Download or read book The Impact of Off Label Compassionate and Unlicensed Use on Health Care Laws in Preselected Countries written by Vanessa Plate and published by Columbia University Press. This book was released on 2010-07-01 with total page 175 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The Impact of Off Label Compassionate and Unlicensed Use on Health Care Laws in Preselected Countries written by Vanessa Plate and published by Columbia University Press. This book was released on 2010-07-01 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Considering the Patient in Pediatric Drug Development written by Klaus Rose and published by Academic Press. This book was released on 2020-11-19 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Abuse of Minors in Clinical Studies written by Klaus Rose and published by Ethics International Press. This book was released on 2023-11-25 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Intellectually Impaired People written by Klaus Rose and published by Elsevier. This book was released on 2023-03-09 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Addressing the Barriers to Pediatric Drug Development written by Institute of Medicine and published by National Academies Press. This book was released on 2008-08-12 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Pediatric Drug Development written by Andrew E. Mulberg and published by John Wiley & Sons. This book was released on 2013-05-20 with total page 782 pages. Available in PDF, EPUB and Kindle. Book excerpt: Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions. Pediatric Drug Development: Concepts and Applications, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations. This new edition covers the legal and ethical issues of consent and assent, the additional legal and safety protections for children, and the appropriate methods of surveillance and assessment for children of varying ages and maturity, particularly for patient reported outcomes. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of global pediatric drug development. It also encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children globally. From an international team of expert contributors Pediatric Drug Development: Concepts and Applications is the practical guide to all aspects of the research and development of safe and effective medicines for children.
Download or read book International Ethical Guidelines for Health Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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.
Download or read book Redirecting Innovation in U S Health Care written by Steven Garber and published by Rand Corporation. This book was released on 2014-03-31 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Ethical and Legal Considerations in Mitigating Pandemic Disease written by Institute of Medicine and published by National Academies Press. This book was released on 2007-07-08 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Hospital Safety Index written by World Health Organization and published by . This book was released on 2017-01-15 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guide provides a step-by-step explanation of how to use the Safe Hospitals Checklist, and how the evaluation can be used to obtain a rating of the structural and nonstructural safety, and the emergency and disaster management capacity, of the hospital. The results of the evaluation enable hospital's own safety index to be calculated. The Hospital Safety Index tool may be applied to individual hospitals or to many hospitals in a public or private hospital network, or in an administrative or geographical area. In some countries, such as Moldova, all government hospitals have been evaluated using the Hospital Safety Index. In this respect, the Hospital Safety Index provides a useful method of comparing the relative safety of hospitals across a country or region, showing which hospitals need investment of resources to improve the functioning of the health system. The purpose of this Guide for Evaluators is to provide guidance to evaluators on applying the checklist, rating a hospital's safety and calculating the hospital's safety index. The evaluation will facilitate the determination of the hospital's capacity to continue providing services following an adverse event, and will guide the actions necessary to increase the hospital's safety and preparedness for response and recovery in case of emergencies and disasters. Throughout this document, the terms "safe" or "safety" cover structural and nonstructural safety and the emergency and disaster management capacity of the hospital. The Hospital Safety Index is a tool that is used to assess hospitals' safety and vulnerabilities, make recommendations on necessary actions, and promote low-cost/high-impact measures for improving safety and strengthening emergency preparedness. The evaluation provides direction on how to optimize the available resources to increase safety and ensure the functioning of hospitals in emergencies and disasters. The results of the evaluation will assist hospital managers and staff, as well as health system managers and decision-makers in other relevant ministries or organizations in prioritizing and allocating limited resources to strengthen the safety of hospitals in a complex network of health services. It is a tool to guide national authorities and international cooperation partners in their planning and resource allocation to support improvement of hospital safety and delivery of health services after emergencies and disasters. Over the past three years, the expert advice of policy-makers and practitioners from disciplines, such as engineering, architecture and emergency medicine, has been compiled, reviewed and incorporated into this second edition of the Guide. Global and regional workshops and virtual consultations have enabled technical and policy experts to contribute to the revision of Hospital Safety Index until consensus was reached on the content for its publication and distribution. Further comments and observations are certain to arise as the Hospital Safety Index continues to be applied across the world and these experiences will enable us to improve future editions. The rapid diagnostic application of the Hospital Safety Index provides, as a comparison, an out-of-focus snapshot of a hospital: it shows enough of the basic features to allow evaluators to confirm or disprove the presence of genuine risks to the safety of the hospital, and the hospital's level of preparedness for the emergencies and disasters to which it will be expected to provide health services in the emergency response. The Hospital Safety Index also takes into account the hospital's environment and the health services network to which it belongs. This second version of the second edition was released in December 2016.
Download or read book Off label Prescribing written by David Cavalla and published by John Wiley & Sons. This book was released on 2015-03-16 with total page 211 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today’s medicines are regulated for their efficacy and safety and, once approved, they can be marketed for certain uses as justified by the data. Regulatory bodies in developed countries are constituted by legal statute and operate as parts of government, ostensibly in the interests of the people as patients. But once approved, medicines can be used for any purpose the prescriber thinks fit and appropriate for the patient. One in five prescriptions is therefore written outside regulatory purview. Off-label Prescribing looks into the corners of our medicated lives, where drug regulation runs up against medical practice, and concerns the use of a drug that has been approved for one use (in medical parlance, ‘indication’) being used for a different indication; alternatively, being used on a different set of patients from the ones it is approved for, or at a different dose. Usually the patient is unaware of what is going on, having not been informed by their doctor of this aspect of his or her prescribing choice. The book examines how and why this occurs, what the various medical professions have to say about it, and how pharmaceutical companies benefit by moving into this poorly regulated area. Off-label Prescribing pulls these complex issues together in one volume, to highlight current practice, its advantages and weaknesses and how the author suggests practice should evolve in the future. It will therefore be of interest to all those who prescribe (and receive) medicines, combined with a greater objective to provide more transparency and discussion for professionals.
Download or read book The Health Effects of Cannabis and Cannabinoids written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-03-31 with total page 487 pages. Available in PDF, EPUB and Kindle. Book excerpt: Significant changes have taken place in the policy landscape surrounding cannabis legalization, production, and use. During the past 20 years, 25 states and the District of Columbia have legalized cannabis and/or cannabidiol (a component of cannabis) for medical conditions or retail sales at the state level and 4 states have legalized both the medical and recreational use of cannabis. These landmark changes in policy have impacted cannabis use patterns and perceived levels of risk. However, despite this changing landscape, evidence regarding the short- and long-term health effects of cannabis use remains elusive. While a myriad of studies have examined cannabis use in all its various forms, often these research conclusions are not appropriately synthesized, translated for, or communicated to policy makers, health care providers, state health officials, or other stakeholders who have been charged with influencing and enacting policies, procedures, and laws related to cannabis use. Unlike other controlled substances such as alcohol or tobacco, no accepted standards for safe use or appropriate dose are available to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely and, in regard to therapeutic uses, effectively. Shifting public sentiment, conflicting and impeded scientific research, and legislative battles have fueled the debate about what, if any, harms or benefits can be attributed to the use of cannabis or its derivatives, and this lack of aggregated knowledge has broad public health implications. The Health Effects of Cannabis and Cannabinoids provides a comprehensive review of scientific evidence related to the health effects and potential therapeutic benefits of cannabis. This report provides a research agendaâ€"outlining gaps in current knowledge and opportunities for providing additional insight into these issuesâ€"that summarizes and prioritizes pressing research needs.
Download or read book Guide to Paediatric Drug Development and Clinical Research written by Klaus Rose and published by Karger Medical and Scientific Publishers. This book was released on 2010-01-01 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by paediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to paediatric needs, US and EU legislators have taken action, and the WHO has initiated a global paediatric campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better understanding of how the child's body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects.A wide spectrum of readers will profit from this book, including paediatricians, pharmacists, general practitioners and health care professionals involved in child care and paediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.
Download or read book Current Challenges in Pharmacovigilance written by World Health Organization and published by . This book was released on 2001-01-01 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
Download or read book Drug Benefits and Risks written by Chris J. van Boxtel and published by John Wiley & Sons. This book was released on 2001-11-28 with total page 738 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is an inclusive reference exploring the scientific basis and practice of drug therapy. The key concept is to look at the balance between the benefits and risks of drugs but in this context also the social impact which drugs have in modern societies is highlighted. Taking an evidence-based approach to the problem, the practice of clinical pharmacology and pharmacotherapy in the developing as well as the developed world is examined. For this purpose the book * Covers general clinical pharmacology, pharmacology of various drug groups and the treatments specific to various diseases * Gives guidance on how doctors should act so that drugs can be used effectively and safely * Encourages the rational use of drugs in society This book brings together a large amount of excellent content that will be invaluable for anyone working within, or associated with, the field of clinical pharmacology and pharmacotherapy - undergraduates, postgraduates, regulatory authorities and the pharmaceutical industry.
Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
