Off-label medication use in pediatrics and associated factors at public hospitals in east Gojjam zone, Ethiopia

Objective: Due to a lack of appropriate pediatric preparations, health providers frequently use adult formulations in an off-label manner. This study aimed to assess pediatric off-label medication use patterns and associated factors in East Gojjam, Ethiopia. Methods: Institutional-based cross-sectional study was conducted from December 2020 to June 2021 at three randomly selected hospitals. Data were collected by using self-structured questionnaires and a data abstraction checklist from health care workers and prescriptions, respectively. The collected data were analyzed using SPSS version 25. Logistic regression analysis was used to assess the association between independent and dependent variables. Results: A total of 285 eligible health professionals from the pediatric unit and pharmacies, and 1,800 eligible prescriptions were involved in the study. The response rate of healthcare workers was 94.37%. Around 74.4% of professionals had good knowledge about off-label medication. Only 8% of participants had taken training on pediatric off-label medications. Of all prescriptions, 27.6% of them have contained at least one off-label medication. Phenobarbitone (16.1%) and phenytoin (12.7%) were the most frequently prescribed off-label medication. In all, 496 (27.6%) prescriptions contained off-label drugs in the form of overdose, cutting adult tablets into small portions, and formulating tablets/capsules into solution. Lack of information on off-label prescribing, shortage of pediatric drugs, and suitable dosage forms showed significant association with off-label prescribing with p-value < 0.001. Conclusion: Almost one-third of pediatric prescriptions contained off-label medication. Only a small number of healthcare workers had taken training on pediatric off-label medications. Lack of sufficient information on risks of off-label medication, shortage of pediatric medication, and suitable pediatric dosage forms were associated with the use of off-label medication compared to non-use. Further research should be done on the long-term effects associated with off-label prescribing in pediatrics to assess whether the potential risks are balanced with the therapeutical benefit.