Advertisement

Supportive Care in Cancer

, Volume 12, Issue 5, pp 302–305 | Cite as

Off-label prescribing in oncology

  • Susan G. PooleEmail author
  • Michael J. Dooley
Original Article

Abstract

Off-label prescribing occurs when a practitioner prescribes a drug for a use, or in a manner, not listed in the ‘approved product information’ (API) for that drug. The literature suggests that this is a frequent occurrence in many areas of medicine, but data are limited in the hospitalized oncology setting. The aim of this study was to quantify the extent of off-label prescribing in a hospitalized oncology population in Australia. The study was conducted at Peter MacCallum Cancer Centre, Australia. On a single day the medication charts of all hospitalized patients were prospectively reviewed. Drug prescribing was assessed for licensing status by comparison with the API as approved by the Therapeutic Goods Administration of Australia. Prescriptions were classified as licensed, off-label or unlicensed. Medication charts of 130 patients were assessed. There were 1351 prescriptions. In 293 (22%) of the prescriptions the drug was either off-label (242, 18%) or unlicensed (51, 4%). Among the 130 patients, 110 (85%) received at least one drug that was prescribed off-label or that was unlicensed. Off-label dosing was the most frequent reason for a drug being off-label (139, 10% of all prescriptions). Off-label due to use for an unapproved indication was found in 118 prescriptions (9%), and off-label due to an unapproved route of administration was found in 38 prescriptions (3%). Off-label prescribing is widespread in the acute hospitalized oncology population, with approximately 22% of all prescriptions being for off-label or unlicensed medication. Such prescribing affects a significant proportion of patients.

Keywords

Off-label drug use Unlicensed drug use Oncology 

References

  1. 1.
    Atkinson CV, Kirkham SR (1999) Unlicensed uses for medication in a palliative care unit. Palliat Med 13:145–152CrossRefPubMedGoogle Scholar
  2. 2.
    Bailes JS (1995) Current issues in oncology reimbursement. Oncology (Huntingt) 9 [11 Suppl]:185–189Google Scholar
  3. 3.
    Banner W Jr (2002) Off label prescribing in children. BMJ 324:1290–1291CrossRefPubMedGoogle Scholar
  4. 4.
    Blum RS (2002) Legal considerations in off-label medication prescribing. Arch Intern Med 162:1777–1779CrossRefPubMedGoogle Scholar
  5. 5.
    Brosgart CL, Mitchell T, Charlebois E, Coleman R, Mehalko S, Young J, Abrams DI (1996) Off-label drug use in human immunodeficiency virus disease. J Acquir Immune Defic Syndr Hum Retrovirol 12:56–62PubMedGoogle Scholar
  6. 6.
    Bucheler R, Schwab M, Morike K, Kalchthaler B, Mohr H, Schroder H, Schwoerer P, Gleiter CH (2002) Off label prescribing to children in primary care in Germany: retrospective cohort study. BMJ 324:1311–1312CrossRefPubMedGoogle Scholar
  7. 7.
    Cohen JS (2001) Adverse drug effects, compliance, and initial doses of antihypertensive drugs recommended by the Joint National Committee vs the Physicians’ Desk Reference. Arch Intern Med 161:880–885CrossRefPubMedGoogle Scholar
  8. 8.
    Cohen JS, Insel PA (1996) The Physicians’ Desk Reference. Problems and possible improvements. Arch Intern Med 156:1375–1380CrossRefPubMedGoogle Scholar
  9. 9.
    Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, Knoeppel C, Seyberth H, Pandolfini C, Raffaelli MP, Rocchi F, Bonati M, Jong G, de Hoog M, van den Anker J (2000) Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. BMJ 320:79–82PubMedGoogle Scholar
  10. 10.
    Horen B, Montastruc JL, Lapeyre-Mestre M (2002) Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol 54:665–670CrossRefPubMedGoogle Scholar
  11. 11.
    Johnson LJ (2001) Off-Label prescribing and the standard of care. Med Econ 78:97PubMedGoogle Scholar
  12. 12.
    Landow L (1999) Off-label use of approved drugs. Chest 116:589–591CrossRefGoogle Scholar
  13. 13.
    McIntyre J, Conroy S, Avery A, Corns H, Choonara I (2000) Unlicensed and off label prescribing of drugs in general practice. Arch Dis Child 83:498–501PubMedGoogle Scholar
  14. 14.
    Mortenson LE (1991) The off-label debate: a threat to the future of cancer care. Cancer Invest 9:597–599PubMedGoogle Scholar
  15. 15.
    Pavis H, Wilcock A (2001) Prescribing of drugs for use outside their licence in palliative care: survey of specialists in the United Kingdom. BMJ 323:484–485CrossRefPubMedGoogle Scholar
  16. 16.
    Schirm E, Tobi H, de Jong-van den Berg LT (2002) Unlicensed and off label drug use by children in the community: cross sectional study. BMJ 324:1312–1313CrossRefPubMedGoogle Scholar
  17. 17.
    Thomas J (ed) (2001) Australian prescription products guide, 30th edn. Australian Pharmaceutical Publishing Company, Hawthorn, VictoriaGoogle Scholar
  18. 18.
    ’t Jong GW, Vulto AG, de Hoog M, Schimmel KJ, Tibboel D, van den Anker JN (2001) A survey of the use of off-label and unlicensed drugs in a Dutch children’s hospital. Pediatrics 108:1089–1093PubMedGoogle Scholar
  19. 19.
    ’t Jong GW, Eland IA, Sturkenboom MC, van den Anker JN, Stricker BH (2002) Unlicensed and off label prescription of drugs to children: population based cohort study. BMJ 324:1313–1314CrossRefPubMedGoogle Scholar
  20. 20.
    Todd J, Davies A (1999) Use of unlicensed medication in palliative medicine. Palliat Med 13:446Google Scholar
  21. 21.
    Turner S (1999) Unregistered and off-label drug use in paediatric inpatients. Aust J Hosp Pharm 29:265–268Google Scholar
  22. 22.
    United States General Accounting Office (1991) Off-label drugs, reimbursement policies constrain physicians in their choice of cancer therapies (report GAO/PEMD-91-14). Washington DCGoogle Scholar

Copyright information

© Springer-Verlag 2004

Authors and Affiliations

  1. 1.Department of PharmacyPeter MacCallum Cancer CentreEast MelbourneAustralia
  2. 2.Department of Pharmacy PracticeMonash UniversityParkvilleAustralia

Personalised recommendations