Investigation of Efficacy of Improved Acetaminophen Labeling
NCT ID: NCT01592448
Last Updated: 2014-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
662 participants
OBSERVATIONAL
2012-10-31
2013-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Usual Care
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.
No interventions assigned to this group
Written Orientation
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.)
Active Ingredient Icon
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.
Written + Verbal Orientation
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.)
Active Ingredient Icon
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.
Interventions
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Active Ingredient Icon
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.
Eligibility Criteria
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Inclusion Criteria
* English speaking
Exclusion Criteria
* Moderate to severe cognitive impairments
18 Years
80 Years
ALL
Yes
Sponsors
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Emory University
OTHER
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
INDUSTRY
Northwestern University
OTHER
Responsible Party
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Michael S. Wolf
Associate Professor
Principal Investigators
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Michael S. Wolf, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Ruth M. Parker, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Grady Memorial Hospital
Atlanta, Georgia, United States
The Emory Clinic
Atlanta, Georgia, United States
Chicago LakeShore Medical Association
Chicago, Illinois, United States
Mercy Hospital
Chicago, Illinois, United States
Countries
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References
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Fosnocht D, Taylor JR, Caravati EM. Emergency department patient knowledge concerning acetaminophen (paracetamol) in over-the-counter and prescription analgesics. Emerg Med J. 2008 Apr;25(4):213-6. doi: 10.1136/emj.2007.053850.
Larson AM, Polson J, Fontana RJ, Davern TJ, Lalani E, Hynan LS, Reisch JS, Schiodt FV, Ostapowicz G, Shakil AO, Lee WM; Acute Liver Failure Study Group. Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology. 2005 Dec;42(6):1364-72. doi: 10.1002/hep.20948.
Bower WA, Johns M, Margolis HS, Williams IT, Bell BP. Population-based surveillance for acute liver failure. Am J Gastroenterol. 2007 Nov;102(11):2459-63. doi: 10.1111/j.1572-0241.2007.01388.x. Epub 2007 Jun 29.
Ostapowicz G, Fontana RJ, Schiodt FV, Larson A, Davern TJ, Han SH, McCashland TM, Shakil AO, Hay JE, Hynan L, Crippin JS, Blei AT, Samuel G, Reisch J, Lee WM; U.S. Acute Liver Failure Study Group. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med. 2002 Dec 17;137(12):947-54. doi: 10.7326/0003-4819-137-12-200212170-00007.
Other Identifiers
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McNeil-7247
Identifier Type: -
Identifier Source: org_study_id