Profile of off-label drug uses in Indonesia particularly in South Borneo is yet unknown. Study of off-label drug uses is necessary because its safety and effectiveness treatment for children are not guaranteed. The purpose of this study was to identify the percentage of pediatric patients who received off-label drug, the most commonly drug that used as an off-label drug, and the percentage of off-label drug based on the criteria, including: age, dose, route of administration, and indication. This research used a prospective study. The study population on this research was patients aged a month to 18 years who is treated at Ulin's Hospital during March to May 2013. The samples of this research were patients who received antibiotics, analgesics, and antipyretics, anti-inflammatory, antihistamine, anticonvulsant, and antiemmetic drug therapy. There was 86 people (32.58%) of the 264 patients who received an off-label drug, anti-inflammatory drug was the most commonly used as an off-label drug with 38 cases (30.64 %) of the 124 cases of an off-label drug, and based on the criteria, there was 41 cases (33,06 %) off-label of age, 45 cases (36.29%) off-label of dose, no cases off-label of route of administration, and 38 cases (30,65 %) off-label of indication. Further research is needed to determine the safety and efficacy of an off-label drug.
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