TY  - GEN
CY  - UNIVERSITAS LAMPUNG 
ID  - eprints85326
UR  - http://digilib.unila.ac.id/85326/
A1  - Ghina,  Nur Alifah	
Y1  - 2024/04/18/
N2  - Background: Off-label medication occurs when a drug is administered not
according to the labelling or permission approved by the BPOM or FDA. The use
of off-label drugs triggers adverse drug reactions or unwanted drug reactions. These
reactions occur as the body's response to drugs used in the patient's usual dose.
Methods: The study was conducted analytical observational with a study sample of
89 paediatric patients aged 0-18 years. The data collection technique used purposive
sampling method. Identification of off-label drugs with the British National
Formulary 2020-2021 and the Indonesian National Drug Informatory 2017. And
causality assessment related to adverse drug reactions using the WHO-UMC
system.
Results: The results of bivariate statistical analysis showed that H0 was accepted,
namely that there was no relationship between the use of off-label drugs and the
incidence of adverse drug reactions in paediatric patients in the inpatient installation
of RSD DR A. Dadi Tjokrodipo for the period January - June 2023 with a p-value
of 1,000.
Conclusion: There is no relationship between the use of off-label drugs and the
incidence of adverse drug reactions in paediatric patients at the inpatient installation
of RSD DR A. Dadi Tjokrodipo for the period January - June 2023.
Keyword: Adverse drug reaction, Off-label, Paediatric

Latar Belakang: Obat off-label yaitu terjadi ketika obat diberikan tidak sesuai
pelabelan atau izin yang disetujui oleh BPOM atau FDA. Penggunaan obat off-label
memicu terjadi adverse drug reaction atau reaksi obat yang tidak dikehendaki.
Reaksi ini terjadi sebagai respon tubuh terhadap obat yang digunakan dalam dosis
lazim pasien.
Metode: Penelitian yang dilakukan observasional analitik dengan sampel
penelitian berjumlah 89 pasien pediatri usia 0-18 tahun. Teknik pengambilan data
menggunakan metode purposive sampling. Identifikasi obat off-label dengan
British National Formulary 2020-2021 dan Informatorium Obat Nasional
Indonesia 2017. Serta penilaian kausalitas terkait adverse drug reaction
menggunakan WHO-UMC system.
Hasil: Hasil analisis statistik bivariat menunjukkan H0 diterima yaitu tidak terdapat
hubungan antara penggunaan obat off-label dengan kejadian adverse drug reaction
pada pasien pediatri di instalasi rawat inap RSD DR A. Dadi Tjokrodipo periode
Januari ? Juni 2023 dengan nilai p-value 1,000.
Kesimpulan: Tidak terdapat hubungan antara penggunaan obat off-label terhadap
kejadian adverse drug reaction pada pasien pediatri di instalasi rawat inap RSD DR
A. Dadi Tjokrodipo periode Januari ? Juni 2023.
Kata Kunci: Adverse drug reaction, Off-label, Pediatri
PB  - KEDOKTERAN
TI  - ANALISIS PENGGUNAAN OBAT OFF-LABEL TERHADAP KEJADIAN
ADVERSE DRUG REACTION PADA PASIEN PEDIATRI DI INSTALASI

RAWAT INAP RSD DR A. DADI TJOKRODIPO
AV  - restricted
ER  -