Association of off-label drug use and adverse drug events in an adult population

JAMA Internal Medicine

Volumn 176, Issue 1, 2016, Pages 55-63

  Eguale, Tewodros ^a,b,c   Buckeridge, David L ^a   Verma, Aman ^a   Winslade, Nancy E ^a   Benedetti, Andrea ^a   Hanley, James A ^a   Tamblyn, Robyn ^a  

^a MCGILL UNIVERSITY   (Canada)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c MASSACHUSETTS COLLEGE OF PHARMACY AND HEALTH SCIENCES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMITRIPTYLINE; ANTICOAGULANT AGENT; ANTICONVULSIVE AGENT; ANTIDEPRESSANT AGENT; ANTIHISTAMINIC AGENT; ANTINEOPLASTIC AGENT; ANXIOLYTIC AGENT; CARDIOVASCULAR AGENT; CYCLOBENZAPRINE; GABAPENTIN; NEUROLEPTIC AGENT; OLANZAPINE; PRESCRIPTION DRUG; QUETIAPINE; SALBUTAMOL SULFATE; TERBUTALINE SULFATE; TRAZODONE;

ADULT; ADVERSE DRUG REACTION; AGED; ARTICLE; DISEASE ASSOCIATION; ELECTRONIC MEDICAL RECORD; FEMALE; HAZARD RATIO; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; OFF LABEL DRUG USE; PATIENT CARE; PRESCRIPTION; PRIORITY JOURNAL; SIDE EFFECT; ADOLESCENT; COHORT ANALYSIS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; MIDDLE AGED; PROPORTIONAL HAZARDS MODEL; QUEBEC; RETROSPECTIVE STUDY; STATISTICS AND NUMERICAL DATA; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; COHORT STUDIES; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; INCIDENCE; MALE; MIDDLE AGED; OFF-LABEL USE; PROPORTIONAL HAZARDS MODELS; QUEBEC; RETROSPECTIVE STUDIES; YOUNG ADULT;

EID: 84954532431     PISSN: 21686106     EISSN: None     Source Type: Journal    
DOI: 10.1001/jamainternmed.2015.6058     Document Type: Article

References (47)

1. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166(9):1021-1026.
2. Eguale T, Buckeridge DL, Winslade NE, Benedetti A, Hanley JA, Tamblyn R. Drug, patient, and physician characteristics associated with off-label prescribing in primary care. Arch Intern Med. 2012; 172(10):781-788.
3. Connolly HM, Crary JL, McGoon MD, et al. Valvular heart disease associated with fenfluramine-phentermine. N Engl J Med. 1997;337 (9):581-588.
4. Flowers CM, Racoosin JA, Kortepeter C. Seizure activity and off-label use of tiagabine. N Engl J Med. 2006;354(7):773-774.
5. US Food and Drug Administration. FDA issues second warning against treating leg camp with quinine. http://www.medscape.com/viewarticle/724798. Published July 8, 2010. Accessed September 28. 2015.
6. Levi M, Levy JH, Andersen HF, Truloff D. Safety of recombinant activated factor VII in randomized clinical trials. N Engl J Med. 2010;363(19):1791-1800.
7. Avorn J, Kesselheim A. A hemorrhage of off-label use. Ann Intern Med. 2011;154(8):566-567.
8. Waller PC, Evans SJ. A model for the future conduct of pharmacovigilance. Pharmacoepidemiol Drug Saf. 2003;12(1):17-29.
9. Schiff GD, Rucker TD. Computerized prescribing: building the electronic infrastructure for better medication usage. JAMA. 1998;279(13):1024-1029.
10. Institute of Medicine, Committee on the Assessment of the US Drug Safety System. Baciu A, Stratton K, Burke SP, eds. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: National Academies Press; 2006.
11. Dal Pan GJ. Monitoring the safety of medicines used off-label. Clin Pharmacol Ther. 2012;91(5):787-795.
12. Eguale T, Winslade N, Hanley JA, Buckeridge DL, Tamblyn R. Enhancing pharmacosurveillance with systematic collection of treatment indication in electronic prescribing: a validation study in Canada. Drug Saf. 2010;33(7):559-567.
13. Eguale T, Tamblyn R, Winslade N, Buckeridge D. Detection of adverse drug events and other treatment outcomes using an electronic prescribing system. Drug Saf. 2008;31(11):1005-1016.
14. Stafford RS. Regulating off-label drug use: rethinking the role of the FDA. N Engl J Med. 2008; 358(14):1427-1429.
15. Emmerich J, Dumarcet N, Lorence A. France's new framework for regulating off-label drug use. N Engl J Med. 2012;367(14):1279-1281.
16. Tamblyn R, Huang A, Perreault R, et al. The Medical Office of the 21st Century (MOXXI): effectiveness of computerized decision-making support in reducing inappropriate prescribing in primary care. CMAJ. 2003;169(6):549-556.
17. Tamblyn R, Eguale T, Huang A, Winslade N, Doran P. The incidence and determinants of primary nonadherence with prescribed medication in primary care: a cohort study. Ann Intern Med. 2014;160(7):441-450.
18. Health Canada. Drug Product Database. 2009. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php. Modified June 18, 2015. Accessed September 28, 2015.
19. Walton SM, Schumock GT, Lee KV, Alexander GC, Meltzer D, Stafford RS. Prioritizing future research on off-label prescribing: results of a quantitative evaluation. Pharmacotherapy. 2008; 28(12):1443-1452.
20. Hutchinson TA, Flegel KM, Kramer MS, Leduc DG, Kong HH. Frequency, severity and risk factors for adverse drug reactions in adult out-patients: a prospective study. J Chronic Dis. 1986;39(7):533-542.
21. Budnitz DS, Pollock DA, Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest JL. National surveillance of emergency department visits for outpatient adverse drug events. JAMA. 2006;296 (15):1858-1866.
22. Weber JCP. Epidemiology of adverse reactions to nonsteroidal anti-inflammatory drugs. In: Rainsford KD, Velo GP, eds. Advances in Inflammation Research. New York, NY: Raven Press; 1984:1-6.
23. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-383.
24. Zhang M, Holman CD, Price SD, Sanfilippo FM, Preen DB, Bulsara MK. Comorbidity and repeat admission to hospital for adverse drug reactions in older adults: retrospective cohort study. BMJ. 2009;338:a2752.
25. Martin RM, Biswas PN, Freemantle SN, Pearce GL, Mann RD. Age and sex distribution of suspected adverse drug reactions to newly marketed drugs in general practice in England: analysis of 48 cohort studies. Br J Clin Pharmacol. 1998;46(5):505-511.
26. Pouyanne P, Haramburu F, Imbs JL, Bégaud B; French Pharmacovigilance Centres. Admissions to hospital caused by adverse drug reactions: cross sectional incidence study. BMJ. 2000;320(7241): 1036.
27. Jacubeit T, Drisch D, Weber E. Risk factors as reflected by an intensive drug monitoring system. Agents Actions Suppl. 1990;29:117-125.
28. Sarkar U, López A, Maselli JH, Gonzales R. Adverse drug events in US adult ambulatory medical care. Health Serv Res. 2011;46(5):1517-1533.
29. Gill JM, Mainous AG III, Nsereko M. The effect of continuity of care on emergency department use. Arch Fam Med. 2000;9(4):333-338.
30. Tamblyn R, Abrahamowicz M, Dauphinee D, et al. Physician scores on a national clinical skills examination as predictors of complaints to medical regulatory authorities. JAMA. 2007;298(9):993-1001.
31. Chuang SK, Wei LJ, Douglass CW, Dodson TB. Risk factors for dental implant failure: a strategy for the analysis of clustered failure-time observations. J Dent Res. 2002;81(8):572-577.
32. Bellera CA, MacGrogan G, Debled M, de Lara CT, Brouste V, Mathoulin-Pélissier S. Variables with time-varying effects and the Cox model: some statistical concepts illustrated with a prognostic factor study in breast cancer. BMC Med Res Methodol. 2010;10:20.
33. Chen DT, Wynia MK, Moloney RM, Alexander GC. US physician knowledge of the FDA-approved indications and evidence base for commonly prescribed drugs: results of a national survey. Pharmacoepidemiol Drug Saf. 2009;18(11):1094-1100.
34. Schiff GD. Computerized prescriber order entry: models and hurdles. Am J Health Syst Pharm. 2002;59(15):1456-1460.
35. Zopf Y, Rabe C, Neubert A, Hahn EG, Dormann H. Risk factors associated with adverse drug reactions following hospital admission: a prospective analysis of 907 patients in two German university hospitals. Drug Saf. 2008;31(9): 789-798.
36. Steinman MA, Landefeld CS, Rosenthal GE, Berthenthal D, Sen S, Kaboli PJ. Polypharmacy and prescribing quality in older people. J Am Geriatr Soc. 2006;54(10):1516-1523.
37. Johnell K, Klarin I. The relationship between number of drugs and potential drug-drug interactions in the elderly: a study of over 600 000 elderly patients from the Swedish Prescribed Drug Register. Drug Saf. 2007;30(10):911-918.
38. Corsonello A, Pedone C, Corica F, Mussi C, Carbonin P, Antonelli Incalzi R; Gruppo Italiano di Farmacovigilanza nell'Anziano (GIFA) Investigators. Concealed renal insufficiency and adverse drug reactions in elderly hospitalized patients. Arch Intern Med. 2005;165(7):790-795.
39. Bates DW, Miller EB, Cullen DJ, et al; ADE Prevention Study Group. Patient risk factors for adverse drug events in hospitalized patients. Arch Intern Med. 1999;159(21):2553-2560.
40. Bégaud B, Martin K, Fourrier A, Haramburu F. Does age increase the risk of adverse drug reactions? Br J Clin Pharmacol. 2002;54(5):550-552.
41. Gurwitz JH, Avorn J. The ambiguous relation between aging and adverse drug reactions. Ann Intern Med. 1991;114(11):956-966.
42. Galanter W, Falck S, Burns M, Laragh M, Lambert BL. Indication-based prescribing prevents wrong-patient medication errors in computerized provider order entry (CPOE). J Am Med Inform Assoc. 2013;20(3):477-481.
43. Forster AJ, Auger C; ISTOP ADE Investigators. Using information technology to improve the monitoring of outpatient prescribing. JAMA Intern Med. 2013;173(5):382-384.
44. Gandhi TK, Weingart SN, Borus J, et al. Adverse drug events in ambulatory care. N Engl J Med. 2003;348(16):1556-1564.
45. Classen DC, Bates DW. Finding the meaning in meaningful use. N Engl J Med. 2011;365(9):855-858.
46. Rodríguez-Monguió R, Otero MJ, Rovira J. Assessing the economic impact of adverse drug effects. Pharmacoeconomics. 2003;21(9):623-650.
47. Al Hamid A, Ghaleb M, Aljadhey H, Aslanpour Z. A systematic review of hospitalization resulting from medicine-related problems in adult patients. Br J Clin Pharmacol. 2014;78(2):202-217.