Almut Winterstein, Ph.D. • Associate Professor of Pharmaceutics Outcomes and Policy
College of Pharmacy

Almut Winterstein is a pharmacoepidemiologist with interest in drug safety and effectiveness, and the evaluation and prevention of inappropriate drug use. Recent years have seen increasing doubt about the scientific evidence available for many FDA-approved drugs and defined a critical need for post-marketing surveillance and comparative effectiveness research. Both mean a change in scope from well-controlled narrow trial settings to large, real-life population-based research. Both define the core of pharmacoepidemiology.

Winterstein recently received federal funding to evaluate the cardiac safety of medications used to treat psychiatric disorders in children. Its focus on severe but rare events will require assessment of more than half a million children, assembled from Medicaid records from fourteen states. Her ongoing research program on treatment of respiratory disease in early childhood, in collaboration with the UF Center for Medicaid and the Uninsured, will soon expand to house a dataset of millions more children.

Winterstein’s interest in quality of care issues is defined through her collaboration with UF & Shands and the Florida Department of Health, and focuses on the development and evaluation of medication safety programs, clinical decision support systems, and quality metrics. Winterstein has received funding from the FDA, AHRQ, American Society of Health System Pharmacist (ASHP) Research Foundation, the Drug Information Association (DIA), the International Federation of Pharmacy Associations (FIP), and various state agencies including the Florida Department of Health. She is a chair of the Research Advisory Board of the American Society of Health Systems Pharmacist (ASHP) Research and Education Foundation, and principal investigator and director of the FDA/CDER & UF graduate program, which trains FDA employees in pharmaceutical outcomes research. Winterstein was recently appointed to the FDA Drug Safety and Risk Management Advisory Board (DSaRM).