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.
Table of Contents:
PREFACE xxi ACKNOWLEDGMENTS xxiii
PART 1 GENERAL THEMES
1 Introduction 3
Why Write This Book? 3
Doesn’t This Book Just Help the Criminals? 4
Who Is the Book Aimed At? 5
2 Origins and Context of Counterfeiting in Healthcare 7
Background and Nature of the Threat 7
R&D Costs, Patent Life, and the Profit Imperative 9
A Low Cost, High Profit Business 10
Research and Development 10
Regulatory Approval 10
Manufacturing 11
Packaging 11
Marketing 11
Logistics 12
Permissive Legal Environment 12
Role of the Internet 13
Global Growth of Counterfeiting 14
3 A Snapshot of the Problem 15
Case Study: Malaria 18
4 Risks and Costs of Counterfeit Pharmaceuticals 21
Risks and Costs for Consumers 21
The Drugs Do Not Work 21
Toxic Products 23
Fear and Mistrust of the Medical Profession 24
Risks and Costs for Businesses 24
Revenue Loss 24
Brand Erosion 28
Litigation 30
Loss of Public Trust 30
Risks and Costs for Governments 31
Public Concern 31
Increased Social and Healthcare Costs 32
Tension between Affordability and Quality 34
Increased Regulatory Costs 34
5 Anti-Counterfeiting Definitions 35
Terminology and General Principles 36
Counterfeiting 38
Diversion 45
Parallel Trade and Re-Importation 46
6 Protecting and Educating Consumers 49
Consumer Behavior 49
Engagement with the Consumer 50
Engaging Through Social Media 51
Social Networking and Blogging as Anti-Counterfeiting Tools 52
Consumer-Focused Authentication Technology 54
Cultural Sensitivity 55
7 Business Risks and Strategy 57
Establishing a Baseline and Prioritizing At-Risk Products 59
Doing the Simple Things 60
Used Manufacturing Equipment 61
Layering of Countermeasures 62
Information Management and "Need-To-Know" 62
Integration with Corporate Strategy 63
8 Government Issues 65
Legal Framework 66
Link with Reimbursement and Social Healthcare 68
Law Enforcement Issues 69
Data Mining 69
Money Transfer and Credit Cards 70
Internet Service Providers and Search Engines 71
9 Intellectual Property and Anti-Counterfeiting 73
Establishing Ownership of Intellectual Property Rights (IPR) 74
Patents 74
Patenting of Security Technologies 75
Trademarks 75
Online Intellectual Property 78
Criminal Prosecution Versus Civil Suit 79
10 Traceability or Authentication? 81
PART 2 AUTHENTICATION
11 What Is Authentication? 87
Digital Versus Sensory Authentication 88
Types of Authentication Technologies 89
International Standards and Norms 91
12 Authentication of the Person 93
13 Authentication of Bulk Products 97
14 On-Dose and In-Dose Authentication 103
On-Dose Features 104
In-Dose Features 106
Regulatory Reporting 109
Labeling and Disclosure of On-Dose and In-Dose Approaches 110
Concealment of Identity 110
On-Product and In-Product Approaches Aimed at Consumers 111
Formulation Additives in Products other than SODFs 112
15 Analytical Detection of Counterfeit Dosage Forms 113
Simple Chemical and Physical Analysis Methods 114
Colorimetry 115
Hardness and Dissolution Tests 115
Thin Layer Chromatography (TLC) 116
Ultraviolet and Visible Spectroscopy 117
Laboratory-Based Methods 118
Atomic Absorption Spectrophotometry (AAS) 118
X-ray Techniques 119
Nuclear Magnetic Resonance (NMR) Spectroscopy 119
Mass Spectrometry (MS) 120
Gas Chromatography (GC) 120
Liquid Chromatography (LC) 121
Capillary Electrophoresis (CE) 121
Forensic Palynology 121
Non-Destructive Methods 123
X-ray Diffraction 123
Infrared Spectroscopy 123
Fourier Transform Infrared (FTIR) Spectroscopy 124
Near-Infrared (NIR) 125
Raman Spectroscopy 125
Terahertz Imaging 126
Conclusions on the Analysis of Dosage Forms 126
16 The Role of Packaging 127
Packaging Design 128
Being Just Slightly Better than the Opposition 130
Security Features on Packaging 131
Integration into Packaging: Bulk Packaging Material at Source 131
Integration into Packaging: By Design Complexity 132
Addition to Packaging: Labels, Printed Packaging, etc. 132
17 Printing Technologies 135
Offset Lithography 135
Flexography 136
Gravure 136
Screen Printing 137
Laser Printing 137
Clichéor Pad Printing 138
Embossing and Debossing 138
Laser Engraving 138
Inkjet Printing 138
Some Technical Considerations 140
How Much Surface Area Is Available
for the Feature? 140
What Is the Budget? 141
Is the Product Surface Flat or Curved? 141
Is the Product Orientation Predictable and Constant? 142
How Much Time Is Available? 142
Direct Application onto Packaging Versus Use of Labeling 143
18 Security Labels 145
Adhesive 146
Frangibility 147
Security Cuts and Perforation 148
Voiding 148
Alignment 149
General Considerations 149
Label Reconciliation and Storage Conditions 151
19 Holograms and DOVIDs 153
Types of Holograms 154
Other Optically Variable Devices 156
20 Specialty Inks 159
Colorshift Inks 160
Other Security Inks 161
Iridescent 161
Metallic 162
Fluorescent 162
Bi-fluorescent 162
Thermochromic 163
Photochromic 163
Coin Reactive 163
Microstructured Taggants 163
21 Covert Taggants and Forensic Markers 165
Infrared-Absorbing Inks 165
Forensic Markers 166
Isotopic Tags 167
DNA Markers 167
Antibody Systems 168
X-Ray Detection of Specific Added Elements 168
Other Markers 168
22 General Conclusions on Printed Packaging and Security Labels 169
Layering 169
Guidelines 170
Flexibility and Vigilance 170
23 Security of Primary Packaging 173
Contact with Dosage Form 173
Types of Primary Packaging 175
Blister Packs 175
Wallets, Carded Blisters, Compliance-Prompting Packaging, etc. 179
Strip Packs, Sachets, and Pouches 180
Bottles or Jars 181
Tubes 183
Vials and Ampoules 184
Other Dosage Forms 187
Syringes 187
Inhalers and Related Devices 187
Implantable Drug-Containing Devices 189
Equipment and Consumables for Diagnostic Products 189
Medical Devices 190
Analytical Considerations for Primary Packaging 191
24 Security of Secondary Packaging 193
Role of Secondary Cartons 193
Outsourced or In-House Application 196
Outsourced Security Features 198
In-House Security Application 198
Planning Ahead 199
Tamper-Evidence: Seals, Shrink Wraps, Pack Closures, and Adhesive 200
Definitions 200
Snap-Off Caps 200
Glued End-Flaps 201
Seals 201
Induction Seals 203
Shrink Wrap and Tear Tape 203
25 Analytical Methods for Packaging 205
Visual Inspection (Visible Light) 206
Other Optical Methods (UV, IR, Polarized Light) 207
Other Methods 207
26 Security of Other Packaging Types 209
Drug–Device Combinations 209
Patient Information Leaflets and Labels 211
Other Documentation 212
Certificates of Analysis, Import Licenses, etc. 212
Prescriptions 213
Reimbursement 213
27 Bulk Packaging and Transport Security 215
Theft of Cargo from Trucks and Warehouses 216
Vigilance 218
Information Management 218
Training 218
Other Factors 219
Technology Approaches: RFID and GPS 219
Radio Frequency Identification (RFID) Technology 219
Global Positioning System (GPS) Technology 220
PART 3 PRODUCT TRACKING
28 Rationale for Pharmaceutical Tracking 225
29 Tracking Technologies 231
Serial Numbers 232
Linear Bar Codes 234
Matrix Codes 234
2D Codes and Mobile Phones 236
Technical Issues with 2D Codes 237
Radio Frequency Identification (RFID) 238
Mobile Phones 242
Other Tracking Technologies 244
Applicability of Tracking Systems Worldwide 245
30 Data Format, Generation, and Storage 247
Serialization 247
Randomization 250
Pedigree/ePedigree 251
Track and Trace 253
Fingerprinting 254
Physical Authentication + Digital Tracking = Enhanced Security 256
31 Management of Packaging Hierarchy 257
Inference Approaches 257
"Bookend" Approaches 262
Batch Level Traceability Versus Full Serialization 266
Digital Signatures 266
Supply Chain Benefits 266
32 Geographical Perspectives 269
U.S. State Laws 269
California 270
Federal Initiatives in the United States 271
Europe 273
The Concept of "Medicrime" 275
European Committee on Crime Problems (CDPC) 275
Purpose 276
Scope 276
Definitions 276
Manufacturing of Counterfeits 278
Supplying, Offering to Supply, and Trafficking in Counterfeits 278
Falsification of Documents 279
Similar Crimes Involving Threats to Public Health 279
Aiding or Abetting and Attempt 279
Jurisdiction 280
Corporate Liability 281
Sanctions and Measures 281
Aggravating Circumstances 282
Criminal Investigations 282
Cooperation and Information Exchange 283
Measures for Prevention 283
Measures for Protection 284
International Cooperation 284
Monitoring Mechanism 284
EFPIA Pilot Coding Project 285
India 287
Malaysia Meditag System 288
Turkey 289
Brazil 290
33 Product Tracking in Other Industries 291
Excise Products: Tobacco and Alcohol 291
Food and Beverage 292
Toys 293
Conclusions 294
34 Supply Chain Security Processes 295
General Security 295
Forward Logistics 296
Reverse Logistics: Returns and Customer Complaints 297
Insider Fraud 298
Security of Security Materials 301
Security of Evidence 302
35 Implementing Anti-Counterfeiting Initiatives—Practical Issues 303
How to Work Together: Getting the Best from Security Partnerships 303
What Do Pharmaceutical Companies Need? 304
What Do Security Suppliers Need? 305
What Do Print and Packaging Suppliers Need? 306
General Observations on Business Models for Product Security 307
Unit Fee Pricing 308
Commodity Pricing 308
Insurance Premium 309
Other Pharmaceutical Service Industries 309
PART 4 CONCLUSIONS AND THE FUTURE
36 Where Do We Go from Here? 313
Future Scenario: Risk of Inaction 313
Future Scenario: Risk of Incomplete Action 314
Future Scenario: Risk of Inappropriate Action 314
Future Policy Approaches 315
Future Authentication Approaches 317
Future Traceability Approaches 318
Global Standards, Worldwide Tracking 318
RFID 319
GPS 319
37 New Models, New Approaches 321
Non-Technological Approaches 322
Lack of Availability of Genuine Drugs 323
Huge Profit Potential 323
Low Entry Costs 324
Law Enforcement Issues 324
Legal Approaches 324
Conclusions 325
38 Selected Examples from Around the World 329
Argentina 329
Brazil 330
Canada 330
China 330
European Union 331
India 331
Laos and Southeast Asia 331
Nigeria 331
Russia 332
Uganda/East Africa 332
United Kingdom 333
United States 333
PART 5 FURTHER RESOURCES
A PATIENT’S GUIDE TO AVOIDING COUNTERFEIT DRUGS 337
Do I Need This Particular Medication? 337
Is My Desired Drug Approved and Available in My Country? 338
Are My Drug Sources and Methods of Purchase Safe? 338
What Does the Packaging Look Like? 339
What Does the Product Itself Look Like? 340
When Taking the Drug 341
After Taking the Drug 341
NOTES AND REFERENCES 343
GLOSSARY 363
INFORMATION SOURCES 379
General Readership 379
Specialist Readership 380
News 381
Education 381
Organizations 381
DRUG REGULATORS 385
INDEX 391
