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.
Over 50 per cent of all medicines given to children (and about 90 per cent of those given to the newly-born) have never been tested or authorised for use on them. The Committee's report examines the European Commission's proposal to introduce a Regulation (the Clinical Trials Directive) on medicinal products for paediatric use which aims to stimulate the development of medicines for children and lay down rules for testing and approval. Issues discussed include: the need for better regulation of paediatric medicines; the ethical considerations involved in clinical trials on children, including the issue of consent; mechanisms for implementing the Regulation; access to the database of information on clinical trials; the rewards and incentives proposed to stimulate the research and development of medicines; and the legal basis for the regulation under the EC Treaty. The Committee's report recognises the urgent need for effective action at the European level to authorise medicines for paediatric use and gives broad support to the proposed Directive. However, a number of key issues are highlighted, including: the need for improved labelling of medicines; that the guidelines underpinning the Directive should take account of ethical considerations involved to ensure the rights and capacity of children to give informed consent to trials; and concerns are raised about the adequacy of proposed incentive mechanisms.
The Pocket Book is for use by doctors nurses and other health workers who are responsible for the care of young children at the first level referral hospitals. This second edition is based on evidence from several WHO updated and published clinical guidelines. It is for use in both inpatient and outpatient care in small hospitals with basic laboratory facilities and essential medicines. In some settings these guidelines can be used in any facilities where sick children are admitted for inpatient care. The Pocket Book is one of a series of documents and tools that support the Integrated Managem.
GAP-f’s three-year strategic plan (2022-2024) builds from the work undertaken to date by the network of leading partners, both individually and collectively, through GAP-f. With this strategy, GAP-f is excited to increase its footprint into a broader set of diseases to bring it closer to its vision of all children having equitable access to the medicines they need.
Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by paediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to paediatric needs, US and EU legislators have taken action, and the WHO has initiated a global paediatric campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better understanding of how the child's body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects.A wide spectrum of readers will profit from this book, including paediatricians, pharmacists, general practitioners and health care professionals involved in child care and paediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.
The goal of the Paediatric drug optimization for cancer exercise was to develop a PADO priority list of formulations to be prioritized with a time horizon of 3–5 years, and a PADO ‘watch list’ containing promising candidates for investigation and development for children with a time horizon of 5–10 years. The PADO–cancer exercise enables alignment between funders, procurers, market-coordination entities, researchers, innovators, generics manufacturers, product development partnerships and regulators on priority products to be investigated and developed, as well as increasing efforts to tackle challenges in access to cancer medicines in LMICs.
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...
A treatment-focused guide for sports-related health issues in children and adolescents JAMA REVIEW! "The editors are outstanding, experienced physicians with a great wealth of knowledge as well as practical proficiency in this field. The other contributors are also first-rate authors, and all have done a wonderful job in researching the subjects and writing them up in a way that is easy to read and understand. I firmly believe that Pediatric Practice Sports Medicine will quickly become the favorite of students, residents, and primary care clinicians. It will be embraced because of its ease of use and its valuable, practical contents. I am sure it will find its way to medical libraries throughout the nation or world and to most offices for primary care clinicians. I would recommend this book for anyone dealing with pediatric and adolescent patients, even if that interaction takes place only a few times per year. I think that this will be a must-have reference for pediatricians, family practitioners, student health clinicians, pediatric and family nurse practitioners, and physician assistants and anyone working with children and adolescents."--Journal of the American Medical Association 4 STAR DOODY'S REVIEW " The book does an outstanding job of describing the etiology, presentation, evaluation, and treatment of various problems, providing a quick and valuable resource for practitioners....This is a well organized, comprehensive book that will prove useful to any primary care physician who treats younger athletes. The detailed discussions of common problems supplemented by numerous illustrations and tables will simplify the often challenging task of caring for this demanding patient population."--Doody's Review Service "Pediatric Practice: Sports Medicine is a 'must-have' book for every medical practitioner who provides care to children and adolescents."--Sandra J. Hoffmann, MD, MS, FACSM, FACP, Fellow of the American College of Sports Medicine, Board of Trustees (2006-2009) of the American College of Sport Medicine, Associate Professor, Dept. of Family Medicine, Idaho State University School of Medicine (from the foreword) Pediatric Practice: Sports Medicine explains the practical aspects of treating children who participate in sports. The authors cover everything from screening and safety issues to the treatment of sports-related injuries and trauma. How to manage patients with medical conditions that impact sports participation is also included. Providing critical information about what you need to know and do in virtually any case, this book also offers valuable perspectives on pathophysiology, epidemiology, and diagnosis. This full color guide is designed to ensure quick, easy searches for treatment directives. Perfect for pediatricians, family practice physicians, and nurse practitioners, Pediatric Practice: Sports Medicine is the handiest and most comprehensive guide available for treating children participating in sports of all kinds. Features of the Pediatric Practice Series: More than 450 full-color illustrations Tips that tell you what you must know--and what you must do--at every stage of care Diagnostic and treatment algorithms Signs/Symptoms and Differential Diagnosis boxes "What to Refer" boxes, which examine all the relevant clinical considerations Diagnostic Tests--with a realistic emphasis on the right tests to order Medical Treatment coverage that includes drugs, dosages, and administration in an easy-to-read tabular format Convenient icons and a templated chapter design
This pocket book contains up-to-date clinical guidelines, based on available published evidence by subject experts, for both inpatient and outpatient care in small hospitals where basic laboratory facilities and essential drugs and inexpensive medicines are available. It is for use by doctors, senior nurses and other senior health workers who are responsible for the care of young children at the first referral level in developing countries. In some settings, these guidelines can be used in the larger health centres where a small number of sick children can be admitted for inpatient care.
