Cancer drug safety and public health policy : a changing landscape
- Author
- Charles Bennett, Courtney Lubaczewski and Bartlett Witherspoon
- Publication Year
- 2022
- Publisher
- Springer
- Language
- English
- Document Type
- Book
- Faculty / Subject Heading
- Pharmacy
- Download Book
Description and analysis of recent developments and current trends in health policy with regard to cancer drug safety. 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.
Subject: Antineoplastic agents - Safety measures / Cancer - Treatment / Pharmaceutical policy / Medical policy / Health policy / Novel informatics / Pharmacovigilance / Cancer drug safety / Cancer blockbuster drogs / Pharmaceutical safety / Advere drug reaction - Identification - Reporting / Legal settlements / Multi-optimal discriminant analysis / Adverse drug - Events - Reports (RADAR) / Fluoroquinolones toxicity / Neuropsychiatric toxicity / False claims actions / Peginesatide and immediate and fatal anaphylaxis / Tyrosine kinase inhibitors / Hepatitis B reactivation / Multifocal leukoencephalopathy / Oncology
