Current status of the spontaneous reporting and classification/coding system for herbal and traditional medicine in pharmacovigilance

Abstract

Background While the use of herbal and traditional medicine (H&TM) has been extensive worldwide, the current status of H&TM management in pharmacovigilance remains to be investigated. To date, there is little information regarding the use of the classification/coding system (CCS) to detect signals for certain drugs within databases built on the basis of the spontaneous reporting system (SRS). The purpose of this study is to investigate the status of the SRS and CCS for H&TM in the pharmacovigilance systems of various countries around the world. Methods An e-mail survey was performed from late December 2018 to early January 2019 with 54 experts in pharmacovigilance. The results based on the information provided by the respondents were summarized. Results Fourteen experts from 13 countries responded to the survey. Eleven countries/regions were found to already include H&TM in their SRSs, managing only limited range of H&TM. Of the 9 countries/regions that provided the information on the status of CCS for H&TM in their domestic pharmacovigilance systems, only China had a separate CCS for H&TM. Conclusion Revising the current pharmacovigilance systems to include or expand the range of H&TM, and developing an internationally harmonized system to classify and code H&TM suitable to the unique characteristics of H&TM are critical and overall beneficial.

Analysis of Reports on Adverse Drug Reactions Related to Herbal Medicinal Products and Herbal Supplements in the Netherlands Received by the National Pharmacovigilance Centre Lareb

“…Second, not all herbal products could be divided into the HATC coding system. Third, the undeclared ingredients that may occur in herbal supplements were difficult to take into account [26]. With the addition of the categories 'Prophylaxis' and 'Product Issue,' it became possible to divide all products into an appropriate category.…”

A survey on the impact of a pharmacovigilance practice training course for future doctors of Korean medicine on their knowledge, attitudes, and perception

“…In addition, some students believed that it was necessary to expand the scope of pharmacovigilance to cover all ranges of herbal and traditional medicines in circulation, and that there was a need to make the SR system more applicable for Korean medicine. The opinion that the current pharmacovigilance system, which has a relatively small proportion of herbal and traditional medicine, needs to be improved has been commonly pointed out in previous studies of experts in pharmacovigilance 24) as well as undergraduates 13) .…”

Complementary and alternative medicine

“…Those systems rely on spontaneous reporting, and WHO is working on a system to gather those reports of adverse events to make available globally ( VigiAccess.org ) ( WHO Collaborating Centre for International Drug Monitoring, 2021 ) [S]. The difference in laws, guidelines, herb nomenclature, and categorization among countries can make this task challenging ( Kim et al, 2021 ) [R]. There is a growing consensus that systematic inclusion of herbal and traditional medicine in pharmacovigilance reporting, including a universal standardized classification system, is needed to facilitate global information sharing and safety tracking.…”

“…There is a growing consensus that systematic inclusion of herbal and traditional medicine in pharmacovigilance reporting, including a universal standardized classification system, is needed to facilitate global information sharing and safety tracking. However, the current spontaneous reporting systems (SRS) are designed for synthetic medications and would require modifications to address HDS, especially in countries that use the theory of Traditional Chinese Medicine ( Bhimaneni et al, 2021 [R]; Kim et al, 2021 [R]). Even the most robust SRS face the challenge of underreporting herbal product usage, the complexity of herbal mixtures, and incomplete or misleading product labelling, making both safety concerns and patient education all the more important as global use of HDS continues to rise.…”