Pharmaceutical Anti-Counterfeiting

400 Pages·2011·2.81 MB·English

Pharmaceutical
Anti-Counterfeiting
Pharmaceutical
Anti-Counterfeiting
Combating the Real Danger
from Fake Drugs
Mark Davison
Blue Sphere Health Ltd.
Cambridge, U.K.
A JOHN WILEY & SONS, INC., PUBLICATION
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LibraryofCongressCataloging-in-PublicationData:
Davison,Mark,1968Mar.1–
Pharmaceuticalanti-counterfeiting:combatingtherealdangerfromfakedrugs/MarkDavison.
p.;cm.
Includesindex.
ISBN978-0-470-61617-8 (cloth)
1. Productcounterfeiting.2. Drugadulteration.I. Title.
[DNLM:1. DrugContamination.2. ConsumerProductSafety.3. Fraud–prevention
&control.4. PharmaceuticalPreparations–standards. QV773]
HD9665.5.D382011
615.1068(cid:2)4–dc22
2010044590
PrintedintheUnitedStatesofAmerica
oBookISBN:9781118023679
ePDFISBN:9781118023655
ePubISBN:9781118023662
10987654321
For Gillian, Daniel, and Matthew
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
vii
viii CONTENTS
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
CONTENTS ix
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
x CONTENTS
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
CONTENTS xi
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
Cliche´ or Pad Printing / 138
Embossing and Debossing / 138
Laser Engraving / 138
Inkjet Printing / 138
Some Technical Considerations / 140
xii CONTENTS
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