Off-Label Drug Use for Pediatric Patients in an Indonesian Hospital

Off-label drug use remains an important public health issue for pediatric. Off-label drug is often used in the treatment of pediatric patients because this age group is limited to clinical trials of a drug. Overwhelming number of drugs still have no information in the labelling for use in pediatrics. The purpose of off-label use is to benefit the individual patient. Therapeutic decision making must always rely on the best available evidence and the importance of the benefit for the individual patient. This study aimed to evaluate of off-label drugs use in in children aged 0-5 years. This is cross-sectional study with descriptive analysis from prospective data collection. Patient and prescribing data were collected from prescription and medical records during the patient's care period. Drugs were classified as on-label or off-label based on the Indonesia National Drug Information (IONI). Off label drugs are categorized into off label indications, age range, dosage, contraindications, and route of administration. The study examined 130 patients with a total of 549 drug use during the 4 months of the study, 25% drugs are used off-label especially antibiotics and anticonvulsant. The main type of off-label drug was indication (76%), followed by age range (16%), dose (6%), and contraindication (5%). The study showed that off-label drug use in children is quite high (25%). Off-label drug use in the paediatric can have a risk of lack of efficacy and safety problems. Monitoring regarding the risk of drug use needs to be done. Research on new drugs and off-label drug use is urgently needed to improve the efficacy and safety of drugs used in the pediatric population.