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.
Download or read book Taking Medicine written by Liz Gogerly and published by Crabtree Publishing Company. This book was released on 2008-09 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides information about the different types of medicines and how to take them safely.
Download or read book Safe Medical Devices for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2006-01-20 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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 Prescribing Medicines for Children written by Mike Sharland and published by . This book was released on 2019-07-17 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Prescribing for children is a particularly challenging discipline due to specific issues of drug absorption, metabolism, distribution and excretion. The aim of this book is to improve understanding in all aspects of paediatric prescribing, from the development of suitable drugs through to their practical administration. With its origins in the EU-funded Global Research in Paediatrics (GRiP) project this is the first truly international textbook to provide guidance on the principles behind optimal neonatal and paediatric prescribing. Harnessing the international expertise of paediatricians and pharmacists in the field, Prescribing Medicines for Children compliments the British National Formulary for Children (BNFC), facilitating translation of essential pharmacological principles into good prescribing practice. It incorporates specific information on how to promote safe and effective prescribing in paediatrics, including how to avoid medication errors and adverse drug reactions in children. Highlights include the differences in prescribing habits between countries and the shared principles that underpin rational prescribing in paediatrics and neonatology. The book is divided into two sections: Section A provides concise educational material relating to paediatric pharmacology and optimising how medicines are developed and prescribed for children. Section B considers key clinical prescribing areas and can be used as a quick reference guide. Each chapter is focused on the key issues in prescribing for a respective clinical specialty or context. Prescribing Medicines for Children is essential reading for all those who are involved in prescribing medicines to neonates and children. This includes undergraduate and postgraduate pharmacists, nurses, paediatricians and primary care physicians, academic scientists, and those working in the pharmaceutical industry and drug regulation.
Download or read book Improving Medicines for Children in Canada written by The Expert Panel on Therapeutic Products for Infants, Children, and Youth and published by Council of CanadianAcademies. This book was released on 2014-09 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Recognizing the importance of developing safe and effective medicines specifically for children, the Minister of Health, on behalf of Health Canada, asked the Council of Canadian Academies to provide an evidence-based and authoritative assessment of the state of research and regulations leading to the approval of therapeutic products for children, in Canada and abroad. Specifically, this assessment examines the following questions: What is the state of clinical pharmacology, in Canada and abroad, that can be applied to the ethical development of safe and effective pharmaceuticals and biologics labelled as therapies for infants, children, and youth? How does human development from infancy to youth alter clinical pharmacology and therefore inform pediatric drug investigations? What are best practices to ethically conduct scientifically sound but adaptive drug studies to confirm the safety and effectiveness of drugs for infants, children, and youth? When the participation of infants, children, and youth in drug studies is not feasible, what are the best practices to confirm drug safety and effectiveness in these populations? What are Canada's strengths to contribute to global pharmacovigilance efforts for drugs that may benefit infants, children, and youth?"--Executive summary.
Download or read book Ethical and Scientific Issues in Studying the Safety of Approved Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2012-07-30 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
Download or read book The Future of Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2007-02-27 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Promoting Safety of Medicines for Children written by World Health Organization and published by World Health Organization. This book was released on 2007 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Smart Medicine for a Healthier Child written by Janet Zand and published by Penguin. This book was released on 2003-01-06 with total page 582 pages. Available in PDF, EPUB and Kindle. Book excerpt: Revised, updated, and expanded to reflect the latest thinking and information on children's health issues, Smart Medicine for a Healthier Child enables parents to combine the best of conventional and alternative approaches. Part One explains the full spectrum of techniques that can be employed to effectively treat childhood health problems, providing an overview of the history, fundamentals, and uses of conventional medicine, herbal medicine, homeopathy, acupressure, diet, and nutritional supplementation. Part Two contains a comprehensive A-to-Z guide to the various health problems of childhood, from acne to chickenpox to thumb-sucking. Finally, Part Three offers guidance on using the therapies and procedures suggested in Part Two, from locating acupressure points to preparing herbal remedies. Written by a naturopathic physician, a medical doctor, and a pediatric nurse, this unique book gives parents easy access to current information and advice regarding their children's health and acts as a bridge between time-honored healing systems and mainstream medicine. Illustrated with line art.
Download or read book The Selection and Use of Essential Medicines written by WHO Expert Committee on the Selection and Use of Essential Medicines and published by WHO. This book was released on 2004 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model List of Essential Medicines. The first part contains a progress report on the new procedures for updating the Model List and the development of the WHO Essential Medicines Library. It continues with a section on changes made in revising the Model List followed by a review of some sections such as hypertensive medicines and fast track procedures for deleting items. Annexes include the 13th version of the Model List and items on the list sorted according to their 5-level Anatomical Therapeutic Chemical classification codes.
Download or read book Ensuring Safe Medicines and Medical Devices for Children written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2008 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Homeopathic Medicine for Children and Infants written by Dana Ullman and published by Penguin. This book was released on 1992-09-08 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: Homeopathic remedies are increasingly being used to treat common childhood ailments. They are safe, have no side effects or allergic reactions, are inexpensive and, above all, effective. In this guide, Dana Ullman explains what homeopathy is, how it works and how you can use it correctly to enhance your child's health. He recommends remedies for more than 75 physical and emotional conditions, including: allergies, grief, anxiety, headaches, asthma, measles, bedwetting, nappy rash, bites and stings, shock, burns, sunburn, colic, teething, coughs and colds and travel sickness Without doubt, this is the most comprehensive book on homeopathic pediatrics. Included is a complete guide to the correct use of homeopathy, recommended remedies for the treatment of more than seventy-five common physical, emotional, and behavioral conditions, and valuable information on the essential medicines that all parents should have in their home medicine kits
Download or read book CDC Yellow Book 2018 Health Information for International Travel written by Centers for Disease Control and Prevention CDC and published by Oxford University Press. This book was released on 2017-04-17 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book FDA s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective written by Susan Thaul and published by Createspace Independent Pub. This book was released on 2012-07-06 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt: On June 20, 2012, the House of Representatives passed, by voice vote and under suspension of the rules, S. 3187 (EAH), the Food and Drug Administration Safety and Innovation Act, as amended. This bill would reauthorize the FDA prescription drug and medical device user fee programs (which would otherwise expire on September 30, 2012), create new user fee programs for generic and biosimilar drug approvals, and make other revisions to other FDA drug and device approval processes. It reflects bicameral compromise on earlier versions of the bill (S. 3187 [ES], which passed the Senate on May 24, 2012, and H.R. 5651 [EH], which passed the House on May 30, 2012). The following CRS reports provide overview information on FDA's processes for approval and regulation of drugs: CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Susan Thaul; CRS Report RL33986, FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, by Susan Thaul; CRS Report R42130, FDA Regulation of Medical Devices, by Judith A. Johnson; CRS Report R42508, The FDA Medical Device User Fee Program, by Judith A. Johnson. (Note: The rest of this report has not been updated since November 10, 2011.) With the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), Congress authorized the Food and Drug Administration (FDA) to offer drug manufacturers financial and regulatory incentives to test their products for use in children. Congress extended both programs with the FDA Amendments of 2007 (FDAAA) and, because of the programs' sunset date, must act before October 1, 2012, to continue them. This report presents the historical development of BPCA and PREA, their rationale and effect, and FDAAA's impact. The report also discusses pediatric drug issues that remain of concern to some in Congress. Most prescription drugs have never been the subject of studies specifically designed to test their effects on children. In these circumstances, clinicians, therefore, may prescribe drugs for children that FDA has approved only for adult use; this practice is known as off-label prescribing. Although some clinicians may believe that the safety and effectiveness demonstrated with adults would hold for younger patients, studies show that the bioavailability of drugs—that is, how much gets into a patient's system and is available for use—varies in children for reasons that include a child's maturation and organ development and other factors. The result of such off-label prescribing may be that some children receive ineffective drugs or too much or too little of potentially useful drugs; or that there may be side effects unique to children, including effects on growth and development. Drug manufacturers are reluctant to test drugs in children because of economic, ethical, legal, and other obstacles. Market forces alone have not provided manufacturers with sufficient incentives to overcome these obstacles. BPCA and PREA represent attempts by Congress to address the need for pediatric testing. FDA had tried unsuccessfully to spur pediatric drug research through administrative action before 1997. With the FDA Modernization Act of 1997 (FDAMA, P.L. 105-115), Congress provided an incentive: if a manufacturer completed pediatric studies that FDA requested, the agency would extend the company's market exclusivity for that product for six months, not approving the sale of another manufacturer's product during that period. In 2002, BPCA (P.L. 107-109) reauthorized this program for five years. In 1998, to obtain pediatric use information on the drugs that manufacturers were not studying, FDA published the Pediatric Rule, which required manufacturers to submit pediatric testing data at the time of all new drug applications.
Download or read book Children s Medicines written by Edward A. Bell and published by JHU Press. This book was released on 2017-12 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: An indispensable guide to children’s medications that belongs on the bookshelf of every parent, grandparent, and teacher. Most parents have worried about the side effects and possible long-term consequences of administering a particular medication to their child. The medication may be available over-the-counter, like cough syrup, or it may be prescribed by a doctor, like an antibiotic. Parents want to know: Is the medication safe? Is it effective? Will it help my child? A pediatric pharmacist for nearly thirty years, Edward A. Bell has spent his career listening carefully to parents' concerns. In Children's Medicines, Bell draws on the latest scientific information, coupled with his experience in hospital and clinic settings, as a university professor, and as a parent, to answer questions about whether, when, and what medications to give to infants, children, and teenagers. Bell touches on practical issues of medication administration and explores areas of particular concern for parents. Inside the book, readers will find • information to help parents weigh the benefits and risks of medicines • an explanation of why some adult medications are not safe for children • descriptions of medicine for treating fever and common illnesses • practical tips on measuring, flavoring, and administering medicines • directions for giving medicine in the mouth, the nose, the ear, and the eye • advice for keeping children of any age safe around medications • facts about vaccinations: how they work, which ones are recommended, and their safety • a guide to the FDA's approval process for use of medicines by children • information about drug pricing, expiration dates, and storing medicine at home • a chapter on ADHD and the treatment of adolescent depression that takes into account the long-term side effects of antidepressants • details about the use of herbal and complementary therapies, including probiotics and vitamins • a discussion of over-the-counter cough/cold products • information on which websites to use for accurate medical and drug information Full of information helpful to parents, grandparents, and others who provide care for children, Children's Medicines is a reliable and insightful guide to how drugs for children of all ages are prescribed and used.
Download or read book Treatment Alternatives for Children written by Dr. Lawrence Rosen and published by Penguin. This book was released on 2012-08-07 with total page 253 pages. Available in PDF, EPUB and Kindle. Book excerpt: Parents worry about their kids, especially when it comes to their health. Conventional medicine has its place, but health conscious parents often worry about the serious side effects associated with many prescription drugs and other conventional treatments. Treatment Alternatives for Children is an easily accessible reference guide that enables parents to look up any number of childhood ailments—acne, ear infections, ADHD . . . you name it—and get all of the vital comparative information about the most common conventional and alternative treatments. For each side-by-side conventional/alternative comparison, readers get: • A description of the ailment each treats. • The generic and common brand names of each treatment. • Active ingredients. • How each treatment works. • Dosage, where applicable. • Treatment efficacy and timing. • Common mild side effects. • Less common serious side effects. Organized from “A” to “Z,” this book also covers a special “spotlight” on various important natural remedies and methods that can be used for a variety of ailments.
