Pharmacovigilance in Psychiatry
The first authoritative textbook specifically addressing issues of the field, this book delivers a focused discussion on several themes in psychiatry while providing a sound background on pharmacovigilance. Internationally-recognised researchers, clinicia
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Pharmacovigilance in Psychiatry
Pharmacovigilance in Psychiatry
Edoardo Spina • Gianluca Trifirò Editors
Pharmacovigilance in Psychiatry
Editors Edoardo Spina Department of Clinical and Experimental Medicine University of Messina Messina Italy
Gianluca Trifirò Department of Clinical and Experimental Medicine University of Messina Messina Italy
ISBN 978-3-319-24739-7 ISBN 978-3-319-24741-0 DOI 10.1007/978-3-319-24741-0
(eBook)
Library of Congress Control Number: 2015957257 Springer Cham Heidelberg New York Dordrecht London © Springer International Publishing Switzerland 2016 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. Printed on acid-free paper Adis is a brand of Springer Springer International Publishing AG Switzerland is part of Springer Science+Business Media (www. springer.com)
Preface and Acknowledgements
Primum non nocere (first, do no harm) is a guiding principle for all physicians including psychiatrists that, whatever the intervention or procedure, the patient’s well-being is the primary consideration. Rational use of psychotropic drugs may improve the quality of life and the functional status of patients with neuropsychiatric diseases while minimizing adverse effects potentially associated to the pharmacological treatment. However, currently, psychotropic medications are often misused and overused, especially in elderly patients; thus, exposing this frail population to unmotivated and potentially lifethreatening risks. In general terms, it is well known that premarketing randomized clinical trials are designed to investigate, primarily, the efficacy of the drugs and may only partly explore the drug safety profile. Therefore, the risks associated with newly marketed drugs can be properly quantified and characterized only after their use in clinical practice (i.e. post-marketing phase). For this reason, post-marketing pharmacovigilance monitoring has been long recognized as the last phase of drug development. Pharmacovigilance is a discipline that ent
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