The Prescription of Off-Label Drugs towards 0–2 Years Old Pediatric Patients in Community Pharmacy in Bandung City

Off-label drug is a drug which is not prescribed in accordance with official drug information, including patient age, drug indications didn’t match with the marketing authorization, dosage and route of administration are not appropriate. This study was conducted to determine the percentage of patients pediatrician who prescribed with containing drugs off-label in pediatric patients aged 0 to 2 years at pharmacy in Bandung and determine the pattern of use through an observational study with retrospective data collection. Identification of medications that are prescribed off-label category or not based on the Pediatric Dosage Handbook 2007, Drug Information Handbook (DIH) in 2012, the British National Formulary (BNF) in 2009, MIMS USA 2013, MIMS Indonesia in 2013, and ISO 2012–2013. Based on the results obtained 542 pieces of off-label prescriptions (19.77%) of the 2741 total pieces recipes, as well as 699 (7.89%) of off-label drug items from 8861 drug, the percentage of off-label age category 70.53%, off-label doses of 19.74% and off-label contraindication 9.73%. The results of this study indicate that the uses of off-label drugs for children is high at Pharmacy in Bandung. This study is expected to be basic consideration in examining the efficacy and safety in off-label drug uses for children aged 0 to 2 years