Introduction to Elements of In-Country Drug Management with Focus on TB Drugs Jim Rankin Director, Center for Pharmaceutical Management Management Sciences for Health

 Government commitment  Case detection by sputum smear microscopy  Standardized treatment regimen  Regular uninterrupted supply of essential TB drugs  Standardized recording and reporting system Five Elements of DOTS

Supply Management Cycle Selection Procurement Management Support Distribution Use Policy and Legal Framework

 National tuberculosis program  Drug policy and legislation  Product registration/licensing  Product quality assurance policies and regulations  Procurement policy  Policies on use of drugs by health providers and consumers

Selection of TB Drugs  Morbidity, resistance patterns, utilization factors, Stop TB guidelines  Standard treatments for country  First-line drugs: INH, rifampicin, ethambutol, pyrazinamide, streptomycin  Second-line drugs: capreomycin, cycloserine, aminoglycosides, quinolones  Limited list  Fixed-dose combinations versus individual products  Packaging for optimal use

Procurement  Follow good procurement practices  Base on accurate quantification  Secure funding to meet needs  Compare potential sources of supply  Choose appropriate procurement method  Select appropriate suppliers  Assure drug quality  Monitor supplier performance

Distribution (Supply Chain Management)  Develop plan to ensure effective/efficient supply chain  Ensure efficient clearance, storage, transport, stock control  Provide qualified staff to manage and operate system  Use effective management information systems  Monitor performance at all levels  Consider public, NGO, and private-sector options

Public-Private Supply Systems

International Manufacturers International Procurement Agencies LEVELS PRIVATE SECTOR PUBLIC SECTOR National Local Manufacturers Regional Local Wholesalers Regions Medical Stores, Hospitals District Districts Medical Stores Hospitals Health Centers Shops, Pharmacies Community Health Workers Government/NGOSupply Services Central Level Procurement Unit Finance Unit Medical Stores Importer-Wholesalers Consumers Key Drug flow in formal system Alternative drug flow (planned or unplanned) Typical Structure of Public-Private Dug Distribution

Rational Use (public or private)  DOTs system for administering drugs  Prescriber/dispenser/observer training  Monitor prescribing and DOTs  Patient and community education  Incentives/enablers for providers and patients

Management Support  Political/senior manager commitment  Effective planning  Effective implementation and management  Effective management information systems  Monitoring and evaluation  Constant vigilance to ensure continuous, unbroken cycle