Prescription Drug Counterfeiting

Table of Contents

CHAPTER 1: EXECUTIVE SUMMARY

• Growth of Counterfeiting
• What is a Counterfeit Medicine?
• Market Drivers
• The Drugs being Counterfeited
• The Value and Cost of the Market
• Where Do They Come From?
• What Can be Done?

CHAPTER 2: THE PROBLEM

• Definitions and Explanations
  • Franchising
  • Parallel Trading
  • Diversion or Illegal Trading
  • Substitution
  • Adulteration and Re-use
• Motive
• Perpetrators
• Mechanisms
  • The European Pharmaceutical Distribution Chain
• Scale: The Countries Involved
  • Counterfeits in Developing Countries
  • Where are Counterfeit Medicines Produced and Sold?
    • Asia
    • Latin America
    • Russia
    • Nigeria
    • European Union
    • United States
  • Diverters and the Gray Market
  • The Role of Drug Wholesalers in the Diversion Market
  • Drug Importation
• The Internet
• The Drugs Most Counterfeited

CHAPTER 3: THE VICTIMS

• The Pharmaceutical Industry
  • Loss of Revenue
  • Loss of Industry Trust
  • Risk of Litigation
  • Added Cost impact of Securing Product Integrity
  • Impact on Health Professions
• International Trade
• Patients: The Ultimate Victims
  • Drug Resistance
  • Malaria
  • HIV/AIDS
  • Bird Flu

CHAPTER 4: THE FIGHTBACK

• Initiatives from Governments and International Bodies
  • USA
    • The FDA and PDMA
  • EU: ‘TAXUD' Legislation
  • WHO: ‘IMPACT' Taskforce
  • Council of Europe Initiatives
  • Pharmaceutical Security Institute (PSI)
  • Individual Countries
    • China
    • Russia
    • USA
  • Pedigree: A long Time Coming
    • Authorized Distributors
  • Technology-based Countermeasures
    • RFID
    • Other Product Authentication Technologies
  • Which Technology is Appropriate?
    • Analyzing the Options
  • Security Marking Options
    • Overt or Covert
    • Level of Security
    • Type of Test„ŸDestructive or Non-destructive
    • Field or Laboratory
    • Method of Detection„ŸUnaided Human Verification or Reader
    • Application„ŸCounterfeiting, Diversion and/or Tampering
    • Cost
    • Technologies Currently Available

CHAPTER 5: WHAT NEEDS TO BE DONE

• Concerted Response
• Effective Legislation and Surveillance
  • Licensing and Screening
    • National Drug Regulatory Authority
  • Industry Regulation
    • Enforcement
  • Wholehearted Industry Involvement
    • WHO Guideline
    • Company Warnings
• Essential to Involve the Consumer
• Is it Enough?

APPENDIX 1: ACKNOWLEDGMENTS AND REFERENCES

APPENDIX 2: GLOSSARY AND ABBREVIATIONS