TY - JOUR
T1 - An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling
AU - Jacobson, Kara L.
AU - Faughnan, Juliette
AU - Myers, Laurie
AU - Dubost, Amy
AU - Courtade, Lisa
AU - von Lutcken, Scott
AU - McCrary Sisk, Christine
AU - Gregory, Suzanne
AU - Cunningham, Anita
AU - Gunther, Cathryn
AU - Wolf, Michael S.
N1 - Funding Information:
The authors thank Lina AlJuburi, a member of the core patient labeling health literacy team, for leading coordination with regulatory and regulatory approach; and Julia Yoshino Benavente, for collection of data, provision of study materials or patients, and administrative or logistical support. Editorial assistance was provided by Michele McColgan; this assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021
Y1 - 2021
N2 - Objective: Limited health literacy negatively impacts understanding of medication-related information. We describe an innovative methodology designed to optimize user understanding of patient medication labeling through the systematic application of evidence-based health literacy principles, using the Patient Package Insert (PPI) for bezlotoxumab (ZINPLAVA™, Merck & Co., Inc., Kenilworth, NJ, USA) as an example. Methods: We used a mixed-model, iterative approach consisting of three phases: (1) content development; (2) focus group testing; and (3) comprehension testing. Content development was based on evidence-based health literacy principles and conducted through a collaborative partnership between industry and academia professionals. The PPI was then tested in four focus groups, two in Atlanta and two in Chicago, with an emphasis on collecting feedback from respondents with limited health literacy, evaluated using the Newest Vital Sign (NVS) health literacy assessment tool. Subsequent comprehension testing included patients with C. diff, caregivers, and general population members, with a pre-defined target sample of 25% with limited health literacy identified through two health literacy assessment tools: the Single Item Literacy Screener and the NVS. Results: Content development of the bezlotoxumab PPI occurred in May 2015. In June 2015, focus group respondents (n = 34) provided generally favorable feedback, with insights revolving around organization and usability; language and comprehension; and volume of information. Comprehension testing of the revised PPI resulted in average comprehension scores of 96% for the overall population (n = 59), 90% for individuals presenting with limited health literacy (n = 14), and 97% for those with adequate health literacy (n = 45). This PPI development approach was similarly effective for subsequent products across diverse therapeutic areas, with comprehension scores ≥ 86% for all participants (n = 1197). Conclusion: This methodology represents a significant advancement for the development of understandable patient medication labeling, especially for people with limited health literacy.
AB - Objective: Limited health literacy negatively impacts understanding of medication-related information. We describe an innovative methodology designed to optimize user understanding of patient medication labeling through the systematic application of evidence-based health literacy principles, using the Patient Package Insert (PPI) for bezlotoxumab (ZINPLAVA™, Merck & Co., Inc., Kenilworth, NJ, USA) as an example. Methods: We used a mixed-model, iterative approach consisting of three phases: (1) content development; (2) focus group testing; and (3) comprehension testing. Content development was based on evidence-based health literacy principles and conducted through a collaborative partnership between industry and academia professionals. The PPI was then tested in four focus groups, two in Atlanta and two in Chicago, with an emphasis on collecting feedback from respondents with limited health literacy, evaluated using the Newest Vital Sign (NVS) health literacy assessment tool. Subsequent comprehension testing included patients with C. diff, caregivers, and general population members, with a pre-defined target sample of 25% with limited health literacy identified through two health literacy assessment tools: the Single Item Literacy Screener and the NVS. Results: Content development of the bezlotoxumab PPI occurred in May 2015. In June 2015, focus group respondents (n = 34) provided generally favorable feedback, with insights revolving around organization and usability; language and comprehension; and volume of information. Comprehension testing of the revised PPI resulted in average comprehension scores of 96% for the overall population (n = 59), 90% for individuals presenting with limited health literacy (n = 14), and 97% for those with adequate health literacy (n = 45). This PPI development approach was similarly effective for subsequent products across diverse therapeutic areas, with comprehension scores ≥ 86% for all participants (n = 1197). Conclusion: This methodology represents a significant advancement for the development of understandable patient medication labeling, especially for people with limited health literacy.
KW - Health literacy
KW - Labeling comprehension
KW - MedGuide
KW - Patient labeling
KW - Patient package insert
KW - Patient understanding
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U2 - 10.1007/s43441-021-00325-5
DO - 10.1007/s43441-021-00325-5
M3 - Article
C2 - 34341945
AN - SCOPUS:85111816380
VL - 55
SP - 1180
EP - 1192
JO - Therapeutic Innovation and Regulatory Science
JF - Therapeutic Innovation and Regulatory Science
SN - 2168-4790
IS - 6
ER -
