Controlling off-label medication use

Annals of Internal Medicine

Volumn 150, Issue 5, 2009, Pages 344-347

  Gillick, Muriel R ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AGALSIDASE BETA; ANTIINFECTIVE AGENT; ANTIRHEUMATIC AGENT; BECAPLERMIN; BEVACIZUMAB; BOSENTAN; CENTRAL NERVOUS SYSTEM AGENTS; CYTOKINE; DERMATOLOGICAL AGENT; ENFUVIRTIDE; ETANERCEPT; HEMATOLOGIC AGENT; IMMUNOLOGIC AGENT; MONOCLONAL ANTIBODY; RECOMBINANT ENZYME; VASODILATOR AGENT; ANTINEOPLASTIC AGENT; PRESCRIPTION DRUG;

ANKYLOSING SPONDYLITIS; ARTICLE; BEHCET DISEASE; BIOTECHNOLOGICAL PRODUCTION; BREAST CANCER; COLON CANCER; COST CONTROL; DIABETIC FOOT; DRUG APPROVAL; DRUG CONTROL; DRUG COST; DRUG INDICATION; DRUG LABELING; DRUG LEGISLATION; DRUG MONITORING; ENZYME DEFICIENCY; FABRY DISEASE; FOOD AND DRUG ADMINISTRATION; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LUNG NON SMALL CELL CANCER; OFF LABEL DRUG USE; PANCREAS CANCER; PATIENT SAFETY; PRESCRIPTION; PRIORITY JOURNAL; PSORIASIS; PSORIATIC ARTHRITIS; PULMONARY HYPERTENSION; PYODERMA GANGRENOSUM; RAYNAUD PHENOMENON; RISK BENEFIT ANALYSIS; SARCOIDOSIS; SCLERODERMA; BOOK; ECONOMICS; LEGISLATION AND JURISPRUDENCE; MEDICAID; MEDICAL LITERATURE; MEDICARE; UNITED STATES;

ANTINEOPLASTIC AGENTS; COST CONTROL; DRUG APPROVAL; DRUG LABELING; MEDICAID; MEDICARE; PHARMACOPOEIAS AS TOPIC; PRESCRIPTION DRUGS; REFERENCE BOOKS, MEDICAL; UNITED STATES;

EID: 61449256105     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/0003-4819-150-5-200903030-00108     Document Type: Article

References (25)

1. Bennett WM. Off-label use of approved drugs: therapeutic opportunity and challenges [Editorial]. J Am Soc Nephrol. 2004;15:830-1. [PMID: 14978188]
2. Committee on Drugs. American Academy of Pediatrics. Uses of drugs not described in the package insert (off-label uses). Pediatrics. 2002;110:181-3. [PMID: 12093968]
3. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166:1021-6. [PMID: 16682577]
4. Eastman P. Reimbursement policies discourage off-label drug use. Oncology Times. 2005;27:8, 10.
5. Kocs D, Fendrick AM. Effect of off-label use of oncology drugs on pharmaceudcal costs: the rituximab experience. Am J Manag Care. 2003;9:393-400. [PMID: 12744301]
6. Rader RA. (Re)defining biopharmaceutical. Nat Biotechnol. 2008;26:743-51. [PMID: 18612293]
7. Biotechnology Industry Organization. Guide to Biotechnology 2007. Accessed at www.bio.org/speeches/pubs/er/BiotechGuide.pdf on 17 September 2008.
8. Graves JE, Nunley K, Heffernan MP. Off-label uses of biologies in dermatology: rituximab, omalizumab, infliximab, etanercept, adalimumab, efalizumab, and alefacept (part 2 of 2). J Am Acad Dermatol. 2007;56:e55-79. [PMID: 17190618]
9. Centers for Medicare & Medicaid Services. Nadonal Health Expenditures 2007. Accessed at www.cms.hhs.gov/NationalHealthExpendData/ downloads/tables.pdf on 19 November 2008.
10. Aggarwal S. What's fueling the biotech engine-2007. Nat Biotechnol. 2008; 26:1227-33. [PMID: 18997759]
11. Moore TJ, Cohen MR, Furberg CD. Serious adverse drug events reported to the Food and Drug Administradon, 1998-2005. Arch Intern Med. 2007;167:1752-9. [PMID: 17846394]
12. Giezen TJ, Mantel-Teeuwisse AK, Straus SM, Schellekens H, Leufkens HG, Egberts AC. Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA. 2008;300:1887-96. [PMID: 18940975]
13. Maisel WH. Medical device regulation: an introduction for the pracdcing physician. Ann Intern Med. 2004;140:296-302. [PMID: 14970153]
14. Centers for Medicare & Medicaid Services. Medicare Coverage Determination Process. Accessed at www.cms.hhs.gov/DeterminationProcess/ on 25 November 2008.
15. HCUP Fact Book No. 7. Hospitalizadons in the United States, 2003. Table 5. Top 10 Procedures Performed in U.S. Hospitals For Various Age Groups (Excluding Pregnancy- and Childbirth-Related Procedures), 2003. Accessed at www.ahrq.gov/data/hcup/factbk7/fbk7tab5.htm on 11 September 2008.
16. Centers for Medicare & Medicaid Services. Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates. August 1, 2007. Accessed at www.cms.hhs.gov/AcuteInpatientPPS/ downloads/CMS-1533-FC.pdfon 11 September 2008.
17. Keenan PS, Neumann PJ, Phillips KA. Biotechnology and Medicare's new technology policy: lessons from three case studies. Health AfT (Millwood). 2006;25:1260-9. [PMID: 16966721]
18. Tunis SR, Pearson SD. Coverage opdons for promising technologies: Medicare's 'coverage with evidence development'. Health AfT (Millwood). 2006;25:1218-30. [PMID: 16966717]
19. Ramsey SD. How should we pay the piper when he's calling the tune? On the long-term affordability of cancer care in the United States. J Clin Oncol. 2007;25:175-9. [PMID: 17210936]
20. Soares M. Off-label indications for oncology drug use and drug compendia: history and current status. J Oncol Pract. 2005;1:102-5.
21. Jacobson PD, Parmet WE. A new era of unapproved drugs: the case of Abigail Alliance v Von Eschenbach. JAMA. 2007;297:205-8. [PMID: 17213404]
22. Ansani N, Sirio C, Smitherman T, Fedutes-Henderson B, Skledar S, Weber RJ, et al. Designing a strategy to promote safe, innovative off-label use of medicadons. Am J Med Qual. 2006;21:255-61. [PMID: 16849782]
23. Boos J. Off label use-label off use? [Editorial]. Ann Oncol. 2003;14:1-5. [PMID: 12488285]
24. Stafford RS. Reguladng off-label drug use - rethinking the role of the FDA. N Engl J Med. 2008;358:1427-9. [PMID: 18385495]
25. Gazarian M, Kelly M, McPhee JR, Graudins LV, Ward RL, Campbell TJ. Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust. 2006;185:544-8. [PMID: 17115966]