Cover
Contributors
Preface
Acknowledgments
Part I: Introduction
1. 1 What Is Pharmacoepidemiology?
  1. Definition of Pharmacoepidemiology
  2. Historical Background
  3. The Current Drug Approval Process
  4. Potential Contributions of Pharmacoepidemiology
  5. References
2. 2 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies
  1. Clinical Pharmacology and Pharmacoepidemiology
  2. Basics of Clinical Pharmacology
  3. Pharmacokinetics
  4. Special Populations
  5. Pharmacodynamics
  6. Pharmacogenomics
  7. Model‐Informed Drug Development
  8. Conclusion
  9. References
3. 3 Basic Principles of Clinical Epidemiology Relevant to Pharmacoepidemiologic Studies
  1. Overview of the Scientific Method
  2. Types of Errors That One Can Make in Performing a Study
  3. Criteria for the Causal Nature of an Association
  4. Epidemiologic Study Designs
  5. Discussion
  6. Conclusion
  7. References
4. 4 Sample Size Considerations for Pharmacoepidemiologic Studies
  1. Sample Size Calculations for Cohort Studies
  2. Sample Size Calculations for Case–Control Studies
  3. Sample Size Calculations for Case Series
  4. Discussion
  5. References
5. 5 When Should One Perform Pharmacoepidemiologic Studies?
  1. Reasons to Perform Pharmacoepidemiologic Studies
  2. Safety versus Risk
  3. Risk Tolerance
  4. Conclusion
  5. References
Part II: The Role of Pharmacoepidemiology in Different Sectors
1. 6 The Role of Pharmacoepidemiology in the Healthcare System and Academia
  1. The Drug Approval Process
  2. Prescribing Practices
  3. Evaluation of Patients’ Use of Drugs in the Healthcare System
  4. Assessment of the Quality and Outcomes of Medication Use in Populations
  5. Policy Analysis
  6. Interventional Pharmacoepidemiology
  7. Economic Assessment of Medication‐Related Issues
  8. The Academic Medical Center
  9. Consortia of Academic Medical Center Programs for Pharmacoepidemiologic Research
  10. The Future
  11. References
  12. Further Reading
2. 7 The Role of Pharmacoepidemiology in Industry
  1. Regulatory and Industry Focus on Risk Management and Epidemiology
  2. Epidemiology in Drug Safety Evaluation
  3. Epidemiology in Evaluation of Risk Mitigation Interventions
  4. Big Data and the Future of Pharmacoepidemiology
  5. Conclusions
  6. References
3. 8 The Role of Pharmacoepidemiology in Regulatory Agencies
  1. The Scope of Pharmacoepidemiology throughout the Medicinal Product Life Cycle
  2. Advancing the Science of Pharmacoepidemiology
  3. References
4. 9 Pharmacoepidemiology and the Law
  1. Tort Law and Product Liability Lawsuits
  2. The Effect of Regulation on Product Liability Litigation in the US
  3. Product Liability Law in Europe
  4. Pharmacoepidemiology and Contract Law
  5. Pharmacoepidemiology and Intellectual Property Law
  6. Intellectual Property Law in Europe
  7. Conclusion
  8. References
Part III: Sources of Data for Pharmacoepidemiology Research
Part IIIa: Spontaneous Reporting
1. 10 Postmarketing Spontaneous Pharmacovigilance Reporting Systems
  1. Description
  2. Strengths
  3. Limitations
  4. Particular Applications
  5. The Future
  6. References
Part IIIb: Electronic Data Systems
1. 11 Overview of Electronic Databases in Pharmacoepidemiology
  1. Description
  2. Strengths
  3. Weaknesses
  4. Particular Applications
  5. The Future
2. 12 Encounter Databases
  1. Description
  2. Strengths
  3. Limitations
  4. Particular Applications
  5. The Future
  6. References
3. 13 Electronic Health Record Databases
  1. Description
  2. Strengths
  3. Limitations
  4. Particular Applications
  5. The Future
  6. References
4. 14 Inpatient Databases
  1. Description
  2. Strengths
  3. Weaknesses
  4. Particular Applications
  5. The Future
  6. References
Part IIIc: Studies Involving Ad Hoc Data Collection
1. 15 Event Monitoring in the UK
  1. Description
  2. Strengths
  3. Limitations
  4. Particular Applications
  5. The Future
  6. References
2. 16 Primary Data Collection for Pharmacoepidemiology
  1. Introduction
  2. Description
  3. Strengths
  4. Limitations
  5. Particular Applications
  6. The Future
  7. References
Part IIId: Choosing a Data Source
1. 17 Choosing among the Available Data Sources for Pharmacoepidemiology Research
  1. Choosing among the Available Approaches to Pharmacoepidemiologic Studies
  2. Examples
  3. Conclusion
  4. References
Part IV: Selected Applications of Pharmacoepidemiology
1. 18 Studies of Drug Utilization
  1. Historical Background
  2. Definitions
  3. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  4. Methodologic Problems to Be Solved by Pharmacoepidemiologic Research
  5. Currently Available Solutions
  6. The Future
  7. References
2. 19 Evaluating and Improving Physician Prescribing
  1. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  2. Methodologic Problems to Be Addressed by Pharmacoepidemiologic Research
  3. Conceptual Framework for Changing Clinical Behaviors
  4. Empirical Evidence on the Effectiveness of Interventions to Improve Prescribing
  5. The Future
  6. References
3. 20 Pharmacoepidemiologic Studies of Vaccine Safety
  1. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  2. Methodologic Problems to Be Addressed by Pharmacoepidemiologic Research
  3. Currently Available Solutions
  4. The Future
  5. References
4. 21 Epidemiologic Studies of Medical Devices: Methodologic Considerations for Implantable Devices
  1. What Is a Medical Device and How Is It Different from a Drug?
  2. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  3. Methodologic Problems to Be Addressed by Pharmacoepidemiologic Research
  4. Currently Available Solutions
  5. The Future
  6. Appendix: Simultaneously Combining All Available Evidence
  7. References
5. 22 Research on the Effects of Medications in Pregnancy and in Children
  1. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  2. Methodological Problems to Be Solved by Pharmacoepidemiologic Research
  3. Currently Available Solutions
  4. The Future
  5. References
6. 23 Study of Biologics and Biosimilars
  1. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  2. Currently Available Solutions: Methodologic Problems to Be Solved by Pharmacoepidemiologic Research
  3. The Future
  4. References
7. 24 Risk Management
  1. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  2. Risk Management Activities
  3. Methodologic Problems to Be Addressed by Pharmacoepidemiologic Research
  4. Currently Available Solutions
  5. The Future
  6. References
8. 25 Distributed Networks of Databases Analyzed Using Common Protocols and/or Common Data Models
  1. Examples of Distributed Data Networks in Pharmacoepidemiology
  2. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  3. Methodologic Problems to Be Addressed by Pharmacoepidemiologic Research
  4. Challenges in Distributed Data Networks
  5. Currently Available Solutions
  6. The Future
  7. References
9. 26 Comparative Effectiveness Research
  1. Comparative Effectiveness Research in the US
  2. CER in Europe and Other Countries
  3. Efficacy vs. Effectiveness
  4. Definitions, Key Components, and Goals of CER
  5. CER and Pharmacoepidemiology
  6. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  7. Methodologic Problems to Be Solved by Pharmacoepidemiologic Research
  8. Currently Available Solutions
  9. The Future
  10. References
10. 27 Data Mining and Other Informatics Approaches to Pharmacoepidemiology
  1. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  2. Methodologic Problems to Be Solved by Pharmacoepidemiologic Research
  3. Currently Available Solutions
  4. The Future
  5. References
11. 28 Pharmacoepidemiologic Research on Drugs of Abuse
  1. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  2. Methodologic Problems to Be Solved by Pharmacoepidemiologic Research
  3. Currently Available Solutions
  4. The Future
  5. References
Part V: Selected Special Methodologic Issues in Pharmacoepidemiology
1. 29 Assessing Causation from Case Reports
  1. Understanding Potential Causal Relationships Supports Clinical and Regulatory Evaluations and Actions
  2. Historical Perspectives
  3. Unstructured Clinical Judgment/Global Introspection
  4. Algorithm/Criterial Method with Verbal Judgments
  5. Algorithms Requiring Scoring of Individual Judgments
  6. Probabilistic Methods
  7. Comparison Among the Different Methods for Causality Assessment
  8. The Future
  9. References
2. 30 Molecular Pharmacoepidemiology
  1. Genetic Variability in Drug Response: Historical Perspective
  2. Definitions and Concepts
  3. The Interface of Pharmacogenetics and Pharmacogenomics with Molecular Pharmacoepidemiology
  4. Clinical Problems to be Addressed by Pharmacoepidemiologic Research
  5. Some Examples of the Progression and Clinical Application of Molecular Pharmacoepidemiology
  6. Methodologic Problems to be Addressed by Pharmacoepidemiologic Research
  7. Currently Available Solutions
  8. The Future
  9. References
3. 31 Bioethical Issues in Pharmacoepidemiologic Research
  1. Clinical Problems to be Addressed by Pharmacoepidemiologic Research
  2. Methodologic Problems to be Solved by Pharmacoepidemiologic Research
  3. Currently Available Solutions
  4. The Future
  5. References
  6. Further Reading
4. 32 The Use of Randomized Controlled Trials in Pharmacoepidemiology
  1. Clinical Problems to be Addressed by Pharmacoepidemiologic Research
  2. Methodologic Problems to be Solved by Pharmacoepidemiologic Research
  3. When is a LST Appropriate?
  4. When is an LST Feasible?
  5. Logistics of Conducting a LST
  6. Analysis
  7. LSTs in Practice: Two Case Studies
  8. Large Simple Trials Using Routine, Electronic Data Capture in Healthcare Systems
  9. The Future
  10. References
5. 33 The Use of Pharmacoepidemiology to Study Beneficial Drug Effects
  1. Definitions
  2. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  3. Methodologic Problems To Be Addressed by Pharmacoepidemiologic Research
  4. Currently Available Solutions
  5. The Future
  6. References
6. 34 Pharmacoeconomics: The Economics of Pharmaceuticals
  1. Clinical Problems to Be Solved by Pharmacoepidemiologic Research
  2. The Economics of Pharmaceutical Products
  3. Health Economics
  4. Currently Available Solutions
  5. Methodologic Issues in the Pharmacoeconomic Assessment of Therapies
  6. Currently Available Solutions: Imatinib Case Study
  7. The Future
  8. Conclusion
  9. References
7. 35 Benefit–Risk Assessments of Medical Treatments
  1. Clinical Problems to be Addressed by Pharmacoepidemiologic Research
  2. Methodologic Problems to be Addressed by Pharmacoepidemiologic Research
  3. Currently Available Solutions
  4. The Future
  5. Conclusion
  6. References
8. 36 The Use of Metaanalysis in Pharmacoepidemiology
  1. Definitions and Rationale
  2. Clinical Problems to be Addressed by Pharmacoepidemiologic Research
  3. Methodologic Problems to be Solved by Pharmacoepidemiologic Research
  4. Currently Available Solutions
  5. The Future
  6. References
9. 37 Validity of Drug and Diagnosis Data in Pharmacoepidemiology
  1. Clinical Problems to be Addressed by Pharmacoepidemiologic Research
  2. Methodologic Problems to be Solved by Pharmacoepidemiologic Research
  3. Currently Available Solutions
  4. The Future
  5. References
10. 38 Studies of Medication Adherence
  1. Clinical Problems Addressed by Pharmacoepidemiologic Research
  2. Methodologic Problems to be Solved by Pharmacoepidemiologic Research
  3. Currently Available Solutions
  4. Future Directions
  5. References
11. 39 Risk Evaluation and Communication
  1. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  2. Methodologic Problems to Be Addressed by Pharmacoepidemiologic Research
  3. Currently Available Solutions
  4. The Future
  5. References
12. 40 Methods for Studying the Health Effects of Drug–Drug Interactions
  1. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  2. Methodologic Problems to Be Addressed by Pharmacoepidemiologic Research
  3. Currently Available Solutions
  4. The Future
  5. Acknowledgments
  6. References
13. 41 The Pharmacoepidemiology of Medication Errors
  1. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  2. Methodologic Problems to Be Addressed by Pharmacoepidemiologic Research
  3. Currently Available Solutions
  4. The Future
  5. References
14. 42 Patient Engagement and Patient‐Reported Outcomes
  1. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  2. Methodologic Problems to Be Solved by Pharmacoepidemiologic Research
  3. Currently Available Solutions
  4. The Future
  5. head-3-424
  6. References
15. 43 Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies
  1. Clinical Problems to Be Addressed by Pharmacoepidemiologic Research
  2. Methodologic Problems to Be Addressed by Pharmacoepidemiologic Research
  3. Currently Available Solutions
  4. The Future
  5. References
Part VI: Conclusion
1. 44 The Future of Pharmacoepidemiology
  1. The View from Academia
  2. The View from Industry
  3. The View from Regulatory Agencies
  4. The View from the Law
  5. Conclusion
  6. References
Appendix A: Sample Size Tables
Appendix B: Glossary
1. References
Index
End User License Agreement

List of Tables

Chapter 1
1. Table 1.1 Potential contributions of pharmacoepidemiology.
Chapter 2
1. Table 2.1 Physiologic systems affected during aging that influence drug pharm...
2. Table 2.2 FDA categories of drug safety during pregnancy.
Chapter 3
1. Table 3.1 Types of associations between factors under study.
2. Table 3.2 Approaches to controlling confounding.
3. Table 3.3 Criteria for the causal nature of an association.
4. Table 3.4 Advantages and disadvantages of epidemiologic study designs.
5. Table 3.5 Epidemiologic study designs.
Chapter 4
1. Table 4.1 Information needed to calculate a study’s sample size.
2. Table 4.2 Examples of sample sizes needed for a cohort study.
3. Table 4.3 Examples of sample sizes needed for a case–control study.
Chapter 5
1. Table 5.1 Reasons to perform pharmacoepidemiologic studies.
2. Table 5.2 Factors affecting the acceptability of risks.
3. Table 5.3 Annual risks of death from some selected hazards.
Chapter 9
1. Table 9.1 Bradford Hill criteria.
2. Table 9.2 Potentially objectionable language in research contracts for pharma...
Chapter 12
1. Table 12.1 Database characteristics^a
Chapter 13
1. Table 13.1 Overview of EHR databases.
2. Table 13.2 Selected variables in EHR databases available for epidemiologic re...
3. Table 13.3 Examples of studies using EHR databases
Chapter 14
1. Table 14.1 Examples of common data elements.
2. Table 14.2 Comparison of selected inpatient databases that contain medication...
3. Table 14.3 Comparison of demographic variables from a pediatric AML cohort cr...
Chapter 15
1. Table 15.1 Incidence densities (ID per 1000 patient‐months) for standard PEM ...
2. Table 15.2 Incidence densities (ID per 1000 patient‐months) for standard PEM ...
3. Table 15.3 Design and applications of event monitoring methods.
Chapter 17
1. Table 17.1 Comparative characteristics of pharmacoepidemiologic data resource...
2. Table 17.2 Characteristics of research questions and their impact on the choi...
Chapter 18
1. Table 18.1 Anatomic Therapeutic Chemical (ATC) and Iowa Drug Information Syst...
2. Table 18.2 World Health Organization/International Network for the Rational U...
Chapter 20
1. Table 20.1 Variables determining the extent of bias attributable to confoundi...
2. Table 20.2 Types of adverse event following immunization (AEFI) by cause.
3. Table 20.3 Reporting efficiencies^* for selected outcomes, two passive surveil...
Chapter 21
1. Table 21.1 International definitions of medical device.
2. Table 21.2 Characteristics of medical devices as compared to drugs (US regula...
3. Table 21.3 Selected examples of strategically coordinated registry networks (...
Chapter 23
1. Table 23.1 Examples of biologics, their mechanism of action, and FDA‐approved...
Chapter 24
1. Table 24.1 Factors the US Food and Drug Administration must consider when det...
2. Table 24.2 Risk evaluation and mitigation strategies in the US: elements to a...
3. Table 24.3 Goals of the Alemtuzumab risk evaluation and mitigation strategy (...
Chapter 25
1. Table 25.1 Select examples of distributed data networks in pharmacoepidemiolo...
2. Table 25.2 Select examples of studies conducted within distributed data netwo...
3. Table 25.3 Strengths and limitations of various structures of distributed dat...
Chapter 26
1. Table 26.1 Definitions of comparative effectiveness research and health techn...
2. Table 26.2 Attributes and corresponding goals of comparative effectiveness re...
Chapter 27
1. Table 27.1 Harmonization process for the identification of medical events in ...
Chapter 30
1. Table 30.1 Hypothetical response to medications by genetic variants in metabo...
2. Table 30.2 Two ways to present effect modification in molecular pharmacoepide...
3. Table 30.3 Gene–exposure interaction analysis in a case–control study.
Chapter 32
1. Table 32.1 Typical design characteristics of a large simple trial (LST) compa...
Chapter 33
1. Table 33.1 Examples of factors determining drug efficacy that were demonstrat...
2. Table 33.2 Classification of research questions according to their problems o...
Chapter 34
1. Table 34.1 Perception of value to the patient.
2. Table 34.2 Pharmaceutical market under conditions of supply‐side moral hazard...
3. Table 34.3 Pharmaceutical market under conditions of market power.
4. Table 34.4 Resource costs for the economic analysis.
Chapter 35
1. Table 35.1 Steps in the BRAT benefit–risk framework.
2. Table 35.2 Effects table for atrial fibrillation (simulated data). All outcom...
3. Table 35.3 Example desirability of outcome rankings (DOORs) for an anticoagul...
Chapter 37
1. Table 37.1 Validation of NSAID exposure in studies using questionnaires.
2. Table 37.2 Validation of myocardial infarction (MI) or gastrointestinal (GI) ...
3. Table 37.3 Validation of myocardial infarction (MI) and gastrointestinal (GI)...
Chapter 39
1. Table 39.1 FDA Action Plan criteria for defining useful consumer medication i...
Chapter 40
1. Table 40.1 Pharmacoepidemiologic designs used to study health effects of pote...
Chapter 43
1. Table 43.1 Hypothetical data for 10 subjects with ventricular tachycardia inc...
2. Table 43.2 Illustration of a case–time–control analysis of data from a case–c...
3. Table 43.3 Selected examples of instrumental variable analyses in clinical ep...
Appendix A
1. Table A1 Sample sizes for cohort studies.
2. Table A2 Sample size for cohort studies.
3. Table A3 Sample sizes for cohort studies.
4. Table A4 Sample sizes for cohort studies.
5. Table A5 Sample sizes for cohort studies.
6. Table A6 Sample sizes for cohort studies.
7. Table A7 Sample sizes for cohort studies.
8. Table A8 Sample sizes for cohort studies.
9. Table A9 Sample sizes for case–control studies.
10. Table A10 Sample sizes for case–control studies.
11. Table A11 Sample size for case–control studies.
12. Table A12 Sample sizes for case–control studies.
13. Table A13 Sample sizes for case–control studies.
14. Table A14 Sample sizes for case–control studies.
15. Table A15 Sample sizes for case–control studies.
16. Table A16 Sample sizes for case–control studies.
17. Table A17 Tabular values of 95% confidence limit factors for estimates of a P...

List of Illustrations

Chapter 2
1. Figure 2.1 Relationship between clinical pharmacology and pharmacoepidemiolo...
2. Figure 2.2 Semi‐logarithmic plot of concentration vs. time after an intraven...
3. Figure 2.3 Representative pharmacodynamic relationships for drugs that exhib...
4. Figure 2.4 (A) Concentration–time, (B) hysteresis, and (C) effect–concentrat...
5. Figure 2.5 The model‐informed drug development (MIDD) approach learns and co...
Chapter 3
1. Figure 3.1 Overview of the scientific method.
2. Figure 3.2 Cohort and case–control studies provide similar information, but ...
Chapter 7
1. Figure 7.1 Harnessing the power of real‐world evidence: Pharmacoepidemiology...
2. Figure 7.2 A closer look at the Xeljanz® (tofacitinib) postapproval Corrona ...
Chapter 14
1. Figure 14.1 Temporal trends in (A) diagnosis and (B) treatment of VTE.
2. Figure 14.2 Variation in (A) corticosteroid and (B) NSAID use among hospital...
Chapter 15
1. Figure 15.1 Comparison of M‐PEM and SCEM study designs.
2. Figure 15.2 The event monitoring process. *RAIDAR, Rare and Iatrogenic Adver...
3. Figure 15.3 Green Form for the PEM study on Celebrex (celecoxib).
4. Figure 15.4 Questionnaire for the M‐PEM study on Prexige (lumiracoxib).
5. Figure 15.5 Reports of gynecomastia during treatment with finasteride.
Chapter 18
1. Figure 18.1 Lorenz curve for insulin use. The graph shows the proportion of ...
2. Figure 18.2 Visual correlates of various measures of insulin use. Hypothetic...
3. Figure 18.3 DU90% (number of substances accounting for 90% of the volume in ...
4. Figure 18.4 Adherence to “Wise List” recommendations for 156 primary healthc...
5. Figure 18.5 DU90% profile for “antibacterial for systemic use” (J01, ATC/DDD...
Chapter 19
1. Figure 19.1 Example of a strong time‐series design that controlled for histo...
2. Figure 19.2 Trend in number of (○) medical and (□) lay press citations on as...
3. Figure 19.3 Rates of (A) antidepressant use and (B) psychotropic drug poison...
Chapter 20
1. Figure 20.1 Three theoretical models of the temporal relationship between im...
2. Figure 20.2 “2 × 2” table necessary for epidemiologic analysis of causality ...
Chapter 21
1. Figure 21.1 Hypothetical funnel plot. In this hypothetical funnel plot from ...
Chapter 23
1. Figure 23.1 Examples of the molecular constructs for several biologics used ...
Chapter 24
1. Figure 24.1 Sources of risk from medical products.
Chapter 26
1. Figure 26.1 Schematic representation of overlap between pharmacoepidemiology...
Chapter 27
1. Figure 27.1 Signal stages after product approval and launch.
2. Figure 27.2 Example of a process for signal substantiation through proteins....
Chapter 28
1. Figure 28.1 Ascertaining exposure and outcomes in studies of pharmaceutical ...
Chapter 29
1. Figure 29.1 Diagram depicting the dilemma for determining causation of an ev...
2. Figure 29.2 A critical scored algorithm illustrated by the method of Naranjo...
3. Figure 29.3 The basic equations for the Bayesian analysis of suspected drug‐...
Chapter 34
1. Figure 34.1 The three dimensions of economic evaluation of clinical care....
2. Figure 34.2 Cost and clinical outcomes.
3. Figure 34.3 Bootstrap scatter plot of 1000 population‐level simulations on a...
4. Figure 34.4 Tornado plot of the effects of multiple one‐way sensitivity anal...
5. Figure 34.5 Specialty pharmaceuticals and premiums.
Chapter 35
1. Figure 35.1 Example value trees for treatment of atrial fibrillation. (A) En...
2. Figure 35.2 Relative importance to US patients of key treatment‐related bene...
3. Figure 35.3 Forest plot showing rate differences per 10 000 person‐years for...
4. Figure 35.4 Forest plot for key benefits and harms in atrial fibrillation tr...
5. Figure 35.5 Output of multicriteria decision analysis (MCDA) model for natal...
6. Figure 35.6 Demonstration of the impact of dependencies between outcomes. Bo...
Chapter 36
1. Figure 36.1 Funnel plot for published studies only: analysis of data from De...
2. Figure 36.2 Funnel plot for published studies (open boxes) and unpublished (
3. Figure 36.3 Indirect evidence involves using data from trials that have comp...
4. Figure 36.4 Results of 17 RCTs of the effect of oral beta‐blockers for secon...
Chapter 37
1. Figure 37.1 Formulas for calculating sensitivity and specificity.
2. Figure 37.2 Formulas for calculating the percent agreement and K.
3. Figure 37.3 Example of differential misclassification of exposure.
4. Figure 37.4 Recall schematic for showing how date of depression diagnosis wa...
Chapter 38
1. Figure 38.1 Phases and taxonomy of adherence.
Chapter 39
1. Figure 39.1 Sample pictograph.
2. Figure 39.2 Conceptual model for evaluating the effectiveness of risk commun...
Chapter 40
1. Figure 40.1 Schematic depiction of the two different potential time‐courses ...
Chapter 41
1. Figure 41.1 Relationship of medication errors and adverse drug events. About...
Chapter 43
1. Figure 43.1 Principle of the new user design and its variations when studyin...
2. Figure 43.2 Study design choice by source of exposure variation. Shaded boxe...
3. Figure 43.3 Illustration of a calendar‐time cohort of 21 subjects foll...
4. Figure 43.4 Illustration of follow‐up‐time cohort representation...
5. Figure 43.5 Nested case–control sample of one control (◼) per case (●) from ...
6. Figure 43.6 Case–cohort sample with six controls (◼) from cohort in Figure 4...
7. Figure 43.7 Two hypothetical propensity score distributions before and after...
8. Figure 43.8 Multivariate propensity score distributions with varying degrees...

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Edition History
5e 2012 John Wiley & Sons Ltd.

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Library of Congress Cataloging‐in‐Publication Data
Names: Strom, Brian L., editor. | Kimmel, Stephen E., editor. | Hennessy, Sean, editor.
Title: Pharmacoepidemiology / edited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy.
Other titles: Pharmacoepidemiology (Strom)
Description: Sixth edition. | Hoboken, NJ : Wiley‐Blackwell, 2020. | Includes bibliographical references and index.
Identifiers: LCCN 2019029935 (print) | ISBN 9781119413417 (cloth) | ISBN 9781119413370 (adobe pdf) | ISBN 9781119413424 (epub)
Subjects: MESH: Pharmacoepidemiology–methods
Classification: LCC RM301.5 (print) | LCC RM301.5 (ebook) | NLM QV 771 | DDC 615.7–dc23 LC record available at https://lccn.loc.gov/2019029935
LC ebook record available at https://lccn.loc.gov/2019029936

Cover images: © jokerpro/iStock.com, © crisserbug/iStock.com, © AlexRaths/iStock.com
Cover design by Wiley

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