<![CDATA[Obat off-label merupakan obat yang diresepkan tetapi tidak sesuai dengan informasi resmi obat seperti indikasi obat yang tidak sesuai dengan yang dinyatakan oleh izin edar serta dosis, umur pasien, dan rute pemberian yang tidak sesuai. Penelitian ini dilakukan untuk mengetahui persentase jumlah resep pasien dokter spesialis anak yang mengandung obat off-label pada pasien anak usia 0 hingga 2 tahun di Apotek Kota Bandung serta mengetahui pola penggunaannya melalui studi observasional dengan pengambilan data secara retrospektif. Identifikasi obat yang diresepkan termasuk kategori off-label atau tidak berdasarkan Pediatric Dosage Handbook 2007, Drug Information Handbook (DIH) 2012, British National Formulary (BNF) 2009, MIMS USA 2013, MIMS Indonesia 2013, dan ISO 2012â2013. Berdasarkan hasil penelitian diperoleh 542 lembar resep off-label (19,77%) dari 2741 total lembar resep, serta sebanyak 699 (7,89%) item obat off-label dari 8861 obat, dengan persentase kategori off-label usia 70,53%, off-label dosis 19,74% dan off-label kontraindikasi 9,73%. Penelitian ini menunjukkan bahwa potensi peresepan obat off-label di apotek di Kota Bandung pada tahun 2012 tinggi sehingga perlu pemilihan obat yang tepat serta pengawasan dalam penggunaan obat pada anak.Kata kunci: Obat off-label, pediatri, peresepan, Bandung The Prescription of Off-Label Drugs towards 0â2 Years Old Pediatric Patients in Community Pharmacy in Bandung CityOff-label drug is a drug which is not prescribed in accordance with official drug information, including patient age, drug indications didnât match with the marketing authorization, dosage and route ofadministration 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 NationalFormulary (BNF) in 2009, MIMS USA 2013, MIMS Indonesia in 2013, and ISO 2012â2013. 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 basicconsideration in examining the efficacy and safety in off-label drug uses for children aged 0 to 2 years.Key words: Off-label drug, pediatric, prescription, Bandung]]>
