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Pharmacovigilance A Practical Approach

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Pharmacovigilance A Practical Approach

Pharmacovigilance  A Practical Approach Book
Author : Thao Doan,Cheryl Renz,Fabio Lievano,Mondira Bhattacharya,Linda Scarazzini
Publisher : Elsevier Health Sciences
Release : 2018-07-31
ISBN : 032358117X
Language : En, Es, Fr & De

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Book Description :

Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.

A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines

A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines Book
Author : World Health Organization
Publisher : World Health Organization
Release : 2008
ISBN : 9241547499
Language : En, Es, Fr & De

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Book Description :

The Handbook is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antimalarials. It is intended to be a source of practical advice for pharmacovigilance centres. It provides information on spontaneous reporting of adverse drug reactions as a complement to other WHO publications. In addition, it provides details on how to conduct cohort event monitoring, which is a method of active safety surveillance collecting information on all adverse events occurring after treatment. It also details how to perform causality assessment and signal identification, applicable to both methods of surveillance.

A Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines

A Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines Book
Author : World Health Organization
Publisher : World Health Organization
Release : 2009
ISBN : 9241547944
Language : En, Es, Fr & De

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Book Description :

This is a detailed manual giving a step-by-step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programs. There is an urgent need to develop robust pharmacovigilance systems for antiretrovirals particularly in resource-limited settings. This detailed manual gives a step by step approach to undertaking the pharmacovigilance of these medicines. Good pharmacovigilance will identify the risks in the shortest possible time after the medicine has been marketed and will help to establish/identify risk factors. This manual describes the principles of both spontaneous reporting systems and cohort event monitoring programs. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS programs.

A Practical Approach to Pharmaceutical Policy

A Practical Approach to Pharmaceutical Policy Book
Author : Andreas Seiter
Publisher : World Bank Publications
Release : 2010-06-17
ISBN : 9780821383872
Language : En, Es, Fr & De

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Book Description :

This book offers policy makers a hands-on approach, tested in the World Bank’s field work in many countries, for developing policies that improve access to safe, effective medicines in health systems of low- and middle-income economies.

The Role of the Pharmacist in Patient Care

The Role of the Pharmacist in Patient Care Book
Author : Abdul Kader Mohiuddin
Publisher : Universal-Publishers
Release : 2020
ISBN : 1627343083
Language : En, Es, Fr & De

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Book Description :

The goal of a high quality, cost-effective and accessible health care for patients is achieved through constructing a team-based and patient-centered health care delivery system. The expanded role of pharmacists uplifts them to patient care from dispensing and manufacturing or marketing of drugs. Along with doctors and allied health professionals, pharmacists are increasingly recognized as an integral part of the patient care team. Furthermore, colleges of pharmacy need to revise and up-date their curricula to accommodate the progressively increasing development in the pharmaceutical education and the evolving new roles of practicing pharmacists in patient care settings. This book focuses on the expanded role of the pharmacists in total patient care including prescribing, dispensing, compounding, administering and monitoring of drugs at home, hospital, community, hospice, critical care, changeover and other care settings. The sector is emerging in both developed and under-developed countries. Overburdened by patient loads and the explosion of new drugs physicians turned to pharmacists more and more for drug information especially within institutional settings. And today’s patient care pharmacists are taking more interests in medication review and reconciliation, patient education and counseling, creating drug therapy regimen and monitoring compliance. The purpose of this book is to guide the pharmacists in their daily interactions with patients and to ensure collaboration with other health professionals. The contents are mostly based on recently published articles related to patient care, with most recent ideas and activities followed by the patient care pharmacists around the globe. However, a pharmacist implements the care plan in collaboration with other health care professionals and the patient or caregiver. Along with professional guidelines, the book discusses the concepts and best practices of patient interaction, patient rights, and ethical decision-making for the professional pharmacist, apprentice and student. In every chapter, the role of pharmacists in that chapter specific issues are detailed explicitly so that a professional pharmacist or a student can figure out his or her do’s and don’ts in that specific situation. Moreover, further reading references are listed as future recommendations. So, the book is an archive of potential references too. Among so many books about patient care, either doctors’ or nurses’ roles are highlighted. The proposed book highlights the pharmacists’ roles and responsibilities to the most, separated from those of doctors and nurses, with the most recent information obtained from most publications in several journals, books, bulletins, newsletter, magazines etc.

A Practical Handbook on the Pharmacovigilance of Medicines Used in the Treatment of Tuberculosis

A Practical Handbook on the Pharmacovigilance of Medicines Used in the Treatment of Tuberculosis Book
Author : N.A
Publisher :
Release : 2012
ISBN : 9789241503495
Language : En, Es, Fr & De

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Book Description :

Most of the medicines used to treat tuberculosis (TB) today have been on the market for several decades. Clinicians treating TB patients around the world know these medicines well, and are usually well aware of their associated adverse drug reactions (ADRs). The occurrence of these reactions is known to be frequent. The TB patient on treatment is taking more than one anti-TB medicine simultaneously and regimens last from many months to 2 years or more. This increases the likelihood of ADRs, some of which are severe. Most patients on treatment for drug-resistant TB experience at least one side-effect, and a recent study has shown that two thirds of such patients have had at least one medicine stopped temporarily or permanently as a result of ADRs. These events may damage public confidence in any national treatment programme and affect patient adherence. Patients who stop taking anti-TB medicines pose a risk to themselves and to others. The generation of drug resistance is a very real risk. So why should TB practitioners today reflect on a more systematic approach to surveillance of drug-related problems, which is at the heart of pharmacovigilance? Firstly, while national TB programmes are generally well structured to monitor patients and have a long tradition of following up care using standardized indicators, they do not collect information on ADRs directly. It is therefore difficult to assess precisely the net benefit of a treatment programme if adversities related to the medicines used are not factored in. The contribution of ADRs to death, treatment default and failure can therefore only be conjectured. Secondly, the widespread recognition by health workers that anti-TB medicines often cause ADRs is poorly reflected in the published information on the subject. There is a dearth of published literature about anti-TB drug-induced mortality, morbidity and reduced quality of life, particularly in low-resource settings. The overall burden of adversity directly attributable to anti-TB medicines is poorly quantified and it is not usually well profiled in individual TB control programmes. Thirdly, with the increasing use worldwide of more extensive regimens for drug-resistant TB, the added use of antiretrovirals (ARVs) in patients with HIV-associated TB, and the imminent advent of new classes of medicines to treat TB, the case for improved pharmacovigilance becomes even stronger. Pharmacovigilance needs to be an integral accompaniment to treatment programmes as they expand their geographical coverage, given that the frequency and expression of ADRs may be influenced by factors linked to the demographic, genetic and nutritional patterns, and to the background co-morbidity (e.g. TB/HIV) in a population. The cornerstones of pharmacovigilance apply equally to TB as to any other disease amenable to medication. Events linked to medications, particularly novel medicines or new combinations thereof, need to be recognized in a timely fashion if the events are to provide benefit to the individual patient and enrich public knowledge. Appropriate measures need to be put in place to ensure that harm is reduced and symptoms relieved. Health-care workers need to be informed and trained about the methodology and routes for reporting ADRs. This handbook aims to satisfy the need for pharmacovigilance, which has been neglected in the domain of TB for too long.

A Practical Approach to Chiral Separations by Liquid Chromatography

A Practical Approach to Chiral Separations by Liquid Chromatography Book
Author : G. Subramanian
Publisher : Wiley-VCH
Release : 1994-10-17
ISBN :
Language : En, Es, Fr & De

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Book Description :

Both analytical and preparative-scale enantioseparation techniques are covered in a down-to-earth practical way. The most important aspects of design, economics and safety are considered with emphasis on current European and North American legislation. In addition, the theory of chiral separation is covered in sufficient detail to guide the practising chromatographer interested in developing new techniques. A team of experts from academic and industrial laboratories throughout the world have compiled their findings and experience to make this book an exceptionally timely and unique contribution to the field.

Pharmacovigilance

Pharmacovigilance Book
Author : Ronald D. Mann,Elizabeth B. Andrews
Publisher : John Wiley & Sons
Release : 2007-02-06
ISBN : 0470059222
Language : En, Es, Fr & De

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Book Description :

Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2nd Edition is the definitive text on this important subject. The new edition has been completely revised and updated to include the latest theoretical and practical aspects of pharmacovigilance including legal issues, drug regulatory requirements, methods of signal generation, reporting schemes and pharmacovigilance in selected system-organ classes. . The editors and contributors are of excellent standing within the pharmacovigilance community The text provides exemplary coverage of all the relevant issues The definitive book on the subject

Clinical Veterinary Toxicology E Book

Clinical Veterinary Toxicology   E Book Book
Author : Konnie Plumlee
Publisher : Elsevier Health Sciences
Release : 2003-12-10
ISBN : 0323058345
Language : En, Es, Fr & De

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Book Description :

This book covers all aspects of toxicology, including toxic diseases of large animals, small animals, and exotic pets. It provides key information on how poisons affect the body, how the body responds to a foreign substance, how poisonings are diagnosed, and how poisonings are treated. Coverage includes every organ system of every species of animal with details on each body system's susceptibility to poison. Poisons affect animals differently depending on species, breed, age, gender, health status, and reproductive status. This resource addresses these differences, allowing the veterinarian to determine the class of toxicant, the mechanism of action, and the proper course of treatment. If confronted with an unknown poison, the information in this book will assist the veterinarian in formulating a list of potential poisons based on the clinical signs that the animal is exhibiting, and in choosing the appropriate tests to narrow the list to one or a few possible poisons. Most comprehensive toxicology book available Written in a user-friendly style that makes it easy to master the content Covers poisonings in both large and small domestic animals The Principles of Toxicology section provides comprehensive coverage of concepts & terminology, toxicokinetics, treatments, and regulatory information The Manifestations of Toxicoses section is devoted to differentiating between poisons based on lesions and clinical signs The Classes of Toxicants section offers detailed information on each poison, including sources, risk factors, pathophysiology, clinical signs and lesions, diagnostic testing, and treatment The author is board-certified in toxicology, and the contributors are all toxicologists and educators, ensuring authoritative, up-to-date clinical information

Dictionary of Pharmacovigilance

Dictionary of Pharmacovigilance Book
Author : Amer Alghabban
Publisher :
Release : 2004
ISBN :
Language : En, Es, Fr & De

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Book Description :

Pharmacovigilance is, in essence, the process of monitoring the everyday use of medicines to identify previously unrecognized adverse drug reactions thereby assessing their risk/benefit balance in order to determine what action, if any, is necessary to improve their safe use by providing information to users to optimize safe and effective use while monitoring the impact of any action taken. The discipline along with its operational and legal facets, for both regulatory authorities and pharmaceutical industry, envelop colossal terminology that has precise legal and scientific significance. Such terminology may vary from country to country, or more confusingly, different countries may use identical or similar abbreviations, terms or phrases to mean different entities. This dictionary contains a list of abbreviations, terms and phrases (in English) giving definitions of commonly (and rarely) encountered pharmacovigilance terms.

Understanding and Using Health Experiences

Understanding and Using Health Experiences Book
Author : Sue Ziebland,Angela Coulter,Joseph D. Calabrese,Louise Locock
Publisher : OUP Oxford
Release : 2013-04-04
ISBN : 0191643246
Language : En, Es, Fr & De

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Book Description :

Improving patient experience is a global priority for health policy-makers and care providers. The need to look at healthcare delivery through the eyes of patients is widely accepted, but how should it be done? What use can be made of this information, and what evidence is there that such exercises lead to better care? Understanding and Using Health Experiences: Improving patient care examines a broad range of different sources and techniques for gathering and analyzing health experiences. Providing an accessible and pragmatic overview of the diversity and richness of research in the field this book explores the strengths and limitations of different approaches, and assesses what each method can contribute to improving people's experience of illness, and the way that health services are delivered. The book looks at topics such as using focus groups to understand experiences of health and illness, patient surveys, and the internet as a source of information on people's experience. Using clear and engaging examples throughout, the book is accessibly written by experts in social science, health services, and health policy, and will be valuable to postgraduate students, healthcare practitioners, and individuals working in health and social policy, public sector management, and research.

Brody s Human Pharmacology E Book

Brody s Human Pharmacology   E Book Book
Author : Lynn Crespo,Lynn Wecker,George Dunaway,Carl Faingold,Stephanie Watts
Publisher : Elsevier Health Sciences
Release : 2009-04-01
ISBN : 0323075754
Language : En, Es, Fr & De

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Book Description :

Featuring the contributions of leading faculty, this new edition provides a succinct overview of the most important aspects of pharmacology necessary for a basic understanding of the subject. It reviews the concepts, clinical applications and side effects of pharmacology, placing an emphasis on practical applications of the material, whenever possible. More than 480 full-color illustrations explain important processes, while color-coded boxes for major drugs, therapeutic overviews, clinical problems, and trade names—as well as USMLE-style self-assessment questions with answers and rationales—reinforce your mastery of the information. A consistent style of writing—and more focused, concise content—provide for better learning of the essentials. Online access to Student Consult—where you’ll find 15 pharmacology animations...150 USMLE-style questions...and more—further enhances your study and prepares you for exams. Includes online access to Student Consult where you’ll find USMLE-style questions, animations showing the actions of various important toxins, and much more. Focuses on the essential aspects of pharmacology for a solid foundation of knowledge in the subject. Includes more than 480 full-color illustrations that explain key pharmacologic processes. Provides between 4 and 6 USMLE-style self-assessment questions at the end of each chapter—with answers and full explanations in the appendix—that help you prepare for exams and master the material. Uses a templated format that promotes more effective and efficient learning. Presents color-coded boxes in each chapter that emphasize key points. Features a clinical emphasis throughout on both the basic science of pharmacology and its clinical relevance. Includes new Gold Standard content on Student Consult with 200 Professional Drug Monographs for additional information on generic and brand names, mechanism of action, pharmacokinetics, indications and dosage, drug interactions, patient education and much more! Features a more consistent style of writing—as well as focused, concise content—for enhanced learning of the essentials. Presents chapters in a re-arranged order for a more logical approach to learning. Includes additional biochemistry and physiology information in the introduction for each section for greater understanding.

Stephens Detection and Evaluation of Adverse Drug Reactions

Stephens  Detection and Evaluation of Adverse Drug Reactions Book
Author : John Talbot,Jeffrey K. Aronson
Publisher : John Wiley & Sons
Release : 2011-10-28
ISBN : 1119952107
Language : En, Es, Fr & De

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Book Description :

The detection and evaluation of adverse drug reactions is crucial for understanding the safety of medicines and for preventing harm in patients. Not only is it necessary to detect new adverse drug reactions, but the principles and practice of pharmacovigilance apply to the surveillance of a wide range of medicinal products. Stephens' Detection and Evaluation of Adverse Drug Reactions provides a comprehensive review of all aspects of adverse drug reactions throughout the life cycle of a medicine, from toxicology and clinical trials through to pharmacovigilance, risk management, and legal and regulatory requirements. It also covers the safety of biotherapeutics and vaccines and includes new chapters on pharmacogenetics, proactive risk management, societal considerations, and the safety of drugs used in oncology and herbal medicines. This sixth edition of the classic text on drug safety is an authoritative reference text for all those who work in pharmacovigilance or have an interest in adverse drug reactions, whether in regulatory authorities, pharmaceutical companies, or academia. Praise for previous editions "This book presents a comprehensive and wide-ranging overview of the science of pharmacovigilance. For those entering or already experienced in the pharmaceutical sciences, this is an essential work.” - from a review in E-STREAMS "...a key text in the area of pharmacovigilance...extensively referenced and well-written...a valuable resource..." - from a review in The Pharmaceutical Journal

Reichman and Hershfield s Tuberculosis

Reichman and Hershfield s Tuberculosis Book
Author : Lee B. Reichman,Earl S. Hershfield
Publisher : CRC Press
Release : 2006-08
ISBN :
Language : En, Es, Fr & De

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Book Description :

Thoroughly examining tuberculosis from historical, theoretical, and clinical perspectives, this Third Edition merges state-of-the-art research developments with principles of programmatic TB management. Each of the 50 chapters analyze current studies on TB mechanisms and treatment and will meet the needs of all who work in the field of TB control, whether in low-income, high-prevalence areas or in low-prevalence industrialized countries.

Clinical Pharmacy Education Practice and Research

Clinical Pharmacy Education  Practice and Research Book
Author : Dixon Thomas
Publisher : Elsevier
Release : 2018-11-23
ISBN : 0128142774
Language : En, Es, Fr & De

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Book Description :

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

FAMLI

FAMLI Book
Author : N.A
Publisher :
Release : 1987
ISBN :
Language : En, Es, Fr & De

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Book Description :

Benefit Risk Appraisal of Medicines

Benefit Risk Appraisal of Medicines Book
Author : Filip Mussen,Sam Salek,Stuart Walker
Publisher : John Wiley & Sons
Release : 2009-08-04
ISBN : 0470748125
Language : En, Es, Fr & De

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Book Description :

Benefit-risk assessment is at the centre of the approval process for every new medicine. The ability to assess the risks of a new medicine accurately and to balance these against the benefits the medicine could bring is critical for every regulatory authority and pharmaceutical company. Despite this there are very few tried and tested evaluative models currently available. The authors of this book have developed a new, pioneering tool for the assessment of benefits and risks for new medicines in development. This model utilises a multi-criteria decision analysis which involves selecting, scoring and weighting key benefit and risk attributes and leads to an overall appraisal of benefits and risks of medicines. Benefit-Risk Appraisal of Medicines establishes the background and criteria required to assess benefit and risk in general and reviews the current practices by regulatory authorities and the pharmaceutical industry, including those models currently available. It outlines the development and evaluation of the authors’ new model and analyses the implications of its implementation. Describes an innovative, systematic model which leads to transparent and responsible benefit-risk decision making Contributes important ideas to the debate on benefit-risk appraisal Provides a future framework for benefit-risk appraisal of medicines Benefit-Risk Appraisal of Medicines covers the entire process from the discovery of new medicines to their marketing and is ideal for all those who work in the pharmaceutical industry and regulatory authorities,, as well as post-graduate students of pharmaceutical medicine and clinical pharmacology.

Practical Guide to Reproductive Medicine

Practical Guide to Reproductive Medicine Book
Author : Paul A. Rainsbury,David A. Viniker
Publisher : Parthenon Publishing
Release : 1997
ISBN :
Language : En, Es, Fr & De

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Book Description :

This is a colour-illustrated, comprehensive clinical textbook and practical guide on reproductive medicine. It covers: the basic priniples of reproductive medicine; male and female infertility; the disorders and diseases associated with sterility and infertility; the climacteric; hormone replacement therapy; paediatric and adolescent endocrinology; endometriosis; contraception; assisted reproduction; surgical procedures, including microsurgery; cryopreservation; surrogacy; and counselling.