This is a list of readings to accompany educational content form JHSPH. This is only a list; due to copyright restrictions, users must individually locate any materials they wish to use. If you wish to locate any of the readings, you may find PubMed helpful.

Readings

Textbook

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.



TOPIC READINGS
 
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 2: International Policy and Legal Framework
Required

MSH Managing Drug Supply Part II: Policy and Legal Framework

  • National Drug Policies (pp. 55-67)
    • Country Study 5.1 The Philippines
    • Country Study 5.2 Australia
  • Drug Supply Strategies (pp. 68-88)
    • Country Study 6.3 Direct Delivery, Prime Vender and Mixed Supply Arrangements
  • Pharmaceutical Legislation and Regulation (pp. 89-100)
  • Legal Aspects of Drug Management (pp. 101-107)

Explore and familiarize yourself with this resource for future use: WHO Essential Drugs and Medicines Policy. Available at: http://www.who.int/medicines/

Recommended

National Institute for Clinical Excellence (NICE). Available at: http://www.nice.org.uk

Canadian Agency for Drugs and Technology in Health. Available at: http://www.cadth.ca/index.php/en/home

 
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)
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 Carribean 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 7: Drug Donations
Required

MSH Managing Drug Supply Part III: Section B. Procurement

  • Drug donations (pp. 304-312)
    • Note: Country Study 19.1 The role of Private NGOs in Providing Health Care Services in Zaire

WHO Guidelines for Drug Donations, revised 1999. Available at: http://whqlibdoc.who.int/hq/1999/WHO_EDM_PAR_99.4.pdf

 
Session 8: The Drug Management Cycle: Distribution
Required

MSH Managing Drug Supply Part III: Section C. Distribution

  • Managing Distribution (pp. 315-333)
  • Importation and Port Clearing (pp. 334-340)
  • Medical Stores Management (pp. 341-363)
  • Drug Management for Health Facilities (pp. 364-377)
    • Country Study 24.1 Zimbabwe Monthly Ordering System
  • Discuss cold chain for vaccines
  • Transport Management (pp. 393-406)
  • Kit System Management (pp. 407-418)
    • Country Study 27.4 Cambodia
    • Country Study 27.5 Solomon Islands
Recommended

MSH Managing Drug Supply

  • Planning and Building Storage Facilities (pp. 378-392)
    • Note: Figure 25.3 Typical Elements of a Project Brief
 
Session 9: Drug Management Cycle: Use
Required

MSH Managing Drug Supply Part III: Section D. Use

  • Managing for Rational Drug Use (pp. 421-429)
  • Investigating Drug Use (pp.430-449)
  • Drug and Therapeutics Information (pp. 450-463)
  • Promoting Rational Drug Prescribing (pp. 464-482)
  • Ensuring Good Dispensing Practices (pp. 483-495)
    • Note: Figure 32.10 Sample Inspection Checklist
  • Encouraging Appropriate Drug Use by the Public and Patients (pp. 496-512)
    • Country Study 33.1 Mexico
Recommended

Lyles A. Direct Marketing of Pharmaceuticals to Consumers. Annual Review of Public Health 2002;23:73-91.

Cabana MD, Rand CS, Powe NR, et al. Why Don't Physicians Follow Clinical Practice Guidelines? A Framework for Improvement. JAMA 1999;282(15):1458-1465.

 
Session 10: Budgeting and Cost Control
Required

MSH Managing Drug Supply Part IV: Section B. Financing and Sustainability

  • Drug Financing Strategies (pp. 607-627)
  • Analyzing and Controlling Drug Expenditures (pp. 628-653)
  • Financial Planning and Management (pp. 654-672)
 
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

Recommended

MSH Managing Drug Supply Force Field Analysis (pp. 527-528, 533, 544)

Sample Gantt Chart (Excel). Available at: http://www.hyperion.ie/SampleGanttChart.xls

 
Session 12: Access to Essential Drugs
Required

MSH Managing Drug Supply Part IV: Section A. Organization and Management

  • Community Participation (pp. 569-581)
    • Focus = 37.5 Facilitating community participation in health programming
    • Country Study 37.1 Canada
    • Country Study 37.2 Thailand
Recommended MSH. Strategies for Enhancing Access to Medicines. Available at: http://www.msh.org/programs/seam.html
 
Session 13: Pharmaceutical Care and Drug Utilization in an HIV/AIDS Clinic
Recommended

Lyles CA, Zuckerman IH, DeSipio SM and Fulda T. When Warnings Are Not Enough: Primary Prevention through Ambulatory Drug Use Review. Health Affairs, 17(4):175-183; 1998.

Harjivan C and Lyles A. Improved Medication Use in Long Term Care: Building on the Consultant Pharmacist's Drug Regimen Review. American Journal of Managed Care 2002;8(4):318-326.

Lyles A, Sleath B, Fulda TR and Collins TM. Ambulatory Drug Utilization Review: Opportunities for Improved Prescription Drug Use. [Continuing Medical Education] American Journal of Managed Care 7(1):75-81, 2001.

 
Session 14: Financing and Sustainability
Required

MSH Managing Drug Supply Part IV: Section B. Financing and Sustainability

  • Donor Financing (pp. 673-685)
  • Revolving Drug Funds (pp. 687-710)

Umenai T and Narula IS. Revolving Drug Funds: A Step Towards Health Security. Bulletin of the World Health Organization 1999;77(2):167-171

Recommended Emmanuel Healthcare. Medicines for Overseas Programme. Available at: http://www.emms.org/support/subindex.php?type=Medicines