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ANALISIS SITUASI MDR TB
DI INDONESIA
NTP INDONESIA
I Wayan Diantika
INTRODUCTION (1)
Mono resistance
MDR
Poly resistance
X-DR
INTRODUCTION (2)
Magnitude of the MDR-TB Problem
WHO/IUATLD Global Projection Drug Resistance
Surveillance, which surveyed fifty-eight different
countries between 1996 and 1999, revealed the
presence of new “hot spots” for MDR-TB in
addition to those reported in the first phase of the
WHO/IUATLD Global Project on Drug Resistance
Surveillance.
MDR-TB was shown to range from 0% to 14.1% among
new TB cases. Another review (1999) compiled by
Harvard Medical School has shown that drug-
resistant TB exists in 104 countries in recent years.
Development of Drug Resistance
from the perspective of the
patient:
• The presence of drug resistant strains
results from simple Darwinian
pressures, brought out by the presence
of antibiotics
• Multiple drug resistant strains result
from the step-wise accumulation of
individual resistance elements
therefore MDR-TB is MAN-MADE
History Elements that place a patient at-risk for
MDR-TB or drug resistance
1. Previous TB treatment with multiple drugs
2. Failed TB Treatment that is documented
3. A known chronic TB case
4. Default from previous TB treatment or erratic use of TB drugs
5. Exposure to a known MDR case
6. Use of TB drugs of poor or unknown quality
7. Prior use of an inadequate regimen
8. Conditions associated with drug malabsorption or severe diarrhea
Problem analysis MDR in
Indonesia
• Only ± 30% of hospitals & < 5% of private
providers are currently involved in DOTS
• No data on TB drug resistance, except for few
small studies (West Java MDR: ± 5% !!!).
• Some second line drugs are free available on
the market and currently used in first line
regimens!
• Under detection of re-treatment cases (Cat2)
Neglect to take treatment history causes ‘’miss-
classification and ’’under-treatment’’..
CASE NOTIFICATION_IND
310000
279695
254601
260000 EP-TB
214658
210000
4809 NEW AFB (-)
4446
160000
4429
RETREATMENT
110000
60000
NEW AFB (+)
10000
2004 2005 2006
CASE NOTIFICATION_IND
310000
EP-TB
260000
210000 4809 NEW AFB (-)
160000
110000
4429
4446
CASE NOTIFICATION_IND
RETREATMENT
60000 NEW AFB (+)
10000
310000
2004 2005 2006
260000 EP-TB
210000
4809 NEW AFB (-)
4446
160000
4429
RETREATMENT
110000
60000
NEW AFB (+)
10000
2004 2005 2006
CASE NOTIFICATION_IND
310000
EP-TB
260000
210000 4809 NEW AFB (-)
4446
160000 4429
RETREATMENT
110000
60000 NEW AFB (+)
10000 TREATMENT OUT COME OF NEW AFB (+)
2004 2005 2006
100% TRANSFERRED
OUT
80% DEFAULT
60% FAILURE
DIED
40%
COMPLETED
20%
CURED
0%
2004 2005
CASE NOTIFICATION_IND
310000
EP-TB
260000
210000 4809 NEW AFB (-)
4446
160000 4429
RETREATMENT
110000
60000 NEW AFB (+)
10000
2004 2005 2006 TREATMENT OUTCOME FOR
RETREATMENT CASES
100%
TRANSFERRED OUT
80% DEFAULT
60% FAILURED
DIED
40%
COMPLETED TR
20%
CURED
0%
2004 2005
TREATMENT OUTCOME FOR
RETREATMENT CASES
4500
180
139
294
4000 143
319
TRANSFERRED OUT
187
DEFAULT
3500
FAILURED
DIED
3000
COMPLETED TR
2500 CURED
2000
2004 2005
Risk factors for increase
of MDR in Indonesia (1)
Therapeutic ‘’chaos’’ : prescription of
inadequate doses / combinations of drugs
unsupervised treatment, no monitoring
no registration, no reporting
high costs to the patients (fees)
inadequate drug supplies and distribution
Risk factors for increased
MDR in Indonesia (2)
• Many TB patients are treated by private providers
(not following DOTS).
• Un-controlled use of second-line drugs in hospitals
and private sector (quinolones, kanamycin etc)
• Poor treatment performance in most hospitals:
- low conversion rate
- low cure rate
because many patients drop-out from treatment.
Risk factors for increased
MDR in Indonesia (3) :
• Currently the chronic TB cases cannot
be treated (no DOTS plus available)
These chronic cases continue to
transmit drug resistant TB
• TB- HIV is looming…
Reason MDR-TB as an Alarm
Multi-Drug Resistant TB prevalence*
6 5.5 %
5
4
3
2 1.6 %
1
0
With good TB With Poor TB
Control Control
*The WHO/IUATLD Global Project on Anti-TB Drug Resistance Surveillance
(1994-1997). Countries with good TB control = >33% DOTS coverage.
Conversion Results New Smear Positives,
East Java, 2004 cohort
100%
90%
80%
70%
DO
60%
Not examined
50%
Still Positive
40%
Conversion
30%
20%
10%
0%
Puskesmas Hospitals/BP4
Treatment Results E.Java, Hospitals 2004
cohort
100%
80% Transfer
DO
60% Failure
40% Died
completed
20% Cured
0%
All Hospital/BP4
Treatment Results Smear Negatives East Java,
2003 Cohort
100%
90%
80%
70% Transfer out
60% DO
50% Failure
40% Died
30% Completed
20%
10%
0%
Puskesmas Hospital/BP4
The basis of anti-TB therapy and MDR-TB:
HDL -- a comprehensive approach and
unified system of care
Drugs
Smear/Culture
Case management
DST & QC
Surgery
Government Health
Services
Private Physicians
and Hospitals
THE NEW MDR-TB Guidelines
• a flexible framework approach combining both
clinical and programmatic aspects of DOTS Plus
• based on essential programme conditions
• But encouraging programs to tailor their case-
finding and treatment strategies to the local
epidemiological and programme situation
• Reflect GLC expert consensus and evidence and
experience from GLC projects thus far
OBJECTIVES of DRS
in Central Java
• To determine levels and pattern of resistance to
first-line anti-TB drugs among new sputum
smear positive cases and among previously
treated TB cases in Central Java province
• To develop a survey model for routine
surveillance of TB drug resistance in the country
EXPECTED OUTCOMES of DRS
• Level and pattern of resistance to first-line
anti-TB drugs among new sputum smear
positive cases and among previously
treated TB cases in Central Java.
• The outcome of treatment of patients with
different resistance patterns.
• A model protocol for surveillance of drug
resistance in Indonesia
DOTS-Plus
A comprehensive strategy of the WHO Stop
TB Partnership, developed by the DOTS-Plus
Working Group, for the diagnosis and
management of MDR-TB and other forms of
drug resistant TB
THE DOTS-Plus Framework
1. Sustained Political commitment
2.Diagnosis of MDR-TB through quality-assured
culture and drug susceptibility testing (DST).
3. Appropriate treatment strategies that utilize
second line drugs under proper management
conditions.
4. Uninterrupted supply of quality assured
second-line anti-tuberculosis drugs.
5. Recording and reporting system designed for
DOTS-Plus programs.
Mainstreaming DOTS-Plus into DOTS
• Referral from DOTS-programme:
failures, chronics
• Same (reference) laboratory
• Same treatment delivery system
• Drug-procurement and R&R: adapted
but integrated!
Preliminary results of DOTS-Plus projects
• In Estonia and Latvia a large proportion of cases
enrolled on MDR-TB treatment are new while in Peru,
Philippines and Tomsk the majority are chronic
• Treatment success rates range from 61-82%
• Only 2% of patients have stopped treatment due to
adverse events
• Future plans: Case-based data is being collected from
these pilot sites to serve as evidence for MDR-TB
policy development
Supranational Laboratory Network 2005
Coordinating Centre
SRL
Under evaluation
3 New SRLs, 2 new candidates and 120 countries/settings linked to SRLN
Global Project coverage 2005
Baseline achieved
Ongoing/Finalizing
Planned
Parameters to consider when designing a
DOTS-Plus strategy
Government and NTP commitment
Well performing basic DOTS
Program is able to implement the 5 components of
DOTS-Plus
Rational case-finding strategy using quality assured
smear, culture and DST ( concordance with a SRL)
Representative DRS data for rational country/area-
specific treatment design and planning of
procurement
Reliable DOT throughout treatment
Free effective side-effect management
Regular supply of ALL drugs involved!
Assessment national level (1)
Strengths
• Impressive progress of NTP in recent years
(expansion, quality and innovations)
• Strong internationally recognized NTP
leadership; focal point for DOTS Plus/lab
• Establishment hospital/NTP linkages
• Increasing collaboration with Medical
Associations
• Approval by the GFATM and extensive
international support
• 4 types of SLDs not yet available (no DR)
Assessment national level (2)
Priority issues to address
• EQA laboratory capacity for DRS and
selected pilot sites
• Expansion of DRS (for Cat 2 and 4)
• Technical DOTS-Plus development
• Protection of crucial second-line drugs
(Kanamycine and Quinolones)
• SLD procurement
• HRD plan in the field of DOTS Plus
Assessment of sites: Issues that
need to be addressed in all sites
• Lack of EQA assured lab capacity
• Inadequate use of available second line
drugs (inadequate regimens, financial
barriers, no SL-DST)
• No experience with 4 types of SLD
• Alternative for family member DOT
• Funding of hospitalization, lab tests,
human resources, incentives.
Next steps
• To do an assessment on MDR situation in
Indonesia,
• assist in identifying potential pilot sites for
implementation of DOTS plus
• provide the necessary technical assistance to
the NTP to starting the project
• To draft a plan for the management of MDR-
TB cases including the possible application to
Green Light Committee
Why should Indonesia consider to
use the GLC mechanism ?
• Access to a complex market of quality
assured second line drugs
• Preferential prices (pooled procurement)
• Technical assistance ; benefiting from
GLC experiences worldwide
• Requirement of the GFATM grant /
International quality label (donors)
Expected output from the
assessment
• Assessment report with recommendations
to the NTP (next steps) concerning
implementation of DOTS plus and
requirements for GLC application.
• Draft work plan for implementation of
DOTS plus
35
DOTS-Plus scale up of through the GLC
40
35 September 2005 – 35 projects
Number of projects
30
25
20
15
10
5
0
2000 2001 2002 2003 2004 2005
Abkhazia
Azerbaijan
Bolivia
GLC approved DOTS-Plus projects Costa Rica
Dominican
Republic
Egypt
El Salvador
Estonia
Georgia
Haiti
Honduras
India
Jordan
Kenya
Kyrgyzstan
Latvia
Lebanon
Malawi
Mexico
Moldova
Nepal
Nicaragua
Peru
Philippines
Romania
Russia
Syria
Tunisia
Uzbekistan
GLC-approved DOTS-Plus projects
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