Pharmacovigilance of Natural Herbal Medicines Research for Efficacy, Safety and Quality Assurance of Phytomedicine Products

Improved traditional medicine/phytomedicine formulations have gained a global acceptability and popularity as therapeutic agents for many diseases in Sub-Saharan Africa. Herbal products are generally considered as safe, environmentally friendly and increasingly consumed by the community without prescription. There is a lack of systematic data on traditional medicine-associated adverse effects due to complex issues such as products with multiple ingredients, poor standardization, lack of clinical trials, variation in manufacturing processes, contamination, adulteration and misidentification of herbs. The aim of pharmacovigilance is to detect, assess, understand, and 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 natural products presents unique challenges, and as such, preparations are available from a wide range of sources where limited qualified healthcare professionals are available. The ethico-legal issues and regulatory approval mechanism of herbal medicine vary from country to country. This paper also elucidates the level of challenges associated with herbal pharmacovigilance geared towards improving safety monitoring for herbal medicines in the future.