Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH Harmonization of TB Drugs and Their Presentations Peter Evans Consultant Global Drug Facility

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH Standardization 15/50

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH All programs standardize, but some allow decisions at different levels.

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH Who Decides to Standardize?  Patient  Health worker  Health center  District  State  Country  Global program

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH The best level at which to standardize depends on the type of program and the advantages to be gained.

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH Successful global programs standardize procedures and products as they accelerate. Or perhaps successful global programs accelerate as they standardize.

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH  Smallpox –Variable products, detection, administration, surveillance, and reporting  Leprosy –Variable products and administration Reflect A single set of products and processes used globally with predictable, measurable, reportable, amazing results

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH Successful health programs have another important characteristic: They recognize that logistics and management are the key to achieving goals.

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH 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

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH  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 How is STOP TB doing in standardizing?

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH TB treatment category TB patientsTB treatment regimens Initial phaseContinuation phase Daily (28 doses/month) Daily (28 doses/month) 1New smear-positive patients; new smear-negative PTB with extensive parenchymal involvement; severe concomitant HIV disease or severe forms of extrapulmonary TB 2 (RHZE) = 56 doses of RHZE 4 (RH) = 112 doses of RH or 6 (HE) = 168 doses of HE 2Previously treated sputum smear-positive PTB: - relapse - treatment after interruption - treatment failure 2 (RHZE)S + 1 (RHZE) = 84 doses of RHZE plus 56 doses of S 5 (RH) E = 140 doses of RHE 3New smear-negative PTB (other than in Category 1) and less severe forms of extrapulmonary TB 2 (RH) Z = 56 doses of RHZ 4 (RH) = 112 doses of RH or 6 (HE) = 168 doses of HE TB Treatment Regimens by Treatment Category

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH TB treatment category TB patientsTB treatment regimens Initial phaseContinuation phase Daily (28 doses/month) 3 times per week (12 doses/month) Daily (28 doses/month) 3 times per week (12 doses/month) 1New smear-positive patients; new smear-negative PTB with extensive parenchymal involvement; severe concomitant HIV disease or severe forms of extrapulmonary TB 2 (RHZE) = 56 doses of RHZE 2 H 3 R 3 Z 3 E 3 = 24 doses of RHZE 4 (RH) = 112 doses of RH or 6 (HE) = 168 doses of HE 4 (RH) 3 = 48 doses of RH 2Previously treated sputum smear-positive PTB: - relapse - treatment after interruption - treatment failure 2 (RHZE)S + 1 (RHZE) = 84 doses of RHZE plus 56 doses of S 2 H 3 R 3 Z 3 E 3 S H 3 R 3 Z 3 E 3 = 36 doses of RHZE plus 24 doses of S 5 (RH) E = 140 doses of RHE 5 (RHE) 3 = 60 doses of RHE 3New smear-negative PTB (other than in Category 1) and less severe forms of extrapulmonary TB. 2 (RH) Z = 56 doses of RHZ 2 (RHZ) 3 = 24 doses of RHZ 4 (RH) = 112 doses of RH or 6 (HE) = 168 doses of HE 4 (RH) 3 = 48 doses of RH

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH Congo Brazzaville Categories 1 & 3 (RHZE) 56 doses (RH) 112 doses Category 2 S + (RHZE) 56 doses (RHZE) 140 doses 3 products; suitable for all weights, all categories

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Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH 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

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH 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.

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH 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?

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH 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

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH 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

Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Stop TB KNCV MSH 50 Thank you.