Epidemiologists working in the area of pharmacoepidemiology apply epidemiologic reasoning, methods, and knowledge to the study of the uses and effects, beneficial and harmful, of prescription and over the counter drugs, biologics, vaccines, and medical devices in human populations.

Traditionally, pharmacoepidemiology was primarily concerned with post-marketing studies of drug safety. Over the past 15 years, it has evolved toward a broader focus on epidemiologic questions arising in drug and vaccine development and in health services research more generally, including the observational study of beneficial or intended effects. Studies of intended drug effects are also known as effectiveness studies and include comparative effectiveness research (CER) studies.

Pharmacoepidemiology research is often based on large health care utilization databases using nonexperimental study of intended and unintended drug effects outside of randomized controlled trials. The scope of pharmacoepidemiology is broad, encompassing such diverse areas as:

Confounding by indication or disease severity	Validation of outcomes in large administrative databases
Methods to reduce bias resulting from healthy initiator, healthy adherer, and healthy user effects	Adverse events and vaccine research
Methods such as propensity score analysis, instrumental variable analysis, and doubly robust estimation	Medical devices
Identification of heterogeneity in treatment effects	Pharmacogenetics
Development and use of patient reported outcomes	Sytematic review and meta-analysis

The UNC Center of Excellence in Pharmacoepidemiology and Public Health is a unique partnership between the UNC Gillings School of Global Public Health and all entities developing, producing, marketing, delivering, or regulating drugs, biologics, vaccines, or medical devices. See CEPEPH.

 

Students in the Pharmacoepidemiology Program receive training in how to conduct high-quality epidemiologic research that directly addresses both substantive and methodologic questions. Students gain experience through interdisciplinary opportunities in courses and collaborative work with researchers from the Schools of Public Health, Medicine, and Pharmacy, as well as through graduate research assistant opportunities with researchers and faculty in the Department of Epidemiology and epidemiology researchers working with GSK, Merck and other industry partners. Through fellowships and internships, students learn how to engage with industry and government stakeholders and become exposed to applied epidemiological research by and for industry partners, federal stakeholders, and international health organizations.

Program faculty (Department of Epidemiology)

Til Stürmer
Program Leader

M Alan Brookhart
Deputy Program Leader

Michelle Jonsson-Funk
Charles L. Poole
Alice White


Collaborating faculty (UNC)

Christy Avery (Department of Epidemiology)
Tim Carey (Sheps Center for Health Services Research)
Bill Carpenter (Health Policy and Management)
Steve Cole (Department of Epidemiology)
Alan Ellis (Sheps Center for Health Services Research)
Gang Fang (Eshelman School of Pharmacy)
Joel Farley (Eshelman School of Pharmacy)
Steve Marshall (Department of Epidemiology)
Steve Meshnick (Department of Epidemiology)
Robert C. Millikan (Department of Epidemiology)
William C. Miller (Department of Epidemiology)
Kari E. North (Department of Epidemiology)
Betsy Sleath (Eshelman School of Pharmacy)
Jennifer Smith (Department of Epidemiology)
Annelies Van Rie (Department of Epidemiology)
Eric Whitsel (Department of Epidemiology)

Pharmacoepidemiology Training at UNC

There are 3 courses specifically for those interested in the pharmacoepidemiology program.
Introduction to Pharmacoepidemiology (EPID 765) is the foundation course for pharmacoepidemiology students. It is taught every other year (odd years, i.e., again in 2013) in the spring semester.	These 2 courses should be taken together either in the first or second year depending on the year students enter the program. They cover the basics of pharmacoepidemiologic research including one of its main aspects, the use of large automated databases.
Epidemiologic Research with Health Care Databases (EPID 690.XXX), is taught in parallel to EPID 765 in the spring semester every other year (odd years, i.e., again in 2013).
Advanced Pharmacoepidemiogic Methods (EPID 690.XXX) will be taught in the spring semester every other year (even years) starting in 2012.	This course should be taken either in the second or third year. The course will cover state-of-the art pharmacoepidemiologic and nonexperimental comparative effectiveness research methods both in theory and in practice (implementation). The introductory pharmacoepidemiology course (EPID 765, see above) is a prerequisite for this course.
These courses supplement the Department's core methodology course sequence by enhancing the student's ability to apply epidemiological methods and reasoning to practical problems of pharmacoepidemiology. Numerous other courses from the School of Public Health and other related UNC departments are available, including health economics, clinical trial design, survey and questionnaire development, and medical geography.

To complement students' academic skills, faculty advisors in the program work with students to identify internship opportunities for gaining first-hand experience in pharmacoepidemiology practice within federal and international agencies, pharmaceutical companies and research organizations.

 

In addition to the coursework available, pharmacoepidemiology faculty and students meet twice monthly to discuss recent pharmacoepidemiology methods and share current research projects.  UNC also has an active student chapter of the  International Society for Pharmacoepidemiology (ISPE) and helps to coordinate the annual Harry Guess Memorial Lecture in Pharmacoepidemiology.