Cancer Drug Safety and Public Health Policy: A Changing Landscape

Bennett, Charles

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Book Information
Edition:	1st
Publisher:	Springer Nature
ISBN:	3-031-04401-0 (3031044010)
ISBN-13:	978-3-031-04401-4 (9783031044014)
Binding:	Hardcover
Copyright:	2022
Publish Date:	12/22
Weight:	0.00 Lbs.
Pages:	167
Subject Class:	ONC (Oncology)
Return Policy:	Returns accepted up to 12 months provided no other recalls or return restrictions apply.
ProQuest Ebook Central:	Available in ProQuest Ebook Central™ View

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Abstract:

This book offers a wide-ranging description and analysis of recent developments and current trends in health policy with regard to cancer drug safety. The book opens with an overview of pharmacovigilance for cancer blockbuster drugs, covering both general considerations and efforts to develop a structured framework for the identification and reporting of adverse drug reactions (ADRs). A number of important examples of serious ADRs to hematology and oncology drugs are then reviewed, with evaluation of the lessons learned and the policy implications of the ensuing legal cases and their settlements. Further, the difficulty of reporting such blockbuster side effects in the medical literature is explored in an empirical study. Significant advances have been achieved in analytic methods for the identification of ADRs, and here there is a particular focus on the value of optimal discriminant analysis. Finally, the impacts on pharmacovigilance and drug safety of the huge fines paid under the U.S. False Claims Act relating to the defrauding of governmental programs also receive careful attention these fines are playing an important role in changing the landscape for pharmaceutical safety.

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