Many common drugs have not been registered for use in children. Therefore, they are sometimes prescribed as unlicensed or off-label. This study, performed at the Department of Paediatrics, University Hospital Olomouc, Czech Republic, evaluated off-label and unlicensed prescriptions. A similar study, conducted in 2013 by the same authors (P. Matalová – maiden name P. Langerová), showed that the number of off-label and unlicensed prescriptions was relatively low, compared to other studies. The goal of this study was to compare the frequency of off-label and unlicensed drug prescriptions, and to assess whether these prescriptions have declined.
The study evaluated the incidence of unlicensed and off-label prescriptions at the Department of Paediatrics, University Hospital Olomouc during a period of six months. A total of 10,710 prescriptions for 5,243 children were processed.
In our previous study, performed from January to June 2012, a total of 8,559 prescriptions for 4,282 children were processed. Off-label and unlicensed prescriptions were found in 9.01% and 1.26% of all prescriptions, respectively. Unlicensed prescriptions were significantly more common in boys (1.5%) than in girls (1.0%). Seven years later, the same study in the same months was performed to ascertain the development in prescribing practice. In the 2019 study, the total number of prescriptions and patients was higher (18.8% vs. 22.2%, respectively) as was the number of off-label and unlicensed prescriptions (11.1% and 1.7%, respectively).
This study shows that the incidence of unlicensed and off-label drug prescriptions is not high, but paediatricians should avoid exposing children to unnecessary risks as well as depriving them of potentially effective pharmacotherapy. The goal was to highlight the need for clinical trials in paediatrics and to determine in which drugs the demand for also being registered for younger children is highest. The number of off-label and unlicensed prescriptions indicates a gap in registration processes and should provide a clue as to which drugs are candidates for having their SPCs changed.