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Drug Management MDR-TB

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Drug Management MDR-TB

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    1. Khaled Soltan GDF Focal Point EMRO EMRO Meeting of the Working Group on MDR-TB 25-29 Nov. 2007, Cairo Egypt Drug Management & MDR-TB

    2. Presentation outline GDF/GLC Procurement Model Existing procurement challenges New MDR-TB sub-group on drug management to address challenges Selecting second-line medicines Procurement process Distribution Medicines use

    3. Procurement cycle: roles and inputs

    4. Procurement challenges (1) Lack of collective sense of urgency, and political engagement Opaque and limited market Current demand outstrips capacity Potential manufacturers face uncertain returns, expensive and long prequalification process. Insufficient coordination of funding and on common Quality standards

    5. Procurement challenges (2) Lack of acknowledgement or awareness in countries of international public health implications of the use of non-QA drugs. Country import barriers, including difficult and/or lengthy registration procedures.

    6. MDR-TB sub-group on Drug Management At the 5th annual meeting of the Stop TB Working Group on MDR-TB it was concluded that a subgroup on second-line anti-TB drug management and supply should be set up with support from the secretariat. Following convergence of the procurement functions of the GLC Initiative with the GDF, the task of establishing this sub-group has been assigned to GDF. The sub-group and its Terms of Reference (TOR) have been endorsed by the Stop TB WG on MDR-TB and it held its first meeting in Cape Town (as part of the 38th IUATLD Congress) 10 Nov. 2007.

    7. Selecting 2nd line Medicines Requirements Only do so after the country has a documented outbreak of multi-drug resistant MDR-TB Qualified specialists should make decisions for selecting 2nd-line medicines for the country, based on drug-resistance patterns

    8. Characteristics of 2ndline drugs Limited supply Number of suppliers Capremycin 1 g. vial few Cylcoserine 250 mg tablet few Ethionamide 250 mg tablet many Kanamycin/amikacin 1 g. vial many Para-aminosalicylic acid 4 g. sachet few Ofloxacin/ciprofloxacin 200/250 mg tablet few More medicines are needed for longer periods of time (up to 24 months) More expensive—can be 100 to 1000 times as expensive as 1st-line TB medicines Not as effective More toxic

    9. Selecting 2nd line Medicines WHO-recommended 2nd line drugs for MDR TB Capreomycin Cycloserine Para-aminosalicylic acid Ethionamide Kanamycin Ciprofloxacin Ofloxacin Levofloxacin List of products and prices via GLC/GDF on GDF website at: www.stoptb.org/GDF

    10. Criteria for Selecting 2nd line Medicines

    11. Cautions for 2nd-line Medicines

    12. Ancillary Medicines for 2nd line treatment: Managing Adverse Effects

    13. Quantifying Medicines need

    14. Critical Issues in Quantification (1)

    15. Critical Issues in Quantification (2)

    16. Activity

    17. Procurement - 1

    18. Good Procurement Practices - 2

    19. Procurement Methods

    20. When Is Direct Procurement Okay?

    21. Quality Assurance

    22. Determinants of Pharmaceutical Product Quality (1)

    23. Determinants of Pharmaceutical Product Quality (2)

    24. Critical Elements of QA for Pharmaceutical Procurement

    25. Distribution

    26. The Distribution Cycle

    27. Recipt and Inspection (1)

    28. Receipt and Inspection(2)

    29. Storage (1)

    30. Storage (2)

    31. Storage (3)

    32. Ordering and Delivering

    33. Mechanism for Applying for & Buying 2nd line drugs through GDF/GLC - 1

    34. Medicine Use Process (1)

    35. Thank you & Discussion

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