340.619.89
Topics in Pharmacoepidemiology

Prerequisite:

Introductory course in epidemiology

Description:

Most adults in the United States and world-wide use daily medications. Learn the best methods to study the utilization, safety, and effectiveness of medicines.

Introduces the key elements of pharmacoepidemiology. Explores the utilization and effects of drugs in large numbers of people and the application of epidemiological methods to pharmacological issues. Focuses on questions of drug safety and effectiveness, concentrating on clinical patient outcomes and on evaluating the use of therapies. Applies the research methods of clinical epidemiology (e.g., randomized trials, cohort studies, case-control studies, use of secondary data, attention to biases and confounding, effects of non-adherence, active and passive surveillance for adverse events) to study medication exposures and outcomes.

Learning Objectives:

Upon successfully completing this course, students will be able to:

1. Describe the process of late-stage drug development and post-market regulation in the United States
2. Explain the concept of pharmacovigilance and articulate methods to examine the safety of marketed products
3. Evaluate studies examining products efficacy or effectiveness with an emphasis on definitions of exposures, outcomes and common validity threats

Methods of Assessment:

This course is evaluated as follows:

• 15% Participation
• 85% Final Exam

Instructor Consent:

No consent required

Special Comments:

Pre course readings will be posted on CoursePlus one week before the start of the course. The final exam will be due 10 days after the conclusion of the course.