Gambaran Penggunaan Obat Off-Label Pada Pasien Pediatrik Rawat Inap di Rumah Sakit

Abstract

Off-label drugs can be interpreted as drugs that are used not in accordance with drug information, distribution permits and sales licenses from the Marketing Authorization (MA) related to indications, age, dosage, route of administration and contraindications. The use of off-label drugs in children occurs because of incomplete data on pharmacokinetics, pharmacodynamics and side effect of a drug. It is because clinical research in children is quite difficult and not in accordance with research ethics and morals, so it has the potential to cause errors in treatment and unwanted drug reactions. This study aims to describe the use of off-label drugs in hospitalized pediatric patients at RSUD of Dr. M.M Dunda Limboto, Gorontalo District, Gorontalo Province. This is an obsevational study using cross sectional design and retrospective data collection. The sampling technique applies a purposive sampling technique with a total of 155 patiens who meet the inclusion criteria during the January-June 2020 period. The finding shows that from 155 patient medical records, there are 172 (16,51%) off-label drug used with a total of 1042 drugs. The off-label drugs used in the indication category are 64,53%, the off-label drugs used in dose category are 17,44%, the off-label drugs used in age category are 14,53%, the off-label drugs used in route of administration category are 3,49% and the off-label drugs used in contraindictions category are not found. The are the most off-label drugs used in each category, including domperidone (off-label in indications and dose), rhinofed (off-label in age) and salbutamol (off-label in route of administration).

Off-Label Drug Use in Acute Respiration Infection Patient at Pangandaran Hospital, Pangandaran District, West Java - Indonesia

“…There were 23 cases of use of off-label drugs in this study; the findings are similar to the study conducted by Tuloli in that the use of offline drugs is mostly given to children under the age of 12 years, especially in children under 2 years of age. 8 Off-label drug prescribing is more common in pediatric patients because special formulations for children are still very limited, while clinical trials for licensed drugs are mostly conducted in children. Cetirizine is the most widely used off-label drug in the age category.…”

Review: Penggunaan Off-Label Obat Golongan Antagonis Reseptor Histamin 2

“…diresepkan atau diberikan untuk penggunaan di luar ketentuan yang disetujui oleh lembaga pengawas obat dan makanan seperti Food Drug and Administration (FDA) (Jung et al, 2014). Ketentuan tersebut meliputi dosis, usia, indikasi, kontraindikasi, dan rute pemberian (Tuloli, Rasdianah, & Datau, 2022). Obat off-label telah digunakan dalam berbagai bidang klinis seperti psikiatri, pediatri, dan unit perawatan intensif (Zheng, Yang, & Wu, 2017).…”