Investigation of Efficacy of Improved Acetaminophen Labeling
Condition: Acetaminophen Overdose; Pain
MeSH terms: Drug Overdose
Study type: Observational

Summary: 
      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: 
      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.
    

Intervention name(s): Active Ingredient Icon
Intervention type(s): Behavioral
Intervention description(s): 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.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Two types of practices - an academic general medicine clinic and the other a community
        health center - will serve as performance sites.
      
Keywords: Acetaminophen; Patient Safety; Health Literacy