Prevention Strategy and Increased Supervision by BPOM Regarding Cases of EG/DEG Contamination in Medicinal Syrup
Article Sidebar
Main Article Content
Page: 1906-1911
Abstract
Contamination of ethylene glycol and diethylene glycol (EG/DEG) is suspected to be the cause of the undesirable incident of acute kidney failure in children, which occurred in Indonesia in 2022. As the institution tasked with monitoring the distribution of medicines in Indonesia, the Food and Drug Supervisory Agency (BPOM) has taken scientifically based strategic, responsive, and professional steps in handling and controlling these cases. The purpose of this article is to provide an overview of prevention strategies and increased supervision carried out by BPOM in handling cases of EG/DEG contamination in medicinal syrups. This article review was prepared through a literature study of 22 pieces of literature published between 2013-2023. The results of the literature review show that BPOM has taken responsive and professional steps in the form of strengthening the pharmacovigilance system, ensuring quality assurance in the pharmaceutical industry, monitoring the import of propylene glycol and polyethylene glycol, strengthening pre-market, post-market, and enforcement supervision, and providing information to the public as a prevention strategy and increased supervision in handling cases of EG/DEG contamination.
Downloads
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
References
BPOM RI. (2022a). Peraturan Badan Pengawas Obat dan Makanan Nomor 15 Tahun 2022 Tentang Penerapan Farmakovigilans. Badan Pengawas Obat dan Makanan Republik Indonesia.
BPOM RI. (2022b). Peraturan Badan Pengawas Obat dan Makanan Nomor 26 Tahun 2022 Tentang Pengawasan Pemasukan Bahan Obat dan Makanan Ke Dalam Wilayah Indonesia. Badan Pengawas Obat dan Makanan Republik Indonesia.
BPOM RI. (2023a). Penjelasan BPOM Rl Nomor HM.01.1.2.09.23.37 Tanggal 13 September 2023 Tentang Tambahan 54 Sirup Obat yang Memenuhi Ketentuan dan Aman Digunakan Sepanjang Aturan Pakai. https://www.pom.go.id/penjelasan-publik/penjelasan-bpom-ri-nomor-hm-01-1-2-09-23-37-tanggal-13-september-2023-tentang-tambahan-54-sirup-obat-yang-memenuhi-ketentuan-dan-aman-digunakan-sepanjang-aturan-pakai
BPOM RI. (2023b). Penjelasan Publik Badan POM. https://www.pom.go.id/penjelasan-publik?page=2
BPOM RI. (2023c). Seri Buku Saku Penanganan Kasus Cemaran Etilen Glikol dan Dietilen Glikol (EG/DEG) Dalam Sirop Obat Jilid I : Kajian Resiko Etilen Glikol dan Dietilen Glikol (EG/DEG) Dalam Sirop Obat. In Jakarta Pusat. Badan Pengawas Obat dan Makanan Republik Indonesia.
BPOM RI. (2023d). Seri Buku Saku Penanganan Kasus Cemaran Etilen Glikol dan Dietilen Glikol (EG/DEG) Dalam Sirop Obat Jilid II : Tindak Lanjut Badan POM dan Edukasi Dampak Risiko Etilen Glikol dan Dietilen Glikol (EG/DEG) Dalam Sirop Obat yang Tidak Memenuhi Syaratfile:///. In Jakarta Pusat.
BPOM RI. (2023e). Seri Buku Saku Penanganan Kasus Cemaran Etilen Glikol Dan Dietilen Glikol (EG/DEG) Dalam Sirop Obat Jilid III: Sirop Obat Yang Aman Digunakan Sepanjang Sesuai Aturan Pakai. Badan Pengawas Obat dan Makanan Republik Indonesia.
BPOM RI. (2023f). Seri Buku Saku Penanganan Kasus Cemaran Etilen Glikol dan Dietilen Glikol (EG/DEG) dalam Sirop Obat Jilid IV: Identifikasi dan Mitigasi Risiko Etilen Glikol dan Dietilen Glikol (EG/DEG) dalam Sirop Obat. Badan Pengawas Obat dan Makanan Republik Indonesia.
Fickri, D. Z. (2018). Formulasi Dan Uji Stabilitas Sediaan Sirup Anti Alergi Dengan. Journal of Pharmaceutical Care Anwar Medika Artikel, 1(1), 16–24.
Fikri, E., & Firmansyah, Y. W. (2023). A Case Report of Contamination and Toxicity of Ethylene Glycol and Diethylene Glycol on Drugs in Indonesia. Environment and Ecology Research, 11(2), 378–384. https://doi.org/10.13189/eer.2023.110211
Fowles, J., Banton, M., Klapacz, J., & Shen, H. (2017). A toxicological review of the ethylene glycol series: Commonalities and differences in toxicity and modes of action. Toxicology Letters, 278(July), 66–83. https://doi.org/10.1016/j.toxlet.2017.06.009
Kementerian Kesehatan Republik Indonesia. (2020). Farmakope Indonesia Edisi VI. Kementerian Kesehatan RI.
Kementerian Kesehatan Republik Indonesia. (2023). Suplemen II Farmakope Indonesia Edisi VI. Kementerian Kesehatan RI.
Latjandu, N., & Oroh, D. (2019). Uji Efektivitas Sediaan Sirup Antipiretik Ekstrak Flavonoid Daun Alvokad (Persea Americana Mill) pada Tikus Putih (Rattus Novergicus L) yang Diinduksi Vaksin DPT-HB. Bio-Edu: Jurnal Pendidikan Biologi, 4(3), 93–97. https://doi.org/10.32938/jbe.v4i3.423
Lukito, J. I. (2023). Tata Laksana Keracunan Ethylene Glycol dan Diethylene Glycol. Cermin Dunia Kedokteran, 50(2), 92–96. https://doi.org/10.55175/cdk.v50i2.526
MohanaSundaram, A. S., Padhi, B. K., Mohanty, A., Shrestha, S., & Sah, R. (2023). The silent epidemic of substandard and falsified medicines in low- and middle-income countries: heed lessons from the tragic deaths of children in Indonesia. International Journal of Surgery (London, England), 109(3), 523–525. https://doi.org/10.1097/JS9.0000000000000059
Salman, S., Nur Darmawan, S. A., Elyyana, N., Khairunnisa, S., Pratama, A. A., & Nurayuni, T. (2023). Pengaruh Kandungan Obat Demam Sirup Terhadap Kasus Gagal Ginjal Akut Pada Anak. Journal of Pharmaceutical and Sciences, 6(2), 451–455. https://doi.org/10.36490/journal-jps.com.v6i2.94
Simorangkir, L. T., & Suharjono, S. (2023). Peran Fomepizole dalam Penanganan Toksisitas Etilen Glikol dan Dietilen Glikol. Journal of Islamic Pharmacy, 8(1), 39–43. https://doi.org/10.18860/jip.v8i1.20790
Sulastri, M., Lengga, V. M., Rahmawati, A., Marliana, L., Rachadi, G. F., Hidayatullah, A. I., & Ramadhan, D. C. (2023). Edukasi Terapi Non-Farmakologi saat Anak Demam, Batuk, dan Pilek Ditengah Kekhawatiran Terjadinya Gagal Ginjal Akut pada Anak di Puskesmas Cibolerang Kota Bandung. Jurnal Kreativitas Pengabdian Kepada Masyarakat (PKM), 6(3), 920–928. https://doi.org/10.33024/jkpm.v6i3.8700
Umar, T. P., Jain, N., & Azis, H. (2023). Endemic rise in cases of acute kidney injury in children in Indonesia and Gambia: what is the likely culprit and why? Kidney International, 103(3), 444–447. https://doi.org/10.1016/j.kint.2022.12.004
WHO. (2023). Investigation of Acute Kidney Injury in Children in Indonesia: Results and Regulatory Actions. https://www.who.int/indonesia/news/detail/01-03-2023-investigation-of-acute-kidney-injury-in-children-in-indonesia--results-and-regulatory-actions
Widiani, A., & Hendriani, R. (2023). Studi Perspektif Masyarakat Terhadap Sirup Pasca Pernyataan Bpom Mengenai Turunan Glikol Di Apotek Kota Bandung. Jurnal Ilmiah Ilmu Kesehatan Dan Kedokteran, 1(2).