Adverse Events and Over-the-Counter (OTC) Drugs: Is Inappropriate Labeling the Problem? - The Case of Acetaminophen

Abstract

Incorrect use of acetaminophen that results in severe liver injury is among the most common adverse drug events (ADEs) in the United States of America (USA), and other countries around the world. Compared to any other drug, it is also on the top for emergency calls, emergency room visits, and acute liver failure in the USA. Consequently, regulating acetaminophen has become a heated and unresolved public debate. During the last decades, multiple efforts have taken place to address the issue, mostly focused on the premise that inappropriate labeling is a leading cause of such ADEs, for failure in communicating the associated risks through warnings. Unlike previous studies, this paper illustrates the importance of considering human factors principles. Three different warning labels were designed and evaluated. The results showed no statistically significant effect, despite the application of best practices for label warning design. Non-design factors, the warning process and why a warning could fail are also illustrated. Implications could help researchers, policy makers, and manufacturers to consider focusing less on traditional labeling interventions, and to invest efforts more systematically considering also the current trends and the current needs of consumers.

Beyond Disease: Technologies for Health Promotion

“…These individuals are not necessarily characterized by a disease condition, although studies often examine groups bounded by age or other demographics (e.g., children, Latinos), geography (e.g., rural, residing in low and middle income countries), or disease risk factors (e.g., obesity, sedentary lifestyle). There have been a number of patient ergonomics studies on health promotion, such as people's use of anecdotal health information on the Internet (Madathil et al, 2014); understanding safety information on over-thecounter medication labels (Rojas & Li, 2017); and factors affecting sleep in adolescents (Vredenburgh, 2017). By far the largest segment of patient ergonomics studies in health promotion addresses technologies for health promotion.…”

An insight into paracetamol and its metabolites using molecular docking and molecular dynamics simulation

“…Data have shown that the proportion of acute liver failure (ALF) cases resulting from deliberate or accidental overdoses of paracetamol, mainly in opioid/paracetamol combination products, increased from 28% in 1998 to 51% in 2003. Thus, the elimination of prescription paracetamol combination products was recommend by the FDA advisory committee in June 2009 [6, 10].…”