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Almut Winterstein, RPh, Ph.D., FISPE

Almut Winterstein

Professor and Chair

Pharmaceutical Outcomes and Policy

OFFICE: HPNP Room 3336


PHONE: 352-273-6258

CV: Link to CV



  • Pharmacy, Friedrich Wilhelm University, Bonn
  • Ph.D. Pharmacoepidemiology and Social Pharmacy, Humboldt University, Charité, Berlin

Research Interests

  • Pharmacoepidemiology
  • Patient Safety and Program Evaluation

Biographical Sketch

  • Chair of Pharmaceutical Outcomes & Policy

Almut Winterstein received her pharmacy degree from Friedrich Wilhelm University in Bonn, Germany and her Ph.D. in Pharmacoepidemiology from the Charité Humboldt University in Berlin, Germany. She joined faculty at the University of Florida in 2000 and holds the position of Professor in the Department of Pharmaceutical Outcomes and Policy at the College of Pharmacy, and in the Department of Epidemiology at the Colleges of Public Health and Health Professions and Medicine.

Almut’s research interests focus on drug safety and effectiveness, and the evaluation and prevention of inappropriate medication use. Clinical areas of pharmacoepidemiologic studies include in particular pediatrics, psychiatry, and infectious disease. Her interest in quality of care issues focuses on the development and evaluation of medication safety programs, clinical decision support systems and quality metrics. Almut has received funding from AHRQ, CMS, FDA, NIH and various professional associations and state agencies including the Florida Department of Health. She chairs the FDA/CDER Drug Safety and Risk Management Advisory Board (DSaRM), serves on the Federal Interagency Work Group on Adverse Drug Events, and as consultant on medication safety issues for the Florida.


Current Affiliations and Appointments

  • FDA/CDER Drug Safety and Risk Management Advisory Board
  • Affiliate Associate Professor, Department of Epidemiology, Colleges of Medicine and Public Health and Health Professions, University of Florida
  • Research Advisory Board, American Society of Health Systems Pharmacists Research Foundation
  • Federal Interagency Workgroup for Adverse Drug Events

Recent Publications (2013-present)

Google Scholar Profile

Research Gate Profile

Bussing R, Narwaney KJ,Winterstein AG, Newton DA, Debar L, Boscarino JA, Toh S, Pawloski P, Nordin JD, Herrinton LJ, Mason D, Daley MF. Pharmacotherapy for Incident Attention-Deficit/Hyperactivity Disorder: Practice Patterns and Quality Metrics. Current Med Res Opinion 2014;(ahead of print) PMID: 24635013

Knox CA**, Delaney JAC, Winterstein AG. Anti-diabetic drug utilization of pregnant diabetic women in us managed care. BMC Pregnancy Childbirth. 2014 Jan;14:28 PMID: 24438493

Winterstein AG, Knox C, Kubilis P. Methods to estimate gestational age can significantly affect study results-reply. JAMA Pediatr. 2014 Apr 1;168(4):388-9. PMID: 24710586

Toh S, Avorn J, D’Agostino RB Sr, Gurwitz JH, Psaty BM, Rothman KJ, Saag KG, Sturkenboom MC, Vandenbroucke JP, Winterstein AG, Strom BL RE: Drug risk assessment and data reuse. Pharmacoepidemiol Drug Saf. 2014 Jan;23(1):109-10 PMID: 24395550

Toh S, Avorn J, D’Agostino RB Sr, Gurwitz JH, Psaty BM, Rothman KJ, Saag KG, Sturkenboom MC, Vandenbroucke JP, Winterstein AG, Strom BL. Re-using Mini-Sentinel data following rapid assessments of potential safety signals via modular analytic programs. Pharmacoepidemiol Drug Saf. 2013;22(10):1036-45 PMID: 23922322

DeHoff R, Delaney JAC, Bird S, Nichols G, Winterstein AG. Antihypertensive Drug Class Interactions and Risk for Incident Diabetes; a Nested Case Control Study. JAHA 2013 Jun 10;2(3):e000125 PMID: 2375271

Birnbaum ML, Saito E, Gerhard T, Winterstein A, Olfson M, Kane JM, Correll CU. Pharmacoepidemiology of Antipsychotic Use in Youth with ADHD: Trends and Clinical Implications. Curr Psychiatry Rep. 2013 Aug;15(8):382. PMID: 23881713.

Winterstein AG, Knox C, Kubilis P, Hampp C. Accuracy of Age Thresholds for Respiratory Syncytial Virus Immunoprophylaxis in Late-Preterm Infants – A cohort study. JAMA Pediatrics 2013 Dec 1;167(12):1118-24 PMID: 24126903

Winterstein AG. Cardiovascular safety of stimulants in children: findings from recent population-based cohort studies. Curr Psychiatry Rep. 2013 Aug;15(8):379. PMID: 23913135

Delaney JA, Lehmann N, Jöckel K-H, Elmariah S, Psaty BM, Mahabadi A, Budoff M, Kronmal RA, Nasir K, O’Brien KD, Möhlenkamp S, Moebus S, Dragano N0, Winterstein A, Erbel R, Kälsch H. Associations between Aspirin and other non-steroidal anti-inflammatory drugs and aortic valve or coronary artery calcification: The Multi-Ethnic Study of Atherosclerosis and the Heinz Nixdorf Recall Study. Atherosclerosis 2013;229:310-316. PubMed PMID: 23880181

Toteja N, Gallego JA, Saito E, Gerhard T, Winterstein A, Olfson M, Correll CU. Prevalence and correlates of antipsychotic polypharmacy in children and adolescents receiving antipsychotic treatment. Int J Neuropsychopharmacology 2013 May 14:1-11 PMID: 23673334

Winterstein AG, Liu W, Xu D, Antonelli PJ. Sensorineural hearing loss associated with neomycin eardrops and non-intact tympanic membranes. Otol Head Neck Surg 2013 Feb;148(2):277-83 PMID: 23264116

Winterstein AG, Eworuke E, Xu D, Schuler P. Palivizumab immunoprophylaxis effectiveness in children with cystic fibrosis. Pediatr Pulmonol 2013 Sep;48(9):874-84 PMID: 23139089

Winterstein AG, Antonelli PJ. Response to Letter to the Editor Regarding Sensorineural Hearing Loss Associated with Neomycin Eardrops and Nonintact Tympanic Membranes. Otolaryngol Head Neck Surg. 2013 Jun;148(6):1061-1062. PMID: 23690083