An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling

Kara L. Jacobson; Juliette Faughnan; Laurie Myers; Amy Dubost; Lisa Courtade; Scott von Lutcken; Christine McCrary Sisk; Suzanne Gregory; Anita Cunningham; Cathryn Gunther; Michael S. Wolf

doi:10.1007/s43441-021-00325-5

An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling

Kara L. Jacobson^*, Juliette Faughnan, Laurie Myers, Amy Dubost, Lisa Courtade, Scott von Lutcken, Christine McCrary Sisk, Suzanne Gregory, Anita Cunningham, Cathryn Gunther, Michael S. Wolf

^*Corresponding author for this work

Medicine, General Medicine Division

Research output: Contribution to journal › Article › peer-review

7 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	1180-1192
Number of pages	13
Journal	Therapeutic Innovation and Regulatory Science
Volume	55
Issue number	6
DOIs	https://doi.org/10.1007/s43441-021-00325-5
State	Published - Nov 2021

Funding

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.

Keywords

Health literacy
Labeling comprehension
MedGuide
Patient labeling
Patient package insert
Patient understanding

ASJC Scopus subject areas

Public Health, Environmental and Occupational Health
Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Pharmacology (medical)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1007/s43441-021-00325-5

Cite this

Jacobson, K. L., Faughnan, J., Myers, L., Dubost, A., Courtade, L., von Lutcken, S., McCrary Sisk, C., Gregory, S., Cunningham, A., Gunther, C., & Wolf, M. S. (2021). An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling. Therapeutic Innovation and Regulatory Science, 55(6), 1180-1192. https://doi.org/10.1007/s43441-021-00325-5

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title = "An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling",

abstract = "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{\texttrademark}, 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.",

keywords = "Health literacy, Labeling comprehension, MedGuide, Patient labeling, Patient package insert, Patient understanding",

author = "Jacobson, {Kara L.} and Juliette Faughnan and Laurie Myers and Amy Dubost and Lisa Courtade and {von Lutcken}, Scott and {McCrary Sisk}, Christine and Suzanne Gregory and Anita Cunningham and Cathryn Gunther and Wolf, {Michael S.}",

note = "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: {\textcopyright} 2021, The Author(s).",

year = "2021",

month = nov,

doi = "10.1007/s43441-021-00325-5",

language = "English (US)",

volume = "55",

pages = "1180--1192",

journal = "Therapeutic Innovation and Regulatory Science",

issn = "2168-4790",

publisher = "SAGE Publications Inc.",

number = "6",

}

Jacobson, KL, Faughnan, J, Myers, L, Dubost, A, Courtade, L, von Lutcken, S, McCrary Sisk, C, Gregory, S, Cunningham, A, Gunther, C & Wolf, MS 2021, 'An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling', Therapeutic Innovation and Regulatory Science, vol. 55, no. 6, pp. 1180-1192. https://doi.org/10.1007/s43441-021-00325-5

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 - 2021/11

Y1 - 2021/11

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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SN - 2168-4790

VL - 55

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JO - Therapeutic Innovation and Regulatory Science

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ER -

An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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