Swiss-Cheese Model Kausalitas Efek Samping Obat: Laporan Kasus Perdarahan Saluran Cerna Pada Penggunaan Obat Herbal

Abstract—Pharmacovigilance is a process to identify, evaluating, comprehending, and avoiding harmful drug or treatment-related events. Unfortunately, Indonesia still has a relatively low rate of reporting adverse drug reactions (ADR), including those caused by herbal medications. Lack of information is one factor contributing to this, among others being ignorance and lack of awareness. The Swiss-cheese model is a risk analysis approach that can be used to examine variables that could contribute to the occurrence of adverse drug reactions. A woman, 72, was checked into the hospital after complaining of melena. The patient had previously used herbal product that containing of Retrofracti fructus, Languatis rhizoma, Piperis nigri fructus, Blumeae folium, and Orthosiphonis folium, patient also consume herbs that made from lemongrass (Cymbopogon citratus) dan turmeric (Curcuma longa). Some herbs may have an impact on the cyclooxygenase (COX) system, raising the danger of gastrointestinal problems including bleeding. Diverse patient comorbidities may potentiate adverse drug reactions, necessitating careful monitoring of medication side effects, encompassing both pharmaceutical and herbal remedies. Swiss-cheese model is an approach that can be used to analyze factors that can contribute to adverse drug event. Naranjo and WHO-UMC were used in the causality analysis. Keywords: herbs; adverse drug reaction, gastrointestinal bleeding, patient safety, pharmacovigilans Abstrak—Farmakovigilans merupakan kegiatan ditujukan sebagai upaya mendeteksi, menilai, memahami, dan mencegah kejadian yang merugikan akibat obat ataupun produk pengobatan. Sayangnya pelaporan efek samping obat (ESO) termasuk obat herbal masih sangat rendah di Indonesia. Hal ini dapat diakibatkan oleh kurangnya pengetahuan dan perhatian, salah satunya akibat kurangnya data. Swiss-cheese model adalah pendekatan analisis risiko yang dapat digunakan untuk menganalisis faktor-faktor yang dapat berkontribusi terhadap kejadian ESO. Seorang wanita 72 tahun masuk ke rumah sakit dengan keluhan melena. Pasien memiliki riwayat penggunaan produk herbal yang mengandung Retrofracti fructus, Languatis rhizoma, Piperis nigri fructus, Blumeae folium, Orthosiphonis folium, serta memiliki riwayat mengonsumsi jamu serai (Cymbopogon citratus) dan kunyit (Curcuma longa). Beberapa herbal memiliki potensi mempengaruhi sistem siklooksigenase (COX), sehingga meningkatkan risiko terjadinya gangguan pada saluran cerna seperti pe