Profil Penggunaan Obat Off-Label pada Pasien Obstetri Ginekologi di RSUD Blambangan Banyuwangi

Ika Norcahyanti; Sinta Rachmawati; Shafira Putri Pertiwi

doi:10.20527/jps.v10i2.17698

Profil Penggunaan Obat Off-Label pada Pasien Obstetri Ginekologi di RSUD Blambangan Banyuwangi

Ika Norcahyanti, Sinta Rachmawati, Shafira Putri Pertiwi

Abstract

Setiap obat yang beredar harus memiliki izin edar yang dikeluarkan dan disetujui oleh FDA atau lembaga yang berwenang seperti BPOM. Obat yang diresepkan, tetapi tidak sesuai dengan informasi resmi obat seperti indikasi, usia pasien, dan rute pemberian disebut sebagai off-label drug. Alasan suatu obat digunakan secara off-label diantaranya adalah obat tersebut memiliki lebih dari satu macam indikasi dan indikasi tersebut belum terdaftar atau belum mendapat persetujuan dari FDA. Penelitian ini bertujuan untuk mengetahui karakteristik pasien serta profil penggunaan off-label drug pada pasien obstetri ginekologi di RSUD Blambangan Banyuwangi. Penelitian ini merupakan penelitian retrospektif menggunakan catatan rekam medis pasien periode bulan Januari-Juni 2018. Sampel yang memenuhi kriteria inklusi sebanyak 233 orang pasien rawat inap. Pengolahan data dianalisis secara statistik deskriptif. Hasil penelitian menunjukkan bahwa pada karakteristik pasien didominasi oleh pasien dengan kelompok usia 20-35 tahun (64%), pasien dengan diagnosis dan tindakan partus section caesarean (44,2%), serta kelompok pasien BPJS (71,7%). Sedangkan pada profil penggunaan off-label drug didominasi oleh penggunaan misoprostol tablet (60,28%); asam traneksamat injeksi (20,57%); serta dexamethasone injeksi (17,38%) dengan kategori sebagai off-label indikasi. Melalui penelitian ini dapat disimpulkan bahwa penggunaan off-label drug pada pasien obstetri ginekologi di RSUD Blambangan Banyuwangi tetap didasarkan pada keuntungan dan manfaat dari setiap obat saat digunakan.

Kata Kunci: Misoprostol, Asam Traneksamat, Deksametason, Partus Section Caesarean, Off-label

Every drug must be issued a distribution permit that is approved by the FDA or an authorized agency such as BPOM. Medications prescribed for indications, patient age, and route of administration not accordance with the official information are referred to as off-label drugs. The reasons for using a drug off-label may include the drug having multiple indications or the indication has not been registered approved by the FDA. This study aimed to determine the characteristics of patients and the profile of off-label drug use in gynecological obstetrics patients at Blambangan Hospital. This retrospective study analyzed patient medical records from January-June 2018, and included 233 patients who met the inclusion criteria. Descriptive statistics were used for data analysis. The results showed that the patients age group of 20-35 years accounted for the majority (64%) of the sample, with a cesarean diagnosis (44.2%), and the BPJS patient group (71.7%). The off-label drug usage profile was primarily composed of misoprostol tablets (60.28%), tranexamic acid injection (20.57%) and dexamethasone injection (17.38%), all of which were used with the category of off-label indications. It can be concluded that the use of off-label drugs in gynecological obstetric patients at Blambangan Hospital was found to be based on the potential advantages and benefits of each drug when used.

Keywords

Misoprostol; Tranexamic Acid; Dexamethasone; Partus Section Caesarean; Off-label

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DOI: http://dx.doi.org/10.20527/jps.v10i2.17698