For the study, 395 patients at outpatient clinics that serve an indigent population were interviewed. The patients indicated their age, sex, race and ethnicity, education, payment source for medications, and number of prescription medications taken daily. Patient age ranged from 19 to 85 years old, with the mean age of 44.8. The patients were taking an average of 1.4 prescription medications. Approximately 28 percent of respondents did not complete high school. Trained research assistants assessed the participants' understanding of instructions on the labels of the medications amoxicillin, trimethoprim, guaifenesen, felodipine, and furosemide. The patients were asked, "How would you take this medicine?" and "Show me how many pills you would take of this medicine in one day." The researchers also investigated the patients' attentiveness to the auxiliary, or warning, labels, such as "Take with food" and "Do not chew or crush, swallow whole." Lastly, patient literacy was assessed with the Rapid Estimate of Adult Literacy in Medicine (REALM).

The results of the study indicated that 28.6 percent of the patients read at the 7th to 8th grade level (marginal literacy) and 19 percent read at or below a 6th grade level (low literacy). Low literacy was associated with older age, African-American race, and less education.

Nearly half (46.3 percent) of patients in the study misunderstood 1 or more of the prescription label instructions, and the prevalence among patients with low literacy was 62.7 percent. The researchers found that patients with low literacy were less able to understand the meaning of all 5 medication labels than the patients with adequate literacy (9th grade level and higher), although one-third of those with adequate literacy misunderstood at least 1 of the label instructions. About half of the incorrect responses reflected an error in dosage, such as tablespoon versus teaspoon. Other incorrect responses indicated wrong dose frequency, such as "1 tablet each day for 7 days" instead of "Take 1 tablet by mouth twice daily for 7 days." Patients of all literacy levels were better able to read the instructions on the label than to demonstrate the correct number of pills to take. Also, patients who took a greater number of prescription medications were more likely to misunderstand the labels. Most patients in the study did not pay attention to the warning labels, which was especially true among those with low literacy. The study's authors noted that failure to heed these special instructions could affect drug potency or rate of absorption or cause adverse events.

The researchers wrote, "Our findings show that patients of all ages would benefit from additional efforts to improve the clarity and comprehensibility of labeling in prescription drugs...The text and format of existing primary and auxiliary labels on prescription medication containers should be redesigned and standardized. Less complex and more explicit dosing instructions may improve patient understanding; however, more research is needed to properly evaluate different instructional formats."

In an accompanying editorial, Dean Schillinger, MD, of the University of California, San Francisco, wrote, "this multi-site study has important implications for practice, research, and policy." He stated that practitioners must ensure that patients know which medications have been prescribed for them and can demonstrate how to correctly use them. Schillinger said that the best way to assess comprehension and elicit correct demonstration is not clear, and will likely include interactive communication strategies and using information from multiple sources such as patient verbal report and pharmacy records. "In the absence of significant changes in labeling or a standardized prescription communication system, medication reconciliation will usurp a substantial portion of clinical visit time, thereby infringing on the practice of a more relationship-centered type of care," Schillinger wrote.

"This study underscores the need for better patient engagement tools to adequately explain how to take medications," said Eleanor Herriman, MD, MBA, Chief Science Officer for NorthPoint Domain. "The alarmingly high rates of misunderstanding medication instructions reported in this indigent population have serious medical implications and warrant the attention of both the provider and industry communities in finding solutions."

NorthPoint Domain remains a leader in the development of physician-directed patient engagement information and Informed Care through its Accelerator Resource Center (ARC) and Patient Literacy Center (PLC) and a forerunner in e-communications between patients and physicians with its Secure Messaging Center (SMC). In addition to articles about specific conditions, tests, and treatments, the PLC features information on how patients can improve their overall health through risk factor management articles that contain advice on exercise, weight loss, and smoking cessation. NorthPoint Domain's wellness library, Take Control of Your Health, also offers easy-to-read lifestyle information, such as tips on healthy eating, being physically active, and reducing stress. To learn more about the ARC, PLC, and SMC, visit NorthPoint Domain.

Sources: Davis TC, Wolf MS, Bass III PF, et al. 2006. Literacy and misunderstanding prescription drug labels. Annals of Internal Medicine 145 (12). Accessed online at www.annals.org.

Schillinger D. 2006. Misunderstanding prescription labels: the genie is out of the bottle. Annals of Internal Medicine 145 (12). Accessed online at www.annals.org.

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