Document Detail

Consumer Understanding of Prescription Drug Information: An Illustration Using an Antidepressant Medication (April).
MedLine Citation:
PMID:  21427296     Owner:  NLM     Status:  Publisher    
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.
Saul Shiffman; Karen K Gerlach; Mark A Sembower; Jeffrey M Rohay
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-3-22
Journal Detail:
Title:  The Annals of pharmacotherapy     Volume:  -     ISSN:  1542-6270     ISO Abbreviation:  -     Publication Date:  2011 Mar 
Date Detail:
Created Date:  2011-3-23     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9203131     Medline TA:  Ann Pharmacother     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Pinney Associates, Inc., Pittsburgh, PA.
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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