Identification of Adverse Drug Reaction Incidents in Statin Use in Depok Hospital Inpatient
DOI:
https://doi.org/10.59188/eduvest.v5i3.50934Keywords:
Adverse Drug Reaction (ADR), Drug Side Effects, Statins, Naranjo AlgorithmAbstract
One of the adverse drug reactions that occur in patients who receive treatment therapy is drug side effects. Statins are the first choice in cholesterol-lowering therapy. Although statins are safe and well tolerated, they have the potential for side effects. The purpose of this study is to determine the prevalence of adverse drug reactions, the incidence of adverse drug reactions that occur, and the probability score of adverse drug reactions based on the Naranjo Algorithm instrument in patients with inpatient atherosclerosis cardiovascular disease who use statin therapy at RSUI. The method used in this study is a prospective observational descriptive method with observation through patient interviews and medical record data collection as well as causality analysis using the Naranjo Algorithm. The results of this study were obtained from 116 patients who used statin therapy in the RSUI inpatient room in accordance with the inclusion and exclusion criteria. Of the 116 patients, as many as 14 patients (12.07%) experienced adverse drug reactions statins. Adverse drug reactions felt included shoulder pain (3.40%), nausea (2.60%), muscle pain (1.70%), blurred vision, difficulty sleeping, chest palpitations, joint pain, dizziness and body aches as much as 0.9% each. The total probability score of the Naranjo algorithm is a probable score of 5-8 in 7 patients (50%) and a possible score of 1-4 (50%).
References
Arfania, M., Mangunsong, D. T., Hamjah, R., & Fariza, W. (2023). Efektifitas Terapi Obat Golongan Statin Terhadap Pasien Dislipidemia. Jurnal Ilmiah Wahana Pendidikan, 9(16), 550–554.
BPOM. (2020). Modul Farmakovigilans Untuk Tenaga Profesional Kesehatan, Proyek “Ensuring Drug and Food Safety.” Badan Pengawas Obat Dan Makanan.
Hariadini, A. L. (2020). Hubungan Tingkat Pengetahuan dan Ketepatan Penggunaan Obat Simvastatin pada Pasien Hiperkolesterolemia di Apotek Kota Malang. Pharmaceutical Journal of Indonesia, 5(2), 91–96. https://doi.org/10.1378/chest.145.1.13
Howard, J. P., Wood, F. A., Finegold, J. A., Nowbar, A. N., Thompson, D. M., Arnold, A. D., Rajkumar, C. A., Connolly, S., Cegla, J., Stride, C., Sever, P., Norton, C., Thom, S. A. M., Shun-Shin, M. J., & Francis, D. P. (2021). Side Effect Patterns in a Crossover Trial of Statin, Placebo, and No Treatment. Journal of the American College of Cardiology, 78(12), 1210–1222. https://doi.org/10.1016/j.jacc.2021.07.022
Indumathi, C., Anusha, N., Vinod, K. V., Santhosh, S., & Dkhar, S. A. (2017). Atorvastatin induced adverse drug reactions among south Indian Tamils. Journal of Clinical and Diagnostic Research, 11(7), FC01–FC05. https://doi.org/10.7860/JCDR/2017/27223.10175
Jutley, G. S., Pucci, M., Ferner, R. E., & Coleman, J. J. (2024). Adverse drug reactions and interactions. Medicine (United Kingdom), 52(1), 15–22. https://doi.org/10.1016/j.mpmed.2023.10.006
Maharani, L., & Yugatama, A. (2023). Prevalence of adverse drug reaction in Indonesia: A systematic review. Journal of Applied Pharmaceutical Science, 13(8), 55–67. https://doi.org/10.7324/JAPS.2023.91550
Mahwal, I., Untari, E. K., & Nurmainah, N. (2022). Perbandingan Statin Terhadap Kejadian Efek Samping Terkait Myalgia. Jurnal Sains Dan Kesehatan, 4(2), 147–154. https://doi.org/10.25026/jsk.v4i2.906
Perkeni. (2021). Pengelolaan Dislipidemia Di Indonesia 2021. PB Perkeni, 1–2.
PERKI. (2022). Panduan Prevensi Penyakit Kardiovaskular Arterosklerosis. In Perhimpunan Dokter Spesialis Kardiovaskular Indonesia 2022.
Pradina, D., Rizkifani, S., & Nurbaeti, S. N. (2023). Studi Penggunaan Obat Golongan Statin pada Pasien Penyakit Jantung Koroner di Ruang ICCU RSUD dr. Soedarso Pontianak. Jurnal Sains Dan Kesehatan, 5(5), 666–674. https://doi.org/10.25026/jsk.v5i5.1979
Shukla, A. K., Jhaj, R., & , Saurav Misra, S. N. A. (2021). Agreement between WHO‑UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions. Journal of Family Medicine and Primary Care, 8(4), 3303–3308. https://doi.org/10.4103/jfmpc.jfmpc
Tsui, L., Ye, P., Xu, S., Lin, Y., Chen, B., Chen, S. P., & Cheng, R. Y. (2023). Adverse drug reactions of statin therapy in China from 1989 to 2019: A national database analysis. European Journal of Hospital Pharmacy, 30(e1), E82–E89. https://doi.org/10.1136/ejhpharm-2022-003333
Published
How to Cite
Issue
Section
License
Copyright (c) 2025 Rizky Nurhikmah, Retnosari Andrajati, Santi Purna Sari

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.