Securing access to highquality TB drugs

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Global TB Drug Facility

• Securing access to high-quality TB drugs

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by providing a new perspective on drug
procurement
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What does the GDF offer?

• 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

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Performance Indicators

• 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

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Impact 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
  4FDC
• is 1 product so far

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DOTS population coverage in selection of GDF
monitored countries
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GDF Countries
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Drug Management issues

• 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

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Response 1Direct procurement service

• 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

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Response 2Pre-qualification service

• 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 without a
  robust quality assurance system.

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Response 3 Technical assistance

• 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

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Response 4 awareness building

• International meetings
• Regional meetings
• Guide on introduction of FDCs published
• Guide on TB Drug management published
• Presence of drug management experts on GDF
  missions

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Response 5 product packaging

• 4FDCs
• Blisters
• Patient kits
• contributing to efficient procurement
• simplifying drug quantification
• promoting rational drug use
• promoting Directly Observed Treatment (DOTS)
• facilitating drug management/logistics

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Stop-TB Patient Kits

• 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

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Future drug management challenges

• Increasing monitoring work/technical assistance
  in country drug management
• Both for GDF and GFATM
• Anti-TB drugs of questionable quality

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Thank you for your continued support to the GDF!
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Q and A session

• What other responses could the GDF adopt ?
• How can we galvanise technical assistance for
  GDF/GFATM in area of drug management ?