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 Pharmaceuticals Management for Under-served Popula  posted by  member150_php   on 3/9/2009  Add Courseware to favorites Add To Favorites  
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Abstract/Syllabus:

Pharmaceuticals Management for Under-served Populations

Spring 2006


Course

Instructors

David Peters & Alan Lyles

Offered By

Extradepartmental

Description

Students will be guided to analyze problems and develop strategies based on real world drug management issues including regulations, manufacture, procurement, distribution, safety, policy, financing and the unique aspects of international pharmaceutical trade, the role of the World Trade Organization - Trade-Related Aspects of Intellectual Property Rights (WTO-TRIPS), government, non-governmental organizations (NGOs) and individuals/programs in the selection and use of pharmaceutical products. Course materials are drawn from both developed and developing countries so that the student will be knowledgeable about the role of Essential Medicines and the formation of a National Drug Policy. The course will use a multidisciplinary approach to provide students with an operational understanding of factors influencing access to and use of pharmaceuticals and other health commodities. Collectively, these materials and approaches are intended to stimulate critical thinking on how to improve access to and the use of pharmaceutical products.

Syllabus

Course Description

Students will be guided to analyze problems and develop strategies based on real world drug management issues including regulations, manufacture, procurement, distribution, safety, policy, financing and the unique aspects of international pharmaceutical trade, the role of the World Trade Organization - Trade-Related Aspects of Intellectual Property Rights (WTO-TRIPS), government, non-governmental organizations (NGOs) and individuals/programs in the selection and use of pharmaceutical products. Course materials are drawn from both developed and developing countries so that the student will be knowledgeable about the role of Essential Medicines and the formation of a National Drug Policy. The course will use a multidisciplinary approach to provide students with an operational understanding of factors influencing access to and use of pharmaceuticals and other health commodities. Collectively, these materials and approaches are intended to stimulate critical thinking on how to improve access to and the use of pharmaceutical products.

Course Objectives

To develop an operational understanding of pharmaceuticals management in developing countries and underserved populations. The course will discuss factors, policies and regulations influencing drug availability and access, procurement, utilization, distribution, rational use, essential drugs, budgeting, inventory, and financing. The course will also discuss and describe the roll of government, non-governmental organizations (NGOs) and individual/program pharmaceuticals management.

Students will identify the different types of health commodities and their regulation, will understand key factors in the drug management cycle, will identify potential obstacles to and problems of access, as well as define creative solutions to these problems. Students will also understand the various factors influencing drug selection and the rational use of pharmaceuticals, and explain the relative strengths and weaknesses of alternative ways to raise revenues to pay for pharmaceuticals.

Readings

Managing Drug Supply: The Selection, Procurement, Distribution, and Use of Pharmaceuticals. 2nd edition. Management Sciences for Health in collaboration with the World Health Organization. Kumarian Press. 1997. ISBN 1-56449-047-9.

Schedule

SESSION # TOPIC ACTIVITIES
 
1

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

 

Lecture

2

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
Lecture
3

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
Lecture
4

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
Lecture
5

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
Laboratory
6

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
Lecture
7

Drug Donations

  • Explain the core principles for drug donations
  • Discuss the main concerns regarding drug donations
Lecture
8

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
Lecture
9

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
Lecture
10

Budgeting and Cost Control

  • Be able to develop a spreadsheet of:
    • budget
    • budget impact
    • forecast(s)
    • breakeven analysis
Laboratory
11

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
Lecture
12

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
Lecture
13

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
Lecture
14

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

 




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