Critical Review of Revised National Tuberculosis Control Programme(RNTCP)

Presenter -Dr Har Ashish Jindal

JR

Contents Introduction Burden of disease Timeline of TB Control National Tuberculosis Programme Revised National Tuberculosis Control Programme(RNTCP) Directly Observed Treatment Short Course(DOTS) STOP TB Strategy RNTCP Funding Diagnosis Treatment Multi Drug Resistant TB TB-HIV Collaboration Recent Advances Conclusion

Introduction Tuberculosis is one of the leading causes of

mortality in India- killing -2 persons every three minute, nearly 1,000 every day.

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.

With emergence of Multi Drug Resistance and co-infection with HIV has weakened our battle against the disease.

Burden of Disease

Globally, in 2011, there were an estimated 8.7 million new cases of TB (13% co-infected with HIV) and 1.4 million people died from TB.

New cases of TB have been falling for several years and fell at a rate of 2.2% between 2010 and 2011.

The TB mortality rate has decreased 41% since 1990 and the world is on track to achieve the global target of a 50% reduction by 2015.(MDG Target)

26%

Global India

Prevalence(million)

12 3.1

Incidence rate(per 100 000 population)

125 181

Mortality rate(per 100 000 population)

14 24

HIV prevalence rate in incident TB cases (%)(per 100 000 population)

13% 4.2%

TB in INDIA Incidence rate(2011): 181 per lakh population Prevalence : 3.8million (2000) to 3.1million(2011) The Annual Risk of TB Infection (ARTI) has

decreased from 1.5% in 2002-03 to 1.1% nationally in 2008-10 with the estimated decline of 3.7% per year (95% confidence interval, 2.4-5.1% per year).

New Smear Positive(NSP) PTB cases in the country is estimated as 55 per 100,000 population.

WHO estimated TB mortality in India as 280,000 (24/100,000 population) in 2011

Source: Global TB Report 2012

Achievements of RNTCP

Evolving Treatments of TB in India

1962 - National Tuberculosis Programme (NTP) started

1992- NTP Reviewed and concluded its failure 1993: RNTCP formulated, adopted Directly

Observed Treatment Short-course (DOTS) strategy. 1997-Large-scale implementation of the RNTCP

with DOTS RNTCP I: 1997-2006 RNTCP II: 2006-11 National Strategic Policy: 2012-17

National Tuberculosis Programme (1962)

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.

FAILURE OF NTP

Results: Low rates of case detection and treatment completion

(30%), Continuing high mortality (50 per 100,000) High rates of default (40–60%),REASONS: More emphasis on case detection rather than cure Inadequate budget and insufficient managerial capacity Shortage of drugs Emphasis on x-ray diagnosis resulting in inaccurate

diagnosis Poor quality sputum microscopy Multiplicity of treatment regimens.

DELAYED POLICY REVISION in RNTCP and DOTS INITIATION

30 years had lapsed before RNTCP is implemented in 1993. why? why the policy not revised much earlier knowing that results are not good with NTP? why wasted 30 years?

HZES-1962 R -1982(leprosy). Led to accumulation of too many old and

retreatment cases.

Revised National Tuberculosis Control Programme(1993)

Goals - To reduce mortality and morbidity from tuberculosis- To interrupt chain of transmission.

Objectives- To cure at least 85% of all newly detected infectious(NSP) cases of Pulmonary tuberculosis- To detect at least 70% of estimated new smear positive pulmonary tuberculosis

Are the targets adequate? Total net missed cases for treatment will be

almost 40%. Is this ethical to leave the patients untreated

when we have detected them with disease?? Have we done like this for any infectious

disease with high communicability and longer period of communicability in the past?

Why should we take a risk in leaving the known infected cases?

What is the rationale behind leaving the detected infectious cases without treatment?

Is it cost-effective to leave the detected cases? We have wasted our valuable resources also to

detect those 15%.

RNTCP(1993) The RNTCP was built on the infrastructure and

systems built through the NTP. Major additions to the RNTCP:

a sub-district supervisory unit, known as a TB Unit decentralization of both diagnostic and treatment

services with treatment given under DOTS (directly observed

treatment). highest priority to the provision of quality assured

sputum smear microscopy services. Patient-Wise Boxes, which contain the full course of

treatment for one individual patient, ensuring that treatment of that patient cannot be interrupted due to a lack of drugs.

RNTCP Organization structure: State level

DOTS(1997)

DOTS is a systematic strategy which emphasizes on: Political and administrative commitment. 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. 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.

Weak Political Approach

Political commitment, the first requisite of dots management is only on paper.

Politicians were not serious and not actively involved in the crusade against tuberculosis.

Example TB was made Notifiable(May 7,2012) Other countries e.g China (2000)

WHERE PATIENT OF TUBERCULOSIS GO FOR

TREATMENT ?

Government Sector Private Sector

Quality diagnosis? Quacks and Private Practioners

Tb is still a poor man's disease in India Quacks And Private Practitioners : The First point of contact for a majority of patients In India, 75% of doctors (6 million) are based in

private practice and only 0.31% are implementing RNTCP.

Treatment in the private sector is often started based on serology results leading to wrong and/or delayed diagnosis.

inflate costs of care. Thus, undiagnosed TB, delayed diagnosis and

mismanaged TB continues to fuel the TB epidemic.

In June 2012, the government banned serological tests for TB.

Improvements In 2009, WHO recommended that conventional

Fluorescence Microscopy be replaced by LED microscopy in all settings and that LED microscopy be phased in as an alternative for conventional ZN microscopy in both high volume and low-volume laboratories.

Success: Central TB Division is planning to replace the Binocular Microscopes with LED Microscopes in a phased manner over the next 5 years especially in the high work load settings.

200 LED Microscopes have already been procured by UNION for use in Projects in Medical Colleges

STOP TB Strategy(2006)

■ In DOTS collaboration ,STOP TB strategy was started with additional six components-1. Pursue high-quality DOTS expansion and enhancement2. Address TB/HIV, MDR-TB, and the needs of poor and vulnerable populations3. Contribute to health system strengthening based on primary health care4. Engage all care providers5. Empower people with TB, and communities through partnership6. Enable and promote research

RNTCP FUNDING

1981 2007-08

2008-09

2009-10

2010-11

2011-12

2012-13

0

50

100

150

200

250

300

350

400

450

1.8

267 275 285 300320

582

Actual allocation as per planning com-mission

actual allocattion as per planning com-mision

Ru

pees in

cro

re

Additional funding of $ 100 million for 2 years up to 2014 for Universal Access goals addressing MDR TB , Scaling up approach and New approaches

1997-2005 2006-2012125

130

135

140

145

150

155

160

165

170

175

142

170

World Bank Funding

World Bank Funding

$ in

million

s

Category Type of Patient Regimen Duration in months

Category I

Color of box: RED

New Sputum Positive ,sputum negative, extra pulmonary

2 (HRZE)3,

4 (HR)3

6

Category II

Color of box: BLUE

Sputum Positive relapseSputum Positive failureSputum Positive treatment after default

2 (HRZES)3,

1 (HRZE)3

5 (HRE)3

8

DOTS Treatment

Lengthy treatment: chemotherapy for six months duration is still a problem for the patient to comply.

Need to reduce the duration of treatment in view of patient’s compliance and side effects of drugs.

Ultra- short treatment regimens for three months duration using quinolones with rifampicin are on the anvil.

DOTS Treatment Inadequate information and poor

management of adverse events and toxicity continue to result in patients defaulting on treatment .

Controversy regarding the efficacy of the 6-month regimen that is recommended under RNTCP in TB meningitis and TB of bones and joints cases compared with the 9–12 month regimen recommended by some experts.

DOTS Implementation Status

31st March 2006

Nationwide DOTS coverage -632 districts and 1164 million people covered under RNTCP

LARGE POPULATION

The provision of quality TB services to a population of over 1 billion is a difficult task.

Providing an uninterrupted supply of Anti-TB drugs to more than 1.3 billion cases each year.

Quality???? Requires a large amount of resources to

be mobilized ???? Human resource management ???

DOTS in India TB as a disease and its treatment may be viewed

differently in the various socio-cultural-economic conditions prevailing in India today. E.g. Muslims during Roza

Socioeconomic factors that have been identified in studies done among patients on DOTS in India include smoking, alcoholism, old age, poverty with default and malnutrition etc. It is unclear to what extent these factors affect the functioning of DOTS treatment.

Poverty, social upheaval and crowded living conditions Inadequate health coverage and poor access to health

services Reluctance to report TB suspects leading to poorly

administered programmes

POOR PATRONAGE OF DOTS REGIMENS Most Indian doctors/health workers are not aware of

DOTS, its success in TB control in other countries and how it is being implemented in the country.

All doctors, some knowingly and some unknowingly are prescribing anti-tuberculosis drugs as they like. Even pulmonologists are not sticking on to dots regimens as recommended in the national program.

The knowledge regarding the treatment guidelines among the residents and consultants is low, points to the fact that re-education of faculty members regarding recent trends or guidelines is essential if we want this knowledge to percolate to the periphery.

RNTCP has consistently shown treatment success rates of around 87%, whilst case detection rates have generally risen to now stand at around 72%.

Progress towards MDG indicator 23

1990 2011 20150

50100150200250300350400450500 459

249 230

Prevalence rate of TB

Prevalence rate of TB

Cases p

er

1,0

0,0

00

pop

u-

lati

on

Progress towards MDG indicator 23

1990 2011 20150

5

10

15

20

25

30

35

40

45

24

19.5

Mortality rate of TB

Mortality rate of TB

Cases p

er

1,0

0,0

00

pop

ula

tion

41%42

Programme Performance Indicator Norm Achievement

Annual case detection rate 135/lakh population 129/lakh (145/lakh)

Case detection rate 70% 71%(Haryana-71.4%)

% of smear positive among total new pulmonary TB cases

50% 62%(Haryana-51.9%)

Proportion of new smear positive cases on DOTS within 7 days of diagnosis

>90% 86%(Haryana-89%)

New sputum positive conversion rate at three months

> 90% 90%(Haryana-90%)

Cure rate >85% 86% (Haryana-84.6%)

Default rate <5% 6% Haryana (6.4%)

Death rate <5% 4%(Haryana -4.4%)

Reasons for Unachieved targets

•Migratory population???

• Poor commitment of DOTS providers and supervisory staff

•Defaulter correction activities need to be more effective

Why is TB a big problem in India, despite the success of the DOTS program?

Misdiagnosis and management can result in only fraction of TB patients getting correct diagnosis, appropriate therapy and positive outcomes

Patients with TB symptoms

Patients investigated

Patients with appropriate TB test

is orderedPatients quality-assured results

Patients width

diagnoses

Patients who get therapy and cured

Patients who get correct TB therapy

High Relapse Rate Irregularity in treatment and presence of initial

drug resistance. There is a choice of providers for the patient and

he is free to discontinue and start treatment from whichever provider he likes, based on his perception of getting benefit for treatment.

Thus, patients can be over treated or started with intensive phase again when they switch providers. This previous treatment history is poorly documented.

Retreatment cases not followed up after treatment for any length of time, there is very less information about relapse

Why intermittent regimen was opted? In a high-burden country as India intermittent

regimen was never critically reviewed. The current WHO guidelines, based on

"strong/high grade evidence" recommends "wherever feasible, the optimal dosing frequency for new patients with pulmonary TB is daily throughout the course of therapy";

Studies have been documented rates of acquired drug resistance were higher among patients receiving three times weekly dosing throughout therapy than among patients who received daily drug administration throughout treatment.

Missed dose in Intermittent Regimen leads to no medicine for 3 or 4 straight days ?????

Recommendations

The model of DOT being implemented in India needs to be reconsidered ,which enable access to treatment and maximize adherence.

There is a need for operational research into alternative models of DOT, especially in urban areas, which do not impede access to care under the RNTCP, and which minimize the indirect costs of DOT based treatment.

Challenges Ahead!!!!!

“If detecting and treating all TB patients who are not drug resistant is challenging enough, detecting and treating drug-resistant TB is riddled with problems.”

MDR-TB & XDR-TB

India, China, the Russian Federation and South Africa have almost 60% of the world’s cases of MDR-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).

Burden of MDR TB Globally, 3.7% (2.1–5.2%) of new cases and 20%

(13–26%) of previously treated cases are estimated to have MDR-TB in 2011

In India, 2.1% have been estimated to be MDR in New TB cases , and 15% in Retreatment cases. respectively(2011)

Extensively drug-resistant TB (XDR-TB) has been identified in 84 countries globally.

Combining data from 65 countries and 3 union territories, the proportion of MDR-TB cases with XDR-TB was 9.0% (95% confidence interval, 6.7%–11.2%).

Drug Resistant TB• In December 2011 , 4 patients from Mumbai,

“totally drug resistant” tuberculosis i.e. resistant to all first -line and second-line drugs tested.

• Media reports have added reports of further cases in Mumbai and in Bangalore.

• Such cases have been reported sporadically in Europe and 15 cases in Iran in 2009.

Audit Reveals: Unsupervised second line drugsIncorrect dosesMultiple private practitioners (on average

from 4 physicians during a 18-month period)

(an attempt to cure their (MDR)tuberculosis.)

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.

Km – Kanamycin ;Ofx- Ofloxacin; Eto-Ethionamide ; Cs- Cycloserin; Z- Pyrazinamide ; E- Ethambutol

Category Category of Patients

Intensive Phase Continuationphase

IV MDR TB Cases 6-9(kmOfxEtoCsZE)

18(OfxEtoCsE)

Gaps in the MDR TB management

Diagnosed with TB and MDR TB in the private sector No notification done to public health authorities, who would be

able to take actions to confirm diagnoses, offer supportive services, and offer free treatment to patients from public sources or at least supervise the quality of care in the private sector.

Inadequate or inefficient administration of effective treatment. Poor case holding . Frequent use of Second line drugs in treatment common

ailments. inadequate or irregular drug supply. Ignorance of health care workers in the treatment and control

of TB. Interruption of chemotherapy due to side effects.

Gaps in the MDR TB management

Anti-TB drugs available without prescription and subsequent widespread irrational and irresponsible use

Insufficient public sector MDR and XDR TB diagnosis and treatment services

Only in recent years has a public sector option for free diagnosis and treatment of MDR TB become available;

Success In 2008 were only 17 accredited facilities for doing

culture and DST (which works out to 0.1 facility per 10 million residents, against a minimum of 1 per 10 million), although efforts are underway to increases the number to 43 laboratories with DST capacity. Indeed, by 2011, 27 accredited laboratories are operational, including 8 private/NGO sector laboratories. Expansion of laboratory capacity is critical to ensure that patients with suspected drug resistant TB can be diagnosed early and.

The RNTCP has begun to incorporate recent, more rapid methods of performing culture and DST (e.g. liquid culture and molecular assays) and this is important to avoid unnecessary delays in the management of patients with MDR–TB

New lines of diagnosis

Xpert MTB/RIF has 72 per cent sensitivity with one test, and 90 per cent with three tests in the case of smear-negative patients. The sensitivity goes up to 98 per cent in the case of smear-positive and culture-positive patients. Xpert MTB/RIF has 99 per cent specificity.

It can turn in results in less than two hours compared with four to six weeks in the case of the culture process.

But the most important advantage is its ability to diagnose rifampicin drug resistance.

Recommendation Need for continuous surveying of drug

resistance by a network of investigators in different regions of the country, by employing a common protocol, with an emphasis on quality control, which will serve as a useful parameter in the evaluation of current and past chemotherapy programs

TB-HIV collaboration

In 2011, 1.1 million (13%) of the 8.7 million people who developed TB worldwide were HIV-positive ; 79% of these HIV-positive TB cases were in the African Region. Globally, there were an estimated 0.4 million HIV-associated TB deaths in 2011, withapproximately equal numbers among men and women

In comparison to 19 states in 2010, in 2011 23 states are implementing the intensified TBHIV package for at least 2 quarters with close to 6 lakh TB patients were ascertained for their HIV status (67% of TB patients registered) and about 44,000 HIV-infected TB patients were diagnosed.

Till December 2011, more than 300 ART centres were operating in the country, and 550 link- ART centres.

TB HIV Collaboration In 2007, the first National Framework for joint TB-HIV

collaborative activities was developed which endorsed a differential strategy reflective of the heterogeneity of TB-HIV epidemic.

Coordinated TB-HIV interventions were implemented including establishment of a coordinating body at national and state level, dedicated human resources, integration of surveillance, joint monitoring and evaluation, capacity building and operational research.

Interventions have focused on improving services for HIV-infected patients, with intensified TB case finding at HIV care settings and linking with TB treatment; and for TB patients with provider initiated HIV testing and counseling, provision of ART and decentralized CPT.

Challenges Treatment outcomes among HIV-infected TB

patients: low failure rates but high case-fatality; death has been associated with lack of ART. .

Only about 50% of TB patients know their HIV status and of those identified as HIV positive, only about 60% are linked to ART as the majority are poor and unable to reach centralized ART centres.

Thus, gap between RNTCP and NACP infrastructure results in suboptimal linkages.

POOR DIAGNOSIS and POOR POLICY Sputum smear microscopy is not a sensitive tool to

diagnose TB among PLHIV, and access to a culture based diagnosis (or equivalent technology) is lacking.

Implementation of airborne infection control measures in health care settings is also limited.

Revised National TB Control Programme (RNTCP) in India uses a fully intermittent thrice-weekly rifampicin containing regimen for all TB patients including those who are HIV-infected; whereas, WHO recommends daily TB treatment at least during the intensive phase.

The WHO recommendation was based on the results of a meta-analysis demonstrating increased risk of recurrence and failure among HIV-infected TB patients receiving intermittent TB treatment, compared to a daily regimen.

Human Resource Vision

A world where every person, everywhere has access to a motivated and supported health worker, who is skilled in TB control.

Goal Health workers at different levels of the health

system have the skills, knowledge, and attitudes (professional competence) necessary to successfully implement and sustain comprehensive TB control services based on the Stop TB Strategy.

NEED FOR HUMAN RESOURCE PLANNING

Unprecedented programme expansion in the last five years has outpaced capacity at central, state and district level to ensure quality of services.

Members of the staff at state and district levels : perform multiple functions , being overburdened.

New Recruits necessitates frequent trainings, which is neglected at times.

Hence, there is an urgent need for national HRD planning that strategically and comprehensively addresses the overall staffing issues related to recruitment, capacity development, performance .

NEED FOR HUMAN RESOURCE PLANNING

Advanced training on management aspects such as health financing, leadership/governance, business planning, organizational development

Engage in strategic partnerships for health workforce development with other Training divisions/ institutions, in-service training for programmes, Ministry of Education and other relevant ministries, Professional associations, Private sector including NGOs and bilateral and international organizations

Monitor and supervise health worker performance to detect performance deficiencies; identify new staff in need of training; identify additional staff needs for current interventions and for new interventions/strategies.

Quality assessment of Training.

National Strategic Plan (NSP)(2012-17)

RNTCP defined newer objectives of 'Universal Access to TB Care' for TB control in India in 2010.

Vision TB-free India

GoalDecrease the morbidity and mortality by early diagnosis and treatment to all TB cases thereby cutting the chain of transmission.

Objectives

Case detectionRNTCP Objective :70% of estimated New Smear Positive TB cases

NSP objective:To Achieve 90% Notification rate for all cases

Treatment successRNTCP Objective:

85% of all New Smear positive TB casesNSP Objective:90% success rate amongst New & 85% amongst retreatment TB cases registered under RNTCP

Drug resistant TBNSP Objective:

Improve the successful outcome of treatment of MDR cases

Objectives

TB-HIV Collaboration

Private Sector

NSP Objective:Decrease Mortality and morbidity of HIV associated TB

NSP Objective:Improve the outcome of TB care in Private sector

Targets planned for 2012 to2017

TB Made Notifiable (May 7,2012)

Mandatory for laboratories, hospitals, nursing homes and doctors, both in the public and private sector, to report every TB case detected.

Once a case is notified govt. will ensure correct diagnosis and complete adherence to treatment during the entire duration of treatment.

This is where the approaches that India and China adopted to fighting TB diverged.

Of the 37 notifiable diseases in China, TB ranks No. 1. It pulled out all the stops by 2000. “The concept of acceptance of the problem, identifying its requirement and the political will of TB eradication has set China on a progressive path,” notes a paper published in the journal Interdisciplinary Perspectives on Infectious Diseases.

Conclusion Join Hands Strong Commitment from TB control Staff Human Resource Management Strong Political Commitment Proper IEC Activities Decentralization of the resources Research

HELP US COMBAT TUBERCULOSIS

Thank you