Skip to main content

Advertisement

SpringerLink
Log in

Off-label drug use in children

  • Original Article
  • Published:
The Indian Journal of Pediatrics Aims and scope Submit manuscript

Abstract

Objective

To determine the extent and nature of off-label drug use in children admitted to a pediatric general ward in a tertiary health care centre

Methods

Consecutive patients aged 1 mo-12 years admitted to the general wards in a tertiary care center in Mumbai over a two-month period were prospectively enrolled in the study. British National Formulary [BNF] version 2005 was used to ascertain if the drug use was “off-label”. The off-label use was categorized as: administration of a greater/lesser dose, administration at a higher/lower frequency than indicated, administration for indications not described, administration of a drug not licensed for use in that age group and/ or use of alternative routes of administration. Descriptive statistics was used for calculating the off-label drug use.

Results

Two thousand prescriptions received by 600 subjects (M:F= 1.47:1) were analyzed. One thousand and forty-five (50.62%) prescriptions were off-label. The off-label drug use rate was 1.74+/−1.56 per patient. The maximum rate of off-label drugs was in infants (2.33/patient). ‘alteration in dosage’ was by far the commonest reason for off-label use; followed by ‘age’ and ‘indication’. Furosemide (i. v.), diazepam (i.v), cefotaxime (i.v), ethambutol (tab) and prednisolone (tab) were the five commonest off-label drugs used in the study population.

Conclusions

Off-label drug use was highly prevalent in general pediatric ward of a tertiary care hospital in India

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ 2000; 320: 79–82

    Article  PubMed  CAS  Google Scholar 

  2. BNF for Children 2005. London, BMJ Publishing Group, 2005

  3. Mudur G. Indian Medical Association wants off-label prescribing. BMJ 2004; 328: 974.

    Article  PubMed  Google Scholar 

  4. Sharma DC. Indian experts protest against off-label drug use. Lancet 2004; 363: 1372.

    Article  PubMed  Google Scholar 

  5. Jhaj R, Bhargava VK, Uppal R, Lekha S, Reeta K, Kaur N. Use of cold medications for upper respiratory tract infections in children. Pharmacoepidemiol Drug Saf 2001; 10: 323–327.

    Article  PubMed  CAS  Google Scholar 

  6. Turner S, Longworth A, Nunn A, Choonara I. Unlicensed and off label drug use in paediatric wards: prospective study. BMJ 1998; 316: 313–315.

    Google Scholar 

  7. Pandolfini C, Impicciatore P, Provasi DP, Rocchi F, Campi R, Bonati M, The Italian Pediatric Off-label Collaborative Group. Off-label use of drugs in Italy: a prospective, observational and multicentre study. Acta Paediatr 2002; 91: 339–347.

    Article  PubMed  CAS  Google Scholar 

  8. ’t Jong GW, Vulto AG, De Hoog M, Schemmel KJ, Tibboel D, van den Anker JN. Unapproved and off-label use of drugs in a children’s hospital. New Engl J Med 2000; 343:1125

    Article  PubMed  Google Scholar 

  9. Gavrilov V, Lifshitz M, Levy J, Gorodischer R. Unlicensed and off-label medication use in a general pediatric ambulatory hospital unit in Israel. Isr Med Assoc J 2000; 2: 595–597.

    PubMed  CAS  Google Scholar 

  10. Craig JS, Henderson CR, Magee FA. The extent of unlicensed and off-label drug use in the pediatric ward of a district general hospital in Northern Ireland. Ir Med J 2001; 94:237–240 [abstract]

    PubMed  CAS  Google Scholar 

  11. Conroy S, Peden V. Unlicensed and off-label analgesic use in pediatric pain management. Paediatr Anaesthesia 2001; 11: 431–436.

    Article  CAS  Google Scholar 

  12. Turner S, Nunn AJ, Fielding K, Choonara I. Adverse drug reactions to unlicensed and off-label drugs in pediatric wards: a prospective study. Acta Paediatr 1999; 88: 965–968.

    Article  PubMed  CAS  Google Scholar 

  13. 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.

    Article  PubMed  CAS  Google Scholar 

  14. Conroy S, McIntyre J, Choonara I. Unlicensed and off-label drug use in neonates. Arch Dis Child Fetal Neonatal Ed 1999; 80: F142–F145.

    Article  PubMed  CAS  Google Scholar 

  15. Cuzzolin L, Zaccaron A, Fanos V. Unlicensed and off-label uses of drugs in paediatrics: a review of the literature. Fundamental and Clinical Pharmacology 2003; 17:125–131

    Article  PubMed  CAS  Google Scholar 

  16. American Academy of Pediatrics. Committee on Drugs 2000–2001. Pediatrics 2002; 110: 181–183.

    Article  Google Scholar 

  17. Hill P. Off license and off label prescribing in children: litigation fears for physicians. Arch Dis Child 2005; 90: 17–18.

    Article  Google Scholar 

  18. Boos J. Off label use-label off use? Ann Oncol 2003; 14: 1–5.

    Article  PubMed  CAS  Google Scholar 

  19. Bavdekar SB, Gogtay NJ. Unlicensed and off-label drug use in children. J Postgrad Med 2005; 51:249–252.

    PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Pediatrics, Seth GS Medical College and KEM Hospital, Parel, Mumbai, India

    Surabhi S. Jain, S. B. Bavdekar & Pranjali A. Sadawarte

  2. Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Parel, Mumbai, India

    Nithya J. Gogtay

  3. 9, A2 Worli Seaside CHS, Pujari Nagar, KAG Khan Road, Worli, Mumbai, 400018, India

    S. B. Bavdekar

Authors
  1. Surabhi S. Jain
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. S. B. Bavdekar
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Nithya J. Gogtay
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Pranjali A. Sadawarte
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to S. B. Bavdekar.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Jain, S.S., Bavdekar, S.B., Gogtay, N.J. et al. Off-label drug use in children. Indian J Pediatr 75, 1133–1136 (2008). https://doi.org/10.1007/s12098-008-0188-1

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12098-008-0188-1

Key words

Search

Navigation