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Published in: International Journal of Clinical Pharmacy 4/2018

Open Access 01-08-2018 | Review Article

Pharmacovigilance in oncology

Authors: Paolo Baldo, Giulia Fornasier, Laura Ciolfi, Ivana Sartor, Sara Francescon

Published in: International Journal of Clinical Pharmacy | Issue 4/2018

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Abstract

Background Side effects of cancer therapy are one of the most important issues faced by cancer patients during their illness. Pharmacovigilance, namely the science and activities aimed at monitoring the safety of drugs, is particularly important in oncology, due to the intrinsic biologic toxicity of antineoplastic agents, their narrow therapeutic windows, and the high doses and rigid timing of treatment regimens. Aim of the review To identify the main issues in carrying out an effective pharmacovigilance activity in oncology. Method We searched PubMed for articles about pharmacovigilance in relation to chemotherapy, radiotherapy and targeted therapy for cancer, using MeSH terms and text words. We also searched Embase, CINAHL, Scopus, Micromedex, the Cochrane Library, two pharmacovigilance databases and the gray literature for articles published in 2012–2018. Overall, 137 articles were considered potentially relevant and were critically appraised independently by two authors, leading to the inclusion of 44 relevant studies, guidelines and reviews. Another 10 important research reports were included in the review. Results Eight critical issues of pharmacovigilance in oncology were identified. These issues pertain to: terminology; range of side effects; targeted therapy and immunotherapy; chemoradiotherapy; generic drugs and biosimilars; drug interactions, pharmacogenetics and polypharmacy; special patient categories; and under-reporting of ADRs. Conclusion The importance of pharmacovigilance in oncology must be highlighted with every effort, to improve safety and offer cancer patients every possible help to improve their quality of life during such a critical period of their lives.
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Metadata
Title
Pharmacovigilance in oncology
Authors
Paolo Baldo
Giulia Fornasier
Laura Ciolfi
Ivana Sartor
Sara Francescon
Publication date
01-08-2018
Publisher
Springer International Publishing
Published in
International Journal of Clinical Pharmacy / Issue 4/2018
Print ISSN: 2210-7703
Electronic ISSN: 2210-7711
DOI
https://doi.org/10.1007/s11096-018-0706-9

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