Profil Penggunaan Obat Off label Pada Pasien Hamil di RSIA Tresna Kota Mataram

Abstract

Off-label drugs are drugs that are prescribed but do not comply with official drug information, such as drug indications that are not in accordance with those stated by the marketing authorization and inappropriate doses, age of the patient, and route of administration. The purpose of this study was to determine the profile of off-label use in pregnant patients at the Inpatient Installation of RSIA Tresna Mataram City in 2020. The design of this study was descriptive observational with a cross sectional method and for medical record data collection was carried out using a simple random sampling technique in accordance with table for determining the number of samples. The total number of samples is 101 Medical Records. The results obtained were the use of off-label drugs by 45.54% of 101 prescriptions/patients with proster (misoprostol 200 mcg) and nifedipine 10 mg. The use of off-label drugs from 46 prescriptions/patients was carried out for spontaneous labor with induction as much as 21.74%, Sectio Cesarean Transperitoneal Profunda (SSTP) as much as 69.57%, and abortion as much as 2.17% and nifedipine 10 mg as much as 6 ,52% as tocolytic. The use of off-label drugs in pregnant patients at the Tresna Hospital, Mataram City in 2020 was still quite high at 45.54% while the use of on-label drugs was 54.46%.

 Keywords: off-label, pregnant patient, RSIA, misoprostol, nifedipineOff-label drugs are drugs that are prescribed but do not comply with official drug information, such as drug indications that are not in accordance with those stated by the marketing authorization and inappropriate doses, age of the patient, and route of administration. The purpose of this study was to determine the profile of off-label use in pregnant patients at the Inpatient Installation of RSIA Tresna Mataram City in 2020. The design of this study was descriptive observational with a cross sectional method and for medical record data collection was carried out using a simple random sampling technique in accordance with table for determining the number of samples. The total number of samples is 101 Medical Records. The results obtained were the use of off-label drugs by 45.54% of 101 prescriptions/patients with proster (misoprostol 200 mcg) and nifedipine 10 mg. The use of off-label drugs from 46 prescriptions/patients was carried out for spontaneous labor with induction as much as 21.74%, Sectio Cesarean Transperitoneal Profunda (SSTP) as much as 69.57%, and abortion as much as 2.17% and nifedipine 10 mg as much as 6 ,52% as tocolytic. The use of off-label drugs in pregnant patients at the Tresna Hospital, Mataram City in 2020 was still quite high at 45.54% while the use of on-label drugs was 54.46%.
Keywords: off-label, pregnant patient, RSIA, misoprostol, nifedipine