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The Science and Ethics of Antipsychotic Use in Children PDF

218 Pages·2015·6.289 MB·English
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The Science and Ethics of Antipsychotic Use in Children The Science and Ethics of Antipsychotic Use in Children Edited by Nina Di Pietro and Judy Illes AMSTERDAM (cid:127) BOSTON (cid:127) HEIDELBERG (cid:127) LONDON NEW YORK (cid:127) OXFORD (cid:127) PARIS (cid:127) SAN DIEGO SAN FRANCISCO (cid:127) SINGAPORE (cid:127) SYDNEY (cid:127) TOKYO Academic Press is an imprint of Elsevier Academic Press is an imprint of Elsevier 125 London Wall, London, EC2Y 5AS, UK 525 B Street, Suite 1800, San Diego, CA 92101–4495, USA 225 Wyman Street, Waltham, MA 02451, USA The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, UK © 2015 Elsevier Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher. Details on how to seek permission, further information about the Publisher’s permissions policies and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions. This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein). Notices Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary. Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility. To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein. Library of Congress Cataloging-in-Publication Data A catalog record for this book is available from the Library of Congress British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library For information on all Academic Press publications visit our website at http://store.elsevier.com/ Printed and bound in the USA ISBN: 978-0-12-800016-8 Contributors Mai Berger Sleep/Wake Behaviour Clinic & Research Lab, BC Children’s Hospital, Division of Developmental Pediatrics, Department of Pediatrics, Faculty of Medicine, University of British Columbia; and Person Centered Medicine, Treatable Intellectual Disability Endeavour in British Columbia (TIDE BC), Vancouver, British Columbia, Canada Bruce Carleton BC Children's Hospital, Division of Translational Therapeutics, Department of Pediatrics, Child & Family Research Institute, University of British Columbia, Vancouver, British Columbia, Canada Lorrie Chow Provincial Mental Health Metabolic Program, BC Children’s Hospital, Vancouver, British Columbia, Canada Jana Davidson Children’s & Women’s Mental Health and Substance Use Services, Children’s and Women’s Health Centre of BC, Provincial Health Services Authority; and Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada Nina Di Pietro National Core for Neuroethics, Division of Neurology, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada Dean Elbe Division of Children’s and Women’s Mental Health, BC Mental Health & Addiction Services; Department of Pharmacy, BC Children’s Hospital; Faculty of Pharmaceutical Sciences, University of British Columbia; and Child & Adolescent Mental Health, BC Children’s Hospital, Vancouver, British Columbia, Canada David Gardner College of Pharmacy, Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada Judy Illes National Core for Neuroethics, Division of Neurology, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada Osman Ipsiroglu Sleep/Wake Behaviour Clinic & Research Lab, BC Children’s Hospital, Division of Developmental Pediatrics, Department of Pediatrics, Faculty of Medicine, University of British Columbia, Vancouver; Faculty of Science, Thompson Rivers University, Kamloops; and Person Centered Medicine, Treatable Intellectual Disability Endeavour in British Columbia (TIDE BC), Vancouver, British Columbia, Canada Kristine Kuss Provincial Mental Health Metabolic Program, BC Children’s Hospital, Vancouver, British Columbia, Canada ix x Contributors Stan Kutcher Department of Psychiatry, Dalhousie University; Sun Life Chair in Adolescent Mental Health, IWK Health Centre and Dalhousie University; and WHO Collaborating Center, IWK Health Centre—Maritime Outpatient Psychiatry, Halifax, Nova Scotia, Canada Tami Lin Sleep/Wake Behaviour Clinic & Research Lab, BC Children’s Hospital, Division of Developmental Pediatrics, Department of Pediatrics, Faculty of Medicine, University of British Columbia; and Person Centered Medicine, Treatable Intellectual Disability Endeavour in British Columbia (TIDE BC), Vancouver, British Columbia, Canada Edel Mc Glanaghy National Core for Neuroethics, Division of Neurology, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada Andrea Murphy College of Pharmacy, Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada Tim F. Oberlander Department of Pediatrics, School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada Iliana Garcia-Ortega Mathison Centre for Mental Health Research and Education, University of Calgary, Calgary, Alberta, Canada Constadina Panagiotopoulos BC Children’s Hospital, Provincial Health Services Authority; and Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada Tamara Pringsheim Department of Clinical Neurosciences, Psychiatry, Pediatrics and Community Health Sciences, University of Calgary, Calgary, Alberta, Canada Rebecca Ronsley BC Children’s Hospital, University of British Columbia, Vancouver, British Columbia, Canada Sylvia Stockler Division of Biochemical Diseases, Department of Pediatrics, Faculty of Medicine, University of British Columbia; and Person Centered Medicine, Treatable Intellectual Disability Endeavour in British Columbia (TIDE BC), Vancouver, British Columbia, Canada Benjamin Wilfond Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute; and Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA Foreword The use of antipsychotic drugs, in particular second-generation antipsychotics (SGAs), in children and adolescents is widespread in Canada and other devel- oped nations, and has increased substantially in the last decade. These agents are used for a variety of conditions, including psychoses, mood disorders, be- havioral disorders, and attention-deficit hyperactivity disorder as well as treat- ment of autism spectrum disorders, tics, sleep disorders, and other nonpsychotic symptoms. The use of SGAs in these populations is off-label as, with the excep- tion of certain limited indications for aripiprazole in adolescents, their use has not been authorized by Health Canada. This is not unusual per se, as the major- ity of prescription drug use in children is off-label. What makes the situation with SGAs of particular concern in children and adolescents is (a) the range of serious or potentially serious adverse effects that are associated with their use, and (b) the lack of hard evidence for their efficacy. In particular, the metabolic and cardiovascular adverse effects associated with the use of SGAs raise seri- ous clinical and ethical questions. These questions are especially pertinent when considering their use in vulnerable populations. This book, which contains a series of excellent articles written by leading authorities in their fields, provides the first extensive evaluation of this complex and important issue available un- der one cover. It is important to remember that the off-label use of drugs in specific popu- lations or disorders is not inherently wrong or unsafe; rather it means that there is insufficient available evidence to allow the regulatory agency con- cerned to include the indication in the label (or product monograph). The term “off-e vidence” might, in fact be more accurate. This highlights a fun- damental issue in the use of drugs in special populations such as children, adolescents, and pregnant women, which is the difficulty, both practically and ethically, in conducting appropriate clinical trials—in particular randomized controlled trials (RCTs). RCTs are considered the gold standard of evidence- based medicine and are essentially mandatory for the regulatory approval of new medicines. Their application in pediatric populations is particularly chal- lenging, although detailed literature review indicates that many of these trials are carried out; indeed, regulatory agencies are increasingly mandating them as part of the post-marketing review process. In addition to improvements in pediatric clinical trial design there, have been exciting new advances in physi- ologically based pharmacokinetic modeling, which will undoubtedly lead to a much stronger evidence base supporting the use of new and existing drugs in these populations. xi xii Foreword This book provides an important and much-needed resource for researchers, students, and practitioners, as well as patients and their families. The detailed analysis and discussion presented in the various chapters will inform the con- tinuing debate surrounding the appropriateness, or otherwise, of using SGAs in children and adolescents. It will hopefully inspire further research into this important issue and ultimately support the development and implementation of rational, evidence-based policy. Michael Coughtrie Faculty of Pharmaceutical Sciences University of British Columbia Vancouver, BC, Canada Acknowledgments Drs. Di Pietro and Illes gratefully acknowledge NeuroDevNet, Inc. for sup- porting their work on this book. NeuroDevNet, Inc. is a Canadian Network of Centres of Excellence dedicated to understanding brain development and helping children and their families overcome the challenges of neurodevel- opmental disorders. We also wish to acknowledge the Peter Wall Institute for Advanced Studies for funding the workshop “Deliberations on the Ethical Use of Antipsychotic Medications in Children” and the subsequent creation of the Canadian Working Group on Antipsychotics for Children. Dr. Illes is Canada Research Chair in Neuroethics. The programs of research at the National Core for Neuroethics under her direction have been generously enabled by the Canadian Institutes of Health, the British Columbia Knowledge Development Fund, the Canadian Foundation for Innovation, the Vancouver Coastal Research Institute, and other private funders. xiii Introduction: A Call for Partnership Nina Di Pietro, Judy Illes There are more than 60 years of clinical evidence demonstrating the benefits of antipsychotic medications for improving the lives of individuals affected by serious mental illnesses such as schizophrenia and bipolar disorder. The ben- efits of these medicines, however, are not without potential risk, ranging from mild unwanted side effects such as drowsiness to serious complications such as diabetes. For children and youth,1 the risks are compounded by therapeutic uncertainties about their effectiveness for treatment of mental health conditions in this group. Nonetheless, antipsychotics are increasingly being applied to treat a wide range of emotional and behavioral problems in children, a trend that is causing many to wonder about how these medications are being used and prescribed. In this book, we explore the tension between the risk of treatment and the risk of illness within the context of off-label antipsychotic prescrib- ing practices. Using a pragmatic neuroethics framework, we build on empirical research to inform best practices for prescribing antipsychotic medications to young people. This approach allows for the integration of a variety of medi- cal, ethical, and sociological perspectives, which are ultimately needed to guide clinical practice (Racine et al., 2011). The book is a direct product of the workshop “Deliberations on the Ethical Use of Antipsychotic Medications in Children” that we held in September 2013 at the University of British Columbia, with the support of the Peter Wall Institute for Advanced Studies and NeuroDevNet, Inc. The workshop brought together research and clinical leaders in child psychiatry, ethics, and neuroscience in a think tank setting to consider the state of the science and ethics of prescribing antipsychotic medicines for children. From it, we identified critical unanswered questions and formed the “Canadian Working Group on Antipsychotics for Children” to address them. The Working Group weighed in on three key questions: 1. What phenomena account for the increase in prescribing antipsychotics for children and adolescents? 2. What gaps in knowledge need to be filled in order to begin to address con- cerns about safety and efficacy? 1 We use the term children to refer to individuals age 0-12 years and youth to refer to individuals age 13-18 years. xv xvi Introduction: A Call for Partnership 3. What are the ethical, legal, and social consequences of increased off-label use of antipsychotic medications in young people, and where do we go from here? The group deliberations under each question are summarized below: (1) What phenomena account for the increase in prescribing antipsychotics for children and adolescents? The Working Group recognized that the reason for the burgeoning off-label use of antipsychotics in children and youth is likely multifactorial—a phenom- enon that situates itself within political, sociocultural, and economic arenas (Di Pietro & Illes, 2014). To date, there has been little attempt to study how or to what extent any of these arenas may influence prescribing practices within the context of antipsychotics for children. Evidence is mostly anecdotal and in the form of news reports in the popular media. The proposed factors that account for the in- crease in second-generation antipsychotic prescription use, as derived from our group discussions and supplemented by the scientific literature, are as follows: i. Wider availability of new antipsychotics on the market in the last 15 years. Throughout the 1970s and 1980s, the term atypical was synonymous with clozapine. At the turn of the millennium, however, several new atypical anti- psychotics were developed and made available on the North American mar- ket: risperidone (1993), olanzapine (1997), quetiapine (1997), ziprasidone HCl (2001), aripiprazole (2002), and paliperidone (2006). Soon after the introduc- tion of these atypical drugs, they quickly became the most studied treatments for schizophrenia and other indications (Meltzer, 2013). As a result, second- generation antipsychotic (SGA) use also increased during this time period. For instance, prescriptions in the province of Manitoba for SGAs went from 1.9 per 1000 in 1999 to 7.4 per 1000 in 2008 (Alessi-Severini et al., 2012). Prior to the 1990s, the level of antipsychotic use among children was relatively constant (Olfson et al., 2002). ii. Approval of antipsychotics to treat indications in adolescents. In 2011, Health Canada approved Abilify® (aripiprazole) for the treatment of schizophrenia and bipolar disorder in adolescents, making it the first atypical antipsychotic to be specifically approved for use in children and youth. In the United States, the FDA approved it for the treatment of irritability in children with autism as young as age 6. Growing approval for use in minors may con- tribute to perceptions that antipsychotics are generally safe and effective, even if evidence for this is limited to older adolescents with serious mental health conditions. iii. Emerging clinical trial data supporting antipsychotic use for youths out- side of approved Health Canada indications. The empirical basis for the use of SGAs outside of approved Health Canada indications is supported by a growing number of studies that show that they may be effective for treating a variety of different mental health problems in children and adolescents. According to the Cochrane Database of Systematic Reviews,

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