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Off-label prescribing in oncology

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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.

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References

  1. Atkinson CV, Kirkham SR (1999) Unlicensed uses for medication in a palliative care unit. Palliat Med 13:145–152

    Article  CAS  PubMed  Google Scholar 

  2. Bailes JS (1995) Current issues in oncology reimbursement. Oncology (Huntingt) 9 [11 Suppl]:185–189

  3. Banner W Jr (2002) Off label prescribing in children. BMJ 324:1290–1291

    Article  PubMed  Google Scholar 

  4. Blum RS (2002) Legal considerations in off-label medication prescribing. Arch Intern Med 162:1777–1779

    Article  PubMed  Google Scholar 

  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 12:56–62

    CAS  PubMed  Google Scholar 

  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 324:1311–1312

    Article  PubMed  Google Scholar 

  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 161:880–885

    Article  CAS  PubMed  Google Scholar 

  8. Cohen JS, Insel PA (1996) The Physicians’ Desk Reference. Problems and possible improvements. Arch Intern Med 156:1375–1380

    Article  CAS  PubMed  Google Scholar 

  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 320:79–82

    CAS  PubMed  Google Scholar 

  10. Horen B, Montastruc JL, Lapeyre-Mestre M (2002) Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol 54:665–670

    Article  PubMed  Google Scholar 

  11. Johnson LJ (2001) Off-Label prescribing and the standard of care. Med Econ 78:97

    CAS  PubMed  Google Scholar 

  12. Landow L (1999) Off-label use of approved drugs. Chest 116:589–591

    Article  CAS  Google Scholar 

  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 83:498–501

    CAS  PubMed  Google Scholar 

  14. Mortenson LE (1991) The off-label debate: a threat to the future of cancer care. Cancer Invest 9:597–599

    CAS  PubMed  Google Scholar 

  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 323:484–485

    Article  CAS  PubMed  Google Scholar 

  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 324:1312–1313

    Article  PubMed  Google Scholar 

  17. Thomas J (ed) (2001) Australian prescription products guide, 30th edn. Australian Pharmaceutical Publishing Company, Hawthorn, Victoria

  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 108:1089–1093

    PubMed  Google Scholar 

  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 324:1313–1314

    Article  PubMed  Google Scholar 

  20. Todd J, Davies A (1999) Use of unlicensed medication in palliative medicine. Palliat Med 13:446

    CAS  Google Scholar 

  21. Turner S (1999) Unregistered and off-label drug use in paediatric inpatients. Aust J Hosp Pharm 29:265–268

    Google Scholar 

  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 DC

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Authors and Affiliations

  1. Department of Pharmacy, Peter MacCallum Cancer Centre, St Andrews Place, 3002, East Melbourne, Victoria, Australia

    Susan G. Poole & Michael J. Dooley

  2. Department of Pharmacy Practice, Monash University, 381 Royal Parade, 3052, Parkville, Victoria, Australia

    Michael J. Dooley

Authors
  1. Susan G. Poole
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  2. Michael J. Dooley
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Correspondence to Susan G. Poole.

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Poole, S.G., Dooley, M.J. Off-label prescribing in oncology. Support Care Cancer 12, 302–305 (2004). https://doi.org/10.1007/s00520-004-0593-6

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  • DOI: https://doi.org/10.1007/s00520-004-0593-6

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