A Framework for Promoting Safety Monitoring of Herbal Medicines: The International Society of Pharmacovigilance Special Interest Group on Herbal and Traditional Medicines
Date
2024-05
Journal Title
Journal ISSN
Volume Title
Type
Article
Publisher
Adis International Ltd
Series Info
Drug Safety;
Scientific Journal Rankings
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.