Safe And Effective Use Of Medicines In Children

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA)
Publisher : National Academies Press
Page : 432 pages
File Size : 54,9 Mb
Release : 2012-10-13
Category : Medical
ISBN : 9780309225496

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Safe and Effective Medicines for Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) Pdf

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.

Author : Mariam Hantash Abdel Jalil
Publisher : Unknown
Page : 0 pages
File Size : 41,6 Mb
Release : 2014
Category : Electronic
ISBN : OCLC:1179473765

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Safe and Effective Use of Medicines in Children by Mariam Hantash Abdel Jalil Pdf

Author : World Health Organization
Publisher : World Health Organization
Page : 65 pages
File Size : 43,8 Mb
Release : 2007
Category : Medical
ISBN : 9789241563437

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Promoting Safety of Medicines for Children by World Health Organization Pdf

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.

Author : Council of Canadian Academies,Council of Canadian Academies: The Expert Panel on Therapeutic Products for Infants, Children, and Youth
Publisher : Council of CanadianAcademies
Page : 266 pages
File Size : 52,9 Mb
Release : 2014-09
Category : Drugs
ISBN : 9781926558851

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Improving Medicines for Children in Canada by Council of Canadian Academies,Council of Canadian Academies: The Expert Panel on Therapeutic Products for Infants, Children, and Youth Pdf

Author : Roger Walker
Publisher : Elsevier Health Sciences
Page : 998 pages
File Size : 43,5 Mb
Release : 2011-10-24
Category : Medical
ISBN : 9780702048487

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Clinical Pharmacy and Therapeutics E-Book by Roger Walker Pdf

Now in its fifth edition, this best-selling, multidisciplinary textbook continues to draw on the skills of pharmacists and clinicians to present optimal drug regimens. The authors integrate an understanding of the disease processes with an appreciation of pathophysiological processes, clinical pharmacy and the evidence base. New to this edition: Stronger emphasis on understanding both the prescribing process and the clinical pharmacy process. All chapters completely revised and updated. Thirty-eight leading new authors. Features: Key points boxes at the beginning of every chapter Case study tests at the end of every chapter Chapters co-authored by pharmacists and clinicians Organised by body system Consistent, clearly signposted chapter layout ‘...a unique and valuable support for all those involved or interested in drug therapy. This is a textbook that no university or pharmacy department, particularly those with employees studying at any level, and no pharmacist trying to develop their knowledge base should be without." Dr Chris Green and John Sexton, The Pharmaceutical Journal Now in its fifth edition, this best-selling, multidisciplinary textbook continues to draw on the skills of pharmacists and clinicians to present optimal drug regimens. The authors integrate an understanding of the disease processes with an appreciation of pathophysiological processes, clinical pharmacy and the evidence base. New to this edition: Stronger emphasis on understanding both the prescribing process and the clinical pharmacy process. All chapters completely revised and updated. Thirty-eight leading new authors. Features: Key points boxes at the beginning of every chapter Case study tests at the end of every chapter Chapters co-authored by pharmacists and clinicians Organised by body system Consistent, clearly signposted chapter layout ‘...a unique and valuable support for all those involved or interested in drug therapy. This is a textbook that no university or pharmacy department, particularly those with employees studying at any level, and no pharmacist trying to develop their knowledge base should be without." Dr Chris Green and John Sexton, The Pharmaceutical Journal Stronger emphasis on understanding both the prescribing process and the clinical pharmacy process. All chapters completely revised and updated. Thirty-eight leading new authors.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Postmarket Surveillance of Pediatric Medical Devices
Publisher : National Academies Press
Page : 481 pages
File Size : 47,8 Mb
Release : 2006-01-20
Category : Medical
ISBN : 9780309096317

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Safe Medical Devices for Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Postmarket Surveillance of Pediatric Medical Devices Pdf

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.

Author : Mervat Musbah Zaki Alsous
Publisher : Unknown
Page : 0 pages
File Size : 50,9 Mb
Release : 2014
Category : Electronic
ISBN : OCLC:1179437652

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Safe and Effective Use of Medicine in Children by Mervat Musbah Zaki Alsous Pdf

Author : Tomoya Tachi,Yuki Kondo,Yen-Ming Huang
Publisher : Frontiers Media SA
Page : 196 pages
File Size : 51,7 Mb
Release : 2023-12-13
Category : Science
ISBN : 9782832540763

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Effective methods to promote appropriate use of medicines by Tomoya Tachi,Yuki Kondo,Yen-Ming Huang Pdf

Author : Mike Sharland
Publisher : Unknown
Page : 0 pages
File Size : 45,7 Mb
Release : 2019-07-17
Category : Chemotherapy
ISBN : 0857111353

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Prescribing Medicines for Children by Mike Sharland Pdf

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.

Author : Edward A. Bell
Publisher : JHU Press
Page : 156 pages
File Size : 49,7 Mb
Release : 2017-12
Category : Family & Relationships
ISBN : 9781421423746

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Children's Medicines by Edward A. Bell Pdf

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.

Author : Evelyne Jacqz-Aigrain,Imti Choonara
Publisher : CRC Press
Page : 500 pages
File Size : 48,5 Mb
Release : 2021-02-25
Category : Medical
ISBN : 9780849374449

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Paediatric Clinical Pharmacology by Evelyne Jacqz-Aigrain,Imti Choonara Pdf

The treatment of children with medicinal products is an important scientific area. It is recognized that many medicines that are used extensively in pediatric patients are either unlicensed or off-label. This textbook will help pediatric health professionals effectively treat children with the most appropriate medicine with minimal side effects.

Author : Institute of Medicine,Board on Health Care Services,Committee on Identifying and Preventing Medication Errors
Publisher : National Academies Press
Page : 481 pages
File Size : 55,6 Mb
Release : 2007-01-11
Category : Medical
ISBN : 9780309101479

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Preventing Medication Errors by Institute of Medicine,Board on Health Care Services,Committee on Identifying and Preventing Medication Errors Pdf

In 1996 the Institute of Medicine launched the Quality Chasm Series, a series of reports focused on assessing and improving the nation's quality of health care. Preventing Medication Errors is the newest volume in the series. Responding to the key messages in earlier volumes of the seriesâ€"To Err Is Human (2000), Crossing the Quality Chasm (2001), and Patient Safety (2004)â€"this book sets forth an agenda for improving the safety of medication use. It begins by providing an overview of the system for drug development, regulation, distribution, and use. Preventing Medication Errors also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error prevention strategies. Presenting data that will foster the reduction of medication errors, the book provides action agendas detailing the measures needed to improve the safety of medication use in both the short- and long-term. Patients, primary health care providers, health care organizations, purchasers of group health care, legislators, and those affiliated with providing medications and medication- related products and services will benefit from this guide to reducing medication errors.

Author : Lynn Hagger
Publisher : Routledge
Page : 268 pages
File Size : 43,6 Mb
Release : 2016-03-23
Category : Law
ISBN : 9781317038597

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The Child As Vulnerable Patient by Lynn Hagger Pdf

How can medical law and ethics take forward the issue of children's empowerment and protection? What are the key factors in considering the balance between protecting the welfare of the young and allowing them rights to autonomy? The Child as Vulnerable Patient investigates the role that a human rights approach can play in establishing the parameters of autonomy and discusses the opportunities presented in the Human Rights Act, the European Convention on the Rights of the Child and new policy initiatives in the NHS. A valuable addition to existing literature in this area, this volume will be of interest to lawyers, health professionals and students of medical law.

Author : William J. Brock,Kenneth L. Hastings,Kathy M. McGown
Publisher : John Wiley & Sons
Page : 492 pages
File Size : 48,9 Mb
Release : 2013-04-29
Category : Medical
ISBN : 9780470745915

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Nonclinical Safety Assessment by William J. Brock,Kenneth L. Hastings,Kathy M. McGown Pdf

Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.

Author : Institute of Medicine,Committee on Quality of Health Care in America
Publisher : National Academies Press
Page : 360 pages
File Size : 41,5 Mb
Release : 2001-08-19
Category : Medical
ISBN : 9780309072809

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Crossing the Quality Chasm by Institute of Medicine,Committee on Quality of Health Care in America Pdf

Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.