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Clinical challenges on how to optimise the use of drugs beyond the label
  1. Birte van Elk,
  2. Sandra Kruger-Peters,
  3. Aimad Torqui,
  4. Hubertus Leufkens,
  5. Yechiel Hekster
  1. Medicines Evaluation Board, The Hague, The Netherlands
  1. Correspondence to Dr Y Hekster, Medicines Evaluation Board, The Hague, The Netherlands; yechielhekster{at}

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It is well recognised that medicinal products are often used beyond the approved labelling and patient groups for which the drug has been licensed. This is referred to as off-label use of drugs. Off-label use most often concerns the drug's indication and dosing, which occurs in various patient groups, such as children. It is a major concern that about 70% of the medicines used in the care of children are not studied, and are applied off-label in one or more of their age groups. Off-label prescribing takes place in daily clinical practice. In some cases, off-label prescribing occurs more frequently than in-label, both for new drugs and for much older drugs.

Currently there is focused media attention on this issue and many articles have discussed this topic. Moreover, off-label promotion seems common practice worldwide. Healthcare providers do often not understand the legal consequences, and are not always aware of the problems involved. Off-label use of drugs should have a higher priority for health authorities, considering the impact on patient care and …

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  • Competing interests None.

  • Provenance and peer review Commissioned; not externally peer reviewed.