Principles and Practice of Pharmacovigilance and Drug Safety

Principles and Practice of Pharmacovigilance and Drug Safety PDF Author: Jimmy Jose
Publisher: Springer Nature
ISBN: 3031510895
Category :
Languages : en
Pages : 557

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Book Description


Safe and Effective Medication Use in the Emergency Department

Safe and Effective Medication Use in the Emergency Department PDF Author: Victor Cohen
Publisher: ASHP
ISBN: 1585282332
Category : Medical
Languages : en
Pages : 270

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Book Description
An important new work developed to improve medication safety and direct patient care in the Emergency Department.

Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research PDF Author: Divya Vohora
Publisher: Academic Press
ISBN: 0128020989
Category : Medical
Languages : en
Pages : 527

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Book Description
Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. - Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and - Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

Practical Aspects of Signal Detection in Pharmacovigilance

Practical Aspects of Signal Detection in Pharmacovigilance PDF Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: Cioms
ISBN: 9789290360827
Category : Drug monitoring
Languages : en
Pages : 0

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Book Description
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.

Mann's Pharmacovigilance

Mann's Pharmacovigilance PDF Author: Elizabeth B. Andrews
Publisher: John Wiley & Sons
ISBN: 1118820142
Category : Medical
Languages : en
Pages : 878

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Book Description
Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann’s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.

Drug War Capitalism

Drug War Capitalism PDF Author: Dawn Paley
Publisher: AK Press
ISBN: 1849351880
Category : Political Science
Languages : en
Pages : 262

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Book Description
Though pillage, profit, and plunder have been a mainstay of war since pre-colonial times, there is little contemporary focus on the role of finance and economics in today's "Drug Wars"—despite the fact that they boost US banks and fill our prisons with poor people. They feed political campaigns, increase the arms trade, and function as long-term fixes to capitalism's woes, cracking open new territories to privatization and foreign direct investment. Combining on-the-ground reporting with extensive research, Dawn Paley moves beyond the usual horror stories, beyond journalistic rubbernecking and hand-wringing, to follow the thread of the Drug War story throughout the entire region of Latin America and all the way back to US boardrooms and political offices. This unprecedented book chronicles how terror is used against the population at large in cities and rural areas, generating panic and facilitating policy changes that benefit the international private sector, particularly extractive industries like petroleum and mining. This is what is really going on. This is drug war capitalism. Dawn Paley is a freelance journalist who has been reporting from South America, Central America, and Mexico for over ten years. Her writing has been published in the Nation, the Guardian, Vancouver Sun, Globe and Mail, Ms. magazine, the Tyee, Georgia Straight, and NACLA, among others.

Medication Safety

Medication Safety PDF Author: Molly Courtenay
Publisher: Cambridge University Press
ISBN: 9780521721639
Category : Medical
Languages : en
Pages : 210

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Book Description
The supply and administration of medicines is an area of practice in which a number of healthcare professionals (e.g. nurses, pharmacists and allied health professionals) are involved. Prescribing is a relatively new role which many of these healthcare professionals have adopted. Medication Safety focuses on promoting safety in the delivery of medicines. Chapters explore the various stages in the medication process including safety in prescribing, dispensing and administering drugs. Adverse reactions, parenteral administration, dosage calculations, safety with controlled drugs, and reporting errors and near misses are all addressed in evidence-based contributions from a highly experienced team of contributors. This text is essential reading for all healthcare professionals involved in the delivery of medicines to patients.

Pain Management and the Opioid Epidemic

Pain Management and the Opioid Epidemic PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483

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Book Description
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.

Pharmacopoeias, Drug Regulation, and Empires

Pharmacopoeias, Drug Regulation, and Empires PDF Author: Stuart Anderson
Publisher: McGill-Queen's Press - MQUP
ISBN: 0228021596
Category : History
Languages : en
Pages : 228

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Book Description
The word "pharmacopoeia" has come to have many meanings, although it is commonly understood to be a book describing approved compositions and standards for drugs. In 1813 the Royal College of Physicians of London considered a proposal to develop an imperial British pharmacopoeia – at a time when separate official pharmacopoeias existed for England, Scotland, and Ireland. A unified British pharmacopoeia was published in 1864, and by 1914 it was considered suitable for the whole Empire. Pharmacopoeias, Drug Regulation, and Empires traces the 350-year development of officially sanctioned pharmacopoeias across the British Empire, first from local to national pharmacopoeias, and later to a standardized pharmacopoeia that would apply throughout Britain’s imperial world. The evolution of British pharmacopoeias and the professionalization of medicine saw developments including a transition from Galenic principles to germ theory, and a shift from plant-based to chemical medicines. While other colonial powers in Europe usually imposed metropolitan pharmacopoeias across their colonies, Britain consulted with practitioners throughout its Empire. As the scope of the pharmacopoeia widened, the process of agreeing upon drug standardization became more complex and fraught. A wide range of issues was exposed, from bioprospecting and the inclusion of indigenous medicines in pharmacopoeias, to adulteration and demands for the substitution of pharmacopoeial drugs with locally available ones. Pharmacopoeias, Drug Regulation, and Empires uses the evolution of an imperial pharmacopoeia in Britain as a vehicle for exploring the hegemonic power of European colonial powers in the medical field, and the meaning of pharmacopoeia more broadly.

Annual Emergency Room Data

Annual Emergency Room Data PDF Author:
Publisher:
ISBN:
Category : Drug abuse
Languages : en
Pages : 138

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Book Description