Pharmacovigilance of traditional Chinese herbal medicine in the UK

Traditional Chinese herbal medicine (TCHM) is a popular healthcare choice in the UK. However, in the UK many TCHMs are unlicensed and TCHMs are widely available without a statutorily regulated healthcare professional. Several high-profile safety problems associated with TCHM provided by TCHM shops in the UK have occurred. All these aspects indicate an urgent need for improved pharmacovigilance (drug safety monitoring) of TCHM. The characteristics of TCHM and current practice status bring several challenges for improving current pharmacovigilance systems. Moreover, there is a lack of formal studies of TCHM in the UK examining issues relevant to pharmacovigilance, such as how TCHM is practised and whether or not there is evidence to support the efficacy and safety of TCHM for use in specific indications. Against this background, several studies were conducted, using both qualitative and quantitative methods, to examine the practice and the use of TCHM in the UK through TCHM shops, which are a major source of TCHMs, and to review the evidence base for the efficacy and safety of TCHM for one of the popular health reasons for which TCHM is used in the UK (i.e. obesity/weight loss). These studies have identified several important factors that could influence good pharmacovigilance practice of TCHM, such as inappropriate medical advertisements in the shops, inconsistent views on the safety of TCHM, and limited practice behaviours of TCHM providers due to traditional practice beliefs. All these findings suggest that, in the UK, there is an urgent need for statutory regulations for TCHM providers, that it is important to improve current risk communication status for TCHM, and that it is necessary to improve the quality of clinical studies on the efficacy and safety of TCHM. Further studies are necessary to further investigate pharmacovigilance relevant issues based on these findings from both TCHM providers' and consumers' perspectives and to examine the impact on the public health of regulatory change and other initiatives aimed at improving safety of TCHM and TCHM practice.