Therapeutic Risk Management of Medicines

Therapeutic Risk Management of Medicines

Author: Stephen J. Mayall

Publisher: Elsevier

Published: 2014-04-16

Total Pages: 435

ISBN-13: 1908818271

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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


Book Synopsis Therapeutic Risk Management of Medicines by : Stephen J. Mayall

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

Pharmacoepidemiology and Therapeutic Risk Management

Pharmacoepidemiology and Therapeutic Risk Management

Author: Abraham G. Hartzema

Publisher:

Published: 2008

Total Pages: 0

ISBN-13: 9780929375304

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Book Synopsis Pharmacoepidemiology and Therapeutic Risk Management by : Abraham G. Hartzema

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:

Smart Health Choices

Smart Health Choices

Author: Les Irwig

Publisher: Judy Irwig

Published: 2008

Total Pages: 255

ISBN-13: 1905140177

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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.


Book Synopsis Smart Health Choices by : Les Irwig

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.

Medications for Opioid Use Disorder Save Lives

Medications for Opioid Use Disorder Save Lives

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2019-06-16

Total Pages: 175

ISBN-13: 0309486483

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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.


Book Synopsis Medications for Opioid Use Disorder Save Lives by : National Academies of Sciences, Engineering, and Medicine

Download or read book Medications for Opioid Use Disorder Save Lives written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-06-16 with total page 175 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Textbook of Patient Safety and Clinical Risk Management

Textbook of Patient Safety and Clinical Risk Management

Author: Liam Donaldson

Publisher: Springer Nature

Published: 2020-12-14

Total Pages: 496

ISBN-13: 3030594033

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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.


Book Synopsis Textbook of Patient Safety and Clinical Risk Management by : Liam Donaldson

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.

Drug-Induced Headache

Drug-Induced Headache

Author: Hans-Christoph Diener

Publisher: Springer Science & Business Media

Published: 2012-12-06

Total Pages: 174

ISBN-13: 3642733271

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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.


Book Synopsis Drug-Induced Headache by : Hans-Christoph Diener

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.

Preventing Medication Errors

Preventing Medication Errors

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2007-01-11

Total Pages: 481

ISBN-13: 0309101476

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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.


Book Synopsis Preventing Medication Errors by : Institute of Medicine

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.

Patient Safety and Quality

Patient Safety and Quality

Author: Ronda Hughes

Publisher: Department of Health and Human Services

Published: 2008

Total Pages: 592

ISBN-13:

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"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/


Book Synopsis Patient Safety and Quality by : Ronda Hughes

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/

Managed Care Pharmacy Practice

Managed Care Pharmacy Practice

Author: Navarro

Publisher: Jones & Bartlett Publishers

Published: 2008-12-11

Total Pages: 659

ISBN-13: 076378883X

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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.


Book Synopsis Managed Care Pharmacy Practice by : Navarro

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.

The Nurse's Role in Medication Safety

The Nurse's Role in Medication Safety

Author: Laura Cima

Publisher: Joint Commission Resources

Published: 2011-12

Total Pages: 179

ISBN-13: 1599406187

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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


Book Synopsis The Nurse's Role in Medication Safety by : Laura Cima

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