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.

The War Against Counterfeit Medicne. My Story

The War Against Counterfeit Medicne. My Story PDF

Author: Dora Nkem Akunyili

Publisher: Safari Books

Published: 2011

Total Pages: 476

ISBN-13: 9789788431015

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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 dared 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 lawbreaking 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.

Bitter Pills

Bitter Pills PDF

Author: Muhammad H. Zaman

Publisher: Oxford University Press

Published: 2018

Total Pages: 281

ISBN-13: 0190219440

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This book will heighten the public's awareness about counterfeit drugs, critically examine possible solutions, and help people protect themselves.

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: 2011-08-04

Total Pages: 432

ISBN-13: 1118023668

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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.

Drug Safety in Developing Countries

Drug Safety in Developing Countries PDF

Author: Yaser Mohammed Al-Worafi

Publisher: Academic Press

Published: 2020-06-03

Total Pages: 656

ISBN-13: 0128204125

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Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues Describes current achievements of drug safety practice in developing countries Addresses the challenges of drug safety in developing countries Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety

Pain Management and the Opioid Epidemic

Pain Management and the Opioid Epidemic PDF

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2017-09-28

Total Pages: 483

ISBN-13: 0309459575

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Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Generic

Generic PDF

Author: Jeremy A. Greene

Publisher: JHU Press

Published: 2014-10-27

Total Pages: 375

ISBN-13: 1421414945

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The turbulent history of generic pharmaceuticals raises powerful questions about similarity and difference in modern medicine. Generic drugs are now familiar objects in clinics, drugstores, and households around the world. We like to think of these tablets, capsules, patches, and ointments as interchangeable with their brand-name counterparts: why pay more for the same? And yet they are not quite the same. They differ in price, in place of origin, in color, shape, and size, in the dyes, binders, fillers, and coatings used, and in a host of other ways. Claims of generic equivalence, as physician-historian Jeremy Greene reveals in this gripping narrative, are never based on being identical to the original drug in all respects, but in being the same in all ways that matter. How do we know what parts of a pill really matter? Decisions about which differences are significant and which are trivial in the world of therapeutics are not resolved by simple chemical or biological assays alone. As Greene reveals in this fascinating account, questions of therapeutic similarity and difference are also always questions of pharmacology and physiology, of economics and politics, of morality and belief. Generic is the first book to chronicle the social, political, and cultural history of generic drugs in America. It narrates the evolution of the generic drug industry from a set of mid-twentieth-century "schlock houses" and "counterfeiters" into an agile and surprisingly powerful set of multinational corporations in the early twenty-first century. The substitution of bioequivalent generic drugs for more expensive brand-name products is a rare success story in a field of failed attempts to deliver equivalent value in health care for a lower price. Greene’s history sheds light on the controversies shadowing the success of generics: problems with the generalizability of medical knowledge, the fragile role of science in public policy, and the increasing role of industry, marketing, and consumer logics in late-twentieth-century and early twenty-first century health care.