Abstract
Herbal therapies are used by more than 12% of the U.S. population each year, resulting in annual out-of-pocket expenses above $5 billion. Utilization rates are particularly high among patients with chronic diseases, and in patients frequently seen in clinic by physicians and nurse practitioners. Most physicians do not receive formal education regarding the safety of these therapies, and there is growing concern in the medical community about the potential risks to patients and the paucity of reliable information. Numerous adverse effects and interactions have been attributed to dietary supplements, based on variable levels of evidence ranging from historical use or anecdotes to pre-clinical research or high-quality clinical trials. Significant potential morbidity and costs have been indirectly associated with herb/supplement-drug interactions, including increased emergency room visits, outpatient clinic visits, and perioperative complications. However, most research has focused on efficacy rather than safety. Post-market surveillance is complicated by the uneven standardization of products between manufacturers, and in some cases between batches produced by the same manufacturer. To assure public safety around the use of dietary supplements within the framework of existing legislation and market realities, schema must evolve to more systematically monitor the safety of agents in the post-market environment; identify potentially dangerous supplements (and/or constituents); study the mechanism and potential hazards of these identified products; and clarify the process by which products may be considered for removal from the market. We discuss research and educational paradigms within this context which make use of existing surveillance mechanisms to more efficiently identify agents of particular concern. Specific examples are given.
Additional information
Notes on contributors
Ethan M. Basch
F. U. Alakbarov is Head Scientific Officer, expert in the Oriental and Folk Medicine, Institute of Manuscripts of the Azerbaijan Academy of Sciences, 8 Istiglaliyat str., Baku, 370001, Azerbaijan.
At the time of writing Liya Davydov was PharmD candidate, College of Pharmacy and Allied Health Professions, St. John’s University. Currently, she is Pharmacy Practice Resident, Mount Sinai Medical Center, New York, NY.
Ila Mehra Harris is Assistant Professor, Department of Pharmaceutical Care & Health Systems, College of Pharmacy, and Clinical Assistant Professor, Department of Family Practice & Community Health, Medical School, University of Minnesota, Minneapolis, MN.
Colin J. Briggs is Professor of Pharmacy, Faculty of Pharmacy, University of Manitoba. Recently he completed a secondment to Health Canada, as Senior Science Advisor in the Therapeutics Products Programme with special responsibility for complementary medicines.
Gemma Briggs is Research Assistant, IMPACT, The Injury Prevention Centre of Children’s Hospital, 501G-715 John Buhler Research Centre, Winnipeg, MB, Canada.
Mary Chavezis Professor of Pharmacy Practice, Director of Complementary Medicine Education and Research, The Center for the Advancement of Pharmacy Practice, Midwestern University, College of Pharmacy Glendale, Glendale, AZ 85308.