1. Vertical versus Decentralized TB Pharmaceutical Management
QUAN 1

2. Preliminary Considerations
Note: it is hard to distinguish which of the following pros & cons are truly different for TB drugs versus other essential medicines.
Determine national EDL along with TB specialist, TB program managers, epidemiologist, pharmacologist, pharmacist, nurse and procurement specialist. Otherwise, select drugs recommended by WHO

3. Pros & Cons: Categorization across Pharmaceutical Management component
Selection
Quantification
Procurement
Receipt, Distribution & Stock Management
Drug Use
Management Support: Training, HR, finances
Quality Assurance
Determine national EDL along with TB specialist, TB program managers, epidemiologist, pharmacologist, pharmacist, nurse and procurement specialist. Otherwise, select drugs recommended by WHO

4. SELECTION: Vertical Pros: Cons:
NTP and national essential medicines programs have extensive knowledge and experience with:
the patient base (national average weight, number patients in each treatment category (I, II, III and MDR-TB)
amount of drug resistance in country to which drugs resistance has developed on a national basis
currently recommended international therapy
current drug packaging available (FDC, patient kit)
national and international fair pricing
Aware of patient adverse reactions when good reporting system is in place
Standardized therapy so that patients get same appropriate drug regimens
Cons:
None

5. SELECTION: Decentralized
Pros:
Local managers have in their areas of responsibility:
Knowledge of patient base
Some knowledge of patient adverse reactions
Cons:
Local managers lack:
knowledge of drug resistance
current drug packaging available
pricing information for comparison
currently recommended international therapy (new drugs, best drugs)
without national guidance no standard therapy is in place and local managers can order whatever drugs they want whether appropriate or not

6. QUANTIFICATION: Vertical
Pros:
National TB program and national essential medicines programs have extensive knowledge and experience with:
the patient base (national average weight, number patients in each treatment category (I, II, III and MDR-TB)
justifying drug budget for current and future financial cycles
national case finding and treatment success numbers
increasing or decreasing trends in case load
Cons:
none

7. QUANTIFICATION: Decentralized
Pros:
Local managers have in their areas of responsibility:
Knowledge of patient base
Cons:
Local managers lack:
Information for justifying budgets
Case finding trends
Increase or decrease in drug needs for entire program

8. PROCUREMENT: Vertical
Pros:
National TB program and national essential medicines program have extensive knowledge and experience with:
current drug packaging available (FDC, patient kit)
national and international fair pricing
tendering to get best drugs
economies of scale (order larger quantities to get smaller price)
mandating standardized treatment will allow even better economies of scale
assuring quality products
track supplier activities
how much buffer stock is needed at national and local levels
quantifies consumed from previous procurement period
Cons:
none

9. PROCUREMENT: Decentralized
Pros:
Local managers have in their areas of responsibility:
Knowledge of buffer stock needs
Better idea of quantities consumed
Cons:
Local managers lack:
current drug packaging available
pricing information for comparison since only order locally
no knowledge or staff to conduct tenders
no resources to assure quality of products received
without standardized drug regimens individual drug costs increase with no potential for economies of scale

10. RECEIPT, DISTRIBUTION & STOCK MANAGEMENT: Vertical
Pros:
National TB program and national essential medicines program have extensive knowledge and experience with:
ability to monitor quantities received from International and National suppliers
ability to monitor quality of products received from International and National suppliers
broad picture of geographical needs based on historical data
delivery vehicles, maintenance and schedules
ability to control quantities distributed
able to monitor stock levels if good information management system exists
Cons:
unable to monitor local stock management activities to prevent stock-outs, stock overages, stock expiry

11. RECEIPT, DISTRIBUTION & STOCK MANAGEMENT: Decentralized
Pros:
Local managers have in their areas of responsibility:
ability to monitor local quantities received from warehouse or local suppliers
able to monitor stock levels
able to avoid stock-outs, stock overages and stock expiry with good management techniques
drugs are delivered by suppliers directly to the local warehouses/storerooms
Cons:
Local managers lack:
ability to monitor quality of products received from National and international suppliers
ability to determine what to do with stock overages and expired stock

12. DRUG USE: Vertical
Pros:
National TB program and national essential medicines programs have extensive knowledge and experience with:
the patient base (national average weight, number patients in each treatment category (I, II, III and MDR-TB)
amount of drug resistance in country to which drugs resistance has developed on a national basis
promote rational drug use through standardized therapy so that patients get same appropriate drug regimens
currently recommended international therapy (new drugs, best drugs)
best drug packaging available to ensure compliance of health care providers and patients (FDC, patient kit)
Aware of patient adverse reactions when good reporting system is in place
Cons:
Not able to monitor patients case by case; must depend on aggregated statistics

13. DRUG USE: Decentralized
Pros:
Local managers have in their areas of responsibility:
Knowledge of patient base
Some knowledge of patient adverse reactions
Can monitor patient responses case by case
Cons:
Local managers lack:
knowledge of drug resistance
current drug packaging available
currently recommended international therapy (new drugs, best drugs)
does not promote rational drug use because no standard therapy is in place since local managers can order whatever drugs they want whether appropriate or not

14. MANAGEMENT SUPPORT: Training, HR & Finances
Vertical
Pros:
National TB program and national essential medicines programs have more resources to:
Prepare training and educational materials
Better economies of scale for training and preparation of educational materials
More funds for hiring and developing staffs
Cons:
None

15. MANAGEMENT SUPPORT: Training, HR & Finances
Decentralized
Pros:
Local managers have:
Better rapport with local staffs because they usually know them on a personal basis
Cons:
Local managers lack:
Sufficient management training
Sufficient management experience
Sufficient funds to develop staffs
Sufficient funds to hire additional staff when needed

16. QUALITY ASSURANCE: Vertical
Pros:
National TB program and national essential medicines program have extensive knowledge and experience with:
how to identify appropriate suppliers whether suppliers are local or international
how to monitor suppliers to assure they are upholding the supplier contracts
ability to prevent drugs from entering the health system by first testing the drugs both by physical inspection and lab testing
aware of new problems with medicines usually coming from international sources (e.g. bioavailability of rifampicin in FDC, and moisture problem with Ethambutol if not packaged (blistered) appropriately)
ability to recall products if a good information management system exists
ability to facilitate drug registration of products
Cons:
None

17. QUALITY ASSURANCE: Decentralized
Pros:
Local managers have in their areas of responsibility:
Ability to monitor quality of products they receive by physical inspection (only if trained on these procedures)
Cons:
Local managers lack ability to:
identify appropriate suppliers whether suppliers are local or international
monitor suppliers to assure they are upholding the supplier contracts
prevent drugs from entering the health system by first testing the drugs (usually no resources for lab testing and often no knowledge of doing physical inspection)
learn of new problems with medicines usually coming from international sources (e.g. bioavailability of rifampicin in FDC, and moisture problem with Ethambutol if not packaged (blistered) appropriately)
recall products when found defective
no ability to facilitate drug registration of new or existing products

18. Conclusion
In general many experts agree that in today’s world perhaps a combination of the two is best, for example:
Selection, procurement, and staff training are best managed by the national level.
Quantification, receipt, distribution, rational use, quality assurance, staff hiring and finances are best managed by a combination of vertical and decentralized settings.
Stock control is obviously best managed at the decentralized setting.