Almut Winterstein

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

Professor & Chair; Director, Center For Drug Evaluation & Safety (CoDES)

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 is the founding Director of the Center for Drug Evaluation and Safety, both at the University of Florida. She has an affiliate appointment in the Department of Epidemiology at the Colleges of Medicine and Public Health and Health Professions. In 2017, she was named the Dr. Robert and Barbara Crisafi Chair for Medication Safety in recognition of her research on drug safety and on devising ways to improve medication use.

Since joining the University of Florida in 2000, Winterstein has served as principal investigator on more than 25 extramurally funded grants and contracts and published more than 400 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 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 currently serves as president of the society. Before she became department chair in 2016, Dr. Winterstein served as graduate program director in her department. She has chaired more than 21 PhD committees and was awarded the UF-wide Dissertation Advisor/Mentoring award for her excellence in graduate training.

Research Profile

Open Researcher and Contributor ID (ORCID)

0000-0002-6518-5961

Areas of Interest
  • Patient Safety
  • Pharmacoepidemiology
  • Program evaluation

Publications

2020 Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
2020 The New England journal of medicine
2020 Otolaryngology–head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery
2020 CPT: pharmacometrics & systems pharmacology
2019 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2019 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2019 Health affairs (Project Hope)
2019 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2019 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2019 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2018 Journal of attention disorders
2018 Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology
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
2017 Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
2017 Journal of child and adolescent psychopharmacology
2017 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2017 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2017 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2017 Journal of the American Pharmacists Association : JAPhA
2016 Biostatistics (Oxford, England)
2016 Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology
2014 Pharmacoepidemiology and drug safety
2014 Otolaryngology–head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery
2014 Pharmacoepidemiology and Drug Safety
2013 Otolaryngology–head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery
2013 Otolaryngology–head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery
2012 Journal of the American Academy of Child and Adolescent Psychiatry
2012 Pharmacoepidemiology and drug safety
2012 Pharmacoepidemiology and Drug Safety
2011 Pharmacoepidemiology and Drug Safety
2011 Clinical pharmacology and therapeutics
2011 The New England journal of medicine
2011 Pharmacoepidemiology and Drug Safety
2011 Pharmacoepidemiology and Drug Safety
2010 Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology
2010 Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
2010 Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
2010 American Journal of Epidemiology
2010 American Journal of Epidemiology
2009 Pharmacoepidemiology and Drug Safety
2009 Pharmacoepidemiology and Drug Safety
2008 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2008 Southern medical journal
2008 Journal of cardiac surgery
2008 Pharmacoepidemiology and Drug Safety
2008 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2008 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2007 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2006 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2005 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2005 Research in social & administrative pharmacy : RSAP
2004 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2003 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2002 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2002 American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
2002 The Annals of pharmacotherapy

Grants

Jul 2020 ACTIVE
Precision antiplatelet therapy after percutaneous coronary intervention
NATL INST OF HLTH NHLBI ·
May 2020 ACTIVE
Epidemiology and cost of RSV infections in infants and toddlers
MERCK AND COMPANY INC · Principal Investigator
Dec 2019 ACTIVE
BD&L Discovery Transactions Work Plan
MERCK AND COMPANY INC · Principal Investigator
Jul 2019 ACTIVE
Together: Transforming and Translating Discovery to Improve Health
NATL INST OF HLTH NCATS · Project Manager
Jul 2019 ACTIVE
Consortium for Medical Marijuana Clinical Outcomes Research
STATE UNIVERSITY SYSTEM OF FLORIDA · Principal Investigator
May 2019 – Sep 2019
Observational External Comparator Cohorts as Controls for Long-Term Uncontrolled Extensions to RCTs
INTL SOC FOR PHARMACOEPIDEMIOLOGY · Principal Investigator
May 2019 ACTIVE
Developing a Real-Time Trajectory Tool to Identify Potentially Unsafe Concurrent Opioid and Benzodiazepine Use among Older Adults
NATL INST OF HLTH NIA ·
Sep 2018 – Feb 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
Sep 2018 ACTIVE
Safety of Gadolinium-Enhanced MRI Exposure During Pregnancy on Adverse Fetal Outcomes
US FOOD AND DRUG ADMN · Principal Investigator
Jul 2018 ACTIVE
Advancing Personalized Hypertension Care through Big Data Science
NATL INST OF HLTH NHLBI ·
May 2018 ACTIVE
Medicaid Prior Authorization Policies for Chronic Hepatitis C Treatment in Vulnerable Populations
NATL INST OF HLTH NIDA ·
May 2018 ACTIVE
Improving Medication Adherence with Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults with Asthma (MATCH)
NEMOURS CHILDRENS CLINIC ·
Nov 2017 ACTIVE
Application of physiologically-based pharmacokinetic models to inform dosing recommendations for hormonal contraceptives co-administered with other medications
GATES FOU, BILL & MELINDA ·
Sep 2017 – Sep 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
Sep 2017 – Sep 2020
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
Aug 2017 ACTIVE
Pharmacological Management of Pain in Alzheimer's Disease and Related Dementia
NATL INST OF HLTH NIA ·
Feb 2017 – Feb 2017
TRAVEL REIMBURSEMENT AGREEMENT
HARVARD PILGRIM HEALTHCARE · Principal Investigator
Sep 2016 – Sep 2020
The Child Health Quality (CHeQ) Partnership Program
AGCY HEALTHCARE RES AND QUALITY ·
Jan 2016 – Jan 2017
evaluating changes in order sets for impatient pain
SHANDS TEACHING HOSPITAL HEALTHCARE · Principal Investigator
Sep 2015 – Jan 2018
Real-time risk stratification for hypo- or hyperglycemia
US FOOD AND DRUG ADMN · Principal Investigator
Sep 2015 – Sep 2017
inpatient psychiatric facility outcome & process measure
HEALTH SERVICES ADVISORY GROUP · Principal Investigator
Sep 2014 – Sep 2015
MIDS-141193: Inpatient Psychiatric Facility Outcome & Pr
HEALTH SERVICES ADVISORY GROUP · Principal Investigator
Jul 2013 – Jun 2016
Development and Validation of a Complexity Score to Iden
AMER SOC HLTH SYS PHARM FOU · Principal Investigator

Education

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

Contact Details

Phones:
Business:
(352) 273-6258
Emails:
Business:
almut@ufl.edu

recent news

UF researchers determine the risk of pregnancy loss associated with a commonly used immunosuppressant drug, effective risk management strategies are warranted

The research provides important information to support the FDA’s REMS program which aims to prevent fetal exposure to mycophenolate.

UF Health researchers develop CMS quality measure to evaluate inpatient psychiatric hospitals

The UF measure tracks 30-day hospital readmission rates for psychiatric patients following discharge.

UF study finds excess use of loop diuretics following initiation of dihydropyridine calcium channel blockers

The study published in JAMA Network Open found a substantial number of patients are being prescribed a loop diuretic for leg swelling induced by calcium channel blocker.

Dr. Almut Winterstein presents at FDA-wide seminar

At the meeting, she was presented an “Outstanding Service Award,” for her exceptional leadership in the field of drug safety.