Obat Off-label pada Pasien Pediatri Rawat Jalan: Penelitian Observasi Retrospektif di RSUD Dr. H. Abdul Moeloek Lampung

Abstract

Several medications are prescribed for infants and children, but adequate information about these drugs are unavailable. Previous studies also revealed that the use of off-label drug is prevalent among pediatric outpatients. Therefore, this study aimed to determine the prevalence of off-label drug use in pediatric outpatients at Dr. H. Abdul Moeloek Lampung Hospital from January–June 2019. This observational descriptive was conducted using simple random and retrospective sampling methods. Drugs were identified using a brochure, British National Formulary for Children (BNF), and Specialist Health Science Formulary from the Indonesian Pediatrician Association (IDAI), followed by classification with the Anatomical Therapeutical Chemical (ATC). The results showed that there were 120 samples, of which 56% are males, while 42% are within the age range of 6–12 years. The most common diagnoses were SNRS, followed by epilepsy and anemia. A total of 393 drugs were used in this study and analgesic-antipyretic was the most prescribed. The prevalence of off-label drug usage in pediatric patients was 19.6%, where the off-label age was higher (16.29%) than indication (2,81%) and doses (0,5). Furthermore, most of these medications were for the cardiovascular, respiratory, digestive, and metabolic systems. There has been a 19,6% prevalence in the use of off-label drug among pediatric outpatients, where off-label age was the highest, and most of the medication are used for the treatment of the cardiovascular system.