Children and Drug Safety

Children and Drug Safety
Author: Cynthia A Connolly
Publisher: Rutgers University Press
Total Pages: 328
Release: 2018-05-11
Genre: Health & Fitness
ISBN: 0813575230
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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/

Safe and Effective Medicines for Children

Safe and Effective Medicines for Children
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 432
Release: 2012-10-13
Genre: Medical
ISBN: 0309225493
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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.

Children and Drug Safety

Children and Drug Safety
Author: Cynthia A Connolly
Publisher: Rutgers University Press
Total Pages: 261
Release: 2018-05-11
Genre: Health & Fitness
ISBN: 0813563895
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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/

Safety Kids Play It Smart

Safety Kids Play It Smart
Author: Janeen Brady
Publisher: Brite Music
Total Pages: 40
Release: 1985-12
Genre: Juvenile Nonfiction
ISBN: 9780944803226
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Provides instruction to help children avoid becoming victims of drug abuse.

Pediatric Drug Development

Pediatric Drug Development
Author: Andrew E. Mulberg
Publisher: John Wiley & Sons
Total Pages: 782
Release: 2013-05-20
Genre: Medical
ISBN: 1118312058
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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.

Promoting Safety of Medicines for Children

Promoting Safety of Medicines for Children
Author: World Health Organization
Publisher: World Health Organization
Total Pages: 65
Release: 2007
Genre: Medical
ISBN: 9241563435
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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.

Drug Safety Data

Drug Safety Data
Author: Michael J. Klepper
Publisher: Jones & Bartlett Learning
Total Pages: 332
Release: 2011
Genre: Medical
ISBN: 0763769126
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Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides pharmaceutical scientists, researchers and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for premarketing risk assessment. This unique resource enhances the ability of pharmaceutical professionalsùthose with and without clinical trainingùto determine the risk of a drug or biologic­ ahead of its release, thereby reducing unnecessary jeopardy to the patient. Authors Dr. Michael Klepper and Dr. Barton Cobert, who together bring decades of pharmaceutical research and drug safety expertise, discuss how quality planning, safety training and data standardization result in significant cost, time and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides the definitive guide to drug safety data analysis and reporting. Key features include: Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports Pragmatic tipsàand mistakes to avoid Simple explanations of what safety data are collected, and what the data mean Practical approaches to determining a drug effect and understanding its clinical significance Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical Examples of user-friendly data displays that enhance safety signal identification Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting Relevant material for the required training of drug safety/pharmacovigilance professionals SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)

Addressing the Barriers to Pediatric Drug Development

Addressing the Barriers to Pediatric Drug Development
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 64
Release: 2008-09-12
Genre: Medical
ISBN: 0309107423
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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.

How to Raise a Drug-Free Kid

How to Raise a Drug-Free Kid
Author: Joseph A. Califano
Publisher: Simon and Schuster
Total Pages: 432
Release: 2014-09-09
Genre: Family & Relationships
ISBN: 1476728496
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The highly acclaimed comprehensive guide to getting your child through the formative pre-teen, teen, and college years drug-free—now completely revised and updated. Nearly every child will be offered drugs or alcohol before graduating high school, and excessive drinking is common at most colleges. But the good news is that a child who gets to age twenty-one without smoking, using illegal drugs, or abusing alcohol or prescription drugs is virtually certain never to do so. Drawing on more than two decades of research at The National Center on Addiction and Substance Abuse at Columbia University (CASAColumbia), founder Joseph A. Califano, Jr., presents a clear, common-sense guide to helping kids stay drug-free. All parents dream of a healthy, productive, and fulfilling future for their children; Califano shows which specific actions work and what parents can do to teach, protect, and empower their children to have the greatest chance of making that future come true. Teenagers who learn about the risks of drugs from their parents are twice as likely never to try them, and this book provides the tools parents need to prepare their children for those crucial decision-making moments. In this revised and updated edition, Califano tackles some of the newest obstacles standing between our kids and a drug-free life—from social media sites and cell phone apps to the explosion in prescription and over-the-counter drug abuse and the increased dangers and addictive power of marijuana. He reveals what teens can’t or won’t tell their parents about their thoughts on drugs and alcohol, and combines the latest research with his discussions with thousands of parents and teens about the challenges that widespread access to drugs and alcohol present, and how parents can instill in their teens the will and skills to choose not to use. Califano’s insightful and lively guide is as readable as it is informative.

Rational Therapeutics for Infants and Children

Rational Therapeutics for Infants and Children
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 135
Release: 2000-04-07
Genre: Medical
ISBN: 0309183642
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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.