DETEKSI POTENSI EFEK SAMPING OBAT TRADISIONAL BERBASIS TANAMAN OBAT: PENTINGNYA FARMAKOVIGILANS DALAM PRAKTIK KEFARMASIAN

Abstrak

Latar belakang: Penggunaan obat tradisional berbasis tanaman obat di Indonesia terus mengalami peningkatan karena dianggap lebih aman, alami, dan mudah diakses oleh masyarakat. Namun, anggapan tersebut tidak selalu sejalan dengan bukti ilmiah, karena berbagai laporan menunjukkan bahwa sejumlah tanaman obat dapat menimbulkan efek samping, baik ringan maupun berat, terutama jika digunakan dalam dosis tinggi, jangka panjang, atau tanpa pengawasan tenaga kesehatan. Tujuan: Penelitian ini bertujuan untuk mendeteksi potensi efek samping obat tradisional berbasis tanaman obat sebagai bagian dari penerapan farmakovigilans dalam praktik kefarmasian. Metode: Kajian literatur (naratif) dilakukan terhadap jurnal nasional dan internasional serta laporan resmi BPOM untuk periode 2020–2025. Pencarian mencakup publikasi yang melaporkan efek samping atau toksisitas terkait penggunaan tanaman obat; data diekstraksi dan dianalisis secara deskriptif. Hasil: Kajian menunjukkan adanya laporan efek samping ringan hingga berat yang dikaitkan dengan penggunaan tanaman obat, termasuk gangguan saluran cerna, reaksi alergi, gangguan sistem saraf, dan toksisitas organ—khususnya hepatotoksisitas. Beberapa laporan kasus dan studi observasional menyebutkan dugaan hubungan antara penggunaan tanaman seperti kunyit, teh hijau, pegagan, mahkota dewa, lidah buaya, dan spesies Tinospora dengan gangguan fungsi hati atau tanda-tanda toksisitas. Namun, bukti bervariasi dan seringkali berasal dari laporan kasus atau studi dengan desain observasional. Kesimpulan: Obat tradisional berbasis tanaman memiliki potensi menimbulkan efek samping; oleh karena itu, penguatan mekanisme farmakovigilans termasuk pelaporan reaksi obat yang merugikan (ADR) oleh tenaga kefarmasian dan edukasi pasien sangat diperlukan untuk menjamin keselamatan pasien. Disarankan penelitian prospektif dan penilaian kualitas bukti lebih lanjut.

Background: The use of traditional plant-based medicines in Indonesia has been increasing because they are perceived as safer, more natural, and more accessible. However, that perception does not always align with scientific evidence, as multiple reports indicate that several medicinal plants can cause adverse effects—ranging from mild to severe—particularly when used at high doses, for prolonged periods, or without supervision by a healthcare professional. Objective: This study aims to detect the potential adverse effects of traditional plant-based medicines as part of the implementation of pharmacovigilance in pharmacy practice. Methods: A narrative literature review was conducted of national and international journals and official reports from the National Agency of Drug and Food Control (BPOM) for the period 2020–2025. The search included publications reporting adverse effects or toxicity associated with the use of medicinal plants; relevant data were extracted and analyzed descriptively. Results: The review identified reports of adverse effects associated with medicinal plant use, ranging from gastrointestinal disturbances and allergic reactions to neurological disorders and organ toxicity—particularly hepatotoxicity. Several case reports and observational studies suggested a possible association between the use of plants such as turmeric (Curcuma longa), green tea (Camellia sinensis), Centella asiatica (pegagan/gotu kola), Phaleria macrocarpa (mahkota dewa), Aloe vera, and Tinospora species (Tinospora spp.) with impaired liver function or other signs of toxicity. However, the evidence is heterogeneous and is frequently derived from case reports or observational study designs. Conclusion: Traditional plant-based medicines have the potential to cause adverse effects; therefore, strengthening pharmacovigilance mechanisms—including adverse drug reaction (ADR) reporting by pharmacy personnel and patient education—is essential to ensure patient safety. Prospective studies and further assessments of evidence quality are recommended.