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.

Prescribing Medicines for Children
Prescribing Medicines for Children

Author: Mike Sharland

Publisher:

Published: 2019-07-17

Total Pages: 0

ISBN-13: 9780857111357

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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.

The Selection and Use of Essential Medicines
The Selection and Use of Essential Medicines

Author: WHO Expert Committee on the Selection and Use of Essential Medicines

Publisher: WHO

Published: 2004

Total Pages: 144

ISBN-13:

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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.

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.

Disease Control Priorities, Third Edition (Volume 6)
Disease Control Priorities, Third Edition (Volume 6)

Author: King K. Holmes

Publisher: World Bank Publications

Published: 2017-11-06

Total Pages: 1027

ISBN-13: 1464805253

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Infectious diseases are the leading cause of death globally, particularly among children and young adults. The spread of new pathogens and the threat of antimicrobial resistance pose particular challenges in combating these diseases. Major Infectious Diseases identifies feasible, cost-effective packages of interventions and strategies across delivery platforms to prevent and treat HIV/AIDS, other sexually transmitted infections, tuberculosis, malaria, adult febrile illness, viral hepatitis, and neglected tropical diseases. The volume emphasizes the need to effectively address emerging antimicrobial resistance, strengthen health systems, and increase access to care. The attainable goals are to reduce incidence, develop innovative approaches, and optimize existing tools in resource-constrained settings.

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.

Medications in Pediatrics
Medications in Pediatrics

Author: American Academy of Pediatrics

Publisher:

Published: 2019-12-20

Total Pages: 500

ISBN-13: 9781610024341

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This new compendium contains AAP clinical practice guidelines, policy statements, clinical reports, and technical reports related to the use of medications in the pediatric population. It is designed to be a handy reference to AAP policies and recommended best practices. Sections include Pediatric Drug Principles Allergy/Asthma Management Contraception Emergency Care Infections Mental Health Management Substance Use Issues Neonatal Care Pain Management Plus much more...

Treatment Alternatives for Children
Treatment Alternatives for Children

Author: Dr. Lawrence Rosen

Publisher: Penguin

Published: 2012-08-07

Total Pages: 253

ISBN-13: 1615642641

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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.

CDC Yellow Book 2018: Health Information for International Travel
CDC Yellow Book 2018: Health Information for International Travel

Author: Centers for Disease Control and Prevention CDC

Publisher: Oxford University Press

Published: 2017-04-17

Total Pages: 705

ISBN-13: 0190628634

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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.

Medical Devices and the Public's Health
Medical Devices and the Public's Health

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-11-25

Total Pages: 318

ISBN-13: 0309212421

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Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.