An Insight to Pharmacovigilance: A Global Perspective


Book Description

An Insight to Pharmacovigilance: A Global Perspective is a step-by-step guide for beginners and personnel involved in this field to give them comprehensive insight about various aspects involved in drug safety departments. The book gives the readers about an in-depth knowledge on the following topics of Pharmacovigilance: Basics of Pharmacovigilance, Global Bodies Governing Pharmacovigilance, Regulatory and Legal Aspects, Reporting Requirement and Reporting Forms, Public Safety Update Report, Individual Case Safety Report, Signal Detection, PV Inspections, Expedited Reporting Requirements, MedDRA, PV Glossary etc




An Insight to Pharmacovigilance


Book Description

An Insight to Pharmacovigilance: A Global Perspective is a step-by-step guide for beginners and personnel involved in this field to give them comprehensive insight about various aspects involved in drug safety departments. The book gives the readers about an in-depth knowledge on the following topics of Pharmacovigilance: Basics of Pharmacovigilance, Global Bodies Governing Pharmacovigilance, Regulatory and Legal Aspects, Reporting Requirement and Reporting Forms, Public Safety Update Report, Individual Case Safety Report, Signal Detection, PV Inspections, Expedited Reporting Requirements, MedDRA, PV Glossary etc




Pharmacovigilance Essentials


Book Description




Pharmacovigilance Insight & Global Perspective


Book Description

Pharmacovigilance Insight & Global Perspective is a step by step guide for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, government and legal professions. It discussed about evolution of pharmacovigilance, ICH guidelines, Partners in Pharmacovigilance, Regulatory and Legal Aspects, Reporting Requirement and Reporting Forms, Public Safety Update Report, Individual Case Safety Report, Signal Detection, PV Inspections, Expedited Reporting Requirements, Global Perspective of Pharmacovigilance and Adverse Drug Reaction (ADR) Reporting, List of Technical Assistance providers in Pharmacovigilance, MedDRA, PV Glossary etc. The text provides exemplary coverage of all the relevant issues. The definitive book on the subject.







The Role of the Pharmacist in Patient Care


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.




Global Perspectives on Precision Medicine


Book Description

This book presents the promises of Precision Medicine (PM) and the challenges of its implementation in daily clinical routine, while addressing the anticipated ethical and social implications. It is the first book that critically analyzes the potential and the dilemmas relevant to genomics and precision medicine from healthcare, public health and global perspectives. The nine chapters presented in this book elaborate on pharmacogenomics' crucial role in maximizing the potential benefits and minimizing medication's potential risks in groups of people, especially in cancer treatment and other health conditions. Infectious and non-communicable diseases (NCDs) are also discussed in this book by identifying challenges and ways to overcome them. Essential concepts are addressed, such as health-related benefits and harm to individuals and the broader community, including threats to individual privacy and autonomy, which warrant just distribution of scarce resources. The book also identifies and addresses the lack of competency in the healthcare workforce in the era of PM and discusses the path to laying the ethical foundation for the implementation of PM in healthcare organizations.




Evidence-Based Pharmacovigilance


Book Description

This book examines insights into the latest thinking and core concepts in areas of key methodological endeavor in Pharmacovigilance (PV), which strives to ever more effectively protect patients from harm caused by the medicines they need. Each book chapter tends to have a clear quantitative or clinical slant and an aim to provide an overview of methodological insights within a specific topic, while also providing a perspective on how the area is anticipated to develop in the future. Quantitative chapters focus more on statistical and epidemiological strategies and the thinking that underpins core developments in Pharmacovigilance, whereas clinical chapters focus on clinical methods for detecting hypotheses for and determining side effects of medicinal products as well as misdiagnosis pitfalls. Examples of areas of importance include signal detection, risk management, and risk benefit assessment. Vital and authoritative, Evidence-Based Pharmacovigilance: Clinical and Quantitative Aspects aims to provide readers with a sense of the advances that have occurred in pharmacovigilance methods and approaches, as well as inspiration and motivation to advance the field of pharmacovigilance with a strong sense that there is much more work to be done in ensuring the safe use of medications by patients.




The Price of Global Health


Book Description

Public debate on the rising cost of new biotechnology drug treatments has intensified over the last few years as healthcare budget pressures have mounted under a strained economy. Meanwhile, the demand for new, effective medical and drug treatments continues to rise as unhealthy lifestyles cause further increases in diabetes and cardiovascular disease. Global drug pricing is one of the most hotly debated yet least understood aspects of the pharmaceutical industry. How should drug prices be set and what does it mean for patients? Why do governments increasingly get involved, and what is its impact on the global competitive environment? How can a life-saving industry have a poorer image than gun and tobacco industries, whose products are associated with death? Ed Schoonveld explains how pharmaceutical prices are determined in a complex global payer environment and what factors influence the process. His insights will help a wide range of audiences, from healthcare industry professionals to policy makers and the broader public, to gain a better understanding of this highly complex and emotionally charged field. The Price of Global Health is recognized as a valued and unique reference book that covers a complete array of topics related to global pharmaceutical pricing. It contains an in-depth but straightforward exploration of the pharmaceutical pricing strategy process, its underlying market access, general business and ethical considerations, and its implications for payers, physicians and patients. It is a much-needed and invaluable resource for anybody interested or involved in, or affected by, the development, funding and use of prescription drugs. In particular, it is of critical importance to pharmaceutical company executives and other leaders and professionals in commercialization and drug development, including marketing, business development, market access and pricing, clinical development, drug discovery, regulatory affairs, health outcomes, market research and public affairs. The second edition includes new chapters on payer value story development, oncology, orphan drugs and payer negotiations. Furthermore, many country chapters have been substantially updated to reflect changes in the healthcare systems, including the Affordable Care Act in the US, AMNOG in Germany, medico-economic requirements in France and many other country-specific changes. Lastly, almost every chapter has been updated with new examples and illustrations.




Global Pharmaceutical Policy


Book Description

Medicines are vital in improving patient health outcomes and pharmaceutical policy is a fundamental component of any health system. However, the global pharmaceutical policy is ever-evolving and data and quality ‘research-based information’ in this field are scarce. This book fills this gap and provides up-to-date empirical information and evidence-based synthesis. It focuses on pertinent key issues in global pharmaceutical policy including medicines safety, generic medicines, pharmaceutical supply chain, medicines financing, access and affordability of medicines, rational use of medicines, pharmacy health services research and access to vaccines and biological products. Featuring policy case studies from varied countries such as Mexico, Russia, China, Kyrgyzstan, and Pakistan, this book comprises a valuable and comprehensive resource for students, funders, policymakers, academics, and researchers interested in this field.