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Updated: Jul 27, 2026

A Novel Approach for the Administration of Medications and Fluids in Emergency Scenarios and Settings
Published on: November 9, 2016
United States medical practice summary: innovative off-label medication use
Nicole Ansani1, Robert Branch, Bethany Fedutes-Henderson
1Center for Clinical Pharmacology, University of Pittsburgh Schools of Medicine and Pharmacy, Pittsburgh, Pennsylvania, USA. nicole.ansani@pfizer.com
Abstract:
Data are limited regarding how academic medical centers (AMCs) deal with medication use that represents a departure from product labeling; has reasonable rationale for use, but insufficient evidence to allay safety, efficacy, and cost-effectiveness concerns; yet is not clinical research (defined as innovative off-label medication use). This report describes national trends in management of innovative off-label medication use. A cross-sectional survey of US AMCs was conducted. Survey questionnaires were directed to drug information centers or pharmacy directors. Of 469 AMCs contacted, 104 responded (22%). Fifty-nine AMCs identified innovative off-label use as a challenge. Only 18 AMCs developed strategies to address this issue: 12 requiring initial reviews and 8 requiring clinical monitoring. Sixty-five AMCs indicated interest in data sharing of clinical outcomes for innovative off-label protocol(s). Innovative off-label medication use is a widely recognized challenge; however, few prospectively active AMC responses exist. The authors suggest development of systematic structured approaches within and across AMCs.
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