Intended for healthcare professionals


Use of unlabelled and off licence drugs in children

BMJ 2000; 320 doi: (Published 29 April 2000) Cite this as: BMJ 2000;320:1210

Use of unlicensed drugs may be recommended in guidelines

  1. F Andrew I Riordan, consultant paediatrician (
  1. Department of Child Health, Birmingham Heartlands Hospital, Birmingham B9 5SS
  2. For the Paediatric Rheumatology International Trials Organisation, Paediatric Clinic, IRCCS S Matteo, University of Pavia, 27100 Pavia, Italy

    EDITOR—Conroy et al report the widespread use of drugs that are either not licensed for use in children or are prescribed outside the terms of their product licence (off label prescribing) in children admitted to hospital.1 Although it is not illegal to use medicines in this way, the responsibility for any adverse events becomes the clinician's or the pharmacist's rather than the manufacturer's. However, much unlicensed use may be recommended in local or national guidelines.

    As part of our trust's response to the use of unlicensed drugs in children, I reviewed all drugs recommended in our local paediatric medical guidelines. These contained 69 guidelines for acute management and elective investigation of children. The guidelines recommended 86 drugs, but only 47 (55%) were licensed for use in children. A further 14 drugs were licensed only for children above a certain age or …

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