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Safe and Effective Medicines for Children
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.
Pediatric Drug Research
About 2/3 of drugs prescribed for children have not been studied & labeled for pediatric use, which places children at risk of being exposed to ineffective treatment or incorrect dosing. The Best Pharm. for Children Act (BPCA), encourages the mfrs. of drugs that still have marketing exclusivity to conduct pediatric drug studies (PDS), as requested by the FDA. If they do so, FDA may extend for 6 mo. the period during which no equivalent generic drugs can be marketed. This report: assessed the extent to which PDS were being conducted under BPCA for on-patent drugs; evaluated the impact of BPCA on labeling drugs for pediatric use & the process by which the labeling was changed; & illustrated the range of diseases treated by the drugs studied under BPCA.
Addressing the Barriers to Pediatric Drug Development
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.
Pediatric Drug Development
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.
Ethical Conduct of Clinical Research Involving Children
In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and ...
Safety Efforts in Pediatric Drug Development
This book focuses on the safety efforts being implemented in paediatric drug development. Although children suffer from many of the same diseases as adults and are often treated with the same drugs, only about one-third of the drugs that are prescribed for children have been studied and labelled for paediatric use. This has placed children taking drugs for which there have not been adequate paediatric drug studies at risk of being exposed to ineffective treatment or receiving incorrect dosing. In order to encourage the study of more drugs for paediatric use, Congress passed the Best Pharmaceuticals for Children Act (BPCA) in 2002 to provide marketing incentives to drug manufacturers for cond...
Pediatric Psychopharmacology for Primary Care
Completely updated and revised, the third edition provides primary care physicians with practice-tested, condition-specific treatment recommendations for various childhood mental disorders. Obtain clear guidance on dosing, monitoring, and potential adverse reactions of psychotropic medications for treatment of common psychiatric disorders and mental health or behavioral problems in children and adolescents. It includes digital tools offering instant access to additional information on psychotropic medications. TOPICS INCLUDE Conceptual framework for prescribing psychotropics Newly approved medications, changes in regulations and guidelines, and updates in the professional literature are included in this new edition Medications for specific diagnoses--ADHD, anxiety, and depression Food and Drug Administration approved antipsychotics and mood stabilizers and all other medications What to do when treatment is unsuccessful
