Trends in Counterfeit Drugs

Cover
Half Title
Series Page
Title Page
Copyright Page
Dedication
Table of Contents
Foreword
Preface
Acknowledgements
List of Abbreviations
About the Editor
List of Contributors
Chapter 1 Introduction to Counterfeit Drugs
	1.1 Introduction
		1.1.1 Counterfeit Drugs
		1.1.2 Defining a Counterfeit Drug
			1.1.2.1 Establishment of an Authentic Drug Product Reference Library
			1.1.2.2 The Manufacturing Process
			1.1.2.3 Types of Counterfeits
		1.1.3 Factors Fostering Drug Counterfeiting
			1.1.3.1 Internet and Demand
			1.1.3.2 Health Crises
			1.1.3.3 Expensive Drug Products
		1.1.4 Analysis of Counterfeit Drugs
			1.1.4.1 Physical Methods (P)
			1.1.4.2 Authenticity Methods (A)
			1.1.4.3 Chemical-Assay-Impurity Methods (C)
			1.1.4.4 Field-Deployable Rapid Screening Technologies (FA)
	1.2 Conclusions
	References
Chapter 2 History and Overview of Counterfeit Drugs Cases
	2.1 The History of the Counterfeit Drug Marketplace
		2.1.1 Definition of Counterfeit Drugs
		2.1.2 Methods of Counterfeit Drug Identification
		2.1.3 Internet Pharmacies and Counterfeit Drugs
			2.1.3.1 The Problem of Internet “Canadian” Pharmacies
			2.1.3.2 Illegal Counterfeit Markets and the Dark Web
			2.1.3.3 Global Counterfeit Drug Trafficking
		2.1.4 Counterfeit Drug Seizures
		2.1.5 Response to the Counterfeit Drug Trade
		2.1.6 Drugs Most Prone to Counterfeiting
			2.1.6.1 Counterfeit Lifestyle Drugs
			2.1.6.2 Counterfeit Life-saving Medicines
			2.1.6.3 Counterfeit Antimalarial Medicines
			2.1.6.4 Counterfeit Pain Medicine
			2.1.6.5 Counterfeit Cannabinoids
			2.1.6.6 Counterfeit Benzodiazepines
			2.1.6.7 Counterfeit COVID-19 Medicines
	2.2 Conclusion
	References
Chapter 3 Fake Pharmaceuticals: Clandestine Tablets and Counterfeit Medicines
	3.1 Overview of Seized Drug Evidence and Paraphernalia
	3.2 Commonly Counterfeited Drugs
	3.3 Sources of Fake Pharmaceuticals
	3.4 Examples of Fake Pharmaceuticals
	3.5 Monitoring Sources of Fake Pharmaceuticals
	3.6 Cases and Prosecutions
	3.7 Conclusion
	References
Chapter 4 Results from a Survey of Trends in Seized Counterfeit Drugs
	4.1 Introduction
	4.2 Methods
	4.3 Results
	4.4 Discussion
	4.5 Conclusion
	Acknowledgments
	References
Chapter 5 Fentanyl Adulteration of Drugs and Seizure Trends
	5.1 Introduction
	5.2 Methods
	5.3 Results
	5.4 Discussion
	5.5 Conclusion
	Acknowledgments
	References
Chapter 6 Detection and Analysis of Counterfeit Drugs
	6.1 Introduction
	6.2 Field Testing versus Laboratory Testing
		6.2.1 Field Testing
		6.2.2 Laboratory Testing
	6.3 Deployment Approaches for Testing Solution Platforms
		6.3.1 Portable Platforms
		6.3.2 Laboratory Platform
	6.4 Methods of Analysis
		6.4.1 Non-Chemical Approaches
			6.4.1.1 Track and Trace
			6.4.1.2 Visual
			6.4.1.3 Physical
		6.4.2 Chemical Approaches
			6.4.2.1 Class Analysis
			6.4.2.2 Vibrational Spectroscopy
			6.4.2.3 Mass Spectrometry (MS)
			6.4.2.4 Ion Mobility Spectrometry (IMS)
			6.4.2.5 X-ray Fluorescence (XRF) Spectroscopy for Elemental Analysis
			6.4.2.6 Nuclear Magnetic Resonance Spectroscopy
	6.5 Conclusions
	Acknowledgments
	Acronyms and Abbreviations
	References
Chapter 7 Trends in Counterfeit Drugs and Toxicology
	7.1 Introduction
	7.2 Counterfeit Pharmaceuticals—Fake Drugs
	7.3 Illicit Opioids
	7.4 New Psychoactive Substances in the Counterfeit Drug Market
	7.5 Conclusion
	References
Chapter 8 Analytical Tools for Examining Counterfeit Drug Products
	8.1 Overview
	8.2 Anti-Counterfeiting Technology and Preventative Measures
	8.3 Counterfeit Detection Methods
		8.3.1 Reviews
		8.3.2 Printing Analysis
			8.3.2.1 Graphics Printing
			8.3.2.2 Variable Data Printing
			8.3.2.3 Printing Defect Analysis
		8.3.3 Forensic Image Analysis (IA)
			8.3.3.1 2D Tablet Face Analysis
			8.3.3.2 3D Tablet Face Analysis
		8.3.4 Visual Analysis Tools
		8.3.5 Rapid Low-Cost Analytical Instruments/Methods
		8.3.6 Near Infrared (NIR) Spectroscopic Imaging
		8.3.7 Near Infrared Spectroscopy (NIR)
		8.3.8 Benchtop Raman Spectroscopy
		8.3.9 Handheld Raman Spectroscopy
		8.3.10 Fourier Transform Infrared (FT-IR) Spectroscopy
		8.3.11 Nuclear Magnetic Resonance (NMR) Spectroscopy
		8.3.12 X-Ray Spectroscopy
		8.3.13 Gas Chromatography with Mass Spectrometry (GC/MS)
		8.3.14 High-Performance Liquid Chromatography (HPLC)
		8.3.15 Ambient Ionization Mass Spectrometry
		8.3.16 Less Commonly Employed Techniques/Methods
	8.4 Guidance for Examining Suspect Counterfeit Drug Products
	8.5 Current Counterfeit Drug Analysis Trends at FDA’s Forensic Chemistry Center
		8.5.1 Example Analysis of Counterfeit Tablets Labeled to Contain Controlled Substances
		8.5.2 Recent Trends Observed by FCC for Opioid-Containing Counterfeit Drug Products
		8.5.3 Biotherapeutics
			8.5.3.1 Example Analysis of Suspect Counterfeit Altuzan
			8.5.3.2 Altuzan Example Printing Analysis
			8.5.3.3 Altuzan Example Chemical Analysis
			8.5.3.4 Altuzan Example Discussion
			8.5.3.5 Challenges and Potential Solutions for Authenticating Counterfeit Biotherapeutics
	8.6 Chapter Conclusions
	Acknowledgements
	References
Chapter 9 Coordinated Response to Poisonings and Fatalities from Counterfeit Tablets
	9.1 In the Beginning
	9.2 At the Hospital
	9.3 At the Morgue
	9.4 In the Public Eye
	9.5 In the Aftermath
	9.6 In the End
	Acknowledgments
	Bibliography
Chapter 10 Laws and Procedures to Counter the Problem of Counterfeit Drugs
	10.1 Introduction
	10.2 Drug Quality and Security Act
	10.3 Federal Food, Drug, and Cosmetic Act (FD&C Act)
	10.4 Other FDA Actions
	10.5 SHOP SAFE Act
	10.6 Lanham Act—Combatting Price-Gouging and Counterfeit Issues through Trademarks
	10.7 Other Actions or Recommendations
	10.8 Conclusion
	References
Index