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Valentina B. Petkova* and Vesela Karamisheva


It has been found that newborn babies receive the most off-label. Pediatric patients make up a large part of the population that requires rational drug therapy. The aim of the study is to assess the extent of off-label prescription in children. In order to achieve the set goal, the following tasks were set: study of prescriptions in a pharmacy for outpatient care for the pediatric population and analysis of prescriptions in terms of dosage, purpose, ATC code and method of administration. The results show that the category of drugs prescribed off-label includes drugs with ATC code R - respiratory system, D-dermatological agents and N-nervous system, respectively 8%. Some of the most common off-label prescriptions are: change in dosage by grinding tablets and taking some of the powder obtained, splitting of film-coated tablets, taking part of a factory-poured suppository, using only part of the capsule contents. The results of the study confirmed the conclusions of the literature review, namely that pediatric patients are subject to off-label prescribing. The main reason for these problems is the lack of medicinal products designed specifically for the pediatric population, which requires modification of the permitted indications.

Keywords: off-label, children, neonates.

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