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.

Session 1: The Global Context of Pharmaceutical Products and Under-served Populations
Required	MSH Managing Drug Supply: Part 1 Introduction Toward Sustainable Supply and Rational Use of Drugs (pp. 3-16) Historical and Institutional Perspectives (pp. 17-25) Economics for Drug Management (pp.26-37) Pharmaceutical Supply System Management (pp. 38-52)
Recommended	WHO Essential Medicines Library (EMLib). Available at: http://mednet3.who.int/eml/ - contains a Model Formulary, Model list of Essential Drugs Lofland JH and Lyles A. Pharmacy Practice and Health Policy within the United States: An Introduction and Overview [Chapter 20] in Managing Pharmacy Practice: Principles, Strategies, and Systems, Andrew Peterson, Editor. CRC Press LLC. Boca Raton, Fl. 2004. Health, United States, 2004. With Chart book on Trends in the Health of Americans with Special Feature on Drugs. Available at: http://www.cdc.gov/nchs/hus.htm

Session 3: Drug Manufacture, Industrial Pharmacy Considerations, Quality Assurance, and Regulation
Required	MSH Managing Drug Supply: Part 1 Introduction Pharmaceutical Production Policy (pp. 108-115) Country Study 9.3 Promoting Local Production of Essential Drugs in Bangladesh Small-scale local production (pp. 288-303) Small Scale Hospital Pharmaceutical Production 592 JE and Trueman P. 'Fourth Hurdle Reviews,' NICE and Database Applications. Pharmacoepidemiology and Drug Safety 2001;10:429-438.
Recommended	U.S. Food and Drug Administration: Good Manufacturing Practices (GMP) / Quality System (QS) Regulation. Available at: http://www.fda.gov/cdrh/devadvice/32.html
Session 4: The Drug Management Cycle: Selection
Required	MSH Managing Drug Supply Part III: Section A. Selection Managing Drug Selection (pp. 121-136) Country Study 10.1 Approaches to updates essential drugs * formulary lists Country Study 10.2 Updating the National Essential Drugs List of Kenya Treatment Guidelines and Formulary Manuals (pp. 137-149) Note Figure 11.2 Sample annotated Page from Malawi Standard Treatment Guidelines Essential Medical Supplies and Equipment (pp. 150-160) Note Box 12.1 ECHO: Nonprofit Equipment Supplier, but see Dec 2002: http://www.echohealth.org.uk/intro.html
Recommended	Lyles A. Formulary Decision-Maker Perspectives: Responding to Changing Environments [Chapter 7] in Economic Evaluation in U.S. Health Care. Jones and Bartlett Publishers, Boston. 2006. ISBN 0-7637-2746-6 Sullivan SD, Lyles A, Luce B and Gricar J. AMCP Guidance for Submission of Clinical and Economic Evaluation Data to Support Formulary Listing in United States Health Plans and Pharmacy Benefits Management Organizations. Journal of Managed Care Pharmacy 7(4):272-282,2001. The AMCP Format for Formulary Submissions,Version 2. 1 April 2005. A Format for Submission of Clinical and Economic Data in Support of Formulary Consideration by Health Care Systems in the United States. Available at: http://www.fmcpnet.org/data/resource/Format~Version_2_1~Final_Final.pdf
Session 5: Forecasting and Quantification
Required	MSH Managing Drug Supply Part III: Section B. Procurement Inventory Management (pp. 207-231) Country Study 15.1 Scheduled Purchasing in the Eastern Carribean Quantifying Drug Requirements (pp. 184-206) Use these methods to estimate actual need and Action Programme on Essential Drugs and Vaccines. Essential Drugs Monitor: Managing Drug Supply. 1998, No.s 25 & 26.
Recommended	Management Sciences for Health. International Drug Price Indicator Guide, 2004 edition. Available at: http://www.msh.org/resources/publications/IDPIG_2004.html
Session 6: The Drug Management Cycle: Procurement
Required	MSH Managing Drug Supply Part III: Section B. Procurement Managing Procurement (pp. 163-183) Country Study 13.2 Pooled Procurement through the Eastern Caribbean Drug Service Country Study 13.3 Problems with Lack of Transparency in Tenders Managing the Tender Process (pp. 232-255) Note Annex 16.2 Criteria for Evaluating Current or Past Suppliers Action Programme on Essential Drugs and Vaccines. Essential Drugs Monitor: Managing Drug Supply. 1998, No.s 25 & 26. Contracting for Drugs and Services (pp. 256-270) Quality Assurance for Drug Procurement (pp. 271-287) Country Study 18.2 Quality Assurance in Selected Countries Figure 18.7 Sample Drug and Supply Evaluation Form

Session 11: Management Support Systems: Planning Cycle

Required

MSH Managing Drug Supply Part IV: Section A. Organization and Management Managing Drug Programs (pp. 517-534) Country Study 34.1 Kenya Planning for Drug Management (pp. 535-552) Focus = 35.4 Monitoring and Evaluation (pp. 553-568) Country Study 36.1 Zimbabwe Country Study 36.2 Kenya Tutorial: Gantt Chart and Timeline: Available at: http://www.smartdraw.com/specials/projectchart.asp?id=3FGPhwtl%22t and http://www.smartdraw.com/tutorials/gantt/tutorial1.htm