Almut Winterstein

Almut Winterstein R.Ph., Ph.D., FISPE

Professor and Chair, Dr. Robert and Barbara Crisafi Chair in Medication Safety; Director of the Center for Drug Evaluation and Safety

Department: Pharmaceutical Outcomes & Policy
Business Phone: (352) 273-6258
Business Email: almut@ufl.edu

About Almut Winterstein

Almut Winterstein received her pharmacy degree from Friedrich Wilhelm University in Bonn, Germany and her PhD in Pharmacoepidemiology from the Charité Humboldt University in Berlin, Germany. She holds the position of Professor and Chair in the Department of Pharmaceutical Outcomes and Policy at the College of Pharmacy, and an affiliate appointment in the Department of Epidemiology at the Colleges of Medicine and Public Health and Health Professions, both at the University of Florida. In 2017, she was named the Dr. Robert and Barbara Crisafi Chair in recognition of her research on evaluating drug safety and effectiveness in real-world populations and on devising ways to improve medication use.

Since joining the UF College of Pharmacy in 2000, Winterstein has served as principal investigator on more than 25 extramurally funded grants and contracts and published more than 300 manuscripts and conference abstracts. Her research interests have centered on the post-marketing evaluation of drugs in pediatrics and perinatal care, infectious disease and psychiatry and the evaluation and improvement of quality surrounding medication use using real-world data. As internationally recognized expert in drug safety, she has chaired the Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee from 2012-2018. Recognizing her contributions in pharmacoepidemiology, Dr. Winterstein was inducted as a fellow of the International Society of Pharmacoepidemiology in 2013 and started her term as president-elect of the society in 2018. Before she became department chair in 2016, Dr. Winterstein served as graduate program director in her department, which included responsibility for a MS program for the FDA. She has chaired a total of 21 PhD committees and has served as member on several others in her department, and the Departments of Epidemiology, Biostatistics and Statistics.

Research Profile

Pharmacoepidemiology, Patient Safety and Program Evaluation

Publications

2018 American Journal Of Health-System Pharmacy : Ajhp : Official Journal Of The American Society Of Health-System Pharmacists
2018 American Journal Of Health-System Pharmacy : Ajhp : Official Journal Of The American Society Of Health-System Pharmacists
2018 Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology
2018 Journal of Attention Disorders
2012 Journal of the American Academy of Child and Adolescent Psychiatry
2011 New England Journal of Medicine
2011 Clinical Pharmacology & Therapeutics
2008 Southern Medical Journal
2008 American Journal of Health-System Pharmacy
2008 American Journal of Health-System Pharmacy
2008 American Journal of Health-System Pharmacy
2006 American Journal of Health-System Pharmacy

Grants

July 2019ACTIVE
Consortium for Medical Marijuana Clinical Outcomes Research
STATE UNIVERSITY SYSTEM OF FLORIDA · Principal Investigator
May 2019ACTIVE
Observational External Comparator Cohorts as Controls for Long-Term Uncontrolled Extensions to RCTs
INTL SOC FOR PHARMACOEPIDEMIOLOGY · Principal Investigator
May 2019ACTIVE
Developing a Real-Time Trajectory Tool to Identify Potentially Unsafe Concurrent Opioid and Benzodiazepine Use among Older Adults
NATL INST OF HLTH NIA ·
September 2018 – February 2019
Inpatient Psychiatric Facility Outcome & Process Amendment 2 – Year 5 Option Year 4 (September 30, 2018 to February 15, 2019)
HEALTH SERVICES ADVISORY GROUP · Principal Investigator
September 2018ACTIVE
Safety of Gadolinium-Enhanced MRI Exposure During Pregnancy on Adverse Fetal Outcomes
US FOOD AND DRUG ADMN · Principal Investigator
July 2018ACTIVE
Advancing Personalized Hypertension Care through Big Data Science
NATL INST OF HLTH NHLBI ·
May 2018ACTIVE
Improving Medication Adherence with Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults with Asthma (MATCH)
NEMOURS CHILDRENS CLINIC ·
May 2018ACTIVE
Medicaid Prior Authorization Policies for Chronic Hepatitis C Treatment in Vulnerable Populations
NATL INST OF HLTH NIDA ·
November 2017ACTIVE
Application of physiologically-based pharmacokinetic models to inform dosing recommendations for hormonal contraceptives co-administered with other medications
GATES FOU, BILL & MELINDA ·
September 2017 – September 2018
HHSM-500-2013-13007I, Task Order # HHSM-500-T0004, Inpatient Psychiatric Facility Outcome and Process Measure Development & Maintenance_Task 2.1
HEALTH SERVICES ADVISORY GROUP · Principal Investigator
September 2017ACTIVE
Task Order: Developing the Capability of Using National Medicaid data for FDA Post-Marketing Surveillance to Assess Medication Safety During Pregnancy
BRIGHAM AND WOMENS HOSPITAL · Principal Investigator
August 2017ACTIVE
Pharmacological Management of Pain in Alzheimer's Disease and Related Dementia
NATL INST OF HLTH NIA · Mentor
February 2017 – February 2017
TRAVEL REIMBURSEMENT AGREEMENT
HARVARD PILGRIM HEALTHCARE · Principal Investigator
September 2016ACTIVE
The Child Health Quality (CHeQ) Partnership Program
AGCY HEALTHCARE RES AND QUALITY ·
January 2016 – January 2017
evaluating changes in order sets for impatient pain
SHANDS TEACHING HOSPITAL HEALTHCARE · Principal Investigator
September 2015 – September 2017
inpatient psychiatric facility outcome & process measure
HEALTH SERVICES ADVISORY GROUP · Principal Investigator
September 2015 – January 2018
Real-time risk stratification for hypo- or hyperglycemia
US FOOD AND DRUG ADMN · Principal Investigator
September 2014 – September 2015
MIDS-141193: Inpatient Psychiatric Facility Outcome & Pr
HEALTH SERVICES ADVISORY GROUP · Principal Investigator
July 2013 – June 2016
Development and Validation of a Complexity Score to Iden
AMER SOC HLTH SYS PHARM FOU · Principal Investigator

Education

1995
Ph.D.
Humboldt University
1990
Pharmacy
Friedrich Wilhelm University

Mentorship Philosophy


Recent News

Board of Governors selects UF to lead medical marijuana research consortium

The State University System of Florida Board of Governors has selected the University of Florida to lead a statewide consortium studying health outcomes related to medical marijuana. UF will lead…

UF Study Questions Federal Opioid Abuse Criteria

A new study by University of Florida researchers questions the accuracy of the criteria used by the Centers for Medicare and Medicaid Services to identify patients at risk of opioid…

UF College of Pharmacy wins three national awards from ASHP Foundation

A pair of Orlando pharmacy students also placed in the top 10 of the Clinical Skills Challenge at ASHP Midyear.

Dr. Almut Winterstein installed as president-elect of the International Society for Pharmacoepidemiology

As president-elect, Winterstein will serve on the executive board and chair the strategic planning committee. She joined ISPE in 2000 and has held numerous leadership roles during the past two…

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