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Patient safety in drug label design: analysis of reported adverse events before and after introducing a new label design
  1. Annemarie Hellebek1,
  2. Simon Schytte-Hansen1,
  3. Hanne Fischer2,
  4. Marianne Hald Clemmensen2,
  5. Trine Kart2
  1. 1Unit for Patient Safety Capital Region of Denmark and Danish Society for Patient Safety, Copenhagen, Denmark
  2. 2The Danish Research Unit for Hospital Pharmacy, Amgros, Copenhagen, Denmark
  1. Correspondence to Dr Annemarie Hellebek, Unit for Patient Safety Capital Region of Denmark and Danish Society for Patient Safety, P610, Hvidovre Hospital, Kettegaard Allé 30, Hvidovre, Copenhagen DK-2650, Denmark; Annemarie.hellebek{at}


Objectives To investigate medication errors related to misinterpretation of a new drug label designed with a focus on reducing the risk of medication errors which introduced nine logical features aimed at improving patient safety.

Method Data on medication errors were collected from the national incidence reporting system, the Danish Patient Safety Database. Medication errors related to misinterpretation of the drug label reported before and after implementation of the new label design were investigated.

Results No overall change in dispensing errors related to misinterpretation of the label before and after introduction of the new design was observed and no substantial changes in specific error types related to features in the new design were evident. However, the present study shows that it is possible to extract valuable information from medication error reports relating the information to specific drugs and specific label features.

Conclusions Implementing patient safety in label design for drugs is highly relevant. The overall lack of effect may be caused by factors such as insufficient introduction of the design features among staff as well as inadequate reporting to the incidence reporting system. Using data from incidence reporting systems in the evaluation of initiatives aimed at reducing medication errors requires detailed incidence reports with consistent and high quality data.

  • Medical Errors
  • Primary Care
  • Pharmacy Management (Personnel)

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