title: Consumer understanding of prescription drug information: an illustration using an antidepressant medication.
abstract: BACKGROUND
  Patient education and warnings have emerged as prominent interventions for improving drug safety. As part of the provision of information and guidance on safe use of drugs, patients often receive multiple pieces of written information when they obtain a prescription medication, including a Food and Drug Administration (FDA)-mandated medication guide (MG), consumer medication information (CMI), and patient package insert (PPI).
  
  
  OBJECTIVE
  To determine whether patients understand the materials providing drug information and whether the materials convey the intended information.
  
  
  METHODS
  Fifty-two adults with a high school education or less were shown an actual (blinded) MG, CMI, and PPI for a marketed antidepressant medication. Comprehension was tested with methods used by the FDA to assess label comprehension for nonprescription products.
  
  
  RESULTS
  The majority of participants (88.2%) looked at all 3 pieces of information provided. The mean (SD) time spent reviewing the CMI was 5.2 (4.8) minutes (range 0-21.9), 16.5 (13.3) minutes for the PPI (range 0-43.0), and 2.5 (1.6) minutes for the MG (range 0-7.6). Less than 20% of participants were able to identify the symptoms of a rare but potentially life-threatening situation that can occur with this medication and only 61.5% recalled the risk of teen suicide, which is the sole focus of the MG. Respondents with lower literacy scores performed more poorly than those with higher literacy scores.
  
  
  CONCLUSIONS
  Information provided with at least some prescription drugs is not adequately understood by less-educated consumers and does not effectively communicate critical safety messages or directions.
authors.affiliation: Pinney Associates, Inc., Pittsburgh, PA, USA.
authors.forename: Saul
authors.initials: S
authors.lastname: Shiffman
authors.forename: Karen K
authors.initials: KK
authors.lastname: Gerlach
authors.forename: Mark A
authors.initials: MA
authors.lastname: Sembower
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Rohay
mesh_terms: D000928:Antidepressive Agents; D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D004366:Nonprescription Drugs; D010353:Patient Education as Topic; D055553:Prescription Drugs; D011795:Surveys and Questionnaires; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000928:Antidepressive Agents; D004366:Nonprescription Drugs; D055553:Prescription Drugs