Rokas Bartuška, Indrė Trečiokienė, Sigita Burokienė
Abstract
Off-label prescribing is common in pediatrics due to limited availability of approved medications for children. This pilot study aimed to assess Lithuanian physicians’ practices, information sources, and communication methods regarding off-label prescribing for pediatric patients. Methods: A cross-sectional online survey was conducted in March 2022 among Lithuanian family doctors and pediatricians. The survey included questions on experience with off-label prescribing, communication practices, and information sources used. Results: Of the 79 respondents, 76% had prescribed off-label treatments to children within the past four weeks. Most respondents believed off-label treatments to be equally effective as on-label treatments but associated with slightly higher safety risks and adverse events. The most commonly used information sources were SmPCs, national guidelines, and the State Medicines Control Agency website. 73% of respondents reported always informing parents/guardians about off-label prescribing, and 70% sought consent and involved parents in decision-making. Conclusions: Off-label prescribing is prevalent in pediatric practice in Lithuania, most physicians inform patients and their parents or guardians about the treatments being off-label.
Keyword(s): off-label, pediatrics, prescribing, children.
DOI: 10.35988/sm-hs.2025.008
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