Critical Review of RNTCP

Dr. Abhishek Tiwari

04/11/20232

Maximum annual deaths than any other infectious

disease in the industrialized world

Most frequent cause of death for young adultsNew outbreaks are increasing after almost 40 years

of a steady decline2 billion people (1/3 of the world's population) exposed to TB

> 8 million cases & 2 million deaths annuallyRajyaroga (king of diseases) in ancient text

Global Burden

04/11/20233

2 million develop TB & 5,00,000 die annually

> 1000 die of TB every day (2 every 3 minutes)

HIV , major risk factor for TB has already infected

4.8 million

Emergence of MDR-TB has added to TB epidemic

An untreated patient can infect 10-15 persons each

year

TB Burden India

04/11/20234

Poorly treated patients develop drug-resistant and

potentially-incurable TB

A major barrier to economic development

> 300,000 children forced to leave school ,parents

have TB

> 100,000 women with TB are rejected by their

families

Tragic because TB is nearly 100% curable

TB Burden India

04/11/20235

Started in 1997Lepra-India , NGO supporting under “Sahayog” &

“Akshaya” project to IEC & BCC activities in 12 districts

Catholic Bishop Conference of India & IMA alsoPopulation covered 424 lakhsSuspects examined in 2012 : 226305Diagnosed new cases : 29728Trained staff , MO 81 % & para staff 87 %Laboratory : ILR Cuttack & RMRC Bhubaneswar

Odisha

04/11/20236

Back groundYear Comments

1962 NTCP30 % diagnosed & 30 % treated

1993 pilot testing based on DOTS Strategy

1998 – 2005 RNTCP I Launched as a NP expanded in 1998

2000 30 %

2002 50 %

2003 778 million

2004 997 million

2005 1080 million 97 %

24th March 2006 Entire Country

2006 – 2010 RNTCP II

04/11/20237

1. Evaluated 55 million & initiated treatment 15.8

million

2. Prevention of mortality : >2.8 million lives

3. National coverage ( unreached areas )

4. Well on track to achieve the MDG of halting &

beginning to reverse the spread of the disease

5. With NACP III : expanded joint TB/HIV services

6. RNTCP conforms to ISTC prescribed standards

7. All Medical colleges involved

Achievements of RNTCP:

04/11/20238

78, 67,194 TB suspects examined for SSM

14, 67,585 initiated on treatment

Case detection rate of New Smear Positive TB was 68%

Treatment success rate of 88%

81,482 pediatric TB cases , accounting for 7% of all cases

8, 21,807 (56%) TB patients tested HIV

44,063 (5%) were positive

92% HIV infected TB patients were initiated on CPT and 74%

ART

Achievements of RNTCP: 2012

04/11/20239

04/11/202310

CTD & NIC develop a Case Based Web application :

Nikshay to improve TB surveillance

Notifiable disease on 7th May 2012 (trace contacts)

The revision of the OR agenda in 2012

The “National Standing Committee” was renamed as

“National Research Committee”

Ban on serological test

New initiatives in 2012

04/11/202311

6.3 million treated (1997-2006)Health benefit of 29.2 million DALYs gained including 1.3 million deaths averted2006, burden of TB = 14.4 million DALYs (1.8 times higher) in absence RNTCP

04/11/202312

Theme : “Universal Access for quality

diagnosis and treatment for all TB patients in

the community”

Target : “reaching the unreached”

Focus : early & complete detection of all cases (DR-

TB ,HIV-TB)

Increase involvement of private sector

Higher commitment

4 fold increase in budget

RNTCP : NSP 2012-17 , 12th FYP

04/11/202313

Vision: “TB-free India - through achieving Universal

Access by provision of quality diagnosis and

treatment for all TB patients in the community”

Goal: to decrease the morbidity and mortality by

early diagnosis and early treatment to all TB cases

thereby cutting the chain of transmission

RNTCP : NSP 2012-17 , 12th FYP

04/11/202314

Early detection & Rx of 90% cases (DR-TB & HIV-TB)Rx 90% of new TB patients, 85% of previously-

treated Reduce default rate : new TB cases to < 5%

re-treatment TB cases to < 10% Initial screening of all re-treatment smear-positive till

2015All Smear positive TB patients by 2017 for DR-TBProvision of treatment for MDR-TBOffer of HIV Counseling and testing for all patientsLink HIV-infected TB patients to HIV careExtend RNTCP services to patients in private sector

Objectives

04/11/202315

Detection , treatment of about 87 lakh TB patients

At least 2 lakh MDR-TB

Reduction in delay in diagnosis and treatment of all

types of TB

Increase in access to services to hard to reach

populations & high risk & vulnerable groups

Targets : 12th FYP

04/11/202316

Over crowded living conditions Closeness of contacts

Absence of native resistance

Infectiousness of the source

Degree of sputum positivity

Pattern of coughing, lack of knowledge , nutrition

Resources : funds , trained manpower , infrastructure

Urbanization & migrations : slums

Unhygienic living conditions , poverty & indifferent

attitude towards health all these are high risk pockets

Epidemiological factors

04/11/202317

No financial constraints (best & 2nd largest)

multi factorial causation

Evidence from developed world

environmental condition & living standards

declined TB even before ATT

Social Stigma

Inhibits to come in early phase, even health workers

behave indifferently to them

72.4 % patients isolated with their utensils in their

home

04/11/202318

Challenge peripheral area : lack of proper referral

system

a chest symptomatic attends a health care provider,

he is not properly referred to DMC

Treatment facility to be accepted & utilized by

community

Availability of all resources essential : drugs , needle

syringe ,forms , chemical

Organizational factors

04/11/202319

Trained manpower still a big hindrance

General services still do not accept RNTCP strategies

In-service training must before merging it

Compulsory imposing of DOTS : resistance among

doctors of different discipline

Organizational factors

04/11/202320

RNTCP plans as NGO but implements as a

government department

Lack of coordination (intra & inter dept..)

DTO government post based on seniority

DTO : priority to clinical functions & failing to do

justice with PH

Organizational factors : District

04/11/202321

Laboratory Supervisors STLs supervise the LTs but

many times they had far less experience than the

technicians

Since they work on contractual basis ,ego problems

may make the technicians hostile

MO-TC , supervise STLs may not have necessary

expertise

Organizational factors : District

04/11/202322

Computer literacy is still poor & networking not

provided at all levels

STDCs serve as hospitals instead of public health

institutions

support training, monitoring, and supervision

State TB Officers don’t take action on DTO

STS ,treatment supervisor (1 lakh) population, has to

observe work by the health staff , no accountability

State level

04/11/202323

Patients reporting to big hospital not referred to DOTS

center due to fear of losing them

Social stigma of high SEC patients to visit DOTS

DOTS center restarts the investigation all again (don’t

rely )

Often these centers are unattended so patients lose

faith

State level

04/11/202324

Inconvenient (time / distance)

Observation may not be acceptable

Worse still : no accessible observer

Has to bear with cumulative side effects

No new drug in last 35 years

Universal coverage with DOTS not desirable

DOTS : patients problem

04/11/202325

1% - 2% need non-DOTS regimen (intolerance, toxicity ,liver disease, immcomp. & migration)

More common in reg. with alcoholism or drug abuse

DOTS should allow other reg. or provision to

accommodate

Most pt. not recover of chest symptom sense of

dissatisfaction

The drug combination & dosages changing over years

creating confusion among Physicians

DOTS : patients problem

04/11/202326

A study found that 60 % of dosages prescribed don’t

correspond to std. guidelines

Patients reluctant to visit DOTS center & take med

for whole month so the monthly doses are not

supervised

Study by Bhatt 1998 showed SCC + HE = DOTS , but

no comparative study done

DOTS : patients problem

04/11/202327

RNTCP based on critical evaluation of NTC

Adopted a victim blaming approach ,

Rather than improving the policy & prog.

Very low targets were set for coverage & cure (85%)

But only 50% -60 % attend Gov. facility

Short comings : policy

04/11/202328

Targets achieved are not uniform , some areas need

greater effort as case detection is passive

(i) lack of participation of other health care providers like

CGHS, Railways, Corporate sector, private

practitioners

(ii) lack of community participation

Short comings : policy

04/11/202329

40 % - 50 % of active pulmonary TB (culture

positive ) can not be detected by microscopy

( Nagpaul 1968 )

Improve quality of sputum microscopy

Undetected smear negative pt will get Cat III or left

untreated if x ray are also neg, but will continue to

infect community

Not providing : leads to loss of faith in Gov. services

RNTCP has quality assured laboratory network

NRL,IRL, & DMC

Short comings : diagnostic

04/11/202330

During 2012, RNTCP finalized protocol & guidelines

for certification for second line Drug Susceptibility

testing (DST)

Some recent advantages in case detection

African giant pouched rats trained to detect pul. TB Alt tool to enhance case detection in resource

limited setting Fast , cheap & low skill Lab 40 sample in a day , HeroRAT same in 7

min With 86 % sensitivity ,89 % specificity ( overall

87 % vs 37 % )

Short comings : diagnostic

04/11/202331

Sputum microscopy instead of X-ray avoids over

diagnosis and identifies infectious cases

Sputum test still not taken seriously

Depends on skill & commitment of technician

IQA & EQA cannot guarantee quality of monitoring

SSM – high tech job needs training & re-training

04/11/202332

Initial drug resistance : effects success

Most of pt. receiving ATT outside are potential for

DR

37.3 % TB pt. develop resistance to rifampcin

Cat II pt. put on 5 drugs without C & DS

DST should be included as one of the diagnostic

criteria in tertiary center rather than changing all

center to DOTS

Short comings : resistance

04/11/202333

In case of CAT I failure , one more drug added but

at least 3 should be added after sensitivity testing

2nd line drugs to be added for MDR-TB

Majority of these are poor & left (DOTS-PLUS not

yet 100%)

Freely available in market , frequently used by PP

All these increase MDR-TB

Short comings : resistance

04/11/202334

Community Participation & Role of NGOCP essential to achieve targetsBest prog. : makes people realize the imp of healthDoes the community thinks same way as health

expert ?Felt need has to be generatedNGOs should be acknowledged & supervisedPP should be trained on differential diagnosis as

silicosis , asbestosis

Short comings : integration

04/11/202335

No National IEC program , needed to change the

attitude

Effective for illiterate population with strong

political leadership , as seen in case of polio prog.

WHO Report 2005 : political commitment not

uniform

Political leaders needed at all stage to mobilize the

resources

With corruption this is hard to be found

IEC , BCC ,training

04/11/202336

RNTCP training modules updated with latest policy

changes

Videos training modules for training DEO in

Nikshay

Relapse more common in smokers

Focus on Anti smoking campaign & counseling of

smoker Tb patient

IEC , BCC ,training

04/11/202337

Recording & Reporting : 3 forms : SSE / C&S / Transfer2 cards : id & treatment2 registers : Lab & TB4 copies of quarterly report TU has to submit

(S/C/NTI/Rec.)New patient , sputum conversion , Rx outcomeData analyzed at Dist. to get age, sex , CAT

distribution of cases , done by technical experts In reality little or no role of CDMO & DM in general

& in supervision & monitoring

Short comings : reporting

04/11/202338

Need huge funding

Improved diagnostic tests

New vaccine in early phases of clinical trials

New drugs : Shorten Rx for drug-susceptible

disease

Refine Rx in special populations (with HIV, children

& elderly)

Short comings : research

04/11/202339

whole blood (finger prick) HIV screening test to all

DMCs and Provider Initiated HIV Testing and

Counseling (PITC)

among presumptive TB cases in all “high” HIV

prevalent settings

Isoniazid prophylaxis therapy (IPT) has also been

accepted for prevention of TB among PLHIV

Future

04/11/202340

To screen all TB patients for DM in the 100 districts

where NPCDCS implemented

Universal Access, school awareness programme

RNTCP field personnel to generate awareness among

students and teachers of all school and colleges in all

the States/UT's

> 3.5 lakh schools visited, 4.5 lakh teachers, 9 lakh

students covered

Future

04/11/202341

Extensive training, supervision and monitoring needed at all levels

Ensuring treatment adherence and timely follow-up, and uninterrupted supply of second line drugs

Unsupervised and uncontrolled private sectorAlmost 100% of second line drugs were sold and

used outside of RNTCP

Conclusion

04/11/202342

Risk of failure of treatment and development of drug resistance

This large unregulated private sector, conflict of interest, and easy availability of anti-TB drugs are important hindrances to a successful programme

Guidelines to all healthcare providers (IMA ,MCI ,DCGI) to draft

Need urgent attention : infection control practices in Hospitals

National guidelines on Airborne Infection control in context of TB

Conclusion

1. http://www.who.int/mediacentre/ factsheets/fs104/en/index.html

2. http://whoindia.org/en/Section3/Section123.htm

3. Lambregts-van Wezenbeek CSB, Veen J. Control of drug-resistant tuberculosis. Tubercle and Lung Disease 1995: 76; 455-458.

4. DOTS PLUS guidelines, Central TB Division, Directorate General of Health Services. GOI,2010

References

04/11/202344

Development & dissemination of different schemes for

the involvement of private practitioners, NGO’s etc.

Conduct sensitization & training Programmes for

medical personnel in other sectors including corporate

sector

Awareness generation activities for health providers in

the community

Recommendations

04/11/202345

Change mindset of doctors & patients

Prog. Does not emphasize on active health education

and counseling of pt. in treatment & follow up

Convince them of RNTCP

Supervise & monitor the programme activities ,

address shortcomings so quality services provided

Recommendations

04/11/202346

Thanks a lot for your cooperation