New Approaches and Perspectives in Pharmacovigilance for Herbal Medicines

In recent years, numerous high-profile safety concerns associated with the use of herbal medicines (HMs; botanicals), including adverse drug reactions (ADRs) from conventional drug-HM interactions, have had an impact on the public health. Safety problems can also arise from the use of poor-quality HMs. Against this background, there is a need to enhance pharmacovigilance (safety monitoring) for HMs. Existing pharmacovigilance methods typically have developed in the context of conventional, prescription medicines; applying them to monitoring safety of HMs presents numerous additional challenges, related to their characteristics and the ways in which HMs are regulated, accessed, used, named, and perceived.²

Spontaneous reporting of suspected ADRs associated with HMs is currently the main method of detection of safety problems. However, under-reporting for these products is likely to be more substantial than for conventional medicines. Modifications to other conventional pharmacovigilance methods and new approaches are needed. Pharmacy-based active surveillance models for collecting reports of suspected ADRs associated with HMs and other natural health products (NHPs) have been developed and piloted in the UK and Canada. Internet-based methods of safety monitoring for HMs, and using ethnobotanical studies for pharmacovigilance purposes in developing countries and with migrant populations in developed countries, may also have potential.

This presentation will discuss current methods of pharmacovigilance for HMs, present results from new and modified methods described, and give a future perspective on pharmacovigilance of HMs.