Anti-Counterfeiting Strategies - Combating Fake Pharmaceuticals

Table of Contents

• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the report
    • Chapter summary
  • Key findings
• CHAPTER 2 COUNTERFEITING - THE SCALE OF THE PROBLEM
  • Pharmaceutical counterfeiting - a growing global problem
    • What is a counterfeit medicine?
    • Counterfeit medicines are on the increase
    • Counterfeits with no API' s predominate
    • What type of drugs are counterfeited - lifestyle versus lifesaving?
    • Counterfeit pharmaceuticals - a problem for both rich and poor nations
    • The cost of counterfeit medicines
      • The economic cost of counterfeiting
      • The health cost of counterfeiting
      • The governmental cost of counterfeiting
    • Sources of counterfeit medicines
    • Factors enabling and driving the production and distribution of counterfeit medicines
    • How counterfeit medicines reach the market
      • Parallel trade provides a point of entry for counterfeit medicines
      • The role of the internet in counterfeiting
• CHAPTER 3 ANTI-COUNTERFEITING STRATEGIES
  • Anti-counterfeiting strategies
    • Internal anti-counterfeiting business units and policies
    • Secured supply chains
      • Simplifying the supply chain
      • FDA' s prescription drug pedigree requirements
      • The emergence of e-pedigrees
    • Use of cutting edge anti-counterfeiting technologies
    • Preventative technologies
      • Unit-of-use packaging
      • Tamper-evident packaging
    • Authentication technologies
      • Overt technologies
      • Covert technologies
      • Forensic technologies
      • Diagnostic anti-counterfeiting strategies
    • Serialization and track & trace technologies
      • RFID
      • 2D-barcodes are favored by EFPIA
      • Which to adopt, RFID or 2D-barcodes?
    • Improving legislation, regulation and law enforcement
      • Inadequate regulation, legislation and enforcement promotes counterfeiting
      • What will be the impact of IMPACT?
      • Summary of national and international anti-counterfeiting initiatives
      • Enhancing law enforcement
    • Education of consumers
      • National and international education initiatives
      • Industry-supported patient education
• CHAPTER 4 BIBLIOGRAPHY
  • Datamonitor reports
  • Websites
  • Publications, online articles and meetings
  • Glossary of terms
  • List of Tables
    • Table 1: Countries with IP concerns to the US - Priority watch list, 2007
    • Table 2: Examples of tamper evident solutions
    • Table 3: Benefits of using different authentication measures throughout the pharmaceutical supply chain
    • Table 4: Overt anti-counterfeiting technologies
    • Table 5: Covert anti-counterfeiting technologies
    • Table 6: Forensic anti-counterfeiting technologies
    • Table 7: Readability of covert/forensic anti-counterfeit technologies
    • Table 8: Serialization/track & trace anti-counterfeiting technologies
    • Table 9: Comparison of RFID and 2D-barcode technologies
    • Table 10: Pros and cons of 2D-barcode, RFID and hybrid strategies
    • Table 11: California Express Solutions Team - project roles and responsibilities to harmonize e-pedigree, serialization and authentication
  • List of Figures
    • Figure 1: Defining counterfeit, substandard, diverted and genuine medicines
    • Figure 2: Counterfeit medicines are on the rise
    • Figure 3: Different types of counterfeit drugs that have been reported, 2000-01
    • Figure 4: Global incidence of counterfeiting, diversion and pharmaceutical theft, 2004-05
    • Figure 5: Number of incidents and seizures of counterfeit medicines by country, 2005
    • Figure 6: Factors enabling and driving the production and distribution of counterfeit medicines
    • Figure 7: Routes of entry for counterfeit medicines in the supply chain
    • Figure 8: Anti-counterfeiting strategies that should be employed throughout the manufacturing and distribution of medicines
    • Figure 9: AstraZeneca' s anti-counterfeiting efforts in the US
    • Figure 10: Distributor Licensing and Pedigree Requirements by State, October 2007
    • Figure 11: SupplyScape' s timeline for meeting the 2009 California deadline
    • Figure 12: Types of anti-counterfeiting strategies
    • Figure 13: The use of bar coding was the most popular anti-counterfeit strategy employed by surveyed pharmaceutical manufacturers, 2005
    • Figure 14: How EPC and RFID work
    • Figure 15: Pfizer' s risk-based approach to track & trace, authentication and pedigree technologies
    • Figure 16: The Declaration of Rome - February 2006
    • Figure 17: Survey findings for the most suitable methods of preventing counterfeit medicines, 2007
    • Figure 18: Anti-counterfeiting strategies that should be employed throughout the manufacturing and distribution of medicines
    • Figure 19: Pfizer educates patients on the threat of counterfeit medicines