Cover: Pharmacoepidemiology by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy

Pharmacoepidemiology

Sixth Edition

Edited by

Brian L. Strom MD, MPH

Chancellor, Rutgers Biomedical & Health Sciences
Executive Vice President for Health Affairs
University Professor
Rutgers, the State University of New Jersey
Newark, NJ, USA

Stephen E. Kimmel MD, MSCE

Professor of Medicine and of Epidemiology
Senior Scholar, Center for Clinical Epidemiology and Biostatistics
University of Pennsylvania Perelman School of Medicine
Philadelphia, PA, USA

Sean Hennessy PharmD, PhD

Professor of Epidemiology
Senior Scholar, Center for Clinical Epidemiology and Biostatistics
University of Pennsylvania Perelman School of Medicine
Philadelphia, PA, USA






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Contributors

Trisha Acri
Philadelphia, PA
USA

Paul Avillach
Department of Biomedical Informatics
Harvard Medical School
Boston, MA
USA

Jerry Avorn
Division of Pharmacoepidemiology and Pharmacoeconomics
Department of Medicine
Brigham and Women’s Hospital and Harvard Medical School
Boston, MA
USA

Jeffrey S. Barrett
Bill and Melinda Gates Medical Research Institute
Cambridge, MA
USA

Andrew Bate
Pfizer Ltd
Walton‐on‐the‐Hill, Surrey
UK

David W. Bates
Division of General Internal Medicine and Primary Care
Brigham and Women’s Hospital and Harvard Medical School
Boston, MA
USA

Bernard Bégaud
School of Medicine
University of Bordeaux
Bordeaux
France

Ulf Bergman
Division of Clinical Pharmacology Department of Laboratory Medicine
Centre for Pharmacoepidemiology Karolinska Institute
Karolinska University Hospital‐Huddinge
Stockholm
Sweden

Jesse A. Berlin
Johnson & Johnson
Titusville, NJ
USA

Harshvinder Bhullar
Real‐World Insights, IQVIA
London
UK

Warren B. Bilker
University of Pennsylvania Perelman School of Medicine
Philadelphia, PA
USA

Susan J. Blalock
Division of Pharmaceutical Outcomes and Policy
Eshelman School of Pharmacy
University of North Carolina at Chapel Hill
Chapel Hill, NC
USA

Laura E. Bothwell
Health Sciences Department
Worcester State University
Worcester, MA
USA

Colleen M. Brensinger
University of Pennsylvania Perelman School of Medicine
Philadelphia, PA
USA

Lucy Carty
Clinical Practice Research Datalink
Medicines and Healthcare Products Regulatory Agency
London
UK

Robert T. Chen
Brighton Collaboration
Task Force for Global Health
Decatur, GA
USA

Emil Cochino
European Medicines Agency
Amsterdam
The Netherlands

Brenda J. Crowe
Eli Lilly and Company
Indianapolis, IN
USA

Francesca Cunningham
Pharmacy Benefits Management, and Center for Medication Safety US Department of Veterans Affairs
Hines, IL
USA

Jeffrey R. Curtis
Division of Clinical Immunology & Rheumatology
University of Alabama at Birmingham
Birmingham, AL
USA

Gerald J. Dal Pan
Office of Surveillance and Epidemiology Center for Drug Evaluation and Research
US Food and Drug Administration
Silver Spring, MD
USA

Rebecca Dickinson
School of Health and Community Studies
Leeds Beckett University
Leeds
UK

Rachael L. DiSantostefano
Janssen Research & Development
Titusville, NJ
USA

Nancy A. Dreyer
IQVIA Real‐World & Analytic Solutions
Boston, MA
University of North Carolina at Chapel Hill
Chapel Hill, NC
USA

Scott Evans
Biostatistics Center
The George Washington University
Rockville, MD
USA

Stephen J.W. Evans
Department of Medical Statistics
London School of Hygiene and Tropical Medicine
London
UK

James A. Feinstein
Adult & Child Health Consortium for Health Outcomes Research and Delivery Science University of Colorado School of Medicine
Aurora, CO
USA

Chris Feudtner
Center for Pediatric Clinical Effectiveness and PolicyLab
The Children's Hospital of Philadelphia
Philadelphia, PA
USA

Brian T. Fisher
Division of Infectious Diseases
The Children’s Hospital of Philadelphia
Philadelphia, PA
USA

James H. Flory
Memorial Sloan Kettering Cancer Center
New York, NY
USA

Joshua J. Gagne
Division of Pharmacoepidemiology and Pharmacoeconomics
Department of Medicine
Brigham and Women’s Hospital and Harvard Medical School
Boston, MA, USA

Nicolle M. Gatto
Department of Epidemiology, Worldwide Research and Development
Pfizer, Inc.
New York, NY
USA

Jamie Geier
Department of Epidemiology, Worldwide Research and Development
Pfizer, Inc.
New York, NY
USA

Kate Gelperin
Division of EpidemiologyOffice of Surveillance and Epidemiology
Center for Drug Evaluation and Research
US Food and Drug Administration
Silver Spring, MD
USA

Tobias Gerhard
Rutgers Center for Pharmacoepidemiology and Treatment Science
Rutgers Ernest Mario School of Pharmacy
New Brunswick, NJ
USA

Jason M. Glanz
Institute for Health ResearchKaiser Permanente Colorado
and
Department of EpidemiologyColorado School of Public Health
Denver, CO
USA

Jeremy A. Greene
Department of the History of Medicine
The Johns Hopkins University School of Medicine
Baltimore, MD
USA

Robert Gross
Departments of Medicine (ID) and Epidemiology/Biostatistics/Informatics
Center for Clinical Epidemiology and Biostatistics
University of Pennsylvania Perelman School of Medicine
Philadelphia, PA
USA

Thomas P. Gross
Office of Surveillance and Biometrics
Center for Devices and Radiological HealthUS Food and Drug Administration
Silver Spring, MD
USA

Sean Hennessy
Center for Clinical Epidemiology and BiostatisticsUniversity of Pennsylvania Perelman School of Medicine
Philadelphia, PA
USA

Sonia Hernandez‐Diaz
Department of EpidemiologyHarvard T.H. Chan School of Public Health
Boston, MA
USA

Daniel B. Horton
Department of PediatricsRutgers Robert Wood Johnson Medical School
Rutgers Center for Pharmacoepidemiology and Treatment Science
New Brunswick, NJ
USA

Krista F. Huybrechts
Division of Pharmacoepidemiology and PharmacoeconomicsDepartment of Medicine
Brigham and Women's Hospital and Harvard Medical School
Boston, MA
USA

Judith K. Jones
PharmaLex, Inc.
Fairfax, VA
University of Michigan School of Public Health Summer Program
Ann Arbor, MI
Georgetown University School of Medicine
Washington, DC
USA

Aaron S. Kesselheim
Program On Regulation, Therapeutics, And Law (PORTAL)
Division of Pharmacoepidemiology and PharmacoeconomicsDepartment of Medicine
Brigham and Women’s Hospital and Harvard Medical School
Boston, MA
USA

Stephen E. Kimmel
Center for Clinical Epidemiology and Biostatistics
University of Pennsylvania Perelman School of Medicine
Philadelphia, PA
USA

Elyse Kingery
Degge Group, Ltd., a PharmaLex Company
Fairfax, VA
USA

Olaf Klungel
Division of Pharmacoepidemiology & Clinical Pharmacology
Utrecht Institute for Pharmaceutical Sciences (UIPS) Utrecht University
Utrecht
The Netherlands

Peter Knapp
Department of Health Sciences and the Hull York Medical School
University of York
York
UK

Cynthia Kornegay
Division of EpidemiologyOffice of Surveillance and Epidemiology
Center for Drug Evaluation and Research
US Food and Drug Administration
Silver Spring, MD
USA

Tamar Lasky
Office of Biostatistics and EpidemiologyCenter for Biologics Evaluation and Research
US Food and Drug Administration
Silver Spring, MD
USA

Julie Lauffenburger
Division of Pharmacoepidemiology and Pharmacoeconomics and Center for Healthcare Delivery Sciences
Brigham and Women’s Hospital and Harvard Medical School
Boston, MA
USA

David Lee
Pharmaceuticals and Health Technologies GroupManagement Sciences for Health
Arlington, VA
USA

Charles E. Leonard
University of Pennsylvania Perelman School of Medicine
Philadelphia, PA
USA

Samuel M. Lesko
Northeast Regional Cancer Institute
Scranton, PA
USA

Bennett Levitan
Department of Epidemiology
Janssen Research & Development
Titusville, NJ
USA

James D. Lewis
Department of Medicine Division of Gastroenterology
Department of Biostatistics, Epidemiology, and InformaticsPerelman School of Medicine University of Pennsylvania
Philadelphia, PA
USA

Peter K. Lindenauer
Center for Quality of Care Research
Baystate Medical Center
Springfield, MA
USA

Marie Lindquist
Uppsala Monitoring Centre
WHO Collaborating Centre for International Drug Monitoring
Uppsala
Sweden

Helene Lipton
School of Medicine and Pharmacy
University of California at San Francisco
San Francisco, CA
USA

Christine Y. Lu
Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute
Boston, MA
USA

Ana Filipa Macedo
Real‐World Evidence Solutions Division
QuintilesIMS
Madrid
Spain

Sumit R. Majumdar (deceased)
Formerly of Department of MedicineFaculty of Medicine and Dentistry
University of Alberta
Edmonton, Alberta
Canada

George Maldonado
Division of Environmental Health Sciences School of Public Health
University of Minnesota
Minneapolis, MN
USA

Claudia Manzo
Office of Surveillance and Epidemiology Center for Drug Evaluation and Research
US Food and Drug Administration
Silver Spring, MD
USA

Danica Marinac‐Dabic
Office of Clinical Evidence and Analysis
Center for Devices and Radiological Health US Food and Drug Administration
Silver Spring, MD
USA

Giampiero Mazzaglia
European Medicines Agency
Amsterdam
The Netherlands

Jana McAninch
Division of Epidemiology
Office of Surveillance and Epidemiology Center for Drug Evaluation and Research
US Food and Drug Administration
Silver Spring, MD
USA

Kenneth L. Melmon (deceased)
Formerly of Stanford University School of Medicine
Stanford, CA
USA

Lubna Merchant
Office of Surveillance and EpidemiologyCenter for Drug Evaluation and Research
US Food and Drug Administration
Silver Spring, MD
USA

Allen A. Mitchell
Slone Epidemiology Center at Boston University
Boston, MA
USA

Jingping Mo
Department of Epidemiology, Worldwide Research and Development
Pfizer, Inc.
New York, NY
USA

Esi M. Morgan
Department of PediatricsDivision of RheumatologyCincinnati Children’s Hospital Medical Center
University of Cincinnati College of Medicine
Cincinnati, OH
USA

Yola Moride
Faculty of Pharmacy Université de Montréal
Montreal, Quebec
Canada
Rutgers Center for Pharmacoepidemiology and Treatment Science
New Brunswick, NJ
USA

Sharon‐Lise Normand
Department of Health Care PolicyHarvard Medical School
and
Department of Biostatistics Harvard T.H. Chan School of Public Health
Boston, MA
USA

Alexis Ogdie
University of Pennsylvania Perelman School of Medicine
Philadelphia, PA
USA

Vicki Osborne
Drug Safety Research Unit
Southampton
UK

Robert W. Platt
Departments of Epidemiology, Biostatistics, and Occupational Health, and of Pediatrics
McGill University
Montreal, Quebec
Canada

Anton Pottegård
Clinical Pharmacology and Pharmacy Department of Public Health
University of Southern Denmark
Odense
Denmark

Nicole Pratt
Quality Use of Medicines and Pharmacy Research Centre
School of Pharmacy and Medical Sciences
University of South Australia
Adelaide, South Australia
Australia

June Raine
Medicines and Healthcare Products Regulatory Agency
London
UK

Robert F. Reynolds
Department of Epidemiology Global Medical Value, Evidence and Outcomes
GlaxoSmithKline
Upper Providence, PA
USA

Annika Richterich
Faculty of Arts & Social Sciences
Maastricht University
Maastricht
The Netherlands

Mary Elizabeth Ritchey
RTI Health Solutions
RTI International
Research Triangle Park, NC
USA

Sebastian Schneeweiss
Harvard Medical School
Harvard T.H. Chan School of Public Health
Division of Pharmacoepidemiology Department of Medicine
Brigham and Women’s Hospital
Boston, MA
USA

Kevin A. Schulman
Clinical Excellence Research Center
Department of Medicine
Stanford University
Stanford, CA
USA

Alex Secora
Division of Epidemiology
Office of Surveillance and EpidemiologyCenter for Drug Evaluation and Research
US Food and Drug Administration
Silver Spring, MD
USA

Art Sedrakyan
Weill Cornell Medical College
New York, NY
USA

Hanna M. Seidling
Division of General Internal Medicine and Primary Care
Brigham and Women’s Hospital and Harvard Medical School
Boston, MA
USA
Department of Clinical Pharmacology and Pharmacoepidemiology
Cooperation Unit Clinical Pharmacy University Hospital Heidelberg
Heidelberg
Germany

Soko Setoguchi
Rutgers Robert Wood Johnson Medical School
Rutgers Center for Pharmacoepidemiology and Treatment Science
New Brunswick, NJ
USA

Saad A.W. Shakir
Drug Safety Research Unit
Southampton
UK

Tom T. Shimabukuro
Immunization Safety Office Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention
Atlanta, GA
USA

Rachel E. Sobel
Department of Epidemiology, Worldwide Research and Development
Pfizer, Inc.
New York, NY
USA

Stephen B. Soumerai
Department of Population Medicine
Harvard Medical School and Harvard Pilgrim Health Care Institute
Boston, MA
USA

Tjeerd P. van Staa
Health eResearch Centre
University of Manchester
Manchester
UK

Judy Staffa
Office of Surveillance and Epidemiology Center for Drug Evaluation and Research
US Food and Drug Administration
Silver Spring, MD
USA

Brian L. Strom
Rutgers Center for Pharmacoepidemiology and Treatment Science
Rutgers Biomedical and Health Sciences
Newark, NJ
USA

Samy Suissa
McGill University
Centre for Clinical Epidemiology
Lady Davis Research Institute – Jewish General Hospital
Montreal, Quebec
Canada

Janet Sultana
Department of Biomedical and Dental Sciences and Morphofunctional Imaging University of Messina
Messina
Italy

Sengwee Toh
Department of Population Medicine
Harvard Medical School and Harvard Pilgrim Health Care Institute
Boston, MA
USA

Gianluca Trifirò
Department of Biomedical and Dental Sciences and Morphofunctional Imaging University of Messina
Messina
Italy

Shinobu Uzu
Pharmaceuticals and Medical Devices Agency
Tokyo
Japan

Priscilla Velentgas
IQVIA, Real‐World Insights
Cambridge, MA
USA

Vera Vlahović‐Palčevski
Department of Clinical PharmacologyUniversity Hospital Rijeka
Department of PharmacologyUniversity of Rijeka Medical Faculty
Department of Basic Medical Sciences Faculty of Health Studies
Rijeka
Croatia

Kerstin N. Vokinger
Program On Regulation, Therapeutics, And Law (PORTAL)
Division of Pharmacoepidemiology and Pharmacoeconomics
Department of Medicine
Brigham and Women’s HospitalHarvard Medical School
Boston, MA
USA

Suzanne L. West
RTI InternationalResearch Triangle Park, NC
Department of EpidemiologyGillings School of Global Public Health
University of North Carolina
Chapel Hill, NC
USA

Björn Wettermark
Division of Clinical PharmacologyDepartment of Laboratory Medicine
Centre for PharmacoepidemiologyKarolinska Institute
Karolinska University Hospital‐Huddinge
Stockholm
Sweden

Ian Chi Kei Wong
Department of Pharmacology and Pharmacy University of Hong Kong
Hong Kong
UCL School of Pharmacy
London
UK

H. Amy Xia
Amgen, Inc.
Thousand Oaks, CA
USA