Pharmacoepidemiology

This book is no surprise. The first four editions were excellent and this one continues that tradition of excellence. This is the only book on pharmacoepidemiology that anyone needs. (Doody s, 10 August 2012)

Brian L Strom, MD, MPH, Chair and Professor, Department of Biostatistics and Epidemiology, Director, Center for Clinical Epidemiology and Biostatistics, George S. Pepper Professor of Public Health and Preventive Medicine, Professor of Medicine, Professor of Pharmacology, University of Pennsylvania School of Medicine. Stephen E. Kimmel, MD, MSCE, Associate Professor of Medicine and Epidemiology, University of Pennsylvania School of Medicine, Department of Biostatistics and Epidemiology. Sean Hennessy, PharmD, PhD, Associate Professor of Epidemiology and Pharmacology, University of Pennsylvania School of Medicine, Department of Biostatistics and Epidemiology.

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 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, Sinead 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 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