a survey of off-label and unlicensed antibiotic and respiratory medications prescribed for toddler patients

Background: many medications are unlicensed for use in toddlers and many drugs are prescribed as off-label in this age group. different studies showed high prevalence of prescribing such medications in children. prescribing off-labeled or unlicensed drugs can cause adverse drug events (ades) and harm to the patients. to evaluate the rate of off-label and unlicensed drugs prescribed for toddlers.  methods: out-patient prescriptions within the electronic database from a main governmental health insurance company in tehran, iran were evaluated for off-label and unlicensed drugs in a two-month period (november-december 2019).  results: 5358 prescriptions for toddlers reached to the insurance database, of these, 461 prescriptions were randomly selected. three hundred and fifty prescriptions contained antibiotics and/or respiratory medications, from them, 183 (52.3%) had at least one off-labeled or unlicensed medication.  conclusion: our study showed high rates of off-label and/or unlicensed medication use in pediatric population.