Therapeutic Risk Management Of Medicines
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Therapeutic Risk Management Of Medicines
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Author : Stephen J. Mayall
language : en
Publisher: Elsevier
Release Date : 2014-04-16
Therapeutic Risk Management Of Medicines written by Stephen J. Mayall and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-04-16 with Medical categories.
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
Pharmacoepidemiology And Therapeutic Risk Management
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Author : Abraham G. Hartzema
language : en
Publisher:
Release Date : 2008
Pharmacoepidemiology And Therapeutic Risk Management written by Abraham G. Hartzema and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with Drug monitoring categories.
The Perception And Management Of Therapeutic Risk
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Author : Paul Slovic
language : en
Publisher:
Release Date : 1989
The Perception And Management Of Therapeutic Risk written by Paul Slovic and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1989 with Medicine categories.
Therapeutic Risk
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Author : William Howard Wallace Inman
language : en
Publisher: John Wiley & Sons
Release Date : 1988
Therapeutic Risk written by William Howard Wallace Inman and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 1988 with Medical categories.
Today's therapeutic drugs are capable of beneficial results but can also cause great harm, especially if administered to the wrong patient in the wrong dosage. This book is devoted to the perception, measurement and management of therapeutic risk, and outlines the results of a conference on the subject held in Brighton, Sussex in June 1987 - a joint enterprise between the Trust for Education and Research in Therapeutics, London, and the Drug Safety Research Trust, Southampton. It examines the results of dispensing drugs, the rarity or seriousness of attendant risks involved and the manner in which therapeutic drugs can be measured and controlled.
Practical Approaches To Risk Minimisation For Medicinal Products
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Author : World Health Organization
language : en
Publisher:
Release Date : 2014
Practical Approaches To Risk Minimisation For Medicinal Products written by World Health Organization and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014 with Drugs categories.
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.
Textbook Of Patient Safety And Clinical Risk Management
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Author : Liam Donaldson
language : en
Publisher: Springer Nature
Release Date : 2020-12-14
Textbook Of Patient Safety And Clinical Risk Management written by Liam Donaldson and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-12-14 with Medical categories.
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.
Smart Health Choices
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Author : Les Irwig
language : en
Publisher: Judy Irwig
Release Date : 2008
Smart Health Choices written by Les Irwig and has been published by Judy Irwig this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with Health & Fitness categories.
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.
Therapeutic Protein Drug Products
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Author : Brian K Meyer
language : en
Publisher: Elsevier
Release Date : 2012-01-02
Therapeutic Protein Drug Products written by Brian K Meyer and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-01-02 with Medical categories.
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
Drug Benefits And Risks
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Author : Chris J. van Boxtel
language : en
Publisher: John Wiley & Sons
Release Date : 2001-11-28
Drug Benefits And Risks written by Chris J. van Boxtel and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-11-28 with Medical categories.
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.
Medications For Opioid Use Disorder Save Lives
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2019-06-16
Medications For Opioid Use Disorder Save Lives written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-16 with Medical categories.
The opioid crisis in the United States has come about because of excessive use of these drugs for both legal and illicit purposes and unprecedented levels of consequent opioid use disorder (OUD). More than 2 million people in the United States are estimated to have OUD, which is caused by prolonged use of prescription opioids, heroin, or other illicit opioids. OUD is a life-threatening condition associated with a 20-fold greater risk of early death due to overdose, infectious diseases, trauma, and suicide. Mortality related to OUD continues to escalate as this public health crisis gathers momentum across the country, with opioid overdoses killing more than 47,000 people in 2017 in the United States. Efforts to date have made no real headway in stemming this crisis, in large part because tools that already existâ€"like evidence-based medicationsâ€"are not being deployed to maximum impact. To support the dissemination of accurate patient-focused information about treatments for addiction, and to help provide scientific solutions to the current opioid crisis, this report studies the evidence base on medication assisted treatment (MAT) for OUD. It examines available evidence on the range of parameters and circumstances in which MAT can be effectively delivered and identifies additional research needed.