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THE PHARMA REVIEW (MAY 2009)

Pharmacovigilance of Herbal Medicines: Current Status and
Future Strategies

Dr. Papiya Bigoniya

Abstract: Herbal formulations have reached widespread acceptability as therapeutic agents for diabetics, arthritics, liver diseases, cough and cold, memory enhancement and immunostimulation throughout the world. Herbals are traditionally considered harmless and increasingly being consumed by people without prescription. Systematic data on the incidence of traditional medicine-associated adverse effects are not available due to many complex issues including; products with multiple ingredients, poor standardization, lack of clinical trials, variation in manufacturing processes, contamination, adulteration and misidentification of herbs etc.
 
The purpose of pharmacovigilance is to detect, assess and understand, and to prevent the adverse effects or any other possible drug-related problems, related to herbal, traditional and complementary medicines. Pharmacovigilance for herbal medicines is in its infancy and monitoring the safety of herbal medicines presents unique challenges as such preparations are available from a wide range of outlets where no healthcare professionals are available. The legal status and approval mechanism of herbal medicine also vary from country to country.
 
World Health Organization has set specific guidelines for the assessment of the safety, efficacy and quality of herbal medicines as a prerequisite for global harmonization. The Medicines and Healthcare Products Regulatory Agency’s, UK has launched ‘yellow card’ scheme for ADR reporting for monitoring the safety of herbal medicines. Indian drug regulation has not yet fully integrated traditional herbal medicine into all aspects of health care system. Herbal pharmacovigilance should be implemented in Indian herbal regulatory system to access various aspects of ADR, delayed or acute toxicities, allergies etc associated with single herb and/or polyherbal formulation. Modified spontaneous reporting forms are to be designed following WHO template to collect information on suspected ADRs of herbal medicines aiming to achieve the ultimate goal of safer and more effective treatment available to patients. This review aims to provide a comprehensive and critical overview of the current state of pharmacovigilance for herbal medicines at national and global levels. This article explores the in depth challenges associated with herbal pharmacovigilance considering emerging issues and recommendations to improve safety monitoring for herbal medicines in the future.

 
Introduction
From prehistoric times, herbal medicine are being used by various communities and civilizations throughout the world. For the past several decades, herbal medicines have been increasingly consumed by people without prescription. Herbal formulations have reached widespread acceptability as therapeutic agents like anti-diabetics, anti-arthritics, aphrodisiacs, hepatoprotective, cough remedies, memory enhancers and adaptogens. Herbals are traditionally considered as harmless since they belong to natural sources. Most over-the-counter herbal products like ginseng have drawn great public attention but there are several case reports of adverse reactions of herbal drugs mentioned in the literature which are generally considered safe. The accurate scientific assessment of herbal medicine is a prerequisite for global harmonization of herbal health claims. In this regard the World Health Organization (WHO) has set specific guidelines for the assessment of the safety, efficacy and quality of herbal medicines. The purpose of pharmacovigilance is to detect, assess and understand, and to prevent the adverse effects or any other possible drug-related problems, which is not only confined to chemical drugs, but extended to herbal, traditional and complementary medicines, biologicals, vaccines, blood products and medical devices. 

 

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