Skripsi

Kajian Penggunaan Obat Off-label pada Pasien Anak di Instalasi Gawat Darurat Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo = Evaluation of off-label drug use on patients in Emergency Room Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusmo.

Pendahuluan Berbagai studi menunjukkan obat off-label banyak diberikan pada pasien anak. Pemberian obat off-label dapat menimngkatkan risiko efek samping obat. Penelitian ini bertujuan mengevaluasi peresepan obat off-label pada pasien anak di Instalasi Gawat Darurat RSUPN dr. Cipto Mangunkusumo (IGD-RSCM) yang selama ini belum pernah diteliti. Metode Desain penelitian ini potong lintnag. Sampel peresepan, diambil dari rekam medis pasien anak di IGD-RSCM secara consecutive sampling. Kriteria inklusi adalah peresepan untuk pasien anak usia 0-18 tahun di IGD RSCM pada periode JanuariDesember 2018. Kriteria eksklusi berupa data tidak terbaca atau tidak lengkap, peresepan elektrolit, suplemen, vitamin, dan obat luar. Data jenis kelamin, usia, dan jenis kelompok obat berdasarkan klasifikasi The Anatomical Therapeutic Chemical (ATC) dicatat. Status peresepan off-label ditentukan berdasarkan usia pasien saat obat diresepkan. Proporsi peresepan off-label pada kelompok gender dan usia anak dianalisis dengan uji Chi-Square. Hasil Dari 446 sampel peresepan yang diuji, 24,7% sampel merupakan peresepan offlabel berdasarkan kategori usia.Berdasarkan kelompok ATC, kelompok obat yang paling sering diresepkan adalah obat sistem saraf dengan proposi off-label paling tinggi ditemukan pada kelompok agen antineoplastik dan imunomodulasi (88,2%). Tidak ada perbedaan proporsi peroff-label yang signifikan antara pasien anak lakilaki (21,9%) dan perempuan (27,4%) (p = 0,169, PR= 0,662 IK= 0,593 – 1,005). Tidak ada hubungan signfikan antara kelompok usia (bayi, anak, dan remaja) terhadap proporsi peresepan off-label (p = 0,086). Kesimpulan Proporsi peresepan obat off-label pasien anak di Instalasi Gawat Darurat RSCM adalah 24,7%. Jenis kelamin dan perbedaan kelompok usia antara bayi, anak, dan remaja tidak berhubungan dengan besar proporsi peresepan off-label.
Kata kunci: Obat, off-label, pediatrik, IGD, RSCM


Introduction Various studies showed that pediatric patients often received off-label drugs. Offlabel drug administration can increase the risk of adverse drug reactions. This study aims to evaluate the off-label prescriptions in pediatric patients at the Emergency Department of dr. Cipto Mangunkusumo Hospital (IGD-RSCM) which has never been studied. Methods This is a cross sectional study. Prescription samples were taken from the medical records at IGD-RSCM by consecutive sampling. The inclusion criteria were prescriptions for children aged 0-18 years treated at IGD-RSCM during JanuaryDecember 2018. The exclusion criteria were unreadable, incomplete prescribing data, electrolytes, supplements, vitamins, and external medications. Data of gender, age, and drug class based on The Anatomical Therapeutic Chemical (ATC) classification were recorded. Off-label prescribing status was determined based on the patient's age at the time of prescription. Proportions of Off-label prescriptions in each gender and pediatric age groups were analyzed using the Chi-Square test. Results Of the 446 prescriptions analyzed , 24.7% were prescribed off-labelly by age category. Based on the ATC, nervous system drugs was the most frequently prescribed medication. The highest proportion of off-label drugs prescription was the antineoplastic and immunomodulating agent (88.2%). There was no significant difference in the off-label prescription proportion between boys (21.9%) and girls (27.4%) (p=0.169, PR=0.662 CI=0.593-1.005). There was no significant association between age groups (infants, children and adolescents) and the proportion of off-label prescriptions (p= 0.086). Conclusion The proportion of pediatric off-label prescription at the IGD-RSCM was 24.7%. Gender and pediatric age group differences were not associated with the level of off-label prescriptions proportions.
Key words: Drug, off-label, pediatric, ER, RSCM