The Law of Off-label Uses of Medicines PDF Download
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Author: Andrea Parziale
Publisher: Taylor & Francis
ISBN: 1000634388
Category : Law
Languages : en
Pages : 183
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Book Description
This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarifies the regulatory mechanisms and litigation trends concerning off-licence prescriptions in these jurisdictions. It assesses how traditional, prevention-driven regulatory and civil liability rules are being adapted to tackle potential risks and scientific uncertainty. The book outlines the applicable regulations, as well as considering Brexit’s impact on off-label policies in the UK, and EU and national off-label policies in the context of the fight against the Covid-19 pandemic. It also explores under what conditions physicians, manufacturers, or regulators must compensate patients injured by untested prescriptions. The book will be an essential resource for researchers, academics and policy-makers working in the areas of medical law and ethics, public health law, pharmaceutical law and private comparative law.
Author: Roy G. Beran
Publisher: Springer
ISBN: 9783642323379
Category : Medical
Languages : en
Pages : 0
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Book Description
This is a comprehensive reference text that examines the current state of Legal Medicine, which encompasses Forensic Medicine, in the 21st century. It examines the scope of both legal and forensic medicine, its application and study and has adopted a wide ranging approach including multinational authorship. It reviews the differences between and similarities of forensic and legal medicine, the need for academic qualification, the applications to many and varied fields including international aid, military medicine, health law and the application of medical knowledge to both criminal law and tort/civil law, sports medicine and law, gender and age related factors from obstetrics through to geriatrics and palliative care as well as cultural differences exploring the Christian/Judeo approach compared with that within Islamic cultures, Buddhism and Hinduism. The book looks at practical applications of legal medicine within various international and intercultural frameworks. This is a seminal authoritative text in legal and forensic medicine. It has a multi-author and multinational approach which crosses national boundaries. There is a great interest in the development of health law and legal medicine institutes around the world and this text comes in on the ground floor of this burgeoning discipline and provides the foundation text for many courses, both undergraduate and postgraduate. It defines the place of legal medicine as a specialized discipline.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309178657
Category : Medical
Languages : en
Pages : 64
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Book Description
Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309225493
Category : Medical
Languages : en
Pages : 432
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Book Description
The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Author: Holly Fernandez Lynch
Publisher: Columbia University Press
ISBN: 0231540078
Category : Business & Economics
Languages : en
Pages : 499
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Book Description
In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309371570
Category : Medical
Languages : en
Pages : 190
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Book Description
In 2004, the Institute of Medicine released Health Literacy: A Prescription to End Confusion, a report on the then-underappreciated challenge of enabling patients to comprehend their condition and treatment, to make the best decisions for their care, and to take the right medications at the right time in the intended dose. That report documented the problems, origins, and consequences of the fact that tens of millions of U.S. adults are unable to read complex texts, including many health-related materials, and it proposed possible solutions to those problems. To commemorate the anniversary of the release of the 2004 health literacy report, the Institute of Medicine's Roundtable on Health Literacy convened a 1-day public workshop to assess the progress made in the field of health literacy over the past decade, the current state of the field, and the future of health literacy at the local, national, and international levels. Health Literacy: Past, Present, and Future summarizes the presentation and discussion of the workshop.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309186501
Category : Medical
Languages : en
Pages : 95
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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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225
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Book Description
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Author: Patrick M. Malone
Publisher: McGraw Hill Professional
ISBN: 0071492038
Category : Medical
Languages : en
Pages : 907
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Book Description
Extensive coverage of the Internet as a source of and distribution means for drug information, and detailed sections on evaluating medical literature from clinical trials Audience includes Pharmacists, Pharmacy students and Pharmacy schools Updated to include using PDAs for medication information Covers the ethical and legal aspects of drug information management Nothing else like it on the market
Author: Andrea Parziale
Publisher: Taylor & Francis
ISBN: 1000634388
Category : Law
Languages : en
Pages : 183
Get Book Here
Book Description
This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarifies the regulatory mechanisms and litigation trends concerning off-licence prescriptions in these jurisdictions. It assesses how traditional, prevention-driven regulatory and civil liability rules are being adapted to tackle potential risks and scientific uncertainty. The book outlines the applicable regulations, as well as considering Brexit’s impact on off-label policies in the UK, and EU and national off-label policies in the context of the fight against the Covid-19 pandemic. It also explores under what conditions physicians, manufacturers, or regulators must compensate patients injured by untested prescriptions. The book will be an essential resource for researchers, academics and policy-makers working in the areas of medical law and ethics, public health law, pharmaceutical law and private comparative law.
Author: Amirala S. Pasha
Publisher: Springer Nature
ISBN: 3031081625
Category : Law
Languages : en
Pages : 548
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Book Description
This book provides an overview of the US laws that affect clinical practice for healthcare professionals with no legal background. Divided into thirteen sections, each chapter starts with a summary of the chapter’s content and relevant legal concepts in bullet points before discussing the topics in detail. An application section is provided in many chapters to clarify essential issues by reflecting on clinically relevant case law or clinical vignette(s). Filling a crucial gap in the literature, this comprehensive guide gives healthcare professionals an understanding or a starting point to legal aspects of healthcare.
