Purpose: 1) To develop new, easy to understand prescription auxiliary labels, 2) To compare the effectiveness of existing auxiliary labels to newly created ones to determine which label most clearly states itsÕ purpose (and determine why) and 3) To compare the effectiveness of existing auxiliary labels to newly created ones by determining the relationship between ease of reading auxiliary labels and corresponding reading level.
Methods: Adults from a minority background, who were able to understand English and did not have any hearing or vision loss, were the sample population. Existing and newly created auxiliary labels were showed to participants in a 10-15 minute interview and interpretations, level of understanding and literacy levels (using the REALM-R) were determined. The level of reading difficulty for all labels was determined using the Lexile Score¨, based on sentence length and word frequency. Data analysis included descriptive statistics and chi-square analysis for all quantitative data and inductive thematic analysis for all open-ended questions.
Results: One hundred and twenty participants completed the study. Some existing auxiliary labels yielded Lexile¨ scores above the sixth grade reading level while all the newly developed labels were third grade level and below. Newly developed labels were either the best understood or second best understood across the auxiliary labels. There was a statistically significant difference in participants interpretation of the Ôtake with food and milkÕ label based on level of education completed (x2 = 20.857, p = 0.02) and literacy level (x2 = 26.785, p = 0.02). All other auxiliary labels did not have significant associations with REALM scores.
Conclusions: Incorrect interpretations of auxiliary labels occur across populations. Simpler auxiliary labels with improved patient comprehension can be developed. Pharmacies must consider how to include and use existing manufacturer auxiliary labels that meet the acceptable criteria for patientsÕ with low health literacy.