PHARMACOEPIDEMIOLOGY METHODS Syllabus
Course Learning Objectives
Upon successfully completing this course, students will be able to:
- Describe the development of the drug regulation processes in the United States
- Recognize the role of industry in drug development
- Appraise pharmacovigilance systems
- Access different data sources for pharmacoepidemiology studies
- Apply epidemiological techniques to questions about drug effectiveness or drug safety
Course DescriptionAcquaints students with the key elements of pharmacoepidemiology. Explores the utilization and effects of drugs in large numbers of people. Discusses the application of epidemiological methods to pharmacological issues. Focuses heavily on questions of pharmacodynamics, concentrating on clinical patient outcomes and on therapeutics (i.e., appropriate use of drugs). Applies the research methods of clinical epidemiology (e.g., randomized trials, cohort studies, case-control studies) to the content area of pharmacology (e.g., determinants of beneficial and adverse drug effects, effects of genetic variation on drug effect, dose-response relationships, duration-response relationships, clinical effects of potential drug-drug interactions, effects of non-adherence). Examines programmatic efforts to improve medication use on a population basis.
Intended AudienceTarget will be second year MHS students and/or PhD students. Anticipate that these will be epidemiology students and possibly HPM students. Would welcome pharmacy residents as well.
Methods of Assessmentclass participation and attendance, performance on a mid-term short answer assignment, and a final written report.
Additional Faculty Notes:
Class Participation: 15%
Details to Follow:
Class participation also includes submission of the take-home exercises that will be due at 5:00 PM the day following the lecture.
Midterm– participation in exercise, write-up following exercise
Final examination – out-of-class, short-answer exercises
Prerequisites340.601 or 340.751 or 550.695
Additional Faculty Notes:
Suggested Textbooks (none required)
Textbook of Pharmacoepidemiology by Brian L. Strom and Stephen E Kimmel (Hardcover- Feb 16, 2007)
Pharmacoepidemiology by Brian L. Strom(Hardcover- Oct 7, 2005)
Rothman K, Greenland S: Modern Epidemiology, 3rd ed. Lippincott, Philadelphia, 2008
Please see the course Session for a full list of dates and items for this course.
Files from the Online Library
Academic Ethics Code
The code, discussed in the Policy and Procedure Memorandum for Students, March 31, 2002, will be adhered to in this class:
Students enrolled in the Bloomberg School of Public Health of The Johns Hopkins University assume an obligation to conduct themselves in a manner appropriate to the University's mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations.
Welcome to the Pharmacoepidemiology Methods Course. We hope that you will leave this course with an understanding of the drug regulation process in the United States and with methdological skills to apply to the study of drug effectiveness and safety.
Please review the syllabus for detail about course topics.
Jodi Segal, MD, MPH Email: firstname.lastname@example.org
Kenneth Shermock, PharmD, PhD Email: email@example.com
Disability Support ServicesIf you are a student with a documented disability who requires an academic accommodation, please contact Betty H. Addison in the Office of Student Life Services: firstname.lastname@example.org, 410-955-3034, or 2017 E. Monument Street.