Anti-Counterfeiting Strategies - Combating Fake Pharmaceuticals

Published by: Datamonitor

Published: Dec. 19, 2007 - 115 Pages

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

Abstract

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