Pharmacovigilance of Natural Herbal Medicines Research for Efficacy, Safety and Quality Assurance of Phytomedicine Products
Estella Tembe Fokunang
Department of Pharmacotoxicology and Pharmacokinetics, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Cameroon.
Dobgima John Fonmboh
Department of Nutrition, Food Science and Bioresource Technology, College of Technology, University of Bamenda, Cameroon.
Rose Ngono Mballa
Department of Pharmacology and Traditional Medicine, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Cameroon.
Andrew Banin Nyuyki
Lead Scientist GE Life Sciences CYTIVA, Logan, Utah, USA.
Lovet Benyella Fokunang
Department of Pathology, New York University School of Medicine, New York, NY 10016, USA.
Nubia Kaba
Department of Clinical Research, Revance Therapeutic Incorporated, Newark California, USA.
Thérèse Bwemba Abong
National Ethics Committee for Human Health Research of Cameroon (CNERSH), Yaoundé, Cameroon.
Ralf Duerr
Department of Pharmacology and Traditional Medicine, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Cameroon.
Ejoh Richard
Department of Nutrition, Food Science and Bioresource Technology, College of Technology, University of Bamenda, Cameroon.
Marie-Thérèse Abena Ondoua
Pediatrics, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Cameroon.
Charles Ntungwen Fokunang *
Department of Pharmacotoxicology and Pharmacokinetics, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Cameroon.
*Author to whom correspondence should be addressed.
Abstract
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.
Keywords: Pharmacovigilance, herbal medicines, improved traditional medicine, regulation, research.