title: Off-label use of gastrointestinal medications in the intensive care unit.
abstract: OBJECTIVE
  Determine the level of evidence supporting off-label gastrointestinal (GI) medication use and identify the medication class and indication whereby off-label use was most common.
  
  
  METHODS
  This prospective, multicentered observational study evaluated all medication orders written in 37 intensive care units (ICUs) in the United States, over a 24-hour period. All medications classified as "GI" according to a national reference were identified. The class and indication whereby off-label use was most prominent were determined and the level of evidence was described.
  
  
  RESULTS
  There were 774 orders from 363 patients and 63% (489 of 774) were considered off-label. Proton pump inhibitors (PPIs) accounted for most of the off-label usage (55% [271 of 489]), followed by laxatives (16% [77 of 489]) and histamine-2-receptor antagonists (H2RAs; 15% [71 of 489]). When prescribed, 99% (271 of 274) of PPIs, 99% (71 of 72) of H2RAs, and 79% (30 of 38) of promotility agents were off-label. Stress ulcer prophylaxis (100% [309 of 309]), GI bleeding (100% [18 of 18]), and gastric motility (88% [30 of 34]) were the most common off-label indications. The most common strength of recommendation and level of evidence for off-label use was indeterminate (58% [282 of 489]) and none (57% [280 of 489]), respectively.
  
  
  CONCLUSIONS
  The PPIs are the most widely used off-label medications in the ICU. Stress ulcer prophylaxis is the most common indication. The level of evidence supporting off-label GI medication use is poor.
authors.affiliation: Department of Pharmacy Practice, Midwestern University, College of Pharmacy-Glendale, Glendale, AZ, USA jbarle@midwestern.edu.
authors.forename: Jeffrey F
authors.initials: JF
authors.lastname: Barletta
authors.affiliation: Department of Pharmacy Services, University of Chicago Medical Center, Chicago, IL, USA.
authors.forename: Ishaq
authors.initials: I
authors.lastname: Lat
authors.affiliation: Department of Pharmacy Practice, St. Louis College of Pharmacy, St. Louis, MO, USA.
authors.forename: Scott T
authors.initials: ST
authors.lastname: Micek
authors.affiliation: Department of Pharmacy Practice, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Department of Pharmacy Services, Kingsbrook Jewish Medical Center, Brooklyn, NY, USA.
authors.forename: Henry
authors.initials: H
authors.lastname: Cohen
authors.affiliation: Department of Pharmacy Practice, University of Nebraska Medical Center, Omaha, NE, USA.
authors.forename: Keith M
authors.initials: KM
authors.lastname: Olsen
authors.affiliation: Department of Pharmacy, University of Rochester Medical Center, Rochester, NY, USA.
authors.forename: Curtis E
authors.initials: CE
authors.lastname: Haas
mesh_terms: D000328:Adult; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006471:Gastrointestinal Hemorrhage / Q000188:drug therapy; D005769:Gastrointestinal Motility; D006635:Histamine H2 Antagonists / Q000627:therapeutic use; D006801:Humans; D007362:Intensive Care Units / Q000706:statistics & numerical data*; D054368:Laxatives / Q000627:therapeutic use; D056687:Off-Label Use / Q000706:statistics & numerical data*; D010437:Peptic Ulcer / Q000517:prevention & control; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D013312:Stress, Physiological
chemical_list: D005765:Gastrointestinal Agents; D006635:Histamine H2 Antagonists; D054368:Laxatives; D054328:Proton Pump Inhibitors
keywords: gastrointestinal; intensive care unit; off-label