Impact of Using Fixed Dose Combinations FDCs versus

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Impact of Using Fixed Dose Combinations (FDCs)
versus Single Dose Combination Among New
Pulmonary Smear Positive Patients in Bangladesh
AuthorDr. Md. Khurshid Alam Hyder, Jr.
Consultant National TB Control
Programme,Directorate General of Health Services
Ministry of Health Family
Welfare,Dhaka, Bangladesh Co-AuthorDr. Moinul
Haque, Coordinator TB LCC NSDP, Dhaka,
Bangladesh
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• Population 132 million (2003)
• Density 981 per-sq-km
• GNP per capita 370 US
• DOTS Geographical Coverage99
• 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

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Year implementation of DOTS started 1993Total
population 132 million (2003)
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Data for 2000-2003Total population 132 million
(2003)Year implementation of DOTS 1993
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DOTS Coverage and Treatment Outcomes2000-2003
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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

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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

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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 FDCs from Global Drug Facility
  ensured

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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
• Received 1st year assignment of 4FDCs and 2FDCs,
  separate Isoniazid, Ethambutol in 2003
• Request sent for 2nd year 4FDCs and 2FDCs which
  is under process

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Global Drug Facility - Bangladesh

• 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

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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

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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

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Treatment Regimens
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Preliminary Results

• Total patients enrolled for the study (Jan-Feb,
  2004) 32
• SDCs 14
• FDCs 18

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Preliminary Results (Cont..)
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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

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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

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Thank You