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

Stop TB KNCV MSH

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Harmonization of TB Drugs and Their Presentations

Peter Evans Consultant

Global Drug Facility

Stop TB KNCV MSH



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Standardization 15/50

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All programs standardize, but some allow decisions at different

levels.

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Who Decides to Standardize?

Patient Health worker Health center District State Country Global program

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The best level at which to standardize depends on the type of program and the advantages to

be gained.

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Successful global programs standardize procedures and products as they

accelerate.

Or perhaps successful global programs accelerate as they standardize.

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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

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Successful health programs have another important characteristic:

They recognize that logistics and management are the key to achieving goals.

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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

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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?

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TB treatmentcategory

TB patients TB treatment regimens

Initial phase Continuation phase

Daily(28 doses/month)


1 New 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

or6 (HE)

= 168 doses of HE

2 Previously treated sputum smear-positive PTB: - relapse - treatment after interruption - treatment failure

2 (RHZE)S + 1 (RHZE)

= 84 doses of RHZEplus 56 doses of S

5 (RH) E= 140 doses of RHE

3 New smear-negative PTB (other than in Category 1) andless severe forms ofextrapulmonary TB

2 (RH) Z= 56 doses of RHZ


or6 (HE)

= 168 doses of HE

TB Treatment Regimens by Treatment Category

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TB treatmentcategory

TB patients TB treatment regimens

Initial phase Continuation phase


3 times per week(12 doses/month)


3 times per week(12 doses/month)

1 New 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 H3R3Z3E 3 = 24 doses of

RHZE


or6 (HE)

= 168 doses of HE

4 (RH) 3

= 48 doses of RH

2 Previously treated sputum smear-positive PTB: - relapse - treatment afterinterruption - treatment failure

2 (RHZE)S +1 (RHZE)

= 84 doses of RHZE

plus 56 doses of S

2 H3R3Z3E3S3 + 1

H3R3Z3E3

= 36 doses of RHZE

plus 24 doses of S

5 (RH) E= 140 doses of

RHE

5 (RHE)3

= 60 doses of RHE

3 New smear-negative PTB (other than in Category 1) and less severe forms ofextrapulmonary TB.

2 (RH) Z= 56 doses of

RHZ

2 (RHZ)3

= 24 doses of RHZ


or6 (HE)

= 168 doses of HE

4 (RH)3

= 48 doses of RH

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Congo BrazzavilleCategories

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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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

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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.

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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?

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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

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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

Stop TB KNCV MSH



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50Thank you.

Documents

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