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Global Drug Facility

Global Drug Facility

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Global Drug Facility

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  1. Global Drug Facility Monitoring Need & use of information

  2. What does the GDF offer? • Now • Grants of first line drugs, to support DOTS expansion For countries who are donor dependent for some or all of their drug supply to expand their DOTS programmes • Direct Procurement mechanism for countries and NGOs, to buy drugs for use in DOTS programmes For countries who are financially sound but without good procurement or quality assurance systems • White-list of ‘pre-qualified’ manufacturers of quality TB drugs For countries which are financially sound and with good procurement mechanisms but without a robust quality assurance system. • Support for in-country drug management • Future - Diagnostics

  3. Application Eligibility criteria Specific conditions Standard form Supporting documents Monitoring Quarterly reports Existing monitoring Independent verification Results based Review Independent Committee 12-15 members meets 3x/year Country visit Supply Pooled procurement Standard products High quality Low cost Grant service

  4. Review by TRC Review by TRC Review by TRC GrantAgreement GrantAgreement MonitoringMission MonitoringMission MonitoringMission QuarterlyReport QuarterlyReport QuarterlyReport QuarterlyReport QuarterlyReport QuarterlyReport QuarterlyReport QuarterlyReport QuarterlyReport QuarterlyReport QuarterlyReport QuarterlyReport AnnualDOTSReport AnnualDOTSReport AnnualDOTSReport FirstDelivery SecondDelivery ThirdDelivery CountryApplies to GDF Review by TRC Country visit Grant Agreement Desk Audit Desk Audit Desk Audit Year 1 Year 2 Year 3 Assessment GDF Monitoring Timeline

  5. Monitoring tools and quality assurance • Standardized application, TRC assessment forms • Standardized Country visit & Monitoring checklist • Specific to individual grant year • Standardized Drug Calculation spreadsheet • Desk audit (MSH, GLRA, STI) • Independent • Ensures Completeness, Consistency and Credibility • Standardized Desk Audit reporting format

  6. Countries approved for emergency grant support from GDF Countries with direct procurement (DP) support from GDF Countries with both grant and DP support from GDF Map of GDF Countries Countries approved for regular grant support from GDF Countries under consideration for GDF grant support Map as of 01 June 2005 The boundaries shown on this map do not imply official endorsement or acceptance by the United Nations.

  7. DOTS population coverage in selection of GDF monitored countries by end 2004 DOTS population coverage in selection of GDF monitored countries by end 2004

  8. GDF Monitoring: Collection and use of information for action • Approval for continuation of grant • Technical support through provision of recommendations and mobilization of partners • Reporting: Donor reporting: Including progress on impact and performance indicators • Advocacy • Problem identification • Strategic planning and forecasting

  9. Drug Management survey Drug Management in GDF Grant Recipient Countries Key Findings and Implications

  10. Survey Purpose • To identify measurable GDF contributions to drug management in grant recipient countries • To identify bottlenecks within the GDF drug supply processes • To evaluate GDF monitoring processes • To enhance understanding about drug management issues, thereby enabling the GDF to maximize delivery of technical support for DM & monitoring processes

  11. The GDF played important role in catalyzing and facilitating improvements in multiple areas of the drug supply process, by providing comprehensive, operational recommendations to country and mobilizing partners for financial and technical assistance GDF recommendations target the full spectrum of the drug management cycle, with an emphasis on distribution and management support

  12. Countries have taken steps to improve DM in accordance with GDF recommendations, following the commencement of the grant service cycle. GDF Recommendations for DM can be operational

  13. Reports indicate systemic bottlenecks in the drug supply process that have compromised GDF drug availability, drug quality, and, possibly, rational drug use

  14. Drug availability: of all 1st and 2nd round countries, 70% experienced a stock out in MOH national stores of at least one TB drug within the first two years of receiving the GDF grant Suggests the number of countries reporting stock-outs or critically low levels of stock has increased since GDF support began

  15. Summary of Findings • While GDF has contributed in measurable ways to the improvement of drug management, key and persistent bottlenecks in the drug supply remain. • These bottlenecks, particularly, problems in inventory control, drug ordering, and central monitoring, have compromised drug availability, quality, and rational drug use. • GDF is limited in its capacity to address these bottlenecks, and thereby maximize its mandate, owing to gaps in the monitoring process and delivery of technical support.

  16. Strategic targets of the GDF for 2005-2010 Use of data for strategic planning

  17. Objectives • Estimation of demand for the TB drugs • Forecast of the supply of fund for drugs • Strategic directions for the GDF • Strategic target by different focus

  18. TB incidence is expected to decrease gradually Estimation of the global TB incidence (All patients in millions) • Assumptions • Incidence will decrease except for the African countries with high-HIV burden and Western-pacific • It will decrease 1.3% every year on average Possible range* *Range of 2 standard deviations Source: Estimation by TME, WHO

  19. DOTS expansion has been driven by geographical expansion Trend in the global DOTS expansion (%) DOTS coverage Geographic expansion has increased rapidly in the last 5 years Case detention in the covered area has been stagnating around 50% Case detection in the DOTS area* Total DDR * DDR/DOTS coverage Source: World health report 2004

  20. DOTS expansion is likely to continue over the next 5 years Trend in the DOTS expansion (%) Actual Estimated Assumptions -Coverage rate 95% in 2006 and saturates after that -Case finding in the area increases by 2-2.5% per year (based on the trend '95-'02) DOTS coverage Case detection in the area DDR 64-67% in 2010 Total DDR Source: World health report 2004

  21. More drugs will be needed as a result of DOTS expansion Estimation of the global TB incidence and DOTS detection (Middle range, million patients) Incidence 70% of incidence 4-6 million patients need drugs in 2010 DOTS detection

  22. GDF has been covering 20-40% of the global demand (DOTS areas) Actual (Grant+DP) Patients treated with GDF grants/DP (Million patients) Expected* Although DOTS program has not been expanded as expected, GDF grant/ DP has been constantly covering 20-40% of the global demand Total patients detected in the DOTS Treated with GDF service Coverage (%) 25 21 40 33 41 35 (5 year average) * Average of aggressive and modest cases for GDF number Source: GDF data, Global TB report, GDF prospectus

  23. Many GDF countries are receiving grants from the GFATM Funding source of TB drugs (number of countries) Funds for drug 34 countries receive support both from the GFATM and the GDF, out of which 19 countries are receiving drug funds from the GFATM We may consider "phase-out" from them if our "gain" is secured GFATM fund for drugs* Eligible GDF grants No GDF and No GFATM GFATM +GDF GFATM only *Excluding countries requesting only 2nd line drugs Source: WHO report 2004, the GFATM applications

  24. There are several strategic options in the future Strategic options Common directions Focus Description • Aggressively expand GDF-grant countries • Focusing on acquiring new grant countries, including NGOs, private practice groups, or local authorities • Continuing current grant even after 3rd year, unless the gain is secured -GDF will approve new grants if the condition is met -GDF will not phase out without securing gains -Our target for the DP service is non-GDF, GFATM countries New Grant • Put priority on the efficient use of our grant service by phasing out from grant countries • Trying to encourage our grant-countries to use DP Grant to DP • Focusing our efforts on DP services • Marketing our services mainly to non-GDF, the GFATM countries New DP

  25. Each option requires different pros/cons Strategic focus Pros Cons Necessary actions Focus Maximize GDF's influence The most expensive Raising more funds Finding and forming partnerships with NGOs, private practices and local authorities New grant Maximize efficiency of GDF grant and least costly Least total patient coverage Educate governments/ CCMs about the importance of quality drugs and encourage them to use our DP services Grant to DP Difficult to implement, as each country has to have their own funding source and there is no requirement for the countries to use DP Less costly with high patient coverage Developing a tailored marketing plan for each DP high-priority countries New DP

  26. The GDF service is expected to achieve original target in 2007-8 Treated patients through the GDF (Grant-focus, cumulative, million patients) Min case Original target in 2005 (10M) Treated patients (million) Grant DP 0.7 - 0.7 0.8 - 0.8 1.4 - 1.4 0.8 0.5 1.3 0.7-1.1 0.4-0.7 1.1-1.8 0.8-1.4 0.9-1.1 1.7-2.5 1.0-1.7 1.4-1.5 2.4-3.2 1.0-1.8 1.3-1.5 2.3-3.3 1.0-1.9 1.3-1.5 2.3-3.4 0.9-2.0 1.3-1.6 2.2-3.6 Total Source: GDF data and discussion

  27. The GDF service is expected to achieve original target in 2007-8 Treated patients through the GDF (Grant to DP, cumulative, million patients) Min case Original target in 2005 (10M) Treated patients (million) Grant DP 0.7 - 0.7 0.8 - 0.8 1.4 - 1.4 0.8 0.5 1.3 0.7-1.1 0.4-0.7 1.1-1.8 0.8-1.4 0.9-1.1 1.7-2.5 1.0-1.7 1.4-1.5 2.4-3.2 0.8-1.3 1.6-2.0 2.4-3.3 0.5-0.9 1.8-2.5 2.3-3.4 0.3-0.5 2.0-3.0 2.3-3.5 Total Source: GDF data and discussion

  28. The GDF service is expected to achieve original target in 2007-8 Treated patients through the GDF (DP-focus, cumulative, million patients) Min case Original target in 2005 (10M) Treated patients (million) Grant DP 0.7 - 0.7 0.8 - 0.8 1.4 - 1.4 0.8 0.5 1.3 0.7-1.1 0.4-0.7 1.1-1.8 0.8-1.4 0.9-1.1 1.7-2.5 1.0-1.7 1.4-1.5 2.4-3.2 1.0-1.8 1.4-1.8 2.4-3.6 0.9-1.8 1.5-2.0 2.4-3.8 0.9-1.8 1.5-2.4 2.4-4.2 Total Source: GDF data and discussion

  29. Strategic planning: Key points • Incidence is expected to decrease gradually over the next 5 years, because of increased treatment success. • Increase of DOTS detection rate will be slower after the most countries achieve 100% geographic coverage. Still, DDR is expected to reach approximately 65% in 2010 • As a result of DOTS expansion, demand for the drug in the DOTS program will increase from 3 million in 2002 to 4-6 million patients in 2010 • GDF could have 3 different strategic focus; grant, transition, and DP. Each option has its pros/cons. • Regardless of its strategy, GDF is expected to achieve its original target (10M) in 2007-8