Author : Elena Ramírez
Publisher : Frontiers Media SA
Page : 165 pages
File Size : 42,95 MB
Release : 2022-10-07
Category : Science
ISBN : 2832501915
Author : Elena Ramírez
Publisher : Frontiers Media SA
Page : 132 pages
File Size : 46,63 MB
Release : 2023-05-02
Category : Medical
ISBN : 2832522246
Author : World Health Organization
Publisher :
Page : 381 pages
File Size : 22,63 MB
Release : 2001-01-01
Category : Medical
ISBN : 9789290360742
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 : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
Page : 385 pages
File Size : 47,90 MB
Release : 2014-04-01
Category : Medical
ISBN : 1587634333
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 : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : Cioms
Page : 0 pages
File Size : 40,96 MB
Release : 2010
Category : Drug monitoring
ISBN : 9789290360827
In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.
Author : Kerm Henriksen
Publisher :
Page : 526 pages
File Size : 49,52 MB
Release : 2005
Category : Medical
ISBN :
v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
Page : 483 pages
File Size : 15,54 MB
Release : 2017-09-28
Category : Medical
ISBN : 0309459575
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Author : Mansour Adam Mahmoud
Publisher : Frontiers Media SA
Page : 217 pages
File Size : 19,77 MB
Release : 2023-02-07
Category : Science
ISBN : 2832513913
Author : Institute of Medicine
Publisher : National Academies Press
Page : 347 pages
File Size : 41,29 MB
Release : 2007-03-27
Category : Medical
ISBN : 0309103045
In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Author : Mr. Chandra Prakash Dwivedi
Publisher : JEC PUBLICATION
Page : 227 pages
File Size : 17,46 MB
Release :
Category : Medical
ISBN : 9361752200
In the vast realm of pharmacy practice, the domains of hospital and clinical pharmacy stand as vital pillars, shaping the landscape of healthcare delivery. "Hospital and Clinical Pharmacy – Theory" emerges from a profound dedication to elucidating the intricacies of these essential fields and a sincere commitment to advancing pharmaceutical education. This book is meticulously crafted to serve as a beacon for students, practitioners, and professionals navigating the intricate pathways of hospital and clinical pharmacy. Whether you are embarking on your educational journey, seeking to deepen your understanding, or striving to refine your practice, "Hospital and Clinical Pharmacy – Theory" endeavors to provide the guidance and insight necessary to traverse this dynamic terrain. Structured with precision and clarity, the content of this book is designed to offer a comprehensive exploration of hospital and clinical pharmacy theory. Each chapter unfolds with precision, unraveling key concepts, elucidating professional responsibilities, and illuminating the standards and practices that underpin effective pharmacy care within hospital settings. From the organizational structure of hospital pharmacies to the nuances of drug distribution, from the complexities of clinical pharmacy to the critical realms of pharmacovigilance and medication error prevention, this book embarks on an exhaustive journey through the multifaceted domains of hospital and clinical pharmacy. Recognizing the diverse needs of learners, "Hospital and Clinical Pharmacy – Theory" integrates a variety of learning aids, including illustrative examples, practical applications, and thoughtprovoking exercises, to enhance understanding and retention. Furthermore, educators will find ample resources to support their teaching endeavors, ensuring that this book serves as a valuable companion in both the classroom and self-directed study. As we embark on this intellectual voyage together, I extend my deepest gratitude to all those who have contributed to the creation of this book. It is my fervent hope that "Hospital and Clinical Pharmacy – Theory" will not only equip you with the knowledge and skills necessary for success but also inspire a lifelong commitment to excellence in pharmacy practice.
