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

作者：Wolf Michael S^*; Davis Terry C; Curtis Laura M; Bailey Stacy Cooper; Knox JoAnn Pearson; Bergeron Ashley; Abbet Mercedes; Shrank William H; Parker Ruth M; Wood Alastair J J

来源：Journal of General Internal Medicine, 2016, 31(12): 1482-1489.

DOI：10.1007/s11606-016-3816-x

• prescription
• medication
• label
• understanding
• adherence
• health literacy
• clinical trial
• pharmacy

Patient misunderstanding of prescription drug label instructions is a common cause of unintentional misuse of medication and adverse health outcomes. Those with limited literacy and English proficiency are at greater risk.
To test the effectiveness of a patient-centered drug label strategy, including a Universal Medication Schedule (UMS), to improve proper regimen use and adherence compared to a current standard.
Two-arm, multi-site patient-randomized pragmatic trial.
English- and Spanish-speaking patients from eight community health centers in northern Virginia who received prescriptions from a central-fill pharmacy and who were 1) 30 years of age, 2) diagnosed with type 2 diabetes and/or hypertension, and 3) taking 2 oral medications.
A patient-centered label (PCL) strategy that incorporated evidence-based practices for format and content, including prioritized information, larger font size, and increased white space. Most notably, instructions were conveyed with the UMS, which uses standard intervals for expressing when to take medicine (morning, noon, evening, bedtime).
Demonstrated proper use of a multi-drug regimen; medication adherence measured by self-report and pill count at 3 and 9 months.
A total of 845 patients participated in the study (85.6 % cooperation rate). Patients receiving the PCL demonstrated slightly better proper use of their drug regimens at first exposure (76.9 % vs. 70.1 %, p = 0.06) and at 9 months (85.9 % vs. 77.4 %, p = 0.03). The effect of the PCL was significant for English-speaking patients (OR 2.21, 95 % CI 1.13-4.31) but not for Spanish speakers (OR 1.19, 95 % CI 0.63-2.24). Overall, the intervention did not improve medication adherence. However, significant benefits from the PCL were found among patients with limited literacy (OR 5.08, 95 % CI 1.15-22.37) and for those with medications to be taken 2 times a day (OR 2.77, 95 % CI 1.17-6.53).
A simple modification to pharmacy-generated labeling, with minimal investment required, can offer modest improvements to regimen use and adherence, mostly among patients with limited literacy and more complex regimens.
Trial Registration (ClinicalTrials.gov): NCT00973180, NCT01200849.

• 出版日期2016-12
• 单位西北大学