Off-label use of gastrointestinal medications in the intensive care unit

Journal of Intensive Care Medicine

Volumn 30, Issue 4, 2015, Pages 217-225

  Barletta, Jeffrey F ^a   Lat, Ishaq ^b   Micek, Scott T ^c   Cohen, Henry ^d   Olsen, Keith M ^e   Haas, Curtis E ^f  

^a MIDWESTERN UNIVERSITY   (United States)

^b UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

^c ST LOUIS COLLEGE OF PHARMACY   (United States)

^d LONG ISLAND UNIVERSITY   (United States)

^e UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^f UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

Author keywords

gastrointestinal; intensive care unit; off label

Indexed keywords

ANTACID AGENT; DOCUSATE SODIUM; ESOMEPRAZOLE; GASTROINTESTINAL AGENT; HISTAMINE H2 RECEPTOR ANTAGONIST; LANSOPRAZOLE; LAXATIVE; OMEPRAZOLE; PANTOPRAZOLE; PROMOTILITY AGENT; PROTON PUMP INHIBITOR; UNCLASSIFIED DRUG;

GASTROESOPHAGEAL REFLUX; GASTROINTESTINAL HEMORRHAGE; HUMAN; INTENSIVE CARE UNIT; MAJOR CLINICAL STUDY; OFF LABEL DRUG USE; PEPTIC ULCER; PRIORITY JOURNAL; PROPHYLAXIS; REVIEW; STOMACH MOTILITY; STRESS ULCER; ADULT; CLINICAL TRIAL; GASTROINTESTINAL MOTILITY; MULTICENTER STUDY; PHYSIOLOGICAL STRESS; PROSPECTIVE STUDY; STATISTICS AND NUMERICAL DATA;

ADULT; GASTROINTESTINAL AGENTS; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL MOTILITY; HISTAMINE H2 ANTAGONISTS; HUMANS; INTENSIVE CARE UNITS; LAXATIVES; OFF-LABEL USE; PEPTIC ULCER; PROSPECTIVE STUDIES; PROTON PUMP INHIBITORS; STRESS, PHYSIOLOGICAL;

EID: 84930513616     PISSN: 08850666     EISSN: 15251489     Source Type: Journal    
DOI: 10.1177/0885066613516574     Document Type: Review

References (38)

1. ASHP Commission on Therapeutics and approved by the ASHP Board of Directors on November 14, 1998. Am J Health Syst Pharm. 1999 ; 56 (4). 347-379
2. Cook D, Guyatt G, Marshall J, et al. A comparison of sucralfate and ranitidine for the prevention of upper gastrointestinal bleeding in patients requiring mechanical ventilation. Canadian critical care trials group. N Engl J Med. 1998 ; 338 (12). 791-797
3. Finfer S, Chittock DR, Su SY, et al. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009 ; 360 (13). 1283-1297
4. Yang CP, Veltri MA, Anton B, Yaster M, Berkowitz ID. Food and Drug Administration approval for medications used in the pediatric intensive care unit: a continuing conundrum. Pediatr Crit Care Med. 2011 ; 12 (5). e195 - e199
5. Flanagan BM, Philpott S, Strosberg MA. Protecting participants of clinical trials conducted in the intensive care unit. J Intensive Care Med. 2011 ; 26 (4). 237-249
6. Vincent JL. We should abandon randomized controlled trials in the intensive care unit. Crit Care Med. 2010 ; 38: S534 - S538
7. Lat I, Micek S, Janzen J, Cohen H, Olsen K, Haas C. Off-label medication use in adult critical care patients. J Crit Care. 2011 ; 26 (1). 89-94
8. Albaladejo P, Caillet B, Moine P, et al. Off-label prescriptions in an adult surgical intensive care unit[Article in French]. Presse Med. 2001 ; 30 (30). 1484-1488
9. Kumar P, Walker JK, Hurt KM, Bennett KM, Grosshans N, Fotis MA. Medication use in the neonatal intensive care unit: current patterns and off-label use of parenteral medications. J Pediatr. 2008 ; 152 (3). 412-415
10. Smith MC, Williamson J, Yaster M, Boyd GJ, Heitmiller ES. Off-label use of medications in children undergoing sedation and anesthesia. Anesth Analg. 2012 ; 115 (5). 1148-1154
11. U.S. Food and Drug Administration. Regulatory Information. "Off-label" and invesitgation use of marketed drugs, biologics and medical devices- Information Sheet. http://wwwfdagov/regulatoryinformation/guidances/ucm126486htm. Accessed August 9, 2013.
12. Institute for Healthcare Improvement. Implement the IHI Ventilator Bundle. http://wwwihiorg/knowledge/Pages/Changes/ImplementtheVentilatorBundleaspx. Accessed May 7, 2013.
13. Conrad SA, Gabrielli A, Margolis B, et al. Randomized, double-blind comparison of immediate-release omeprazole oral suspension versus intravenous cimetidine for the prevention of upper gastrointestinal bleeding in critically ill patients. Crit Care Med. 2005 ; 33 (4). 760-765
14. Alhazzani W, Alenezi F, Jaeschke RZ, Moayyedi P, Cook DJ. Proton pump inhibitors versus histamine 2 receptor antagonists for stress ulcer prophylaxis in critically ill patients: a systematic review and meta-analysis∗. Crit Care Med. 2013 ; 41 (3). 693-705
15. Olsen KM, Devlin JW. Comparison of the enteral and intravenous lansoprazole pharmacodynamic responses in critically ill patients. Aliment Pharmacol Ther. 2008 ; 28 (3). 326-333
16. Banerjee R, Reddy DN, Guda NM, et al. Oral buffered esomeprazole is superior to i.v. pantoprazole for rapid rise of intragastric pH: a wireless pH metry analysis. J Gastroenterol Hepatol. 2010 ; 25 (1). 43-47
17. Freston J, Chiu YL, Pan WJ, Lukasik N, Täubel J. Effects on 24-hour intragastric pH: a comparison of lansoprazole administered nasogastrically in apple juice and pantoprazole administered intravenously. Am J Gastroenterol. 2001 ; 96 (7). 2058-2065
18. Taubel JJ, Sharma VK, Chiu YL, Lukasik NL, Pilmer BL, Pan WJ. A comparison of simplified lansoprazole suspension administered nasogastrically and pantoprazole administered intravenously: effects on 24-h intragastric pH. Aliment Pharmacol Ther. 2001 ; 15 (11). 1807-1817
19. Devlin JW, Bakshi A, Bungay K, Olsen KM. An in vitro comparison of different providers to deliver four proton pump inhibitor products through a feeding tube. Aliment Pharmacol Ther. 2006 ; 24 (11-12). 1603-1611
20. Devlin JW. Proton pump inhibitors for acid suppression in the intensive care unit: formulary considerations. Am J Health Syst Pharm. 2005 ; 62: S24 - S30
21. Devlin JW, Welage LS, Olsen KM. Proton pump inhibitor formulary considerations in the acutely ill. Part 1: pharmacology, pharmacodynamics, and available formulations. Ann Pharmacother. 2005 ; 39 (10). 1667-1677
22. Canadian Clinical Practice Guidelines. Strategies to optimize delivery and minimize risk of enteral nutrition. Motility agents. March, 2013. http://www.criticalcarenutrition.com/docs/cpgs2012/5.2.pdf. Accessed May 23, 2013.
23. Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 ; 1 (2). 71-80
24. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006 ; 166 (9). 1021-1026
25. Kuehn BM. IOM urges FDA to be more aggressive in monitoring safety of approved drugs. JAMA. 2012 ; 307 (23). 2475-2476
26. Stafford RS. Regulating off-label drug use - rethinking the role of the FDA. N Engl J Med. 2008 ; 358 (14). 1427-1429
27. Wood AJ. A proposal for radical changes in the drug-approval process. N Engl J Med. 2006 ; 355 (6). 618-623
28. Coopersmith CM, Wunsch H, Fink MP, et al. A comparison of critical care research funding and the financial burden of critical illness in the United States. Crit Care Med. 2012 ; 40 (4). 1072-1079
29. Bernard GR, Vincent JL, Laterre PF, et al. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 2001 ; 344 (10). 699-709
30. Ranieri VM, Thompson BT, Barie PS, et al. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med. 2012 ; 366 (22). 2055-2064
31. www.clinicaltrials.gov. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2013 May 24]. http://www.clinicaltrials.gov/ct2/results?term=stress+ulcer+prophylaxis&Search=Search. Accessed May 24, 2013.
32. Largent EA, Miller FG, Pearson SD. Going off-label without venturing off-course: evidence and ethical off-label prescribing. Arch Intern Med. 2009 ; 169 (19). 1745-1747
33. effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. the cardiac arrhythmia suppression trial (CAST) investigators. N Engl J Med. 1989 ; 321 (16). 406-412
34. US Food and Drug Administration. Proton pump inhibitors- Drug safety communication: Clostridium difficile-associated diarrhea can be associated with stomach acid drugs. http://wwwfdagov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm290838htm. Accessed October 23, 2012.
35. Maggio M, Corsonello A, Ceda G, et al. Proton pump inhibitors and risk of 1-year mortality and rehospitalization in older patients discharged from acute care hospitals. JAMA Intern Med. 2013 ; 173 (7). 518-523
36. Murphy CE, Stevens AM, Ferrentino N, et al. Frequency of inappropriate continuation of acid suppressive therapy after discharge in patients who began therapy in the surgical intensive care unit. Pharmacotherapy. 2008 ; 28 (8). 968-976
37. Wohlt PD, Hansen LA, Fish JT. Inappropriate continuation of stress ulcer prophylactic therapy after discharge. Ann Pharmacother. 2007 ; 41 (10). 1611-1616
38. Zeigler AJ, McAllen KJ, Slot MG, Barletta JF. Medication reconciliation effect on prolonged inpatient stress ulcer prophylaxis. Ann Pharmacother. 2008 ; 42 (7). 940-946