Herbal medicines pharmacovigilance in Iran

The global consumption of herbal medicines continues to increase steadily. Indeed, many people use herbal medicines for health promotion and therapeutic purposes in developing and industrialized countries. However, reports of adverse events in mass media are usually sentimental and generally render a negative feeling about the usage of herbal medicines instead of identifying the reasons for such incidences, which can be associated with a number of issues. Both national health specialists and the common people are concerned about the safety of herbal medicines. The World Health Organization (WHO) has recommended the inclusion of herbal medicines in the current national pharmacovigilance systems to fortify national capability in keeping the safety of herbal medicines under surveillance and investigating the reasons for adverse events, and to share related data at different levels in the world. Iranian pharmacovigilance system fulfills most of the WHO pharmacovigilance criteria. However, the underreporting of adverse drug reactions (ADRs), particularly medicine-related hospital admissions and deaths is a major weakness of this system. In addition to paying more attention to ADRs reporting, the Iranian pharmacovigilance program requires to include herbal medicines that constitute a high proportion of medicinal products in Iran. Due to the absence of reporting mechanisms (for herbal medicines), there have so far been few reports on herbal medicine-induced adverse events. However, an extremely small number of reports do not guarantee the complete safety of herbal products. Therefore, herbal pharmacovigilance is required to ensure safety of herbal medicines in Iran.