Pharmaceutical Anti-Counterfeiting
Combating the Real Danger from Fake Drugs
1. Edition August 2011
426 Pages, Hardcover
Practical Approach Book
Short Description
Counterfeiting of pharmaceutical products is a multi-billion dollar area and a major threat to the pharmaceutical and medical industries. Integrating business and technical issues to combat the major global problem of counterfeit medicines, Pharmaceutical Anti-Counterfeiting addresses analytical techniques scientists use to detect counterfeits, costs / risks to consumers and business, government oversight and regulation, authentication strategies, product tracking and supply chain, and possible solutions and case studies from the USA, Europe, and worldwide, to help pharmaceutical professionals combat the threat of counterfeit medical products.
This book overviews and integrates the business and technical issues that pharmaceutical companies need to know in order to combat the major global problem of counterfeit medicines. In addition to discussion of the problems, the author Davison addresses analytical techniques scientists use to detect counterfeits and presents some possible solutions to the threat of counterfeit medical products. Coverage moves from basic overview of the problem, costs / risks to consumers (toxic products, mistrust of drug companies) and business (revenue loss, public trust), government oversight and regulation, authentication strategies (packaging, analytical techniques), product tracking and supply chain, and case studies from around the globe.
ACKNOWLEDGMENTS xxiii
PART 1 GENERAL THEMES
1 Introduction 3
2 Origins and Context of Counterfeiting in Healthcare 7
3 A Snapshot of the Problem 15
4 Risks and Costs of Counterfeit Pharmaceuticals 21
5 Anti-Counterfeiting Definitions 35
6 Protecting and Educating Consumers 49
7 Business Risks and Strategy 57
8 Government Issues 65
9 Intellectual Property and Anti-Counterfeiting 73
10 Traceability or Authentication? 81
PART 2 AUTHENTICATION
11 What Is Authentication? 87
12 Authentication of the Person 93
13 Authentication of Bulk Products 97
14 On-Dose and In-Dose Authentication 103
15 Analytical Detection of Counterfeit Dosage Forms 113
16 The Role of Packaging 127
17 Printing Technologies 135
18 Security Labels 145
19 Holograms and DOVIDs 153
20 Specialty Inks 159
21 Covert Taggants and Forensic Markers 165
22 General Conclusions on Printed Packaging and Security Labels 169
23 Security of Primary Packaging 173
24 Security of Secondary Packaging 193
25 Analytical Methods for Packaging 205
26 Security of Other Packaging Types 209
27 Bulk Packaging and Transport Security 215
PART 3 PRODUCT TRACKING
28 Rationale for Pharmaceutical Tracking 225
29 Tracking Technologies 231
30 Data Format, Generation, and Storage 247
31 Management of Packaging Hierarchy 257
32 Geographical Perspectives 269
33 Product Tracking in Other Industries 291
34 Supply Chain Security Processes 295
35 Implementing Anti-Counterfeiting Initiatives--Practical Issues 303
PART 4 CONCLUSIONS AND THE FUTURE
36 Where Do We Go from Here? 313
37 New Models, New Approaches 321
38 Selected Examples from Around the World 329
PART 5 FURTHER RESOURCES
A PATIENT'S GUIDE TO AVOIDING COUNTERFEIT DRUGS 337
NOTES AND REFERENCES 343
GLOSSARY 363
INFORMATION SOURCES 379
DRUG REGULATORS 385
INDEX 391
"Pharmaceutical Anti-Counterfeiting" covers the key concepts and explains the available options in pharmaceutical anti-counterfeiting including a mix of policy, strategy, tactics and practical implementation tips. A must-read for those determined to do something about counterfeit pharmaceutical and healthcare products, and will prove useful to brand protection professionals in other industries." (Chemanager, 24 January 2012)
"For those determined to take an action against counterfeit pharmaceutical and healthcare products, will find the book useful." (The Holography Times, 1 December 2011)
"Using accessible and interesting language, Mark Davison talks the reader right the way through the issue of drug counterfeiting - its origins and context within healthcare , the risks presented to companies and consumers alike, anti-counterfeiting strategies and technologies - the result being a definitive guide to the inner workings of the counterfeit industry and a myriad of ways to stymie the counterfeiter's every step ... Reading this book will provide any pharmaceutical brand owner with a solid and informed grounding for making any decisions related to anti-counterfeiting strategy." (Notofakes.com, 16 November 2011)
"In writing this book Davison has made a great contribution to the global fight against counterfeit drugs. For the first time we have a single reference that collects explanations of every significant anti-counterfeiting technology and approach used around the globe, including both sensory authentication and traceability technologies." (RxTrace, September 2011)
"Best Pharma Anit-Counterfeiting Book Ever...Davison does not back away from or avoid pointing out conflicts and disagreements that exist between approaches to solving problems (digital vs. physical authentication), but he is quick to help the reader find the strongest solution by seeing the ways that solutions and technologies can work together." (Randall Burgess, Pharmaceutical AntiCounterfeiting Blog, October 5, 2011)
"Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs by Mark Davison succeeds in providing a handbook for professionals involved in product security and brand protection. . . Davison has a great deal of industry experience in pharmaceuticals as well as product security and is well positioned and qualified to be the one to write this book. The industry owes him a debt of gratitude for committing himself to this effort." (Pharma AntiCounterfeiting News, 1 August 2011)
"Cambridge-based consultant and entrepreneur Mark Davison, CEO of Blue Sphere Health Ltd, has written a comprehensive guide for drug company executives, technology vendors, healthcare professionals and policy-makers. . . This newly-released 426pp volume is a must-read primer for those determined to do something about counterfeit pharmaceutical and healthcare products, and will prove useful to brand protection professionals in other industries." (Cambridge Network , 6 September 2011)
