[Drug use in a neonatal ICU: a prospective study]

Many drugs prescribed in pediatric units do not meet the conditions of use defined in their corresponding prescription information sheets, or their use has not been approved by the Spanish Health Authorities. The lack of clinical trials in children, and of adequate dosage forms, reduces drug safety, assuming both the physician and the pharmacist the responsibility for the drug use.

To assess drug prescription status within a neonatal intensive care unit in a third-level hospital.

A 3-months prospective study was performed, and information was collected from all admitted children along four time periods. Sixty-one complete therapies were evaluated, with a total of 236 drugs prescribed. Fifty percent were off-label, 13% were unlicensed, and 37% were correctly used.

These figures resemble those from, similar studies carried out in other European hospitals. This is therefore a common practice resulting from the need to treat. Health authorities should encourage clinical trials so that drug therapies for children become evidence-based.