Course: Pharmaceuticals Management for Underserved Populations

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Session Topic Activites


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

Planning Laboratory