Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs

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John Wiley & Sons, Aug 4, 2011 - Medical - 426 pages
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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.
 

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Contents

Marketing
11
Risks and Costs of Counterfeit Pharmaceuticals
21
AntiCounterfeiting Definitions
35
Protecting and Educating Consumers
49
Social Networking and Blogging as AntiCounterfeiting
52
Government Issues
65
Intellectual Property and AntiCounterfeiting
73
Traceability or Authentication?
81
Analytical Methods for Packaging
205
Bulk Packaging and Transport Security
215
RFID and GPS
219
Rationale for Pharmaceutical Tracking
225
Tracking Technologies
231
Data Format Generation and Storage
247
Management of Packaging Hierarchy
257
Digital Signatures
266

AUTHENTICATION
85
Authentication of the Person
93
OnDose and InDose Authentication
103
Analytical Detection of Counterfeit Dosage Forms
113
Liquid Chromatography LC
121
The Role of Packaging
127
Printing Technologies
135
How Much Surface Area Is Available
140
Holograms and DOVIDs
153
Specialty Inks
159
Covert Taggants and Forensic Markers
165
Security of Primary Packaging
173
Security of Secondary Packaging
193
Product Tracking in Other Industries
291
Implementing AntiCounterfeiting InitiativesPractical Issues
303
CONCLUSIONS AND THE FUTURE
311
Risk of Incomplete Action
314
New Models New Approaches
321
Selected Examples from Around the World
329
FURTHER RESOURCES
335
NOTES AND REFERENCES
343
GLOSSARY
363
INFORMATION SOURCES
379
DRUG REGULATORS
385
INDEX
391
Copyright

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About the author (2011)

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.

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