Schedule

The Global Context of Pharmaceutical Products and Underserved Populations

• Become familiar with the key components and sequence of the Drug Management Cycle
• Understand the leading patient, product and pharmaceutical services management
• Describe the main functions of managing the pharmaceutical supply system
• Identify access barriers arising from globalization and the interrelationships between developed and developing countries
• Identify some key characteristics of underserved populations
• Understand the barrier to access of pharmaceuticals by underserved populations

International Policy and Legal Framework

• Describe the main features of the World Trade Organization (WTO) and its actions regarding pharmaceutical products
• Discuss the main concerns regarding bilateral trade agreements
• Understand Orphan Drugs and be able to assess the effectiveness of policies designed to encouraged their development and marketing
• Explain Trade-Related Aspects of Intellectual Property (TRIPs) in relation to access and cost of pharmaceuticals

Drug Manufacture, Industrial Pharmacy Considerations, Quality Assurance and Regulation

• Be familiar with drug manufacturing requirements and industry regulations
• Describe Good Manufacturing Practices (GMP)
• Understand requirements for developing domestic manufacturing capabilities
• Differentiate between brand vs generics and the conditions for interchange
• Become familiar with the procedures to prevent and detect counterfeit products
• Describe relevant drug regulations
• Describe the Guiding Principles for small national drug regulatory authorities
• Describe relevant drug regulations
• Understand basics of and issues relating to drug product quality assurance
• Understand differences relating to full-scale manufacturing, small-scale institutional/local production, and extemporaneous compounding

The Drug Management Cycle: Selection

• Be able to apply evidence-based criteria for pharmaceutical product selection
• Describe approaches to developing Essential Medicines Lists, Formularies, and Standard Treatment Guidelines
• Recognize the challenges in implementing treatment guidelines and formulary systems and ways to overcome them

Forecasting and Quantification

• Discuss the critical issues in forecasting and quantifying drug requirements
• Explain the four general methods for quantification
• Apply the consumption-based method to estimate actual need and costs
• Develop a basic spreadsheet for budget and forecasting models
• Become aware of the potential of MSH's Quantimed software to project drug needs

The Drug Management Cycle: Procurement

• Explain the factors influencing drug prices and total costs
• Understand different types of procurement
• Describe good pharmaceutical procurement practices
• Describe the tender process
• Describe the steps in the tender cycle and related critical management consideration
• Explain the process for developing a contract for services
• Identify the procurement-related determinants of drug quality and the process(es) for obtaining quality drugs

Drug Donations

• Explain the core principles for drug donations
• Discuss the main concerns regarding drug donations

The Drug Management Cycle: Distribution

• Explain the critical elements in designing a distribution system
• Understand the port clearing process and key documents
• Discuss the main considerations for managing medical stores independent of health facilities
• Explain inventory processes within health facilities
• Logistic management of drug distribution chains: transport, storage warehousing, customs and Kit System.
• Describe standard reports used to manage inventory
• Explain safety stock and service levels in determining inventory practices
• Apply the EOQ model for reordering

The Drug Management Cycle: Use

• Define rational drug use
• Explain the main factors contributing to irrational drug use
• Discuss the steps in developing strategies to improve drug use
• Apply data and quantitative methods to identify drug interventions
• Evaluate drug information sources
• Understand drug promotion
• Explain the framework for improving drug prescribing - including educational, managerial and regulatory approaches
• Describe the steps in good dispensing practice(s)
• Identify the process for public education in appropriate drug use
• Discuss the role(s) of Medicinal Plants and Traditional Healers

Budgeting and Cost Control

• Be able to develop a spreadsheet of:
  • budget
  • budget impact
  • forecast(s)
  • breakeven analysis

Access to Essential Drugs

• Explain how to appraise access to essential drugs at the community level
• Understand the different dimensions and determinants of access to medicines
• Describe different types of community participation that affect access to essential medicines
• Describe how to do a community needs assessment
• Describe recent innovations to increase access to medicines involving the private sector and communities, including participatory monitoring
• Explain the main factors influencing cost, use and access to pharmaceuticals

Management Support Systems: Planning Cycle

• Explain the management cycle and implementation strategies
• Apply Gantt charts as a work planning tools
• Design a monitoring system and appropriate indicators

Pharmaceutical Care and Drug Utilization in an HIV/AIDS Clinic

• Understand the terminology and concepts used in DUR
• Be able to explain models for prospective DUR and for retrospective DUR
• Be able to discuss DUR applications to detect inappropriate drug use in addition to fraud and abuse

Financing and Sustainability

• Explain the different types of financing and assistance
• {Discuss strategic considerations in product pricing from the perspective of the manufacturer and distributor}
• Discuss the revolving fund concept