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

ISBN: 978-0-470-61617-8
426 pages
July 2011
Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs (0470616172) cover image
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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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

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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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“The book is an excellent resource and I would recommend it to anyone with either an interest in anti-counterfeiting technology or pharmaceutical counterfeiting in general.”   (International Journal of Comparative and Applied Criminal Justice, 26 April 2012)

"Pharmaceutical Anti-Counterfeiting" covers the key concepts and explains the available options in pharmaceutical anti-counterfeiting including a mix of policy, strategy, tactics and practical implementation tips. A must-read for those determined to do something about counterfeit pharmaceutical and healthcare products, and will prove useful to brand protection professionals in other industries." (Chemanager, 24 January 2012)

"For those determined to take an action against counterfeit pharmaceutical and healthcare products, will find the book useful." (The Holography Times, 1 December 2011)

"Using accessible and interesting language, Mark Davison talks the reader right the way through the issue of drug counterfeiting - its origins and context within healthcare , the risks presented to companies and consumers alike, anti-counterfeiting strategies and technologies - the result being a definitive guide to the inner workings of the counterfeit industry and a myriad of ways to stymie the counterfeiter's every step ... Reading this book will provide any pharmaceutical brand owner with a solid and informed grounding for making any decisions related to anti-counterfeiting strategy." (Notofakes.com, 16 November 2011)

"In writing this book Davison has made a great contribution to the global fight against counterfeit drugs. For the first time we have a single reference that collects explanations of every significant anti-counterfeiting technology and approach used around the globe, including both sensory authentication and traceability technologies." (RxTrace, September 2011)

"Best Pharma Anit-Counterfeiting Book Ever...Davison does not back away from or avoid pointing out conflicts and disagreements that exist between approaches to solving problems (digital vs. physical authentication), but he is quick to help the reader find the strongest solution by seeing the ways that solutions and technologies can work together." (Randall Burgess, Pharmaceutical AntiCounterfeiting Blog, October 5, 2011)

"Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs by Mark Davison succeeds in providing a handbook for professionals involved in product security and brand protection. . . Davison has a great deal of industry experience in pharmaceuticals as well as product security and is well positioned and qualified to be the one to write this book. The industry owes him a debt of gratitude for committing himself to this effort." (Pharma AntiCounterfeiting News, 1 August 2011)

"Cambridge-based consultant and entrepreneur Mark Davison, CEO of Blue Sphere Health Ltd, has written a comprehensive guide for drug company executives, technology vendors, healthcare professionals and policy-makers. . . This newly-released 426pp volume is a must-read primer for those determined to do something about counterfeit pharmaceutical and healthcare products, and will prove useful to brand protection professionals in other industries." (Cambridge Network , 6 September 2011)

 

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August 08, 2011
Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs

HOBOKEN, NJ - Wiley is pleased to announce the publication of Pharmaceutical Anti-Counterfeiting:  Combating the Real Danger from Fake Drugs, a new book that will aid law makers, drug companies, technology vendors, doctors and pharmacists in fight against counterfeit medicines

The scourge of counterfeit drugs poses an ever-increasing threat to the global healthcare system.  The problem is not limited to internet pharmacies or developing countries but has the potential to affect all of us.  Fighting back against fake and diverted medicines requires a mix of laws, processes and technologies, underpinned by a sound understanding of the strategic principles.  There are already a number of major initiatives to increase the traceability of drugs and improve supply chain security, such as serialization, e-pedigree, SMS verification etc.  Some of these will become mandatory requirements (for example in Europe and California) within a few years.  Individual companies also put security features on their packaging to aid in the authentication of their products when suspected fake drugs are identified. The number of technology options and legal obligations can be confusing and clear guidance has been hard to come by.

Pharmaceutical consultant Mark Davison, CEO of Blue Sphere Health Ltd, has written a comprehensive guide for drug company executives, technology vendors, healthcare professionals and policy-makers.  The book covers the key concepts and explains the available options in pharmaceutical anti-counterfeiting including a mix of policy, strategy, tactics and practical implementation tips.

This newly-released 426pp volume is a must-read primer for those determined to do something about counterfeit pharmaceutical and healthcare products, and will prove useful to brand protection professionals in other industries.

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