Off-Label Manipulation of Paediatric Medication Remains a Challenge in Clinical Practice: An Observational Study.

aimThe aim was to observe the methods used for off-label manipulation of medication on Norwegian paediatric wards.

methodsThis prospective observational study used a digital form to collect information on how medicine was manipulated on five paediatric wards in four university and local hospitals, from October 2023 to May 2024.

resultsWe observed 31 off-label manipulations over 41 days. Tablets were the most frequently manipulated dosage form (71%). All tablets were manipulated by dispersing them in water, either to ease administration or to extract a partial paediatric dose. The tablets were dispersed whole or after splitting or crushing them. Most partial doses from tablets were difficult to achieve by splitting alone, as they were outside of half or quarter doses. There did not appear to be a standard routine for how to manipulate tablets, even when they had the same active pharmaceutical ingredients and target doses. Manipulation methods used did not always follow the available guidelines. Potentially hazardous medication was sometimes manipulated without adequate safety measures.

conclusionThe way that medication was manipulated varied and did not always follow the available guidelines. Safety procedures were not always followed when manipulating tablets.