Countering the Problem of Falsified and Substandard Drugs

Countering the Problem of Falsified and Substandard Drugs PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2013-06-20

Total Pages: 377

ISBN-13: 0309269393

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The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

Pharmaceutical Anti-Counterfeiting

Pharmaceutical Anti-Counterfeiting PDF

Author: Mark Davison

Publisher: John Wiley & Sons

Published: 2011-07-26

Total Pages: 432

ISBN-13: 0470616172

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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.

Counterfeit Medicines

Counterfeit Medicines PDF

Author: Jonathan Harper

Publisher: Council of Europe

Published: 2006-01-01

Total Pages: 242

ISBN-13: 9287158630

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This report has been commissioned by the Council of Europe as part of its ongoing activities to minimise the public health risks posed by the production of counterfeit medicines. It is based on surveys undertaken in 2003-04 within Council of Europe member states, as well as amongst pharmaceutical manufacturers and wholesalers in Europe. Issues considered include: the current and estimated market and trade matters, national and international co-operation between regulatory authorities, the adequacy of legal, judicial and administrative systems, and professional training aspects.

Trends in Counterfeit Drugs

Trends in Counterfeit Drugs PDF

Author: Kelly M. Elkins

Publisher: CRC Press

Published: 2023-07-06

Total Pages: 222

ISBN-13: 1000875555

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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.

Bitter Pills

Bitter Pills PDF

Author: Muhammad H. Zaman

Publisher: Oxford University Press

Published: 2018-03-01

Total Pages: 281

ISBN-13: 0190219467

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Long the scourge of developing countries, fake pills are now increasingly common in the United States. The explosion of Internet commerce, coupled with globalization and increased pharmaceutical use has led to an unprecedented vulnerability in the U.S. drug supply. Today, an estimated 80% of our drugs are manufactured overseas, mostly in India and China. Every link along this supply chain offers an opportunity for counterfeiters, and increasingly, they are breaking in. In 2008, fake doses of the blood thinner Heparin killed 81 people worldwide and resulted in hundreds of severe allergic reactions in the United States. In 2012, a counterfeit version of the cancer drug Avastin, containing no active chemotherapy ingredient, was widely distributed in the United States. In early 2013, a drug trafficker named Francis Ortiz Gonzalez was sentenced to prison for distributing an assortment of counterfeit, Chinese-made pharmaceuticals across America. By the time he was arrested, he had already sold over 140,000 fake pills to customers. Even when the U.S. system works, as it mostly does, consumers are increasingly circumventing the safeguards. Skyrocketing health care costs in the U.S. have forced more Americans to become "medical tourists" seeking drugs, life-saving treatments and transplants abroad, sometimes in countries with rampant counterfeit drug problems and no FDA. Bitter Pills will heighten the public's awareness about counterfeit drugs, critically examine possible solutions, and help people protect themselves. Author Muhammad H. Zaman pays special attention to the science and engineering behind both counterfeit and legitimate drugs, and the role of a "technological fix" for the fake drug problem. Increasingly, fake drugs affect us all.

The War Against Counterfeit Medicine

The War Against Counterfeit Medicine PDF

Author: Dora Nkem Akunyili

Publisher: African Books Collective

Published: 2011-12-29

Total Pages: 476

ISBN-13: 9788431569

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There is a general agreement that piracy; counterfeiting and passing off are unfair. However, there is often surreptitious - or even open - sympathy for, say, those who purchase counterfeit designer fashions or the latest technical gadgets. The pirate is even sometimes represented as a daring evil hero. In this book, Prof. Dora Nkem Akunyili, Director General of Nigeria's National Agency for Food and Drug Administration and Control, presents a unique study of a global phenomenon in which law-breaking and profiteering prevail at the cost of human health and life - and of the ways in which this can be fought by appropriate legislation, regulation and enforcement.

Quantitative and Qualitative Determination Technologies of Counterfeit Drugs

Quantitative and Qualitative Determination Technologies of Counterfeit Drugs PDF

Author: Ronny Priefer

Publisher: CRC Press

Published: 2023-08-10

Total Pages: 192

ISBN-13: 1000914011

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Drugs are often counterfeited to reduce manufacture costs, while still marketing it at as an authentic product. Increased incidence of drug counterfeiting is most noticeable in developing countries, which may not have the resources to supply counterfeit detection devices on a large scale. It is important to consider the problems caused and to propose options for controlling and reducing the prevalence of counterfeit medications. Various technologies are needed to identify the chemical properties of a questioned medicinal product, which can then be used to determine its authenticity. This volume focuses on current technological approaches that are able to detect counterfeited pharmaceuticals. Features Focuses on current technological approaches that are able to detect counterfeited pharmaceuticals Assesses the chemical methods of identifying counterfeit medicinal products and explains the theoretical underpinnings of the methods Provides case study type examples of the application for analysis of suspected counterfeit pharmaceuticals Discusses the detection and analysis of counterfeit drugs, and appropriate tools for combating this issue The editor draws on his experience as a respected chemist and prolific author in the field to provide this unique text on drug counterfeiting detection