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Biennial Analysis of Medication Guide Length and Estimated Readability for New Molecular Entity Drugs, 2011–2017

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Abstract

Background

A medication guide (MG) is a form of FDA-approved labeling that provides patients with information about certain prescribed drugs so that patients can use these drugs safely and effectively. Given ongoing efforts by FDA and industry to continuously improve MG content and format, we hypothesized that more recently approved MGs for new molecular entities (NMEs) would be shorter and more readable compared to NME MGs approved earlier.

Methods

We analyzed 53 NME MGs that were either approved in 2011 (n = 16), 2013 (n = 9), 2015 (n = 12), or 2017 (n = 16) to determine whether MG page length, word count, and readability scores differed by year. Readability was estimated by Flesch Reading Ease, Flesch–Kincaid Grade Level (FKGL), Fry graph (FRY), and Gunning’s Fog Index (FOG) scores.

Results

Mean page length was significantly lower in 2017 than in 2011 and 2013 (ps < .0001). Mean FKGL scores reflected sentences and words found in 8th grade textbooks, but mean FOG and FRY scores were consistent with sentences and words found in 10th and 11th grade textbooks.

Conclusions

Although more recent NME MGs were shorter than older NME MGs, additional research is warranted to determine whether shorter MGs lead to improved readability. Developers choosing to estimate MG readability with equations should consider using multiple readability formulas and weigh the strengths and weaknesses of this approach. Using validated tools to more comprehensively assess MG readability should also be considered.

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Notes

  1. Updated MGs are available at http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

  2. Our hypothesis presumes that multiple factors (from the top-down and bottom-up [17]), operating independently and collectively, could help to drive changes (and potential improvements) in MG readability over time. These factors include (but are not limited to) efforts from FDA (e.g., to educate the public about MG regulations in papers, workshops, and meetings, and incorporate advances in health literacy and plain language into patient labeling reviews [5, 12,13,14]); healthcare providers (e.g., pharmacists’ face-to-face interactions with patients concerning MGs); drug companies (e.g., using health literacy experts and consumer testing to develop and enhance patient labeling [15]); academia (e.g., research aimed at improving patient information [8, 11]); and patients and caregivers (e.g., providing feedback during consumer tests of patient information).

  3. Our MG sample did not include MGs for all drug products approved in 2011, 2013, 2015, and 2017 because MGs are only required for certain drugs.

  4. We recognize that, by excluding punctuation and non-sentences, we may be inadvertently eliminating the evidence-based health literacy practice of using bullets to simplify information. Nevertheless, we wanted to remain consistent with McGee’s [22] instructions and reduce potential sources of measurement error in our readability computations.

  5. Because FRY and FOG formulas were hand-scored, and to help control our experimentwise error rate, we only ran statistical tests on FRY and FOG scores computed with adjusted MGs.

  6. Our FOG and FRY readability computations focused on early sections in each MG under the assumption that patients would read this information first. As recommended (e.g., [24]), complex words with three (or more) syllables used in our FOG computations did not include common suffixes as a syllable (e.g., -ing), proper nouns, familiar jargon, or compound or hyphenated words.

  7. Our sample size did not allow us to conduct meaningful subgroup analyses (e.g., analyzing year-based differences in the severity of illness treated by the drugs in our sample).

  8. Two MGs—one approved in 2011, the other approved in 2013—were flagged as suspected outliers (i.e., ± 2 SDs above/below the mean) on the FKGLRAW variable. Rather than excluding these two MGs from our analysis (which could create selection bias in our results), we conducted all of our statistical tests involving this variable both with and without these two MGs. Because we found no appreciable differences in the direction or magnitude of our results, we only report our findings from tests that included these MGs in this paper

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Acknowledgments

The authors give special thanks to Carley Castelein for her assistance in medication guide preparation. They also thank Philip Budashewitz, Dr. Tala Fakhouri, and the anonymous reviewers for their comments on an earlier draft.

Funding

The authors are full-time FDA employees and wrote this paper as part of their official federal duties. They did not receive any additional financial support for their work on this paper.

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  1. Center for Drug Evaluation and Research, Office of Medical Policy, Office of Medical Policy Initiatives, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, WO Bldg 51, Third Floor, Silver Spring, MD, 20993, USA

    Paul R. Jones, Elisabeth J. Walther, Andrew Nguyen, Jonas Santiago & Bryon M. Pearsall

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  1. Paul R. Jones
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Correspondence to Paul R. Jones.

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The authors declared no conflicts of interest. The views expressed in the article are the views of the authors and do not reflect an official position of the FDA or U.S. Government.

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The authors stated that no ethical approval was required because this article does not contain any studies with human or animal subjects performed by any of the authors.

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Jones, P.R., Walther, E.J., Nguyen, A. et al. Biennial Analysis of Medication Guide Length and Estimated Readability for New Molecular Entity Drugs, 2011–2017. Ther Innov Regul Sci 55, 918–925 (2021). https://doi.org/10.1007/s43441-021-00270-3

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