› › The Drug Supply Chain Security Act Explained

Pharmaceutical Supply Chain

Author : Fred A. Kuglin

Publisher : CRC Press

Page : 204 pages

File Size : 39,29 MB

Release : 2015-07-29

Category : Business & Economics

ISBN : 1482258943

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Book Description

Error-proofing in the production process of pharmaceuticals isn‘t just a matter of good business, it has life-and-death implications for consumers. The 2013 Drug Quality and Security Act introduces more stringent compliance factors towards this common goal, in large part requiring new mandates on tracking and tracing chain of custody in the supply chain. This book comprehensively overviews the new mandate and its implications, including implementation strategies for track-and-trace programs along with presenting a fuller understanding of the mechanics of intergovernmental policies and oversights.



The Drug Supply Chain Security Act Explained

Author : Dirk Rodgers

Publisher : Createspace Independent Publishing Platform

Page : 352 pages

File Size : 37,21 MB

Release : 2016-01-26

Category :

ISBN : 9781522904908

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Book Description

The Drug Supply Chain Security Act (DSCSA) was passed by Congress in the fall of 2013 and signed into law by President Barack Obama on November 27, 2013. The DSCSA was Title II of the Drug Quality and Security Act (DQSA). The law establishes new requirements that must be administered by the Food and Drug Administration (FDA). These requirements escalate over time from 2015 through 2023 in a series of stages. They include lot-based tracing of prescription pharmaceuticals from the manufacturer to the dispenser from 2015 through 2023 and serialization-based tracing after 2023. Drug manufacturers must apply unique identifiers on all prescription drug packages by November 2017 and repackagers, wholesale distributors and dispensers must begin to buy and sell products marked with those identifiers by November of 2018, 2019 and 2020 respectively. This book explains the DSCSA, section by section, so that drug manufacturers, repackagers, wholesale distributors, dispensers, contract partners (CMOs, CPOs, 3PLs), solution providers, consultants, law firms, regulators and students can understand the text, the meaning and the significance of the law. The book also includes more than two dozen of the most informative RxTrace essays about various aspects of the DSCSA. These essays, by Dirk Rodgers, help to expose the implications of the law and provide the context necessary to understand its full impact on companies in the supply chain. In these essays, the latest FDA guidance related to the DSCSA, as of book publication, are explained. Praise for The Drug Supply Chain Security Act Explained, Second Edition: "Dirk Rodgers has an unparalleled knowledge of federal track and trace legislation. This book is essential reading for anyone who wants to understand and benefit from coming changes to the pharmaceutical supply chain." -- Adam J. Fein, Ph.D., president, Pembroke Consulting, Inc., and CEO, Drug Channels Institute "Through RxTrace, Dirk Rodgers has provided stakeholders valuable insights on DSCSA. As DSCSA has evolved, his questions and opinions have helped all the stakeholders understand compliance. Dirk's new book brings years of wisdom from RxTrace and more together in one volume." -- Napoleon Monroe, Managing Director, New Directions Technology Consulting, LLC "As dispensers entrusted with the last encounter for patient safety, it is important to have a venue for discussion on DSCSA implementation challenges amongst trading partners. In this book, Dirk provides his experience as a resource for companies to use to create solutions." -- Chris Chandler, PharmD, VP of USDM Healthcare



Countering the Problem of Falsified and Substandard Drugs

Author : Institute of Medicine

Publisher : National Academies Press

Page : 377 pages

File Size : 30,90 MB

Release : 2013-06-20

Category : Medical

ISBN : 0309269393

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Book Description

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.



Pain Management and the Opioid Epidemic

Author : National Academies of Sciences, Engineering, and Medicine

Publisher : National Academies Press

Page : 483 pages

File Size : 39,1 MB

Release : 2017-09-28

Category : Medical

ISBN : 0309459575

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Book Description

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.



Enhancing Food Safety

Author : National Research Council

Publisher : National Academies Press

Page : 589 pages

File Size : 34,41 MB

Release : 2010-11-04

Category : Medical

ISBN : 0309163587

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Book Description

Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.



Programs in Brief

Author : United States. Substance Abuse and Mental Health Services Administration

Publisher :

Page : 98 pages

File Size : 30,42 MB

Release : 2007

Category : Drug abuse

ISBN :

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Book Description

Descriptions of many SAMSHA's major grants and contract programs funded in 2007.



Making Medicines Affordable

Author : National Academies of Sciences, Engineering, and Medicine

Publisher : National Academies Press

Page : 235 pages

File Size : 36,19 MB

Release : 2018-03-01

Category : Medical

ISBN : 0309468086

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Book Description

Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.



Medical Countermeasures Dispensing

Author : Institute of Medicine

Publisher : National Academies Press

Page : 95 pages

File Size : 26,57 MB

Release : 2010-12-16

Category : Medical

ISBN : 0309186501

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Book Description

During public health emergencies such as terrorist attacks or influenza outbreaks, the public health system's ability to save lives could depend on dispensing medical countermeasures such as antibiotics, antiviral medications, and vaccines to a large number of people in a short amount of time. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop on November 18, 2009, to provide an overview of current threats, recent progress made in the public health system for distributing and dispensing countermeasures, and remaining vulnerabilities.



Dangerous Doses

Author : Katherine Eban

Publisher : Houghton Mifflin Harcourt

Page : 479 pages

File Size : 19,53 MB

Release : 2006-04-18

Category : Medical

ISBN : 9780156030854

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Book Description

An exploration of drug counterfeiting activities in America traces a drug theft investigation in Florida with ties to a national network of drug polluters and the government, exposing how political interests may be compromising the integrity of the nation's medical distribution system. Reprint. 30,000 first printing.



Model Rules of Professional Conduct

Author : American Bar Association. House of Delegates

Publisher : American Bar Association

Page : 216 pages

File Size : 43,83 MB

Release : 2007

Category : Law

ISBN : 9781590318737

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Book Description

The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.