Effect of Standardized, Patient-Centered Label Instructions to Improve Comprehension of Prescription Drug Use

Abstract

Objective To evaluate the effectiveness of standardized, patient-centered label (PCL) instructions to improve comprehension of prescription drug use compared to typical instructions. Methods 500 adult patients recruited from two academic and two community primary care clinics in Chicago, IL and Shreveport, LA were assigned to receive: 1) standard prescription instructions written as times per day (once, twice three times per day) [usual care], 2) PCL instructions that specify explicit timing with standard intervals (morning, noon, evening, bedtime) [PCL], or 3) PCL instructions with a graphic aid to visually depict dose and timing of the medication [PCL + Graphic]. The outcome was correct interpretation of label instructions. Results Instructions with the PCL format were more likely to be correctly interpreted compared to standard instructions (Adjusted Relative Risk (RR) 1.33, 95% Confidence Interval (CI) 1.25 – 1.41). Inclusion of the graphic aid (PCL + Graphic) decreased rates of correct interpretation compared to PCL instructions alone (RR 0.93, 95% CI 0.89 - 0.97). Lower literate patients were better able to interpret PCL instructions (low literacy: RR 1.39, 95% CI 1.14 – 1.68; p=0.001). Conclusion The PCL approach could improve patients' understanding and use of their medication regimen.

A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence

“…This has served as a common outcome in prior studies. 2,4,[19][20][21][22][23] A regimen summary score at the patient level was also calculated, indicating whether the dosing of all medications a patient was taking was correct. The secondary outcome under study was adherence, measured via 1) self-report of missed or incorrect doses in the prior 4 days using the Patient Medication Adherence Questionnaire (PMAQ) 28,29 and 2) pill count (for diabetes and hypertensive medicines).…”

“…Btake 1 tablet twice daily^) were better able to demonstrate proper dosing and spacing of medication. [19][20][21][22] This has even led to a reduction in known disparities, as adults with low literacy benefited the most. These findings have since been replicated in one international study 23 and among LEP patients.…”

Getting to Better Prescription Drug Information

“…Fundamental changes in the presentation and content are needed to ensure that patients get the information that Medication Guides should communicate. Here are some suggestions based on the findings of Wolf et al, 4 other recent literature, 3,[5][6][7][8] and our own work in this area over the past decade : [9][10][11][12][13][14][15] …”

Promoting Health Literacy to Prevent Hospital Readmissions: Necessary but not Sufficient

“…Prior trials targeting improved patient comprehension and medication use have yielded the same findings; when seeking to promote health literacy within a specified clinical context, benefits may be modest among the sample as a whole, but those who are at greater risk of an adverse outcome due to limited health literacy still benefit. 7,8 This in itself is a very important message. However, the value of such a finding must also be considered while taking into account the cost a healthcare system would ultimately incur to set a PILL-CVD type intervention as a new standard of care.…”