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Rntcp 2018
- 1. RNTCP 3/12/2020 1 PRESENTER – DR. BUSHRAJABEEN MODERATOR – DR. S. V. DIVAKAR
- 2. Contents • Introduction • Problemstatement • Evolution of NTCP and RNTCP • Organizational structure of RNTCP • Technical operational guidelines RNTCP-2016 • References 3/12/2020 2
- 3. Tuberculosis • One ofthe oldest diseases known. • Caused by Mycobacterium tuberculosis • In March 1882, Dr. Robert Koch discovered Mycobacterium Bacillus, in Germany. • Affects lungs 3/12/2020 3
- 4. Burden of TB 3/12/2020 4 Estimatesof TB Burden (2017) Global India Karnataka Incidence TB cases 133/100000 204/100000 68462/65200000 Mortality of TB 17/100000 31/100000 Incidence HIV TB 9.2/100000 3.1/100000 7230/65723 Mortality of HIV-TB 4/100000 0.79/100000 MDR-TB 153119/66245 23 147000 1.16/1000 WHO Global TB Report 2018
- 5. Evolution • Government ofIndia along with WHO & SIDA reviewed the TB situation in country & came up with following recommendations: 1. NTP though technically sound suffer from managerial weakness. 2. Inadequate funding 3. Over reliance on X-ray for diagnosis. 4. Frequent interruption of drug supplies 5. Low rate of treatment completion. • In 1993 government of India gave new thrust to TB control activities by formulating RNTCP with assistance from international agencies. 5
- 6. 3/12/2020 6 • 1997-RNTCP waslaunched • Adopted- DOTS • Goals : To reduce mortality and morbidity To interrupt chain of transmission • Objectives: Achieve at least 85% cure rate among new smear-positive cases initiated on Rx Case detection rate of at least 70% of such cases • Establishment of sub-district supervisory unit with RNTCP supervisor and decentralization of diagnostic and treatment services with treatment given under the support of DOT provider
- 7. Vision: A TB FREEINDIA Goal: Universal Access to quality TB diagnosis and treatment for all TB patients in the country (2,8 million) (4.8 lakh) SDGs and End TB Targets
- 8. The End TBStrategy: 3 pillars and 4 principles 3/12/2020 8
- 9. DIFFERENCES BETWEEN NTP& RNTCP NTP RNTCP Objective Early diagnosis and treatment Breaking the chain of transmission Operational targets Not defined Cure rate 85% Case finding 70% of estimated cases Strategy SCC unsupervised DOTS Uninterrupted drug supply Diagnosis X rays 2 sputum smears One sputum positive is considered a case Mainly sputum microscopy 2 sputum smears One smear positive/clinically positive is a case 3/12/2020 9
- 10. Objectives of RNTCP 1.Achievement of at least 85% cure rate of infectious causes of TB through DOTS involving peripheral health functionaries. 2. Augmentation of case finding activities through quality sputum microscopy to detect at least 70% of estimated cases. 10
- 11. Strategies under RNTCP 1.DOTS strategy adopted by RNTCP has 5 main components: A. Political will & administrative commitment. B. Diagnosis by quality assured sputum microscopy. C. Adequate supply of quality assured short course chemotherapy drugs. D. Directly observed treatment. E. Systematic monitoring & accountability. 11
- 12. Provision of care: 1.Diagnostic algorithms. 2. Treatment guideline. 12
- 13.
- 14. Case Definition TB suspect– Presumptive TB 3/12/2020 14 Case definition Bacteriologic ally confirmed Clinically diagnosed Anatomical site Pulmonary Extra pulmonary History of ATT New Recurrent (Relapse/reinfection) Treatment after failure Treatment after lost to follow up (Default) Other previously treated patients Treatment outcome Cure Treatment completed Died Failure Lost to follow up Change of regimen Not evaluated
- 15. Diagnostic Tools Tools formicrobiological confirmation of TB All efforts should be undertaken for microbiologically confirming the diagnosis in presumptive TB patients. Under RNTCP, acceptable methods for microbiological diagnosis of TB are: 3/12/2020 15 Sputum Smear Microscopy (for AFB) Culture Rapid Molecular diagnostic testing - Zeihl -Neelson Staining - Fluorescent Staining - Solid (LJ) media - Liquid Culture System - Line Probe Assay - CBNAAT
- 16. Diagnostic Tools •Sputum SmearMicroscopy(for AFB): - Ziehl -Neelsen Staining - Fluorescent Staining •Culture: - Solid(Lowenstein Jensen) media - Automated Liquid Culture System eg. BACTEC MGIT 960, BacT Alert etc., •Rapid Molecular diagnostic testing: - Line Probe Assay for MTB complex and detection of Rif and INH resistance - Nucleic Acid Amplification testing ( NAAT) Xpert MTB/RIF testing 16
- 17.
- 18. Diagnostic Algorithm 18 Pulmonary TBExtra Pulmonary TB Paediatric TB Drug Resistant TB
- 19. Diagnostic algorithm 1:Pulmonary Tuberculosis • PLHIV confirmed by CBNAAT 3/12/2020 19
- 20. Diagnostic Algorithm 2:EPTB • If high clinical suspicion then follow high clinical suspicion flow diagram 3/12/2020 20
- 21. 3/12/2020 21 Diagnostic algorithm 3:Pediatric Pulmonary Tuberculosis Investigations: Diagnosis:
- 22.
- 23. 99DOTS: Workflow -Summary 3/12/2020 23 CBNAAT testing for rapid microbiological diagnosis Patient at ART Centre with symptoms of TB Cough, Fever, Night sweats, Weight loss Patient identified positive for TB Patient is counseled at ART Centre to take medication in the 99DOTS packaging & registered on 99DOTS website Patient’s sputum is sent for testing to the RNTCP center Continuous monitoring and follow up by RNTCP staff
- 24. Intensified TB CaseFinding in Key Population 3/12/2020 24 Clinical Social Geographical Clients attending HIV Care Settings Prisoners Urban Slums Substance abuse including smokers Occupations with risk of developing TB Hard to reach areas Co-morbidities like Diabetes Mellitus, Malignancies, patients on dialysis and on long term immunosuppressant therapy People in Congregated settings – night shelters, De- addiction centers, Old age homes Indigenous and tribal populations Health Care Workers Household & Workplace Contacts Patients with Past History of TB Malnourished Antenatal mothers attending ANC/MCH
- 25. Surveillance • Electronic healthrecording NIKSHAY 3/12/2020 25
- 26. Treatment categories: (Drugsensitive TB) New cases Previously treated cases New sputum smear positive sputum smear positive relapse New sputum smear negative sputum smear positive failure New extra pulmonary tuberculosis sputum smear positive treatment after default 26
- 27. Drug Regimen –Drug Sensitive Tuberculosis-2 3/12/2020 27 Regimen HRZE + HRE Daily FDC WeightBands MON TUE WED THU FRI SAT SUN Weight category 25-39 kg 40-54 kg 55-69 kg ≥70 kg
- 28. Drugs Adult Children Isoniazid5 mg/kg (4 to 6 mg/kg) daily 10 mg/kg (7-15 mg/kg) daily Rifampicin 10 mg/kg (8-12 mg/kg) daily 15 mg/kg (10-20 mg/kg) daily Pyrazinamide 25 mg/kg (20-30 mg/kg) daily 35 mg/kg (30-40 mg/kg) daily Ethambutol 15mg/kg (12-18 mg/kg) daily 20 mg/kg (15-25 mg/kg) daily Streptomycin 15 mg/kg (15-20 mg/kg) daily 15 mg/kg (12-18 mg/kg) daily Drug dosages for anti-TB drugs 28
- 29. Doses in RNTCPDaily Regimen Type of TB Case Doses in IP Doses in CP# New 56 doses (8 weeks x 7 days/week) or 28*2 112 doses(16 weeks x 7 days/week) or 28*4 Previously treated 84 doses (12 weeks x 7 days/week) or 28*3 140 doses(20 weeks x 7 days/week) or 28*5 3/12/2020 29 #CP can be extended 12 to 24 weeks in certain forms like CNS TB, Skeletal TB and Disseminated TB, based on clinical decision of the treating physician
- 30. Daily Dose Schedulefor Adults (as per weight bands) Weight band Number of tablets Inj. Streptomycin Intensive phase Continuation phase HRZE HRE 75/150/400/27 5 mg 75/150/275 mg gm 25-39 kg 2 2 0.5 gm 40-54 kg 3 3 0.75 gm 55-69 kg 4 4 1 gm ≥70 5 5 1 gm 3/12/2020 30
- 31. Drug Dosage forPaediatric TB Weight category Number of tablets (dispersible FDCs) Inj. Streptomyci n Intensive phase Continuation phase HRZ E HR E 50/75/150 100 50/75 100 mg 4-7 kg 1 1 1 1 100 8-11 kg 2 2 2 2 150 12-15 kg 3 3 3 3 200 16-24 kg 4 4 4 4 300 25-29 kg 3 + 1A* 3 3 + 1A* 3 400 30-39 kg 2 + 2A* 2 2 + 2A* 2 500 3/12/2020 31 A=Adult FDC (HRZE = 75/150/400/275; HRE = 75/150/275)
- 32. Newer Drugs • BEDAQUILINE(Target Mycobacterial ATP synthase) • DELAMANID (Mycolic acid synthesis inhibitor) • PRETOMANID • DIAMINES • PYRROLES 32
- 33. Treatment in SpecialSituation 33
- 34. PREGNANCY MDR – TBpatients who are found to be pregnant prior to treatment initiation or whilst on treatment- consider the following factors: • Risks and benefits of MDR- TB treatment • Severity of MDR –TB • Gestational Age • Potential risk to the fetus. 34
- 35. TB-HIV Single window fordelivery of HIV-TB care 3/12/2020 35 Rapid molecular diagnosis Daily FDC ICT based adherence support Pharmacovigilance IPT ART Centre
- 36. LIVER DISORDERS Clinical monitoringof all patients with pre – existing liver disease should be performed during treatment. If serum alanine aminotransferase is more than 3 times normal before treatment, consider the following regimen • Conatining 2 hepatotoxic drugs: 9HR+ E 2HRSE+ 7HR 6-9 RZE • Conatining 1 hepatotoxic drug: 2SHE+ 10 HE • Containing no hepatotoxic drugs: 18-24 SE and fluroquinolone. 36
- 37. RENAL FAILURE OR INSUFFICIENCY •All CKD patients are at increased risk of developing TB. • Treatment can be given immediately after hemodialysis to avoid premature drug removal. 37
- 38. Systems to strengthenADR management FEATURES: • Patient guide • Ready reckoner for health worker and medical officers • Reference manuals for medical offices and specialists 38
- 39.
- 40. Causality assessment ofthe ADR and furnish the mandatory fields in the suspected ADR form Upload the ADRs in VigiFlow ADR – Monitoring 40
- 41. ADR – Monitoring- Needs • Training of staff on ADR management and monitoring • Communication material to support staff on ADR management and monitoring • Register health care providers on ADR monitoring mobile app. • Facilitate to establish more ADR monitoring centres • Linkages with ADR monitoring centres • Review of ADR monitoring activities 41 Helpline No. 1800-180-3024 (Toll Free)
- 42. Cohort event monitoring- NIKSHAY 42
- 43. Role of RNTCPfor Safety Monitoring of Anti-TB drugs • Training RNTCP managerial and field staff on Pharmacovigilance • Developing a mechanism and guidelines for RNTCP staff for reporting Spontaneously reported ADRs • Establishing a collaboration with field RNTCP staff for ADR reporting • Targeted spontaneous reporting of SAEs in MDR TB patients at TB Centres • Cohort Event Monitoring by RNTCP through post-marketing surveillance of newer Anti-TB Drugs. 43
- 44. Role of MedicalColleges in End TB 2025 • Medical colleges contribute to RNTCP in following ways: 1. Role in case finding 2. Role in treatment 3. Role in control of drug resistant TB 4. Role in research 5. Implementation of air borne infection control in health care facilities. 6. Planning, surveillance & quality improvement supports to districts. 7. Training activities 8. Referral services 9. Centre of excellence 44
- 45. Difference of RNTCPregimen between new and previous guidelines New guidlines Daily regimen Ethambutol in CP of both cat I & II regimen Fixed dose combination as per weight band No need of extension of IP Follow-up-clinical, laboratory investigation Long –term follow-up, up to 2 years Previous guidelines Intermittent regimen Ethambutol in CP of cat II regimen only No fixed dose, limited weight band Extension of IP for 1 month if sputum is +ve Follow-up-laboratory only No long-term follow up 3/12/2020 45
- 46. TOG- the wayforward • Revised diagnostic Algorithm • Newer diagnostics • Active Case Finding • Daily regimen with FDCs • Universal DST • Enhanced adherence support strategy • Single window delivery of HIV TB care services • Intensified partnership efforts • ICT supported case based surveillance 46
- 47. References • Park K.Park’s Textbook of Preventive and Social Medicine. 24nd ed. Jabalpur (India): Banarsidas Bhanot Publishers; 2017. • J.Kishore. National health programmes of India. 12th ed: century publications; 2017 • Chaudhrui AD. Recent changes in technical and operational guidelines for tuberculosis control prgramme in India-2016: A paradigm shift in tuberculosis control. J Assoc Chest Physicians 2017;5:1-9 • End-TB strategy-2015 3/12/2020 47
- 48. •Together we will END TB Thankyou. 3/12/2020 48
Editor's Notes
- #4 It is a ch communicable bacterial ds, n It is one of the oldest ds known.the organism responsible for tb is M.TB n It was discovered by R.KOCH in 1882, almost 135 yrs ago. It commonly affects lungs but it can also affects other organs of the human body like intestine, meninges, bones and joints, lymph nodes, skins n other tissues of the body. This ds also affects animals like cattle, this is known as BOVINE TB, which may sometimes be communicated to man.it usually affects human in age group of 15 to 59 years, which is the most productive age group, coz of which community suffers from economic, social and health burdens.
- #5 105/100000, TB notification from programme – especially the private sector notification in routine and substantial increase in some pilot interventions Prevalence survey – state levels New evidences of burden of TB in private sectors as reveled using drug sales data
- #8 We have to now move towards new era of SDG and from STOP TB Strategy to END TB Strategy. The Government of India has also endorsed End TB Strategy and is committed to execute Vision of GoI is to have a TB FREE INDIA and the Goal is to achieve universal access to quality TB diagnosis and treatment for all TB patients in the country. The targets are set for reduction inn deaths, incidence and catastrophic cost.
- #9 To achieve those targets under The End TB Strategy, 3 pillars and 4 principles are described.
- #14 NTI- national tuberculosis institution NIRT – National Institution of research in TB NITRD – National institute of TB and respiratory disease JALMA- Japanese Leprosy Mission for Asia NTWG- National technical working group DST- Drug Sensitivity testing SDS- State drug store IRL-Intermediate reference laboratory DR-TB- drug resistant TB
- #15 To begin with, the some of the case definitions and terminologies are changed. TB suspect changed presumptive TB. Smear positive is replaced with microbiological confirmed to cover patients diagnosed on CBNAAT / Culture. Relapse – changed to recurrent to cover both relapse and reinfection Default is replaced with lost to followup and duration of interruption to define lost to follow up will be 1 month
- #18 NIRT, Chennai; NTI Bangalore; NITRD Delhi, and JALMA Institute of Leprosy and other Mycobacterial Diseases,Agra., RMRC,Bhubaneswar and BMHRC, Bhopal.
- #19 Four diagnostic algorithms – with effective utilization of high sensitive diagnostic tools. Triage through chest xray to use CBNAAT Adult pulmonary TB Pediatric pulmonary TB Extra pulmonary TB Drug resistant TB
- #25 Community Screening Institutional Screening The programme is explicitly putting forward intensified and active TB case finding as an effort to early detection and reaching the unreached or missing TB cases. Clinical, social and geographical high risk groups (key populations) are identified. Systematic active TB screening approach is advocated by the programme in these group of population.
- #26 The programme is continuously improving its surveillance system. The programme is moving from notification at treatment to notification at diagnosis both in public and private sector. NIKSHAY is enhanced with e NIKSHAY with digital tools to be provided to field staff.
- #28 There is change in treatment strategy for drug sensitive Tb patients. it is not only change in the frequency from intermittent to daily. But, there is lot more. Strengthen regimen by adding Ethambutol in Continuation phase for all tb patients including new and previously treated Frequency – daily Fixed dose combinations in place of multi blister combipacks Weight band wise dosing – four weight bands for adult and six weight bands for children Different dosing for adult and children in same weight bands
- #30 For new TB cases, the treatment in intensive phase (IP) will consist of eight weeks of Isoniazid, Rifampicin, Pyrazinamide and Ethambutol in daily dosages as per four weight band categories. There will be no need for extension of IP. Only Pyrazinamide will be stopped in the Continuation Phase (CP), while the other three drugs will be continued for another 16 weeks as daily dosages. For previously treated cases of TB, the IP will be of 12 weeks, where injection Streptomycin will be stopped after 8-weeks and the remaining four drugs (INH, Rifampicin, Pyrazinamide and Ethambutol) in daily dosages as per weight bands will be continued for another 4-weeks. There will be no need for extension of IP. At the start of CP, Pyrazinamide will be stopped while the rest of the drugs – Rifampicin, INH and Ethambutol will be continued for another 20 weeks as daily dosages in the CP. The CP in both new and previously treated cases may be extended by 12-24 weeks in certain forms of TB like CNS TB, Skeletal TB, Disseminated TB etc. based on clinical decision of the treating physician. Extension beyond 12 weeks should only be on recommendation of experts of the concerned field. Loose Drugs would be needed as substitutions in case of adverse drug reaction or with co-morbid conditions.
- #34 TB in Pregnant and Lactating women TB and Contraceptive pills usage Management of TB in patients with liver disorders TB patient with renal failure and severe renal insufficiency TB in patients with seizure disorders DR-TB in patients with psychosis Hospitalization
- #36 Single window for delivery of HIV-TB care at ART centre will provide one stop patients centric care for patients with co-infection of both HIV and TB. It has following care components: CBNAAT for diagnsosis of TB among PLHIV Daily FDC for treatment of TB ICT based adherence support Pharmacovigilance – ART centres are one of the ADR monitoring centre INH Preventive Therapy for PLHIV without TB
- #37 Normal range – 20-60 IU/L
- #39 Prevention and management of Adverse Reactions associated with Antitubercular Drugs is published jointly by ICMR and Central TB Division. Ready reckoners are incorporated within the technical and operational guidelines. The details of ADR identification and management is given in the TOG
- #40 The patient guide in English and Hindi given with pictorial illustration of information on side effects, ways and means of preventing and managing these
- #41 AMC do this work
- #42 ADR reporting app, is a smart phone application for android users, conceived by Dr Sachin Kuchya, Associate Professor in Pharmacology at NSCB Medical College, Jabalpur (MP, India) & developed in collaboration with Indian Pharmacopoeia Commission, National Coordination Centre, Pharmacovigilance Programme of India (NCC-PvPI) Ghaziabad (UP, India). With the help of ADR reporting app, Physicians – Nurses – Pharmacists, can instantly report any suspected Adverse Drug Reaction, to NCC PvPI, from all over India.
- #48 Barati banerjee. DK Taneja’s heath policies programmes in India. 15th ed: Jaypee publishers; 2017.