BACKGROUND: Adverse events resulting from medication error are a serious concern. Patients’ literacy and their ability to understand
medication information are increasingly seen as a safety issue.
OBJECTIVE: To examine whether adult patients receiving primary care services at a public hospital clinic were able to correctly interpret
commonly used prescription medication warning labels.
DESIGN: In-person structured interviews with literacy assessment.
SETTING: Public hospital, primary care clinic.
PARTICIPANTS: A total of 251 adult patients waiting for an appointment at the Louisiana State University Health Sciences Center in Shreveport
(LSUHSC-S) Primary Care Clinic.
MEASUREMENTS: Correct interpretation, as determined by expert panel review of patients’ verbatim responses, for each of 8 commonly used
prescription medication warning labels.
RESULTS: Approximately one-third of patients (n=74) were reading at or below the 6th-grade level (low literacy). Patient comprehension of warning labels was associated with
one’s literacy level. Multistep instructions proved difficult for patients across all literacy levels. After controlling for
relevant potential confounding variables, patients with low literacy were 3.4 times less likely to interpret prescription
medication warning labels correctly (95% confidence interval: 2.3 to 4.9).
CONCLUSIONS: Patients with low literacy had difficulty understanding prescription medication warning labels. Patients of all literacy
levels had better understanding of warning labels that contained single-step versus multiple-step instructions. Warning labels
should be developed with consumer participation, especially with lower literate populations, to ensure comprehension of short,
concise messages created with familiar words and recognizable icons.
Key words literacy - warning labels - prescription drug labels - medication error - patient comprehension - lexile
None of the authors have any conflicts of interest to report.
Dr. Wolf is supported by a career development award through the Centers for Disease Control and Prevention (1 K01 EH000067-01).