Vertical versus Decentralized TB Pharmaceutical Management QUAN 1

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.