Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Download or read book Crossing the Quality Chasm written by Institute of Medicine and published by National Academies Press. This book was released on 2001-07-19 with total page 359 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book The Future of Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2007-03-27 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Science Medicine and Animals written by National Research Council and published by National Academies Press. This book was released on 2006-02-19 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher's Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher's Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher's Guide was reviewed by members of the National Academies' Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher's Association NSTA Recommends.

Download or read book Drug Safety in Developing Countries written by Yaser Mohammed Al-Worafi and published by Academic Press. This book was released on 2020-06-03 with total page 656 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. - Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues - Describes current achievements of drug safety practice in developing countries - Addresses the challenges of drug safety in developing countries - Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety

Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Comprehensive Dermatologic Drug Therapy written by Stephen E Wolverton and published by Elsevier Health Sciences. This book was released on 2019-12-14 with total page 1073 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designed with practical usability in mind, Comprehensive Dermatologic Drug Therapy, 4th Edition, helps you safely and effectively treat the skin disorders you're likely to see in your practice. Dr. Stephen E. Wolverton and new associate editor Dr. Jashin J. Wu lead a team of global experts to bring you concise, complete guidance on today's full spectrum of topical, intralesional, and systemic drugs. You'll prescribe with confidence thanks to expert coverage of which drugs to use, when to use them, and adverse effects to monitor. - Includes new drug interaction tables, drug risk profiles, and FDA guidelines, as well as two new appendices that summarize chapter questions and summarize highest-risk drug interactions. - Covers the best uses for new biologic therapeutics. - Contains new chapters covering medical decision-making principles, PDE-4 and JAK inhibitors, interleukin 17 inhibitors, interleukin 23 inhibitors, additional biologic therapeutics, and hedgehog pathway inhibitors. - Contains quick-access summaries of indications/contraindications, dosage guidelines, drug interactions, drug monitoring guidelines, adverse effects, and treatment protocols. - Features a highly detailed, disease-specific index, as well as purchase information for major drugs. - Helps you assess your knowledge and prepare for certification or recertification with about 800 review questions and answers throughout the book. - Enhanced eBook version included with purchase. Your enhanced eBook allows you to access all of the text, figures, and references from the book on a variety of devices.

Download or read book Principles of Safety Pharmacology written by Michael K. Pugsley and published by Springer. This book was released on 2015-06-19 with total page 477 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.

Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.

Download or read book Communicating about Risks and Safe Use of Medicines written by Priya Bahri and published by Springer Nature. This book was released on 2020-06-17 with total page 523 pages. Available in PDF, EPUB and Kindle. Book excerpt: At the core of this book lies the question how to approach medicines, risks and communication as a researcher - or anybody planning and evaluating a communication intervention, or wanting to understand communication events in private and the media. With a view to tackle current shortcomings of communication systems and processes for improved implementation, patient satisfaction and health outcomes, a multilayered approach is presented. This combines multiple data types and methods to obtain a wider and deeper understanding of the major parties and their interactions, as well as the healthcare, social and political contexts of information flows, how they interfere and which impact they have. Illustrated with real life experiences of safety concerns with medicines, worldwide active experts discuss the methods and contributions their disciplines can offer. With considerations on terminologies, tabulated overviews on communication types and outcomes, a patient-centred vision and plain language for non-medical readers, the book creates a platform for multidisciplinary collaborations amongst researchers as well as practitioners from communications, healthcare, the social sciences and pharmacovigilance. Importantly, it advocates for an active role of patients and highlights the achievements and aspirations of patient organisations. Finally, the book suggests establishing an inclusive discipline of humanities and epidemiology of medicinal product risk communication to realise full research potential. The authors are driven by the curiosity for communication as the most human behaviour, and as good health is amongst the basic human needs, medicinal product risk communication is an exciting research field of high global relevance.

Download or read book Tutorial for Outline of the Healthy China 2030 Plan written by Bin Li and published by Springer Nature. This book was released on 2020-07-01 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: “Healthy China 2030” is a national strategy for improving the health of the population and coordinating health and socio-economic development, and a major means for the country to participate in global health governance and meet targets set in the 2030 Agenda for Sustainable Development. This outline of the plan will be a blueprint and an action plan for facilitating the development of Healthy China. This tutorial book is a guide for “Outline of the Healthy China 2030 Plan” released on October 25, 2016. This book is organized by 29 chapters. It uses data, background description and figures to facilitate readers to know the plan. The book Editor-in-Chief Bin Li is the Former Minister of National Health Commission of PRC, and is the Vice Chairman of the National Committee of the Chinese People's Political Consultative Conference. The book Associate Editor-in-Chief Xiaowei Ma is the Minister of National Health Commission of PRC.

Download or read book Injection Techniques in Musculoskeletal Medicine E Book written by Stephanie Saunders and published by Elsevier Health Sciences. This book was released on 2011-10-24 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in its fourth edition and with a new title – Injection Techniques in Musculoskeletal Medicine – this successful step-by-step guide is a trusted resource used by a wide range of practitioners who have to deal with the management of painful joints and soft tissues, particularly in relation to sports and overuse injuries. Area by area, guidance is given for each lesion on appropriate patient selection and delivery of the drug. Every technique has its own two-page spread containing a written description along with an anatomical illustration of the region and a photograph showing the anatomical landmarks for the injection. This new edition is now accompanied by a Trainer available via www.injectiontechniquesonline.com. Please see log on for further details on how to access the virtual training guide - introduced by Stephanie Saunders herself - which covers the top most common injection techniques for each of the body regions. Through key text, videos, animations and interactive self-assessment, users are tested on their knowledge of anatomical landmarks, differential diagnoses, assessment criteria, drug selection and technical skill. Further access is given to a library of over 50 video clips showing supplementary injection techniques which clearly demonstrate the correct anatomical position for each needle insertion. Illustrations, references, lesions, drugs, controversies! Chapters on Other Injectable Substances; Landmark and Image Guided Injections Latest evidence in injection therapy literature Adapted and simplified practical sections Access to Musculoskeletal Injection Techniques Trainer – a virtual aid to test your anatomical and technical skills on the top most common injections for the upper and lower limbs and spine – perfect for self-testing and honing your skills! Log on to www.injectiontechniquesonline.com to begin The Trainer also gives unlimited access to a bank of over 50 video clips demonstrating actual needle insertion for each lesion

Download or read book The Nurse s Role in Medication Safety written by Laura Cima and published by Joint Commission Resources. This book was released on 2011-12 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written especially for nurses in all disciplines and health care settings, this second edition of The Nurses's Role in Medication Safety focuses on the hands-on role nurses play in the delivery of care and their unique opportunity and responsibility to identify potential medication safety issues. Reflecting the contributions of several dozen nurses who provided new and updated content, this book includes strategies, examples, and advice on how to: * Develop effective medication reconciliation processes * Identify and address causes of medication errors * Encourage the reporting of medication errors in a safe and just culture * Apply human factors solutions to medication management issues and the implementation of programs to reduce medication errors * Use technology (such as smart pumps and computerized provider order entry) to improve medication safety * Recognize the special issues of medication safety in disciplines such as obstetrics, pediatrics, geriatrics, and oncology and within program settings beyond large urban hospitals, including long term care, behavioral health care, critical access hospitals, and ambulatory care and office-based surgery

Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

Download or read book Drug Safety Data How to Analyze Summarize and Interpret to Determine Risk written by Michael J. Klepper and published by Jones & Bartlett Publishers. This book was released on 2010-09-15 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)

Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Download or read book Cobert s Manual Of Drug Safety And Pharmacovigilance Third Edition written by Barton Cobert and published by World Scientific. This book was released on 2019-04-09 with total page 525 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies — both in the United States and around the world — and provides critical information about what to do when confronted with a drug safety problem.Related Link(s)