Investigation of Efficacy of Improved Acetaminophen Labeling

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Consumer Understanding and Use of Non-Prescription Analgesics, Investigation of Efficacy of Improved Acetaminophen Labeling

Conditions
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Acetaminophen Overdose, Pain

Intervention / Treatment
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* Behavioral: Active Ingredient Icon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years old English speaking Exclusion Criteria: Visual or hearing impairments Moderate to severe cognitive impairments

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Usual Care<br>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<br>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.) | Behavioral: Active Ingredient Icon<br>* Enhanced bottles will have a symbol, or icon, designed to draw attention to active ingredient information. The icon is a black hexagon containing two letters denoting the active ingredient of the medication (i.e. Ac for acetaminophen). Over-the-counter bottles will have the icon placed on the front of the bottle next to active ingredient information and on the back of the bottle in the drug facts to the left of the active ingredient information. Prescription bottles will have the icon placed below the directions for how to take the medication and will be accompanied by a brief statement indicating the medicine contains acetaminophen.<br>|
| Written + Verbal Orientation<br>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.) | Behavioral: Active Ingredient Icon<br>* Enhanced bottles will have a symbol, or icon, designed to draw attention to active ingredient information. The icon is a black hexagon containing two letters denoting the active ingredient of the medication (i.e. Ac for acetaminophen). Over-the-counter bottles will have the icon placed on the front of the bottle next to active ingredient information and on the back of the bottle in the drug facts to the left of the active ingredient information. Prescription bottles will have the icon placed below the directions for how to take the medication and will be accompanied by a brief statement indicating the medicine contains acetaminophen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Understanding and Use | Functional understanding (via teachback and demonstration) of acetaminophen label information (OTC & Rx), including 1) active ingredient, 2) maximum daily dose, and 3) risks associated with misuse. | 40 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health literacy (NVS) | The NVS (Newest Vitals Sign) is designed to provide a valid and quick assessment of participant health literacy. The assessment is based on a nutrition label from an ice cream container. Patients are given the label and then asked 6 questions about it. | 40 minutes | 
| Participant characteristics | Basic demographic characteristics (age, sex, race/ ethnicity), socioeconomic information (education, household income), health status information (self-reported overall health), recent medication use and beliefs about over-the-counter medicines will be collected. | 40 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetaminophen, Patient Safety, Health Literacy