Children And Drug Safety
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Children And Drug Safety
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Author : Cynthia A Connolly
language : en
Publisher: Rutgers University Press
Release Date : 2018-05-11
Children And Drug Safety written by Cynthia A Connolly and has been published by Rutgers University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-11 with Health & Fitness categories.
Winner of the 2018 Arthur J. Viseltear Award from the Medical Care Section of the American Public Health Association Children and Drug Safety traces the development, use, and marketing of drugs for children in the twentieth century, a history that sits at the interface of the state, business, health care providers, parents, and children. This book illuminates the historical dimension of a clinical and policy issue with great contemporary significance—many of the drugs administered to children today have never been tested for safety and efficacy in the pediatric population. Each chapter of Children and Drug Safety engages with major turning points in pediatric drug development; themes of children’s risk, rights, protection and the evolving context of childhood; child-rearing; and family life in ways freighted with nuances of race, class, and gender. Cynthia A. Connolly charts the numerous attempts by Congress, the Food and Drug Administration, the American Academy of Pediatrics, and leading pediatric pharmacologists, scientists, clinicians, and parents to address a situation that all found untenable. Open access edition funded by the National Endowment for the Humanities. The text of this book is licensed under a Creative Commons Attribution NonCommercial-NoDerivatives 4.0 International License: https://creativecommons.org/licenses/by-nc-nd/4.0/
Promoting Safety Of Medicines For Children
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2007
Promoting Safety Of Medicines For Children written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Medical categories.
Monitoring the safety of medicine use in children is of paramount importance since during the clinical development of medicines only limited data on this aspect are generated through clinical trials. Use of medicines outside the specifications described in the license (e.g. in terms of formulation indications contraindications or age) constitutes off-label and off-license use and these are a major area of concern. These guidelines are intended to improve awareness of medicine safety issues among everyone who has an interest in the safety of medicines in children and to provide guidance on effective systems for monitoring medicine safety in pediatric populations. This book will be of interest to all health care professionals medicine regulatory authorities pharmacovigilance centres academia the pharmaceutical industry and policy-makers. Systems for monitoring medicine safety are described in Annex 1. Pharmacovigilance methods and some examples of recent information on adverse reactions to marketed medicines are discussed in Annex 2.
Safety Kids Play It Smart
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Author : Janeen Brady
language : en
Publisher: Brite Music
Release Date : 1985-12
Safety Kids Play It Smart written by Janeen Brady and has been published by Brite Music this book supported file pdf, txt, epub, kindle and other format this book has been release on 1985-12 with Juvenile Nonfiction categories.
Provides instruction to help children avoid becoming victims of drug abuse.
Safe And Effective Medicines For Children
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-10-13
Safe And Effective Medicines For Children written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-10-13 with Medical categories.
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.
General Considerations For The Clinical Evaluation Of Drugs In Infants And Children
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Author : United States. Food and Drug Administration. Bureau of Drugs
language : en
Publisher:
Release Date : 1977
General Considerations For The Clinical Evaluation Of Drugs In Infants And Children written by United States. Food and Drug Administration. Bureau of Drugs and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1977 with Drugs categories.
Rational Therapeutics For Infants And Children
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2000-04-07
Rational Therapeutics For Infants And Children written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000-04-07 with Medical categories.
The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.
Paediatric Drug Handling
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Author : Ian Costello
language : en
Publisher: Pharmaceutical Press
Release Date : 2007
Paediatric Drug Handling written by Ian Costello and has been published by Pharmaceutical Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Medical categories.
This book provides a comprehensive overview of all of the issues pharmacists serving pediatric patients must consider. Chapters relating to pharmacogenomics, medication error prevention, compounding, and government regulations are extremely informative.
Safe Medical Devices For Children
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2006-01-20
Safe Medical Devices For Children written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-01-20 with Medical categories.
Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.
General Considerations For The Clinical Evaluation Of Drugs In Infants And Children
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Author : United States. Food and Drug Administration
language : en
Publisher:
Release Date : 1977
General Considerations For The Clinical Evaluation Of Drugs In Infants And Children written by United States. Food and Drug Administration and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1977 with Chemotherapy categories.
Fda S Authority To Ensure That Drugs Prescribed To Children Are Safe And Effective
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Author : Susan Thaul
language : en
Publisher:
Release Date : 2007
Fda S Authority To Ensure That Drugs Prescribed To Children Are Safe And Effective written by Susan Thaul and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Children categories.
The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) reauthorized and strengthened two laws addressing drugs--the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003--and enacted a new law addressing devices--the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. The historical approach of this report allows an understanding of how and why Congress took these steps.