title: United States medical practice summary: innovative off-label medication use.
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.
authors.affiliation: Center for Clinical Pharmacology, University of Pittsburgh Schools of Medicine and Pharmacy, Pittsburgh, Pennsylvania, USA. nicole.ansani@pfizer.com
authors.forename: Nicole
authors.initials: N
authors.lastname: Ansani
authors.forename: Robert
authors.initials: R
authors.lastname: Branch
authors.forename: Bethany
authors.initials: B
authors.lastname: Fedutes-Henderson
authors.forename: Thomas
authors.initials: T
authors.lastname: Smitherman
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Weber
authors.forename: Susan
authors.initials: S
authors.lastname: Skledar
authors.forename: Nathalie
authors.initials: N
authors.lastname: Zgheib
authors.forename: Carl
authors.initials: C
authors.lastname: Sirio
mesh_terms: D003430:Cross-Sectional Studies; D004348:Drug Labeling; D004358:Drug Therapy / Q000639:trends*; D006801:Humans; D004364:Pharmaceutical Preparations; D010593:Pharmaceutical Services; D011216:Practice Management, Medical; D014481:United States
chemical_list: D004364:Pharmaceutical Preparations