By Mark Land, AAHP President
Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.1 Serious adverse events for non-prescription drugs including homeopathic drug products have been required to be reported to FDA since 2007.2 Today it seems hard to believe that reporting serious adverse events for OTC drug products and dietary supplements was not required prior to 2007. Encoded in the previous sentence lives the sentiment that OTC drug products are inherently safe and that close monitoring of consumers’ experiences is a low priority.
Homeopathic companies may be at particular risk for complacency in this area, considering the remarkable safety record of our products.3 The nature of homeopathic medicines makes it easy to dismiss adverse event reports as unrelated. Because adverse events are rare for homeopathic drug products, each report becomes that much more precious in understanding the complex interaction between consumers and our products.
Mann and Andrews tell us that pharmacovigilance is the study of the safety of marketed drugs under practical conditions of clinical usage in large communities.4 Important in that statement are the words practical conditions. Practical conditions implicate: product quality, patient adherence, concomitant medications, disease progression, and medication errors just to name a few of risks associated with marketed drugs in large communities.
Pharmacovigilance is the discipline within our organizations that receives, records, analyzes, and acts on adverse user experiences with our products. Its importance cannot be overstated. Dedicating the necessary resources to pharmacovigilance is fundamental.
Take advantage of other AAHP articles on pharmacovigilance to improve your company’s expertise in this fundamental area and make contact with professional resources available to support your organization.
Additionally, the Quality Summit in June of this year in Baltimore will include a workshop on pharmacovigilance. Learn more here.
- World Health Organization Pharmacovigilance http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/
- Public Law 109-462, the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.
- Krenzelock, E. Homeopathic Product Exposures National Poison Data System (NPDS) 2006 to 2013. https://www.regulations.gov/document?D=FDA-2015-N-0540-4429
- Pharmacovigilance p3 Mann, R.D and Andrews, E.B, 2002 John Wiley & Sons. Ltd. Chichester, West Sussex PO19 8SQ, England.