Reports for Herbal Medicines in the Global Suspected ADR Database VigiBase

VigiBase is the World Health Organization global database of individual case safety reports (ICSRs), reports of suspected adverse drug reactions to medicines. VigiBase is maintained by the Uppsala Monitoring Centre, an independent centre for drug safety and scientific research. By June 2020, VigiBase contained over 21 million de-duplicated ICSRs, submitted since 1968 by member countries of the WHO Programme for International Drug Monitoring. Currently (2020), 140 countries are members of the programme. In VigiBase, non-plant/non-allopathic substances, including ingredients of animal origin, e.g. deer velvet, and substances such as vitamins/minerals and plant substances have an autogenerated 10-digit identification (ID) number that can be used to identify them. To perform the descriptive analysis presented in this chapter, a data extraction was performed by UMC. Substances were retrieved from the WHODrug database on 2020-05-03, filtered using Excel software, based on their ID number. Substances that were not herbal were manually identified and excluded. Based on the characterization of the substances, products were classified. This chapter describes a descriptive analysis of VigiBase reports involving herbal medicines and dated between ‘1968-01-01’ and ‘2019-12-31’, from a data extraction performed by UMC on a frozen version of VigiBase, dated May 3rd, 2020. VigiBase contains almost 128,000 reports listing at least one herbal ingredient as the ‘suspected’ or ‘interacting’ drug. These reports represent around 0.6% of the total number of reports in VigiBase. There are almost 24,000 reports listing a sole-suspected/interacting single herbal substance for which the herbal ingredient is identifiable at the species level. Even though the level of documentation in VigiBase is heterogeneous, the database can provide a rich source of information concerning pharmacovigilance for herbal medicines.