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

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ISBN-13:
9780470616178
Einband:
Buch
Erscheinungsdatum:
01.07.2011
Seiten:
402
Autor:
Mark Davison
Gewicht:
544 g
Format:
231x155x23 mm
Sprache:
Englisch
Beschreibung:

Effective strategies to deal with the growingproblem 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 e-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.
PREFACE xxiACKNOWLEDGMENTS 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 Fe
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.