Children and Drug Safety

Children and Drug Safety

Author: Cynthia A Connolly

Publisher: Rutgers University Press

Published: 2018-05-11

Total Pages: 328

ISBN-13: 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

Published: 2012-10-13

Total Pages: 432

ISBN-13: 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.


How to Raise a Drug-Free Kid

How to Raise a Drug-Free Kid

Author: Joseph A. Califano

Publisher: Simon and Schuster

Published: 2014-09-09

Total Pages: 432

ISBN-13: 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.


Children and Drug Safety

Children and Drug Safety

Author: Cynthia A Connolly

Publisher: Rutgers University Press

Published: 2018-05-11

Total Pages: 261

ISBN-13: 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/


Science, Medicine, and Animals

Science, Medicine, and Animals

Author: National Research Council

Publisher: National Academies Press

Published: 2006-02-19

Total Pages: 23

ISBN-13: 0309101174

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Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher's Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher's Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher's Guide was reviewed by members of the National Academies' Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher's Association NSTA Recommends.


Rational Therapeutics for Infants and Children

Rational Therapeutics for Infants and Children

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2000-04-07

Total Pages: 135

ISBN-13: 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.


The Future of Drug Safety

The Future of Drug Safety

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2007-03-27

Total Pages: 347

ISBN-13: 0309103045

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In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.


Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2004-07-09

Total Pages: 445

ISBN-13: 0309133386

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In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.


Facing Addiction in America

Facing Addiction in America

Author: Office of the Surgeon General

Publisher: Createspace Independent Publishing Platform

Published: 2017-08-15

Total Pages: 420

ISBN-13: 9781974580620

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All across the United States, individuals, families, communities, and health care systems are struggling to cope with substance use, misuse, and substance use disorders. Substance misuse and substance use disorders have devastating effects, disrupt the future plans of too many young people, and all too often, end lives prematurely and tragically. Substance misuse is a major public health challenge and a priority for our nation to address. The effects of substance use are cumulative and costly for our society, placing burdens on workplaces, the health care system, families, states, and communities. The Report discusses opportunities to bring substance use disorder treatment and mainstream health care systems into alignment so that they can address a person's overall health, rather than a substance misuse or a physical health condition alone or in isolation. It also provides suggestions and recommendations for action that everyone-individuals, families, community leaders, law enforcement, health care professionals, policymakers, and researchers-can take to prevent substance misuse and reduce its consequences.


The Morning After

The Morning After

Author: Heather Munro Prescott

Publisher: Rutgers University Press

Published: 2011-09-15

Total Pages: 181

ISBN-13: 0813552176

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Since 2006, when the “morning-after pill” Plan B was first sold over the counter, sales of emergency contraceptives have soared, becoming an $80-million industry in the United States and throughout the Western world. But emergency contraception is nothing new. It has a long and often contentious history as the subject of clashes not only between medical researchers and religious groups, but also between different factions of feminist health advocates. The Morning After tells the story of emergency contraception in America from the 1960s to the present day and, more importantly, it tells the story of the women who have used it. Side-stepping simplistic readings of these women as either radical feminist trailblazers or guinea pigs for the pharmaceutical industry, medical historian Heather Munro Prescott offers a portrait of how ordinary women participated in the development and popularization of emergency contraception, bringing a groundbreaking technology into the mainstream with the potential to alter radically reproductive health practices.