Background: Hospitalized children are prone to experience harm from medication errors (MEs). Strategies to prevent MEs can be developed from identified malfunctioning practices and conditions in the medication use process. In this study, we aimed to identify MEs and potentially unsafe medication practices (PUMPs) in hospitalized children, and to assess the potential harm of these, using raters of different professions.

Methods: A 1-week observation using an undisguised technique was conducted on four paediatric hospital wards. One observer followed ward staff during medication prescribing, preparation and administration. MEs and PUMPs were documented using field notes. Three raters including a physician, a nurse and a clinical pharmacist assessed the potential harm of each ME and PUMP using a six-point Likert scale. Agreement was analysed using Fleiss' Kappa.

Results: A total of 16 MEs and 809 PUMPs were identified involving a preparation and administration error rate of 8%. No actual harm to patients was observed during the study. Raters assessed the potential harm of 318 unique MEs and PUMPs. Only slight agreement was found (Kappa = 0.26-0.33). A 4-hour delay in the administration of intravenous cefuroxime received the highest harm score. Observations involving no information during prescribing and variations in medication preparation were considered potentially fatal for medications such as digoxin, morphine, enoxaparin and insulin.

Conclusions: MEs and potentially unsafe practices and conditions may affect medication safety of hospitalized children. However, observed MEs did not result in any harm. The agreement among raters assessing the potential harm of observations was low. Alternative methods to determine the clinical relevance of errors are needed.