Evaluation of Language Concordant, Patient-Centered Drug Label Instructions

BACKGROUND: Despite federal laws requiring language access in healthcare settings, most US pharmacies are unable to provide prescription (Rx) medication instructions to limited English proficient (LEP) patients in their native language. OBJECTIVE: To evaluate the efficacy of health literacy-informed, multilingual Rx instructions (the ConcordantRx instructions) to improve Rx understanding, regimen dosing and regimen consolidation in comparison to standard, language-concordant Rx instructions. DESIGN: Randomized, experimental evaluation. PARTICIPANTS: Two hundred and two LEP adults speaking five non-English languages (Chinese, Korean, Russian, Spanish, Vietnamese), recruited from nine clinics and community organizations in San Francisco and Chicago. INTERVENTION: Subjects were randomized to review Rx bottles with either ConcordantRx or standard instructions. MAIN MEASURES: Proper demonstration of common prescription label instructions for single and multi-drug medication regimens. Regimen consolidation was assessed by determining how many times per day subjects would take medicine for a multi-drug regimen. KEY RESULTS: Subjects receiving the ConcordantRx instructions demonstrated significantly greater Rx understanding, regimen dosing and regimen consolidation in comparison to those receiving standard instructions (incidence rate ratio [IRR]: 1.25, 95 % confidence interval [CI]: 1.06-1.48; P = 0.007 for Rx understanding, IRR: 1.19, 95 % CI: 1.03-1.39; P = 0.02 for regimen dosing and IRR: 0.76, 95 % CI: 0.64-0.90; P = 0.001 for regimen consolidation). In most cases, instruction type was the sole, independent predictor of outcomes in multivariate models controlling for relevant covariates. CONCLUSIONS: There is a need for standardized, multilingual Rx instructions that can be implemented in pharmacy practices to promote safe medication use among LEP patients. The ConcordantRx instructions represent an important step towards achieving this goal.