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

Abstract

BACKGROUND: 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. OBJECTIVE: To test the effectiveness of a patientcentered drug label strategy, including a Universal Medication Schedule (UMS), to improve proper regimen use and adherence compared to a current standard. DESIGN: Two-arm, multi-site patient-randomized pragmatic trial. PARTICIPANTS: 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. INTERVENTION: 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). MAIN MEASURES: Demonstrated proper use of a multidrug regimen; medication adherence measured by selfreport and pill count at 3 and 9 months. KEY RESULTS: 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,) and for those with medications to be taken ≥2 times a day (OR 2.77, 95 % CI 1.17-6.53). CONCLUSIONS:A simple modification to pharmacygenerated 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

Safer dispensing labels for prescription medicines

“…12 While there was no difference in adherence in the groups overall, participants with low health literacy who received patient-centred labels were more likely to adhere to their medicine than those who received standard labels.…”

“…Spanish-speaking participants did not receive the same benefit from patient-centred labels that was observed in English-speaking participants. 12 This finding highlights the importance of further research in the use of patient-centred labels in patients from non-English speaking backgrounds. Most of the studies to date have excluded people who do not speak English.…”

“…10, 12 The use of standard dosing times is feasible for most drugs and is less confusing, more informative and makes it easier for patients to consolidate multiple medicines into fewer dosing times throughout the day.…”

“…[12][13][14] One trial randomised 845 participants to receive a patient-centred label or standard dispensing label for their medicine. 12 The study assessed whether participants could show appropriate use of the medicine at baseline, three months and nine months. 'Appropriate use' meant the participant could report how many tablets or capsules per dose, how many times the medicine needed to be taken per day, and the total number of tablets or capsules to be taken per day.…”

“…The Table provides examples of common instructions provided in a way that implements the recommendations for patient-centred labels. [12][13][14]19 While there is work to be done to ensure patient-centred labels are implemented in Australia in a safe and effective manner, some aspects can be implemented immediately. Prescribers should, when possible, avoid 'as directed' and provide the indication.…”