Improved Label and Liver Warning for Nonprescription Acetaminophen Products

Soller, R. William; Ho, Tien D.; Lightwood, James

doi:10.1177/2168479015586002

Cited by 4 publications

(3 citation statements)

References 13 publications

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“…Acetaminophen is a safe OTC analgesic when used as directed, but can cause liver injury when label doses are exceeded. A label comprehension study of revised liver damage warning for acetaminophen found that labels more clearly stating organ damage along with more prominent information about the seriousness of overdose and how to take action led to more accurate behavioral intentions than with existing OTC labeling [52]. Moreover, a within-subjects study found that perceived risk of liver damage for acetaminophen was higher when labels contained revised warnings from the FDA (“organ-specific warning label”) [53].…”

Section: Tests Of Modifications To the Drug Facts Labelingmentioning

confidence: 99%

The Effectiveness of Nonprescription Drug Labels in the United States: Insights from Recent Research and Opportunities for the Future

Catlin

Brass

2018

Pharmacy

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Despite providing a consistent and comprehensible format for over-the-counter (OTC) drug communication, research suggests important limitations in the communication effectiveness of the Drug Facts Label required on OTC drugs in the United States. This literature is reviewed and some of these critical limitations of the Drug Facts Label (DFL) highlighted. These include difficulty communicating complex information that requires integration of multiple pieces of label information and limited adaptability to serve the unique needs of individual populations (e.g., low literacy or older consumers). Potential ways to improve the DFL’s communication effectiveness are identified along with complementary opportunities to improve OTC drug communication by leveraging the role of pharmacists and use of adjunctive technologies.

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Section: Tests Of Modifications To the Drug Facts Labelingmentioning

confidence: 99%

The Effectiveness of Nonprescription Drug Labels in the United States: Insights from Recent Research and Opportunities for the Future

Catlin

Brass

2018

Pharmacy

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“…While some authors continue to suggest more changes to the labels (e.g. format, content, organization, font size) could improve communication of the associated risks (King et al, 2011(King et al, , 2015Soller, Ho, & Lightwood, 2015;Trivedi, Trivedi, & Hannan, 2014); others have established that understanding a risk does not determine whether users will actually comply with a warning (Frantz, Young, Rhoades, & Wisniewski, 2005;Eric F Shaver et al, 2006). In fact, Goya et al 2012evaluated the old and new labels of OTC acetaminophen, and although the new labels were found to be better in increasing perception of the risk of liver damage, they expressed concerns whether users of OTC acetaminophen would actually comply with the better-perceived warning message and instructions (Goyal, Rajan, & Essien, 2012).…”

Section: The Controversy: Perception Implies Compliance?mentioning

confidence: 99%

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

Rojas

2017

Proceedings of the Human Factors and Ergonomics Society Annual

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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.

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“…It's moreover prescribed for youthful children in lower measurements. It's unsafe to require more than the recommended dosage as you'll harm your liver, which may be irreversible and lethal (Soller, Ho, & Lightwood, 2015;Yoon, Babar, Choudhary, Kutner, & Pyrsopoulos, 2016). Paracetamol available under a variety of brands and, it is often combined with other medications such as cold medications.…”

Section: Introductionmentioning

confidence: 99%

Oxidative Coupling-Base Reaction for the Indirect Spectrophotometric Determination of Paracetamol in Drug Formulations

Thanoon

Raheed

Hasan

2021

IJONEST

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A simple, rapid, and specific spectrophotometric method was developed for the determination of paracetamol in pure form and drug formulations. The method depended on the hydrolysis of paracetamol to p-aminophenol, which, oxidized under the effect of dissolved oxygen to benzoquinoneimine. In the alkaline medium, benzoquinoneimine reacts with Methyldopa to produce a high stabile indophenol dye. The absorbance was measured at 580 nm, and the molar absorptivity was found to be 7.75 x 10-5 L/(mol cm). Paracetamol was determined in pharmaceutical products in the 10–100 μg.mL-1 concentration range with a detection limit of 1.5 μg.mL-1 PAP. The developed method can be applied to the determination of both paracetamol and p-aminophenol in the presence of each other without prior separation. The proposed method is successfully employed for the determination of paracetamol in various synthetic mixtures and pharmaceutical preparations. Our obtained results were statistically compared with those given by the similar methods and the procedures evaluated as regards to both figures of merit and ease of applicability.

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Improved Label and Liver Warning for Nonprescription Acetaminophen Products

Abstract: Findings support revision of acetaminophen ODFLs to improve liver damage warnings and to optimize labeling likely to be useful in prevention of and response to overdose.

Cited by 4 publications

References 13 publications

The Effectiveness of Nonprescription Drug Labels in the United States: Insights from Recent Research and Opportunities for the Future

The Effectiveness of Nonprescription Drug Labels in the United States: Insights from Recent Research and Opportunities for the Future

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

Oxidative Coupling-Base Reaction for the Indirect Spectrophotometric Determination of Paracetamol in Drug Formulations

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