Academic Pediatrics
Volume 9, Issue 2 , Pages 81-88 , March 2009

Off-Label Prescribing to Children in the United States Outpatient Setting

Received 15 June 2007 ,Accepted 21 November 2008.

References 

  1. Horen B, Montastruc J, Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Phamacol. 2002;54:665–670
  2. Ufer M, Kimland E, Bergman M. Adverse drug reactions and off-label prescribing for paediatric outpatients: a one-year survey of spontaneous reports in Sweden. Pharmacoepidemiol Drug Saf. 2004;13:147–152
  3. Best Pharmaceuticals for Children Act. Pub L No. 107-109, 115 Stat 1408.
  4. Pediatric Research Equity Act of 2003. Pub L No. 108-155, 117 Stat 1936.
  5. Roberts R, Rodriguez W, Murphy D, Crescenzi T. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies. JAMA. 2003;290:905–911
  6. 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
  7. Shah S, Hall M, Goodman D, et al. Off-label drug use in hospitalized children. Arch Pediatr Adolesc Med. 2007;161:282–290
  8. Chalumeau M, Treluyer J, Salanave B, et al. Off label and unlicensed drug use among French office based paediatricians. Arch Dis Child. 2000;83:502–505
  9. Ekins-Daukes S, Helms PJ, Simpson CR, Taylor MW, McLay JS. Off-label prescribing to children in primary care: a retrospective observational study. Eur J Clin Pharmacol. 2004;60:349–353
  10. Ufer M, Rane A, Karlsoon A, et al. Widespread off-label prescribing of topical but not systemic drugs for 350,000 paeditric patients in Stockholm. Eur J Clin Pharmacol. 2003;58:779–783
  11. Schirm E, Tobi H, de Jong-van den Berg T. Risk factors for unlicensed and off-label drug use in children outside the hospital. Pediatrics. 2003;111:291–295
  12. Bajcetic M, Jelisavcic M, Mitrovic J, et al. Off label and unlicensed drugs use in paediatric cardiology. Eur J Clin Pharmacol. 2005;61:775–779
  13. McKinzie J, Wright S, Wrenn K. Pediatric drug therapy in the emergency department: does it meet FDA-approved prescribing guidelines?. Am J Emerg Med. 1997;15(2):118–122
  14. Eiland L, Knight P. Evaluating the off-label use of medications in children. Am J Health Syst Pharm. 2006;63:1062–1065
  15. Chen H, Reeves J, Fincham J, et al. Off label use of antidepressant, anticonvulsant, and antipsychotic medications among Georgia Medicaid enrollees in 2001. J Clin Psychiatry. 2006;67:972–982
  16. Yoon EY, Dombkowski KJ, Rocchini A, Lin J-J, Davis MM. Off-label utilization of antihypertensive medications in children. Ambul Pediatr. 2007;7:299–303
  17. Cherry DK, Burt CW, Woodwell D. National Ambulatory Medical Care Survey: 2001 Summary. Adv Data. 2003;(337):1–44
  18. International Classification of Disease, 9th Revision, Clinical Modification. 6th edition. Los Angeles: Calif; 2006;
  19. Physician's Desk Reference Web site. Available at: http://www.pdr.net. Accessed October 23, 2006.
  20. Center for Drug Evaluation and Research, Food and Drug Administration. Drugs@FDA. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed July 27, 2006>.
  21. Volume I Usp DI. Drug Information for the Heatlh Care Professional. 24th ed. Greenwood Village: Colo: Thompson MICROMEDEX; 2004;
  22. National Center for Health Statistics. Ambulatory Care Drug Database System. Available at: http://www.cdc.gov/nchs/about/major/ahcd/ambulatory.htm. Accessed March 12, 2008.
  23. 't Jong GW, Eland IA, Sturkenboem MC, van der Anker JN, Stricker BH. Determinants for drug prescribing to children below the minimum licensed age. Eur J Clin Pharmacol. 2003;58:701–705
  24. Carrin G. Drug prescribing: a discussion of its variability and (ir)rationality. Health Policy. 1987;7:73–94
  25. Kuhlthau K, Beal A, Ferris T, Perrin J. Comparing a diagnosis list with a survey method to identify children with chronic conditions in an urban health center. Ambul Pediatr. 2002;2:58–62
  26. Turner S, Nunn AJ, Fielding K, Choonara I. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study. Acta Paediatra. 1999;88:965–968
  27. Henney J. Withdrawal of troglitazone and cisapride. JAMA. 2000;283:2228
  28. Starke PR, Weaver J, Chowdhury BA. Boxed warning added to promethazine labeling for pediatric use. New Engl J Med. 2005;352:2653
  29. U.S. Food and Drug Administration. Center for Drug Evaluation and Research. Suicidality in Children and Adolescents Being Treated with Antidepressant Medications. Available at: http://www.fda.gov/cder/drug/antidepressants/ssripha200410.htm. Accessed March 7, 2008.
  30. Novartis. Elidel (pimecrolimus) Cream 1%. Available at: http://www.pharma.us.novartis.com/product/pi/pdf/elidel.pdf. Accessed September 21, 2007.
  31. US Food and Drug Administration. Pediatric exclusivity labeling changes. Available at: http://www.fda.gov/cder/pediatric/labelchange.htm. Accessed September 20, 2007.
  32. Nyquist AC, Gonzales R, Steiner JF, Sande MA. Antibiotic prescribing for children with colds, upper respiratory tract infections, and bronchitis. JAMA. 1998;279:875–877
  33. Arroll B, Kenealy T. Antibiotics for the common cold and acute purulent rhinitis. Cochrane Database Syst Rev. 2005;3:CD000247
  34. Centers for Disease Control and Prevention . Infant deaths associated with cough and cold medications—two states, 2005. MMWR Morb Mortal Wkly Rep. 2007;56:1–4
  35. Zito JM, Safer DJ, dosReis S, Gardner JF, Boles M, Lynch F. Trends in the prescribing of psychotropic medications to preschoolers. JAMA. 2000;283:1025–1030
  36. Cooper WO, Arbogast PG, Ding H, et al. Trends in prescribing of antipsychotic medications for US children. Ambul Pediatr. 2006;6:79–83
  37. Bhatara V, Feil M, Hoagwood K, et al. National trends in concomitant psychotropic medications with stimulants in pediatric visits: practice versus knowledge. J Atten Disord. 2004;7:217–226
  38. Findling R, Steiner H, Weller EB. Use of antipsychotics in children and adolescents. J Clin Psychiatry. 2005;66:29–40
  39. Sikich L, Hamer RM, Bashford RA, et al. A pilot study of risperidone, olanzapine, and haloperidol in psychotic youth: a double-blind, randomized, 8-week trial. Neuropsychopharmacology. 2004;29:133–145
  40. King B, Zwi K, Nunn K, Longworth J, Dossetor D. Use of risperidone in a paediatric population: an observational study. J Paediatr Child Health. 2003;39:523–527
  41. Chen S, Lu K, Sun H. Randomized placebo-controlled trial comparing montelukast and cetirizine for treating perennial allergic rhinitis in children aged 2–6 yr. Pediatr Allergy Immunol. 2006;17:49–54
  42. National Institute of Child Health and Human Development. Table 1: current status of drugs that have been listed by NIH (NICHD) for BPCA. Available at: http://bpca.nichd.nih.gov/about/process/upload/Drug_Table_2007.pdf. Accessed May 4, 2008.
  43. Giacoia G, Birenbaum D, Sachs H, Mattison D. The newborn drug development intiative. Pediatrics. 2006;117:S1–S8
  44. Giacoia G, Mattison D. Newborns and drug studies: the NICHD/FDA newborn drug development initiative. Clin Ther. 2005;27:796–813
  45. Radley D, Finkelstein S, Stafford R. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166:1021–1026
  46. Li V, Jaffe M, Li W, Haynes H. Off-label dermatologic therapies. Arch Dermatol. 1998;134:1449–1454
  47. Robertson J, Shilkofski N. The Harriet Lane Handbook: A Manual for Pediatric House Officers. 17th ed.. Philadelphia, Pa: Mosby; 2005;
  48. Thomas C, Conrad P, Casler R, Goodman E. Trends in the use of psychotropic medications among adolescents, 1994 to 2001. Psychiatric Serv. 2006;57:63–69

PII: S1876-2859(08)00269-6

doi: 10.1016/j.acap.2008.11.010

Academic Pediatrics
Volume 9, Issue 2 , Pages 81-88 , March 2009