Unlicensed and Off-label Utilization of Oral Drugs in Pediatrics in a Vietnamese Tertiary Teaching Hospital

Context: Off-label or unlicensed medicine utilization is very prevalent in pediatric practice. Aims: This investigation aimed to determine the frequency and nature of unlicensed and off-label oral medicine prescriptions in children. Method: A prospective cross-sectional research was carried out in a pediatric department in a tertiary university hospital for one month. Results: A total of 320 oral prescription medicines were assessed for 104 patients, with an average age of 2.9 years. The frequency of unlicensed and off-label administration of drugs was 17.8% and 28.1%, respectively. In all, 54 (51.9%) children received at least one unlicensed or off-label drug. All unlicensed drug utilizations were for marketed drugs with pharmacy compounding. The types for off-label utilization were unapproved age (15.9%) and unapproved dosage (12.2%). Paracetamol was the most frequently prescribed unlicensed and off-label drug. Oral solid preparation was more prone to unlicensed prescriptions (p < 0.001). Age (< 2 years), number of oral drugs per patient (> 3 drugs), and oral dosage forms (liquid) were highly correlated with off-label regimen (p = 0.003, 0.028, < 0.001, respectively). Off-label utilization was highly correlated with having difficulty in dosing (p < 0.001) while unlicensed utilization was highly related to having difficulty in taking the drug orally (p < 0.001). Conclusion: A high rate of unlicensed/off-label drug utilization was revealed and was also correlated with an enhanced risk of having difficulty in dose preparations and administrations. More efforts should be required to enhance rational drug utilization in children.