Table Of Content

Pharmacoepidemiology Pharmacoepidemiology EDITED BY Brian L. Strom MD, MPH George S. Pepper Professor of Public Health and Preventive Medicine Professor of Biostatistics and Epidemiology, of Medicine, and of Pharmacology Chair, Department of Biostatistics and Epidemiology Director, Center for Clinical Epidemiology and Biostatistics Vice Dean for Institutional Affairs Perelman School of Medicine at the University of Pennsylvania Philadelphia, PA, USA Stephen E. Kimmel MD, MSCE Professor of Medicine and of Epidemiology Senior Scholar, Center for Clinical Epidemiology and Biostatistics Perelman School of Medicine at the University of Pennsylvania Philadelphia, PA, USA Sean Hennessy PHARMD, PHD Associate Professor of Epidemiology and of Pharmacology Senior Scholar, Center for Clinical Epidemiology and Biostatistics Perelman School of Medicine at the University of Pennsylvania Philadelphia, PA, USA FIFTH EDITION A John Wiley & Sons, Ltd., Publication This edition fi rst published 2012, © 2012 by John Wiley & Sons, Ltd. Wiley-Blackwell is an imprint of John Wiley & Sons, formed by the merger of Wiley’s global Scientifi c, Technical and Medical business with Blackwell Publishing. Registered offi ce: John Wiley & Sons, Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK Editorial offi ces: 9600 Garsington Road, Oxford, OX4 2DQ, UK The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK 111 River Street, Hoboken, NJ 07030-5774, USA For details of our global editorial offi ces, for customer services and for information about how to apply for permission to reuse the copyright material in this book please see our website at www.wiley.com/ wiley-blackwell The right of the author to be identifi ed as the author of this work has been asserted in accordance with the UK Copyright, Designs and Patents Act 1988. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by the UK Copyright, Designs and Patents Act 1988, without the prior permission of the publisher. Designations used by companies to distinguish their products are often claimed as trademarks. All brand names and product names used in this book are trade names, service marks, trademarks or registered trademarks of their respective owners. The publisher is not associated with any product or vendor mentioned in this book. This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. It is sold on the understanding that the publisher is not engaged in rendering professional services. If professional advice or other expert assistance is required, the services of a competent professional should be sought. The contents of this work are intended to further general scientifi c research, understanding, and discussion only and are not intended and should not be relied upon as recommending or promoting a specifi c method, diagnosis, or treatment by physicians for any particular patient. The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifi cally disclaim all warranties, including without limitation any implied warranties of fi tness for a particular purpose. In view of ongoing research, equipment modifi cations, changes in governmental regulations, and the constant fl ow of information relating to the use of medicines, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine, equipment, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. Readers should consult with a specialist where appropriate. The fact that an organization or Website is referred to in this work as a citation and/or a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make. Further, readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read. No warranty may be created or extended by any promotional statements for this work. Neither the publisher nor the author shall be liable for any damages arising herefrom. Library of Congress Cataloging-in-Publication Data Pharmacoepidemiology / edited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy. – 5th ed. p. ; cm. Includes bibliographical references and index. ISBN-13: 978-0-470-65475-0 (hard cover : alk. paper) ISBN-10: 0-470-65475-9 (hard cover : alk. paper) 1. Pharmacoepidemiology. 2. Pharmacology. I. Strom, Brian L. II. Kimmel, Stephen E. III. Hennessy, Sean. [DNLM: 1. Pharmacoepidemiology–methods. QZ 42] RM302.5.P53 2012 615'.7042–dc23 2011019285 A catalogue record for this book is available from the British Library. Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic books. Set in 9/12pt Meridien by Toppan Best-set Premedia Limited, Hong Kong 1 2012 Contents List of Contributors, ix Preface, xvi Acknowledgements, xx PART I Introduction, 1 1 What is Pharmacoepidemiology?, 3 Brian L. Strom 2 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies, 23 Jeffrey S. Barrett and Athena F. Zuppa 3 Basic Principles of Clinical Epidemiology Relevant to Pharmacoepidemiologic Studies, 38 Brian L. Strom 4 Sample Size Considerations for Pharmacoepidemiologic Studies, 52 Brian L. Strom 5 When Should One Perform Pharmacoepidemiologic Studies?, 62 Brian L. Strom PART II The Role of Pharmacoepidemiology in Different Sectors, 71 6 The Role of Pharmacoepidemiology in the Health-Care System and Academia, 73 Jerry Avorn 7 The Role of Pharmacoepidemiology in Industry, 84 Jingping Mo, Nicolle M. Gatto, Rachel E. Sobel, and Robert F. Reynolds 8 The Role of Pharmacoepidemiology in Regulatory Agencies, 107 Gerald J. Dal Pan and Peter Arlett 9 Pharmacoepidemiology and the Law, 117 Aaron S. Kesselheim PART III Sources of Data for Pharmacoepidemiologic Studies, 135 Section A: Spontaneous Reporting 10 Postmarketing Spontaneous Pharmacovigilance Reporting Systems, 137 Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin v vi Contents Section B: Automated Data Systems 11 Overview of Automated Databases in Pharmacoepidemiology, 158 Brian L. Strom 12 Health Maintenance Organizations/Health Plans, 163 Susan E. Andrade, Marsha A. Raebel, Denise Boudreau, Robert L. Davis, Katherine Haffenreffer, Pamala A. Pawloski, Sengwee Toh, and Richard Platt 13 Commercial Insurance Databases, 189 John Seeger and Gregory W. Daniel 14 US Government Claims Databases, 209 Sean Hennessy, Cristin Palumbo Freeman, and Francesca Cunningham 15 Medical Record Databases, 224 Alexis Ogdie, Sinéad M. Langan, John Parkinson, Hassy Dattani, Karel Kostev, and Joel M. Gelfand 16 In-hospital Databases, 244 Brian T. Fisher, Peter K. Lindenauer, and Chris Feudtner 17 Canadian Provincial Databases, 259 Yola Moride and Colleen J. Metge 18 Pharmacy-based Medical Record Linkage Systems, 270 Ron M.C. Herings and Lars Pedersen Section C: Ad Hoc Studies—Ongoing Systems for Pharmacoepidemiologic Studies 19 Case–Control Surveillance, 287 Lynn Rosenberg, Patricia F. Coogan, and Julie R. Palmer 20 Prescription–Event Monitoring, 301 Deborah Layton and Saad A.W. Shakir 21 Registries, 331 Nancy A. Dreyer and Priscilla Velentgas Section D: Ad Hoc Studies—De Novo Studies 22 Field Studies, 347 David W. Kaufman Section E: Choosing Among the Available Alternatives 23 How Should One Perform Pharmacoepidemiologic Studies? Choosing Among the Available Alternatives, 364 Brian L. Strom PART IV Selected Special Applications of Pharmacoepidemiology, 377 24 Studies of Drug Utilization, 379 David Lee and Ulf Bergman 25 Evaluating and Improving Physician Prescribing, 402 Sumit R. Majumdar, Helene Levens Lipton, and Stephen B. Soumerai Contents vii 26 Pharmacoepidemiologic Studies of Vaccine Safety, 423 Robert T. Chen, Jason M. Glanz, and Claudia Vellozzi 27 Epidemiologic Studies of Medical Devices: Methodologic Considerations for Implantable Devices, 469 Danica Marinac-Dabic, Sharon-Lise Normand, Art Sedrakyan, and Thomas Gross 28 Studies of Drug-Induced Birth Defects, 487 Allen A. Mitchell 29 Risk Management, 505 Gerald J. Dal Pan, Stella Blackburn, and Claudia Karwoski 30 FDA’s Sentinel Initiative: Active Surveillance to Identify Safety Signals, 534 Judith A. Racoosin, Melissa A. Robb, Rachel E. Sherman, and Janet Woodcock 31 Pharmacoepidemiology and Pharmaceutical Reimbursement Policy, 555 Mitchell Levine and Jacques LeLorier 32 Comparative Effectiveness Research, 561 Brian L. Strom, Rita Schinnar, and Sean Hennessy PART V Selected Special Methodologic Issues in Pharmacoepidemiology, 581 33 Assessing Causality of Case Reports of Suspected Adverse Events, 583 Judith K. Jones 34 Molecular Pharmacoepidemiology, 601 Stephen E. Kimmel, Hubert G. Leufkens, and Timothy R. Rebbeck 35 Bioethical Issues in Pharmacoepidemiologic Research, 623 Antoine C. El Khoury, Jason Karlawish, Elizabeth Andrews, and Arthur Caplan 36 The Use of Randomized Controlled Trials for Pharmacoepidemiologic Studies, 640 Samuel M. Lesko and Allen A. Mitchell 37 The Use of Pharmacoepidemiology to Study Benefi cial Drug Effects, 655 Brian L. Strom and Kenneth L. Melmon 38 Pharmacoeconomics: Economic Evaluation of Pharmaceuticals, 678 Kevin A. Schulman, Henry A. Glick, Daniel Polsky, and Shelby D. Reed 39 Using Quality-of-Life Measurements in Pharmacoepidemiologic Research, 709 Holger Schünemann, Bradley C. Johnston, Roman Jaeschke, and Gordon H. Guyatt 40 The Use of Meta-analysis in Pharmacoepidemiology, 723 Jesse A. Berlin, M. Soledad Cepeda, and Carin J. Kim 41 Validity of Pharmacoepidemiologic Drug and Diagnosis Data, 757 Suzanne L. West, Mary Elizabeth Ritchey, and Charles Poole 42 Studies of Medication Adherence, 795 Trisha Acri and Robert Gross viii Contents 43 Risk Evaluation and Communication, 810 Susan J. Blalock and Betsy L. Sleath 44 Studying Effects of Antibiotics, 827 Darren R. Linkin and Ebbing Lautenbach 45 The Pharmacoepidemiology of Medication Errors, 840 Hanna M. Seidling and David W. Bates 46 Sequential Statistical Methods for Prospective Postmarketing Safety Surveillance, 852 Martin Kulldorff 47 Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies, 868 Sebastian Schneeweiss and Samy Suissa PART VI Conclusion, 893 48 The Future of Pharmacoepidemiology, 895 Brian L. Strom, Stephen E. Kimmel, and Sean Hennessy Appendix A: Sample Size Tables, 904 Appendix B: Glossary, 921 Index, 931 List of Contributors Trisha Acri Jeffrey S. Barrett Jesse A. Berlin Assistant Professor Director Vice President Department of Family and Laboratory for Applied Department of Epidemiology Community Medicine Pharmacokinetics and Johnson& Johnson Pharmaceutical Temple University School of Medicine Pharmacodynamics Research and Development Philadelphia, PA Director Titusville, NJ USA Pediatric Pharmacology Research Unit USA The Children’ s Hospital of Susan E. Andrade Philadelphia Stella Blackburn Senior Research Associate and Research Professor, Pediatrics EMA Risk Management Development Research Associate Professor Kinetic Modeling and Simulation and Scientifi c Lead Meyers Primary Care Institute (KMAS) Core Director European Medicines Agency and Perelman School of Medicine at the London, UK University of Massachusetts Medical University of Pennsylvania School Philadelphia, PA Susan J. Blalock Worcester, MA USA Associate Professor USA Division of Pharmaceutical Outcomes David W. Bates and Policy Elizabeth Andrews Chief Eshelman School of Pharmacy Vice President General Medicine Division University of North Carolina at Pharmacoepidemiology and Risk Brigham and Women’ s Hospital Chapel Hill Management and Chapel Hill, NC Research Triangle Institute Health Professor of Medicine USA Solutions Harvard Medical School Research Triangle Park, NC Boston, MA Denise Boudreau USA USA Scientifi c Investigator Group Health Research Institute Peter Arlett Ulf Bergman Seattle, WA Head Professor, Senior Medical Offi cer USA Pharmacovigilance and Risk Division of Clinical Pharmacology Management Department of Laboratory Medicine Arthur Caplan European Medicines Agency Karolinska Institute Director London, UK WHO Collaborating Centre for Drug Center for Bioethics Utilization Research and Clinical Professor of Medical Ethics Jerry Avorn Pharmacological Services Perelman School of Medicine at the Chief and University of Pennsylvania Division of Pharmacoepidemiology Centre for Pharmacoepidemiology Philadelphia, PA and Pharmacoeconomics Karolinska University USA Brigham and Women’ s Hospital Hospital-Huddinge and Stockholm, Sweden Professor of Medicine Harvard Medical School Boston, MA USA ix x List of Contributors M. Soledad Cepeda Hassy Dattani Nicolle M. Gatto Director Research Director Senior Director Department of Epidemiology Cegedim Strategic Data Medical Epidemiology Johnson& Johnson Pharmaceutical Research Ltd Worldwide Safety Strategy Research and Development London, UK Pfi zer Inc. Titusville, NJ New York, NY USA Robert L. Davis USA Director of Research Robert T. Chen Center for Health Joel M. Gelfand HIV Vaccine and Special Studies Team Research—Southeast Medical Director, Clinical Studies Unit Leader Kaiser Permanente Georgia Assistant Professor of Dermatology Division of HIV/AIDS Prevention Atlanta, GA and Epidemiology Centers for Disease Control and USA Senior Scholar, Center for Clinical Prevention Epidemiology and Biostatistics Atlanta, GA Nancy A. Dreyer Departments of Dermatology and USA Chief of Scientifi c Affairs Biostatistics and Epidemiology Outcome Sciences Inc. Perelman School of Medicine at the Patricia F. Coogan Cambridge, MA University of Pennsylvania Associate Professor of Epidemiology USA Philadelphia, PA Slone Epidemiology Center USA Boston University Antoine C. El Khoury Boston, MA Leader, Outcomes Research Kate Gelperin USA Global Health Outcomes Medical Offi cer Merck & co., Inc Division of Epidemiology Francesca Cunningham West Point, PA Offi ce of Surveillance and Director USA Epidemiology Center for Medication Safety Center for Drug Evaluation and and Chris Feudtner Research Program Manager Associate Professor US Food and Drug Administration Outcomes Research PBM Services Department of Pediatrics Silver Spring, MD Department of Veterans Affairs The Children ’s Hospital of Philadelphia USA Center for Medication Safety Perelman School of Medicine at the Hines, IL University of Pennsylvania Jason M. Glanz USA Philadelphia, PA Epidemiologist USA Institute for Health Research Gerald J. Dal Pan Kaiser Permanente Colorado Director Brian T. Fisher Department of Epidemiology Colorado Offi ce of Surveillance and Assistant Professor of Pediatrics School of Public Health Epidemiology Center for Pediatric Clinical Denver, CO Center for Drug Evaluation and Effectiveness USA Research The Children’ s Hospital of US Food and Drug Administration Philadelphia Henry A. Glick Silver Spring, MA Perelman School of Medicine at the Professor of Medicine USA University of Pennsylvania Perelman School of Medicine at the Philadelphia, PA University of Pennsylvania Gregory W. Daniel USA Philadelphia, PA Vice President USA Government and Academic Research Cristin Palumbo Freeman Healthcore Research Project Manager Alexandria, VA Center for Clinical Epidemiology and USA Biostatistics Perelman School of Medicine at the University of Pennsylvania Philadelphia, PA USA List of Contributors xi Robert Gross Ron M.C. Herings Claudia Karwoski Associate Professor of Medicine and Director Director Epidemiology PHARMO Institute Division of Risk Management Center for Clinical Epidemiology and Utrecht Offi ce of Surveillance and Biostatistics The Netherlands Epidemiology Perelman School of Medicine at the and Center for Drug Evaluation and University of Pennsylvania Associate Professor of Research Philadelphia, PA Pharmacoepidemiology US Food and Drug Administration USA Department of Health Policy and Silver Spring, MA Management USA Thomas Gross Erasmus University Rotterdam Deputy Director Rotterdam, The Netherlands David W. Kaufman Offi ce of Surveillance and Biometrics Associate Director Center for Devices and Radiological Roman Jaeschke Slone Epidemiology Center at Boston Health Professor University US Food and Drug Administration Department of Clinical Epidemiology and Silver Spring, MD and Biostatistics Professor of Epidemiology USA McMaster University Boston University School of Public Health Sciences Center Health Gordon H. Guyatt and Boston, MA Professor Professor USA Department of Clinical Epidemiology Department of Medicine and Biostatistics St Joseph ’s Hospital Aaron S. Kesselheim McMaster University Hamilton Assistant Professor of Medicine Health Sciences Center Ontario, Canada Division of Pharmacoepidemiology and and Pharmacoeconomics Department of Medicine Bradley C. Johnston Department of Medicine St Joseph ’s Hospital Assistant Professor Brigham and Women’ s Hospital Hamilton Department of Clinical Epidemiology Harvard Medical School Ontario, Canada and Biostatistics Boston, MA McMaster University USA Katherine Haffenreffer Health Sciences Center Project Administrator Hamilton Carin J. Kim Harvard Pilgrim Health Care Institute Ontario, Canada Mathematical Statistician and Center for Drug Evaluation and Department of Population Medicine Judith K. Jones Research Harvard Medical School President and CEO US Food and Drug Administration Boston, MA The Degge Group Ltd Silver Spring, MD USA Arlington, VA USA USA Sean Hennessy and Stephen E. Kimmel Associate Professor of Epidemiology Adjunct Professor and Lecturer Professor of Medicine and and of Pharmacology University of Michigan School of Epidemiology Senior Scholar, Center for Clinical Public Health Summer Program Senior Scholar, Center for Clinical Epidemiology and Biostatistics Georgetown University Epidemiology and Biostatistics Perelman School of Medicine at the Washington, DC Perelman School of Medicine at the University of Pennsylvania USA University of Pennsylvania Philadelphia, PA Philadelphia, PA USA Jason Karlawish USA Professor of Medicine Perelman School of Medicine at the Karel Kostev University of Pennsylvania Senior Research Analyst Philadelphia, PA Centre of Excellence Patient Data USA IMS Health GmbH& Co OHG Frankfurt/Main, Germany

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Pharmacoepidemiology Pharmacoepidemiology EDITED BY Brian L. Strom MD, MPH George S. Pepper Professor of Public Health and Preventive Medicine Professor of Biostatistics and Epidemiology, of Medicine, and of Pharmacology Chair, Department of Biostatistics and Epidemiology Director, Center for Clinical Epidemiology and Biostatistics Vice Dean for Institutional Affairs Perelman School of Medicine at the University of Pennsylvania Philadelphia, PA, USA Stephen E. Kimmel MD, MSCE Professor of Medicine and of Epidemiology Senior Scholar, Center for Clinical Epidemiology and Biostatistics Perelman School of Medicine at the University of Pennsylvania Philadelphia, PA, USA Sean Hennessy PHARMD, PHD Associate Professor of Epidemiology and of Pharmacology Senior Scholar, Center for Clinical Epidemiology and Biostatistics Perelman School of Medicine at the University of Pennsylvania Philadelphia, PA, USA FIFTH EDITION A John Wiley & Sons, Ltd., Publication This edition fi rst published 2012, © 2012 by John Wiley & Sons, Ltd. Wiley-Blackwell is an imprint of John Wiley & Sons, formed by the merger of Wiley’s global Scientifi c, Technical and Medical business with Blackwell Publishing. Registered offi ce: John Wiley & Sons, Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK Editorial offi ces: 9600 Garsington Road, Oxford, OX4 2DQ, UK The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK 111 River Street, Hoboken, NJ 07030-5774, USA For details of our global editorial offi ces, for customer services and for information about how to apply for permission to reuse the copyright material in this book please see our website at www.wiley.com/ wiley-blackwell The right of the author to be identifi ed as the author of this work has been asserted in accordance with the UK Copyright, Designs and Patents Act 1988. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by the UK Copyright, Designs and Patents Act 1988, without the prior permission of the publisher. Designations used by companies to distinguish their products are often claimed as trademarks. All brand names and product names used in this book are trade names, service marks, trademarks or registered trademarks of their respective owners. The publisher is not associated with any product or vendor mentioned in this book. This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. It is sold on the understanding that the publisher is not engaged in rendering professional services. If professional advice or other expert assistance is required, the services of a competent professional should be sought. The contents of this work are intended to further general scientifi c research, understanding, and discussion only and are not intended and should not be relied upon as recommending or promoting a specifi c method, diagnosis, or treatment by physicians for any particular patient. The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifi cally disclaim all warranties, including without limitation any implied warranties of fi tness for a particular purpose. In view of ongoing research, equipment modifi cations, changes in governmental regulations, and the constant fl ow of information relating to the use of medicines, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine, equipment, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. Readers should consult with a specialist where appropriate. The fact that an organization or Website is referred to in this work as a citation and/or a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make. Further, readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read. No warranty may be created or extended by any promotional statements for this work. Neither the publisher nor the author shall be liable for any damages arising herefrom. Library of Congress Cataloging-in-Publication Data Pharmacoepidemiology / edited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy. – 5th ed. p. ; cm. Includes bibliographical references and index. ISBN-13: 978-0-470-65475-0 (hard cover : alk. paper) ISBN-10: 0-470-65475-9 (hard cover : alk. paper) 1. Pharmacoepidemiology. 2. Pharmacology. I. Strom, Brian L. II. Kimmel, Stephen E. III. Hennessy, Sean. [DNLM: 1. Pharmacoepidemiology–methods. QZ 42] RM302.5.P53 2012 615'.7042–dc23 2011019285 A catalogue record for this book is available from the British Library. Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic books. Set in 9/12pt Meridien by Toppan Best-set Premedia Limited, Hong Kong 1 2012 Contents List of Contributors, ix Preface, xvi Acknowledgements, xx PART I Introduction, 1 1 What is Pharmacoepidemiology?, 3 Brian L. Strom 2 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies, 23 Jeffrey S. Barrett and Athena F. Zuppa 3 Basic Principles of Clinical Epidemiology Relevant to Pharmacoepidemiologic Studies, 38 Brian L. Strom 4 Sample Size Considerations for Pharmacoepidemiologic Studies, 52 Brian L. Strom 5 When Should One Perform Pharmacoepidemiologic Studies?, 62 Brian L. Strom PART II The Role of Pharmacoepidemiology in Different Sectors, 71 6 The Role of Pharmacoepidemiology in the Health-Care System and Academia, 73 Jerry Avorn 7 The Role of Pharmacoepidemiology in Industry, 84 Jingping Mo, Nicolle M. Gatto, Rachel E. Sobel, and Robert F. Reynolds 8 The Role of Pharmacoepidemiology in Regulatory Agencies, 107 Gerald J. Dal Pan and Peter Arlett 9 Pharmacoepidemiology and the Law, 117 Aaron S. Kesselheim PART III Sources of Data for Pharmacoepidemiologic Studies, 135 Section A: Spontaneous Reporting 10 Postmarketing Spontaneous Pharmacovigilance Reporting Systems, 137 Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin v vi Contents Section B: Automated Data Systems 11 Overview of Automated Databases in Pharmacoepidemiology, 158 Brian L. Strom 12 Health Maintenance Organizations/Health Plans, 163 Susan E. Andrade, Marsha A. Raebel, Denise Boudreau, Robert L. Davis, Katherine Haffenreffer, Pamala A. Pawloski, Sengwee Toh, and Richard Platt 13 Commercial Insurance Databases, 189 John Seeger and Gregory W. Daniel 14 US Government Claims Databases, 209 Sean Hennessy, Cristin Palumbo Freeman, and Francesca Cunningham 15 Medical Record Databases, 224 Alexis Ogdie, Sinéad M. Langan, John Parkinson, Hassy Dattani, Karel Kostev, and Joel M. Gelfand 16 In-hospital Databases, 244 Brian T. Fisher, Peter K. Lindenauer, and Chris Feudtner 17 Canadian Provincial Databases, 259 Yola Moride and Colleen J. Metge 18 Pharmacy-based Medical Record Linkage Systems, 270 Ron M.C. Herings and Lars Pedersen Section C: Ad Hoc Studies—Ongoing Systems for Pharmacoepidemiologic Studies 19 Case–Control Surveillance, 287 Lynn Rosenberg, Patricia F. Coogan, and Julie R. Palmer 20 Prescription–Event Monitoring, 301 Deborah Layton and Saad A.W. Shakir 21 Registries, 331 Nancy A. Dreyer and Priscilla Velentgas Section D: Ad Hoc Studies—De Novo Studies 22 Field Studies, 347 David W. Kaufman Section E: Choosing Among the Available Alternatives 23 How Should One Perform Pharmacoepidemiologic Studies? Choosing Among the Available Alternatives, 364 Brian L. Strom PART IV Selected Special Applications of Pharmacoepidemiology, 377 24 Studies of Drug Utilization, 379 David Lee and Ulf Bergman 25 Evaluating and Improving Physician Prescribing, 402 Sumit R. Majumdar, Helene Levens Lipton, and Stephen B. Soumerai Contents vii 26 Pharmacoepidemiologic Studies of Vaccine Safety, 423 Robert T. Chen, Jason M. Glanz, and Claudia Vellozzi 27 Epidemiologic Studies of Medical Devices: Methodologic Considerations for Implantable Devices, 469 Danica Marinac-Dabic, Sharon-Lise Normand, Art Sedrakyan, and Thomas Gross 28 Studies of Drug-Induced Birth Defects, 487 Allen A. Mitchell 29 Risk Management, 505 Gerald J. Dal Pan, Stella Blackburn, and Claudia Karwoski 30 FDA’s Sentinel Initiative: Active Surveillance to Identify Safety Signals, 534 Judith A. Racoosin, Melissa A. Robb, Rachel E. Sherman, and Janet Woodcock 31 Pharmacoepidemiology and Pharmaceutical Reimbursement Policy, 555 Mitchell Levine and Jacques LeLorier 32 Comparative Effectiveness Research, 561 Brian L. Strom, Rita Schinnar, and Sean Hennessy PART V Selected Special Methodologic Issues in Pharmacoepidemiology, 581 33 Assessing Causality of Case Reports of Suspected Adverse Events, 583 Judith K. Jones 34 Molecular Pharmacoepidemiology, 601 Stephen E. Kimmel, Hubert G. Leufkens, and Timothy R. Rebbeck 35 Bioethical Issues in Pharmacoepidemiologic Research, 623 Antoine C. El Khoury, Jason Karlawish, Elizabeth Andrews, and Arthur Caplan 36 The Use of Randomized Controlled Trials for Pharmacoepidemiologic Studies, 640 Samuel M. Lesko and Allen A. Mitchell 37 The Use of Pharmacoepidemiology to Study Benefi cial Drug Effects, 655 Brian L. Strom and Kenneth L. Melmon 38 Pharmacoeconomics: Economic Evaluation of Pharmaceuticals, 678 Kevin A. Schulman, Henry A. Glick, Daniel Polsky, and Shelby D. Reed 39 Using Quality-of-Life Measurements in Pharmacoepidemiologic Research, 709 Holger Schünemann, Bradley C. Johnston, Roman Jaeschke, and Gordon H. Guyatt 40 The Use of Meta-analysis in Pharmacoepidemiology, 723 Jesse A. Berlin, M. Soledad Cepeda, and Carin J. Kim 41 Validity of Pharmacoepidemiologic Drug and Diagnosis Data, 757 Suzanne L. West, Mary Elizabeth Ritchey, and Charles Poole 42 Studies of Medication Adherence, 795 Trisha Acri and Robert Gross viii Contents 43 Risk Evaluation and Communication, 810 Susan J. Blalock and Betsy L. Sleath 44 Studying Effects of Antibiotics, 827 Darren R. Linkin and Ebbing Lautenbach 45 The Pharmacoepidemiology of Medication Errors, 840 Hanna M. Seidling and David W. Bates 46 Sequential Statistical Methods for Prospective Postmarketing Safety Surveillance, 852 Martin Kulldorff 47 Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies, 868 Sebastian Schneeweiss and Samy Suissa PART VI Conclusion, 893 48 The Future of Pharmacoepidemiology, 895 Brian L. Strom, Stephen E. Kimmel, and Sean Hennessy Appendix A: Sample Size Tables, 904 Appendix B: Glossary, 921 Index, 931 List of Contributors Trisha Acri Jeffrey S. Barrett Jesse A. Berlin Assistant Professor Director Vice President Department of Family and Laboratory for Applied Department of Epidemiology Community Medicine Pharmacokinetics and Johnson& Johnson Pharmaceutical Temple University School of Medicine Pharmacodynamics Research and Development Philadelphia, PA Director Titusville, NJ USA Pediatric Pharmacology Research Unit USA The Children’ s Hospital of Susan E. Andrade Philadelphia Stella Blackburn Senior Research Associate and Research Professor, Pediatrics EMA Risk Management Development Research Associate Professor Kinetic Modeling and Simulation and Scientifi c Lead Meyers Primary Care Institute (KMAS) Core Director European Medicines Agency and Perelman School of Medicine at the London, UK University of Massachusetts Medical University of Pennsylvania School Philadelphia, PA Susan J. Blalock Worcester, MA USA Associate Professor USA Division of Pharmaceutical Outcomes David W. Bates and Policy Elizabeth Andrews Chief Eshelman School of Pharmacy Vice President General Medicine Division University of North Carolina at Pharmacoepidemiology and Risk Brigham and Women’ s Hospital Chapel Hill Management and Chapel Hill, NC Research Triangle Institute Health Professor of Medicine USA Solutions Harvard Medical School Research Triangle Park, NC Boston, MA Denise Boudreau USA USA Scientifi c Investigator Group Health Research Institute Peter Arlett Ulf Bergman Seattle, WA Head Professor, Senior Medical Offi cer USA Pharmacovigilance and Risk Division of Clinical Pharmacology Management Department of Laboratory Medicine Arthur Caplan European Medicines Agency Karolinska Institute Director London, UK WHO Collaborating Centre for Drug Center for Bioethics Utilization Research and Clinical Professor of Medical Ethics Jerry Avorn Pharmacological Services Perelman School of Medicine at the Chief and University of Pennsylvania Division of Pharmacoepidemiology Centre for Pharmacoepidemiology Philadelphia, PA and Pharmacoeconomics Karolinska University USA Brigham and Women’ s Hospital Hospital-Huddinge and Stockholm, Sweden Professor of Medicine Harvard Medical School Boston, MA USA ix x List of Contributors M. Soledad Cepeda Hassy Dattani Nicolle M. Gatto Director Research Director Senior Director Department of Epidemiology Cegedim Strategic Data Medical Epidemiology Johnson& Johnson Pharmaceutical Research Ltd Worldwide Safety Strategy Research and Development London, UK Pfi zer Inc. Titusville, NJ New York, NY USA Robert L. Davis USA Director of Research Robert T. Chen Center for Health Joel M. Gelfand HIV Vaccine and Special Studies Team Research—Southeast Medical Director, Clinical Studies Unit Leader Kaiser Permanente Georgia Assistant Professor of Dermatology Division of HIV/AIDS Prevention Atlanta, GA and Epidemiology Centers for Disease Control and USA Senior Scholar, Center for Clinical Prevention Epidemiology and Biostatistics Atlanta, GA Nancy A. Dreyer Departments of Dermatology and USA Chief of Scientifi c Affairs Biostatistics and Epidemiology Outcome Sciences Inc. Perelman School of Medicine at the Patricia F. Coogan Cambridge, MA University of Pennsylvania Associate Professor of Epidemiology USA Philadelphia, PA Slone Epidemiology Center USA Boston University Antoine C. El Khoury Boston, MA Leader, Outcomes Research Kate Gelperin USA Global Health Outcomes Medical Offi cer Merck & co., Inc Division of Epidemiology Francesca Cunningham West Point, PA Offi ce of Surveillance and Director USA Epidemiology Center for Medication Safety Center for Drug Evaluation and and Chris Feudtner Research Program Manager Associate Professor US Food and Drug Administration Outcomes Research PBM Services Department of Pediatrics Silver Spring, MD Department of Veterans Affairs The Children ’s Hospital of Philadelphia USA Center for Medication Safety Perelman School of Medicine at the Hines, IL University of Pennsylvania Jason M. Glanz USA Philadelphia, PA Epidemiologist USA Institute for Health Research Gerald J. Dal Pan Kaiser Permanente Colorado Director Brian T. Fisher Department of Epidemiology Colorado Offi ce of Surveillance and Assistant Professor of Pediatrics School of Public Health Epidemiology Center for Pediatric Clinical Denver, CO Center for Drug Evaluation and Effectiveness USA Research The Children’ s Hospital of US Food and Drug Administration Philadelphia Henry A. Glick Silver Spring, MA Perelman School of Medicine at the Professor of Medicine USA University of Pennsylvania Perelman School of Medicine at the Philadelphia, PA University of Pennsylvania Gregory W. Daniel USA Philadelphia, PA Vice President USA Government and Academic Research Cristin Palumbo Freeman Healthcore Research Project Manager Alexandria, VA Center for Clinical Epidemiology and USA Biostatistics Perelman School of Medicine at the University of Pennsylvania Philadelphia, PA USA List of Contributors xi Robert Gross Ron M.C. Herings Claudia Karwoski Associate Professor of Medicine and Director Director Epidemiology PHARMO Institute Division of Risk Management Center for Clinical Epidemiology and Utrecht Offi ce of Surveillance and Biostatistics The Netherlands Epidemiology Perelman School of Medicine at the and Center for Drug Evaluation and University of Pennsylvania Associate Professor of Research Philadelphia, PA Pharmacoepidemiology US Food and Drug Administration USA Department of Health Policy and Silver Spring, MA Management USA Thomas Gross Erasmus University Rotterdam Deputy Director Rotterdam, The Netherlands David W. Kaufman Offi ce of Surveillance and Biometrics Associate Director Center for Devices and Radiological Roman Jaeschke Slone Epidemiology Center at Boston Health Professor University US Food and Drug Administration Department of Clinical Epidemiology and Silver Spring, MD and Biostatistics Professor of Epidemiology USA McMaster University Boston University School of Public Health Sciences Center Health Gordon H. Guyatt and Boston, MA Professor Professor USA Department of Clinical Epidemiology Department of Medicine and Biostatistics St Joseph ’s Hospital Aaron S. Kesselheim McMaster University Hamilton Assistant Professor of Medicine Health Sciences Center Ontario, Canada Division of Pharmacoepidemiology and and Pharmacoeconomics Department of Medicine Bradley C. Johnston Department of Medicine St Joseph ’s Hospital Assistant Professor Brigham and Women’ s Hospital Hamilton Department of Clinical Epidemiology Harvard Medical School Ontario, Canada and Biostatistics Boston, MA McMaster University USA Katherine Haffenreffer Health Sciences Center Project Administrator Hamilton Carin J. Kim Harvard Pilgrim Health Care Institute Ontario, Canada Mathematical Statistician and Center for Drug Evaluation and Department of Population Medicine Judith K. Jones Research Harvard Medical School President and CEO US Food and Drug Administration Boston, MA The Degge Group Ltd Silver Spring, MD USA Arlington, VA USA USA Sean Hennessy and Stephen E. Kimmel Associate Professor of Epidemiology Adjunct Professor and Lecturer Professor of Medicine and and of Pharmacology University of Michigan School of Epidemiology Senior Scholar, Center for Clinical Public Health Summer Program Senior Scholar, Center for Clinical Epidemiology and Biostatistics Georgetown University Epidemiology and Biostatistics Perelman School of Medicine at the Washington, DC Perelman School of Medicine at the University of Pennsylvania USA University of Pennsylvania Philadelphia, PA Philadelphia, PA USA Jason Karlawish USA Professor of Medicine Perelman School of Medicine at the Karel Kostev University of Pennsylvania Senior Research Analyst Philadelphia, PA Centre of Excellence Patient Data USA IMS Health GmbH& Co OHG Frankfurt/Main, Germany

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Now in its fifth edition, Pharmacoepidemiology defines the discipline and provides the most comprehensive guidance of any book on the topic. Written by world renowned experts in the field, this valuable text surveys the research designs and sources of data available for pharmacoepidemiologic researc
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