Tuberculosis & NTEP guidelines, National tb strategic plan

Tuberculosis and NTEP

1. Tuberculosis & NTEP Roll no. 183-187

2. Plan Of Presentation 1. Roll no. 183- Tuberculosis -introduction, epidemiology ,burden 2. Roll no. 185- NTEP- Evolution, strategies, organogram, lab services, newer strategies 3. Roll no. 184- Diagnostic Methods & Revised Case Definitions 4.Roll no. 186-Management of Tuberculosis 5.Roll no. 187- Prevention and Control

3. Tuberculosis- Introduction,Burden and Epidemiology Sapna Roll no. 183

4. INTRODUCTION Tuberculosis is a specific infectious disease caused by Myobacterium tuberculosis The disease primarily affect lungs and cause pulmonary tuberculosis It can also affect intestine, meninges, bones and joints ,lymph node ,skin etc The disease also affects animals like cattle called“ bovine tuberculosis ”which may sometime communicated to man .

5. HISTORY OF TUBERCULOSIS On March 24, 1882, Dr. Robert Koch announced the discovery of Mycobacterium tuberculosis, the bacteria that causes tuberculosis (TB). Johann Schonlein coined the term “tuberculosis” in the 1834, though it is estimated that Mycobacterium tuberculosis may have been around as long as 3 million years! In the 1700s, TB was called “the white plague” due to the paleness of the patients. March 24 was designated as World TB Day Source :https://www.cdc.gov/tb/worldtbday/history

6. TB Sanatoriums What is a sanatorium? A sanatorium is a medical facility for long term illness. Most often for the care of people with Tuberculosis. How does it work? Bed rest, fresh air, recreational activities First TB Sanatorium In 1854 Brehmer established an institution for the treatment of tuberculosis at Gorbersdorf in the mountains of Silesia. Madras Experiment Recovery at home ~ recovery in a sanatorium End of Sanatorium Movement By 1950s, sanatoriums started closing and drug treatment gradually came into effect. Source: http://tbfacts.org

7. PROBLEM STATEMENT World ⅓ of the current global population is infected asymptomatically with TB,of whom 5-10%will develop clinical disease during their lifetime Most new cases and deaths occur in developing countries where infection is acquired in childhood In the year 2020 ,out of estimated 10 million cases ,5.6 million were men ,3.3million women,1.1 million children. In 2020 ,57 countries had a low insidence of TB ,mostly in WHO region of the America and Europe region . Source :WHO(2021),Global tuberculosis Report,2021

8. About 10% of total tb load is found in children Globally about 1million cases of pediatrics TB are estimated to occur every year with more than 100,000deaths Childhood death from tb caused by meningitis and dissemination disease Poverty, malnutrition, overcrowding,tobacco ,alcohol abuse, diabetes make population more vulnerable to TB Source: govt.of India (2014),TB India 2014 ,RNTCP annual status report ,DGHS, ministry of health and family welfare,new delhi

9. India India is the highest TB burden country in the world in terms of absolute number of incident cases that occur each year Overall the age distribution of TB diagnosed incident cases show a predominance in adolescent and young adult age group between 15 to 30 year of age. Tuberculosis kill more women in reproductive age group. ⅓ of the female infertility in India is caused by TB . The majority of victims in India are migrant labourers ,slum dwellers,residents of backward areas. source: WHO (2016) ,fact sheet No.104,March 2016 Source: govt.of India(2020)India TB report (2020), National Tuberculosis Elimination programme annual report 2020 Source : govt. Of India (2010) ,TB India 2010,RNTCP status report,I am I am stopping TB , ministry of health and family welfare,new delhi

10. TB Disease Burden In India Despite the brief decline in TB notification observed in 2020 and 2021 , NTEP reclaimed and achieved beyond these numbers,the year 2022 mark a milestone efforts in India with a record high notification of 24.2 lakh cases . This translates to a case notification rate of 172 cases per lakh population . The total number of MDR/RR patient diagnosed in 2022 is 63801. Sustaining the momentum of finding missed TB patient by strengthening the case finding efforts let to the above achievement under the program. In 2022 the presumptive TB examination rate (PTBER) for a country rose to 1281 per lakh population from 763 in 2021 Source : India TB report MoHFw(2023)

11. National TB prevalence survey (2019-2021) The estimated point prevalence of microbiologically confirmed pulmonary TB among person aged more than 15 year at national level was 316per lakh population The prevalence of all form of TB was estimated to be 312 per lakh population . Source : India TB report MoHFw(2023)

12. Natural History of Tuberculosis Agent factor a. Agent : typical and atypical mycobacterium b.source of infection: human and bovine source c.communicability: patients are infective as long as they remain untreated.

13. Host Factor Age : In developing countries show a sharp rise in infection from childhood to Adolescent. In developed countries, the disease is more common in elderly. Sex: male is more prevalent than female C. Hereditary D. Nutrition E. Immunity

14. Social factors Non medical factor Poor quality of life Poor housing Overcrowding Population explosion Undernutrition Smoking Alcohol abuse Lack of education etc

15. Mode of transmission Mainly by droplets infection and droplet nuclei generated by sputum- positive patients with pulmonary tuberculosis. Incubation period - 3-6 weeks

16. SYMPTOMS OF TB 1. Cough with blood 5. Weight loss 2. Fever 6. Night sweats 3. Chest pain 7. Fatigue 4. Chills 8. Long term cough

17. NATIONAL TB ELIMINATION PROGRAMME Sarvanishtha Roll no. 185

18. NTP RNTCP NTEP 1962 1993 2020 1939 - TB Association of India estabilished for the management of TB 1951 - Mass BCG Vaccination Campaign 1959 - National TB Institute, Bangalore developed

19. RNTCP OBJECTIVES- Achievement of at least 85% cure rate of infectious cases of tuberculosis, through DOTS involving peripheral health functionaries; and Augmentation of case finding activities through quality sputum microscopy to detect at least 70% of estimated cases .

20. Evolution of WHO Global TB Strategies- DOTS Strategy 1994 STOP TB Strategy 2006 END TB Strategy 2014 Fig. 1. LHMC DOTS CENTRE

21. NATIONAL STRATEGIC PLAN (2017-2025) FOR TB ELIMINATION (UNDER NTEP) VISION- TB free India with zero deaths, disease and poverty due to TB. OBJECTIVES- 1. Find all the drug sensitive TB and drug resistant TB cases with an emphasis on reaching TB patients seeking care from providers, and undiagnosed TB in high-risk populations. 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.

22. KEY STRATEGIES- Private sector engagement Active case finding Drug resistant TB case management Addressing social determinants including nutrition Robust surveillance system Community engagement and multi-sectoral approach

23. Reduction in number of TB deaths compared with 2015(%) 90% 90% 95% Reduction in TB incidence rate compared with 2015(%) 80% 80% 90% INDICATORS TARGETS NSP 2025 SDG 2030 END TB 2035 EXPECTED OUTCOMES

24. NTEP ORGANOGRAM

25. TB LABORATORY SERVICES National Reference Laboratories Intermediate Reference Laboratories Peripheral Laboratories Microscopy, NAAT, LPA, Liquid culture, LCDST Microscopy, NAAT Six in total- National Tuberculosis Institute, Bengaluru National Institute for Research in TB (NIRT), Chennai National Institute of TB and Respiratory Diseases,(NITRD), Delhi National JALMA Institute, Agra Regional Medical Research Centre, Bhubaneshwar Bhopal Memorial Hospital & Research Centre(BMHRC), Bhopal

26. NEWER INITIATIVES NIKSHAY : Software used for patient management and compliance ,Launched in May 2012 TB notification : According to Govt. of India notification dated 7 May 2012 , it is now mandatory to notify every TB case to DHO/CMO of a district every month. Ban on TB serodiagnostics : Based on antibody response; highly variable; may reflect remote infection rather than active disease.

27. Direct benefit transfer schemes : Nikshay Poshan Yojana where all TB patients get financial assistance of Rs.500/month Case finding strategies : active case finding to reach the unreached Expansion of universal drug susceptibility testing using CBNAAT. Shorter regimen with Bedaquiline 99 Dots: Anti-TB blister pack wrapped in a custom envelope, with hidden phone numbers that are visible only when doses are dispensed

28. MERM Container: Medicine Event Reminder Monitoring Systems is a GPS enabled box which detect when the tablet are taken from the container and inform onto the nikshay portal. Dare2erad TB: Uses AI to predict loss of follow ups TRACE - TB Project : Transformative Research and Artificial intelligence Capacity for elimination of TB and responding to infectious diseases. Pradhan Mantri TB Mukt Bharat Abhiyaan(PMTBMBA) : Launched on 9th Sept, 2022 for community support to TB patients to provide people with TB and their families, increased nutritional, diagnostic and vocational support.

29. Diagnostic Methods and Revised Case Definitions Roll no. 184 Sapna Kumari

30. Diagnostic Criteria Under NTEP Smear Examination Chest X-ray Xpert MTB/RIF- CBNAAT LPA (Line probe assay) First line LPA- Detect rifampicin and isoniazid resistance Second line LPA- Detect resistance to second line injectables and fluoroquinolones

31. Presumptive Case : A patient who presents with symptoms or signs suggestive of TB. Bacteriologically Confirmed Case: A patient from whom a biological specimen is positive by smear microscopy, culture. Clinically Diagnosed Case: A patient who doesn’t fulfill the criteria for bacteriological confirmation but has been diagnosed with active TB by a clinician or other medical practitioner who has decided to give him/her a full course of treatment. Revised Case Definitions Source - WHO(2016) Global Tuberculosis Report 2016

32. Other Classifications Of TB Cases Based on Anatomical site of disease Based on History of previous TB treatment Based on Drug resistance Based on HIV status

33. Classification Of TB cases Based On Anatomical site of Disease 🔶 Pulmonary Tuberculosis ( PTB ) - Refers to any bacteriologically confirmed or clinically diagnosed case of TB involving the lung parenchyma or the tracheobronchial tree. Eg- Miliary TB it has lesions in the lungs. 🔶 Extra Pulmonary TB - Refers to any bacteriologically confirmed or clinically diagnosed case of TB involving organs other than lungs. Eg- pleura, lymph node, abdomen, genitourinary tract, skin, joints and bones.

34. 2. Classification Of TB Cases Based On History Of Previous TB Treatment 🔴 New Patients 🔴 Previously Treated Patients Patients who have never been treated for TB or have taken anti-TB drugs for less than 1 month. Patients who received 1 month or more of anti- TB drugs in the past. They are further classified by the outcome of their most recent course of treatment.

35. Classification of previously treated TB patients 🔹 Relapse patients 🔹 Treatment after failure patients 🔹 Treatment after loss to follow up patients 🔹 Other previously treated patients 🔹 Patients with unknown previous TB treatment history

36. 3. Classification Based On Drug Resistance ♦️ Monoresistance ♦️ Poly drug resistance ♦️ Multi drug resistance ♦️ Extensive drug resistance ♦️ Rifampicin resistance

37. 4. Classification Based On HIV status 🔸 HIV - positive TB patients 🔸 HIV - negative TB patients 🔸 HIV status unknown TB patients

38. Management of Tuberculosis Saumya Roll no: 186

39. ANTI- TB DRUGS First line drugs Second line drugs Bactericidal Isoniazid (H) Rifampicin(R) Pyrazinamide (Z) Bacteriostatic Ethambutol (E) Group A ( Fluroqinolone) Levofloxacin Moxifloxacin Group B Streptomycin Amikacin Kanamycin Group C Cycloserine Clofazimine Linezolid Ethionamide Group D Bedaquiline Delamanid PAS Meropenem

40. TWO PHASE CHEMOTHERAPY Intensive Phase (IP) Continuous Phase(CP) More number of drugs are given for a lesser number of time. Aggressive Duration- 8 Weeks 56 doses of HRZE Aim at sterilising the smaller number of dormant or persisting bacilli Duration- 16 weeks 112 doses of HRE

41. DAILY DOSE REGIMEN IN NTEP The principle of treatment for tuberculosis with daily regimen is to administer daily fixed dose combination of first line anti tuberculosis drugs in appropriate weight bands. FIXED DOSE COMBINATIONS Fixed dose combinations refer to products containing two or more active ingredients in fixed doses , used for a particular indication(s).

42. Type of TB case Treatment regimen in IP Treatment regimen in CP New and previously treated cases (H and R sensitive/unknown) 2 HRZE 4 HRE The CP maybe extended by 12 to 24 weeks in certain forms of TB like CNS TB , Skeletal TB disseminated TB etc based on clinical decision of the treating physician on case to case basis. Treatment is given in 2 phases:

43. Drug dosage for paediatric TB Weight category Number of tablets ( dispersible FDCs ) Intensive phase Continuous phase HRZ E HR E 50/75/150 100 50/75 100 4-7 kg 1 1 1 1 8-11 kg 2 2 2 2 12-15 kg 3 3 3 3 16-24 kg 4 4 4 4 25-29kg 3+1A* 3 3+1A* 3 30-39kg 2+2A* 2 2+2A* 2

44. Nikshay entry Once the treatment regimen is finalised all patients should be initiated on treatment after opening the treatment card and entries are done in Nikshay Follow up of the treatement Clinical follow up Done at monthly Interval Improvement in chest symptoms ,increase in weight may indicate good prognosis 2. . Laboratory investigations Sputum smear microscopy should be done at the end of intensive phase and end of treatment Negative Sputum smear at the end of IP indicate good prognosis.

45. MANAGEMENT OF DRUG RESISTANT TB Guidelines for Programmatic Management of Drug resistant TB (PMDT) was released under NTEP in the year 2019 fig.2.

46. Management of TB in a special cases Pregnancy and lactating women HIV Diabetes

47. Fig. 3.Management of DR-TB With Pregnancy

48. Management for HIV infected TB patients Start anti- tuberculosis treatment first and then start ART as soon as TB treatment is tolerated (between 2 weeks and 2 months). ART must be offered to all patients with HIV and TB and HIV and MDR-TB, irrespective of CD4 cell count.

49. Screening TB and diabetes Diabetes increases the risk of TB disease by 2-3 times. Implementation of the National framework for Joint TB-Diabetes Collaborative Activities in 2017, activities for addressing the joint burden of TB and Diabetes have been scaled up. Source: India TB report 2023 Anti- Diabetes treatment

50. PREVENTION & CONTROL Sakshi Chaudhry Roll no. 187

51. The BCG Vaccination ‘Bacille Calmette Guerin’ Avirulent strain Live attenuated bacterial vaccine Vaccine strain : Mycobacterium bovis Is reconstituted with normal saline (NaCl), used within 1 hour Dose: 0.05mL (neonates) 0.1mL (infant & children) Strength: 0.1mg in 0.1mL volume Route: intradermal site: above the insertion of left deltoid (fig.5.) Administration: at birth or at 6th week Protective value: 15-20 years Fig.4. BCG vaccine Fig.5.

52. Phenomenon after vaccination : a) After 2-3 weeks- Papule formation b)After 5 weeks- 4-8mm of diameter of papule c)After 6-8 weeks- Breaks into a shallow ulcer, seen covered with a crust d)After 6-12 weeks- Permanent tiny, round scar, typically 4-8mm diameter e) After 8-14 weeks- Mantoux test becomes positive Complications: a) Prolonged severe ulceration at site of vaccination b)Disseminated BCG infection c)Suppurative lymphadenitis d)Osteomyelitis e)Death Fig.6. scar formation

53. 2. Early Diagnosis Most effective way to prevent the spread of tb WHO develops guidelines and operational handbooks(fig.7) to accelerate increased treatment coverage in countries. Tools such as the Prevent TB (fig.8) platform support national health systems to strengthen their strategic information. Fig.7 handbook by who Fig.8 android and ios prevent TB platform

54. Fig.9 Ni-kshay dashboard Fig.10 Ni-kshay metrics

55. 3. Case Finding Passive case detection: 1962 Patient with symptoms of tb voluntarily seek health care. The medical officers follows diagnostic algorithm for evaluating tb patients. Intensified case finding: 2001 This is a provider initiated screening of outpatient clinic/hospital attendees for symptoms of tb. Tb screening for patients attending health facilities with comorbidities Active case finding: 2017 Actively searching for tb patients among population at higher risk of tb in the community Population based screening: 2020 .

56. 4. Managing the Environment As TB is an airborne infection; spreads via coughing or sneezing. The risk of infection can be reduced by using a few simple precautions: Good ventilation - as TB can remain suspended in the air for several hours with no ventilation Natural light - UV light kills tb bacteria Good hygiene - covering the mouth and nose when coughing or sneezing reduces the spread of TB bacteria. Respiratory hygiene (including cough etiquette) Fig.11 Tb cough etiquette

57. Fig.12 cough awareness to prevent TB

58. 5. A healthy immune system Having a healthy immune system is the best form of defence against TB: 60% of adults with a healthy immune system can completely kill TB bacteria. Maintain a well-balanced diet to keep immune system strong. Don’t smoke or drink Fig.13 awareness for well balanced diet to prevent tb

59. 6. Education & Awareness Limiting the spread of TB depends on successfully finding and treating people with the illness, to prevent them from passing it on to others. This can be done through : Educating people about tb Raising awareness so people with TB symptoms know to seek help Outreach workers and volunteers within communities with high rates of TB to find people with symptoms and refer them for testing. TB research Fig.16 raising awareness Fig.15 tb research Fig.14 educating people

60. 7. Advocacy, Communication & Social Mobilization (ACSM) A) Advocacy is an activity by an individual or a group that aims to influence the decisions within political, economic and social institutions. Target audience- Decision-makers at national, regional and district levels Policy-makers Professional groups Funders Media Fig.17 ACSM handbook by WHO

61. Fig.18 celebrity endorsement

62. B) Communication aims to favourably change knowledge, attitudes and practices among various groups of people. Target audience- General public, including different vulnerable groups, healthcare workers TB patients currently on treatment as well as cured TB patients Contacts of patients with active TB People at high risk of developing TB C) Social mobilisation is the process of bringing together different stakeholders and building partnerships to prevent, detect, and cure TB. Target audience includes- Communities Community groups, e.g., mahila mandals, youth groups National and local level leaders Local Non-government Organisations (NGOs), Youth organizations, Community-based Organisations ( CBOs) Fig.19 public interaction Fig.20 community group participation

63. 8. Supervision & Monitoring Routine monitoring is conducted under the supervision of the District TB Programme Officer by- Senior TB Treatment Supervisor, Senior TB Laboratory Supervisor, and The designated Medical Officer for TB Control Staff from the state and central governments also make regular site visits to identify problems and facilitate improvements, particularly in districts that are seen to be performing poorly. A monthly programme management and logistics report is provided by all health facilities to monitor facility performance , and manage drug supply and laboratory consumables . Tuberculosis units submit quarterly reports to the district on case detection , treatment outcomes , and programme logistics. The respective district enters these reports into the RNTCP electronic information management system and sends them to the respective state government TB cells and to the Central TB Division in the Ministry of Health and Family Welfare.

64. References: https://www.tbalert.org/about-tb/what-is-tb/prevention/ https://www.who.int/activities/preventing-tb https://www.ncbi.nlm.nih.gov/books/NBK344409/ https://www.who.int/publications/i/item/9789240055889 https://twitter.com/TBHDJ https://tbcindia.gov.in/showfile.php?lid=3680 https://apps.who.int/iris/rest/bitstreams/52020/retrieve https://ntep.in/node/4610/dr-tb-coordinator-general-concepts-acsm RNTCP(2017), Guidelines on Programmatic Management of DR-TB in India,2017 WHO (2016), Global Tuberculosis Report 2016 WHO (2021) ,Global tuberculosis Report,2021 Govt. Of India (2014), TB India 2014,RNTCP Annual status Report, DGHS,ministry of health and family welfare ,new Delhi WHO (2016) ,fact sheet No.104,March 2016 http://tbfacts.org

65. THANK YOU