Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised RevisedRevised Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised National National National National National National National National National National National National National National National National National National National National National National National National National National National National National National National National National National National National National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Central TB Division Tuberculosis Control Programme Revised National Directorate General of Health Services Tuberculosis Controland Family Welfare Revised National Ministry of Health Programme Tuberculosis Control Programme Revised National Nirman Bhavan, New Delhi - 110 011 Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Tuberculosis Control Programme Revised National Revised National Tuberculosis Control Programme RNTCP at a GLANCE CONTENTS DEFINITIONS: THE REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME DIAGNOSTIC ALGORITHM FOR PULMONARY TB STAINING METHOD Key steps in the preparation and staining of smears Ziehl .Neelsen Staining Method TREATMENT ZONAL ARTIS AND ESTIMATED NSP CASES PER LAKH POPULATION TREATMENT CATEGORIES AND SPUTUM EXAMINATION SCHEDULE MANAGEMENT OF PATIENTS WHO INTERRUPT TREATMENT TREATMENT OF CHILDREN Algorithm for clinical monitoring of Pediatric TB Chemoprophylaxis for Children 5 6 7 7 8 9 9 10 12 15 16 17 SYMPTOM-BASED APPROACH TO EVALUATION OF POSSIBLE SIDE EFFECTS OF ANTI-TB DRUGS USED IN RNTCP 18 MANAGEMENT OF TB PATIENTS ON DOT IN SPECIAL SITUATIONS HOSPITALIZATION OF TB PATIENTS SUPERVISORY VISITS SUMMARY OF KEY INDICATORS AND POSSIBLE CORRECTIVE ACTIONS NEW INDICATORS 19 20 21 22 26 . . Relapse A TB patient who was declared cured or treatment completed by a physician. after starting treatment in another unit where s/he has been registered. not taken anti-TB drugs consecutively for two months or more. Transferred out A patient who has been transferred to another Tuberculosis Unit/District and his/her treatment result (outcome) is not known. Or: Sputum smear-negative TB patient who has received a full course of treatment and has not become smear-positive during or at the end of treatment. RNTCP at a Glance 5 . with negative smears at the end of the intensive phase but none at the end of treatment. Chronic A TB patient who remains smear positive after completing a re-treatment regimen. Failure also includes a patient who was treated with Category III regimen but who becomes smear positive during treatment. Case definitions Treatment outcomes Cured Initially sputum smear-positive patient who has completed treatment and had negative sputum smears. and radiographic abnormalities consistent with active pulmonary TB as determined by the treating MO followed by a decision to treat the patient with a full course of anti-tuberculosis therapy. Extra Pulmonary tuberculosis TB of any organ other than the lungs. such as the pleura (TB pleurisy). intestines. Pulmonary tuberculosis. Smear-Positive TB in a patient with at least 2 initial sputum smear examinations (direct smear microscopy) positive for AFB. but who reports back to the health service and is now found to be sputum smear positive. on two occasions.. or strong clinical evidence consistent with active extra pulmonary TB followed by decision of the treating MO to treat with a full course of antiTB therapy. Or: TB in a patient with one sputum smear specimen positive for AFB and culture positive for M.DEFINITIONS: THE REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME Types of cases New A TB patient who has never had treatment for tuberculosis or has taken anti-tuberculosis drugs for less than one month. Or: Diagnosis based on positive culture but negative AFB sputum smear examinations. Pulmonary Tuberculosis. Transferred in A TB patient who has been received for treatment into a Tuberculosis Unit. Died Patient who died during the course of treatment regardless of cause Failure Any TB patient who is smear positive at 5 months or more after starting treatment. Pleurisy is classified as extra pulmonary TB. Reasons for putting a patient in this type must be specified. Or: Extra-pulmonary TB patient who has received a full course of treatment and has not become smearpositive during or at the end of treatment.tuberculosis. etc. histological. Treatment after default A TB patient who received anti-tuberculosis treatment for one month or more from any source and returns to treatment after having defaulted. Defaulted A patient who has not taken anti-TB drugs for 2 months or more consecutively after starting treatment. and is found to be sputum smear positive. Failure Any TB patient who is smear positive at 5 months or more after starting treatment. Diagnosis should be based on culture-positive specimen from the extra-pulmonary site. Failure also includes a patient who was treated with Category III regimen but who becomes smear positive during treatment. joints and bones. Others TB patients who do not fit into the above mentioned types. Or: TB in a patient with one sputum smear examination positive for AFB and radiographic abnormalities consistent with active pulmonary TB as determined by the treating MO. i. Smear-negative TB in a patient with symptoms suggestive of TB with at least 3 sputum smear examinations negative for AFB. lymph nodes. radiological.e. A patient diagnosed with both sputum smear positive pulmonary and extra pulmonary TB should be classified as pulmonary TB. one of which was at the end of treatment Treatment completed Sputum smear-positive patient who has completed treatment. meninges of the brain. skin. genitourinary tract. DIAGNOSTIC ALGORITHM FOR PULMONARY TB COUGH FOR 3 WEEKS OR MORE 3 Sputum smears 2 or 3 Positives 3 Negatives Antibiotics 10-14 days Cough Persists Repeat 3 Sputum Examinations 1 Positive X-Ray Negative 2 or 3 Positives Suggestive of TB Negative for TB Sputum Positive TB (Anti-TB Treatment) X-Ray Sputum Positive TB (Anti-TB Treatment) Negative for TB Suggestive of TB Non TB Sputum Smear Negative TB (Anti-TB Treatment) 6 RNTCP at a Glance . and allow the slide to dry Examine the slides under the microscope examine at least 100 fields. RNTCP at a Glance 7 . if necessary) Step 9 Rinse away excess stain with tap water Drain off the water Step 10 Counterstain with 0. letting stand for 1–3 minutes.STAINING METHOD Key steps in the preparation and staining of smears Step 1 Break a broomstick into two Pick up the large. drain the water off.1% methylene blue and let stand for 30 seconds Gently rinse the slides with tap water. yellow purulent portion of sputum Spread evenly onto 2/3 of central portion of the numbered slide Spread evenly onto 2/3 of central portion of the numbered slide Step 2 Air-dry the slide for 15–30 minutes Step 3 Fix the dry slide by heating briefly 3–5 times for 3–4 seconds each time Step 4 Place the slides in serial order on the staining rack Stain the slides with 1% carbol fuchsin Step 5 Heat the slides from underneath until vapours rise Step 6 Let the slides stand for 5 minutes Step 7 Rinse the slides with tap water Drain off excess water Step 8 Decolourize with 25% sulphuric acid and let it stand for 2–4 minutes (repeat. 17. Tilt the slide to drain off the water. Rinse gently with tap water.1% methylene blue onto the slide.Ziehl . Invert the slides on tissue paper till the immersion oil is completely absorbed. Let the slide stand for 2–4 minutes. Gently heat the slide with carbol fuchsin on it. Record the results in the Laboratory Form and the Laboratory Register. 8 RNTCP at a Glance . Examine the slide under the microscope using x 40 lens to select the suitable area and then examine under x100 lens using a drop of immersion oil. 2 cms x 3 cms in size and is neither too thick nor too thin. 2.g. Select a new unscratched slide and label the slide with the Laboratory Serial Number with a diamond marking pencil.If the slide is still red. Rinse gently with tap water. 9. Wipe the back of the slide clean with a swab dipped in sulphuric acid. 8. until vapours rise. 21. Allow the slide to dry. Fix the slide by passing it over a flame 3–5 times for 3–4 seconds each time. reapply sulphuric acid for 1–3 minutes and rinse gently with tap water. 12. 3. “Scanty 4” 19. of fields to be examined 20 50 100 100 100 *Record actual number of bacilli seen in 100 fields – e. 18. 11. 5. 16. 6. Gently rinse the slide with tap water until all free carbol fuchsin stain is washed away. Do not boil. If the slide has: More than 10 AFB per oil immersion field 1-10 AFB per oil immersion field 10-99 AFB per 100 oil immersion fields 1-9 AFB per 100 oil immersion fields No AFB in 100 oil immersion fields Result Pos Pos Pos Pos Neg Grading 3+ 2+ 1+ Scanty-B* No. Do not use xylene for cleaning the slides. A good smear is spread evenly. Leave carbol fuchsin on the slide for 5 minutes. as it may give false results at repeat examination after storage. 14. This is required. Pour 0. 10. 13. The optimum thickness of the smear can be assessed by placing the smear on a printed matter. Pour 1% filtered carbol fuchsin to cover the entire slide. 7. Disinfect all contaminated material before discarding.Neelsen Staining Method 1. 4. as six inches around the flame is considered as a sterile zone which coagulates the aerosol raised during smear preparation. Store all positive and negative slides serially in the same slide-box until instructed by the supervisor. Pour 25% sulphuric acid onto the slide. Leave methylene blue on the slide for 30 seconds. A properly decolourised slide will appear light pink in color . Smear preparation should be done near a flame. Allow the slide to air dry for 15–30 minutes. At this point. The print should be readable through the smear. the smear on the slide looks red in colour. 15. Make a smear from yellow purulent portion of the sputum using a broom stick. 20. Maharashtra. YES Has the patient been treated for TB for one month or more previously NO YES YES CAT I CAT II ZONAL ANNUAL RISK OF TUBERCULOUS INFECTION (ARTI) AND ESTIMATED NSP CASES PER LAKH POPULATION Zone North East* States/Union Territories Haryana. ** Examples of seriously ill patients are those suffering from meningitis. Nagaland. Uttar Pradesh. Arunachal Pradesh. Jammu & Kashmir. Punjab. Gujarat. West Bengal. in which case they should receive Category I treatment. Andaman & Nicobar. Sikkim. Rajasthan. Uttaranchal Assam. Tamil Nadu. tuberculous pericarditis. spinal TB with neurological complications. Karnataka.TREATMENT Is the patient sputum-smear positive* NO Does the patient have TB? YES NO Is the patient seriously ill?** NO CAT III No Anti-TB treatment * Patients with extra-pulmonary TB should receive Category III treatment unless they are seriously ill. smearnegative pulmonary TB with extensive parenchymal involvement. Bihar. Manipur. Kerala. Chandigarh. intestinal. Lakshadweep Goa. Himachal Pradesh. Jharkhand Andhra Pradesh. peritonitis. Daman & Diu. Tripura. Chhattisgarh Orissa Estimated NSP cases per lakh population 95 75 South* West 75 80 State specific 85 RNTCP at a Glance 9 . Mizoram. genito-urinary TB and co-infection with HIV. disseminated TB. Madhya Pradesh. bilateral or extensive pleurisy. Dadra & Nagar Haveli. All forms of pediatric smear negative TB except primary complex and pediatric extrapulmonary TB except lymph node TB and unilateral pleural effusion. Delhi. Meghalaya. Pondicherry. test sputum again at 2 months in CP (5 months) and at the end of treatment (8 months) Continue Intensive phase for one more month. S: Streptomycin (750 mg). Z: Pyrazinamide (1500 mg). For the purpose of categorization. pulmonary or extra-pulmonary who is HIV positive and declares his sero-status to the categorizing/ treating medical officer. test sputum again at end of extended IP (3 months). test sputum again at the end of treatment (6 months) Continue Intensive phase for one more month. In these cases. and then at 2 months in CP (5 months) and at the end of treatment (7 months)† Start continuation phase. Patients in Categories I and II who have a positive sputum smear at the end of the initial intensive phase receive an additional month of intensive phase treatment. E: Ethambutol (1200 mg). ** Seriously ill also includes. . active TB. the patient should be categorized as ‘Others’ and given Category II treatment. Patients who weigh less than 30 kg. test sputum again at the end of treatment (6 months) Re-register the patient and begin Category II treatment† Seriously ill** sputum smear-negative Seriously ill** extra-pulmonary Category II Sputum smear-positive Relapse Sputum smear-positive Failure Sputum smear-positive Treatment after default Others*** New sputum smear-negative. test sputum again at end of extended IP (4 months).TREATMENT CATEGORIES AND SPUTUM EXAMINATION SCHEDULE Regimen* Pre-treatment sputum SPUTUM EXAMINATIONS FOR PULMONARY TB Test at If result Then month is (end IP) Category of Treat ment TREATMENT REGIMEN Type of patient New sputum smear-positive – 2 + 2H3R3Z3E3 + 4H3R3 Start continuation phase. Any patient on Category III who has a positive smear anytime during the treatment is also considered as Failure and started on Category II treatment. not seriously ill Category III New extra-pulmonary. Patients who weigh 60 kg or more receive additional rifampicin 150 mg. The subscript after the letters refers to the number of doses per week. test sputum again at end of extended IP (3 months). any patient. HIV testing should not be done *** In rare and exceptional cases. and then at 2 months in CP (5 months) and at the end of treatment (7 months)† Start continuation phase. This diagnosis in all such cases should always be made by an MO and should be supported by culture or histological evidence of current. patients who are sputum smear-negative or who have extra-pulmonary disease can have Relapse or Failure. and then at 2 months in CP (6 months) and at the end of treatment (9 months) Start continuation phase. Patients who are more than 50 years old receive streptomycin 500 mg. The dosage strengths are as follows: H: Isoniazid (600 mg). † Any patient treated with Category I who has a positive smear at 5 months or later should be considered a Failure and started on Category II treatment afresh. not seriously ill * The number before the letters refers to the number of months of treatment. receive drugs as per body weight. test sputum again at 2 months in CP (4 months) and at the end of treatment (6 months) + 10 RNTCP at a Glance – – + 2 2H3R3Z3E3S3 + 1H3R3Z3E3 + 5H3R3E3 + 3 + – 2H3R3Z3 + 4H3R3 – + 2 – Category I Continue Intensive phase for one more month. R: Rifampicin (450 mg). not seriously ill Regimen 2 HSE + 10 HE 12 HE In RNTCP areas.MEDICATION Medication Isonazid Rifampicin Pyrazinamide Ethambutol Streptomycin Dose (thrice a week)*** 600mg 450mg* 1500mg 1200mg 0. less then 5% of patients may get Non-DOTS Treatment RNTCP at a Glance 11 .5g of streptomycin. *** Adult patients who weigh less than 30kg receive drugs in patient-wise boxes from the weight band suggested for pediatric patients Phases and duration of treatment Category Category I Category II Category III Duration (number of doses) Intensive Phase (IP) Continuation Phase (CP) 8 weeks (24 doses) 18 weeks (54 doses) 12 weeks (36 doses) 22 weeks (66 doses) 8 weeks (24 doses) 18 weeks (54 doses) Total 26 weeks (78 doses) 34 weeks (102 doses) 26 weeks (78 doses) Duration if sputum is positive at end of Intensive Phase* Category Category I Category II Duration (number of doses) Intensive Phase (IP) Continuation Phase (CP) 12 weeks (36 doses) 18 weeks (54 doses) 16 weeks (48 doses) 22 weeks (66 doses) Cat II – at the end of 3 months Total 26 weeks (90 doses) 34 weeks (114doses) * Cat I – at the end of 2 months Regimen for non-DOTS in RNTCP areas Treatment Non-DOTS Regimen 1 (ND 1) Non-DOTS Regimen 2 (ND 2) Type of Patient New smear-positive pulmonary Seriously ill sputum smear-negative Seriously ill extra-pulmonary Smear-negative pulmonary.75g** Number of pills in combipack 2 1 2 2 - * Patients who weigh 60kg or more at the start of treatment are given an extra 150mg dose of rifampicin ** Patients over 50 years of age and those who weigh less than 30 kg are given 0. not seriously ill Extra-pulmonary. MANAGEMENT OF PATIENTS WHO INTERRUPT TREATMENT Management of patients who were smear-negative at diagnosis and who interrupt treatment Treatment received before interruption Length of interruption Do a sputum Smear examination No Result of Outcome sputum Smear examination __ __ Reregistration Treatment Less than 2 months __ Less than 1 month Resume Treatment and Complete All doses Resume Treatment Begin CAT I afresh Resume Treatment and Complete All doses Resume Treatment and Complete All doses Begin CAT II Treatment afresh 2 months or more Yes Neg Pos __ Default __ New Less than 2 months No __ __ __ More than 1 month More than 2 months Yes Neg __ __ Pos Default Treatment After Default 12 RNTCP at a Glance . although at re-registration the patient should be categorized as ‘Other’. He will have to take 1 more month (12 doses) of the intensive phase treatment. Default most closely describes the outcome of this patient. RNTCP at a Glance 13 . if a patient has to continue his previous treatment and he took 1 month of treatment (12 doses) before interrupting. The patient will then start the continuation phase of treatment. ** A patient who must start again will restart treatment from the beginning.MANAGEMENT OF PATIENTS WHO INTERRUPT TREATMENT Treatment for New smear-positive cases who interrupt treatment (Category I) Treatment received before interruption Less than 1 month Length of interruption Do a sputum Smear examination? No No Yes Result of Outcome sputum Smear examination __ __ Positive Negative 1-2 months More than 2 months Less than 2 weeks 2-7 weeks No Yes __ Positive __ __ Default __ __ __ ReTreatment registration Less than 2 weeks 2-7 weeks 8 weeks or more __ __ New __ __ __ Continue CAT I* Start again on CAT I** Start again on CAT I** Continue CAT I* Continue CAT I* 1 extra month of intensive phase of CAT I Continue CAT I* Start on CAT II* Continue CAT I* Continue CAT I* Start on CAT II** Continue CAT I* Start on CAT II** Continue CAT I* 8 weeks or more Yes Negative Positive __ Default __ __ Default*** __ Default __ Treatment After Default __ __ Other __ Treatment After Default __ Less than 2 weeks No Negative __ 2-7 weeks 8 weeks or more Yes Positive Negative Yes Positive Negative * __ A patient must complete all 24 doses of the initial intensive phase. *** Although this patient does not strictly fit the definition of default. For example. MANAGEMENT OF PATIENTS WHO INTERRUPT TREATMENT Treatment for smear-positive retreatment cases who interrupt treatment (Category II) Treatment received before interruption Length of interruption Do a sputum Smear examination No No Yes Result of sputum Smear examination __ __ Positive Negative Less than 2 weeks 2-7 weeks 1-2 months 8 weeks or more Less than 2 weeks Yes Negative Positive No Negative __ 2-7 weeks More than 2 months Yes Positive __ Default __ __ Default*** __ No Yes __ Positive Outcome Reregistration Treatment Less than 2 weeks Less than 1 month 2-7 weeks 8 weeks or more __ __ Default __ __ __ __ __ Continue CAT II* Start again on CAT II** Treatment Start again on After Default CAT II** __ __ __ Continue CAT II* Continue CAT II* 1 extra month of intensive phase of CAT II Continue CAT II* Treatment Start again on After Default CAT II** __ Continue CAT II* __ Other Continue CAT II* Start again on CAT II** Continue CAT II* 8 weeks or more Yes Negative Positive Negative __ Default __ __ Treatment Start again on After Default CAT II __ Continue CAT II* * A patient must complete all 36 doses of the initial intensive phase. ** A patient who must “start again” will restart treatment from the beginning. although at re-registration the patient should be categorized as ‘Other’. *** Although this patient does not strictly fit the definition of default. 14 RNTCP at a Glance . Default most closely describes the outcome of this patient. gain History of contact with suspected or diagnosed case of active TB Is expectoration present? If no.TREATMENT OF CHILDREN Diagnostic Algorithm for Pediatric Pulmonary TB Pulmonary TB Suspect Fever and/or cough 3 weeks Loss of wt/ No wt. examine 3 sputum 2 or 3 Positives 3 Negatives Antibiotics 10-14 days Cough Persists Repeat 3 Sputum Examinations 1 Positive X-Ray Negative 2 or 3 Positives Suggestive of TB Negative for TB X-Ray + Mantoux Sputum Positive TB (Anti-TB Treatment) Sputum Positive TB (Anti-TB Treatment) Negative for TB Suggestive of TB Refer to Pediatrician Sputum Smear Negative TB (Anti-TB Treatment) . refer to Pediatrician If yes. Algorithm for Clinical Monitoring of Pediatric TB Patient on treatment Review at 2 months. nonsatisfactory response assessed by: – adherence to treatment – weight loss – worsening of symptoms Follow up clinically Refer to Pediatrician/TB specialist for assessment (consider sputum examination) Clinical assessment and X-ray at completion of treatment Sputum positive Sputum negative or not available – Review diagnosis – extend IP by 1 month No improvement = Pediatric non-responder Failure Category II 16 RNTCP at a Glance . satisfactory response assessed by: – improvement in symptoms – no weight loss and or weight gain Review at 2 months. must be screened for symptoms of tuberculosis. chemoprophylaxis with isoniazid (5 mg per kg body wt) should be administered daily for a period of six months. the diagnostic algorithm for pediatric TB should be followed and the child should be given a full course of anti TB treatment if s/he is diagnosed as a TB case. especially those below 6 years of age.Dosages for children Drugs Isonoazid Rifampicin Pyrazinamide Streptomycin Ethambutol Dosage (Thrice a week) 10-15mg/kg 10mg/kg 35mg/kg 15mg/kg 30mg/kg Chemoprophylaxis for Children Household contacts of smear-positive TB cases. This is regardless of the BCG vaccination status. In case of symptoms being present. For asymptomatic children and those who are not found to be suffering from TB. RNTCP at a Glance 17 . refer patient for evaluation Itching Burning in the hands and feet Joint pains Impaired vision Ringing in the ears Loss of hearing Dizziness and loss of balance Jaundice Isoniazid (H) (Other drugs also) Isoniazid (H) Pyrazinamide (Z) Ethambutol (E) Streptomycin (S) Streptomycin (S) Streptomycin (S) Isoniazid (H) Rifampicin (R) Pyrazinamide (Z) In cases of jaundice. stop all drugs and refer patient to MO Give pyridoxine 100 mg/day until symptoms subside If severe. refer patient for evaluation STOP all drugs.g.SYMPTOM-BASED APPROACH TO EVALUATION OF POSSIBLE SIDE EFFECTS OF ANTI-TB DRUGS USED IN RNTCP Symptom Gastrointestinal upset Drug (abbreviation) Any oral medication Action to be taken Reassure patient Give drugs with less water Give drugs over a longer period of time (e. give antiemetic if appropriate Reassure patient If severe. refer patient for evaluation STOP streptomycin. refer patient for Evaluation STOP ethambutol. 20 minutes) Do not give drugs on empty stomach If the above fails. all anti-TB drugs should be stopped immediately and the patient referred for evaluation. refer patient for evaluation STOP streptomycin. 18 RNTCP at a Glance . refer patient for evaluation STOP streptomycin. isoniazid and pyrazinamide can be safely given • Streptomycin and ethambutol. while breastfeeding the baby • Chemoprophylaxis for the baby is advisable if mother is sputum smear-positive • Rifampicin. If patient is already on ART. pneumothorax or large accumulation of pleural fluid leading to breathlessness need to be hospitalized • Flow chart for hospitalized patients is given on next page • Fatal if untreated • Patient should be referred to the hospital • Total duration of treatment is 8–9 months. if she is smear-positive.MANAGEMENT OF TB PATIENTS ON DOT IN SPECIAL SITUATIONS Situation Hospitalization Management • Only extremely ill patients need hospitalization during the treatment • Patients with significant haemoptysis. other drugs used in RNTCP are safe • Breast feeding should continue regardless of the mother’s TB status • Advise the mother to cover her mouth. The continuation phase should be given for 6–7 months • Steroids should be given initially and gradually reduced over 6–8 weeks • Streptomycin should not be given. if given. with or without resistance to other anti TB drugs. • Management of MDR –TB is very complex • Prevention of MDR–TB rather than its treatment is the priority under RNTCP Tuberculous meningitis Treatment of TB during pregnancy and postnatal period Treatment in patients with renal failure Treatment in women taking oral contraceptive pills TB and HIV MDR TB RNTCP at a Glance 19 . should be closely monitored with reduced dosage • Rifampicin decreases the efficiency of oral contraceptives. increase the dosage of the oral contraceptive or switch to another method of contraception • Anti-TB Treatment is same for HIV-infected people as it is for HIV negative TB patients • DOT assumes greater importance for HIV infected patients • All new TB cases who are known to be HIV positive based on voluntary sharing of results and/or history of anti-retroviral therapy are considered to be seriously ill • Patients with TB-HIV should complete their TB treatment prior to beginning ART (if not already on ART). it should be modified to be rifampicin-friendly • MDR-TB is drug resistant TB caused due to bacilli resistant to Isoniazid and Rifampicin. to continue and complete treatment 20 RNTCP at a Glance . The treatment is given using prolongation pouches which will be supplied by District TB Officer through the STS of that TU. patients may be given a maximum of three doses (1 week drug supply) to cover the intervening period prior to their continuation of treatment at their respective DOT Centre. should be registered under the local TU in which the hospital is located. on discharge transfer out to PHI/TU nearest to his/her residence. do not re-register. All indoor patients treated under RNTCP. hence ensuring no interruption in treatment. on discharge send to the PHI nearest to his/her residence to continue and complete treatment If the patient does not reside in the same TU. If the patient resides in the same TU. On discharge send back to treating PHI to continue and complete treatment. which may/not be in the same district.HOSPITALIZATION OF TB PATIENTS Some TB patients may need hospitalization during their illness. Management of Hospitalized patients Patient is admittted with tuberculosis for indications like significant haemoptysis. pneumothorax or large accumulation of pleural fluid leading to breathlessnes Attending physician prescribes RNTCP regimen using prolongation pouches Inform DOT centre of that hospital Register in the TU. All indoor patients are to be treated with RNTCP regimens. On discharge. where the hospital belongs if the patient is not already registered If the patient is already registered. and stock of anti-TB drugs and laboratory consumables. stock of anti-tuberculosis drugs and laboratory consumables. MO-TC Interact with community and local opinion leaders Randomly check the microscopy centre and treatment observation centre. Visit all CHCs and Block PHCs in the district every quarter. Inspect records of the TU. one subcentre from each Block PHC area and a proportion of treatment observation centres every quarter. STLS RNTCP at a Glance 21 . Interview the MO I/C BPHC/ CHC/PHC. health personnel of other sectors (NGO. Randomly check the microscopy centre and treatment observation centres. MO I/C of PHC-CHC. STLS. STS Inspect records. Tuberculosis Treatment Cards and Tuberculosis Laboratory Register. STS. Visit all microscopy centres in the jurisdiction of the TU at least once a month. private etc. Interact with community and local opinion leaders Randomly interview patients and community leaders. Visit at least three patients at their homes per visit DTO/MO –DTC Visit all PHIs at least once every month and all treatment observation centres once every quarter. Visit all CHCs/BPHCs/ PHCs and a proportion of treatment observation centres at least once every quarter. Conduct supervisory visits 7days a month. Visit at least three patients at their homes per visit. Interview MPHS and MPWs at the PHC sub-centre. Randomly interview patients. Visit all DMCs every month. Number of supervisory visits Visit all TUs every month and all DMCs every quarter.SUPERVISORY VISITS Category of supervisor Methodology of supervision Interview the MO-TC. Conduct supervisory visits at least 5 days a week. PHC and CHC. Inspect all microscopy centres and laboratory records. Visit all new sputum positive patients at their home within one month of treatment initiation. Conduct supervisory visit at least 3-5 days a week. Randomly interview patients and community leaders.) and the person in-charge of antiTB drug & consumable storage. Visit all sputum collection centres at least once a month. LT and DOT-provider. Ensure that sputum smear microscopy is accurate. Quarterly Report Expected: New smearpositive cases case detection of ≥ 70% Expected: Re-treatment smear-positive cases are about 30% of all smear-positive cases in initial years of RNTCP implementation Expected: 50% of all new pulmonary cases will be smear-positive Expected: Not more than 20% of smear-negative and extra-pulmonary patients are considered seriously ill and placed under Category I . Review slides of smear negative patients placed on treatment. Ensure that 3 sputum smear examinations are done for TB suspects. and the laboratory technician is trained. Ensure that over-diagnosis of sputum smear-negative patients is not happening due to over reliance on radiography. and non-resident patients are referred for treatment to health facilities in the areas that they reside in. It should be explained to patients that only if they provide accurate information can the most effective treatment be given. Ensure that sputum microscopy is done correctly. Any smear-positive patient treated in the past for more than one month and has defaulted for more than two months. Ensure that sputum smear microscopy is accessible to patients. Ensure review of slides of smear-positive patients. Arrange review of slides of smear-negative patients placed on treatment. Ensure that new symptomatic patients undergo three sputum smear examinations for acid-fast bacilli (AFB). 22 RNTCP at a Glance Annualized registered number of new smear-positive cases is >100% Re-treatment cases are <20% of all smear -positive cases Re-treatment cases are >40% of all smear-positive cases Among new pulmonary cases. particularly those of patients placed on treatment. Intensify review of slides read as smear-negative. Non-seriously ill New smear-negative patients should receive Category III treatment. Ensure that sputum smear microscopy is done correctly (5%–15% positivity is expected among patients examined for diagnosis). Patients must be asked carefully about any prior treatment taken for TB from any source. Ensure that 3 sputum smears are examined for all TB suspects. Ensure that history-taking is accurate and definitions are being correctly applied. No patient should begin treatment without the mandatory three sputum smear examinations. many ‘old’ TB cases are reported.SUMMARY OF KEY INDICATORS AND POSSIBLE CORRECTIVE ACTIONS Case Finding Indicators and possible responses to problems Indicator Annualized registered number of new smear-positive cases is <50% Possible Actions Ensure that every TB suspect in all peripheral health facilities undergo sputum smear examination (in at least 2% of new adult outpatients). With active case-finding. should receive the re-treatment (Category II) regimen Ensure that active case-finding is not being resorted to. Ensure that only patients who reside in the area are started on treatment. Ensure that only seriously ill patients are given Category I treatment. Ensure that no active case-finding is being done in any area. Ensure that all smear-positives in the Laboratory Register are started on treatment and registered in the TB Register. Ensure that repeat sputum smear examinations are done for patients who continue to have symptoms after a course of antibiotics. Make sure that definitions are applied correctly. proportion of smearpositive is <45% Proportion of smearnegative or extrapulmonary seriously ill patients given Category I regimen is >25% Ensure that accurate history taking is done at all levels. Ensure that sputum smear microscopy is done correctly. and the number of patients who die or transferred out are minimized. treatment supervisors. Conversion of sputum at the end of IP increases patient confidence and is critical to programme evaluation. Make sure that definitions are applied correctly. Ensure review of slides of patients who remained smear positive at the end of the intensive phase. If previously treated patients are not placed on the re-treatment regimen. Any smear-positive patient treated for more than one month in the past and with a default of more than two months. Visit all centres with low sputum conversion rate and resolve any problem with the help of the staff. Follow-up sputum examinations are the best measure of patient response to treatment. and all other staff involved in the programme at peripheral centres understand the importance of follow-up sputum examinations. Quarterly Report Expected: Conversion rate is >90% of new smear-positive patients at 3 months RNTCP at a Glance 23 . It should be explained to patients that only if they provide accurate information can effective treatment be given. The quality of DOTS should be checked at the time of supervision. should receive the re-treatment (Category II) regimen. including checking of entries in the Treatment Cards with the drugs available in patient-wise boxes. Ensure that every dose of medication is observed during the intensive phase of treatment.Sputum Conversion Indicators and possible responses to problems Indicator Less than 85% of New smear-positive patients are documented to become sputum smearnegative at 3 months Possible Actions Ensure that Medical Officers. Ensure that accurate history-taking takes place at all levels. Ensure that sputum microscopy is accurate. Observation sites should be convenient to the patient. Patients must be asked carefully about any prior treatment for TB from any source. they may not respond well to treatment. Make sure default rates in the first two months are <5%. Result of Treatment Indicators and possible solution to problems Indicator Cure rate of new smear-positive patients is <80% Possible Actions Visit centres with low cure rates to discuss with patients and staff the reasons for low cure rate and possible solutions. All diagnosed smear-positive patients started on treatment should be registered. with default of more than two months. Ensure that health workers are dispensing medication properly as per technical guidelines. Carefully track this at all treatment units. should receive the re-treatment (Category II) regimen. Ensure that accurate history-taking takes place at all levels. to be done strictly as per policy with safeguards of confidentiality. It should be explained to patients that only if they provide accurate information can the most effective treatment be given. Ensure that every dose of medication is observed during the intensive phase of treatment. if the death rate is still more than 5%.positive patients who are classified as having ‘completed’ treatment is >5% Proportion of new smearpositive patients who die during treatment is >5% Expected: Cure rate for new smear-positive cases is ≥85% Expected: Not more than 3% of new smearpositive patients are given the Expected: Not more than 4% of new smearpositive patients die during treatment . Quarterly Report 24 RNTCP at a Glance Proportion of new smear. Make sure that Result of Treatments are correctly recorded and reported. Ensure that follow-up sputum examinations are done as per policy. Patients must be asked carefully about any prior treatment for tuberculosis taken from any source. Make sure that definitions are applied correctly. and at least one dose per week in the continuation phase. Ensure that every dose of medication is observed during the intensive phase of treatment. consider ways and means to encourage more prompt referral and diagnosis so that patients can be treated earlier in the course of their TB illness. In-spite of all the above. and at least one dose per week in the continuation phase. Sensitize the Medical Officers and other health staff about the importance of follow-up sputum examinations. Any smear-positive patient treated for more than one month in the past. Cure rate of new smear. If patients are presenting for treatment when already moribund. If previously treated patients are not given the re-treatment regimen. Ensure return of empty blister packs during weekly collection of drugs. Carefully review the patient data for accuracy and to ensure that treatment is being given under direct observation as per policy. consider evaluation of the prevalence of HIV infection among TB patients.positive CAT I patients is >95% Check for the accuracy of the report. Locate patients who have recently completed treatment and obtain sputum samples for examination. Review information on patients who died to determine reasons. they may not respond well to treatment. Ensure that follow-up sputum smear examinations are done according to guidelines. Observation sites should be convenient for the patient. Observation sites should be convenient to the patient. In-spite of all the above. Any smear-positive patient treated for more than one month in the past. It should be explained to patients that only if they provide accurate information can the most effective treatment be given. consider evaluation of the level of primary drug resistance in the community. including the address. Services should be convenient to the patient in terms of distance. time and staff attitudes. A visit to patients’ home should be made to verify address and landmarks near the house should be recorded in the Treatment Card. Make sure that centres are aware of their default rate so that they can take steps to reduce it. Ensure that every dose of medication is observed during the intensive phase of treatment and at least one dose per week in the continuation phase. if the failure rate remains higher than 5%. Ensure that directly observed treatment is given to patients in the intensive phase and at least one dose per week is directly observed during the continuation phase. Patients should be categorized as ‘Transferred out’ only if they have been given a Transfer Form to be taken to the facility where they are transferred to. stored in appropriate conditions and are used before the expiry period. Ensure that drugs are of acceptable quality.Expected: Proportion of new smear-positive patients who fail treatment is >5% Ensure that accurate history-taking is done at all levels. Observation sites should be convenient to the patient. Ensure that health workers are dispensing medication properly as per technical guidelines. Expected: Proportion of patients who are ‘Transferred out’ is >5% Transfer out can be a way of disguising default. Ensure that patient history is carefully ascertained. Make sure that definitions are applied correctly. If previously treated patients are not given the re-treatment regimen. Patients must be asked carefully about prior treatment for tuberculosis from any source. they may not respond well to treatment. Ensure the receipt of results of follow up sputum examinations and treatment Transferred out is <3% RNTCP at a Glance 25 . the reasons for default and possible solutions. During the visit to the house for verification of address. with default of more than two months. should receive the re-treatment (Category II) regimen. Failure: Not more than 4% of new smearpositive patients continue to be smearpositive at 5 months or later from the start of treatment Expected Default rate of smearpositive Category I patients is >8% Default rate is <5% Visit centres which have reported the highest default rates and interview staff and patients to determine the efforts made to retrieve patients. note the name and address of a person who can be contacted in the event the patient defaults. Ensure return of empty blister packs during weekly collection of drugs in the continuation phase. of sputum positive patients put on RNTCP Non-DOTS during the quarter in the district / (Nos. or referred for treatment outside the district / (Nos. of sputum positive patients diagnosed during the respective quarter – Nos. Expected value is 1015% Indicators % new smear positive out of total new pulmonary cases % of new extra pulmonary cases out of all new cases 26 RNTCP at a Glance Expected value less than 5% Nos. Others) registered / Total Nos. of new pulmonary (NSP+NSN) cases registered in the same quarter X 100 Nos. of sputum positive patients diagnosed X 100 Nos. of new pediatric cases registered (new smear positive pulmonary pediatric cases + new smear negative pulmonary pediatric cases + new extra pulmonary pediatric cases) / Total Nos. of new extrapulmonary cases registered / Nos. NSN. of new cases registered (NSP+NSN+new extra pulmonary) X 100 Total Nos. of smear positive retreatment cases (Relapse. of NSP cases registered during the respective quarter with treatment outcome as cured X 100 % of retreatment cases out of all smear positive cases % of pediatric cases out of all new cases % smear positive patients living in the district placed on DOTS % of smear positive patients placed on Non-DOTS treatment regimen % of initial defaulters % of new smear positive cases started on RNTCP DOTS within 7 days of diagnosis % of new smear positive cases registered within one month of diagnosis % of interviewed new smear positive cases who received DOT during Intensive Phase as per guidelines % of cured NSP cases having end of treatment follow-up sputum done within 7 days of last dose NSP. of NSP cases interviewed X 100 Data obtained from TB register Data obtained from TB register Data obtained from Patients interviews during supervisory field visits Data obtained from TB register Expected value > 95% Comments Expected value is 50%.New Indicators Formula Nos. of new cases registered (NSP+NSN+ new extrapulmonary) X 100 Nos. of sputum positive patients put on RNTCP DOTS during the quarter in the district / (Nos. of sputum positive patients referred for treatment outside the district) X 100 Nos. Treatment after default. of smear positive cases (new smear positive pulmonary cases + smear positive retreatment cases) X 100 Total Nos. of NSP cases registered during the quarter having an outcome cured. of sputum positive patients diagnosed started on treatment with in 7 days of diagnosis / Total Nos. of sputum positive patients diagnosed and started on treatment under RNTCP. Failure. of NSP cases registered in the quarter / Total Nos. of sputum positive patients diagnosed during the respective quarter – Nos. of sputum positive patients referred for treatment outside the district) X 100 Nos. of sputum positive patients diagnosed who are neither put on RNTCP DOTS or RNTCP Non-DOTS in the district. of interviewed NSP cases who received DOT as per guidelines (>21/24 doses)/ Total Nos. of sputum positive patients referred for treatment outside the district) X 100 Nos.New Smear Negative . who are registered within 1 month of diagnosis / Total Nos.New Smear Positive. of sputum positive patients diagnosed X 100 Nos. of sputum positive patients diagnosed during the respective quarter – Nos. who had their end of treatment sputum examined within 7 days of last dose/ Total Nos. RNTCP at a Glance 27 . Reports to be sent to quarterlyreports@tbcindia. All reports to reach Central TB Division by the 24th of the month.org .Due dates for reports from Tuberculosis Units to DTC in the year 2006 Due On Quarterly Report on Case Finding 7 January 2006 Programme Management Sputum Conversion Results of Treatment Case Finding 7 April 2006 Programme Management Sputum Conversion Results of Treatment Case Finding 7 July 2006 Programme Management Sputum Conversion Results of Treatment Case Finding 7 October 2006 Programme Management Sputum Conversion Results of Treatment Period Covered 1 October – 31 December 2005 1 October – 31 December 2005 1 July – 30 September 2005 1 October – 31 December 2004 1 January – 31 March 2006 1 January – 31 March 2006 1 October – 31 December 2005 1 January – 31 March 2005 1 April – 30 June 2006 1 April – 30 June 2006 1 January – 31 March 2006 1 April – 30 June 2005 1 July – 30 September 2006 1 July – 30 September 2006 1 April – 30 June 2006 1 July – 30 September 2005 The District TB Officer is to retain one copy of records and send the quarterly reports to the state TB Officer.