Minilecture

DOTS MANAGEMENT IN TUBERCULOSIS

Zul Dahlan
Subdivision Pulmonology Department of Internal Medicine Medical Faculty of Padjadjaran University Hasan Sadikin Hospital , BANDUNG

Female 40 yrs Cough for >3 months 3 x to GP, only presciption No sputum or CXR She did CXR on her initiative Her sputum AFB pos

INTRODUCTION

Tuberculosis is an infectious disease that remain to be a major health problem in the world including Indonesia. Indonesia like other countries had adapted WHO DOTS strategy for national TB control and had succeed in variety of setting. This presentation will disclose a few aspect in the implementation of DOTS in the management tuberculosis, in pulmonary and extrapulmonary sites.

DIAGNOSIS

SPUTUM EXAMINATION :
. 3 times, Ziehl Neelsen smear

POSITIVE RESULT :

Positive In 2 of 3 AFB smears, or Positive in 1 AFB smear and chest x- ray (+)

MICROSCOPIC EXAMINATION
More objective and reliable than chest x ray

100 90 80 70 60 50 40 30 20 10 0

98% 70%

Agreement of medical Practitioner

AFB Exam

Chest xray

CHEST X-RAY EXAMINATION

Causing over- diagnosis of TB
100 90 80 70 60 50 40 30 20 10 0

OVER DIAGNOSIS

Suspect with positive Chest x-ray

True positive TB case

FACTORS THAT PLAY ROLE IN THE MANAGEMENT OF TB

1. MYCOBACTERIUM: . SPECIES - . VIRULENCE

INTERACTION

2. HOST : . IMMUNITY . ADHERENCE

3. MANAGEMENT & MEDICINE

CURED

ASPECT OF TREATMENT FAILURE IN TUBERCULOSIS

1. ETIOLOGIC DIAGNOSIS :
AFB/ PA/ DNA

- TB MANIFESTATION MICOBACTERIOSIS 2. HOST : - IMMUNITY DEFICIENCY 3. DRUG ASPECT : - RESISTANT MYCOBACTERIUM - ADHERENCE TO THERAPY 4. SOURCE OF INFECTION : - EASIER TRANSPORTATION BETWEEN COUNTRIES

EFFORT TO CONTAIN TUBERCULOSIS :

- IDENTIFY MYCOBACTERIUM RESISTANCY - ADHERENCE TO TB THERAPY DOTS METHOD

TB MANIFESTATION AT HASAN SADIKIN HOSPITAL PULMONARY TB 55 % EXTRAPULMONARY TB 45 %

. Pleura : 16,2 % . Meningeal : 9,9 % . Peritonitis : 8,3% . Spondylitis : 4,0 % . Limphadenitis: 2,2 %
. Pericarditis : 1,0%

Coxitis . Supracondylus . Skin . Sinovitis . Hepar . Renal

.

: : : : : :

1.0 % 0.7 % 0,4 % 0,3 % 0,1 % 0,1 %

1. ETIOLOGY TABLE - GROUP OF MYCOBACTERIUM FOUND IN PATIENT DIAGNOSED TUBERCULOSIS

16,9% MTC 49,3%

MNTB 50,7% 83,1%

SLOW GROWING

Table Frequency Species of Mycobacterium Found in Various Organs

Mycobactrium Species
I.M. NonTuberculosis -MNTB 1. M. gordonae 2. M. alvei 3. M. ratisbonen 4. M. concordense 5. M.mucogenicum 6. M. avium 7. M. fortuitum 8. Uncultured Mycob. 9. M.peregrinum 10. M.septicum 11. M.paratuberculosis Total II. M. Tuberculosis Complex 1. M. africanum 2. M. tuberculosis 3. M. canetti Total 4 3 1 2 1 1 1 1 0 0 0 14

Organ Lung Pleura

3 1 3 1 1 0 1 0 1 1 0 12

Gland Peritoneum Total

3 0 0 0 0 2 0 1 0 0 1 7 1 1 0 0 1 0 0 0 0 0 0 3 11 5 4 3 3 3 2 2 1 1 1 36 (50,7%)

6 4 0 10

4 3 1 8

12 5 0 17

0 0 0 0

22 12 1 35 (49,3%)

2. HOST FACTOR

. GENETIC SENSITIVITY TO TB :
- FAMILIAL SYNDROMES : DISSEMINATION POST BCG - MENDELIAN SENSITIVITY : IMPAIRMENT OF IFN FUNCTION

.
.

INADEQUATE DRUGS DOSAGE

COMPLIANCE

EFFORT TO CONTAIN TUBERCULOSIS :

- IDENTIFY MYCOBACTERIUM RESISTANCY - ADHERENCE TO TB THERAPY > DOTS METHOD

COMPLIANCE
TB Patient frequently did not have their medicine regularly and continuously because of : Limited effort because of false understanding : . Stopping medicine halfway because they are feeling better TB relapse again . Taking the medicine too long . Medicine too much High cost of therapy Drug side effect/ untoward effect

WITH TUBERCULOSIS :
- Treatment is more than treatment - Treatment is prevention of : . further spreading of infection . further process of disease

Direct Observed Treatment Short-Course

DOTS

ACCURATE DIAGNOSIS,ADEQUATE PERIOD FREE ANTI TB DRUGS TAKING DRUGS UNDER SUPERVISING MONITORING AND EVALUATION

POLITICAL COMMITMENT

INCLUDING
FINANCIAL SUPPORT

TAKING COMBINATION DRUGS ON SUFFICIENT DOSAGE, REGULARLY, AND CONTINOUSLY

CURED

BASIC PRINCIPLES OF ANTI TUBERCULOSIS DRUGS

Drug is effective during active multiplication phase of mycobacterium, not in dormant phase Use combination of 4 5 drugs, for 6 mo. or more Use of still effective drug for etiologic mycobacterium

Patient has to take the medicine regularly, continuously in adequate dosage and period

CLASSIFICATION TB :
Related to 4 aspects : - Organ involved in TB process : lung/ extra-lung - result of sputum examination : AFB (+)/ AFB (-) - Previous history of TB therapy : . New/ exacerbation, relapse, migration/ drop out, failure

- Degree of severity of disease: mild or severe

DECISION ON CATEGORY OF THERAPY

IMPLEMENTATION OF TB THERAPY
Aspectaspect :
Decision

on the category of TB therapy

Therapy

supervising :

. Healthcare officer, family, friend, etc Monitoring of sputum ACB, during : - intensive period - the end of therapy/ 1 month before the - follow up of sputum conversion Monitoring of therapy : - cured, drop out, not cure

THE CHOICE OF ANTITUBERCULOSIS DRUG BASED ON CATEGORIES

Alternative of Combined Drug Category Of therapy I Classification and Type of TB Patient TB Intensive phase (daily or 3x / week) Late Phase

New case AFB (+) 2 HRZE* New case AFB (-) 2 HRZE Chest x-ray (+) with advanced lung damage/ severe disease New case of TB 2 HRZE Severe extra pulmonary TB case Patients : relapse failure drop out (after default) New case TB AFB (-) , Chest x-ray (+), mild disease 2 HRZES / 1 HRZE* 2 HRZES / 1 HRZE 2 HRZ* 2 HRZ 2 HRZ

4 HRZE* 4 HR

6 HE 5 H3R3E3* 5 HRE

II

4 H3R3* 6 HE 4 HR

III IV

Mild new ekstrapulmonary case Chronic case

Consultation to specialist for secondary medicine

MULTI DRUG RESISTANCE TB (MDR TB)

DEFINITION OF RESISTANCE

Mono Resistant:
Resistant to 1 drug:: OAT:H/ R/ S/ E

Multi Drug Resistance (MDR) :

Minimally resistant to INH and Rifampisin: H+R/ H+R+S/ H+R+E.

Poly Resistant :
Resistant to a few OAT exept INH & Rifampisin: H+S+E/ S+E/ H+E.

Extensive Drug Resistance (XDR):

MDR resistant also to fluoroquinolon and kanamicin/ amikacin/ capreomicyn: MDR+Cipro+kana/ MDR+cipro+ami.

Causes of Drug resistant TB

Due to physician inappropriate drug, dosage and duration Due to patient compliance, malabsorption, financial, Due to drug substandard formulation, poor bioavailability Due to health care non availability source was MDR TB

Treatment of Poli/ MDR : More difficult, costly, and more side effect Individualized : - tailor made
- Package

MANAGEMENT OF MDR
DOTS Plus Strategy Base on : Anamnesis. Diagnosis berdasarkan laboratorium. Pengobatan berdasarkan laboratorium. Evaluasi pengobatan berdasarkan laboratorium. Evaluasi efek samping, faal hati, faal ginjal, dll berdasarkan laboratorium. Lama pengobatan min. 18 bln, dg tahap intensif 6 bln paduan mengandung OAT suntik.

Indonesia :
22 High Burden Countries
1. 2. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. India China Bangladesh Nigeria Pakistan South Africa Philippines Russia Ethiopia Kenya DR Congo Viet Nam UR Tanzania Brazil Thailand Zimbabwe Cambodia Myanmar Uganda Afghanistan Mozambique

3. Indonesia

Indonesia 10%
Bangladesh 4% Pakistan 4% Philippines 3% Nigeria 3% South Africa 2% Russia 1%

China 15%

India 30%

Other 28%

Penyebab kematian terbanyak penyakit infeksi (SKRT 1995) 583.000 kasus baru/tahun, 140.000 kematian /tahun (WHO)

BACKGROUND OF TB PROBLEM IN DEVELOPING COUNTRIES

* HIGH MORBIDITY AND MORTALITY RATE -Annually there are 1 millions new TB patients - And TB is responsible for an annual 3 millions death

- 97 % patients located in developing c tries 25% can be avoided - In Indonesia : TB is third major cause of mortality ( SKRT 95)
MANAGEMENT OF TB IS BASED ON : -Species of causal mycobacterium - Infected organs - Advanced and progression of diseases THE STRATEGY IS TO MORBIDITY & MORTALITY

Estimated Annual Incidence of TB in Selected High Burden Countries, 2000

World Health Organization

Country 1. India 2. China 3. Indonesia

Population Cases (thousands (thousands ) ) 1,008,937 1,856 1,275,133 1,365

Rate x105 184 107

212,092
75,653 141,256

595
249 247

280
330 175

7. Philippines
8. Pakistan 10. Russia 13. Viet Nam

145,491
78,137

193
148 70

132
189 321

22. Afghanistan 21,765

Background

Indonesian situation : - population : 222,781,000 - global rank : 3 - incidence : 239 (239/100,000/year) - incidence of new cases : 108 (108/100,000/year) - prevalence : 262 (262/100,000/year) - mortality : 41 (41/100,000/year) - co-infection TB/HIV : 0,8% - MDR-TB : 1,6%

The Global Plan

The Regional Plan Country Plans

A pessimist sees the difficulty in every opportunity:

an optimist sees the opportunity in every difficulty.

Sir Winston Churchill

Global Strategy to Stop TB 20062015

1. Pursuing quality DOTS expansion and enhancement
Government commitment with long-term planning and adequate resources to reach targets Case detection : bacteriology and strengthening of laboratory network Standardised treatment, under proper case management conditions including DOT and patient support Effective and regular drug supply system Monitoring system for supervision and evaluation, including impact measurement 2. Additional components

1 2. 3.

Addressing TB/HIV and MDR-TB Contributing to health system strengthening Engaging all care providers

4. 5.

Empowering patients and communities Enabling and promoting research

Stop TB Department

The new Stop TB Strategy and the Regional Strategic Plan, 2006-2015

Sustaining and enhancing DOTS to reach all TB patients, improve case detection and treatment success Establishing interventions to address TB/HIV and MDR-TB Forging partnerships, including with communities, to ensure equitable access to international standards of TB care for all Contributing to strengthening health systems

DOTS Success Story

DOTS the internationally recommended control strategy was launched in 1994 The DOTS framework has subsequently been expanded and implemented in 182 countries. DOTS implementation has helped countries to improve national TB control programmes (NTPs) and make major progress in TB control By 2004, more than 20 million patients had been treated in DOTS programmes worldwide and more than 16 million of them had been cured.

HEALTH CENTER INVOLVED IN DOTS < 60 % 60 - 80 % 81 - 100 %

Hospital distribution
(absolute numbers)

Coverage of DOTS Services in National TB Program

GPs etc ?? Source of Thy failure, MDR-TB, TB-HIV, XDR
HOSPITAL, LUNG CLINICS (N 1316)

PUSKESMAS (N 7489)

98.5%

37%

The practices of TB care among doctors in private sector

Over diagnosis and under diagnosis Over treatment and under treatment Chest X-ray regarded as the most important diagnostic tool Sputum smear is mostly neglected Non standard tests gaining popularity (serology, PCR etc) Incorrect use of anti TB drugs (regimen, doses, duration, compliance)

Eur Respir J 2006; 28: 687690

Lead to substandard care and failure

Involvement of All Health Personnel & health centers

Extension of DOTS Service in Hospital through Hospital DOTS Extension of PPM (Public Private Mix) (DPS, Jail, Army/ Police Dept.) Extended of working cooperation with LSM with Health Service DOTS in Work Place Extension of working cooperation with Medical Proffesion to facilitate DOTS ISTC & PCTC (Patients charter for TB Care)

ISTC: Key Points

Audience: all health care practitioners, public and private Scope: diagnosis, treatment, and public health responsibilities; intended to complement local and national guidelines Rationale: sound tuberculosis control requires the effective engagement of all providers in providing high quality care and in collaborating with TB control programs
ISTC TB Training Modules 2009

ISTC Objectives

The Standards are intended that all care provider delivered high quality care: for patients of all ages, those with sputum smear (+), sputum smear (-), and extra pulmonary TB TB caused by drug-resistant M tuberculosis complex TB + HIV

ISTC: Key Points (Edition 1)

17 Standards Differ from existing guidelines: standards present what should be done, whereas, guidelines describe how the action is to be accomplished Evidence-based, living document Developed in tandem with Patients Charter for Tuberculosis Care Handbook for Using the International Standards for Tuberculosis Care
ISTC TB Training Modules 2009

ISTC: Key Points (Edit. 2- 2009)

21 Standards Original Standards were renumbered and new Standards were written Evidence-based, living document, will require future revisions as well ISTC Tuberculosis Training Modules and Facilitators Guide were updated and developed to be in agreement with Edition 2 of the ISTC
ISTC TB Training Modules 2009

ISTC Standard 1
All persons with otherwise unexplained productive cough lasting two-three weeks or more should be evaluated for tuberculosis
ISTC TB Training Modules 2009

The Indonesian Version of ISTC

ISTC in Indonesia
Indonesian Standard for Tuberculosis Control

Is accepted and being endorsed by several profession organization In socialization phase Has been disseminated and implemented in Jakarta, West Java, East Java, and Central Java as pilot project

Goals
Equitable quality DOTS for all
- To standardize the care of TB patients in variety of different providers - To provide high quality of care - Improve CDR, cure rate - Prevention of MDR - Reduce mortality - Cover co-infection TB/HIV The first priority is to endorse and implement ISTC among private physicians and hospitals

RESPIROLOGY TEAM
WORKING TEAM ON PULMONARY & EXTRAPULMONARY TB ERADICATION PROGRAM

TRAINING

DOKTER/PERAWAT/

PARAMEDIS

PULMONARY & EXTRAPULMONARY TUBERCULOSIS CENTRAL CLINIC

DOTS PROGRAM AT HASAN SADIKIN HOSPITAL BANDUNG TB PATIENTS

OTHER CLINICS

PAEDIC CLINIC CLINIC

NEURO ORTHO

INTERNAL MEDICINE CLINIC

PEDIATRIC CLINIC

TBE (+)
THERAPY (+)

TBP +/- TBE

TBP +/- TBE

THERAPY

THERAPY

DOTS CORNER

MEDICAL PRACTITIONER

SOCIAL WORKER

FARMACYOFFICER

LABORATORY OFFICER

DATA COLLECTING REPORTING OFFICER

Conclusion 1
1.

TUBERCULOSIS REMAINS TO BE A MAJOR HEALTH PROBLEM IN INDONESIA WITH A HIGH MORBIDITY AND MORTALITY RATE . STRATEGY OF DOTS HAS BEEN PROVEN TO BE AN EFFECTIVE METHOD TO ERADICATE UBERCULOSIS. IT MUST BE DONE NATIONALLY AND SUPPORTED BY WHOLE COMMUNITY WITH ADEQUATE PERSONNEL, MEDICINE, AND FINANCIAL. RESISTANT MYCOBACTERIUM TUBERCULOSIS AND OTHER SPECIES MAY HAMPER THE ERADICATION OF TUBERCULOSIS AND MYCOBACTERIOSIS.

2.

3.

ON THIS CIRCUMSTANCES CONFIRMATION OF ETIOLOGIC AGENT MUST BE DONE WHICH WILL BE HELPFUL IN TREATING THE RESISTANT SPECIES.

Conclusion 2

The result of Indonesian National TB Program was encouraging However, Puskesmas gave the biggest contribution to successful outcome The problems lie on Hospitals and Private providers The Implementation of ISTC expected to be complimentary to existing DOTS program

DOTS
TB Epidemic
HIV Epidemic

Working groups of the Stop TB Partnership

1. DOTS Expansion 2. DOTS-Plus 3. TB/HIV 4. Drugs 5. Diagnostics 6. Vaccines

GP2

Analysis of costs and benefits

7. Advocacy, Communication & Social Mobilization

Stop TB Department

WIPE OUT MYCOBACTERIUM

.. THE VICIOUS ENEMY

THANK YOU