The Impact of Off-Label, Compassionate and Unlicensed Use on Health Care Laws in Preselected Countries PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download The Impact of Off-Label, Compassionate and Unlicensed Use on Health Care Laws in Preselected Countries PDF full book. Access full book title The Impact of Off-Label, Compassionate and Unlicensed Use on Health Care Laws in Preselected Countries by Vanessa Plate. Download full books in PDF and EPUB format.
Author: Vanessa Plate
Publisher: Columbia University Press
ISBN: 3838201353
Category : Law
Languages : en
Pages : 176
Get Book Here
Book Description
In times of situational therapeutic impasse, health care professionals (HCPs) are under pressure to conduct off-label, unlicensed and compassionate drug use—generally summarized under the term non-licensed drug use (NDU). Liability, contractual and penal risks pose a problem when treating a patient in a non-licensed way. There is a knowledge gap about institutional and governmental methods to resolve these problems. Different countries have developed strategies to manage NDU. Vanessa Platé gives a comprehensive overview of practices Canada, the U.S., the U.K., Japan, France, Germany, Switzerland, Austria, and the transnational E.U. A must-read for everyone interested in the discussion on how to administer the best treatment, especially regarding early access to yet unapproved treatments.
Author: Vanessa Plate
Publisher: Columbia University Press
ISBN: 3838201353
Category : Law
Languages : en
Pages : 176
Get Book Here
Book Description
In times of situational therapeutic impasse, health care professionals (HCPs) are under pressure to conduct off-label, unlicensed and compassionate drug use—generally summarized under the term non-licensed drug use (NDU). Liability, contractual and penal risks pose a problem when treating a patient in a non-licensed way. There is a knowledge gap about institutional and governmental methods to resolve these problems. Different countries have developed strategies to manage NDU. Vanessa Platé gives a comprehensive overview of practices Canada, the U.S., the U.K., Japan, France, Germany, Switzerland, Austria, and the transnational E.U. A must-read for everyone interested in the discussion on how to administer the best treatment, especially regarding early access to yet unapproved treatments.
Author: Klaus Rose
Publisher: Academic Press
ISBN: 0128242051
Category : Medical
Languages : en
Pages : 416
Get Book Here
Book Description
Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm addresses a fundamental challenge in drug development and healthcare for young patients. In clinical trials and clinical practice, the term "children" is used ambiguously to confer physiological characteristics to a chronological age limit, which in reality does not exist. This book outlines why the United States (US) and European Union's (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support and perform pediatric drug studies, along with the key flaws of this demand that blurs the different administrative and physiological meanings of the term "child." In addition, the book covers why most pediatric regulatory studies lack medical sense and many even harm young patients and the conflicts of interest behind pediatric drug studies. It includes relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs as well as key differences between newborns, infants, older children and adolescents. - Explains relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs, including key differences between newborns, infants, older children and adolescents - Discusses historical roots of separate drug approval in officially labeled "children" and conflicts of interest in performing and publishing "pediatric" research - Helps to decipher justifications for pediatric studies to help people navigate the relevance of the information
Author: Klaus Rose
Publisher: Ethics International Press
ISBN: 1804411361
Category : Medical
Languages : en
Pages : 306
Get Book Here
Book Description
With the emergence of effective drugs and observed drug toxicities in babies, two mantras emerged: that children are therapeutic orphans, and that children are not small adults. US and EU laws demand pediatric studies as a condition for the approval of new drugs in adults. This is called “Pediatric Drug Development” (PDD). Although apparently reasonable, there are catches. Children are vulnerable at birth, but they grow and become bodily mature with puberty, well before coming of age. Minors are not another species. The 18th birthday, an administrative/ legal limit, does not correspond to a physiological change. Drugs treat the body, not the legal status. PDD results in pointless studies in bodily mature adolescents, and in exaggerated studies in younger minors. An originally well-intentioned concept results in thousands of questionable studies worldwide. This book draws attention to conflicts of interest and ethical dilemmas of PDD and questions its applicability for adolescents and minors that are no longer babies.
Author: Klaus Rose
Publisher: Elsevier
ISBN: 0443188122
Category : Science
Languages : en
Pages : 284
Get Book Here
Book Description
Intellectually Impaired People: The Ongoing Battle addresses challenges against the background of history, changing societal environments, and current intellectual approaches and attitudes toward persons with disabilities. The book discusses national and international conventions, societal attitudes, sheltered workshops, the right of intellectually impaired persons for self-responsibility and its limitations, and the place of mentally impaired persons in the public image. Additionally, the book attempts to capture the forces that drive the changes of our conceptual frameworks. The US Tuskegee study which withheld antibiotics from black men with syphilis was not ended by scientific criticism but by a courageous man, press reports, and a changed social perception. The non-hiding of handicapped children is not the result of government orders, there are many non-resolvable dilemmas and tension between supporting, understanding, and patronizing a complex situation with many potential future avenues. - Recognizes how contradictory feelings and attitudes toward impaired persons have a complex historical background - Sheds light on society and our institutions that deal with disabled people and the limitations of an isolated medical approach - Covers national and international conventions of mentally impaired persons
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309178657
Category : Medical
Languages : en
Pages : 64
Get Book Here
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:
Publisher: World Health Organization
ISBN: 9240011870
Category : Business & Economics
Languages : en
Pages : 70
Get Book Here
Book Description
In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.
Author: Steven Garber
Publisher: Rand Corporation
ISBN: 0833085468
Category : History
Languages : en
Pages : 135
Get Book Here
Book Description
New medical technologies are a leading driver of U.S. health care spending. This report identifies promising policy options to change which medical technologies are created, with two related policy goals: (1) Reduce total health care spending with the smallest possible loss of health benefits, and (2) ensure that new medical products that increase spending are accompanied by health benefits that are worth the spending increases.
Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: World Health Organization
ISBN: 9789290360889
Category : Bioethics
Languages : en
Pages : 0
Get Book Here
Book Description
"In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309107695
Category : Medical
Languages : en
Pages : 250
Get Book Here
Book Description
In recent public workshops and working group meetings, the Forum on Microbial Threats of the Institute of Medicine (IOM) has examined a variety of infectious disease outbreaks with pandemic potential, including those caused by influenza (IOM, 2005) and severe acute respiratory syndrome (SARS) (IOM, 2004). Particular attention has been paid to the potential pandemic threat posed by the H5N1 strain of avian influenza, which is now endemic in many Southeast Asian bird populations. Since 2003, the H5N1 subtype of avian influenza has caused 185 confirmed human deaths in 11 countries, including some cases of viral transmission from human to human (WHO, 2007). But as worrisome as these developments are, at least they are caused by known pathogens. The next pandemic could well be caused by the emergence of a microbe that is still unknown, much as happened in the 1980s with the emergence of the human immunodeficiency virus (HIV) and in 2003 with the appearance of the SARS coronavirus. Previous Forum meetings on pandemic disease have discussed the scientific and logistical challenges associated with pandemic disease recognition, identification, and response. Participants in these earlier meetings also recognized the difficulty of implementing disease control strategies effectively. Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary as a factual summary of what occurred at the workshop.
Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: Cioms
ISBN: 9789290360827
Category : Drug monitoring
Languages : en
Pages : 0
Get Book Here
Book Description
In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.
