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Understanding Pharmacoepidemiology is an introduction to the study of medication utilization and safety in large populations of people. During the last 20 years, the discipline of pharmacoepidemiology has grown significantly. Clinicians, policy makers, researchers, academicians, marketers, and others are all interested in pharmacoepidemiology study findings. With the increasing use of medications, it is natural for there to be more interest in the use and safety of medications. The U.S. Food and Drug Administration (FDA), the pharmaceutical industry, health care professionals, and society as a whole need to understand how medications are used in the “real world” and need to ensure that medications are used appropriately and safely. We hope that this book will serve as a primer to the health care professional or student who wants to better understand pharmacoepidemiology or medication safety.


The main audience for the book is the student or health care professional who will apply information about medication safety and pharmacoepidemiology to make health care decisions at the individual or population level. The book is written primarily for health care professionals in training, specifically pharmacy and public health students. Pharmacists, public health practitioners, and other individuals who seek an introduction to the field of pharmacoepidemiology will also find the book useful. The authors of the chapters in this book are pharmacists or have faculty appointments in schools of pharmacy. Some of the authors also have training or appointments in public health. Although the book is an introduction to the topic, the reader will find it helpful if he or she already has some appreciation for research methods and statistics. The book is not intended for those who want to learn how to conduct advanced pharmacoepidemiology techniques or analyses; other books on the subject are available for the pharmacoepidemiology researcher.


This book attempts to explain what pharmacoepidemiology is, how pharmacoepidemiology studies are conducted, and how to interpret pharmacoepidemiology findings. In Chapters 1 to 6, we explain the importance of pharmacoepidemiology, basic terminology used in pharmacoepidemiology research, and the data sources, study designs, and statistical analyses often employed in pharmacoepidemiology research. Chapter 7 provides examples of evaluating a pharmacoepidemiology study. Two chapters provide detailed descriptions of the use of pharmacoepidemiology to understand medication utilization (Chapter 8) and medication safety issues (Chapter 9). The final chapter discusses the perspective of the FDA on medication safety, the importance of health care professionals to the process of improving medication safety, and the ways in which pharmacoepidemiology will be a key component of future medication safety initiatives. After reading the book, the reader should have a better understanding of how to evaluate the associations between medication utilization and outcomes.


The heath care professional and student will find the format of the book useful in learning this material. Each chapter includes a list of learning objectives, case studies or examples, discussion questions, and tables and figures. The book also includes a glossary to help the reader to master the pharmacoepidemiology language. Moreover, faculty in schools of pharmacy or public health will find the book a useful resource when developing and teaching introductory pharmacoepidemiology courses. As mentioned in the book, the Accreditation Council for Pharmaceutical Education (ACPE) requires all pharmacy students to receive some training in pharmacoepidemiology. This requirement reinforces the importance of the topic to pharmacists and other health care professionals and the need for introductory pharmacoepidemiology textbooks.


The editors want to thank all the authors for their contributions. Each chapter is written by an expert in the area and we appreciate their willingness to participate in this project. The editors also thank all the graduate students in the Department of Pharmacy Administration at The University of Mississippi, who assisted with reading various chapters and making helpful suggestions about the book.


We have enjoyed editing this book and we hope that it provides a foundation for health care professionals and students who are interested in medication use and safety in large populations of people. We also hope that this book sparks an interest for some persons to pursue advanced training in pharmacoepidemiology. The U.S. health care system needs clinicians who can interpret pharmacoepidemiology studies and apply the findings to make evidence-based decisions, as well as researchers who can employ the various pharmacoepidemiology techniques to provide insight into the relationship between medication use and outcomes.

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