Investigation of Efficacy of Improved Acetaminophen Labeling

Northwestern University

Status: Completed

Conditions: Pain; Acetaminophen Overdose

Treatments: Behavioral: Active Ingredient Icon

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01592448

McNeil-7247

Details and patient eligibility

About

The purpose of this study is to evaluate, through brief, one-on-one cognitive interviews, the efficacy of 'enhanced' acetaminophen messages and icons in improving consumer understanding and use of prescription (Rx) and non-prescription (over-the-counter, OTC) acetaminophen containing products compared to the current standard.

Full description

Acetaminophen is a pain reliever and fever reducer found in many over-the-counter (OTC) analgesics as well as prescription (Rx) products commonly prescribed at discharge from the emergency department. 1 An estimated 36% of Americans ingest acetaminophen at least once a month.1, 2 While acetaminophen is generally safe and effective when used at recommended doses, acetaminophen overdose has surpassed viral hepatitis as the leading cause of acute liver failure (ALF) in the United States.2-4 Moreover, one half to two-thirds of overdoses leading to acute liver failure are unintentional, suggesting the root cause may be poor understanding of medication labeling or failure to recognize the consequences of exceeding the recommended maximum daily dosage.2-4 On-going studies by this research group have shown patient misunderstanding of dosing instructions and warnings associated with OTC medicines to be prevalent.

It has also been suggested that patients receiving prescription medications containing acetaminophen may not be informed or aware of the potential risk of acetaminophen overuse when taking prescription products in combination with over-the-counter pain relievers.1 This is supported by the finding that a third of narcotic users were simultaneously using an OTC acetaminophen containing product in a multicenter study of ALF cases.2 To address the growing concern of acetaminophen misuse, in June 2009 the US Food and Drug Administration (FDA) convened a panel to discuss the maximum dose recommendations of acetaminophen found in OTC medications. The panel concluded that there was a notable lack of available evidence on consumer understanding and use of over-the-counter acetaminophen products. Studies are needed to explore patients' 1) knowledge of potential acetaminophen overdose when using prescription analgesics simultaneously with non-prescription acetaminophen and 2) avenues available to increase awareness of potential acetaminophen overdose from misuse of both OTC and Rx acetaminophen containing medicines.

Enrollment: 662 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-80 years old
• English speaking

Exclusion criteria

• Visual or hearing impairments
• Moderate to severe cognitive impairments

Trial design

662 participants in 3 patient groups

Usual Care

Description:

Participants will be shown "standard" (defined as currently commercially available) over-the-counter and prescription medicine bottles and asked questions regarding safety and use. Participants will also be shown additional "standard" over-the-counter bottles and asked whether these comparison bottles could safely be taken in addition to the primary products shown.

Written Orientation

Description:

Participants will be exposed to over-the-counter and prescription bottles "enhanced" with an icon pertaining to active ingredient and asked questions regarding safety and use. Participants will be exposed to a flier describing the safe use of acetaminophen and orienting the participant towards the icon that is used to indicate the presence of acetaminophen in a product. This flier will be passively hanging within sight of the participant in the room, but no verbal explanation of the flier will be given to the participant. (This is designed to represent a passive education campaign such as posters in drug stores that may be used should these icons be adopted by manufacturers.)

Treatment:

Behavioral: Active Ingredient Icon

Written + Verbal Orientation

Description:

Participants will be exposed to over-the-counter and prescription bottles "enhanced" with an icon pertaining to active ingredient and asked questions regarding safety and use. Participants will be exposed to a flier describing the safe use of acetaminophen and orienting the participant towards the icon that is used to indicate the presence of acetaminophen in a product. Research personnel will also verbally go through the flier with the participant and answer any questions in a standardized fashion. (This is designed to represent an active education campaign such as pharmacist counseling that may be used should these icons be adopted by manufacturers.)

Treatment:

Behavioral: Active Ingredient Icon