Off-label and unlicensed drug use in a Spanish Neonatal Intensive Care Unit

To describe off-label and unlicensed drugs in clinical practice in a Neonatal Intensive Care Unit (NICU). The design of the study was a descriptive and retrospective three months research in a NICU of a Spanish University Hospital. All prescriptions were classified as approved, off-label and unlicensed drug used, according to the information available on the Summary of Product Characteristics. Off-label drugs prescriptions were divided into four groups (dose, frecuency, age and indication of use) depending on the reason of disconformity. Forty-one neonates were included (46.3% premature patients) and a total of 273 drug prescriptions were evaluated. Of them, 53.1% (145) were classified as an approved drug prescriptions, 41.4% (113) were off-label use and 5.5% (15) were unlicensed drugs. 90.2% of the patients (37/41) received at least one off label prescription, with a median of 3 (range 1-7). Age was the foremost reason for off-label use (42.5%), followed by dose (31.0%), frecuency (16.8%) and dose-frecuency off-label drug use (8.8%). The last place was reserved for off-label drug use by indication (0.9%). Group J (corresponding with antiinfectives for systemic use) was the most frecuently prescribed, with ampicillin (18.6%) and gentamicin (16.8%) as the drugs most commonly use as off-label prescriptions. Finally, caffeine citrate was the unlicensed drug most frecuently prescribed. Off-label and unlicensed drug use prescriptions in our NICU clinical practice are highly frecuent as other authors have previously published in other countries where they were studied. Although there are few studies in newborn patients, both off-label and unlicensed drug prescriptions are commonly recomended in Paediatrics Guidelines. Describir la utilización de medicamentos fuera de ficha técnica (FFT) y sin licencia en una Unidad de Cuidados Intensivos Neonatales (UCIN). Estudio descriptivo y retrospectivo realizado durante tres meses en la UCIN de un hospital público español. Las prescripciones se clasificaron según la ficha técnica oficial en tres grupos: dentro de ficha técnica, FFT y sin licencia. Las prescripciones FFT se clasificaron según la razón por la que no se ajustaban a ella en cuatro grupos: dosis, frecuencia, edad e indicación. Se incluyeron 41 neonatos (46,3% prematuros) y 273 prescripciones. De ellas, el 53,1% (145) se prescribieron según ficha técnica, el 41,4% (113) FFT y el 5,5% (15) sin licencia. El 90,2% de los pacientes (37/41) recibieron al menos un tra