Trends in Counterfeit Drugs

Description

Counterfeit drugs continue to infiltrate the drug market in the United States, causing illness and death. This book addresses this issue and examines the recent trends in drug counterfeiting over the past 5-10 years. The text shows perspectives from crime lab and toxicology lab personnel and academic researchers, and includes topics such as a history of cases and issues with counterfeit drugs, trends observed in forensic labs, instrumental methods and approaches used in detecting counterfeit medicines, and policy approaches for controlling counterfeit drugs. There is a focus on ways to reduce counterfeit drugs in the market, to help improve the health and safety of people all over the world. Features : Focuses on recent (5-10) year trends in counterfeit drugs and analysis. Shows perspectives from crime lab and toxicology lab personnel and academic researchers. Focuses on drugs seized by law enforcement and approaches to reducing counterfeit medicine in the market. Discusses the detection and analysis of counterfeit drugs, and appropriate tools for combating this issue. Emphasizes the global impact of illegal medicines. 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