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Impact of Using Fixed Dose Combinations (FDCs) versus

Impact of Using Fixed Dose Combinations (FDCs) versus Single Dose Combination Among New Pulmonary Smear Positive Patients in Bangladesh. Dr. Md. Khurshid Alam Hyder, Jr. Consultant National TB Control Programme,Directorate General of Health Services

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Impact of Using Fixed Dose Combinations (FDCs) versus

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  1. Impact of Using Fixed Dose Combinations (FDCs) versus Single Dose Combination Among New Pulmonary Smear Positive Patients in Bangladesh Dr. Md. Khurshid Alam Hyder, Jr. Consultant National TB Control Programme,Directorate General of Health Services Ministry of Health & Family Welfare,Dhaka, Bangladesh

  2. 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%

  3. Year implementation of DOTS started: 1993Total population : 132 million (2003)

  4. Data for 2000-2003Total population: 132 million (2003)Year implementation of DOTS: 1993

  5. DOTS Coverage and Treatment Outcomes2000-2003

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. Treatment Regimens

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

  15. Preliminary Results (Cont..)

  16. 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

  17. 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

  18. Thank You

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