Pharmacovigilance of Herbal Medicines

Abstract: Pharmacovigilance involves the assessment of risks and benefits of medicines and plays a key role in pharmacotherapeutic decision making. For several years now, herbal medicines have been increasingly consumed by patients as most of them are available over the counter (OTC). Like synthetic drugs, herbal medicinal products also need drug surveillance in order to identify their possible long term risks. Recently, guidelines for the safe use of herbal drugs were developed by participants attending the regional workshop on the Regulation of Herbal Medicines, organized by the WHO Regional Office for South-East Asia. The guidelines are beneficial to countries by serving as a reference to facilitate setting up requirements for registration and regulation of herbal medicines. The present models of pharmacovigilance and its associated tools have been developed in relation to synthetic drugs. Improvements in safety monitoring of herbal medicines may include modifications to existing methodology, patient reporting and greater consideration of pharmacogenetics and pharmacogenomics in optimizing the safety of herbal medicines.

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