Adverse Experience Reporting for OTC Medicines: Scientific/Regulatory Framework and Review of a Hypothetical Case Study

Abstract

Adverse experience reports have been a vital aspect of postmarketing surveillance for all drug products, including those marketed without a prescription. Despite the paucity of details often accompanying the events reportedly associated with drug use, adverse experience reports can nevertheless be vital sources of information for hypothesis-generating activities, leading to additional research to resolve putative side effects as well as drug-condition and drug-drug interactions. This information can also be used to improve product labeling and/or marketing practices. Recently, the Food and Drug Administration reemphasized the use of adverse experience reports in developing signals of potential drug-related risk, in part a result of recent estimates on the great cost of drug-related morbidity and mortality. While these estimates relate principally to prescription drugs, the potential for over-the-counter drug-related adverse experience reports is nonetheless an important consideration from a preventive perspective. This paper summarizes the key factors contributing to the agency's current emphasis on adverse experience report evaluations and discusses a hypothetical case study of a newly switched over-the-counter product challenged by a series of emergent adverse experience reports.