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Unlicensed and off label drug use in paediatric wards: prospective study

BMJ 1998; 316 doi: https://doi.org/10.1136/bmj.316.7128.343 (Published 31 January 1998) Cite this as: BMJ 1998;316:343
  1. Sean Turner, clinical research pharmacista,
  2. Alexandra Longworth, research assistantb,
  3. Anthony J Nunn, director of pharmacya,
  4. Imti Choonara (imti.choonara{at}nottingham.ac.uk), senior lecturer in paediatric clinical pharmacologyb
  1. a Department of Pharmacy, Alder Hey Children's Hospital, Liverpool L12 2AP
  2. b Institute of Child Health, Alder Hey Children's Hospital
  1. Correspondence to: Professor Imti Choonara Academic Division of Child Health, Derbyshire Children's Hospital, Derby DE22 3NE
  • Accepted 23 September 1997

Abstract

Objective: To determine the extent of use in children in hospital of drugs that are not specifically licensed for use in children (unlicensed) and of drugs that are used outside the terms of their product licence that apply to indication, age, dose, or route of administration (off label).

Design: Prospective study of drugs administered on paediatric medical and surgical wards for 13 weeks.

Setting: Regional children's hospital.

Subjects: Paediatric inpatients in medical and surgical wards.

Main outcome measures: Comparison of the use of each drug with its product licence to determine whether the drug was used in an unlicensed or off label manner.

Results: 2013 courses of drugs were administered to 609 paediatric patients in 707 admissions. 506 (25%) of the drug courses (prescriptions) were either unlicensed (139) or off label (367) uses. In 256 (36%) of the 707 admissions patients received one or more courses of an unlicensed or off label treatment in hospital.

Conclusions: Use of drugs in an off label or unlicensed manner to treat children is widespread. Drugs are more likely to be used in an off label manner than in an unlicensed manner.

Key messages

  • Children in hospital are often treated with drugs not specifically licensed for use in children (unlicensed), and drugs are also used outside the terms of the product licence that apply to indication, age, dose, or route of administration (off label prescribing)

  • In this study 36% of children in 707 admissions received drugs prescribed in either an unlicensed or off label manner

  • Off label drug prescribing was more common than unlicensed drug prescribing

  • All drugs used to treat children should be subjected to the licensing process to ensure their quality, safety, and efficacy

  • The Medicines Control Agency, the pharmaceutical industry, and the NHS need to address the issue of drugs being used in these ways

Footnotes

    • Accepted 23 September 1997
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