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Welcome Scott K. Winiecki, MD Team Lead, FDA Safe Use Initiative, Professional Affairs and Stakeholder Engagement Staff (PASE) FDA Public Workshop: Reducing the Risk of Adverse Drug Events Associated with Hypoglycemia in the Older Population Scott K. Winiecki, MD Team Lead, Safe Use Initiative Professional Affairs and Stakeholder Engagement Center For Drug Evaluation and Research (CDER) U.S. Food and Drug Administration September 12, 2017 Disclosures • I have nothing to disclose. 4 Disclaimer This presentation reflects the views of the author and should not be construed to represent FDA’s views or policies. 5 Welcome • Wi-Fi Network: FDA-Public – Passcode is “publicaccess” • Opportunities for lunch are limited – Consider purchasing lunch from the kiosk to avoid lines at lunchtime Safe Use Initiative • Mission: Create and facilitate public and private collaborations within the healthcare community. • Goal: Reduce preventable harm by developing, implementing, and evaluating cross sector interventions with partners committed to safe and appropriate medication use. 7 How do you Reduce Preventable Harm? • Identify patients at highest risk • Provider and facility feedback and/or self- assessment • Make meds easier to use • Patient education • Improve communication  There is no “one size fits all” solution Safe Use Partners • Federal agencies • Healthcare professionals and professional societies • Pharmacies, hospitals, and other health care entities • Patients, caregivers, consumers, and their representative organizations = Almost anyone 9 Drugs with Active Safe Use Projects Safe Use has 16 current projects. These involve a wide variety of drugs and potential adverse events. • Opioids • Antibiotics • Anti-hyperglycemic agents • Stimulants • Pediatric cough and cold medications • Appearance and Performance Enhancing Substances • NSAIDS https://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/ucm277720.htm 10

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1. anticoagulants,. 2. diabetes agents, and. 3. opioid analgesics. "Of the thousands of drugs available to older adults, it is a really small group of medications that creates most of the hospitalizations." Ref: Shehab et al. US Emergency Department Visits for Outpatient Adverse Drug Events, 2013-.
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1. anticoagulants,. 2. diabetes agents, and. 3. opioid analgesics. "Of the thousands of drugs available to older adults, it is a really small group of medications that creates most of the hospitalizations." Ref: Shehab et al. US Emergency Department Visits for Outpatient Adverse Drug Events, 2013-.

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Publication Year:2017
Pages:365
Language:English
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