Pharmaceutical Anti-Counterfeiting

PREFACE xxi
 
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

MARK DAVISON, CEO of Blue Sphere Health, is a pharmaceutical consultant and entrepreneur with more than twenty years of industry experience. He was formerly business development director for healthcare at SICPA, one of the world's leading anti-counterfeiting and product security technology providers, where he gained an in-depth, global perspective on counterfeit pharmaceuticals and medical devices. He is a writer, seminar leader, and international conference speaker on pharmaceutical security matters. His article "Drugs for the Developing World: Obligation, Opportunity and Threat" won the Royal Society of Medicine Oswald Morton Essay Prize in 2010.

"The book is an excellent resource and I would recommend it to anyone with either an interest in anti-counterfeiting technology or pharmaceutical counterfeiting in general." ( International Journal of Comparative and Applied Criminal Justice , 26 April 2012) "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

"The book is an excellent resource and I would recommend it to anyone with either an interest in anti-counterfeiting technology or pharmaceutical counterfeiting in general." (International Journal of Comparative and Applied Criminal Justice, 26 April 2012)
 
"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