U.S. physician knowledge of the FDA-approved indications and evidence base for commonly prescribed drugs: Results of a national survey

Pharmacoepidemiology and Drug Safety

Volumn 18, Issue 11, 2009, Pages 1094-1100

  Chen, Donna T ^a,b   Wynia, Matthew K ^c,d   Moloney, Rachael M ^e   Alexander, G Caleb ^e,f,g,h  

^a UNIVERSITY OF VIRGINIA   (United States)

^b UNIVERSITY OF VIRGINIA   (United States)

^c AMERICAN MEDICAL ASSOCIATION   (United States)

^d UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

^e UNIVERSITY OF CHICAGO   (United States)

^f UNIVERSITY OF CHICAGO   (United States)

^g UNIVERSITY OF CHICAGO   (United States)

^h UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

Author keywords

Drug regulation; FDA approval; FDA label; Off label prescribing; Physician knowledge

Indexed keywords

AMFEBUTAMONE; ATORVASTATIN; AZITHROMYCIN; BUDESONIDE; DONEPEZIL; ESCITALOPRAM; FLUTICASONE; FLUTICASONE PROPIONATE; GABAPENTIN; HALOPERIDOL; LISINOPRIL; LORAZEPAM; MELOXICAM; METOPROLOL; METOPROLOL TARTRATE; MODAFINIL; MONTELUKAST; PAROXETINE; QUETIAPINE; SERTRALINE; TOPIRAMATE; TRAZODONE; VALPROATE SEMISODIUM; VALPROIC ACID; VENLAFAXINE;

ACCURACY; ARTICLE; DRUG APPROVAL; DRUG INDICATION; DRUG MARKETING; EVIDENCE BASED PRACTICE; FOOD AND DRUG ADMINISTRATION; HUMAN; OFF LABEL DRUG USE; PHYSICIAN; PHYSICIAN ATTITUDE; PRESCRIPTION; PRIMARY MEDICAL CARE; PRIORITY JOURNAL; PROFESSIONAL KNOWLEDGE; PSYCHIATRIST; UNITED STATES;

AMINES; ANALGESICS; CYCLOHEXANECARBOXYLIC ACIDS; DATA COLLECTION; DIABETIC NEPHROPATHIES; DRUG APPROVAL; DRUG LABELING; DRUG PRESCRIPTIONS; DRUG UTILIZATION REVIEW; EVIDENCE-BASED MEDICINE; GAMMA-AMINOBUTYRIC ACID; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; OFF-LABEL USE; PHYSICIAN'S PRACTICE PATTERNS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 70549113620     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1825     Document Type: Article

References (22)

1. US Food and Drug Administration. Use of approved drugs for unlabeled indications. FDA Drug Bulletin. 1982; 12(1): 4-5. Available from http://www.bioethicswatch.org/pubs/FDA-MedBull.pdf. Accessibility verified 8/6/2009.
2. Beck JM, Azari EDFDA. Off-label use, and informed consent: debunking myths and misconceptions. Food Drug Law J 1998; 53(71): 1-46.
3. Loder EW, Biondi DM. Off-label prescribing of drugs in specialty headache practice. Headache 2004; 44: 636-641.
4. Brosgart CL, Mitchell T, Charlebois E, et al. Off-label drug use in human immunodeficiency virus disease. J Acquir Immune Defic Syndr Hum Retrovirol. 1996; 12: 56-62. (Pubitemid 26144709)
5. Choonara I, Conroy S. Unlicensed and off-label drug use in children: implications for safety. Drug Saf 2002; 25: 1-5. (Pubitemid 34208327)
6. Rayburn WF, Turnbull GL. Off-label drug prescribing on a state university obstetric service. J Reprod Med 1995; 40: 186-188.
7. McIntyre J, Conroy S, Avery A, Corns H, Choonara I. Unlicensed and off-label prescribing of drugs in general practice. Arch Dis Child 2000; 83: 498-501.
8. Adams C, Young A. Risky Rx: A Knight Ridder Investigation. Newspaper article series, Nov 2-4, 2003. http://www.realcities.com/mld/ krwashington/news/special-packages/riskyrx/ [Accessed 15 September 2008].
9. Radley D, Finkelstein S, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med 2006; 166: 1021-1026.
10. DeMonaco NA, Ali A, von Hippel E. The major role of clinicians in the discovery of off-label drug therapies. Pharmacotherapy 2006; 26: 323-332. (Pubitemid 43334671)
11. Cranston JW, Williams MA, Nielsen NH, Bezman RJ. For the Council on Scientific Affairs. Report of the council on scientific affairs: unlabeled indications of Food and Drug Administration-approved drugs. Drug Inf J 1998; 32: 1049-1061.
12. Meadows WA, Hollowell BD. 'Off-label' drug use: an FDA regulatory term, not a negative implication of its medical use. Int J Impot Res 2008; 20: 135-144.
13. Walton SM, Schumock GT, Lee KV, Alexander GC, Meltzer D, Stafford RS. Prioritizing medications for policy and research initiatives examining off-label prescribing. Pharmacotherapy 2008; 28: 1443-1452.
14. Thomson Healthcare. Drugdex1 Consults: Recommendation, Evidence, and Efficacy Ratings. [Accessed 17 July 2008 http://www. thomsonhc.com/home/ dispatch]
15. Dillman DA. The design and administration of mail surveys. Ann Rev Sociol 1991; 17: 225-249.
16. American Association for Public Opinion Research. Standard Definitions: Final Dispositions of Case Codes and Outcome Rates for Surveys. 5th ed. Lenexa, Kansas: AAPOR; 2008:35. Available at: http://www.aapor.org/uploads/Standard- Definitions-04-08-Final.pdf [Accessed 15 October 2008].
17. Black box warning for quetiapine. FDA label revision, action date 20/9/2006. http://www.fda.gov/cder/foi/label/2006/020639s023lbl.pdf [Accessed 15 September 2008].
18. Label revision for lorazepam (Ativan1) FDA label revision, action date 18/4/2007 http://www.fda.gov/cder/foi/label/2007/017794s034s035lbl.pdf [Accessed 9 October 2008].
19. Center for Drug Evaluation and Research (CDER). US Food and Drug Administration 2003. Oncology Tools: A Short Tour. http://www.fda. gov/Cder/cancer/tour.htm [Accessed 15 September 2008].
20. US Department of Health and Human Services, Food and Drug Administration. Guidance for Industry: Consumer-directed Broadcast Advertisements. August 1999.
21. Dai C, Stafford RS, Alexander C. National trends in Cox-2 inhibitor use since market release: non-selective diffusion of a selectively costeffective innovation. Arch Intern Med 2005; 165: 171-177.
22. Thomson Micromedex DrugDex1 Compendium Revision Request - CAG-00391. Centers for Medicare and Medicaid Services 2008. Available at: http://www.cms.hhs.gov/mcd/ncpc-view-document.asp?id=16 [Accessed 13 August 2008].