Usability of FDA-Approved Medication Guides
- Michael S. Wolf PhD, MPH,
- Jennifer King MPH,
- Elizabeth A. H. Wilson PhD,
- Laura M. Curtis MS,
- Stacy Cooper Bailey PhD, MPH,
- James Duhig PhD,
- Allison Russell BA,
- Ashley Bergeron MPH,
- Amanda Daly BA,
- Ruth M. Parker MD,
- Terry C. Davis PhD,
- William H. Shrank MD, MSHS,
- Bruce Lambert PhD
- … show all 13 hide
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Medication guides are required documents to be distributed to patients in order to convey serious risks associated with certain prescribed medicines. Little is known about the effectiveness of this information to adequately inform patients on safe use.
To examine the readability, suitability, and comprehensibility of medication guides, particularly for those with limited literacy.
Assessments of suitability and readability of 185 medication guides, and a sub-study examining change in suitability and readability from 2006 to 2010 among 32 of the medication guides (Study 1); ‘open book’ comprehension assessment of medication guides (Study 2).
Two general internal medicine clinics in Chicago, IL.
Four hundred and forty-nine adults seeking primary care services, ages 18–85.
For Study 1, the Suitability Assessment of Materials (SAM) and Lexile score for readability. For Study 2, a tailored comprehension assessment of content found in three representative medication guides.
The 185 analyzed medication guides were on average 1923 words (SD = 1022), with a mean reading level of 10–11th grade. Only one medication guide was deemed suitable in SAM analyses. None provided summaries or reviews, or framed the context first, while very few were rated as having made the purpose evident (8 %), or limited the scope of content (22 %). For Study 2, participants’ comprehension of medication guides was poor (M = 52.7 % correct responses, SD = 22.6). In multivariable analysis, low and marginal literacy were independently associated with poorer understanding (β = –14.3, 95 % CI –18.0 – –10.6, p < 0.001; low: β = –23.7, 95 % CI –28.3 – –19.0, p < 0.001).
Current medication guides are of little value to patients, as they are too complex and difficult to understand especially for individuals with limited literacy. Explicit guidance is offered for improving these print materials.
- Usability of FDA-Approved Medication Guides
Journal of General Internal Medicine
Volume 27, Issue 12 , pp 1714-1720
- Cover Date
- Print ISSN
- Online ISSN
- Additional Links
- medication information
- medication guide
- health literacy
- Industry Sectors
- Michael S. Wolf PhD, MPH (1) (2)
- Jennifer King MPH (1)
- Elizabeth A. H. Wilson PhD (1)
- Laura M. Curtis MS (1)
- Stacy Cooper Bailey PhD, MPH (1)
- James Duhig PhD (3)
- Allison Russell BA (1)
- Ashley Bergeron MPH (1)
- Amanda Daly BA (1)
- Ruth M. Parker MD (4)
- Terry C. Davis PhD (5)
- William H. Shrank MD, MSHS (6)
- Bruce Lambert PhD (3)
- Author Affiliations
- 1. Health Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine at Northwestern University, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL, 60611, USA
- 2. Department of Learning Sciences, School of Education and Social Policy, Northwestern University, Evanston, IL, USA
- 3. Department of Pharmacy Administration, University of Illinois at Chicago College of Pharmacy, Chicago, IL, USA
- 4. Division of General Medicine, Emory University School of Medicine, Atlanta, GA, USA
- 5. Department of Medicine-Pediatrics, Louisiana State University Health Sciences Center, Shreveport, LA, USA
- 6. Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA