Pharmaceutical anti-counterfeiting: combating the real danger from fake drugs
Saved in:
| Main Author: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Hoboken, NJ
Wiley
2011
|
| Subjects: | |
| Online Access: | Inhaltsverzeichnis Klappentext |
| Physical Description: | XXIII, 402 S. graph. Darst. |
| ISBN: | 9780470616178 |
Staff View
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| 245 | 1 | 0 | |a Pharmaceutical anti-counterfeiting |b combating the real danger from fake drugs |c Mark Davison |
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| 336 | |b txt |2 rdacontent | ||
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| 650 | 4 | |a Product counterfeiting | |
| 650 | 4 | |a Drug adulteration | |
| 650 | 4 | |a Drug Contamination | |
| 650 | 4 | |a Consumer Product Safety | |
| 650 | 4 | |a Fraud |x prevention & control | |
| 650 | 4 | |a Pharmaceutical Preparations |x standards | |
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Record in the Search Index
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|---|---|
| adam_text | 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
Vili
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
ІХ
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
ХІ
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
Cliché
or Pad Printing
/ 138
Embossing and Debossing
/ 138
Laser Engraving
/ 138
InkJet Printing
/ 138
Some Technical Considerations
/ 140
XU 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
В і
-fluorescent
/ 162
Thermochromic
/ 163
Photochrom
ic /
163
Coin Reactive
/ 163
Microstructured Taggants
/ 163
CONTENTS
ХНІ
21
Covert Taggants and Forensic Markers
165
Infrared-Absorbing Inks
/ 165
Forensic Markers
/ 166
Isotopie
Tags
/ 167
DNA
Markers
/ 167
Antibody Systems
/ 168
Х
-Ray Detection of Specific Added Elements
/
1
68
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
XIV
CONTENTS
IA
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
CONTENTS
XV
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
XVI
CONTENTS
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
CONTENTS
XVII
33
Product
Tracking in Other Industries
291
Excise Products: Tobacco and Alcohol
/ 29]
Food and Beverage
/ 292
Toys
/ 293
Conclusions
/ 294
34
Supply Chain Security Processes
295
Genera] 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
XViii
CONTENTS
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
CONTENTS
ХІХ
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
Effective
strategies to deal with the growing
problem of counterfeit drugs
Counterfeit and illegally diverted drugs are a global problem representing a serious
threat to patients and to our healthcare systems. To combat fake medicines you
need to understand both the problems and the solutions. This book gives you these
vital perspectives. It not only provides a detailed examination of the causes and
consequences of pharmaceutical counterfeiting, it also provides practical advice
and tested and proven strategies to deal with this growing threat to the international
drug supply. Moreover, it investigates and explains the tactics and technologies you
need to protect your patients, brands, and profits.
Addressing both business and technical issues, this book enables you to understand
and tackle the problem of counterfeit and illegally diverted drugs on all fronts:
•
Guides you through the complex legal and compliance issues
•
Explores the complexities of the drug supply chain, demonstrating why
certain approaches to reducing counterfeit drugs are more likely to work
than others
•
Sets forth the pros and cons of technologies designed to authenticate drugs
and secure packaging, to enable traceability or
е
-pedigree,
and to protect the
supply chain
•
Offers an easy-to-read guide for patients to help them avoid counterfeit drugs
•
Illustrates key problems and solutions using realistic examples
•
Features anti-counterfeiting case studies from Africa, Asia, Europe, Latin
America and North America
Covering pharmaceutical security from factory to patient, this book helps you better
understand the issues around counterfeiting and diversion and then implement
effective strategies to fight back against these pharmaceutical crimes.
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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ISBN
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90000
9ll780470 616178l
|
| any_adam_object | 1 |
| author | Davison, Mark |
| author_facet | Davison, Mark |
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| dewey-full | 615.1068/4 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.1068/4 |
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| dewey-sort | 3615.1068 14 |
| dewey-tens | 610 - Medicine and health |
| discipline | Wirtschaftswissenschaften Medizin |
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| id | DE-604.BV039552336 |
| illustrated | Illustrated |
| indexdate | 2024-07-10T00:06:06Z |
| institution | BVB |
| isbn | 9780470616178 |
| language | English |
| lccn | 2010044590 |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-024404191 |
| oclc_num | 750978205 |
| open_access_boolean | |
| owner | DE-703 |
| owner_facet | DE-703 |
| physical | XXIII, 402 S. graph. Darst. |
| publishDate | 2011 |
| publishDateSearch | 2011 |
| publishDateSort | 2011 |
| publisher | Wiley |
| record_format | marc |
| spelling | Davison, Mark Verfasser aut Pharmaceutical anti-counterfeiting combating the real danger from fake drugs Mark Davison Hoboken, NJ Wiley 2011 XXIII, 402 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Product counterfeiting Drug adulteration Drug Contamination Consumer Product Safety Fraud prevention & control Pharmaceutical Preparations standards Imitationsprodukt (DE-588)4232796-9 gnd rswk-swf Arzneimittel (DE-588)4003115-9 gnd rswk-swf Arzneimittel (DE-588)4003115-9 s Imitationsprodukt (DE-588)4232796-9 s DE-604 Digitalisierung UB Bayreuth application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=024404191&sequence=000003&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis Digitalisierung UB Bayreuth application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=024404191&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Klappentext |
| spellingShingle | Davison, Mark Pharmaceutical anti-counterfeiting combating the real danger from fake drugs Product counterfeiting Drug adulteration Drug Contamination Consumer Product Safety Fraud prevention & control Pharmaceutical Preparations standards Imitationsprodukt (DE-588)4232796-9 gnd Arzneimittel (DE-588)4003115-9 gnd |
| subject_GND | (DE-588)4232796-9 (DE-588)4003115-9 |
| title | Pharmaceutical anti-counterfeiting combating the real danger from fake drugs |
| title_auth | Pharmaceutical anti-counterfeiting combating the real danger from fake drugs |
| title_exact_search | Pharmaceutical anti-counterfeiting combating the real danger from fake drugs |
| title_full | Pharmaceutical anti-counterfeiting combating the real danger from fake drugs Mark Davison |
| title_fullStr | Pharmaceutical anti-counterfeiting combating the real danger from fake drugs Mark Davison |
| title_full_unstemmed | Pharmaceutical anti-counterfeiting combating the real danger from fake drugs Mark Davison |
| title_short | Pharmaceutical anti-counterfeiting |
| title_sort | pharmaceutical anti counterfeiting combating the real danger from fake drugs |
| title_sub | combating the real danger from fake drugs |
| topic | Product counterfeiting Drug adulteration Drug Contamination Consumer Product Safety Fraud prevention & control Pharmaceutical Preparations standards Imitationsprodukt (DE-588)4232796-9 gnd Arzneimittel (DE-588)4003115-9 gnd |
| topic_facet | Product counterfeiting Drug adulteration Drug Contamination Consumer Product Safety Fraud prevention & control Pharmaceutical Preparations standards Imitationsprodukt Arzneimittel |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=024404191&sequence=000003&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=024404191&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA |
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