Global TB Drug Facility “Securing access to high-quality TB
“by providing a new perspective on drug procurement”
– 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 white list of ‘pre-qualified’ manufacturers of quality TB drugs – A web-based tool for placing orders / tracking shipments – Standardised drug products and user friendly packaging – Ongoing technical support and annual monitoring mission – Support for in-country drug management What does the GDF offer?
• Total raised and committed $31 million for grants • Processed over 80 applications • Committed drugs: 2. 7 million patients – (2. 3 million through grants, 472, 000 through direct procurement) • Approved applications: regular support (58), emergency (15) • Drugs delivered to 52 applicants • Total value of direct procurement orders $6 million • Quality assured - First workable TB White List Performance Indicators
• Cost - GDF drug prices 30% lower than international prices • Average drug cost per patient (inc freight): ~$11 • Procurement - GDF countries running on buffer stock = 0 • Quality - GDF batches recalled in country = 0% • DOTS - average increase of 20% • Standardisation - Blisters outselling bulk and 4 FDC is #1 product so far Impact indicators
DOTS population coverage in selection of GDF monitored countries
Countries approved for regular GDF support Countries approved for emergency GDF support Countries with direct procurement support from GDF Countries with both grant and DP support from GDF Countries under consideration for GDF support GDF Countries
• GDF responsibility is to the port, GDF concern is to the patient • Some countries have substantial problems in maintaining an uninterrupted supply of quality drugs to all patients – Inefficient procurement mechanisms – Inadequate quality control – Inefficient in-country logistics mechanisms – Lack of awareness – Poor compliance Drug Management issues
• At cost drugs for DOTS • For countries which are financially sound but without good procurement or quality assurance systems • Set up in 2003; 11 countries Response #1 Direct procurement
• GDF in partnership with WHO EDM pioneered the WHO prequalification project for manufacturers • Pre-shipment inspection + random samples of all GDF batches tested by an independent PIC/S approved laboratory. • Monitoring looks at post delivery quality control. • For countries which are financially sound and with good procurement mechanisms but Response assurance system. without a robust quality # 2 Pre-qualification
• Country visits for grant countries • Monitoring missions for all countries 6 -8 months after receipt of GDF drugs in country • Missions organised by Stop TB partners Response # 3 Technical assistance
• International meetings • Regional meetings • Guide on introduction of FDC’s published • Guide on TB Drug management published • Presence of drug management experts on GDF missions Response #4 awareness building
• 4 FDCs • Blisters • Patient kits – contributing to efficient procurement – simplifying drug quantification – promoting rational drug use – promoting Directly Observed Treatment (DOTS) – facilitating drug management/logistics Response # 5 product packaging
· Kit contains all drugs needed to cure one middle weight patient in one container · Kits are easily adjustable by Health worker at start of treatment by removing or adding blister sheets · Patient sees the kit and knows the drugs are his and will be there when he arrives for treatment (not stock outs) · Kits will enhance compliance through its high-tech look and feel · When patient transfers to another treatment centre, the kit can easily go with the patient Stop-TB Patient Kits
• Increasing monitoring work/technical assistance & in country drug management – Both for GDF and GFATM • Anti-TB drugs of questionable quality Future drug management
Thank you for your continued support to the GDF!
• What other responses could the GDF adopt ? • How can we galvanise technical assistance for GDF/GFATM in area of drug management ? Q and A session
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