Almut Winterstein

Distinguished Professor University of Florida

  • Gainesville FL

Almut Winterstein is an expert in drug safety and ways to improve medication use.

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University of Florida

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Biography

Almut Winterstein is a distinguished professor and chair of the Department of Pharmaceutical Outcomes and Policy in the College of Pharmacy. She is the founding director of the Center for Drug Evaluation and Safety. Almut is co-leader of the state of Florida's Consortium for Medical Marijuana Clinical Outcomes Research. She is an expert in drug safety and ways to improve medication use. Almut's 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.

Areas of Expertise

Medical Marijuana
Healthcare Quality
Drug Use in Maternal and Child Health
Medical Marijuana Safety
Pharmacoepidemiology
Drug Safety
Patient Safety
Medical Marijuana Effectiveness
Teratogenic Drug Effects
Risk Mitigation of Adverse Drug Effects

Media Appearances

UF study finds 1 in 16 women take harmful drugs during pregnancy

UF College of Pharmacy  online

2022-02-10

In a review of more than 3 million pregnancies, University of Florida researchers found 1 in 16 women were exposed to harmful teratogenic drugs — medications that can cause pregnancy loss, birth defects and other health problems for the unborn child. The study published in the American Journal of Obstetrics and Gynecology highlights the need for women and their providers to carefully examine medications taken during pregnancy.

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FDA Panels Say Risks of Opana ER Outweigh Benefits

Medscape  online

2017-03-17

A panel of US Food and Drug Administration (FDA) experts has advised the agency that the risks of an abuse-deterrent extended-release formulation of oxymorphone (Opana ER, Endo Pharmaceuticals) for relief of severe pain now outweigh its benefits.

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Social

Articles

CYP2C19 Genotype‐Guided Antiplatelet Therapy After Percutaneous Coronary Intervention in Diverse Clinical Settings

Journal of the American Heart Association

Amber L. Beitelshees, et al.

2022-02-12

Studies have demonstrated increased risk of major atherothrombotic events in CYP2C19 loss‐of‐function (LOF) variant carriers versus non‐carriers treated with clopidogrel after percutaneous coronary intervention (PCI). We sought to evaluate real‐world outcomes with the clinical implementation of CYP2C19‐guided antiplatelet therapy after PCI.

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Discontinuation of Long-Term Opioid Therapy in Patients With Versus Without Dementia

American Journal of Preventive Medicine

Yu-Jung J. Wei, Cheng Chen and Almut G. Winterstein

2022-02-01

Discontinuation of long-term opioid therapy has increased in recent years, but whether this trend extends to patients with Alzheimer disease and related dementia remains unclear.

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Generalizability and accuracy of IBM MarketScan health risk assessment instrument data for augmentation of commercial claims data

Pharmacoepidemiology & Drug Safety

Yasser Albogami, Yu-Jung J. Wei and Almut G. Winterstein

2021-10-17

We evaluated the generalizability and accuracy of the IBM® MarketScan® Health Risk Assessment (HRA) data to assess its suitability as supplement to linked claims data.

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Spotlight

3 min

Does medical marijuana work? Florida consortium seeks answers

By Emma Richards A consortium of nine universities in Florida, led by faculty at the University of Florida, is in the early stages of investigating the effectiveness of marijuana as a medical treatment. Almut Winterstein, a professor at the University of Florida who also serves as the director of the Consortium for Medical Marijuana Outcomes Research, says there is promising data on pain therapy and epilepsy but much still to learn about cannabis as a medical treatment. The Consortium for Medical Marijuana Outcomes Research is assessing the drug’s risks and benefits for different medical conditions and its safety and side effects when used alone or in conjunction with other prescription medications. “What I can tell you is that right now there is promising and fairly solid data that supports the use of medical marijuana as an adjuvant for pain therapy,” said Almut Winterstein, a professor in the College of Pharmacy at UF who also serves as the director of the consortium. “And there’s also evidence that supports the use for certain types of epilepsy.” As for other conditions, the impacts of medical marijuana are still unknown. The Florida State Legislature created the consortium in 2019, four years after enacting legislation that permits use of marijuana for certain clinical conditions. Currently, 37 states have a medical marijuana program, though the programs vary as far as how and to whom cannabis can be prescribed. But, Winterstein said, little is known about marijuana’s clinical safety and effectiveness. “I think that the Legislature was really forward looking in creating something that supplements the research that is currently not sufficient,” she said in an episode of the From Florida Podcast. The consortium will also gauge who is using and able to access medical marijuana and determine the benefits and drawbacks of different dosages. To do so, the group is working on three primary branches of research. The first area is a competitive grants program that funds researchers across all participating universities. The second branch is M3, or Medical Marijuana and Me, a new study that will track patients from their first use of medical marijuana for a year to assess their experiences. “That will give us ideas about what type of dosage, form and product do patients eventually end up on,” Winterstein said. “That is a very empirical approach because we have no head-to-head comparison of what works better or worse, but we can capture patients’ experiences, what they think works, what doesn't, what kind of side effects they might experience and so on.” Finally, what Winterstein calls the consortium’s “biggest baby and most important baby” is the Medical Marijuana Outcomes Research Repository, known as MEMORY. The repository will allow researchers to use de-identified dispensing data from the Department of Health to monitor health outcomes of the large population of 700,000 registered medical marijuana patients. These data will give researchers insight on cannabis safety and effects, whether positive or negative, linking to healthcare utilization, such as hospitalization or emergency department visits. The consortium is hosting the second annual Cannabis Clinical Outcomes Research Conference May, 19-20 in Orlando, where researchers will discuss the latest research on medical marijuana. “We are really trying to get people interested in this topic,” Winterstein said. “And in particular making sure that they have access to objective information that really allows them to make the right decision with respect to the use of medical marijuana.” To hear more about the consortium’s medical marijuana research, listen to the episode on From Florida at this link. Listen to other episodes in the From Florida podcast here. Read a recent article quoting Professor Winterstein here:

Almut Winterstein