Primary Care

Unlicensed and off label drug use by children in the community: cross sectional study

BMJ 2002; 324 doi: (Published 01 June 2002) Cite this as: BMJ 2002;324:1312
  1. Eric Schirm, research pharmacist,
  2. Hilde Tobi, assistant professor,
  3. Lolkje T W de Jong-van den Berg, professor ({at}
  1. Department of Social Pharmacy, Pharmacotherapy and Pharmacoepidemiology, Groningen University Institute for Drug Exploration, University of Groningen, Groningen, Netherlands
  1. Correspondence to: L T W de Jong- van den Berg
  • Accepted 4 October 2001

Editorial by Banner and pp 1311, 1313

Studies in various hospital settings showed that many drugs taken by children either are not licensed or are used outside the terms of the product licence.13 Information on the extent of paediatric labelling of drugs taken by children in the community is, however, limited and based on small study populations. 4 5 We studied drugs taken by children in the community, based on the pharmacy records of prescriptions from both general practitioners and outpatient departments. We aimed to determine the number of prescriptions for unlicensed drugs for children in the community and to investigate paediatric labelling of all drugs with a product licence to determine the extent of off label use.

Participants, methods, and results

In the Netherlands people commonly register with one pharmacy, from which they obtain their drugs, including those prescribed as outpatients. Excluded are drugs used during hospital stays and those bought over the counter. We obtained our data on dispensing from the InterAction database, which covers part of the northern Netherlands.

We selected all prescriptions for children aged 0-16 years in 2000. Dutch pharmacies are allowed to prepare their own formulations and to modify commercial preparations. These pharmacy based preparations are exempt from licensing, and we classified them as unlicensed. For each prescription of a licensed drug (all remaining prescriptions) we examined the official licence information—the summary of product characteristics—in detail. We determined whether the summary mentioned use in children and, if so, the minimum age. When age was unspecified we set it at a minimum of 0 years. If use in children was not mentioned or was advised against without an indication of age, we set the minimum age at 18 years. We considered that a drug with a product licence was used according to the label if the summary of product characteristics stated that it could be used in children, and if the child was of the minimum age for use or older; otherwise we considered the drug was used off label. As information about indications was not available, we were not able to distinguish between different indications in the summary.

We analysed 68 019 prescriptions for 19 283 children aged 0-16 years. General practitioners were responsible for 56 961 (83.7%) of the prescriptions; the remainder came from specialists. Unlicensed drugs amounted to 16.6% (11 288) of the total prescriptions and were mainly dermatological and liquid preparations.

The table shows the official labelling of drugs prescribed for children. In 21.3% of the prescriptions for licensed drugs, use in children was not mentioned in the summary, and 19.7% mentioned use in children but without any indication of age. Although the summaries of remaining drugs indicated age, children were often divided into just two age groups.

Information given in summary of product characteristics of drugs prescribed to children in the community in the Netherlands

View this table:

Overall, 22.7% (15 453) of the prescriptions for children were used off label. Drug groups with the highest percentages of off label use were urologicals or sex hormones (mainly oral contraceptives; 85.9%), ophthalmological and otological drugs (79.4%), dermatological drugs (55.9%), and cardiovascular drugs (48.3%). In the group with the highest number of prescriptions—respiratory drugs—16.1% of all prescriptions were used off label.


Many licensed drugs used by children in the community are poorly labelled for use in children, resulting in high percentages of off label use. Therefore labelling for children needs to be improved, with the support of everyone working in pharmacotherapy.


Contributors: ES and HT were involved in the design, analysis, interpretation, and writing of the manuscript. LTWdJ-vdB supervised the design and execution of the study and contributed to the writing of the manuscript and will act as guarantor for the paper.


  • Funding None.

  • Competing interests None declared.


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