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

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.