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