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,…mehr
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.
Inhaltsangabe
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 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
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 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
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