Ensuring Drug Safety


Book Description




Registries for Evaluating Patient Outcomes


Book Description

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.




The Future of Drug Safety


Book Description

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.




Comprehensive Dermatologic Drug Therapy


Book Description

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.







Basics of Pharmacovigilance


Book Description

"Basics of Pharmacovigilance" is an introductory guide to drug safety monitoring and reporting, providing readers with a comprehensive overview of pharmacovigilance and its role in ensuring the safety and efficacy of pharmaceutical products. This book covers the fundamentals of drug safety monitoring and reporting, including adverse drug reactions, risk management plans, and pharmacovigilance in special populations. It also provides real-world examples of data visualization and signal detection tools used in pharmacovigilance, as well as guidance on how to interpret the results. Whether you're a healthcare professional, a regulatory authority, or a pharmaceutical industry professional, "Basics of Pharmacovigilance" provides the knowledge and tools necessary to ensure the safety and efficacy of pharmaceutical products. With practical advice and real-world examples, this book is a must-read for anyone interested in pursuing a career in pharmacovigilance or anyone who wants to gain a better understanding of this important field.




Science, Medicine, and Animals


Book Description

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.




Cobert's Manual of Drug Safety and Pharmacovigilance


Book Description

Completely revised and updated, the Manual of Drug Safety and Pharmacovigilance, Second Edition is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, government and legal professions. This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance) and side effects, as well as providing essential information on drug safety and regulations, including: recognizing, monitoring, reporting and cataloging serious adverse drug reactions. The Manual of Drug Safety and Pharmacovigilance, Second Edition teaches the ins and outs of drug safety in the industry, hospitals, FDA, and other health agencies both in the US and around the world, and presents critical information about what is done when confronted with a drug safety problem.




The Nurse's Role in Medication Safety


Book Description

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




Injection Techniques in Musculoskeletal Medicine E-Book


Book Description

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