OFF-LABEL AND UNLICENSED PRESCRIBING IN HOSPITALIZED
CHILDREN: PREVALENCE AND REASONS
SORIN CLAUDIU MAN1, DANIELA PETRUȚA PRIMEJDIE2*, INGRID-KRISZTINA SÁRKŐZI2, ADINA POPA2
1Mother and Child Department, Faculty of Medicine, ”Iuliu Hațieganu” University of Medicine and Pharmacy, 2-4 Câmpeni
Street, 400217, Cluj-Napoca, Romania
2Clinical Pharmacy Department, Faculty of Pharmacy, “Iuliu Hațieganu” University of Medicine and Pharmacy, 12 Ion
Creangă Street, 400010, Cluj-Napoca, Romania
*corresponding author: danaprimejdie@gmail.com
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Abstract:
There is limited information regarding the extent of the unapproved drug use in Romanian hospitalized children. The
objective of this study was to identify the prevalence of the off-label and unlicensed recommendations during hospitalization
and the reasons of the prescribing physicians in one paediatrics clinic. A total of 70 drugs were recommended to 100
hospitalized children, with an average (± SD) of 4.62 (± 2.65) drugs per patient. 54% of all drugs were involved in 177
instances of off-label prescribing. 89% of infants and toddlers and 85% of children 2 - 11 years old had at least one off-label
recommendation. Off-label for dose was the most prevalent category. Previous positive experiences of the prescribing
paediatrician and the hospital guidelines were the most frequently expressed reasons. The high prevalence of the off-label
prescribing suggests the need for improving the strategies of paediatric drug research and registration.

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