Citation

Kingston R, Sioris K, Gualtieri J, Brutlag A, Droege W, Osimitz TG. Regul. Toxicol. Pharmacol. 2021; ePub(ePub): ePub.

Copyright

(Copyright © 2021, Elsevier Publishing)

DOI

10.1016/j.yrtph.2021.105028

PMID

unavailable

Abstract

Analysis of spontaneous reports of adverse events is an important source of information that can be used to improve consumer products. Various agencies have adverse event reporting requirements and many companies collect such data directly from consumers. Nonetheless, a universal framework is absent that identifies and evaluates spontaneously reported adverse events, and, most important, assesses the potential association between exposure and adverse events. We are presenting a three-part framework: Phase I - Intake and Documentation of Original Incidents; Phase II - In Depth Review and Follow-up of Phase I Incidents (enhanced, tailored questionnaire); Phase III - Association Assessment. The basis for scoring the strength of association between exposure and adverse events requires assessment of standard factors of association including: temporality; biological, physiological, or pharmacological plausibility; results of de-challenge; results of re-challenge; and consideration of confounding factors. Scores tied to the answers to these questions are totaled for each incident to determine the strength of association between exposure and reported adverse event. We propose that consumer product companies come together to adopt such an association assessment framework to improve adverse event management, obtain maximum value from the data obtained, and use the knowledge derived to improve overall product safety for consumers.

Language: en

Keywords

correlation; outcome; adverse event; association assessment; consumer products; pharmacovigilance; poison control; post-market surveillance system; scoring system; spontaneous reports