Penulis / NIM
RAHMATIYA RAMDANI HUWOLE / 821417066
Program Studi
S1 - FARMASI
Pembimbing 1 / NIDN
Dr. TETI SUTRIYATI TULOLI, S.Farm. M.Si. Apt / 0020028004
Pembimbing 2 / NIDN
Dr. NUR RASDIANAH, S.Si., M.Si., Apt / 0013057504
Abstrak
ABSTRAK INDONESIA
Rahmatiya Ramdani Huwole, 2022. Gambaran Penggunaan Obat Off-Label Pada Pasien Pediatrik Rawat Inap Di RSIA Sitti Khadijah Kota Gorontalo. Skripsi. Program Studdi S1 Farmasi, Fakultas Olahraga dan Kesehatan, Universitas Negeri Gorontalo. Pembimbing I Dr. Teti Sutriyati Tuloli, M.Si., Apt dan Pembimbing II Dr. Nur Rasdianah, S.Si., M.Si., Apt
Obat diluar label (Off-Label Drug) dapat diartikan sebagai obat yang digunakan tidak sesuai dengan informasi obat, izin edar dan izin ketentuan penjualan dari Marketing Authorisan (MA), yang berhubungan dengan indikasi, usia, dosis, rute pemberian dan kontraindikasi. Penggunaan obat off-label pada anak terjadi karena tidak lengkapnya data farmakokinetik, farmakodinamik dan efek samping dari suatu obat. Karena, penelitian klinik pada anak cukup sulit dan tidak sesuai dengan etika dan moral penelitian sehingga berpotensi menimbulkan kesalahan dalam pengobatan dan reaksi obat yang tidak diinginkan. Penelitian ini bertujuan untuk mengetahui gambaran penggunaan obat off-label pada pasien pediatrik rawat inap di RSIA Sitti Khadijah Kota Gorontalo. Penelitian ini merupakan penelitian observasional menggunakan rancangan cross sectional dan pengambilan data secara retrospektif. Teknik pengambilan sampel menggunakan teknik purposive sampling dengan jumlah pasien sebanyak 174 sampel yang memenuhi kriteria inklusi selama periode Juli-Desember 2021. Hasil penelitian menunjukkan bahwa dari 174 data rekam medik pasien didapatkan 236 (23,18%) penggunaan obat off-label dengan total penggunaan obat sebanyak 1018 obat. Penggunaan obat off-label kategori indikasi sebanyak 167 (70,76%), off-label dosis sebanyak 35 (14,83%), off-label usia sebanyak 33 (13,98%), off-label rute pemberian sebanyak 1 (0,42%) dan untuk off-label kontraindikasi tidak ditemukan. Terdapat penggunaan obat off-label terbanyak tiap kategori yaitu ondansetron (off-label indikasi), domperidone (off-label dosis), sucralfat (off-label usia) dan salbutamol (off-label rute pemberian).
Kata Kunci : Obat Off-Label, Pasien Pediatrik, RSIA Sitti Khadijah Kota Gorontalo
ABSTRACT INGGRIS
Rahmatiya Ramdani Huwole, 2022. Overview of Off-Label Drug Use in Inpatient Pediatric Patients at RSIA (Mother and Child Hospital) Sitti Khadijah Kota Gorontalo. Undergraduate Thesis. Bachelor's DegreemProgram in Pharmacy, Faculty of Sports and Health, Universitas Negeri Gorontalo. The principal supervisor is Dr. Teti Sutriyati Tuloli, M.Si., Apt, and the co-supervisor is Dr. Nur Rasdianah, S.Si., M.Si., Apt.
Off-label drugs are referred to as drugs that are being taken without drug information, distribution permits, and sales licenses from the Marketing Authorisation (MA). Which relate to indications, age, dosage, route of administration, and contraindications. The use off-label drugs in children occurs due to incomplete data on pharmacokinetics, pharmacodynamics, and side effect of a drug. Meanwhile, clinical research in children is quite difficult and not under research ethics and morals that it has the potential to cause medication errors and unwanted drug reactions. This study aimed to describe the use of off-label drugs in inpatient pediatric patients at RSIA Sitti Khadijah Kota Gorontalo. This study was an observational study using a cross-sectional design and retrospective data collection. And it applied a purposive sampling with 174 patients who met the incusion criteria during July-Desember 2021 period. The results showed that from 174 patient medical record data, 236 (23,18%) used off-label drugs with a total of 1018 drugs. While the use of off-label drugs in the indication category was 167 (70,76%), the off-label for dose was 35 (14,83%), the off-label for age was 33 (13,98%), off-label for route of administration was 1 (0,42%), and off-label for contraindications were not found. There was the highest use of off-label drugs in each category, namely ondansetron (off-label for indication), domperidone (off-label for dose, sucralfate (off-label for age), and salbutamol (off-label for route of administration).
Keywords : Off-Label Drugs, Pediatric Patients, RSIA Sitti Khadijah Kota Gorontalo
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