Original Research

Journal of General Internal Medicine

, Volume 27, Issue 12, pp 1714-1720

Usability of FDA-Approved Medication Guides

  • Michael S. WolfAffiliated withHealth Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine at Northwestern UniversityDepartment of Learning Sciences, School of Education and Social Policy, Northwestern University Email author 
  • , Jennifer KingAffiliated withHealth Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine at Northwestern University
  • , Elizabeth A. H. WilsonAffiliated withHealth Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine at Northwestern University
  • , Laura M. CurtisAffiliated withHealth Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine at Northwestern University
  • , Stacy Cooper BaileyAffiliated withHealth Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine at Northwestern University
  • , James DuhigAffiliated withDepartment of Pharmacy Administration, University of Illinois at Chicago College of Pharmacy
  • , Allison RussellAffiliated withHealth Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine at Northwestern University
  • , Ashley BergeronAffiliated withHealth Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine at Northwestern University
  • , Amanda DalyAffiliated withHealth Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine at Northwestern University
    • , Ruth M. ParkerAffiliated withDivision of General Medicine, Emory University School of Medicine
    • , Terry C. DavisAffiliated withDepartment of Medicine-Pediatrics, Louisiana State University Health Sciences Center
    • , William H. ShrankAffiliated withBrigham and Women’s Hospital, Harvard Medical School
    • , Bruce LambertAffiliated withDepartment of Pharmacy Administration, University of Illinois at Chicago College of Pharmacy

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Abstract

BACKGROUND

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.

OBJECTIVE

To examine the readability, suitability, and comprehensibility of medication guides, particularly for those with limited literacy.

DESIGN

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).

SETTING

Two general internal medicine clinics in Chicago, IL.

PATIENTS

Four hundred and forty-nine adults seeking primary care services, ages 18–85.

MEASUREMENTS

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.

RESULTS

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).

CONCLUSION

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.

KEY WORDS

prescription medication information comprehension FDA medication guide health literacy