HERBAL PHARMACOVIGILANCE is the practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions.
•Recording and coding the identity of herbal medicines
Use of a standardized classification and identification for transmitting reports to UMC is desirable. Coding of adverse events/adverse reactions to herbal medicines should be compatible with that for other medicines.
•Individual case reports
Assessment of reports on adverse reactions to herbal medicines should be undertaken by national pharmacovigilance centres in the same way as for other medicines. Each data element in the report should be considered and a causality assessment made using a standard approach.
•Detection of signals at national level
The national pharmacovigilance centre should, at regular intervals, analyze the case reports in its database by class of organ system and in smaller groups of clinically related events. This may reveal case series of similar events that could constitute a signal and/or indicate the need for further study or regulatory action. Such signals should be communicated to UMC.
•Detection of signals at international level –
The major aim of pharmacovigilance is the early detection of signals of previously unrecognized adverse reactions. Early signals may be strengthened by combining the experiences reported in various countries.
