Abstract
Congestive Heart Failure (CHF) is a progressive health problem with high mortality and morbidity and has the potential to develop adverse drug reactions (ADRs). This study was conducted to determine the prevalence of potential ADRs, the types of drugs that cause ADRs, the types of ADRs, and the risk factors that affect the ADRs in CHF patients. Data were collected using medical record of hospitalized patient at the West Nusa Tenggara (NTB) Provincial Hospital, Indonesia, in 2017 to 2019. The assessment of the causality and severity of ADRs used the Naranjo algorithm and the Hartwig and Siegel scale. This study used 325 CHF patients’ data. Of 325 CHF patients, 223 patients (69%) were recorded as having ADRs with 446 total cases of ADRs, consisted of 4 (0.9%) highly probable, 187 (41.9%) probable, and 255 (57.2%) possible. The drugs that cause ADRs with a highly probable status are bisoprolol and ramipril. The most ADRs categories were level 1 (76.0%), followed by level 2 (17.3%), level 3 (6.5%), and level 4A (0.2%). The most affected organ systems were the muscles, joints, and nervous system (n=136, 37.7%), followed by renal, and gastrointestinal system. No association between ADRs with several risk factors, such as gender, age, and comorbidities. The prevalence of ADRs in CHF patients in this study was 69%, with the highly probable category in causing ADRs were bisoprolol and ramipril. ADRs that mostly occurred were in the mild category. ADRs monitoring in CHF patients is especially important to achieve optimal therapeutic results.
References
Alomar, M. J. (2014). Factors affecting the development of adverse drug reactions ( Review article ). Saudi Pharmaceutical Journal, 22(2), 83–94. https://doi.org/10.1016/j.jsps.2013.02.003
Anand, S., & Tamura, M. K. (2012). Combining Angiotensin Receptor Blockers With ACE Inhibitors in Elderly Patients. American Journal of Kidney Disease, 59(1), 11–14. https://doi.org/10.1053/j.ajkd.2011.09.002.Combining
Bots, S. H., Groepenhoff, F., Eikendal, A. L. M., Tannenbaum, C., Rochon, P. A., Regitz-Zagrosek, V., Miller, V. M., Day, D., Asselbergs, F. W., den Ruijter, H. M. (2019). Adverse Drug Reactions to Guideline-Recommended Heart Failure Drugs in Women: A Systematic Review of the Literature. JACC: Heart Failure, 7(3), 258–266. https://doi.org/10.1016/j.jchf.2019.01.009
BPOM, RI. (2019). Panduan deteksi dan pelaporan efek samping obat untuk tenaga kesehatan. 1–26.
BPOM RI. Peraturan Badan pengawas Obat dan Makanan Republik Indonesia No HK.03.1.23.12.11.10690 Tahun 2011 Tentang Penerapan Farmakovigilans Bagi Industri Farmasi. , Badan Pengawas Obat dan Makanan RI (2011).
BPOM RI. (2012). Pedoman Monioring Efek Samping Obat (MESO) Bagi Tenaga Kesehatan. Direktorat Pengawasan Distribusi Produk Terapetik dan PKRT Badan Pom RI, 1–35.
Catananti, C., Liperoti, R., Settanni, S., Lattanzio, F., Bernabei, R., Fialova, D., Landi, F., Onder, G. (2009). Heart failure and adverse drug reactions among hospitalized older adults. Clinical Pharmacology and Therapeutics, 86(3), 307–310. https://doi.org/10.1038/clpt.2009.89
Christianie, M., Setiati, S., Trisna, Y., & Andrajati, R. (2008). Kejadian Reaksi Obat yang Tidak Dikehendaki yang Menyebabkan Pasien Usia Lanjut Dirawat di Ruang Perawatan Penyakit Dalam Instalasi Rawat Inap B Rumah Sakit Dr. Cipto Mangunkusumo. Majalah Ilmu Kefarmasian, 5(3), 138–149. https://doi.org/10.7454/psr.v5i3.3428
Dicpinigaitis, P. V. (2006). Angiotensin-Converting Enzyme Inhibitor-Induced Cough, ACCP Evidence-based Clinical Practice Guidelines. Chest Journal, 129(1), 169S-173S. https://doi.org/10.1378/chest.129.1
Kemenkes.RI. (2016). Profil Penyakit Tidak Menular Tahun 2016. Jakarta.
McAlister, F. A., Zhang, J., Tonelli, M., Klarenbach, S., Manns, B. J., & Hemmelgarn, B. R. (2011). The safety of combining angiotensin-converting-enzyme inhibitors with angiotensin-receptor blockers in elderly patients: A population-based longitudinal analysis. Canadian Medical Association Journal, 183(6), 655–662. https://doi.org/10.1503/cmaj.101333
Mehta, P. A., & Cowie, M. R. (2006). Gender and heart failure: A population perspective. Heart, 92(SUPPL. 3), 14–18. https://doi.org/10.1136/hrt.2005.070342
Palau, P., Seller, J., Domínguez, E., Gómez, I., Ramón, J. M., Sastre, C., Espriella. R., Santas, E., Miñana, G., Chorro, F. J., González-Juanatey, J. R., Núñez, J. (2020). Beta-blockers withdrawal in patients with heart failure with preserved ejection fraction and chronotropic incompetence: Effect on functional capacity rationale and study design of a prospective, randomized, controlled trial (The Preserve-HR trial). Clinical Cardiology, 43(5), 423–429. https://doi.org/10.1002/clc.23345
PERKI. (2015). Pedoman Tatalaksana Gagal Jantung. In Pedoman Tatalaksana Gagal Jantung (Pertama). Perhimpunan Dokter Spesialis Kardiovaskular Indonesia.
Ponnusankar, S., Tejaswini, M., & Chaitanya, M. (2015). Assessment of adverse drug reactions based on spontaneous signals at secondary care public hospital. Indian Journal of Pharmaceutical Sciences, 77(4), 490–493. https://doi.org/10.4103/0250-474X.164771
Prasetyo, S. D., & Chrisandyani, D. (2010). Gambaran Efek Samping Obat Antihipertensi Pada Pasien Hipertensi di Instalasi Rawat Inap RS PKU Muhammadiyah Yogyakarta Periode Oktober-November 2009. Majalah Farmaseutik, 6(2), 19–25.
Razzolini, R., & Lin, C. D. (2015). Gender diff erences in heart failure. Italian Journal of Gender-Specific Medicine, (June), 15–20.
Redfield, M. M., Anstrom, K. J., Levine, J. A., Koepp, G. A., Borlaug, B. A., Chen, H. H., LeWinter, M. M., Joseph, S. M., Shah, S. J., Semigran, M. J., Felker, G. M., Cole, R. T., Reeves, G. R., Tedford, R. J., Tang, W. H. W., McNulty, S. E., Velazquez, E. J., Shah, M. R., Braunwald, E. (2015). Isosorbide Mononitrate in Heart Failure with Preserved Ejection Fraction. New England Journal of Medicine, 373(24), 2314–2324. https://doi.org/10.1056/nejmoa1510774
Regitz-Zagrosek, V., Oertelt-Prigione, S., Prescott, E., Franconi, F., Gerdts, E., Foryst-Ludwig, A., Mass, A.H.EM., Kautzky-Willer, A., Knappe-Wegner, D., Kintscher, U., Heinz Ladwig, K., Schenck-Gustafsson, K., Stangl, V. (2016). Gender in cardiovascular diseases: Impact on clinical manifestations, management, and outcomes. European Heart Journal, 37(1), 24–34. https://doi.org/10.1093/eurheartj/ehv598
Rich, M. W. (2011). Pharmacotherapy of heart failure in the elderly: Adverse events. Heart Failure Reviews, 17(4–5), 589–595. https://doi.org/10.1007/s10741-011-9263-1
Strömberg, A., & Mårtensson, J. (2003). Gender differences in patients with heart failure. European Journal of Cardiovascular Nursing: Journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology, 2(1), 7–18. Retrieved from https://doi.org/10.1016/S1474-5151(03)00002-1
Surjeet, S., & Wafai, Z. (2012). Adverse Drug Reaction Monitoring at Tertiary Care Hospital S.K.I.M.S. JK- Practitioner, 17(1–3), 58–63. Wadhwa, T., El Sheikh, S. G., & Rao, P. G. M. (2018). Monitoring and Reporting of Adverse Drug Reactions Due to Cardiovascular Drugs in Patients Admitted to a Secondary Care Hospital in Northern Emirate- a Prospective Surveillance Study. Indian Journal of Pharmacy Practice, 11(2), 71–78. https://doi.org/10.5530/ijopp.11.2.16
Wankhede, S. Y., Pardeshi, M. L., Ghorpade, V. V, & Ghongane, B. B. (2018). An assessment of pattern of adverse drug reactions of cardiovascular drugs in a tertiary care institute. IJBCP: International Journal of Basic & Clinical Pharmacology, 7(2), 273–277.
WHO, MSH, & USAID. (2007). Drug and Therapeutics Committee Training Course: Assessing and Managing Medicine Safety. Drug and Therapeutics, 1–24. Retrieved from http://www.who.int/medicines/technical_briefing/tbs/04-PG_Dug-Safety_final-08.pdf?ua=1
Wyskida, K., Jura-Szołtys, E., Smertka, M., Owczarek, A., & Chudek, J. (2012). Factors that favor the occurrence of cough in patients treated with ramipril - A pharmacoepidemiological study. Medical Science Monitor, 18(9), 21–28. https://doi.org/10.12659/MSM.883336
Yılmaz, İ. (2019). Angiotensin-converting enzyme inhibitors induce cough. Turkish Thoracic Journal, 20(1), 36–42. https://doi.org/10.5152/TurkThoracJ.2018.18014
Recommended Citation
Lupitaningrum, Dita Marina; Ramdaniah, Putri; and Yuliana, Depi
(2021)
"Identification of Adverse Drug Reactions in Congestive Heart Failure Patients in a Tertiary Care Hospital, West Nusa Tenggara, Indonesia,"
Pharmaceutical Sciences and Research: Vol. 8:
No.
1, Article 4.
DOI: 10.7454/psr.v8i1.1198
Available at:
https://scholarhub.ui.ac.id/psr/vol8/iss1/4
Included in
Natural Products Chemistry and Pharmacognosy Commons, Other Pharmacy and Pharmaceutical Sciences Commons, Pharmaceutics and Drug Design Commons