Download or read book Therapeutic Risk Management of Medicines written by Stephen J. Mayall and published by Elsevier. This book was released on 2014-04-16 with total page 435 pages. Available in PDF, EPUB and Kindle. Book excerpt: Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders. A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US. This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts. An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicines A number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan) A comprehensive guide for performing risk management more effectively throughout a product’s life-cycle

Download or read book Pharmacoepidemiology and Therapeutic Risk Management written by Abraham G. Hartzema and published by . This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Smart Health Choices written by Les Irwig and published by Judy Irwig. This book was released on 2008 with total page 255 pages. Available in PDF, EPUB and Kindle. Book excerpt: Every day we make decisions about our health - some big and some small. What we eat, how we live and even where we live can affect our health. But how can we be sure that the advice we are given about these important matters is right for us? This book will provide you with the right tools for assessing health advice.

Download or read book Practical Approaches to Risk Minimisation for Medicinal Products written by World Health Organization and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large. Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of risk, "risk minimization" is used as an umbrella term for the prevention or mitigation of an undesirable outcome. Risk management always includes tools for "routine risk minimization" such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects. Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need "additional risk minimization," select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable. Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimization, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life.

Download or read book Textbook of Patient Safety and Clinical Risk Management written by Liam Donaldson and published by Springer Nature. This book was released on 2020-12-14 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: Implementing safety practices in healthcare saves lives and improves the quality of care: it is therefore vital to apply good clinical practices, such as the WHO surgical checklist, to adopt the most appropriate measures for the prevention of assistance-related risks, and to identify the potential ones using tools such as reporting & learning systems. The culture of safety in the care environment and of human factors influencing it should be developed from the beginning of medical studies and in the first years of professional practice, in order to have the maximum impact on clinicians' and nurses' behavior. Medical errors tend to vary with the level of proficiency and experience, and this must be taken into account in adverse events prevention. Human factors assume a decisive importance in resilient organizations, and an understanding of risk control and containment is fundamental for all medical and surgical specialties. This open access book offers recommendations and examples of how to improve patient safety by changing practices, introducing organizational and technological innovations, and creating effective, patient-centered, timely, efficient, and equitable care systems, in order to spread the quality and patient safety culture among the new generation of healthcare professionals, and is intended for residents and young professionals in different clinical specialties.

Download or read book Drug Induced Headache written by Hans-Christoph Diener and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt: M. WILKINSON Patients with frequent or daily headaches pose a very difficult problem for the physician who has to treat them, particularly as many patients think that there should be a medicine or medicines which give them instant relief. In the search for the compound which would meet this very natural desire, many drugs have been manufactured and the temptation for the physician is either to increase the dose of a drug which seems to be, at any rate, partially effective, or to add one or more drugs to those which the patient is already taking. Although there have been some references to the dangers of overdosage of drugs for migraine in the past, it was not until relatively recently that it was recognized that drugs given for the relief of headache, if taken injudiciously, may themselves cause headache. The first drugs to be implicated in this way were ergotamine and phenazone. In the case of ergotamine tartrate, the dangers of ergotism were well known as this was a disorder which had been known and written about for many years. In the treatment of headache, fully blown ergotism is rare and in recent years has usually been due to self-medication in doses much greater than those prescribed although there are a few recorded cases where toxic amounts have been given.

Download or read book Managed Care Pharmacy Practice written by Navarro and published by Jones & Bartlett Publishers. This book was released on 2008-12-11 with total page 659 pages. Available in PDF, EPUB and Kindle. Book excerpt: Managed Care Pharmacy Practice, Second Edition offers information critical to the development and operation of a managed care pharmacy program. The text also covers the changes that have taken place within the delivery of pharmacy services, as well as the evolving role of pharmacists.

Download or read book Ethical and Scientific Issues in Studying the Safety of Approved Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2012-07-30 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Preventing Medication Errors written by Institute of Medicine and published by National Academies Press. This book was released on 2007-01-11 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 1996 the Institute of Medicine launched the Quality Chasm Series, a series of reports focused on assessing and improving the nation's quality of health care. Preventing Medication Errors is the newest volume in the series. Responding to the key messages in earlier volumes of the seriesâ€"To Err Is Human (2000), Crossing the Quality Chasm (2001), and Patient Safety (2004)â€"this book sets forth an agenda for improving the safety of medication use. It begins by providing an overview of the system for drug development, regulation, distribution, and use. Preventing Medication Errors also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error prevention strategies. Presenting data that will foster the reduction of medication errors, the book provides action agendas detailing the measures needed to improve the safety of medication use in both the short- and long-term. Patients, primary health care providers, health care organizations, purchasers of group health care, legislators, and those affiliated with providing medications and medication- related products and services will benefit from this guide to reducing medication errors.

Download or read book Patient Safety and Quality written by Ronda Hughes and published by Department of Health and Human Services. This book was released on 2008 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Nurses play a vital role in improving the safety and quality of patient car -- not only in the hospital or ambulatory treatment facility, but also of community-based care and the care performed by family members. Nurses need know what proven techniques and interventions they can use to enhance patient outcomes. To address this need, the Agency for Healthcare Research and Quality (AHRQ), with additional funding from the Robert Wood Johnson Foundation, has prepared this comprehensive, 1,400-page, handbook for nurses on patient safety and quality -- Patient Safety and Quality: An Evidence-Based Handbook for Nurses. (AHRQ Publication No. 08-0043)." - online AHRQ blurb, http://www.ahrq.gov/qual/nurseshdbk/

Download or read book Principles and Practice of Pharmaceutical Medicine written by Lionel D. Edwards and published by John Wiley & Sons. This book was released on 2007-04-30 with total page 780 pages. Available in PDF, EPUB and Kindle. Book excerpt: The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS

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 CDC Yellow Book 2018 Health Information for International Travel written by Centers for Disease Control and Prevention CDC and published by Oxford University Press. This book was released on 2017-04-17 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: THE ESSENTIAL WORK IN TRAVEL MEDICINE -- NOW COMPLETELY UPDATED FOR 2018 As unprecedented numbers of travelers cross international borders each day, the need for up-to-date, practical information about the health challenges posed by travel has never been greater. For both international travelers and the health professionals who care for them, the CDC Yellow Book 2018: Health Information for International Travel is the definitive guide to staying safe and healthy anywhere in the world. The fully revised and updated 2018 edition codifies the U.S. government's most current health guidelines and information for international travelers, including pretravel vaccine recommendations, destination-specific health advice, and easy-to-reference maps, tables, and charts. The 2018 Yellow Book also addresses the needs of specific types of travelers, with dedicated sections on: · Precautions for pregnant travelers, immunocompromised travelers, and travelers with disabilities · Special considerations for newly arrived adoptees, immigrants, and refugees · Practical tips for last-minute or resource-limited travelers · Advice for air crews, humanitarian workers, missionaries, and others who provide care and support overseas Authored by a team of the world's most esteemed travel medicine experts, the Yellow Book is an essential resource for travelers -- and the clinicians overseeing their care -- at home and abroad.

Download or read book Risk Assessment and Management in Mental Health Nursing written by Phil Woods and published by John Wiley & Sons. This book was released on 2009-04-13 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk assessment and management is a core element of mental health practice, and all nurses need to be aware of the risks surrounding them and their patients in order to create a safe working environment. This timely and accessible text explores how nurses can enhance their skills, and improve their practice so that risk is assessed and managed safely and effectively. Risk Assessment and Management in Mental Health Nursing explores issues including context and definitions of risk, risk assessment tools and techniques, strategies for preventing risk situations, suicide, self-harm, neglect, forensic aspects of risk, substance misuse, ethical considerations, , victimology, risk to others and risk to self. Special Features: Written in the context of latest policy developments such as the National Service Frameworks Discusses the role of the mental health nurse in the assessment and management of risk Explores an increasingly important and timely subject in mental health practice Practical focus, with case studies throughout Written by experts in the field

Download or read book How to Conduct a Comprehensive Medication Review written by Lauren B. Angelo and published by American Pharmacists Association (APhA). This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The medication therapy management (MTM) process gives pharmacists an opportunity to work directly with patients to optimize their medication use. A key component of MTM is the comprehensive medication review (CMR). This guidebook provides pharmacists with a detailed description of each step in the process. Following the steps outlined in this guidebook will ensure a standardized and comprehensive approach to the delivery of MTM services.

Download or read book Therapeutic Protein Drug Products written by Brian K Meyer and published by Elsevier. This book was released on 2012-01-02 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed. Provides a list and description of commercially available therapeutic drug products and their formulations A comprehensive and practical overview of protein formulation in the laboratory, manufacturing, and the clinic Discusses recent topics including high protein concentration, phase separation, opalescence, and subvisible particles

Download or read book Oxford Handbook of Prescribing for Nurses and Allied Health Professionals written by Sue Beckwith and published by Oxford University Press. This book was released on 2011-05-12 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: "1st ed. published as Oxford handbook of nurse prescribing, 2006"--t.p. verso.