European Journal of Clinical Pharmacology

, Volume 58, Issue 4, pp 293–297 | Cite as

Unlicensed and off-label drug use in a paediatric ward of a general hospital in the Netherlands

  • G. 't Jong
  • P. van der Linden
  • E. Bakker
  • N. van der Lely
  • I. Eland
  • B. Stricker
  • J. van den Anker
Pharmacoepidemiology and Prescription

Heading

Abstract

Objectives. Many drugs used in paediatric care are not licensed for that use or are prescribed outside the terms of the product license (off-label). Studies in the UK and Europe showed a large number of unlicensed and off-label drug prescription in specialised paediatric health care centres. We determined the extent and nature of use of unlicensed drugs and off-label prescriptions in children in a general hospital in the Netherlands.

Methods. We conducted a longitudinal prospective cohort study in a dynamic population consisting of patients admitted to the paediatric ward and the neonatology unit of a general hospital during a 19-week period. Drug-licensing status of all prescriptions given to these patients was determined.

Results. A total of 1017 prescriptions was administered to 293 paediatric patients for 114 different drugs. The median number of prescriptions per patient was three (interquartile range 2–5). The most commonly administered drugs were acetaminophen (14%), cefotaxime (8%), amoxicillin (7%), caffeine (4%) and prednisolone (4%). Four hundred and forty-three (44%) prescriptions were off-label, and 285 (28%) were for unlicensed drugs. Ninety-two percent of patients received one or more unlicensed or off-label prescriptions, and this proportion was significantly higher in children below 6 months of age than in older children.

Conclusions. This study shows that the extent of unlicensed and off-label drug prescription in a paediatric ward and neonatology unit of a general hospital is large and not smaller than in an academic paediatric setting. Lack of paediatric drug labelling is therefore not solely a problem with drugs used in university hospitals, but also in general hospitals. Efforts must be taken to change the current situation.

Children Licensing EMEA 

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Copyright information

© Springer-Verlag 2002

Authors and Affiliations

  • G. 't Jong
    • 1
  • P. van der Linden
    • 2
  • E. Bakker
    • 1
  • N. van der Lely
    • 4
  • I. Eland
    • 2
  • B. Stricker
    • 2
  • J. van den Anker
    • 1
  1. 1.Department of Paediatrics, Sophia Children's Hospital, Erasmus Medical Centre Rotterdam, the Netherlandsthe Netherlands
  2. 2.Pharmacoepidemiology Unit, Department of Internal Medicine, Epidemiology & Biostatistics, Erasmus Medical Centre Rotterdam, the Netherlandsthe Netherlands
  3. 3.Department of Clinical Pharmacy, Reinier de Graaf Hospital, Delft, the Netherlandsthe Netherlands
  4. 4.Department of Paediatrics, Reinier de Graaf Hospital, Delft, the Netherlandsthe Netherlands
  5. 5.Division of Clinical Pharmacology and Medical Toxicology, Columbus Children's Hospital, Columbus, OH 43205, USAUSA
  6. 6.Department of Paediatrics, Ohio State University, Columbus, Ohio, USAUSA
  7. 7.Drug Safety Unit, Ministry of Health, The Hague, the Netherlandsthe Netherlands

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