Pharmacoepidemiology

Contributors x
 
Preface xix
 
Acknowledgments xxiii
 
Part I Introduction 1
 
1 What is Pharmacoepidemiology? 3
Brian L. Strom
 
2 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies 27
Jeffrey S. Barrett
 
3 Basic Principles of Clinical Epidemiology Relevant to Pharmacoepidemiologic Studies 44
Brian L. Strom
 
4 Sample Size Considerations for Pharmacoepidemiologic Studies 60
Brian L. Strom
 
5 When Should One Perform Pharmacoepidemiologic Studies? 71
Brian L. Strom
 
Part II The Role of Pharmacoepidemiology in Different Sectors 81
 
6 The Role of Pharmacoepidemiology in the Healthcare System and Academia 83
Joshua J. Gagne and Jerry Avorn
 
7 The Role of Pharmacoepidemiology in Industry 98
Nicolle M. Gatto, Rachel E. Sobel, Jamie Geier, Jingping Mo, Andrew Bate, and Robert F. Reynolds
 
8 The Role of Pharmacoepidemiology in Regulatory Agencies 126
Gerald J. Dal Pan, June Raine, and Shinobu Uzu
 
9 Pharmacoepidemiology and the Law 140
Aaron S. Kesselheim and Kerstin N. Vokinger
 
Part III Sources of Data for Pharmacoepidemiology Research 165
 
Part IIIa Spontaneous Reporting 167
 
10 Postmarketing Spontaneous Pharmacovigilance Reporting Systems 169
Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin
 
Part IIIb Electronic Data Systems 203
 
11 Overview of Electronic Databases in Pharmacoepidemiology 205
Brian L. Strom
 
12 Encounter Databases 211
Tobias Gerhard, Yola Moride, Anton Pottegård , and Nicole Pratt
 
13 Electronic Health Record Databases 241
Daniel B. Horton, Harshvinder Bhullar, Lucy Carty, Francesca Cunningham, Alexis Ogdie, Janet Sultana, and Gianluca Trifiro
 
14 Inpatient Databases 290
James A. Feinstein, Peter K. Lindenauer, Chris Feudtner, and Brian T. Fisher
 
Part IIIc Studies Involving Ad Hoc Data Collection 305
 
15 Event Monitoring in

The Editors
 
Brian L. Strom is Chancellor, Rutgers Biomedical and Health Sciences and Executive Vice President for Health Affairs, Rutgers University, Newark, NJ, USA.
 
Stephen E. Kimmel is Professor of Medicine and Director of the Division of Epidemiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
 
Sean Hennessy is Professor of Epidemiology and Director of the Center for Pharmacoepidemiology Research and Training, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.