Pharmacovigilance in Psychiatry

Transcription

1 Pharmacovigilance in Psychiatry

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3 Edoardo Spina Gianluca Trifirò Editors Pharmacovigilance in Psychiatry

4 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 ISBN (ebook) DOI / Library of Congress Control Number: 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)

5 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 entails both cultural and scientific aspects. On one hand, traditional pharmacovigilance activities based on spontaneous reporting of adverse drug reactions from patients and healthcare professionals are essential to increase the awareness of prescribers and users about the potential risks associated to exposure to medicines. On the other, in the last few years, pharmacovigilance as a science is rapidly evolving towards a more proactive approach in terms of emerging safety issues detection, strengthening and validation, thanks to innovative methodologies that have been developed in the context of outstanding initiatives, such as US FDA-endorsed Sentinel and European FP-7- funded EU-ADR and IMI-funded PROTECT. It is nowadays well acknowledged that continuously growing availability of databases with longitudinal electronic health records of millions of persons worldwide offers the opportunity to get better insight, rapidly and cheaply, into real-life psychotropic drug use and the benefit-risk profile of those medications in the general population, as well as in specific frail categories of patients such as older people, children and pregnant women. v

6 vi Preface and Acknowledgements A number of large-size observational studies have been conducted in several continents in the last decades, exploring and confirming the associations of potentially serious safety outcomes and use of drugs commonly prescribed in psychiatry, ranging from risk of hemorrhagic stroke and use of antidepressants, especially selective serotonin reuptake inhibitors, to risk of all-cause mortality and use of both atypical and conventional antipsychotics in older people with dementia, to risk of falls and benzodiazepine use and so on. Those data sources can complement the traditional spontaneous adverse drug reaction reporting system in drug safety signal management, also regarding psychotropic drugs. Knowledge in pharmacovigilance is dynamic and requires rapid (re)assessment of risk associated with currently marketed drugs, including psychotropic drugs. This book presents a timely overview of updated evidence about the safety profile of drugs that are commonly used in psychiatry, as well as of established and advanced methodologies that have been used up to now for the conduct of postmarketing pharmacovigilance studies. We gratefully acknowledge the continuous advice from Prof. Bruno Stricker (Erasmus University Medical Center of Rotterdam, the Netherlands) and Prof. Achille P. Caputi (University of Messina, Italy), who inspired relevant parts of this book through their innovative research in the field of pharmacovigilance. Messina, Italy Messina, Italy Gianluca Trifirò Edoardo Spina

7 Contents Part I General Aspects of Pharmacovigilance in Psychiatry 1 Pharmacovigilance in Psychiatry: An Introduction Edoardo Spina, Gianluca Trifirò, and Achille Patrizio Caputi 2 Adverse Drug Reactions: Definitions, Classifications and Regulatory Aspects Paola Maria Cutroneo and Giovanni Polimeni 3 Methods for the Post-Marketing Monitoring of Psychotropics Safety: Interests and Pitfalls Francesco Salvo, Annie Fourrier-Réglat, Nicholas Moore, Bernard Bégaud, and Antoine Pariente 4 Contribution of UK Prescription-Based Event Monitoring Methods in the Pharmacovigilance of Psychotropic Medications Deborah Layton 5 The Role of Healthcare Databases in Pharmacovigilance of Psychotropic Drugs Gianluca Trifirò and Janet Sultana 6 Monitoring of Plasma Concentrations of Psychotropic Drugs in Pharmacovigilance Christoph Hiemke and Ekkehard Haen 7 The Role of Pharmacogenetics in Pharmacovigilance of Psychotropic Drugs Alessandro Serretti and Chiara Fabbri Part II Pharmacovigilance of Specific Psychotropic Drug Classes 8 Safety and Tolerability of Antidepressants Chris Manson, Robert Gordon, and David Baldwin vii

8 viii Contents 9 Safety and Tolerability of Antipsychotics Michael W. Jann and William K. Kennedy 10 Safety and Tolerability of Anxiolytics/Sedative-Hypnotics Vincenzo Arcoraci and Edoardo Spina 11 Safety and Tolerability of Mood Stabilisers Michele Fabrazzo and Alfonso Tortorella 12 Safety and Tolerability of Medications for ADHD Antonio Clavenna and Maurizio Bonati Part III Pharmacovigilance of Psychotropic Drugs in Special Populations 13 Safety of Psychotropic Drugs in Children and Adolescents Florentia Kaguelidou and Eric Acquaviva 14 Safety of Psychotropic Drugs in the Elderly Kate L. Lapane, Anne Hume, Christine Ulbricht, and Giovanni Gambassi 15 Safety of Psychotropic Drugs in Pregnancy and Breastfeeding Olav Spigset and Hedvig Nordeng

9 List of Contributors Editors Edoardo Spina, MD, PhD Department of Clinical and Experimental Medicine, Gianluca Trifirò, MD, PhD Department of Clinical and Experimental Medicine, Contributors Eric Acquaviva Department of Child and Adolescent Psychiatry, Assistance Publique - Hôpitaux de Paris, Robert Debré University Hospital, Paris, France Vincenzo Arcoraci Department of Clinical and Experimental Medicine, David Baldwin University Department of Psychiatry, Clinical and Experimental Sciences Academic Unit, Faculty of Medicine, University of Southampton, Southampton, UK Bernard Bégaud Department of Medical Pharmacology, INSERM U657, Bordeaux University, Bordeaux, France University Hospital Centre de Bordeaux, Bordeaux, France Maurizio Bonati Department of Public Health, Laboratory for Mother and Child Health, Mario Negri IRCCS Institute of Pharmacological Research, Milan, Italy Achille Patrizio Caputi Department of Clinical and Experimental Medicine, ix

10 x List of Contributors Antonio Clavenna Department of Public Health, Laboratory for Mother and Child Health, Mario Negri IRCCS Institute of Pharmacological Research, Milan, Italy Paola Maria Cutroneo Department of Clinical and Experimental Medicine, Chiara Fabbri Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy Michele Fabrazzo Department of Psychiatry, University of Naples SUN, Naples, Italy Annie Fourrier-Réglat Department of Medical Pharmacology, INSERM U657, Bordeaux University, Bordeaux, France University Hospital Centre de Bordeaux, Bordeaux, France Giovanni Gambassi Department of Medical Sciences, Università Cattolica del Sacro Cuore, Rome, Italy Robert Gordon University Department of Psychiatry, Clinical and Experimental Sciences Academic Unit, Faculty of Medicine, University of Southampton, Southampton, UK Ekkehard Haen Department of Psychiatry and Psychotherapy and Department of Pharmacology and Toxicology, University of Regensburg, Regensburg, Germany Institute AGATE e.v., Pentling, Germany Christoph Hiemke Department of Psychiatry and Psychotherapy, University Medical Center of Mainz, Mainz, Germany Anne Hume College of Pharmacy, Rhode Island University, Kingston, RI, USA Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA Michael W. Jann Department of Pharmacotherapy, University of North Texas System College of Pharmacy (UNTSCP), Fort Worth, TX, USA Department of Pharmacotherapy, University of North Texas Health Science Center (UNTHSC), Fort Worth, TX, USA Florentia Kaguelidou Department of Pediatric Pharmacology and Pharmacogenetics, Assistance Publique - Hôpitaux de Paris, Robert Debré University Hospital, Paris, France University Paris 7 - Diderot, Sorbonne Paris Cité, Paris, France William K. Kennedy Department of Pharmacy Practice, Mercer University College of Pharmacy, Atlanta, GA, USA

11 List of Contributors xi Department of Pharmacotherapy, University of North Texas Health Science Center (UNTHSC), Fort Worth, TX, USA Kate L. Lapane Department of Quantitative Health Sciences, Division of Epidemiology of Chronic Diseases and Vulnerable Populations, University of Massachusetts Medical School, Worcester, MA, USA Deborah Layton Drug Safety Research Unit, Southampton, UK Chris Manson University Department of Psychiatry, Clinical and Experimental Sciences Academic Unit, Faculty of Medicine, University of Southampton, Southampton, UK Nicholas Moore Department of Medical Pharmacology, INSERM U657, Bordeaux University, Bordeaux, France University Hospital Centre de Bordeaux, Bordeaux, France Hedvig Nordeng Pharmacoepidemiology and Drug Safety Research Group, School of Pharmacy, PharmaTox Strategic Research Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway Division of Mental Health, Norwegian Institute of Public Health, Oslo, Norway Antoine Pariente Department of Pharmacology, INSERM U657, BP 36, Bordeaux University, Bordeaux, France Giovanni Polimeni Department of Clinical and Experimental Medicine, Francesco Salvo Department of Pharmacology, INSERM U657, University of Bordeaux, Bordeaux, France Alessandro Serretti Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy Olav Spigset Department of Clinical Pharmacology, St. Olav University Hospital, Trondheim, Norway Department of Laboratory Medicine, Children s and Women s Health, Norwegian University of Science and Technology, Trondheim, Norway Janet Sultana Department of Clinical and Experimental Medicine, Alfonso Tortorella Department of Psychiatry, University of Naples SUN, Naples, Italy Christine Ulbricht Department of Quantitative Health Sciences, Division of Epidemiology of Chronic Diseases and Vulnerable Populations, University of Massachusetts Medical School, Worcester, MA, USA