LAUSR

Herbal medicines, or herbal medicinal products, cover manufactured products containing herbal ingredients, and simple preparations of herbal substances. Most, if not all, traditional medical systems, including traditional Chinese medicine (China), Ayurvedic medicine (Indian subcontinent), Aboriginal medicine (Australia), te rongoā Māori (New Zealand), and many others, include the use of herbal ingredients (i.e. substances originating from plants); many traditional (indigenous) medicines also include ingredients from other sources (e.g. animals, insects, minerals). Herbal and traditional medicines (H&TMs) are a popular, sometimes the only, healthcare choice among people worldwide. In Western countries, out-of-pocket expenditure on herbal medicines and other ‘natural health’ products (NHPs), and on consultations with H&TM practitioners, is substantial [1–8]. Market data indicate large sales volumes: for the year 2018, in the USA alone, estimated retail sales of “herbal supplements” totaled more than $US8.84 billion, an increase of almost 10% over the previous year [9]. Many consumers of these types of products use them concurrently with conventional prescription medicines [10], which can lead to serious drug interactions. In many lowto middleincome countries, a substantial proportion of the population relies on H&TMs and traditional healers as their main, or only, source of primary healthcare [11]. The need to improve pharmacovigilance for H&TMs and other NHPs is recognized internationally, not least because the use of these types of products is highly prevalent and because safety concerns associated with their use continue to emerge. For example, in recent years, signals (i.e. a causal relationship has not necessarily been established) of hepatotoxicity associated with black cohosh (Actaea racemosa L.) root extracts [12], green tea (Camellia sinensis (L.) Kuntze) leaf extracts [13], and a supercritical carbon-dioxide extract of Artemisia annua L. in grapeseed oil [14] have emerged in different countries. Detection of signals of safety concerns associated with H&TMs continues to rely almost solely on analysis and assessment of spontaneous reports of suspected adverse drug reactions (ADRs) associated with the use of these types of products submitted by health professionals and the general public. The limitations of spontaneous reporting, and the unique and additional challenges in pharmacovigilance for H&TMs, are well-documented, but progress toward resolving them has been slow. Key international organizations have supported the development of pharmacovigilance practices for H&TMs. For example, the World Health Organization (WHO) published guidelines on safety monitoring and pharmacovigilance for herbal medicines [15]. Also, the Uppsala Monitoring Centre (UMC) launched a traditional medicines programme to stimulate reporting for these products and developed the herbal anatomical therapeutic chemical (ATC) classification system [16], which has a structure consistent with that of the regular ATC system and provides a unique framework for the nomenclature and therapeutic classification of herbal substances and combinations of herbal ingredients. The International Society of Pharmacovigilance (ISoP) has also focused attention on this topic. Pharmacovigilance for H&TMs has featured at ISoP annual conferences for * Joanne Barnes [email protected]