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Author: World Health Organization Publisher: ISBN: 9789290360742 Category : Medical Languages : en Pages : 381
Book Description
In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
Author: World Health Organization Publisher: ISBN: 9789290360742 Category : Medical Languages : en Pages : 381
Book Description
In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 0309672104 Category : Medical Languages : en Pages : 427
Book Description
Among the many who serve in the United States Armed Forces and who are deployed to distant locations around the world, myriad health threats are encountered. In addition to those associated with the disruption of their home life and potential for combat, they may face distinctive disease threats that are specific to the locations to which they are deployed. U.S. forces have been deployed many times over the years to areas in which malaria is endemic, including in parts of Afghanistan and Iraq. Department of Defense (DoD) policy requires that antimalarial drugs be issued and regimens adhered to for deployments to malaria-endemic areas. Policies directing which should be used as first and as second-line agents have evolved over time based on new data regarding adverse events or precautions for specific underlying health conditions, areas of deployment, and other operational factors At the request of the Veterans Administration, Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis assesses the scientific evidence regarding the potential for long-term health effects resulting from the use of antimalarial drugs that were approved by FDA or used by U.S. service members for malaria prophylaxis, with a focus on mefloquine, tafenoquine, and other antimalarial drugs that have been used by DoD in the past 25 years. This report offers conclusions based on available evidence regarding associations of persistent or latent adverse events.
Author: Agency for Healthcare Research and Quality/AHRQ Publisher: Government Printing Office ISBN: 1587634333 Category : Medical Languages : en Pages : 385
Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. 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.
Author: Peter Riederer Publisher: Springer Nature ISBN: 303062059X Category : Medical Languages : en Pages : 4652
Book Description
This book provides a reference guide describing the current status of medication in all major psychiatric and neurological indications, together with comparisons of pharmacological treatment strategies in clinical settings in Europe, USA, Japan and China. In addition, it highlights herbal medicine as used in China and Japan, as well as complementary medicine and nutritional aspects. This novel approach offers international readers a global approach in a single dedicated publication and is also a valuable resource for anyone interested in comparing treatments for psychiatric disorders in three different cultural areas. There are three volumes devoted to Basic Principles and General Aspects, offering a general overview of psychopharmacotherapy (Vol. 1); Classes, Drugs and Special Aspects covering the role of psychotropic drugs in the field of psychiatry and neurology (Vol. 2) and Applied Psychopharmacotherapy focusing on applied psychopharmacotherapy (Vol. 3). These books are invaluable to psychiatrists, neurologists, neuroscientists, medical practitioners and clinical psychologists.
Author: Alan F. Schatzberg Publisher: American Psychiatric Pub ISBN: 1585624195 Category : Medical Languages : en Pages : 902
Book Description
This third edition of Essentials of Psychopharmacology is, like its predecessors, based on the premier textbook in the field, The American Psychiatric Publishing Textbook of Psychopharmacology, now in its fourth edition. The Essentials format is designed to deliver core knowledge to the busy trainee or practitioner in a succinct and accessible manner. Essentials of Psychopharmacology provides a complete overview of clinically focused pharmacotherapeutic principles of vital interest to psychiatry residents, primary care physicians, and other health care professionals. Updated with the latest research findings since the publishing of the fourth edition, Essentials features new chapters on recently introduced medications and updated chapters on others. The book is divided into two parts: Classes of Psychiatric Treatments, which systematically reviews psychotropic medications within each drug class (e.g., antidepressants and anxiolytics, antipsychotics), and Psychopharmacological Treatment, which outlines current pharmacotherapeutic approaches in the major psychiatric disorders as well as in specific patient populations. Although the latter part has been streamlined in this new edition, coverage of critical information such as approved indications, drug interactions, side effects, and other prescribing factors remains comprehensive. Clinicians seeking a reliable reference and guide to the core knowledge base and practice of clinical psychopharmacology can do no better than this new edition of Essentials of Psychopharmacology.
Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 0309377676 Category : Medical Languages : en Pages : 247
Book Description
Mental, neurological, and substance use (MNS) disorders have a substantial impact on global health and well-being. Disorders such as depression, alcohol abuse, and schizophrenia constitute about 13 percent of the total burden of disease. Worldwide, MNS disorders are the leading cause of disability, and the 10th leading cause of death. Despite this high burden, there is a significant shortage of resources available to prevent, diagnose, and treat MNS disorders. Approximately four out of five people with serious MNS disorders living in low- and middle-income countries do not receive needed health services. This treatment gap is particularly high in Sub-Saharan Africa (SSA). Challenges to MNS care in SSA countries include a lack of trained mental health professionals, few mental health facilities, and low prioritization for MNS disorders in budget allocations. African countries, on average, have one psychiatrist for every 2 million people, whereas European countries have one psychiatrist per 12,000 people. Expanding on previous efforts to address the development and improvement of sustainable mental health systems in SSA, the Institute of Medicine convened this 2015 workshop series, bringing together key stakeholders to examine country-specific opportunities to improve the health care infrastructure in order to better prevent, diagnose, and treat MNS disorders. Providing Sustainable Mental and Neurological Health Care in Ghana and Kenya summarizes the presentations and discussions from these workshops.
Author: Domenic A. Ciraulo Publisher: Lippincott Williams & Wilkins ISBN: 9780781748179 Category : Medical Languages : en Pages : 474
Book Description
Thoroughly updated for its Third Edition, this handbook provides complete, current, and easily accessible information on how psychotropic drugs interact with one another and with compounds used to treat non-psychiatric medical conditions. The book is organized for rapid reference, includes numerous tables, and offers guidelines for managing adverse effects. The Third Edition includes an adverse drug effects table in the appendix section, tables on receptor binding and dosing, and the latest information on drugs of abuse and chemical dependence. This edition also includes drug-food interactions for each drug category and interactions of psychotropic drugs with HIV medications.
Author: Publisher: Academic Press ISBN: 0128173173 Category : Medical Languages : en Pages : 290
Book Description
Drug-Induced Liver Injury, Volume 85, the newest volume in the Advances in Pharmacology series, presents a variety of chapters from the best authors in the field. Chapters in this new release include Cell death mechanisms in DILI, Mitochondria in DILI, Primary hepatocytes and their cultures for the testing of drug-induced liver injury, MetaHeps an alternate approach to identify IDILI, Autophagy and DILI, Biomarkers and DILI, Regeneration and DILI, Drug-induced liver injury in obesity and nonalcoholic fatty liver disease, Mechanisms of Idiosyncratic Drug-Induced Liver Injury, the Evaluation and Treatment of Acetaminophen Toxicity, and much more. - Includes the authority and expertise of leading contributors in pharmacology - Presents the latest release in the Advances in Pharmacology series
Author: World Health Organization Publisher: ISBN: 9789241590150 Category : Drug monitoring Languages : en Pages : 48
Book Description
The purpose of this document is to present the case for the importance of pharmacovigilance, to record its growth and potential as a significant discipline within medical science, and to describe its impact on patient welfare and public health.
Author: World Health Organization
Author: World Health Organization
Author: Andre F. Carvalho
Author: National Academies of Sciences, Engineering, and Medicine
Author: Agency for Healthcare Research and Quality/AHRQ
Author: Peter Riederer
Author: Alan F. Schatzberg
Author: National Academies of Sciences, Engineering, and Medicine
Author: Domenic A. Ciraulo
Author: 
Author: World Health Organization