偽造防止戦略：偽造医薬品との戦い

Abstract

Overview

Introduction

Counterfeit medicines are a global problem costing patient' s their health and the pharmaceutical industry and governmental organizations millions of dollars per year. Although there is no one preventative strategy, there are several measures that can be employed simultaneously to reduce the risk of fake medicines entering the pharmaceutical supply chain.

Scope

• Overview of the prevalence and drivers of counterfeit medicines, examining the economic and health cost of fake medicines
• Analysis of how counterfeit medicines enter the market, and strategies taken to tighten up supply chain security
• Assessment of key anti-counterfeiting technologies employed by pharmaceutical manufacturers, supported by case study analysis
• Examination of governmental and NGO based initiatives to improve regulation, legislation and enforcement of anti-counterfeiting protocols

Report Highlights

Incidents of counterfeit medicines are on the increase. However, reported figures only represent the tip of the iceberg, particularly in developing countries due to the insufficient anti-counterfeiting resources available

Parallel importation and online pharmacies are increasingly becoming the route of choice for counterfeiters to distribute fake medicines to patients on a global scale. Find out why, and what is being done to address these matters

Currently, 2D-barcodes and radio frequency identification tagging (RFID) are the two most prominent track & trace technologies. However, with the FDA having no preference, which technologies will pharmaceutical companies opt for?

Reasons to Purchase

• Identify the cause, prevalence and drivers of counterfeiting in the world today
• Evaluate which anti-counterfeiting strategies are available, and which ones to adopt
• Understand what anti-counterfeiting regulations and legislations will likely affect the pharmaceutical industry in the near future

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