6. Source: Global TB Report 2018

7. Burden of Disease … Contd … Globally, TB incidence is falling at about 2% per year. This needs to accelerate to a 4–5% annual decline to reach the 2020 milestones of the End TB Strategy. An estimated 54 million lives were saved through TB diagnosis and treatment between 2000 and 2017. Ending the TB epidemic by 2030 is among the health targets of the Sustainable Development Goals. Source: Global TB Report 2018

8. Evolution of TB Control In India 1962 - National Tuberculosis Programme (NTP) started 1992 - NTP Reviewed 1993 - RNTCP formulated, adopted Directly Observed Treatment Short course (DOTS) strategy. 1997 - Large-scale implementation of the RNTCP with DOTS 2006 - Entire country covered by RNTCP on 24th march

9. Evolution of TB Control In India - contd …. 2006 - India adopts the STOP TB Strategy 2008 - NACP & RNTCP have developed “National framework of TB/HIV Collaborative activities” 2012-17 - National Strategic Policy 2017-22 - National Strategic Policy

10. National Tuberculosis Programme ( 1962) Based on strategic principles of domiciliary treatment Use of a self-administered standard drug regimen of initially 12-18 months duration. --------- Treatment free of cost Priority to newly diagnosed patients over previously treated patient Treatment organization decentralized to district level . The NTP created an extensive infrastructure for TB control, with a network of 446 district TB centres and 330 TB clinics. Kumar P. Journey of tuberculosis control movement in India: National tuberculosis programme to revised national tuberculosis control programme . Indian J tuberc . 2005;52:63-71.

11. Failure of NTP Results: Low rates of case detection and treatment completion (30%), C ontinuing high mortality (50 per 100,000) High rates of default (40–60 %) Reasons More emphasis on case detection rather than cure Shortage of drugs Emphasis on x-ray diagnosis resulting in inaccurate diagnosis Poor quality sputum microscopy Multiplicity of treatment regimens . Kumar P. Journey of tuberculosis control movement in India: National tuberculosis programme to revised national tuberculosis control programme . Indian J tuberc . 2005;52:63-71.

12. Revised National Tuberculosis Control Programme (1993) Goals To reduce mortality and morbidity from tuberculosis To interrupt chain of transmission. Objectives To cure at least 85% of all newly detected infectious (NSP) cases of Pulmonary tuberculosis To detect at least 70% of estimated new smear positive pulmonary tuberculosis

13. RNTCP (1993) Major additions to the RNTCP: Sub-district supervisory unit, known as a TB Unit. D ecentralization of diagnostic and treatment services. T reatment given under DOTS (directly observed treatment) . Provision of quality assured sputum smear microscopy services. Patient-Wise Boxes

14. DOTS (1997) Emphasizes on: Political and administrative commitment. Good quality diagnosis. Good quality drugs. Directly observed treatment short-course chemotherapy Systematic monitoring and accountability. Kumar P. Journey of tuberculosis control movement in India: National tuberculosis programme to revised national tuberculosis control programme . Indian J tuberc . 2005;52:63-71.

15. Paradigm Shift in Tuberculosis Control Significant changes in the definition of cases as per New Guidelines: Microbiologically confirmed : : Presumptive TB patient with 1. Biological specimen positive for AFB 2. Positive for M.tuberculosis on culture 3. Positive for TB through quality assured rapid diagnostic molecular test Technical and operational guidelines for TB control in India, 2016

16. Clinically diagnosed TB case Presumptive TB who is not microbiologically confirmed Has been diagnosed with active TB by a clinician on the basis of X ray abnormalities Histopathology Clinical signs With decision to treat the patient with full course of ATT Technical and operational guidelines for TB control in India, 2016 Contd …

17. Contd.. Mono-resistance: Resistant to one first line anti ‑ TB drug only. Poly drug resistance : More than one first line anti ‑TB drug, other than both INH and Rifampicin. Rifampicin resistance (RR) : Resistance to Rifampicin MDR : Both INH and Rifampicin with or without resistance other first line ATD XDR : MDR TB + Fluroquinolone (FQ) and a second line injectable ATD. Technical and operational guidelines for TB control in India, 2016

18. Paradigm Shift in Tuberculosis Control Contd.. Previous Guidelines New Guidelines 3 categories for treatment (I , II , III ) 2 categories ( New and Previously treated ) Extension of IP No extension of IP Intermittent regimen FDC Daily regimen as per weight bands Streptomycin in Cat II , IP No streptomycin* Introduction of new medicines ( Bedaquiline and Delamanid ) * Notification / MOHFW dated 18 / 12 / 2018

19. NSP 2017- 2025 Goal : To achieve a rapid decline in burden of TB, morbidity and mortality while working towards elimination of TB in India. Objectives: 1. Find all Drug Sensitive TB and Drug Resistant TB cases with an emphasis on reaching TB patients seeking care from private providers and undiagnosed TB in high-risk populations Source - National strategic plan for tuberculosis elimination 2017–2025

20. NSP 2017- 2025 2. Initiate and sustain all patients on appropriate anti-TB treatment wherever they seek care, with patient friendly systems and social support. 3. Prevent the emergence of TB in susceptible populations. 4. Build and strengthen enabling policies, empowered institutions, additional human resources with enhanced capacities, and provide adequate financial resources. Source - National strategic plan for tuberculosis elimination 2017–2025

21. NSP 2017- 2025 Key Strategies: 1. Private sector engagement 2. Active Case finding 3. Drug resistant TB case management 4. Addressing social determinants including nutrition 5. Robust Surveillance system 6. Community engagement & Multi- sectoral approach Source - National strategic plan for tuberculosis elimination 2017–2025

22. NSP 2017- 2025 Expected Outcomes: 80% reduction in TB incidence (i.e. reduction from 211 per lakh to 43 per lakh ) 90% reduction in TB mortality (i.e. reduction from 32 per lakh to 3 per lakh ) 0% patient having catastrophic expenditure due to TB Source - National strategic plan for tuberculosis elimination 2017–2025

23. NSP 2017- 2025 Four strategic pillars of TB elimination

24. DETECT HOW DO WE DO IT? Find all DS-TB and DR-TB cases with an emphasis on reaching TB patients seeking care from private providers and undiagnosed TB in high-risk populations. Laboratory systems Case findings Patients in private sectors

25. Strategies 1. To use high efficiency diagnostic tools for early and accurate diagnosis linked treatment across the country 2 . Purchasing services and ensuring notification through laboratories from the private sector and link to laboratory surveillance 3 . To promote research for new diagnostic tools 4 . To build capacity for diagnosis of LTBI Source - National strategic plan for tuberculosis elimination 2017–2025

26. DRTB Case Detection and Initiation 2007 - 2017 India TB Report 2018

27. Case Findings Early identification of people with a high probability of having active TB (presumptive TB) is the most important activity of the case finding strategy. Screening and diagnosing patients with appropriate tests and strategies will largely determine the response to appropriate treatment. ACF - primary objective of detecting TB cases early in targeted groups and to initiate treatment promptly. Active case finding guidelines – MOHFW June 2017

28. A ctive C ase F inding Screening strategies 1. Community screening can be done by: a. Inviting people to attend screening at a mobile facility or a fixed facility. Invitations may target specifically people within a given vulnerable group, those who have had recent close contact with someone who has TB and people with symptoms of TB. b. Going door to door to screen households . Active case finding guidelines – MOHFW June 2017

29. Contd …. 2. Institutional screening: a . In Health care facilities : Active screening of vulnerable individuals attending hospitals and other health care institution. b . In congregate settings: Active screening of vulnerable individuals in shelters, old age homes, refugee camps, correctional facilities and other specific locations such as workplaces. Active case finding guidelines – MOHFW June 2017

30. Patients in Private Sectors 80% of people with TB first attend the private sector or Quacks Diagnosis and treatment are of variable quality. Diagnostic delays occur, Patients from low-income households lose several months of their income in the process of paying for inappropriate diagnostics and treatments before starting approved therapy. Source - National strategic plan for tuberculosis elimination 2017–2025

31. The Incentives Rs 250/- on notification of a TB case diagnosed as per Standards for TB Care in India. Rs 500/- on completion of entire course of TB treatment. For notification and correct management of a drug-resistant case over 24 months as per STCI, a private provider will be eligible to receive Rs 6750/- Source - National strategic plan for tuberculosis elimination 2017–2025

32. The Incentives For Patients : 500/- month for nutritional support for DS TB cases 1000/- month for nutritional support for MDR TB Source - National strategic plan for tuberculosis elimination 2017–2025

33. TREAT HOW DO WE DO IT? Initiate and sustain all patients on appropriate anti-TB treatment wherever they seek care, with patient friendly systems and social support. Providing daily regimen using FDCs to all TB patients DST guided treatment for DR TB. Patient centric approach to treatment.

34. The principles of treatment for TB is: 1. Screen all patients for RR and additional drugs wherever indicated. 2. For drug sensitive TB ---- daily FDC of first line ATT drugs in appropriate weight bands for all forms of TB and in all ages. 4 drug FDC in IP and 3 FDC in the CP. 3. All RR /MDR TB patients are subjected to baseline Levofloxacin sensitivity . In addition extended DST to all second line drugs in a phased manner. Source - National strategic plan for tuberculosis elimination 2017–2025

35. FDC Drugs by Weight WEIGHT CLASS # OF PILLS # STRIPS FOR 28 DAYS < 25 kgs Does not receive FDCs or 99DOTS 25 – 39 kgs 2 pills per day 2 40 – 54 kgs 3 pills per day 3 55 – 70 kgs 4 pills per day 4 > 70 kgs 5 pills per day 5 Operational Guidelines Daily Regimen in first-line TB treatment under RNTCP

36. Using mobile phones to monitor and improve adherence to tuberculosis medications Goal: to provide 99% of the benefits of dots at a fraction of the cost and inconvenience to patients Source - National strategic plan for tuberculosis elimination 2017–2025.

37. Anti-TB drugs wrapped in envelopes printed with hidden numbers behind the pills Patients dispense a dose, reveal a hidden TOLL FREE number ----- call Call reflects on the 99DOTS dashboard and the 99 DOTS Android Mobile App immediately as a taken dose . Training module 99 DOTS - 2018

38. SMS Alerts from 99DOTS Analytics and Reports for Program SMS Message: [0000] Please take pills Notification of new patients New patient (740XXXXXX) enrolled, Yelahanka district Two of your patients have missed doses Raj (979XXXXXX) & Om (812XXXXXX) SMS Message: Two of your patients have missed doses today: Raj & Om [0000] Please take pills SMS Message: [0000] Please take pills Reminders to Patients Alerts to Staff Training module 99 DOTS - 2018

39. Benefits of 99DOTS Training module 99 DOTS - 2018

40. PREVENT HOW DO WE DO IT ?? Prevent the emergence of TB in susceptible populations Scale up air-borne infection control measures at health care facilities. Testing and treatment for latent TB infection in contacts of bacteriologically confirmed cases and in individuals at high risk of getting TB disease Address social determinants of TB through intersectoral approach

41. Air Borne Infection Control : CHALLENGES AT COMMUNITY LEVEL :- Cough etiquettes not being followed Indiscriminate spitting Sneezing without covering face Alcoholics and mentally challenged patients Delay in reaching health facility for specific diagnosis Delay in diagnosis in co-morbid conditions like Diabetes, HIV, Cancers etc. Source - National strategic plan for tuberculosis elimination 2017–2025

42. Contd …. CHALLENGES AT INSTITUTIONAL LEVEL Outpatient facility • Patients with chest infection at outpatient settings • Overcrowding - mixing of patients in queues and waiting areas • Poor ventilation in the facilities In patient facility • Cough screening, separation, mask and counseling provision missing • Infectious patients getting admitted at General wards • Cough etiquettes not followed in wards • Overcrowding in the wards – no restricted entries Source - National strategic plan for tuberculosis elimination 2017–2025

43. Contact Tracing All close contacts, especially household contacts will be screened for TB using Chest X Rays. In case of pediatric TB patients, reverse contact tracing for search of any active TB case in the household of the child must be undertaken. Since transmission can happen from index case to the contact any time (before diagnosis or during treatment) all contacts of TB patients must be evaluated. Source - National strategic plan for tuberculosis elimination 2017–2025

44. LTBI Treatment The lifetime risk of reactivation of LTBI in healthy HIV-uninfected individuals is 10%, with 5% developing TB disease during the first 2 to 5 years after infection . ART reduces the risk of TB by approximately two thirds. Source - National strategic plan for tuberculosis elimination 2017–2025

45. BUILD HOW DO WE DO IT ?? Build and strengthen enabling policies, empowered institutions, human resources with enhanced capacities, and financial resources to match the plan. Urban TB control systems • Health system strengthening • Advocacy, communications and social mobilization • Surveillance, monitoring and evaluation • Research and technical assistance

46. A web based solution for monitoring of TB patients launced on 15th May 2012 by Developed by NIC (National Informatics Centre) The data entry of the individual TB cases at the block level DEOs (data entry operator) of NHM The system has been extended to include drug resistant TB cases, online referral and transfer of patients

47. TB-HIV Collaborative activities Establishment/Strengthening NACP-RNTCP coordination mechanisms at national, state and district level in 2001 Joint M&E including standardized reporting shared between the two programmes Training of the programme and field staff on HIV/TB TB and HIV service delivery co-ordination India TB Report 2018

48. TB and diabetes co-morbidity About 10% of TB cases globally are linked to diabetes. People with a weak immune system (diabetes) are at a higher risk of progressing from latent to active TB. People with diabetes have a two to three times higher risk of getting infected with TB, compared to people without diabetes. People with TB and coexisting diabetes have a four times higher risk of death during TB treatment and higher risk of TB relapse after treatment. National framework for joint TB-Diabetes collaborative activities

49. Public Private Partnership Several organizations and Projects like Programme for Appropriate Technology in Health (PATH), The Union , Foundation for Innovative New Diagnostics (FIND), World Vision India – Project Axshya , Project Saksham Pravaah etc are actively involved in the programme . At present around 1,900 NGOs collaborations are involved in the programmes in different schemes. India TB Report 2018

50. Status in Punjab District TB Centers ( DTCs) - 22 TB units (TU) - 134 Designated Microscopy Centers (DMCs) - 274 Culture and Drug Sensitivity lab ( C& DST ) - GMC Faridkot Liquid Culture Labs for 2 nd line DST - TB Hospital Patiala CBNAAT labs - 29 Bedaquiline treatment for DR TB - All 3 medical Colleges

51. Status in Chandigarh Designated Microscopy Centers (DMCs) - 17 Designated Microscopy Centers ( DMCs) - 15 with HIV testing CBNAAT labs - 2 ( PGI and GMCH 32) Bedaquiline & Delamanid treatment for DR TB - GMCH 32 Total notification of TB cases in 2018 - Around 6000

52. Status in PGIMER DMC (Designated Microscopy Centre) (New OPD/1)

53. Status in PGIMER Culture & DST Laboratory (Research Block A) Gene Xpert and LPA - available Solid culture and DST for First Line DST (RIF + INH + STR + ETM) - 2011 Line Probe Assay For First Line DST (RIF+ INH) - April 2013 Liquid culture and DST for First Line DST (RIF + INH + STR + ETM) – Feb 2015 Liquid culture and DST for Second Line DST ( OFLx + AMK + KAN + CAP) – Sept 2015

54. Challenges Collection of appropriate specimens from children and EPTB. Transportation of specimens from hard to reach areas (hilly, tribal, deserts, etc.) The paper based system of monitoring (recording and reporting) is tedious leading to delayed reporting. Retention of trained staff and compensation packages is a barrier for sustainability for ensuring consistent performance.

55. Challenges Lack of awareness in the community on TB diagnostic facilities in the programme Case finding is largely passive New diagnostic algorithm will require additional resources for CXR, and molecular tests. Ensuring active case finding in at risk groups and repeating the activity periodically.

56. Thank You