A Framework for Promoting Safety Monitoring of Herbal Medicines: The International Society of Pharmacovigilance Special Interest Group on Herbal and Traditional Medicines

Abstract

Herbal products are used globally for diferent purposes (e.g., therapeutic, cosmetic, etc.) and are easy to obtain as in most cases they do not require a prescription. Herbal and traditional medicines (H&TMs) have been used for generations and are part of the culture of many communities. Furthermore, in many countries, their introduction into the market is not yet fully regulated [1]. This calls for more safety monitoring for these products. In fact, there is a continuous progress in pharmacovigilance (PV) of herbal medicines (HMs) or “phytovigilance” in the context of regulations, terminologies for coding, etc. [2]. Hitherto, phytovigilance still faces many challenges, the most notable of which is underreporting of herbal medicines’ adverse reactions (ARs) [3]. There is a notion among the public that H&TMs are safe because of their natural origin [4]. Also, healthcare professionals (HCPs), in some cases, fnd complexity to distinguish between whether these ARs are caused by herbal products or whether these are consequence symptoms of the comorbid conditions or even interactions between HMs and conventional drugs [5]. Over and above that, sometimes they have no idea that H&TMs can cause unexpected and serious ARs (e.g., hepatic disorders, renal disorders, carcinogenic efects, etc.) [6]. This is due to the absence of a curriculum on PV in general and phytovigilance in particular within their undergraduate studies [7, 8]. In addition, some may not realize that the origin of the herbal products, the way of extraction, their source, and the method of storage are aspects that must be considered, otherwise they will become contributing factors for the appearance of ARs or increase in severity and seriousness of these ARs [9]. Such perceptions hinder the spontaneous reporting of ARs and result in difculty in the detection, assessment, and understanding processes [10]. Accordingly, it will be difcult to take the necessary measures to minimize the risks of H&TMs. Addressing these challenges that face the PV activities demands multidisciplinary collaborations between the diferent stakeholders of phytovigilance.