Pharmaceutical Anti-Counterfeiting: Combating The Real Danger From Fake Drugs

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.

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.

Part 1: General Themes.

Chapter 1: Introduction.

Chapter 2: Origins and Context of Counterfeiting in Healthcare.

Chapter 3: A Snapshot of the Problem.

Chapter 4: Risks and Costs of Counterfeit Pharmaceuticals.

Chapter 5: Anti-Counterfeiting Definitions.

Chapter 6: Protecting and Educating Consumers.

Chapter 7: Business Risks and Strategy.

Chapter 8: Government Issues.

Chapter 9: Intellectual Property and Anti-Counterfeiting.

Chapter 10: 'Track & Trace' or 'Authentication'?

Part 2: Authentication.

Chapter 11: What is Authentication?

Chapter 12: Authentication of the Person.

Chapter 13: Authentication of Bulk Products.

Chapter 14: On-Dose and In-Dose Authentication.

Chapter 15: Analytical Detection of Counterfeit Dosage Forms.

Chapter 16: The Role of Packaging.

Chapter 17: Printing Technologies.

Chapter 18: Security Labels.

Chapter 19: Holograms and DOVIDS.

Chapter 20: Specialty Inks.

Chapter 21: Covert Taggants and Forensic Markers.

Chapter 22: General Conclusions on Printed Packaging and Security Labels.

Chapter 23: Security of Primary Packaging.

Chapter 24: Security of Secondary Packaging.

Chapter 25: Analytical Methods for Packaging.

Chapter 26: Security of Other Packaging Types.

Chapter 27: Bulk Packaging and Transport Security.

Part 3: Product Tracking.

Chapter 28: Rationale for Pharmaceutical Tracking.

Chapter 29: Tracking Technologies.

Chapter 30: Data Format, Generation and Storage.

Chapter 31: Management of Packaging Hierarchy.

Chapter 32: Geographical Perspectives.

Chapter 33: Product Tracking in Other Industries.

Chapter 34: Supply Chain Security Processes.

Chapter 35: Implementing Anti-Counterfeiting Initiatives - Practical Issues.

Part 4: Conclusions and the Future.

Chapter 36: Where Do We Go From Here?

Chapter 37: New Models, New Approaches.

Chapter 38: Selected Examples from Around the World.

Part 5: Further Resources.

A Patient's Guide to Avoiding Counterfeit Drugs.

Notes and References.

Glossary.

Information Sources.

Drug Regulators.