Harmonization of TB Drugs and Their Presentations Peter Evans Consultant Global Drug Facility

1. Harmonization of TB Drugs and Their Presentations Peter Evans Consultant Global Drug Facility KNCV MSH

2. Standardization 15/50 KNCV MSH

3. All programs standardize, but some allow decisions at different levels. KNCV MSH

4. Who Decides to Standardize? • Patient • Health worker • Health center • District • State • Country • Global program KNCV MSH

5. The best level at which to standardize depends on the type of program and the advantages to be gained. KNCV MSH

6. Successful global programs standardize procedures and products as they accelerate. Or perhaps successful global programs accelerate as they standardize. KNCV MSH

7. Reflect • Smallpox • Variable products, detection, administration, surveillance, and reporting • Leprosy • Variable products and administration A single set of products and processes used globally with predictable, measurable, reportable, amazing results KNCV MSH

8. Successful health programs have another important characteristic: They recognize that logistics and management are the key to achieving goals. KNCV MSH

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10. Advantages of Standardization • Easier logistics • Available when needed • Know what you are getting • Higher quality • STOP TB standards, easier to control • More voice in the market • Larger orders may receive lower prices • Change specifications to match needs KNCV MSH

11. How is STOP TB doing in standardizing? • 19 TB products for 6 drugs on the WHO Model Essential Drugs List (and many other products in use by national programs) • 11 regimens approved by WHO in 3 treatment categories • 2 recommended dosages, daily and intermittent • 3 weight categories (not always consistent) • Variety of packaging: blisters, foil wrapped, loose tablets KNCV MSH

12. TB Treatment Regimens by Treatment Category KNCV MSH

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14. Congo Brazzaville 3 products; suitable for all weights, all categories KNCV MSH

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16. India advantage • One pack suits all • No weight differentiation • Simplified dispensing system • One blister per visit, missing patients obvious • Much lower cost per patient • World Bank Loan being returned • Full treatment reserved for patient • Impact on private market • Simplified ordering system KNCV MSH

17. Simplified ordering system • Traditional system • Look up how many patients for each category have been treated since last order came, write this down, then . . . There are often several pages of considerations and calculations before the number of tablets and the number of containers are known and ready for ordering. KNCV MSH

18. Simplified ordering system • India system • Look up how many new patients, for each category, have been treated since last order came, write this down, then . . . That’s it. There is no next step. Can you imagine how simple stock control has just become? KNCV MSH

19. GDF • Work within WHO and IUATLD guidelines • Adopt existing standards • Consider the best of what is available • Don’t try to be all things to all people • Put the most effort into what will have the most impact • High quality, low cost, meet program needs KNCV MSH

20. GDF • Limited list of products • Focus on (RHZE), (RH), (RH)3,(HE), S • Limited presentations – Focus on blister packing, suitable for patient packs • Maximum quality • Testing and bioavailability standards followed • Maximum service • Products always available when needed KNCV MSH

21. 50 Thank you. KNCV MSH