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Usability of FDA-Approved Medication Guides

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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.

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Acknowledgments

This project was supported by an unrestricted grant from Abbott Labs (PI: Wolf).

Conflict of Interest

Drs. Wolf and Bailey have served as paid consultants to Abbott Labs for research services and advisory committee activities. Both Drs. Davis and Wolf have served as paid consultants to McNeil Consumer Healthcare in service for advisory board membership on drug labeling initiatives.

Competing Interests

Drs. Wolf, Davis, and Lambert have previously provided research consultation services to Abbott Labs.

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Authors and 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

    Michael S. Wolf PhD, MPH, Jennifer King MPH, Elizabeth A. H. Wilson PhD, Laura M. Curtis MS, Stacy Cooper Bailey PhD, MPH, Allison Russell BA, Ashley Bergeron MPH & Amanda Daly BA

  2. Department of Learning Sciences, School of Education and Social Policy, Northwestern University, Evanston, IL, USA

    Michael S. Wolf PhD, MPH

  3. Department of Pharmacy Administration, University of Illinois at Chicago College of Pharmacy, Chicago, IL, USA

    James Duhig PhD & Bruce Lambert PhD

  4. Division of General Medicine, Emory University School of Medicine, Atlanta, GA, USA

    Ruth M. Parker MD

  5. Department of Medicine-Pediatrics, Louisiana State University Health Sciences Center, Shreveport, LA, USA

    Terry C. Davis PhD

  6. Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

    William H. Shrank MD, MSHS

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  1. Michael S. Wolf PhD, MPH
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  2. Jennifer King MPH
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  12. William H. Shrank MD, MSHS
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Corresponding author

Correspondence to Michael S. Wolf PhD, MPH.

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Wolf, M.S., King, J., Wilson, E.A.H. et al. Usability of FDA-Approved Medication Guides. J GEN INTERN MED 27, 1714–1720 (2012). https://doi.org/10.1007/s11606-012-2068-7

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  • DOI: https://doi.org/10.1007/s11606-012-2068-7

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