Romanian Society of Pharmaceutical Sciences

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OFF-LABEL AND UNLICENSED PRESCRIBING IN HOSPITALIZED CHILDREN: PREVALENCE AND REASONS

SORIN CLAUDIU MAN1, DANIELA PETRUȚA PRIMEJDIE2*, INGRID-KRISZTINA SÁRKŐZI2, ADINA POPA2

1.Mother and Child Department, Faculty of Medicine, ”Iuliu Hațieganu” University of Medicine and Pharmacy, 2-4 Câmpeni Street, 400217, Cluj-Napoca, Romania
2.Clinical Pharmacy Department, Faculty of Pharmacy, “Iuliu Hațieganu” University of Medicine and Pharmacy, 12 Ion Creangă Street, 400010, Cluj-Napoca, Romania

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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.