ABSTRACT

Use that does not correspond to drug information and marketing authorization is referred to as off-label drug prescribing. The child population is particularly at risk of off-label drug prescribing due to the specificity of the condition. This study was conducted to find out how the prevalence of off-label drug use in children in Saras Sehat Pharmacy in Tegal City. This study is a descriptive study with data retrieval retrospectively. The study subjects in the form of recipes and medical record data of children aged 0–12 years in November 2021. Classification of off-label drugs is grouped with the ATC (Anatomical Therapeutic Chemical) system. Identify off-label drugs using BNFC, DIH, PDH, and IONI. The total prescribing of children during the study period was 1,495 prescriptions, a total of 368 prescriptions met the inclusion criteria. The total drug use of 368 prescribing was 2,743 drugs with 67 types of drugs. Based on the results of a study of 368 recipes found a total of 177 prescription sheets (48.10%) identified off-label. The prevalence of off-label drug prescribing categorized as off-label indications amounted to 40 (1.45%), off-label age 341 (12.43%), off-label contraindications 22 (0.80%), off-label dose 3 (0.11%), and no off-label category of route giving was found. The most widely prescribed off-label drugs are Decongestant drugs, namely Triprolidin and Pseudoephedrine as much as 124 (4.52%). Based on the results of this study it is known that off-label drug prescribing in children is still high enough that supervision related to the risk of drug use needs to be done.