(1298) Comprehension, Cosmetics, Convenience, Content, and Credibility of Infographic Patient Information Leaflets (iPILs) Compared to Existing Pils (ePILs)

Objectives: Current existing patient information leaflets (ePILs), also called consumer medication information (CMI) leaflets, are informative paper handouts mandated by the FDA to accompany each new prescription. Unlike patient package inserts generated by drug manufacturers, ePILs are created by pharmacies or private vendors and are not reviewed or approved by the FDA. However, the FDA has established specific content and format guidelines to ensure clarity and accuracy. ePILs typically cover essential medication details, including proper usage, adverse effects, precautions and warnings, and patient counseling information.

While ePILs have been a credible resource of medication information, their complexity, and poor visual presentation can pose challenges for patients to read and understand, particularly for vulnerable populations such as the elderly, low health literacy, or low English proficiency (LEP). Research has shown that PILs are rarely or never read by approximately 30% of patients for new medications and 65% for refilled medications.

Guided by prior studies in label redesign, concepts such as cosmetics, convenience, and content were used as a framework to develop infographic-based PILs (iPILs), for four commonly used medications (atorvastatin, lisinopril, metformin, and sertraline). The iPILs used a concise Q&A format with limited wording, focusing on the essential information specified by the FDA.

To examine the comprehension, cosmetics, convenience, content, and credibility of modified infographic PILs (iPILs) compared to current existing PILs (ePILs) in an English-speaking population.

Methods: This IRB-approved prospective cross-sectional study with a crossover design used an in-person administered survey assessing the 5 aforementioned factors. Face and content validation was conducted with nine experts and eight laypeople to ensure the accuracy and clarity of the iPILs and survey.

English-speaking adults who took at least one chronic medication were recruited from an independent community pharmacy located in La Verne, CA. Participants were randomly stratified to start with either ePILs or iPILs versions for one of the four medications. Following review, participants took a Medication Knowledge Quiz (MKQ) containing six open-ended questions resulting in an overall MKQ or comprehension score. Subsequently, they received the other PILs version and completed 10 comparison questions, evaluating cosmetics, convenience, content, and credibility. Additionally, they answered two preference questions (overall and media format). Lastly, participants responded to four health literacy and eight demographic questions. If participants agreed to complete the survey for a second medication, the process was repeated beginning with the other PIL version.

Results: Among 254 individuals approached, 91 were eligible and completed a total of 105 surveys (14 completed surveys for two medications). Participant characteristics, such as age, gender, race/ethnicity, education level, health literacy, conditions, and number of prescription medications were similar between iPILs (n=49) and ePILs (n=56) groups. iPILs scored higher in all MKQ questions, with statistically significant differences observed in medication precautions and overall scores (4.81 vs. 3.97, p<.001). Regardless of the order of PILs version presentation, iPIL preference scores were significantly higher compared to ePILs (74.3% vs 17.1%) in cosmetics, convenience, and content domains; with no difference in credibility between the two versions. No significant associations were noted between overall MKQ scores and participant characteristics in either ePILs or iPILs, except for two exceptions: education level for iPILs only (p <.001) and health literacy for ePIL exclusively (p <.05).

Conclusions: This study showed that iPILs outperformed ePILs in terms of user comprehension; and were preferred due to their simple layout, ease of finding and learning information, and helpfulness in managing medication usage and side effects. While both iPILs and ePILs had similar credibility, most participants agreed that ePILs provided more detailed information, while iPILs were easier to read, navigate and understand. Further research will extend the study to different settings, populations, and languages.