Revised national tuberculosis control programme

RNTCP programme and its structure.

1. RAVI ROHILLA DEPTT OF COMMUNITY MEDICINE PGIMS Rohtak REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME

2. CONTENTS Background Information World Scenario Indian Scenario TB control in India RNTCP STOP TB strategy RNTCP Funding Classification and diagnostic algorithm

3. CONTENTS Case registration Treatment Follow-up schedule for sputum examination Reports and feedback Achievements

4. Background Information 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. One in ten people infected with TB (but who are not infected with HIV) become ill with TB at some time during their life. People with both HIV and TB infection are much more likely to become ill with TB.

5. In 2009, there were an estimated 9.4 million incident cases (range, 8.9 million–9.9 million ) of TB globally There were an estimated 14 million prevalent cases(range 12 million–16 million) of TB in 2009 In 2009, an estimated 1.3 million deaths ( range 1.2 million–1.5 million) occurred among HIV-negative cases of TB There were an estimated 440 000 cases of multi-drug resistant TB (MDR-TB) in 2008 T here were an estimated 0.4 million deaths ( range,0.32 million–0.45 million) among incident TB cases that were HIV-positive WORLD SCENERIO

6. INDIAN Scenario India is the highest TB burden country accounting for more than one fifth of the global incidence . Global annual incidence estimate is 9.4 million cases out of which it is estimated that 1.98 million cases are from India. India is 17th among 22 High Burden Countries in terms of TB incidence rate (Source: WHO global TB report 2009).

7. Other Countries 20% Other HBCs 16%

8. TUBERCULOSIS CONTROL IN INDIA National TB Control Programme ( NTP) 1962 RNTCP – 1993 as pilot project RNTCP: 1997 expanded across the country in a phased manner with support from the World Bank and other development partners RNTCP I: 1997-2006 RNTCP II: 2006-2011 (Sept.)

9. NTP G round-breaking research in the 1950s and early 1960s by the Tuberculosis Research Centre at Chennai and the National TB Institute at Bangalore, a National Tuberculosis Programme (NTP) was implemented by Government of India in 1962. The NTP was implemented on a 50:50 cost sharing basis between Centre and State.

10. NTP 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.

11. FAILURE OF NTP Inadequate budget and insufficient managerial capacity Shortage of drugs Less than 40% of patients completed the treatment Emphasis on x-ray diagnosis resulting in inaccurate diagnosis Poor quality sputum microscopy Multiplicity of treatment regimens.

12. Revised strategy Augmentation of organizational support Increased budgetary outlay Use of sputum as a primary method of diagnosis Standardize treatment regimens Augmentation of the peripheral level supervision Ensuring a regular, uninterrupted supply of drugs up to the periphery health unit Emphasis on training, IEC, and Operational research

13. RNTCP GOI –WHO revised strategy for control of TB in India RNTCP application of WHO – DOTS launched in 1993 as pilot project covering 2.35 – 20 million population (1993-1997)

14. STRATEGIES The Revised National TB Control Programme (RNTCP ), based on the internationally recommended Directly Observed Treatment Short-course ( DOTS) strategy

15. OBJECTIVES The objectives of the programme are to: To achieve and maintain cure rate of at least 85% among New Sputum Positive (NSP) patients. To achieve and maintain case detection of at least 70% of the estimated NSP cases in the community .

16. UNIQUE FEATURES OF RNTCP District TB Control Society Modular training Patient wise boxes Sub-district level supervisory staff (STS, STLS) for treatment & microscopy Robust reporting and recording system

17. RNTCP Organization structure : State level

18. Designated Microscopy Centre Tertiary / Secondary level health care institutions Block PHCs / other equivalent institutions Caters to a population of 1 lakh (0.5 lakh in hilly, tribal and difficult areas) 60 -100 new adult outpatient attendance per day The laboratory technician must be examining an average of at least 3 – 5 smears and not more than 20 – 25 smears per day.

19. Annual Risk of Tuberculosis Infection 1.5% Means out of 100000 people, 1500 people would be infected of Tuberculosis. Out of these 1500 infected subjects, 10% would be the number of people who will be developing the disease It means 150 people will be developing the TB. Out of these, 50% of the cases will be new sputum positive cases. This shows that for ARTI of 1.5%, there will be 75 new sputum positive cases per year per lakh population

20. DOTS Strategy DOTS is a systematic strategy which has five components: Political and administrative commitment . TB is the leading infectious cause of death . Since TB can be cured and the epidemic reversed, it warrants the topmost priority as given by GoI . Good quality diagnosis . Good quality microscopy is essential to identify the infectious patients who need treatment the most. Good quality drugs. An uninterrupted supply of good quality anti-TB drugs must be available.

21. Directly observed treatment short-course chemotherapy The DOTS strategy along with the other components of the Stop TB strategy, implemented under the Revised National Tuberculosis Control Programme (RNTCP) in India, is a comprehensive package for TB control. Systematic monitoring and accountability. The programme is accountable for the outcome of every patient treated. The RNTCP shifts the responsibility for cure from the patient to the health system. DOTS Strategy

22. RNTCP In the first phase of RNTCP ( 1997-2006), the programme’s focus was on ensuring expansion of quality DOTS services to the entire country. The RNTCP has now entered its second phase (2006-2011)in which the programme aims to firstly consolidate the gains made to date, to widen services both in terms of activities and access, and to sustain the achievements for decades to come in order to achieve ultimate objective of TB control in the country.

23. RNTCP Phase II (2006-11) is in line with the new WHO Stop TB Strategy for TB control and covers all the activities proposed under the strategy . RNTCP is committed to implementing the 2006 Global Strategy to Stop TB and reaching the TB related targets of the Millennium Development Goals by 2015 . The RNTCP II aims to provide a road map for TB control to achieve the long term goal, by 2015, of reducing the prevalence of TB by 50%. RNTCP

24. TB in MDGs Goal 6 – to combat HIV/AIDS, malaria and other diseases Target 8 – to have halted by 2015 and begun to reverse the incidence of malaria and other major diseases, including tuberculosis. Indicator 23: Between 1990 and 2015, to halve the prevalence and death rates associated with tuberculosis; and Indicator 24: by 2005, to detect 70% of new smear positive TB cases arising annually, and to successfully treat 85% of these cases

25. THE STOP TB STRATEGY The new WHO Stop TB Strategy, released in 2006 , has identified six principal components to realise the global TB related MDGs by 2015. These components were further revised in 2009:

26. All components of new Stop TB Strategy are incorporated in the second phase of RNTCP. These are : 1.Pursue quality DOTS expansion and enhancement, by improving the case finding are cure through an effective patient-centred approach to reach all patients, especially the poor. 2. Address TB-HIV, MDR-TB and other challenges, by scaling up TB-HIV joint activities, DOTS Plus, and other relevant approaches. 3. Contribute to health system strengthening, by collaborating with other health programmes and general services. THE STOP TB STRATEGY

27. 4. Involve all health care providers, public, nongovernmental and private, by scaling up approaches based on a public-private mix (PPM), to ensure adherence to the International Standards of TB care. 5. Engage people with TB, and affected communities to demand, and contribute to effective care. This will involve scaling-up of community TB care; creating demand through context-specific advocacy, communication and social mobilization. 6.Enable and promote research for the development of new drugs, diagnostic and vaccines. Operational Research will also be needed to improve programme performance. THE STOP TB STRATEGY

28. “In recent years India has taken major strides towards controlling TB. The Stop TB Partnership is confident that India will continue the momentum and contribute significantly towards the implementation of the Global Plan to Stop TB, 2006-2015.” Dr. Marcos Espinal , Executive Secretary, Stop TB Partnership Secretariat, Geneva THE STOP TB STRATEGY

29. RNTCP FUNDING

30. The RNTCP Phase II of the World Bank project has been approved by the CCEA for the period Oct 2006 to Sep 2011 for a total outlay of USD 256.9 million which includes credit from World Bank of USD 170 million and commodity assistance of anti-TB drugs from DFID ( Department For International Development)through WHO for USD 62.5 million, and the balance by Government of India. RNTCP FUNDING

31. CLASSIFICATION Tuberculosis cases are classified as either pulmonary or extra pulmonary. Pulmonary tuberculosis is defined as having lesions in lungs. It is divided into two types: Smear-positive pulmonary TB: A patient with one or two smears positive for AFB out of the two sputum specimens subjected for smear examination by direct microscopy is classified as having smear positive pulmonary TB.

32. CLASSIFICATION Smear-negative pulmonary TB : Patients with two initial negative smear results, whose symptoms persist after two weeks of broad spectrum antibiotics and whose repeat sputum examination results are also negative along with radiological abnormalities suggestive of active TB is classified as having smear negative pulmonary tuberculosis.

33. Extra-pulmonary TB : Tuberculosis of organs other than the lungs such as pleura, lymph nodes, intestine, genitor-urinary tract, joint and bones, meninges of the brain etc., is called as extra pulmonary TB . Pleural tuberculosis is classified as extra pulmonary . If a patient has both smear-positive pulmonary TB and extra-pulmonary TB, the patient is classified as having pulmonary TB and the site of extra-pulmonary TB is recorded as well . CLASSIFICATION

34. Case registration Types of cases to be registered: All tuberculosis patients put on DOTS or non DOTS regimen under RNTCP are to be registered. This includes new smear positive, new smear negative, new extra pulmonary, new others and re-treatment cases comprising of relapses, treatment after defaults, failures and others. Besides, transfer-in cases are also to be registered.

35. Person responsible for registration : Senior Treatment Supervisor (STS) is responsible for registering all TB cases put on treatment under the jurisdiction of TB Unit . He / She is also responsible for updating and maintenance of the TB register under the overall supervision of the MOTC. Case registration

36. Tuberculosis number Each patient who is being registered is assigned a new Tuberculosis Number and this number is written in the Tuberculosis Register. The number should be started with number ‘1’ (e.g. -01 / 2010 at the beginning of every year and patients are registered serially. After TB number is written in the TB register the same is recorded in the treatment card also. Case registration

37. TB number facilitates identification of the patient in the TB register and other details pertaining to treatment. An individual TB patient may have more than one TB number if he is reregistered (e.g. after declaring him as ‘Defaulted’ and restarting on treatment afresh or after declaring as failure and initiating on regimen for previously treated cases, details of which will be recorded in the remarks column). Case registration

38. The STS should write the TB number in the following records: • TB register • TB treatment card • TB laboratory register (Remarks column) Case registration

39. Timeline for registration: All tuberculosis patients should be registered within a month after the initiation of the treatment and after patient’s home visit by the STS. Under no circumstances the treatment should be delayed pending the registration of the patient. Case registration

40. Types of cases New A TB patient who has never had treatment for TB or has taken anti-TB drugs for less than one month is considered as a new case. Transferred in A TB patient who has been received for treatment in a Tuberculosis Unit, after starting treatment in another TB unit where s/he has been registered is considered as a case of transferred in.

41. Treatment after default patient : who has received treatment for TB for a month or more from any source and returns for treatment after having defaulted i.e., not taken anti-TB drugs consecutively for two months or more and found to be smear-positive is a case of treatment after default. Failure: Any TB patient who is smear-positive at 5 months or more after initiation of treatment is considered as failure . Types of cases

42. Relapse: A TB patient who was declared cured or treatment completed by a physician and who reports back to the health facility and is now found to be sputum smear positive is a relapse case. Others: A patient who does not fit into the any of the types mentioned above. The reasons for labelling a patient under this type must be specified in the Treatment card and TB Register Types of cases

43. Cured Initially sputum smear positive patient who has completed treatment and had negative sputum smears on two occasions, one of which is at the end of the treatment is declared as cured. Treatment completed Initially sputum smear positive patient who has completed treatment with negative smears at end of the intensive phase / two months in the continuation phase, but none at the end of treatment the treatment is declared as treatment completed , or Initially sputum smear negative patient who has received full course of treatment and has not become smear positive at the end of the treatment, or Extra pulmonary TB patient who has received full course of treatment and has not become smear positive during or at the end of treatment is also declared as treatment completed. Types of cases

44. Patient wise drug boxes Drugs are supplied in patient-wise boxes (PWB) containing the full course of treatment , and packaged in blister packs. The PWB have a color code indicating the two regimen - Red for “New”, Blue for “Previously Treated”. In each PWB, there are two pouches one for intensive phase and one for continuous phase . In the intensive phase , each blister pack contains one day’s medication. For the continuation phase, each blister pack contains one week’s supply of medication. The drugs for extension of the intensive phase (prolongation pouches) are supplied separately.

45. Regimen for New cases treatment consists of total 78 doses and for previously treated cases consists of 102 doses.

46. Drug dosages for adults in the blister packs

47. MDR-TB & XDR-TB MDR-TB is defined as resistance to isoniazid and rifampicin, with or without resistance to other anti-TB drugs. XDR-TB is defined as resistance to at least Isoniazid and Rifampicin (i.e. MDR-TB) plus resistance to any of the fluoro -quinolones and any one of the second line injectable drugs ( amikacin , kanamycin or capreomycin ). Cure rate for MDR-TB is 20-30%.

48. Treatment Of MDR-TB Cases RNTCP will be using a Standardised Treatment Regimen (Cat IV) for the treatment of MDR-TB cases ( and those with rifampicin resistance) under the programme . Cat IV regimen comprises of 6 drugs- kanamycin, ofloxacin (levofloxacin)†, ethionamide , pyrazinamide, ethambutol and cycloserine during 6-9 months of the Intensive Phase and 4 drugs- ofloxacin (levofloxacin), ethionamide , ethambutol and cycloserine during the 18 months of the Continuation Phase. p - aminosalicylic acid (PAS) is included in the regimen as a substitute drug if any bactericidal drug (K, Ofl , Z and Eto ) or 2 bacteriostatic (E and Cs) drugs are not tolerated.

49. Monitoring the MDR-TB patient Close monitoring is essential during treatment of MDR-TB patients . To assess treatment response, sputum smears and cultures should be performed monthly until smear and culture conversion. (Conversion is defined as two consecutive negative smears and cultures taken 30 days apart .) After conversion, the minimum frequency recommended for bacteriological monitoring is monthly for smears and quarterly for cultures . Monitoring of MDR-TB patients by a clinician should be at least monthly until sputum conversion, then every 2–3 months . Each patient’s weight should be monitored monthly.

50. Non-DOTS (ND) treatment regimen In rare and exceptional situations, non-DOTS treatment (with a self-administered non-rifampicin containing regimen) may be needed in a few TB cases. Examples include : 1 . Those with adverse reactions to rifampicin and / or pyrazinamide 2 . “New” patients who refuse DOT,S despite all efforts To facilitate registration of patients started on non-DOTS regimens, a Tuberculosis Treatment Card should be filled . A maximum of 1% of patients may get non-DOTS treatment in an RNTCP area.

51. NON DOTS The justification for initiating patient on non-DOTS treatment should be specified in the “Remarks” column of the treatment card and TB register . This is a treatment regimen of 12-month duration comprising 2 months of SHE and 10 months of HE (2SHE / 10HE). Dosages administered per day in the regimen are: Isoniazid - 300 mg Ethambutol - 800 mg Streptomycin - 750 mg (500 mg for >50 years of age). Those who weigh less than 30 kgs receive dosages calculated as per body-weight .

52. Follow up schedule for sputum examination: Follow up sputum examination is recommended as follows For New Cases At the end of Intensive Phase (2nd month) Two months into the Continuation Phase (4th month) End of treatment (6th month)

53. New smear positive patients remaining smear positive at the end of 2 months of treatment and new smear negative cases becoming smear positive at the end of 2 months will have their intensive phase extended by 4 weeks by administering 12 blisters from prolongation pouch. They would be subjected for repeat follow up sputum examination at the end of 3 months. Irrespective of the smear results (whether positive or negative) at the end of third month, continuation phase is started . Follow up schedule for sputum examination:

54. Subsequently, the patient is subjected for sputum examination at 2 months into the continuation phase i.e. at the end of 5 months of treatment. The final follow up sputum examination is done at the end of the treatment. If patients are found to be positive either at the end of 5 months or at the end of treatment they are declared as failure and sputum is sent for culture and drug sensitivity testing. Then, they are registered afresh and put on treatment regimen for previously treated. Follow up schedule for sputum examination:

55. For Previously treated cases 1. At the end of Intensive Phase (3rd month) 2. Two months into the Continuation Phase (5th month) 3. End of treatment (8th month) Follow up schedule for sputum examination:

56. In situations where sputum is positive at the end of three months, intensive phase is extended by four weeks by administering additional 12 blister packs and a follow up sputum examination is undertaken at the end of fourth month. Irrespective of the smear results (whether positive or negative) at fourth month, continuation phase is started . In case sputum is positive at the end of the fourth month, sputum is sent for culture and drug sensitivity testing. Subsequently , the patient is subjected for sputum examination at the end of sixth and ninth month. Follow up schedule for sputum examination:

57. Points worth mentioned Smear conversion at the end of the intensive phase is an early indication for achieving high cure rates. This has to be ensured by regular monitoring of the treatment . Treatment of smear-negative and extra-pulmonary TB is monitored by regularity of drug intake and clinical improvement. A patient initiated on treatment for tuberculosis will have only one of the seven outcomes (cured, treatment completed, died, failure, defaulted, transferred out or switched over to MDR-TB treatment). While determining the date of outcome in cure and treatment completed, the date on which the last dose of drug consumed is considered and not the last date when drugs were collected.

58. During follow-up sputum smear examinations, if 2 specimens are examined and one of them is positive , the patient is considered smear-positive . If both specimens are positive, the higher grade out of the two results is written on the patient’s Tuberculosis Treatment Card . If both specimens are negative, the patient is smear-negative and ‘NEG’ is recorded in the appropriate space . The results of follow up sputum smear examination done at the end of treatment should be available not later than two week of completion of treatment, so that appropriate outcome for the patient can be given in the TB Treatment Card. Points worth mentioned

59. Flow of reports and feedback The monthly PHI level PMR is prepared by the MO of the PHI and sent to the district and TU . At the TU a quarterly PMR is prepared by the MOTC with support of STS/STLS and despatched to the DTO. Quarterly reports on case finding, sputum conversion and treatment outcome are prepared at the TU level from the TB register. The STS is responsible for preparing the reports mentioned above under the overall supervision of the MOTC at TU level. The MOTC is responsible for validating and signing the reports and despatching it to DTO.

60. The quarterly reports received from all the TUs in the district are consolidated at District TB Centre. District TB Officers in turn are responsible for reporting the same to the state level authorities [STC and STDC] and CTD. The reports are consolidated at STC and sent to CTD. The reports are analysed at the STC/STDC and feedback given to districts . The quarterly reports are also analysed by CTD and feedback is provided to the state for corrective actions. All the above reporting activities are undertaken on a quarterly basis from TU to central level. A diagrammatic flow chart is provided below depicting the monitoring process. Flow of reports and feedback

61. Achievements With respect to the progress towards indicator 23 , as per the WHO estimates in the year 1990, the prevalence of TB in India was 586 per 100,000 populations and the mortality due to TB was 42 per 100,000 population. In comparison, in the year 2008, the prevalence of TB in India was estimated by WHO to be 185 per 100,000 populations, and the mortality due to TB is 24 per 100,000 populations. The estimates show that India has progressed in reducing the prevalence rate by 68% and mortality rate by 43 %.

62. Progress towards MDG indicator 23

63. Progress towards MDG indicator 23

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