1 NHPP14 – Revised National Tuberculosis Control Programme Quadrant – I
Personal details:
Role Name Affiliation
Principal Investigator Dr. C.P. Mishra Professor
Department of Community Medicine Banaras Hindu University, Varanasi Uttar Pradesh, India
Paper Coordinator Dr. Davendra Kumar Taneja Director Professor
Department of Community Medicine Maulana Azad Medical College New Delhi, India
Content Writer/Author Dr. Abhik Sinha Assistant Professor
Department of Community Medicine R.G. Kar Medical College
Kolkata, India Content Reviewer Dr. Bratati Banerjee Professor
Department of Community Medicine Maulana Azad Medical College New Delhi, India
Description of Module:
Items Description of Module Subject Name Community Medicine
Paper Name National Health Policies and Programmes
Module Name/Title Revised National Tuberculosis Control Programme
Module Id NHPP14
Pre-requisites Knowledge on burden and epidemiology of tuberculosis Knowledge on national programmes in general
Objectives To study about the Revised National Tuberculosis Control Programme Key words National programme, Tuberculosis
2 Introduction
Tuberculosis (TB) is an infectious disease caused predominantly by Mycobacterium tuberculosis. Pulmonary tuberculosis is the most common site for tuberculosis but it also affects other sites, which is called extra -pulmonary tuberculosis.
Pulmonary TB accounts for 85% of all cases. As per WHO estimates TB accounts for 7.6% of all deaths from communicable diseases and for 3.5% of all causes of mortality.1
India, the world's second most populous country, accounts for a quarter of the world's annual incide nce of TB and India accounts for 1/5 of the global TB burden. In 2012, out of the estimated global annual incidence of 8.6 million TB cases, 2.3 million were estimated to have occurred in India. Every year around two million people develop TB in India and 300,000 die of TB.1
India has declared tuberculosis (TB) a notifiable disease. The notification was sent to all the states and union territories on May 7, 2012. The move makes it mandatory to all health care providers dealing with TB cases to report every single case to the local authorities i.e. District Health Officer/Chief Medical Officer of a district and Municipal Health Officer of a Municipal Corporation/Municipality every month in a given format.2
Thus a public health programme to deal with this dreaded disease was needed in a country like India. National Tuberculosis control programme was launched in 1962 in this regard.
Learning outcomes
At the end of the chapter they learner should be able to:
• Describe the goals and objectives of RNTCP
• Describe the treatment categories under RNTCP
• Describe the management of various types of tuberculosis under RNTCP
• Describe the monitoring and evaluation under RNTCP
• Describe the TB- HIV coordination
• Describe TB – Diabetes collaboration
Main Text
National Tuberculosis Control Programme: A Review
National Tuberculosis Programme (NTP) was in operation since 1962. However a review of NTP in 1992 revealed poor performance of the programme. It was observed that only 30% of existing cases were being diagnosed with accuracy and of these only 30% were completing their treatment. Moreover the death rate was 29% among infectious patients. Key problems identified by the review were: overemphasis on x-ray rather than sputum microscopy for case detection, poor quality of microscopy, more emphasis on case detection than on cure, inadequate budgetary outlays and shortage of drugs, poor organizational set up and support for tuberculosis control, and lack of consensus among practitioners regarding treatment regimens.
Revised National Tuberculosis Programme 3
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In 1993, in order to overcome these lacunae, the Government of India decided to give a new thrust to TB control activities by revitalizing the NTP, with assistance from International agencies. A revised strategy called DOTS (Directly Observed Treatment Short-course) to control TB was pilot tested.
As a result of tremendous success in the pilot projects, Revised National Tuberculosis Contro l Programme (RNTCP) was launched in the country in 1997 with WHO recommended DOTS strategy. This revised strategy was introduced in the country in a phased manner as Pilot Phase I, Pilot Phase II and Pilot Phase III. By March 2006, the entire country had been covered under the programme.
1. Revised National Tuberculosis Programme
1.1. RNTCP Goals
– To reduce mortality and morbidity from tuberculosis and – To interrupt chain of transmission.
1.2. RNTCP Objectives
– To cure at least 85% of all newly detected infectious cases of pulmonary tuberculosis (new sputum smear- positive)
– To detect at least 70% of estimated new smear positive pulmonary tuberculosis cases.
1.3. Components of DOTS
DOTS is a systematic strategy having five components:
– Political and administrative commitment
– Good quality diagnosis, primarily by sputum smear microscopy – Uninterrupted supply of good quality drugs.
– Directly Observed Treatment (DOT) – Systematic monitoring and accountability
For management of Multi-Drug Resistant tuberculosis (MDR-TB) in the 12th five year Plan (2012-17) for RNTCP has the objective to provide universal access to quality diagnosis and treatment to all TB cases in the community including TB HIV and Drug Resistance TB cases.1
To ensure proper treatment of pediatric cases, supply of pediatric drug boxes has also been started.
Phase I of RNTCP in India has been completed in 2006 with expansion of DOTS to cover the entire country. Phase II (2006-2011) aims to further increase the access of services to marginalized groups in hard-to-reach areas through continuation of activities of phase I and with intensive monitoring, supervision and evaluation.3
1.4. REVISED DEFINITIONS UNDER RNTCP 4
1.4.1. Classification of Cases
Presumptive TB refers to a person with any of the symptoms and signs suggestive of TB including cough >2 weeks, fever > 2 weeks, significant weight loss, haemoptysis, any abnormality in chest radiograph.
Note: In addition, contacts of bacteriologically confirmed TB Patients, PLHIV, diabetics, malnourished, cancer patients, patients on immune-suppressants or steroid should be regularly screened for sign and symptoms of TB.
Pulmonary tuberculosis (PTB) refers to any bacteriologically confirmed or clinically diagnosed case of TB involving the lung parenchyma or the tracheo-bronchial tree.
Note: Miliary TB is classified as PTB because there are lesions in the lungs. Tuberculous intrathoracic
4 classified as a case of PTB.
Extra Pulmonary tuberculosis (EPTB) refers to any bacteriologically confirmed or clinically diagnosed case of TB involving organs other than the lungs such as pleura, lymph nodes, intestine, genitourinary tract, joint and bones, meninges of the brain etc
Pleurisy is classified as extra-pulmonary TB.
A patient diagnosed with both pulmonary and extra-pulmonary TB should be classified as a case of pulmonary TB.
Bacteriological confirmed TB case (Definitive TB Case) refers to a presumptive TB patient from whom a biological specimen is positive for acid fast bacilli, or positive for Mycobacterium tuberculosis on culture, or positive for tuberculosis through Quality Assured Rapid Diagnostic molecular test
1.4.2. Clinically diagnosed TB case
A clinically diagnosed TB case (probable TB) refers to a presumptive TB patient who is not bacteriologically confirmed, but has been diagnosed with active TB by a clinician on the basis of X-ray abnormalities, histopathology or clinical signs with a decision to treat the patient with a full course of Anti-TB treatment.
A patient diagnosed with both pulmonary and extra-pulmonary TB should be classified as a case of pulmonary TB.
1.4.3. Types of Cases 4
New case is a TB patient who never received treatment for TB or received anti-TB treatment for less than one month.
Previously treated case is a TB patient who received anti-TB treatment for 1 month or more in the past.
Recurrent case is a TB Patient previously declared as successfully treated (cured/treatment completed) and is subsequently found to be bacteriologically confirmed TB case is a recurrent TB case.
Treatment after failure A TB patient whose anti-TB treatment failed at the end of the most recent course
Treatment after loss to follow up: A TB patient previously treated for TB for 1 month or more and was declared lost to follow-up in their most recent course of treatment and subsequently found to be bacteriologically confirmed TB case.
Example: TB patient not taken anti-TB drugs consecutively for one month or more and found to be bacteriological confirmed TB case after lost to follow-up.
Other previously treated patients: A TB patient who has been previously treated for TB but whose outcome after their most recent course of treatment is unknown or undocumented.
Transferred in: A TB patient who is received for treatment in a Tuberculosis Unit, after being registered for treatment in another TB unit is considered as a case of transferred in.
1.4.4. Treatment Outcomes 4
Cured: Bacteriologically confirmed TB patients at the beginning of treatment who was smear or culture negative at the end of the complete treatment.
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Treatment completed: A TB patient who completed treatment without evidence of failure but with no record to show that the smear or culture results of biological specimen in the last month of treatment was negative, either because test was not done or because result is unavailable.
Failure: A TB patient whose biological specimen is positive by smear or culture at end of treatment.
Defaulted: A patient who at any time after completion of 1 month of treatment has not taken anti TB drugs for 2 months or more consecutively.
Lost to follow up (LTFU): A TB patient whose treatment was interrupted for 1 consecutive month or more.
Treatment success: The sum of cured and treatment completed.
Not evaluated: A TB Patient for whom no treatment outcome is assigned, this includes former “transfer-out”.
Tre atment regimen changed: A TB patient who is on first line regimen and has been diagnosed as having DRTB and switched to drug resistant TB regimen prior to being declared as failed.
Died: A patient who has died during the course of anti-TB treatment
1.4.5. Drug resistant TB (DRTB) definitions 4
Presumptive DRTB case refers to those TB patients who have failed treatment with first line drugs, paediatric TB non responders, TB patients who are contacts of MDR-TB (or R resistance), TB patients who are found positive on any follow-up sputum smear examination during treatment with first line drugs, previously treated TB cases, TB patients with HIV co-infection.
MDR TB case is a presumptive DRTB case, whose biological specimen resistant to both isoniazid and rifampicin with or without resistance to other first line drugs, based on the results from a quality assured laboratory.
XDR TB Case is an MDR TB case whose recovered M. tuberculosis isolate is resistant to at least isoniazid, rifampicin, a fluoroquinolone (ofloxacin, levofloxacin, or moxifloxacin) and a second-line injectable anti TB drug (kanamycin, amikacin, or capreomycin) at a quality assured Laboratory
1.4.6. Definitions pertaining to paediatric TB 4
Probable paediatric TB is a case diagnosed based on the presence of abnormalities consistent with TB on radiography, or a history of exposure to an infectious case, or evidence of TB infection (positive TST), when there are clinical findings suggestive of TB in children in event of negative or unavailable microbiological results.
Failure to respond: A case of paediatric TB who fails to have bacteriological conversion to negative status or fails to respond clinically / or deteriorates after 12 weeks of compliant intensive phase shall be deemed to have failed response provided alternative diagnoses/ reasons for non‐response have been ruled out.
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Photograph 1. Microscopic feature of Mycobacterium Tuberculosis
Photograph 2. AFB slide for detection of Mycobacterium Tuberculosis
7 Diagnostic Algorithm in Tuberculosis as per RNTCP 5,6
8
9
10 Abbreviations
NTI: National Tuberculosis Institute, TRC: Tuberculosis Research Centre, LRS:Lala Ram Swarup Institute of TB and Respiratory Diseases, JALMA: National JALMA Institute of Leprosy and other Mycobacterial Diseases, TWG;
Technical Working Group, NTF: National task Force, OR: Operational Research, SDS: State Drug Store, IRL:
Intermediate Reference Laboratory, STO: State Tuberculosis Officer, DEO: Data Entry Operator, IEC: Information Education & Communication, DTO: District TB Officer, MO-DTC: Medical Officer - District TB Centre, MO-TC:
Medical Officer-Tuberculosis Control, STS: Senior TB Treatment Supervisor, STLS: Senior TB Laboratory Supervisor, LT: Lab Technician
11 1.5. RNTCP Organisation 5
1.5.1. Sub-district level
There is a Tuberculosis Unit (TU) for a population of approximately 5 lakh (2.5 lakhs in tribal, desert, remote and hilly areas). One of the medical officers posted at the health facility is designated as MO-TC.
1.5.2. Functions of different officers in RNTCP
Designation Function
District Tuberculosis Officer Smooth implementation and achieving the program objectives in his district.
Planning and coordinating TB control activities
Supervision of Tuberculosis Unit (TU)
Coordination between RNTCP and ICTC
Maintenance of appropriate financial records Medical Officer in the District
Tuberculosis Center
To assist the DTO in his function
To act as MOTC for tuberculosis unit in the area of the district
Sub-district level There is a Tuberculosis Unit (TU) for a population of approximately 5 lakh (2.5 lakhs in tribal, desert, remote and hilly areas). One of the medical officers posted at the health facility is designated as MO-TC.
1.5.3. Designated Microscopy Centre 5,6
Designated Microscopy Centres (DMC) are located at health centres, dispensaries or equivalent private and NGO facilities. It caters to one lakh population (in hilly, tribal areas 50,000 population)3 and has a laboratory technician trained in RNTCP. It provides sputum microscopy services in the area. DMC can also be located in the hospitals or private nursing homes.
1.5.4. RNTCP laboratory network 5,6
RNTCP laboratory network for sputum smear microscopy comprises three tier systems.
National Reference laboratory
Intermediate reference laboratory (State level)
Designated microscopy center (DMC) (Peripheral level)
External Quality Assessment (EQA) and for supervision and monitoring of diagnostic systems by RNTCP Senior TB Laboratory Supervisors (STLSs) locally and by the Intermediate and National Reference Laboratories network at state and higher levels. Onsite Evaluation, Panel Testing (PT) and Random Blinded Rechecking (RBRC) are done.
1.5.5. DOT Centre
It can be located at a facility run by Govt., Private or NGOs. Idea is to provide directly observed treatment to patients at a place convenient to them. Anybody except family members of a TB patient can be DOTS provider e.g health workers, private practitioners, AWWs and link workers like ASHA.
1.6. RNTCP guidelines for Chemotherapy 6 1.6.1. Objectives of Chemotherapy:
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– To achieve at least 90% treatment completion rate of all retreatment cases and sputum negative cases.
1.6.2. Chemotherapy:
Short Course Chemotherapy is given in two phases, i.e. intensive phase and continuation phase. Under the National Programme intermittent supervised regimens are preferred. Daily self administered Non-DOTS regimen (ND) is followed in exceptional cases who cannot comply with SCC or have adverse reactions to drugs used in SCC.
For ease of description treatment regimens are abbreviated using standard abbreviations. Prefix denotes duration in months and suffix frequency of administration per week. For example 2 (HRZE)3 means isoniazid, rifampicin, pyrazinamide and ethambutol are to be given thrice a week for two months.
In intensive phase medication is taken under direct observation of health staff (Directly Observed Therapy). In continuation phase one dose is given directly observed and the other two for the week are self administered. Medication is given on a domiciliary basis and patients are not admitted except in case of complications.
All patients of MDR and XDR TB will receive drugs under direct observation on 6 days of the week. If intolerance occurs to the drugs, Ethionamide, Cycloserine and PAS may be split into two dosages and the morning dose administered under DOT. The evening dose will be self-administered. The empty blister packs of the self-administered doses will be checked the next morning during DOT. Pyridoxine should be administered to all patients on Regimen for MDR TB.
1.6.3. Duration: Duration of chemotherapy is 6 months for new cases and 8 months for retreatment cases. For MDR and XDR TB cases it is minimum of 24 months.
Photograph 3. RNTCP Patient Box For Category 1 Treatment
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Photograph 4. Drug strip for category 1 treatment under RNTCP
Photograph 5. Drug strip for category 2 treatment under RNTCP
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Photograph 6. Patient box for category 2 treatment under RNTCP
1.6.4. RNTCP Recommended treatment regimens 5,6
TB patients are now classified into two groups, viz. new and previously treated, based on previous history of treatment.
Further, these regimens will be called regimen for “new” (Category I) and “previously treated” (Category II) cases. It has been recommended to substitute rifabutin in place of rifampicin for those on anti-retroviral therapy using protease inhibitors, as rifabutin does not interfere with protease inhibitors.
Under RNTCP, drugs are supplied in prefixed doses in the blister packs. For each patient full course of treatment is supplied in a box. These boxes have different colours according to the category of patients, red colour for category I and blue for category II patients.
Cate gory of patient Intensive phase Continuation phase I. New
(Red)
New smear positives New smear negatives New EP cases New others
2 (HRZE)3* 4 (HR)3**
II.
Previously treated (Blue)
Smear positive relapse Smear positive failure
Smear positive treatment after default
Others
2 (HRZES)3 +
1 (HRZE)3*
5 (HRE)3
Non- DOTS
Patients who refuse SCC or cannot comply with it.
ND1 Smear positive ND2 Smear negative
2 (SHE) + 10 (HE) 12 (HE)
IV. MDR TB cases 6-9 (KmLvxEtoCsZE)*** 18 (LvxEtoCsE)
V. XDR TB cases 6-12 (CmPAS,Mfx,High dose-
H,
Cfz, Lzd, Amx/Clv)***
18 (PAS, Mfx,
High dose-H, Cfz, Lzd, Amx/Clv)
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* If sputum + ve for AFB at end of prescribed intensive phase, extend it by one month.
** For patients with T.B. meningitis, disseminated disease and spinal T.B. with neurological complications, continuation phase may be upto 7 months.
*** Km: Kanamycin, Lvx: Levofloxacin, Eto: Ethionamide, Cs: Cycloserine, Cm: Capreomycin, Mfx: Moxifloxacin, Cfz:
Clofazimine, Lzd: Linezolid, Amx/Clv: Amoxyc lav
1.7. Programmatic Management of Drug Resistant Tuberculosis (PMDT) 7
In 1998 the DOTS-Plus strategy was conceived by WHO and several partners around the world. In India, RNTCP initiated the DOTS Plus services in 2007 in the identified districts in the states of Gujarat and Maharashtra.
The programme is currently known as “Programmatic Management of Drug Resistant TB” (PMDT) which refers to programme based MDR-TB diagnosis, management and treatment.9 These guidelines promote full integration of basic TB control and PMDT activities under the RNTCP, so that patients with TB are evaluated for drug-resistance and placed on the appropriate treatment regimen and properly managed from the outset of treatment, or as early as possible. These guidelines also integrate the identification and treatment of more severe forms of drug resistance, such as extensively drug resistant TB (XDR-TB).
PMDT services have been expanded to all states in 2012. The programme is presently in the process of decentralising DOTS Plus services with the aim to make these services available in all districts. As on Feb 2013 PMDT services were available in all 35 states of the country across 638 districts covering a population of 1089 million (92%) and are being rapidly scaled up.
1.8. Newer Focus areas of RNTCP
1. Early diagnosis and treatment of all TB cases including DR TB, HIV associated TB, Pediatric TB and EP TB. The Target population groups to be covered would be clinically vulnerable and marginalised groups like HIV, malnourishe d children, diabetes, indoor pollution, migrants, slum dwellers, IDU groups, socially vulnerable household contacts and tribal population, co morbidities like TB/HIV, diabetes etc and pediatric population group.
2. Urban TB
The target population groups to be covered would be urban slums (both notified and not-notified), homeless, migrants, slum dwellers, IDU groups and other such vulnerable and marginalised groups.
3. Special populations
The target population groups to be covered would be clinically vulnerable and marginalised groups like HIV, malnourished children, tribal population and pediatric population group.
4. Private sector engagement
Private sector needs to be involved on a scale commensurate with their dominant presence in health sector.
5. Operational Research
Generating evidence for scale up of programme to achieve objectives of universal access.
1.9. RNTCP Guidelines 5,6 1.9.1. Case finding methods
16 within two consecutive days.8
X-Ray chest: This is unreliable. However, it is useful when both sput um samples are negative in chest symptomatics, in miliary or extrapulmonary tuberculosis and contacts of infectious cases.
Culture: Useful to confirm the diagnosis in smear negative but it takes long time and its availability is limited. It is valuable for epidemiological surveillance and culture sensitivity for resistant/failure cases.
Tuberculin test: It has a limited value and is important in children where a positive test indicates likelihood of a more recent infection with tuberculosis and a much higher risk of developing the disease.
1.9.2. RNTCP guidelines for diagnosis of Tuberculosis 6,8
1.9.2.1. Identification of suspects
The most common symptom of pulmonary TB is persistent cough, with or without expectoration. It may be accompanied by other symptoms like weight loss, tiredness, fever with evening rise, night sweats, chest pain, anorexia and haemoptysis etc. Anybody having cough for more than two weeks is suspected to be suffering from pulmonary TB. Patients with extrapulmonary TB who also have cough of any duration, should have 2 sputum samples examined.
A child with any sample (sputum, induced sputum, gastric lavage, br oncho-alveolar lavage) positive for acid fast bacilli is classified as smear positive case.
1.9.2.2. Tuberculosis in children 8
The National guidelines on Pediatric TB diagnosis and management were updated based on the recent evidence and advances in pediatric TB diagnosis and treatment during, January- February 2012. A new diagnostic algorithm is developed for pulmonary TB, the commonest type of extra pulmonary TB (Lymph node TB) and for other types of extra- pulmonary TB. The diagnostic algorithms for the diagnosis of pulmonary TB and Lymph node tuberculosis are provided.
Diagnosis of TB in children should be based on a combination of clinical presentation, sputum examination (wherever possible), chest X-Ray, Mantoux test and history of contact.
1.9.2.3. Suspect definition among HIV infected individuals
There is increased evidence globally that cough for 2 weeks alone is not a sensitive indicator of TB among HIV-infected people. Hence, it has been decided to change the definition of TB suspect among this group which is at high risk of developing TB. A combination of 4 symptoms will be used for screening “Any cough, any fever, night sweats and weight loss”. Hence, if a HIV-infected person has any of the four symptoms, evaluation for TB and other respiratory diseases should be carried out. Also, it has been decided that chest radiography may be used upfront along with sputu m microscopy among HIV chest symptomatics without having to recourse to antibiotic trial.3
1.9.2.4. Extrapulmonary TB (EP)
Patients presenting with chest pain with or without difficulty in breathing for more than two weeks should be referred for X-Ray chest. For other forms of extrapulmonary TB, diagnosis depends on clinical picture supplemented by relevant investigations.
1.9.3. Pediatric Tuberculosis: RNTCP Guidelines 8
The actual burden of pediatric TB is not known due to diagnostic difficulties but has been assumed that 10% of total TB load is found in children. It is one of the top 10 causes of childhood mortality. Though MDR-TB and XDR-TB is documented among pediatric age group, there are no estimates of overall burden, chiefly because of diagnostic difficulties and exclusion of children in most of the drug resistance surveys.
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In consensus with Indian Academy of Paediatrics, a National Consultation on Management of Childhood Tuberculosis was organised in January 2012, where several changes have been recommended in the diagnosis, treatment and prevention of childhood TB.
1.9.3.1. Pediatric Case definitions 8
The following newer Case definitions for pediatric TB patients were incorporated in the RNTCP manuals.
(a) Failure to respond: A case of pediatric TB who fails to have bacteriological conversion to negative status or fails to respond clinically / or deteriorates after 12 weeks of compliant intensive phase shall be deemed to have failed response provided alternative diagnoses/ reasons for non-response have been ruled out.
(b) Relapse: A case of pediatric TB declared cured/completed therapy in past and has (clinical or bacteriological) evidence of recurrence.
(c) Treatment after default: A case of pediatric TB who has taken treatment for at least 4 weeks and comes after interruption of treatment for 2 months or more and has active disease (clinical or bacteriological).
(d) For programmatic purposes of reporting, all types of retreatment cases where bacteriological evidence could not be demonstrated but decision to treat again was taken on clinical grounds would continue to be recorded and reported as“OTHERS” for surveillance purposes.
1.9.3.2. Drug dosages 8
(a) There will be six weight bands and three generic patient wise boxes, to be used in combination to treat patients in the six weight bands. Since, it would take at-least 2 years for supply of these products under RNTCP an interim guidance to optimise the use of the existing patient wise boxes and align them as much as possible to the new dosing recommendations has been developed.
1.9.3.3. RNTCP Treatment regimens
There will be only two treatment categories – one for treating ‘new’ cases and another for treating ‘previously treated cases’. Treatment regimens will be similar to that of adults.
Children who show poor or no response at 8 weeks of intensive phase should be given benefit of extension of IP for one more month.
In patients with TB Meningitis, spinal TB, miliary/disseminated TB and osteoarticular TB, the continuation phase shall be extended by 3 months making the total duration of treatment to a total of 9 months. A further extension may be done for 3 more months in continuation phase (making the total duration of treatment to 12 months) on a case to case basis in case of delayed response and as per the discretion of the treating physician/ pediatrician.
1.9.3.4. RNTCP guidelines for TB preventive therapy 8
The dose of INH for chemoprophylaxis is 10 mg/kg (instead of currently recommended dosage of 5 mg/kg) administered daily for 6 months. TB preventive therapy should be provided to:
All asymptomatic contacts (under 6 years of age) of a smear positive case, after ruling out active disease and irrespective of their BCG or nutritional status.
All HIV infected children who either had a known exposure to an infectious TB case or are Tuberculin skin test (TST) positive (>=5mm induration) but have no active TB disease.
All TST positive children who are receiving immunosuppressive therapy (e.g. Children with nephrotic syndrome, acute leukemia, etc.).
A child born to mother who was diagnosed to have TB in pregnancy should receive prophylaxis for 6 months, provided congenital TB has been ruled out. BCG vaccination can be given at birth even if INH chemoprophylaxis is planned.
1.9.4. Drug dosage
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Drugs Thrice weekly therapy
Rifampicin INH Ethambutol Pyrazinamide
Streptomycin < 50 years > 50 years
450mg.*
600mg.
1200mg.
1500mg.
0.75gm.
0.50gm.
* If weight of patient > 60 kg, then 150mg extra rifampicin is given.
Note : Drugs for adults are provided in blister packs, In intensive phase there is one day pack and in continuation phase there is one weekly pack having all the required drugs.
1.9.4.2. Pediatric drug dose 8
Drugs Thrice weekly INH
Rifampicin Streptomycin Ethambutol Pyrazinamide
10-15 mg/kg.
10 mg/kg 15 mg/kg 30 mg/kg 30-35 mg/kg
If a patient fails to report for treatment on a due date, health worker or volunteer visits the patient’s home. In intensive phase this is done on the next day while in continuation phase it is done within a week.
1.9.5. Follow Up 4,6
To assess the response to treatment, sputum smear examination is done for AFB. This is done at the end of intensive phase, 2 months thereafter and at the end of continuation phase. Two sputum samples, one spot and one overnight are examined each time.
1.9.5.1. New smear + ve patients
Sputum smears are examined at the end of 2, 4 and 6 months. If negative at 4 and 6 months, patient is discharged from the treatment as cured.
If smear is positive at end of 2nd month, intensive phase is extended by one month followed by continuation phase.
Sputum examination is repeated at 3, 5 and 7 months. If sputum is positive at 5 months, patient is declared as a Failure Case, and if negative, treatment is completed in 7 months.
1.9.5.2. Retreatment Cases
Sputum examination is done at 3, 5 and 8 months. If negative, patient is discharged from treatment as cured.
If sputum smear is positive at 3 months, then intensive phase is extended by one more month i.e. total of 4 months.
Sputum examination is then repeated at 4 months. If it is positive, then sputum sample from the patient is sent for culture and sensitivity to an RNTCP laboratory, as the patient may be having MDR–TB.
The new followup schedule suggested is as follows :
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Response to therapy in patients with pulmonary tuberculosis, new as well as previously treated cases, should be monitored by follow-up microscopy (one specimen) at the time of completion of the intensive phase of treatment, (if applicable at end of extended IP) and at the end of treatment. Rule out DR-TB if any follow-up is positive.
1.9.5.3. Sputum negative patients
Smear examination is done at the end of intensive phase and completion of treatment, i.e. 2 months and 6 months. If the patient becomes sputum positive at 2 months or at the end of treatment, he is categorised as a failure case and put afresh on retreatment regimen.
Photograph 7 : streptomucin injection for category 2 treatment under RNTCP
1.9.6. Special Situations 6
Pregnancy: If active tuberculosis is present, start or continue antitubercular treatment. Do not give streptomycin as it may cause damage to the foetus.
TB meningitis: Since ethambutol does not cross blood brain barrier, in intensive phase of Cat I regimen, ethambutol is replaced by streptomycin.
Use of steroids: Steroids are recommended in early part of treatment in TB meningitis, TB pericarditis and bilateral or massive pleural effusion. The doses are then tapered off over 6-8 weeks.
TB and HIV co-infection: In TB patients co-infected with HIV, treatment of TB should be completed prior to Anti- Retroviral Therapy (ART) unless there is high risk of progression of HIV disease and death (CD4 count < 200 mm3 or presence of disseminated TB) during the period of anti-TB-treatment. In patients on SCC, ART should not include non- nucleoside reverse transcriptase inhibitors (nevirapine) or any of the protease inhibitors (ritonavir, indinavir, nelfinavir) as they alter serum concentration of rifamycins.
Outcome of DOTS in HIV positive TB patients is good except that relapse rate is slightly higher. This may be due to re - infection or interruption in treatment consequent to higher occurrence of adverse drug reactions or intercurrent opportunistic infections.
1.9.7. Management of MDR-TB:RNTCP guidelines 7
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and sputum positive contacts of MDR cases may be suspected of having MDR-TB. These patients should have a sputum sample collected and sent for culture and sensitivity to an RNTCP laboratory. Diagnosed cases of MDR -TB should be referred to and treated only at specialised centres. Treatment of MDR-TB requires prolonged chemotherapy (24 months), which is also very expensive and toxic. Moreover the chances of treatment success are moderate.
1.9.7.1. Definitions 6,7
RNTCP is in the process of scaling up laboratory services for drug-susceptibility testing nationwide. In that process, the eligibility for DST will expand in a phased manner. Therefore the definition of an MDR TB suspect must be flexible for that expansion of services.
MDR TB suspect: A patient suspected of drug-resistant tuberculosis, based on RNTCP criteria for submission of specimens for drug-susceptibility testing. A patient is confirmed to have MDR or XDR TB only when the results are from a RNTCP quality-assured Culture & DST Laboratory and by a RNTCP-endorsed testing method. Such patients are classified according to the following definition:
MDR-TB case: A TB patient whose sputum is culture positive for Mycobacterium tuberculosis and is resistant in- vitro to isoniazid and rifampicin with or without other anti-tubercular drugs based on DST results from an RNTCP- certified Culture & DST Laboratory
XDR TB case: An MDR TB case whose recovered M. tuberculosis isolate is resistant to at least isoniazid, rifampicin, a fluoroquinolone (ofloxacin, levofloxacin, or moxifloxacin) and a second-line injectable anti TB drug (kanamycin, amikacin, or capreomycin) at a RNTCP-certified Culture & DST Laboratory.
1.9.8. Record Maintenance
Tuberculosis register: Kept at sub-district level.
Tuberculosis treatment card: For each patient this is kept at peripheral health units. It contains details of treatment, due date for collection of medicines and results of bacteriological examination. A sample treatment card is show n in the anphotographs 8 and 9.
Reports are sent quarterly on case finding, smear conversion, results of chemotherapy and programme management.
These are filled at sub-district level.
21 Photograph 8 : RNTCP treatment card
Photograph 9 : RNTCP treatment card other side
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Cross referral mechanism between Integrated Counselling and Testing Centres (ICTC) and RNTCP diagnostic and treatment services is now being implemented in all states. Substantial numbers of ICTC clients are being referred to RNTCP, diagnosed as TB and initiated on DOTS treatment. Similarly large numbers of TB patients are being referred to ICTC for HIV testing and a significant number of them have tested positive.
RNTCP and NACP (National AIDS Control Programme) have jointly planned the following interventions in their next strategic plans (2012-17):
Focus on reinforcing mechanisms for ensuring effective implementation and improving service delivery for TB and HIV infected patients.
Decentralisation of HIV testing facilities and co location in all TB microscopy centres.
Early and improved diagnosis of TB and Rifampicin resistance, through rapid diagnostic technology for PLHIV.
Measures to improve access of HIV-infected TB patients to ART centres by provision of travel support and engagement with the affected community.
Early initiation of ART for all PLHIV with CD4 counts of <350, and for all HIV-infected TB patients irrespective of CD4 count.
Recording and reporting formats have been modified.
The intensified TB-HIV package was scaled up in the entire country in June 2012. In 2013, out of total registered cases (7,25,332) in first two quarters, HIV status of 4,57,572 TB patients was known of them about 22,355 were HIV positive.
1.10. Surveillance 5
With the objective to improve TB surveillance in the country, the programme has undertaken the initiative to develop a Case Based Web Based application named Nikshay. This ICT application (Nikshay) was launched on 15th May 2012 by NIC (HQ) and Central TB Division. The data entry of the individual TB cases is being done at the block level DEOs of NRHM (same person doing the MCTS entry). The system has been extended to include drug resistant TB cases, online referral and transfer of patients.
1.11. Involvement of Medical Colleges 5
Priority has been given to systematic involvement of medical colleges under RNTCP. Under RNTCP, Medical Colleges play important roles in service delivery, advocacy, training and operational research. Medical colleges, through task force mechanisms at state, zonal and national levels, with RNTCP supporting with additional human resources, logistics for microscopy, funds to conduct sensitisations, trainings and research in RNTCP priority areas.
1.12. TB Serology 5
The Gazette of India, Ministry of Health and Family Welfare (Department of Health and Family Welfare) has banned import, manufacture, sale, distribution and use of the serodiangostic test kits for tuberculosis as the World Health Organization experts Group and Strategic and Technical Advisory Group for Tuberculosis (STAG-TB) which reviewed the data and concluded that currently available commercial serological test provide inconsistent and imprecise estimates of sensitivity and specificity and strongly recommended that these tests should not be used for the diagnosis of pulmonary and extra-pulmonary TB.
1.13. RNTCP TB Diabetes Collaboration 9
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Epidemiological surveys and studies have been completed and published or are currently being conducted in India on the association between DM and TB. Epidemiological models using 2000 data in India have shown that DM accounts for 20% of smear-positive pulmonary TB and recent analyses have indicated that the increase in DM prevalence in India has been an important obstacle to reducing TB incidence in the country.
A national stakeholders meeting was held in Delhi, India, (October 2011) between The Union, WHO, World Diabetes Foundation (WDF), and National diabetes, noncommunicable disease and tuberculosis authorities to review and dis cuss linkages between diabetes mellitus (DM) and tuberculosis (TB), the need for bi-directional screening and the WHO-Union Collaborative Framework.
At the national stakeholders’ meeting it was agreed that the feasibility of bi-directional screening should be assessed as pilot projects within routine health care services.
Specific objectives are:-
a) To actively screen TB patients for DM
b) To refer those suspected or diagnosed with DM to appropriate diabetes care c) To record and report on the screening data.
It is under implementation all over the country.
1.14. Public Private Partnership in RNTCP 5,6
Intensified Public Private Mix project is being undertaken with Indian Medical Association (IMA) in 16 states and with Catholic Bishop Conference of India (CBCI), a faith based organization (FBO), in 19 States under the Global Fund supported Single Stream Funding Project .
1.15. RNTCP Programme Performance 5,6
Indicator Norm Achievement
Annual case detection rate
Annual new sputum positive case detection rate
Percent of smear positives among total new pulmonary TB cases
135/lakh pop.
70%
50%
129/lakh pop.
71%
62%
Proportion of new smear positive cases placed on DOTS within 7 days of diagnosis
> 90% 86%
New sputum positive conversion rate at three months Cure rate
> 90%
> 85%
90%
87%
Default rate < 5% 6%
Death rate < 5% 4%
India has achieved MDG targets in case detection and treatment outcome 2007 onwards. Treatment success rate in RNTCP has tripled from 25% to 88% and TB death rates have been cut 7 fold from 29% to less than 5% compared to pre- RNTCP era.
1.16. RNTCP: Impact 3,10
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the WHO global report 2013. The programme has been monitoring two important indicators, incident case notification rate and treatment success rate among New Smear Positives, among many others. The indicators reflect that there has been consistent progress towards achieving Millennium Development Goals.
1.17. Budget 3,10
For RNTCP, central government provides 100% grant-in-aid to states/UTs besides free drugs. Proposed budget for the RNTCP under the XIIth Five year plan is Rs. 4500.15 crores. Budget outlay for the year 2014-15 for RNTCP is Rs1100.04 crore
References
1) WHO.Global Tuberculosis Report 2013. Available at
apps.who.int/iris/bitstream/10665/91355/1/9789241564656_ eng.pdf, (last accessed on 17.7.15)
2) Central TB Division, MOHFW, GOI. TB India 2014 RNTCP Status Report. MOHFW, Govt. of India New Delhi 3) MOHFW National programmes under NHM, Annual report 2013-14 , MOHFW, Govt. of India New Delhi 2013
p. 95-98
4) MOHFW New TB Case Definitions under RNTCP Central TB Division, MOHFW, GOI.
5) MOHFW National programmes under NRHM, Annual report 2014, MOHFW, Govt. of India New Delhi
6) Revised National Tuberculosis Control Programme, Training Course for Programme Manager (Module 1-4) April 2011, Central TB Division, DGHS, M/O Health & FW, Nirman Bhawan, New Delhi 110108.
7) MOHFW RNTCP Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India , MOHFW New Delhi 2012
8) MOHFW RNTCP National guidelines on diagnosis and treatment of Pediatric tuberculosis, MOHFW, New Delhi-2013. Available at www.tbcindia.nic.in/Paediatric%20guidelines_New.pdf, (last accessed on 01.06.2015.) 9) Central TB Division, MOHFW, GOI Screening of tuberculosis patients for diabetes mellitus : A pilot project
.Training module for RNTCP staff . MOHFW New Delhi .
10) MOHFW Revised financial norms RNTCP 2013 MOHFW New Delhi 2013
25 Quadrant III. Self-Assessment
I. Short questions
Q. When did Phase 2 of RNTCP start ? A. 2006
Q. Precursor of RNTCP National Tuberculosis Control programme was launched in which year ? A. 1962.
Q. When was tuberculosis declared as a notifiable disease?
A. May 7, 2012.
Q. What are the goals of RNTCP?
A. 1. To reduce mortality & morbidity from tuberculosis.
2. To interrupt chain of transmission.
Q. What are the objectives of RNTCP?
A. 1. To cure at least 85% of all newly detected infectious cases of pulmonary tuberculosis (New sputum smear positive).
2. To detect at least 70% of estimated new smear positive pulmonary tuberculosis.
Q. What are the components of DOTS?
A. 1. Political & administrative commitments
2. Good quality diagnosis, primarily by sputum smear microscopy.
3. Uninterrupted supply of good quality drugs.
4. Directly observed treatment.
5. Systematic monitoring & accountability
Q. How much population does a tuberculosis unit cater?
A. 5 lacs in normal plains & 2.5 lacs in tribal, hilly & difficult areas.
Q. How much population does a designated microscopy center cater?
A. 1 lacs in normal plains, 0.5 lacs in tribal, hilly & difficult ares.
Q. What is the full form of GFATM?
A. Global Fund for AIDS, TB Management.
Q. What is MDR-TB?
A. MDR-TB is defined as resistance to Isoniazid & Rifampicin with/without resistance to other anti TB drugs.
Q. What is XDR-TB?
A. XDR-TB is defined as resistance to at least Isoniazid & Rifampicin plus resistance to any of the fluroquinolones and any one of the second line injectable drugs (amikacin, kanamycin, capreomycin).
Q. What is Nikshay?
A. It is a case based web based recording and reporting software used in RNTCP.
Q. In a patient with HIV=TB coinfection which treatment should be started first?
A. In HIV= TB coinfection, treatment of TB should be completed prior to anti retroviral therapy (ART).
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1. X-ray is the most important investigation in diagnosis of tuberculosis.
A. (False)
2. Massive bilateral Pleural effusion may require steroids in management.
A. True
3. RNTCP has diagnostic algorithm for Pulmonary TB in children.
A. True
4. In subdistrict level tuberculosis register is available.
A. True
5. Serological Tests for Tuberculosis are recommended by RNTCP.
A. False
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Quadrant-IV: Learn more/Web Resources/Supporting Materials/Interesting Facts:
www.tbfacts.org/rntcp/
https://en.wikipedia.org/wiki/Revised_National_Tuberculosis_Control_Program
tbcindia.nic.in/
www.nhp.gov.in/revised-national-tuberculosis-control-programme_pg
www.searo.who.int/india/tuberculosis/topic/tb_rntcpguidelines/en/
gmch.gov.in/e-study/e%20lectures/Community%20Medicine/RNTCP.pdf
