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Impact of Using Fixed Dose Combinations (FDCs)
versus
Single Dose Combination Among New Pulmonary
Smear Positive Patients in Bangladesh
Author:Dr. Md. Khurshid Alam Hyder, Jr. Consultant
National TB Control Programme,Directorate General of Health Services
Ministry of Health & Family Welfare,Dhaka, Bangladesh
Co-Author:Dr. Moinul Haque, Coordinator TB & LCC
NSDP, Dhaka, Bangladesh
• Population: 132 million (2003)
• Density: 981 per-sq-km
• GNP per capita: 370 US $
• DOTS Geographical Coverage:99 %
• Estimated sm +ve TB incidence
105/100,000 popul. (2002)
• No. of sputum microscopy centre
functioning 559
• TB case detection Rates: (2003) 38%
(ranging from 10% to 80%)
• Over 52,000 smear positive cases
detected in 2003 compared to base line
smear positive cases of
38,500 in 2000
• Treatment success rate : 84%
Year implementation of DOTS started: 1993
Total population : 132 million (2003)
Estimated population
2000
2001
2002
2003
DOTS coverage
(Geographical)
95%
95%
98%
99%
Estimated all new cases
290,000 302,000
307,000 310,000
Total cases notified
73,977
81,833
Estimated new smear
positive cases
130,000 136,000
138,000 140,000
New Smear positive cases
notified
38,484
(29.9%)
40,771
(31.4%)
46,771
(33.8%)
52,500
(38%)
New Smear positive cases
treated successfully under
DOTS
83%
84%
84%
84%
(upto
3rd
quarter
2002)
74,252
86,000
Data for 2000-2003
Total population: 132 million (2003)
Year implementation of DOTS: 1993
350,000
302,000
300,000
307,000
310,000
290,000
Estimated new cases of
TB
Total new cases notified
250,000
Estimated new smear
positive cases
200,000
Smear positive cases
notified
150,000
130,000
100,000
73,977
50,000
38,484
136,000
74,252
40,771
138,000
140,000
81,833
86,000
46,771
52,500
0
2000
2001
2002
2003
DOTS Coverage and Treatment Outcomes
2000-2003
105%
100%
98%
95%
99%
95%
95%
DOTS coverage
90%
New Smear positive cases
treated successfully under
DOTS
85%
84%
83%
84%
80%
75%
2000
2001
2002
2003
Background on the involvement of NGOs
 The NGOs under the banner of Leprosy
Coordination Committee were working for
leprosy control since 1972. The Damien
Foundation has been treating TB cases since
1991
 BRAC has been working for TB control in a
limited area since 1984
 Bangladesh introduced DOTS in 1993,
however the formal collaboration with NGOs
was 1st initiated in 1994 through two separate
MOUs
 MOUs have been signed between NSDP,
UPHCP and Public-Private Pilot Project for
Urban TB Programme
Principles of Collaboration
 Mutual respect and trust
 Commitment to follow NTP
guidelines
 Pulling of resources to maximize
the use of expertise of partners to
make the programme cost effective
 Periodic review of programme
performance
NTPs initiatives to involve other
stake holder
 National TB Control Programme has
recently revised the national guidelines
 Introduced Fixed Dosed Combination
from 1st quarter 2004
 Availability of FDC’s from Global Drug
Facility ensured
Global Drug Facility - Services
 Grants of first line drugs, to
support DOTS expansion
 A direct procurement mechanism
for countries and NGOs, to buy
drugs for use in DOTS
programmes
 A web-based tool for placing
orders and tracking shipments
 A white list of ‘pre-qualified’
manufacturers of quality TB drugs
Global Drug Facility - Bangladesh
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Applied - March 02
Approved for 3 years
1st year (55,700 patients; $700,000)
Received 1st year assignment of 4FDCs and
2FDCs, separate Isoniazid, Ethambutol in
2003
Technical assistance - GDF country visit (May
02), GDF monitoring visit (Sept 03)
2nd year request (97,000 patients; $1.2
million)
Request for 2nd year is for 4FDCs and 2FDCs
which is under process
Bought additional drugs through GDF Direct
Procurement mechanism in 2003
Background Information of the Study
 NTP Bangladesh recently introduced FDCs in
treatment regimen to rationalize the use of fewer
tablets compared to a larger number of tablets in a
single drug combination to increase compliance
 The objectives of the study are to assess the impact
of FDCs on efficacy, sputum conversion and side
effects among new pulmonary smear positive
patients compared to those on single drug
combinations under DOT
 Prospective study with comparison series
 Two Public Urban Chest Disease Clinics, and
Centers of NSDP at Dhaka were selected
Methodology
Two phases of intervention
 BCC among service providers at the
study centers during last two quarters of
2003
 Development of questionnaire for
collection of information
 Implementation among two groups of
new pulmonary smear positive patients –
FDCs and Single Drug Combination
started from first quarter of 2004
Treatment Regimens
SDC regimen
Intensive phase
Drug
Isoniazid 300 mg
Rifampicin 450 mg
Pyrazinamide 500 mg
Ethambutol 400 mg
FDC regimen
Intensive phase
No. of tablets
per day
1
1
3
3
3 tablets per day
Isoniazid 75 mg
Rifampicin 150 mg
Pyrazinamide 400 mg
Ethambutol 275 mg
Continuation phase
Continuation phase
3 times per week
Isoniazid 300 mg
Rifampicin 450 mg
3 tab 3 times per
week
Isoniazid 150 mg
Rifampicin 150 mg
2
1
Preliminary Results
Total patients enrolled for the study (Jan-Feb, 2004): 32
SDCs: 14
FDCs: 18
Sex of 32 new smear positive patients by regimen
Regimen
Males
Females
Total
SDCs
9 (64%)
5 (36%)
14 (44%)
FDCs
12 (67%)
6 (33%)
18 (56%)
Total
21 (65.5%)
11 (34.5%)
32
Preliminary Results (Cont..)
Frequency of all complaints during the first
month of intensive phase of treatment by
regimen
Regimen GastroSkin
Joint Pain
intestinal
reaction/
Itching
SDCs
2 (14 %)
-
3 (21 %)
FDCs
2 (11 %)
-
1 (6 %)
Inference
 Too early to comment as
implementation started in 1st qr. 2004,
however, preliminary results shows
that more patients on SDCs have joint
pains as compared to patients on
FDCs
Expected Outcome from the Study
 Efficacy of FDCs in the treatment
regimen of NTP in Bangladesh
 Sputum conversion rates comparison
among new pulmonary smear positive
patients using SDCs and FDCs
 Knowledge of Adverse/Side effect using
SDCs and FDCs
 Provide information to the policy
makers and program management on
use of FDCs in NTP of Bangladesh
Thank You