Control of Tuberculosis

by

Dr. Sridhar.D

2nd year PG

Department of Community Medicine

Osmania Medical College

Hyderabad

Global and Indian scenario Control of tuberculosis RNTCP

OVERVIEW

Estimated TB incidence rates 2010

8.8 million incident cases of TB (range, 8.5million-9.2 million) globally in 2010

1.1 million deaths (range, 0.9 million-1.2 million) among HIV-negative cases of TB and

An additional 0.35 million deaths (range, 0.32million-0.39 million) among people who were HIV positive In 2009

There were an estimated 9.7 million (range, 8.5-11 million) children who were orphans as a result of parental deaths caused by Tuberculosis.

The WHO Global TB Report 2011

Global TB disease burden

Global estimation of burden of HIV positive incident

TB cases is 10,00,000 (11,00,000-12,00,000) while the

estimates of HIV positive incident TB cases in India is

75,000 (1,10,000 - 1,60,000), HIV prevalence amongst incident TB cases is estimated to be 3.3% (5%-7.1%).

Globally, about 1 million cases of paediatric TB are estimated to occur every year accounting for 10-15% of all TB; with more than 100,000 estimated deaths every year, it is one of the top 10 causes of childhood mortality.

The WHO's Global TB Report of 2011

Number (Millions)(95%CI)

Rate Per 100000 persons(95 CI)

Incidence

All cases(2009 WHO estimates)

2.0(1.6-2.4) 168

Period Prevalence (2000 GoI estimate)

AFB positive 1.7 (1.3-2.1) 165 (126-204)

Bacillary 3.8 (2.8-4.7) 369 (272-457)

Prevalence, all cases (2009 WHO estimate)

3.0 (1.3-5.0) 249

Estimated burden of tuberculosis in India

India is the highest TB burden country in the world accounts 20% of global burden of TB and 2/3rd of cases in SEAR.

Every year approximately 1.8million persons develop tuberculosis, of which about 0.8 million are new cases.

Annual risk of becoming infected with tb is 1.5% and once infected there is 10% life time risk of developing TB disease.

Patients with infectious pulmonary tuberculosis disease can infect 10-15 persons in a year.

New cases Number(thousands)& %

Retreatment cases Number(thousands)& %%

Smear +ve 630165(51) relapse 110691(38)

Smear -ve 366381(30) Treatment after failure

18463(6)

Smear unknown Treatment after default

72110(25)

extrapulmonary 231121(19) other 91708(31)

other 1508(<1)

Total new 1229175 Total rertretment 292972

Total <15 years 13415

Case notification 2010 in India

Total new and relapse 1339866 88% of totalTotal notified cases 1522147

The estimated MDR TB cases emerging annually in India are reported to be 99,000 among incident total TB cases in India in 2008 (range 79,000 - 1,20,000).

As per the WHO Global TB Report 2011, Estimated number of MDR-TB cases out of notified Pulmonary TB cases in India is 64,000 (range 44,000 to 84,000) emerge annually.

WHO Global TB Report 2010 and Multidrug and

extensively drug-resistant TB (M/XDR-TB) - 2010 Global

Report on Surveillance and Response

TB India annual report 2012.

Tuberculosis control means reduction in the prevalence and incidence of the disease in the community.

The WHO defines that tuberculosis “control” is said to be achieved when the prevalence of natural infection in the age group 0-14 years is of the order of 1 %. This is about 40% in India.

The control measures consists of a curative component- namely case finding and treatment and prevention.

The control of tuberculosis

A “case” is defined by WHO as a patient whose sputum is positive for TB bacilli and such cases are the target of case finding.

All other possible sufferers from TB whose sputum is negative but who show suggestive shadows in chest x-ray’s are reckoned as “suspects”.

Case finding

Park’s text book of Preventive and Social Medicine 21st editionAFMC Text book of Public Health and Community Medicinewww.WHO.int

Target group-pulmonary TB patients because pulmonary TB is most common and causes pool of infection every year.

Case finding tools:-

{1}sputum examination: direct microscopy

Collection of samples- 2samples

day1 sample1 Patient provides an “on the spot “ sample

day2 sample2 Patient brings an early morning sample

Slide reporting

Slide reporting

Number of bacilli Results reported

No AFB per 100 oil immersion fields

0

1-9 AFB per 100 oil immersion fields

Scanty( number AFB seen)

10-99 AFB per 100 oil immersion fields

+(1+)

1-10 AFB oil immersion fields ++(2+)

>10 AFB oil immersion fields +++(3+)

RNTCP Laboratory Network

4 NRLs27 IRLs

>12,000 DMCs(one per 50,000-100,000

population)

Quality Assurance (QA)

External QualityAssessment (EQA)

1. On Site Evaluation(OSE)

2. Panel Testing

3. Random BlindedRechecking(RBRC)

Internal QualityAssurance

(Quality Control)

1. Instrumentchecks

2. Reagentquality check

QualityImprovement

(QI)

1. DataCollection

2. Data Analysis

3. Solvingproblems

One specimen out two is enough to declare positive TB. Patients in whom both specimens are smear negative

should be prescribed symptomatic treatment and broad spectrum antibiotic for 10-14 days.

If symptoms persists after treatment repeat sputum smear . if one smear is positive label as smear positive and none of the repeated smear positive take chest x-ray if it suggests pulmonary TB label as sputum negative pulmonary TB .

Sputum culture: it is only second in importance in case finding.

Available at district and regional chest clinics Necessary for carrying out sensitivity tests and

monitoring drug treatment.

{2}mass miniature radiography : stopped as general measure of case finding due to lack of definitiveness, high cost , erroneous interpretation of films, very low yield of cases.

{3}tuberculin test: invalidated as case finding tool.

Two phase chemo therapy: 1st is short , aggressive or intensive phase fo 1-3 months 2nd is continuation phase

Treatment

1st line drugs 2nd line drugs

Bactericidal Bacteriostatic Fluroquinolones

Rifampicin(RMP) Ethambutol Ethionamide

Isoniazide(INH) Thioacetazone Capreomycin

Streptomycin Kanamycin and Amikacin

Pyraxinamide Cycloserine

Macrolides

Long course regimens:

daily regimens

bi-weekly regimens Short course chemotherapy: 1972 Wallace Fox

advantages- rapid bacteriological conversion, lower failure rates, and reduction in frequency of emergence of drug resistant bacilli. Patient compliance will improve

disadvantage- high cost of short –term chemotherapy.

cost effective approach to tuberculosis control.

(a) accuracy of diagnosis is more than doubled

(b) treatment success rate is upto95%

(c) prevents the spread of infection thus reducing the incidence and prevalence of tb.

(d)improves quality of health care and removes stigma associated with Tb

(e) prevents failure of treatment and the emergence of MDR-TB by ensuring patient adherence and uninterrupted drug supply

(f) helps alleviate poverty by saving lives , reducing duration of illness and preventing spread of infection

(g) lends credibility to TB control efforts

DOTS

The success of DOTS depends on five components:

- Political commitment

- Good quality sputum microscopy

- Directly observed treatment

- Uninterrupted supply of good quality drugs, and

- Accountability

Treatment groups Type of Patient Regimen

Intensive Phase(IP)

Continuation Phase(CP)

New (Cat I) New Sputum smear-positiveNew Sputum smear-negativeNew Extra-pulmonaryNew Others

2(HRZE)3 4(HR)3

Previously Treated (Cat II) Smear-positive relapseSmear-positive failureSmear-positive treatment after defaultOthers

2 (HRZES)3/ 1(HRZE)3

5(HRE)3

MDR-TB Cases(Cat IV) 6 (9) Km Ofx (Lvx) Eto Cs Z E

18 Ofx (Lvx)Eto Cs E

Revised Categories

MDR / XDR

MDR-TB is defined as resistance to isoniazid and rifampicin, with or without resistance to other anti-TB drugs from an accredited RNTCP Laboratory

XDR-TB is defined as resistance to at least Isoniazid and Rifampicin (i.e. MDR-TB) with resistance to any of the fluoroquinolones and any one of the second-line injectable drugs (amikacin, kanamycin, or capreomycin).

NTM is Non-Tuberculous Mycobacteria reported in the sputum specimen by an accredited RNTCP Laboratory

It refers to DOTS programs that add components for MDR-TB diagnosis, management and treatment

DOTS-plus strategy promotes full integration of DOTS and DOTS-plus activities under the RNTCP

1. Sustained government commitment

2. Accurate , timely diagnosis through quality assured culture and drug susceptibility testing

3. Appropriate treatment utilizing second line drugs under strict supervision

4. Uninterrupted supply of quality assured anti-TB drugs

5. Standardized recording and reporting.

DOTS-plus

in place of Streptomycin Ethambutol added INH , RMP , Pyrazinamide and Ethambutol are safe Ethionamide and Protionamide are teratogenic.

Treatment during pregnancy

10-20% of all tb cases Usally sputum smear –ve Children under 5years of age ae more prone to develop the disase mostly with in

2years following infection The commonest age is 1-4 years.

Ethambutol should not be given to children below 6years of age

Childhood tuberculosis

drugs dosage

Isoniazide 10-15mg/kg

Rifampicin 10mg/kg

Pyrazinamide 35mg/kg

Streptomycin 15mg/kg

Ethambutol 30mg/kg

For infants if the mother or any other household member is smear positive then chemoprophylaxis should be given for 3 months then do mantoux test. If test is negetive stop chempprophylaxis and give BCG

(if previously not vaccinated). If test is positive continue chemoprophylaxis for a total duration of 6months

Aim: to reduce morbidity mortality from primary infection.

Vaccine: Danish 1331 strain Types of vaccine: liquid(fresh) vaccine

freeze dried vaccine Dosage: 0.1mg in 0.1ml volume administration: tuberculin syringe

intra dermal

just above the insertion of deltoid

BCG vaccination

Age: either at birth or at 6weeks of age (tuberculosis high prevalent countries)

high risk groups ( low prevalent countries). Phenomena after vaccination:

2-3 wks - develops papule

5 weeks - 4-8mm diameter

develops into shallow ulcer

6-12 weeks - permanent scar Complications: prolonged ulceration

suppurative lymphadenitis

osteomyelitis

disseminated infection

Protective value: 15-20 years

protection offered by BCG varies from 0-80%. Because prior exposure to non tuberculous environmental mycobacteria.

Contra indications: generalized eczema, infective dermatosis, hypogammaglobulinaemia, history of deficient immunity, patients under immuno suppressive treatment.

With INH for 1year or INH + Ethambutol for 9months It is costly exercise , not effective, causes drug induced

hepatitis. Chemoprophylaxis with INH can prevent the

development of tb in infected individuals, but impact on the community will be minimal because it cannot applied on mass scale.

Chemoprophylaxis (preventive treatment)

It is an integral part of any effective tuberculosis programme

By annual infection rates Surveillance of control measures applied such as BCG

vaccination and chemotherapy.

surveillance

The Goal and Objectives of the RNTCP Goal: The goal of RNTCP is to decrease mortality and

morbidity due to TB and cut transmission until TB ceases to be a major public health problem in India.

Objectives:

1) To achieve at least 85% cure rate of the newly diagnosed sputum smear-positive TB patients; and

2) To detect at least 70% of new sputum smear-positive patients after the 1st goal is met.

Strategy: DOTS is a systematic strategy which has five components.

Revised National Tuberculosis Control Programme (RNTCP)

The revised strategy was introduced in the country as a pilot project since 1993 in a phased manner as Pilot Phase I, II, III.

RNTCP has expanded rapidly over the years and now it covers the whole country.

It has now entered into its second phase.

Cont…

National level Deputy Director General, TB

State level (State TB Officer)

District level (District TB Officer)

Sub-district level (Medical Officer-TB Control)

Peripheral health levelMedical Officer

National Institutes

State TB Training and Demonstration Centre

Metropolitan City(City TB Officer)

District TB Centre

Municipal Ward(Chest Clinic)

Tuberculosis Unit

Health Post / Microscopy Centres

Primary Health CentreMicroscopy Centres

Technical Organization of the Tuberculosis Programme in India

At the Center: The Central TB Division (CTD) is responsible for developing technical policies, procuring drugs, preparing training modules, quality assurance, advocacy, operational research priorities and mobilizing funds.

At the State: State Tuberculosis Officer ( STO) is responsible for planning, training, supervising and monitoring the programme in their states as per guidelines.

RNTCP Structure and Service Delivery Mechanisms

At the District: District TB Centre(DTC) is the key organizational unit for implementation of the programme. It’s the nodal point for TB control activities in the district.

In RNTCP, the primary role of DTC has shifted from a clinical one to a managerial one.

District TB Officer (DTO) has overall responsibility of management of RNTCP at district level.

Cont..

Tuberculosis Unit(TU): A major organizational change in RNTCP is the creation of a sub-district level Tuberculosis Unit.

TU consists of a designated Medical Officer-Tuberculosis Control(MO-TC), as well as a Senior Treatment Officer(STS) and a Senior Tuberculosis Laboratory Supervisor(STLS).

TU covers a population of approximately 5lakh or it covers 5 Designated Microscopic Centres(DMC)

Cont..

Maintain the TB Register which contains information on the diagnosis and treatment of every patient

Ensure effective diagnosis by microscopy and directly observed treatment

Complete quarterly reports on diagnosis, sputum conversion, treatment outcome, and programme management

Key Functions of the TU

Programme Surveillance System

Peripheral HealthInstitute (DMC and other PHIs)

Monthly PHI Report

System electronicfrom district level

Tuberculosis Unit Cohort analysis

upwards

AdditionalFeedback

Quarterly CF, SC, RT, PM Reports

District TB Centre QuarterlyElectronic reports) Feedback

Quarterly ReportsCF, SC, RT, PM

State TB CellCentral TB Division

WHO-recommended Stop TB Strategy (2006)to Reach the 2015 MDGs

Goal 6--to combat HIV/AIDS, malaria and other diseases.

Target 8– to have halted by 2015 and begun to reverse the incidence of malaria and other major diseases, including tuberculosis.

Indicators for Target 8 to be used to evaluate the implementation and impact of TB control (derived from STOP TB strategy)

Indicator 23: Between 1990 and 2015, to halve the prevalence and death rates associated with tuberculosis; and

Indicator 24: By 2005, to detect 70% of new smear positive TB cases arising annually, and to successfully treat 85% of these cases.

Millennium Development Goals related to Tuberculosis

The RNTCP PMDT Vision is as follows: By end 2011, basic RNTCP PMDT services will be initially

introduced in all states, with complete geographical coverage by end 2012

By 2013, access to laboratory based quality assured DST and appropriate treatment for at least

all smear-positive re-treatment TB cases at diagnosis, and

all cases who remain smear-positive after first-line drug treatment By 2015, access to MDR-TB diagnosis and treatment for all

smear-positive TB (new and retreatment) cases registered under RNTCP early during their treatment

RNTCP plans to initiate at least 30,000 MDR cases on treatment annually by 2013

Programmatic management of drug resistant TB(PMDT)

GoI commitment at Beijing Ministerial Meeting – 2009

Plan for patients to be tested and treated for MDR-TB

*Based on RNTCP 2012 goal of MDR diagnosis for all S+ retreatment patients,

12th Five Year Plan: RNTCP has developed National Strategic Plan to be implemented during 2012-2017, the national 12th Five Year plan period, with following Vision and objectives for RNTCP:

Vision: "TB-free India“

Goal: Universal Access to quality TB diagnosis & treatment for all pulmonary & extra pulmonary TB patients including drug resistant and HIV associated TB.

12th Five year plan

Objectives: To achieve 90% notification rate for all types of TB cases To achieve 90% success rate for all new and 85% for re-

treatment cases To significantly improve the successful outcomes of

treatment of Drug Resistant TB To achieve decreased morbidity and mortality of HIV

associated TB To improve outcomes of TB care in the private sector

Cont…

Central TB Division(CTD) & National AIDS Control Organization(NACO) have revised the “National framework for joint TB-HIV collaborative activities” in Oct 2009.

All the WHO recommended TB/HIV collaborative activities have been incorporated and include the following:

1) Strengthen NACP-RNTCP coordination mechanisms at national, state and district levels.

2) Joint Monitoring and Evaluation between 2 programmes.

TB/HIV Collaborative Efforts

3) Training of Programme and field staff

4) Scaling up of Intensified TB/HIV Package of services across the country

5) Activities to reduce the burden of TB among HIV-infected individuals

6) Involvement of NGO’s

7) Operational research

Cont..

Falling on March 24th each year, is designed to build public awareness that TB today remains an epidemic in much of the day, causing deaths of several million people each year.

It commemorates the day in 1882 when Dr.Robert Koch astounded the scientific community by announcing that he had discovered the cause of tuberculosis, the TB bacillus.

World TB day

Theme for 2012’s world TB day is

“Stop TB--- in my life time” Some hopes people of different ages and living in

different countries may have for stopping TB in their lifetimes…

Zero deaths from TB

Faster treatment

A quick, cheap, low-tech test

An effective vaccine

A world free of TB

Theme for 2012

WHO's Global TB Report of 2011. Multidrug and extensively drug-resistant TB (M/XDR-TB) -

2010 Global Report on Surveillance and Response. TB India annual report 2012. Park’s text book of Preventive and Social Medicine 21st edition. AFMC Text book of Public Health and Community Medicine. J . Kishore’s National Health Programs of India 10th edition. www.WHO.int National Scale-up Plan for the Programmatic Management of

Drug Resistant Tuberculosis (PMDT)2011 – 2012. http://www.stoptb.org/ Tuberculosis Control Laws and Policies: A Handbook for Public

Health and Legal Practitioners by CDC.

References