CHICAGO—Companies that adhere to adverse event reports (AERs) by the book follow the law, but may not be increasing the safety of the industry or the public as a whole, said Rick Kingston, PharmD, president of regulatory and scientific affairs, SafetyCall International PLLC, at the Natural Health Research Institute’s (NHRI) symposium on the cost effectiveness and safety of dietary supplements on Nov. 18, 2010.
To help reduce risk, Kingston promoted post-market surveillance, whereby manufactures, regulators, health professionals, the public at large and others monitor the performance and experience related to a given products lifecycle in the open market. Using this process, he said, helps identify intended and unintended use patterns that may potentially contribute to unintended effects, allows assessment of how the product performs by itself or in the presence of other products or substances, and helps ensure effects in “unique" populations are considered when evaluating risk.
Submitting AERs allows product manufactures to meet the letter of the law by receiving, documenting and tabulating information from AERs, but post-market surveillance, on the other hand, allows them to meet the intent of the law with investigation, interpretation and analysis.
AERs can come from an inherent product or ingredient issue; a manufacturing issue; or interaction with a drug, food or disease. However, most adverse reaction allegations are due to what Kingston called “Background Noise," such as a product user’s concomitant disease, the consumer misidentifying the offending substance or product, the “herd mentality" that causes one to join others who say they’ve suffered an event or the “syringe in the Pepsi can" syndrome where no event occurred in the first place.
FDA’s database of serious AERs likely contain all of these events; some that could help the industry be safer, others not. When a company implements post-market surveillance, they are better able to predict and evaluate adverse reactions to their products to determine if safety changes need to be made, he said.
Post-market surveillance evaluates causal links and associations using expectedness; relative incidence rates; temporality; biologic, pharmacologic, toxicologic plausibility; and confounding variables.
Kingston noted with FDA’s new GMP-compliance standards AER submissions are likely to increase, making the monitoring of products more crucial than ever before. He said companies using effective principles of post-market surveillance can quickly sort out the background noise and identify emerging safety issues if and when they occur. Ultimately, this leads to good product stewardship, safer products and increased consumer confidence.
