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Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309225493 Category : Medical Languages : en Pages : 432
Book Description
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: Institute of Medicine Publisher: National Academies Press ISBN: 0309225493 Category : Medical Languages : en Pages : 432
Book Description
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: Mike Sharland Publisher: ISBN: 9780857111357 Category : Chemotherapy Languages : en Pages : 0
Book Description
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: Institute of Medicine Publisher: National Academies Press ISBN: 0309178657 Category : Medical Languages : en Pages : 64
Book Description
Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.
Author: Roger Finch Publisher: OUP Oxford ISBN: 0191628654 Category : Medical Languages : en Pages : 409
Book Description
Antimicrobial agents are essential for the treatment of life-threatening infections and for managing the burden of minor infections in the community. In addition, they play a key role in organ and bone marrow transplantation, cancer chemotherapy, artificial joint and heart valve surgery. Unlike other classes of medicines, they are vulnerable to resistance from mutations in target microorganisms, and their adverse effects may extend to other patients (increased risk of cross-infection). As a consequence, there is a constant requirement for new agents, as well as practices that ensure the continued effective prescribing of licensed agents. Public awareness and concerns about drug resistant organisms has led to widespread publicity and political action in the UK, Europe and worldwide. The control of drug resistance and the implementation of good prescribing practice are now legal requirements in the UK as a result of the UK Health Act (2008). These fundamental changes underscore the need for a thorough understanding of the advantages and risks associated with specific antibiotic choices. This sixth edition of Antimicrobial Chemotherapy continues to be a valuable resource for undergraduates and graduates requiring a thorough grounding in the scientific basis and clinical application of these drugs. This new edition is updated to include the most recently licensed agents, notably in the treatment of viral infections including HIV/AIDS, and contains new guidance on prescribing practice and infection control practices that limit the development and spread of resistant organisms.
Author: World Health Organization Publisher: World Health Organization ISBN: 9241563435 Category : Medical Languages : en Pages : 65
Book Description
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: American Academy of Pediatrics Publisher: ISBN: 9781610024341 Category : Languages : en Pages : 500
Book Description
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...
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309183642 Category : Medical Languages : en Pages : 135
Book Description
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.
Author: May Loo Publisher: Elsevier Health Sciences ISBN: 1416022996 Category : Health & Fitness Languages : en Pages : 533
Book Description
"Many parents today are turning to or seeking information about Complementary and Alternative Medicine (CAM) for their children. Whether you initiate alternative therapies or simply need to respond when asked for information or advice, it's crucial to have the most recent, evidence-based information about alternative therapies and know how to safely and effectively integrate them with conventional treatment. This innovative and reliable reference is the ideal resource to have at hand." "This book includes a wide range of complementary and alternative therapies, focusing on those most often used with children: mind/body approaches, manual therapies, lifestyle approaches, alternative systems, energy medicine, and biological agents. Within these main categories, therapies such as acupuncture, chiropractic, massage, homeopathy, herbs, and magnets are covered." "Fifty-five common pediatric conditions are comprehensively discussed, with diagnostic and evidence-based treatment information, followed by authoritative information on the major CAM therapies available for treatment of the condition. Whenever possible, an integrative approach that combines conventional and alternative approaches is presented."--BOOK JACKET.
Author: Shashank V. Joshi, M.D., FAAP, DFAACAP Publisher: American Psychiatric Pub ISBN: 1615373888 Category : Medical Languages : en Pages : 398
Book Description
Our remedies are only as good as the way in which we dispense them. That is the central premise of Thinking About Prescribing. In this new, thought-provoking volume, more than two dozen experts make the case for an ongoing alliance between pharmacotherapists, young patients, and their families. Chapters tackle issues ranging from the psychodynamics of medication use in youth with serious mental illness, adapting evidence-based motivation and therapy techniques to enhance adherence, cultivating the synergistic role of primary care providers and psychotherapists, engaging in psychoeducation with patients, to prescribing via telemedicine. Readers will pick up the foundational knowledge they need to develop a partnership with patients that is based on trust and candid communication--rather than on just the cold facts about psychotropic medications. Chapters feature key takeaways that distill the most salient points, helping readers to reference--and retain--the information easily.
Author: Institute of Medicine
Author: Institute of Medicine
Author: Mike Sharland
Author: Institute of Medicine
Author: Roger Finch
Author: World Health Organization
Author: American Academy of Pediatrics
Author: Kerm Henriksen
Author: Institute of Medicine
Author: May Loo
Author: Shashank V. Joshi, M.D., FAAP, DFAACAP