Off-label and unlicensed use of medicines for children

***

Off-label and unlicensed use of medicines for children in a neonatal intensive care unit in a Brazilian teaching hospital

S.C. Brassica, E. Ribeiro, A.B. Sousa
University of São Paulo, Pharmacy Service from University Hospital, São Paulo, Brazil

Background: Many medicines used in newborns, infants, children and adolescents are not licensed ("unlicensed") or are prescribed outside the terms of the marketing authorization ("off-label"). Several studies have shown that this is a common practice in various healthcare settings in the USA, Europe and Australia, but data are escarce in Brazil. The aim of our prospective study was to determine the proportion of unlicensed or off-label prescriptions in paediatric patients

Methodology: This pilot study was conducted prospectively over a three month period, from March to August 2008, in the department of a neonatal intensive care unit in a Brazilian teaching hospital.

Results: Forty-two patients aged from zero to 44 days were included in the study. A total of 173 prescriptions were written for the patients. Nine prescriptions (5%) were unlicensed. The unlicensed medicines prescribed were calcium, chloral hydrate,
phosphorous, hydrochlorothiazide and spironolactone. Off-label prescriptions accounted for 50% of them (n=82). Sixteen different medicines were used off-label (epinephrine, aminophylline, ampicillin, cefotaxime, dexamethasone, metamizole, dobutamine, dopamine, phenobarbital, fentanyl, filgrastim, midazolam, pancuronium, proparacaine, ranitidine and salbutamol. It was observed that analgesics and
anesthesics were the medicines most used off-label (n=46, 55%), followed by cardiovascular drugs (n=16, 19%) and antimicrobials (n=8, 10%).Twenty six patients (62%) received at least one off label drug. The main types of off-label usage were
age (53%) and indication (39%) followed by dosage (7%) and administration for different ways (1%).

Conclusions: The use of unlicensed or off-label medicines to treat children was found to be common. Cooperation between the pharmaceutical industry, national regulatory authorities, clinical researchers and healthcare professionals is required in order to ensure that medicines for children do not remain off-label or
unlicensed.

Refernce: Poster in: 14th Congress of EAHP. Barcelona. 2009