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Author : Mina Tadrous,Andrea Burden
Publisher : Frontiers Media SA
Page : 164 pages
File Size : 44,7 Mb
Release : 2022-11-15
Category : Science
ISBN : 9782832505915
Author : Miriam Sturkenboom,Tania Schink
Publisher : Springer Nature
Page : 276 pages
File Size : 44,5 Mb
Release : 2021-01-12
Category : Medical
ISBN : 9783030514556
This book allows readers to gain an in-depth understanding of the role of real-world data in pharmacoepidemiology, and highlights the strengths and limitations of the respective databases with regard to pharmacoepidemiological research. Over the past decade, the increasing use of real-world data in pharmacoepidemiological research has been accompanied by a growing recognition of the value of real-world evidence in clinical and regulatory decision-making. Electronic healthcare databases allow analyses of drug and vaccine utilization in routine care after approval, as well as investigations of their comparative effectiveness and safety. They are especially useful for the identification of rare risks and rare drug exposures over long periods of time, and as such sustainably extend the basis for drug safety research. This book provides an introduction to the role of real-world data in pharmacoepidemiological research and the main developments in the last 15 years. It also offers a comprehensive overview of the general classification characteristics of databases, together with their strengths and limitations, and a detailed description of 21 individual databases, written by professionals who work with or maintain them.
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse
Publisher : National Academies Press
Page : 483 pages
File Size : 53,6 Mb
Release : 2017-09-28
Category : Medical
ISBN : 9780309459570
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Author : Dixon Thomas
Publisher : Elsevier
Page : 540 pages
File Size : 46,6 Mb
Release : 2018-11-23
Category : Business & Economics
ISBN : 9780128142776
Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a basis to standardize and coordinate learning to practice, explaining basics and using self-learning strategies through online resources or other advanced texts. With an educational approach, it guides pharmacy students and pharmacists to learn quickly and apply. Clinical Pharmacy Education, Practice and Research provides an essential foundation for pharmacy students and pharmacists globally. Covers the core information needed for pharmacy practice courses Includes multiple case studies and practical situations with 70% focused on practical clinical pharmacology knowledge Designed for educational settings, but also useful as a refresher for advanced students and researchers
Author : Institute of Medicine,Board on Health Care Services,Board on Health Sciences Policy,Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule
Publisher : National Academies Press
Page : 334 pages
File Size : 47,5 Mb
Release : 2009-03-24
Category : Computers
ISBN : 9780309124997
In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Author : Rolf Dinkel,Bruno Horisberger,Kenneth W. Tolo
Publisher : Springer Science & Business Media
Page : 338 pages
File Size : 53,7 Mb
Release : 2013-03-07
Category : Medical
ISBN : 9783642612503
As the focus on pharmaceuticals has broadened from concern for their cost and effectiveness to their real and potential risks and benefits, a critical question has been raised: whose responsibility is it to improve drug safety? In April 1990, this question became the theme for a conference at Wolfsberg, Switzerland, near the shores of Lake Constance. Called an "international dialogue conference" by its organizers, the meeting brought together leaders from the pharmaceutical industry, regulatory authorities, academia, medicine, consumer organizations and the media. Opening addresses were given by representatives of the Council for International Organizations of Medical Sciences (CIOMS), the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), the Swiss International Pharmaceutical Agency, and the RAD-AR Consortium. This book documents the papers presented and discussions held at this conference, which took the topic of risks and benefits of drug therapy one step further to responsibility. It includes a rich menu of issues for those who care about the evaluation of drug therapy, the ethics behind it, the expectations of the patient, and the role of traditional and nontraditional drug safety communica tions. The ideas expressed here come from different parts of the world but relate to common drug safety problems, observations, and scientific assessments; they provide insights into innovative approaches, cautious changes, and desired actions. The papers in this volume are broadly divided into conceptual perspectives (ethics, how the knowledge about drug risks and benefits is generated and appraised, the expectations in drug safety) and operational perspectives (communication, discussion, and action).
Author : The Expert Panel on Effectiveness of Health Product Risk Communication
Publisher : Council of CanadianAcademies
Page : 212 pages
File Size : 51,5 Mb
Release : 2015-06-09
Category : Health & Fitness
ISBN : 9781926522135
Communicating about risk cannot be reduced to a simple formula. There are a range of potential hazards that can pose risks to health, and these risks can vary in severity, certainty, probability, and complexity.
Author : Jerry Avorn, M.D.
Publisher : Vintage
Page : 476 pages
File Size : 49,6 Mb
Release : 2008-12-10
Category : Medical
ISBN : 9780307489753
If you believe that the latest blockbuster medication is worth a premium price over your generic brand, or that doctors have access to all the information they need about a drug’s safety and effectiveness each time they write a prescription, Dr. Jerry Avorn has some sobering news. Drawing on more than twenty-five years of patient care, teaching, and research at Harvard Medical School, he shares his firsthand experience of the wide gap in our knowledge of the effectiveness of one medication as compared to another. In Powerful Medicines, he reminds us that every pill we take represents a delicate compromise between the promise of healing, the risk of side effects, and an increasingly daunting price. The stakes on each front grow higher every year as new drugs with impressive power, worrisome side effects, and troubling costs are introduced. This is a comprehensive behind-the-scenes look at issues that affect everyone: our shortage of data comparing the worth of similar drugs for the same condition; alarming lapses in the detection of lethal side effects; the underuse of life-saving medications; lavish marketing campaigns that influence what doctors prescribe; and the resulting upward spiral of costs that places vital drugs beyond the reach of many Americans. In this engagingly written book, Dr. Avorn asks questions that will interest every consumer: How can a product judged safe by the Food and Drug Administration turn out to have unexpectedly lethal side effects? Why has the nation’s drug bill been growing at nearly 20 percent per year? How can physicians and patients pick the best medication in its class? How do doctors actually make their prescribing decisions, and why do those decisions sometimes go wrong? Why do so many Americans suffer preventable illnesses and deaths that proper drug use could have averted? How can the nation gain control over its escalating drug budget without resorting to rationing or draconian governmental controls? Using clinical case histories taken from his own work as a practitioner, researcher, and advocate, Dr. Avorn demonstrates the impressive power of the well-conceived prescription as well as the debacles that can result when medications are misused. He describes an innovative program that employs the pharmaceutical industry’s own marketing techniques to reduce use of some of the most overprescribed and overpriced products. Powerful Medicines offers timely and practical advice on how the nation can improve its drug-approval process, and how patients can work with doctors to make sure their prescriptions are safe, effective, and as affordable as possible. This is a passionate and provocative call for action as well as a compelling work of clear-headed science.
Author : Agency for Health Care Research and Quality (U.S.)
Publisher : Government Printing Office
Page : 204 pages
File Size : 52,8 Mb
Release : 2013-02-21
Category : Medical
ISBN : 9781587634239
This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. 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. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)
Author : Institute of Medicine,Roundtable on Value and Science-Driven Health Care
Publisher : National Academies Press
Page : 442 pages
File Size : 49,8 Mb
Release : 2010-09-20
Category : Medical
ISBN : 9780309162326
Recent scientific and technological advances have accelerated our understanding of the causes of disease development and progression, and resulted in innovative treatments and therapies. Ongoing work to elucidate the effects of individual genetic variation on patient outcomes suggests the rapid pace of discovery in the biomedical sciences will only accelerate. However, these advances belie an important and increasing shortfall between the expansion in therapy and treatment options and knowledge about how these interventions might be applied appropriately to individual patients. The impressive gains made in Americans' health over the past decades provide only a preview of what might be possible when data on treatment effects and patient outcomes are systematically captured and used to evaluate their effectiveness. Needed for progress are advances as dramatic as those experienced in biomedicine in our approach to assessing clinical effectiveness. In the emerging era of tailored treatments and rapidly evolving practice, ensuring the translation of scientific discovery into improved health outcomes requires a new approach to clinical evaluation. A paradigm that supports a continual learning process about what works best for individual patients will not only take advantage of the rigor of trials, but also incorporate other methods that might bring insights relevant to clinical care and endeavor to match the right method to the question at hand. The Institute of Medicine Roundtable on Value & Science-Driven Health Care's vision for a learning healthcare system, in which evidence is applied and generated as a natural course of care, is premised on the development of a research capacity that is structured to provide timely and accurate evidence relevant to the clinical decisions faced by patients and providers. As part of the Roundtable's Learning Healthcare System series of workshops, clinical researchers, academics, and policy makers gathered for the workshop Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches. Participants explored cutting-edge research designs and methods and discussed strategies for development of a research paradigm to better accommodate the diverse array of emerging data resources, study designs, tools, and techniques. Presentations and discussions are summarized in this volume.
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Publisher : National Academies Press
Page : 292 pages
File Size : 41,8 Mb
Release : 2012-07-30
Category : Medical
ISBN : 9780309218160
An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
Author : Chris J. van Boxtel,Budiono Santoso,I. Ralph Edwards
Publisher : John Wiley & Sons
Page : 738 pages
File Size : 45,8 Mb
Release : 2001-11-28
Category : Medical
ISBN : 0471899275
This is an inclusive reference exploring the scientific basis and practice of drug therapy. The key concept is to look at the balance between the benefits and risks of drugs but in this context also the social impact which drugs have in modern societies is highlighted. Taking an evidence-based approach to the problem, the practice of clinical pharmacology and pharmacotherapy in the developing as well as the developed world is examined. For this purpose the book * Covers general clinical pharmacology, pharmacology of various drug groups and the treatments specific to various diseases * Gives guidance on how doctors should act so that drugs can be used effectively and safely * Encourages the rational use of drugs in society This book brings together a large amount of excellent content that will be invaluable for anyone working within, or associated with, the field of clinical pharmacology and pharmacotherapy - undergraduates, postgraduates, regulatory authorities and the pharmaceutical industry.
Author : Sabrina Nour,Gilles Plourde
Publisher : Academic Press
Page : 144 pages
File Size : 44,7 Mb
Release : 2018-10-17
Category : Medical
ISBN : 9780128163818
Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologic research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate the passive and active surveillance of adverse drug reactions in clinical situations, covering important pharmacoepidemiologic concepts like health risk management and safety. The book helps pharmaceutical industry groups engaged in drug safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for all patient populations. Describes the main prevention tools for the passive and active surveillance of adverse effects associated with drugs Provides examples of diseases in various contexts related to clinical studies and the analysis of adverse drug reactions Offers case studies that illustrate real-life clinical situations Discusses important concepts related to pharmacoepidemiology and pharmacovigilance
Author : Harry Yang,Binbing Yu
Publisher : CRC Press
Page : 191 pages
File Size : 40,7 Mb
Release : 2021-01-11
Category : Mathematics
ISBN : 9780429676826
Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise
Author : Brian L. Strom,Stephen E. Kimmel
Publisher : John Wiley & Sons
Page : 756 pages
File Size : 46,9 Mb
Release : 2013-05-13
Category : Medical
ISBN : 9781118708002
The Textbook of Pharmacoepidemiology provides a streamlined text for evaluating the safety and effectiveness of medicines. It includes a brief introduction to pharmacoepidemiology as well as sections on data sources, methodology and applications. Each chapter includes key points, case studies and essential references. One-step resource to gain understanding of the subject of pharmacoepidemiology at an affordable price Gives a perspective on the subject from academia, pharmaceutical industry and regulatory agencies Designed for students with basic knowledge of epidemiology and public health Includes many case studies to illustrate pharmacoepidemiology in real clinical setting