Paul R Jones1, Elisabeth J Walther2, Andrew Nguyen2, Jonas Santiago2, Bryon M Pearsall2. 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.jones2@fda.hhs.gov. 2. 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.
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.
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.
Authors: Julia Kish-Doto; Monica Scales; Paula Eguino-Medina; Tania Fitzgerald; Janice P Tzeng; Lauren A McCormack; Amie O'Donoghue; Oluwamurewa Oguntimein; Suzanne L West Journal: J Health Commun Date: 2014
Authors: Michael S Wolf; Jennifer King; Elizabeth A H Wilson; Laura M Curtis; Stacy Cooper Bailey; James Duhig; Allison Russell; Ashley Bergeron; Amanda Daly; Ruth M Parker; Terry C Davis; William H Shrank; Bruce Lambert Journal: J Gen Intern Med Date: 2012-05-08 Impact factor: 5.128