Obat Off-label pada Pasien Pediatri Rawat Jalan: Penelitian Observasi Retrospektif di RSUD Dr. H. Abdul Moeloek Lampung

Cheri F. A. Dera; Nurma Suri

doi:10.15416/ijcp.2022.11.2.116

Obat Off-label pada Pasien Pediatri Rawat Jalan: Penelitian Observasi Retrospektif di RSUD Dr. H. Abdul Moeloek Lampung

Cheri F. A. Dera, Nurma Suri

Abstract

Informasi pada pelabelan obat data khasiat dan keamanan pada populasi anak terbatas. Keterbatasan informasi mngakibatkan peresepan obat off-label banyak terdapat pada pasien pediatri. Penelitian ini bertujuan untuk mendapatkan gambaran penggunaan obat off-label pada pasien pediatri. Metode penelitian yang digunakan yaitu deskriptif observasional dengan pengambilan sampel dilakukan secara simple random sampling dan pengumpulan data secara retrospektif pada Poli Anak RSUD Dr. H. Abdul Moeloek Provinsi Lampung periode Januari–Juni 2019. Brosur obat, Pusat Informasi Obat Nasional (PIO Nas), British National Formulary for Children (BNF), dan Formularium Spesialistik Ilmu Kesehatan dari Ikatan Dokter Anak Indonesia (IDAI) digunakan untuk identifikasi obat off-label. Anatomical Therapeutical Chemical (ATC) digunakan sebagai rujukan dalam penggolongan obat. Hasil penelitian memperlihatkan ada 120 sampel dengan persentase terbanyak adalah pasien laki-laki (56%) dan karakteristik usia terbanyak pada rentang 6–12 tahun (42%). Diagnosis terbanyak pada sampel penelitian adalah Sindrom Nefrotik Resisten Steroid (SNRS) diikuti dengan epilepsi dan anemia. Ada 393 obat yang diresepkan dan pola peresepan terbanyak merupakan obat golongan analgesik-antipiretik. Hasil analisis memperlihatkan 19,6% obat diresepkan off-label. Off-label kategori usia adalah yang tertinggi, yaitu 16,29% dari total resep off-label yang ada diikuti off-label indikasi 2,81% dan off-label dosis 0,5%. Obat sistem kardiovaskular merupakan golongan obat yang banyak diresepkan secara off-label, diikuti dengan golongan obat sistem pernafasan dan pencernaan-metabolisme. Simpulan penelitian ini yaitu terdapat 19,6% penggunaan obat off-label untuk pasien pediatri dan off-label kategori usia adalah yang terbanyak. Obat sistem kardiovaskular adalah golongan obat yang banyak diresepkan off-label.

Kata kunci: Obat off-label, pediatri, rawat jalan

Off-label Medication Use in Pediatric Outpatients: A Retrospective Observational Study at Dr. H. Abdul Moeloek Hospital in Lampung

Abstract

Several medications are prescribed for infants and children, but adequate information about these drugs are unavailable. Previous studies also revealed that the use of off-label drug is prevalent among pediatric outpatients. Therefore, this study aimed to determine the prevalence of off-label drug use in pediatric outpatients at Dr. H. Abdul Moeloek Lampung Hospital from January–June 2019. This observational descriptive was conducted using simple random and retrospective sampling methods. Drugs were identified using a brochure, British National Formulary for Children (BNF), and Specialist Health Science Formulary from the Indonesian Pediatrician Association (IDAI), followed by classification with the Anatomical Therapeutical Chemical (ATC). The results showed that there were 120 samples, of which 56% are males, while 42% are within the age range of 6–12 years. The most common diagnoses were SNRS, followed by epilepsy and anemia. A total of 393 drugs were used in this study and analgesic-antipyretic was the most prescribed. The prevalence of off-label drug usage in pediatric patients was 19.6%, where the off-label age was higher (16.29%) than indication (2,81%) and doses (0,5). Furthermore, most of these medications were for the cardiovascular, respiratory, digestive, and metabolic systems. There has been a 19,6% prevalence in the use of off-label drug among pediatric outpatients, where off-label age was the highest, and most of the medication are used for the treatment of the cardiovascular system.

Keywords: Off-label drug, outpatients, pediatric

Keywords

Obat off-label; pediatri; rawat jalan

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