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.
What you should know about the Covid-19 vaccines from top experts in the field. As the SARS-Cov2 virus emerged and spread globally in early 2020, unprecedented international efforts began to develop and test vaccines to control the devastating pandemic. This book focuses on the remarkable progress in developing vaccines, the amazing effectiveness of the early vaccines, and the challenges of delivering them to the population. To put this extraordinary progress into perspective, the history of other vaccines is presented and their roles in individual protection and protection of the community, “vaccines that protect the unvaccinated,” are outlined. The rigorous processes whereby vaccines are evaluated in distinct phases and the steps that must be met prior to obtaining regulatory approval for both vaccine safety and effectiveness are highlighted. Multiple vaccine approaches are reviewed, including new approaches such as “messenger or mRNA vaccine” that may revolutionize future vaccine development. The comprehensive models used to provide recommendations and priorities for vaccination of groups of people at risk are summarized. The book also focuses on the questions that remain unanswered after the vaccines are approved. These include duration of immunity, risk factors for vaccine failure, impact of viral evolution and variant strains, and assessment of both immediate and long-term safety. The authors also address concerns about vaccine acceptance including roll-out, access, and detailed and trusted sources of information.
An accessible and reassuring guide to childhood health and immunity from a pediatrician who’s both knowledgeable about the latest scientific research and respectful of a family’s risk factors, health history, and concerns In The Vaccine-Friendly Plan, Paul Thomas, M.D., presents his proven approach to building immunity: a new protocol that limits a child’s exposure to aluminum, mercury, and other neurotoxins while building overall good health. Based on the results from his pediatric practice of more than eleven thousand children, as well as data from other credible and scientifically minded medical doctors, Dr. Paul’s vaccine-friendly protocol gives readers • recommendations for a healthy pregnancy and childbirth • vital information about what to expect at every well child visit from birth through adolescence • a slower, evidence-based vaccine schedule that calls for only one aluminum-containing shot at a time • important questions to ask about your child’s first few weeks, first years, and beyond • advice about how to talk to health care providers when you have concerns • the risks associated with opting out of vaccinations • a practical approach to common illnesses throughout the school years • simple tips and tricks for healthy eating and toxin-free living at any age The Vaccine-Friendly Plan presents a new standard for pediatric care, giving parents peace of mind in raising happy, healthy children. Praise for The Vaccine-Friendly Plan “Finally, a book about vaccines that respects parents! If you choose only one book to read on the topic, read The Vaccine-Friendly Plan. This impeccably researched, well-balanced book puts you in the driver’s seat and empowers you to make conscientious vaccine decisions for your family.”—Peggy O’Mara, editor and publisher, Mothering Magazine “Sure to appeal to readers of all kinds as a friendly, no-nonsense book that cuts through the rhetoric surrounding vaccines. It offers validation to those who avoid some or all, while offering those who do want to vaccinate help on how to do so safely. This is a great book for anyone with children in their lives.”—Natural Mother “A valuable, science-supported guide to optimizing your child’s health while you navigate through complex choices in a toxic, challenging world.”—Martha Herbert, M.D., Ph.D., Harvard Medical School “An impressively researched guide, this important book is essential reading for parents. With clear and practical advice for shielding children from harmful toxins, it will compel us all to think differently about how to protect health.”—Jay Gordon, M.D., FAAP “Rather than a one-size-fits-all vaccine strategy, the authors suggest thoughtful, individualized decisions based on research and collaboration between parents and clinicians—a plan to optimize a child’s immune system and minimize any risks.”—Elizabeth Mumper, M.D., founder and CEO, The Rimland Center for Integrative Pediatrics “This well-written and thought-provoking book will encourage parents to think through decisions—such as food choices and the timing of vaccines—that affect the well-being of their children. In a world where children’s immune systems are increasingly challenged, this is a timely addition to the literature.”—Harriet Lerner, Ph.D., bestselling author of The Dance of Anger and The Mother Dance
Building on the revolutionary Institute of Medicine reports To Err is Human and Crossing the Quality Chasm, Keeping Patients Safe lays out guidelines for improving patient safety by changing nurses' working conditions and demands. Licensed nurses and unlicensed nursing assistants are critical participants in our national effort to protect patients from health care errors. The nature of the activities nurses typically perform â€" monitoring patients, educating home caretakers, performing treatments, and rescuing patients who are in crisis â€" provides an indispensable resource in detecting and remedying error-producing defects in the U.S. health care system. During the past two decades, substantial changes have been made in the organization and delivery of health care â€" and consequently in the job description and work environment of nurses. As patients are increasingly cared for as outpatients, nurses in hospitals and nursing homes deal with greater severity of illness. Problems in management practices, employee deployment, work and workspace design, and the basic safety culture of health care organizations place patients at further risk. This newest edition in the groundbreaking Institute of Medicine Quality Chasm series discusses the key aspects of the work environment for nurses and reviews the potential improvements in working conditions that are likely to have an impact on patient safety.
"Nurses play a vital role in improving the safety and quality of patient car -- not only in the hospital or ambulatory treatment facility, but also of community-based care and the care performed by family members. Nurses need know what proven techniques and interventions they can use to enhance patient outcomes. To address this need, the Agency for Healthcare Research and Quality (AHRQ), with additional funding from the Robert Wood Johnson Foundation, has prepared this comprehensive, 1,400-page, handbook for nurses on patient safety and quality -- Patient Safety and Quality: An Evidence-Based Handbook for Nurses. (AHRQ Publication No. 08-0043)." - online AHRQ blurb, http://www.ahrq.gov/qual/nurseshdbk/
The Immunization Safety Review Committee was established by the Institute of Medicine (IOM) to evaluate the evidence on possible causal associations between immunizations and certain adverse outcomes, and to then present conclusions and recommendations. The committee's mandate also includes assessing the broader societal significance of these immunization safety issues. While all the committee members share the view that immunization is generally beneficial, none of them has a vested interest in the specific immunization safety issues that come before the group. The committee reviews three immunization safety review topics each year, addressing each one at a time. In this fifth report in a series, the committee examines the hypothesis that exposure to polio vaccine contaminated with simian virus 40 (SV40), a virus that causes inapparent infection in some monkeys, can cause certain types of cancer.
The first update to this key reference guide in over 15 years! This revised edition contains a new format making it even easier to study for the DPR exams. In addition to the review questions found at the end of each chapter, this new edition contains knowledge expectations at the beginning of each chapter. These brief statements describe what you are expected to learn after reading that chapter, allowing you to study more effectively for DPR’s pesticide applicator licensing (QAL/QAC) exams. These knowledge expectations are also highlighted in sidebars throughout each chapter, providing a study roadmap so you know which sections of each chapter are most important. Also new: Updated pesticides table to reflect products available in CaliforniaUpdated information on nematodes, vertebrates, and pathogensExpanded information on environmental hazards, expanded information on personal protective equipment including EPA respirator criteriaUp-to-date information on worker protection standardsExpanded information on pesticide resistanceUpdated compliance guidelines for pesticide use reporting as required by California lawA dedicated chapter covering label reading, including an updated label that reflects current regulations The Safe and Effective Use of Pesticides provides detailed information for selecting, using, handling, storing, and disposing of pesticides. It emphasizes worker protection, prevention of groundwater contamination, protection of endangered species and wildlife, and reduction of environmental problems. This is a significant update to the 2nd Edition, so everyone will want to update their reference library with this new edition. The principles described in this volume apply to all areas of pest control, including agricultural, structural, landscape, greenhouse, and public health applications. Volume 1 in the Pesticide Application Compendium. This is recommended study material for all categories of the California Department of Pesticide Regulation’s (DPR) Qualified Pesticide Applicator License (QAL) and Qualified Pesticide Applicator Certificate (QAC) exams.
THE ESSENTIAL WORK IN TRAVEL MEDICINE -- NOW COMPLETELY UPDATED FOR 2018 As unprecedented numbers of travelers cross international borders each day, the need for up-to-date, practical information about the health challenges posed by travel has never been greater. For both international travelers and the health professionals who care for them, the CDC Yellow Book 2018: Health Information for International Travel is the definitive guide to staying safe and healthy anywhere in the world. The fully revised and updated 2018 edition codifies the U.S. government's most current health guidelines and information for international travelers, including pretravel vaccine recommendations, destination-specific health advice, and easy-to-reference maps, tables, and charts. The 2018 Yellow Book also addresses the needs of specific types of travelers, with dedicated sections on: · Precautions for pregnant travelers, immunocompromised travelers, and travelers with disabilities · Special considerations for newly arrived adoptees, immigrants, and refugees · Practical tips for last-minute or resource-limited travelers · Advice for air crews, humanitarian workers, missionaries, and others who provide care and support overseas Authored by a team of the world's most esteemed travel medicine experts, the Yellow Book is an essential resource for travelers -- and the clinicians overseeing their care -- at home and abroad.
A NEW YORK TIMES BESTSELLER * New York Times Notable Book * Best Book of the Year: New York Public Library, Kirkus Reviews, Science Friday With a new postscript by the author From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.
