Patient counseling materials: The effect of patient health literacy on the comprehension of printed prescription drug information

Patel, Amit; Bakina, Daria A.; Kirk, Jim; Lutcken, Scott von; Donnelly, Thomas M.; Stone, W. E.; Ashley-Collins, Heather; Tibbals, Karen; Ricker, Lynn; Adler, Jeffrey M.; Ewing, John C.; Blechman, Michelle; Fox, Sherry; Leopold, Will; Ryan, Daniel; Wray, Donna; Turkoz, Heather

doi:10.1016/j.sapharm.2018.04.035

Cited by 10 publications

(9 citation statements)

References 11 publications

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“…By comparison, a recent study by Patel and colleagues examined comprehension of standard or health literacy-friendly drug summaries among cohorts of patients with adequate and low literacy. The authors reported that comprehension improved from 42% to only 52% among low literacy patients [28], much lower than the 90% level of comprehension observed using our approach to developing health literate PPIs. Notably, 71% of respondents in our study were aged 65 years and older, a sample representative of patients who would use medications to treat C. diff infection, which is prevalent among older populations.…”

Section: Discussioncontrasting

confidence: 61%

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

Jacobson

Faughnan

Myers

et al. 2021

Ther Innov Regul Sci

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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.

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Section: Discussioncontrasting

confidence: 61%

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

Jacobson

Faughnan

Myers

et al. 2021

Ther Innov Regul Sci

Self Cite

View full text Add to dashboard Cite

show abstract

“…Placing each part of the instruction on a separate instruction line (i.e., ‘ carriage returns’ ) was proposed as an effective way to enhance comprehensibility [ 26 ] as well as the use of single step instructions (e.g. ‘ Take with food ’) [ 14 , 27 , 44 ].…”

Section: Resultsmentioning

confidence: 99%

“…Patients with limited health literacy skills often experience difficulties in reading, understanding, and applying DLIs compared to patients with adequate health literacy [ 12 , 14 , 26 ]. Therefore, it is important to take health literacy into account when evaluating the comprehensibility of DLI’s (cf., [ 27 ]). Especially as research shows 46 per cent of the Europeans have limited health literacy skills, varying from 29 per cent in the Netherlands to 62 per cent in Bulgaria [ 28 ].…”

Section: Introductionmentioning

confidence: 99%

The impact of textual elements on the comprehensibility of drug label instructions (DLIs): A systematic review

et al. 2021

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Introduction Correct interpretation of drug labels instructions (DLIs) is needed for safe use and better adherence to prescribed drugs. DLIs are often too difficult for patients, especially for those with limited health literacy. What is yet unknown, is how specific textual elements in DLIs (e.g., the presentation of numbers, or use of medical jargon) and patients’ health literacy skills are related to the comprehension of DLIs. In order to provide concrete directions for health professionals on how to optimize drug prescriptions, we performed a systematic review to summarize the available research findings on which textual elements facilitate or hinder the correct interpretation of DLIs in relation to patients’ health literacy. Method A systematic search was performed in PubMed, EMBASE, PsychINFO, and Smartcat (until April 2019) to identify studies investigating textual elements that facilitate or hinder the correct interpretation of DLIs in relation to patients’ health literacy. Results A total of 434 studies were identified of which 28 studies met our inclusion criteria. We found that textual elements contributing to the correct interpretation of DLIs were: using explicit time periods in dosage instructions, using plain language, presenting numbers in a numerical format, and providing DLIs in patients’ native language. Multistep instructions per instruction line, using abbreviations and medical jargon seem to hinder the correct interpretation of DLIs. Although health literacy was taken into account in a majority of the studies, none of them assessed the effectiveness of specific textual elements on patients’ comprehensibility of DLIs. Conclusion Based on our findings, we provide an overview of textual elements that contribute to the correct interpretation of DLIs. Optimizing the textual instruction on drug labels may increase the safety and adherence to prescribed drugs, taking into account that a significant proportion of patients has low health literacy.

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“…[3] There are a multitude of factors associated with poor medication adherence, such as socioeconomic status, age, and health literacy. [9,10] Poor understanding of medications is a contributor to poor medication adherence, illustrating the importance of providing appropriate medication and disease education to patients. [10] This study seeks to build upon existing literature in targeted medication adherence interventions.…”

Section: Introductionmentioning

confidence: 99%

Assessing optimal medical therapy adherence following acute coronary syndrome utilising telehealth cardiology pharmacist clinics

Livori

Pol

Levkovich

et al. 2022

Preprint

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Background: Optimal medical therapy (OMT) following acute coronary syndromes (ACS) and percutaneous coronary intervention (PCI) is a predictor of future major adverse cardiovascular events (MACE). Underutilisation of OMT is associated with higher risk of MACE within Australian populations. Aims: Effects of a telehealth cardiology pharmacist clinic (TCPC) on patient adherence to OMT and MACE in patients who received PCI for ACS. Methods: Retrospective matched cohort study within a large regional health service comparing patient populations before and after implementation of post-PCI TCPC with twelve-month follow up. Patients who received PCI for ACS were consulted by the pharmacist at one, three- and twelve-months’. Matching criteria included age, sex, presence of left ventricular dysfunction and ACS type. Primary outcome was difference in adherence to OMT at twelve months post PCI. Secondary outcomes included 4-point MACE at twelve months and validation of self-reported adherence using medication possession ratios from pharmacy dispensing records. Results: There were 156 patients in this study (78 matched pairs). Analysis of adherence to OMT at twelve months demonstrated an absolute increase in adherence to OMT by 13% (31 vs. 44%, p = 0.038). Furthermore, sub-optimal medication therapy (less than ACS medication groups at twelve months) reduced by 23% (31–8%, p = 0.004). MACE at twelve months reduced by 23% (31 vs.8% p = 0.004). Conclusions: This novel intervention significantly improved adherence at to OMT at twelve months; a demonstrated contributor to clinical outcomes. Primary and secondary outcomes in the intervention group were both statistically significant. Pharmacist-led follow up is both cost effective and improves patient outcomes.

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Patient counseling materials: The effect of patient health literacy on the comprehension of printed prescription drug information

Cited by 10 publications

References 11 publications

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

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

The impact of textual elements on the comprehensibility of drug label instructions (DLIs): A systematic review

Assessing optimal medical therapy adherence following acute coronary syndrome utilising telehealth cardiology pharmacist clinics

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