Skripsi

Kajian Penggunaan Obat Off-label pada Pasien di Pediatric intensive care unit Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusmo = Evaluation of off-label drug use on patients in Pediatric Intensive Care Unit Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusmo.

Pasien anak, termasuk di Pediatric Intensive Care Unit (PICU), tergolong rentan menerima peresepan obat off-label, yang berpotensi menimbulkan kejadian efek samping obat. Penelitian ini bertujuan mengevaluasi penggunaan obat off-label pada pasien anak di PICU RSCM, yang belum pernah diteliti. Metode Sampel merupakan peresepan yang diambil dari rekam medis secara consecutive sampling. Perhitungan jumlah sampel menggunakan proporsi tunggal dan beda dua proporsi. Kriteria inklusi adalah pasien anak < 18 tahun yang dirawat di PICU RSCM tahun 2018. Kriteria eksklusi adalah pasien dengan data pengobatan yang sulit dibaca atau tidak lengkap, obat luar, elektrolit, dan suplemen. Data ditabulasi berdasarkan nama obat, jenis kelamin, usia, status off-label obat berdasarkan usia pasien, dan klasifikasi Anatomical Therapeutic Chemical (ATC). Uji Chi-Square dipakai untuk mengetahui beda proporsi penggunaan obat off-label antar kelompok. Hasil Dari 400 peresepan yang dievaluasi, 23,8% tergolong off-label kategori usia. Berdasarkan klasifikasi ATC, peresepan di PICU didominasi oleh obat kardiovaskular (25,25%). Obat muskuloskeletal paling sering diresepkan secara off-label (84,6%). Tidak ada perbedaan signifikan proporsi penggunaan obat offlabel pada kelompok laki-laki (21%) dan perempuan (26,5%) (p = 0,196,). Proporsi off-label pada kelompok usia bayi (0-2 tahun) 33,8%, anak (2-12 tahun) 18,6%, dan remaja (12-18 tahun) 14,3%. Peresepan off-label pada bayi lebih tinggi secara signifikan dibandingkan anak (p = 0,002) dan remaja (p = 0,001) Kesimpulan Sebanyak 23,8% peresepan pada pasien PICU diberikan secara off-label berdasarkan usia, dan yang tersering adalah obat muskuloskeletal. Perbedaan proporsi obat off-label antar jenis kelamin tidak signifikan, sedangkan antar kelompok usia signifikan.
Kata kunci: Obat, off-label, pediatrik, PICU, RSCM


Introduction Pediatric patients, including Pediatric Intensive Care Unit (PICU) patients, are prone to off-label drug prescriptions, which potentially lead to adverse drug reactions. This study aimed to assess the use of off-label drugs on PICU patients at RSCM, which has never been studied before. Methods Samples were prescriptions taken from medical records connsecutively. Sample size were calculated using single proportion and difference between two proportions. The inclusion criteria were < 18 years old PICU patients at RSCM admitted in 2018. The exclusion criteria were patients with unclear or incomplete data, external drugs, electrolytes, and supplements. Data were tabulated by drug name, sex, age, off-label drug status based on patient age, and Anatomical Therapeutic Chemical (ATC) classification. Difference in proportions between groups were tested using Chi-Square. Results Of the 400 prescriptions evaluated, 23.8% were off-label by age. Based on the ATC classification, PICU prescription was dominated by cardiovascular drugs (25.25%). Musculoskeletal drugs were most often prescribed off-label (84.6%). There was no significant difference in off-label prescription between males (21%) and females (26.5%) (p = 0.196). The proportion of off-label in the infant age group (0-2 years) was 33.8%, in children (2-12 years) 18.6%, and in adolescents (12-18 years) 14.3%. Infants were given off-label drugs significantly higher than children (p = 0.002) and adolescents (p = 0.001) Conclusion Off-label prescription in PICU patients is 23.8%. Musculoskeletal drugs are most often prescribed off-label. The difference in the proportion of off-label drugs between sexes was not significant, whereas between age groups was significant.
Key words: Drug, off-label, pediatric, PICU, RSCM