title: A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence.
abstract: 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.
authors.affiliation: Health Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine at Northwestern University, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL, 60611, USA. mswolf@northwestern.edu.|Department of Learning Sciences, School of Education and Social Policy, Northwestern University, Evanston, IL, USA. mswolf@northwestern.edu.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Wolf
authors.affiliation: Department of Medicine-Pediatrics, Louisiana State University Health Sciences Center - Shreveport, Shreveport, LA, USA.
authors.forename: Terry C
authors.initials: TC
authors.lastname: Davis
authors.affiliation: Health Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine at Northwestern University, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL, 60611, USA.
authors.forename: Laura M
authors.initials: LM
authors.lastname: Curtis
authors.affiliation: Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina - Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Stacy Cooper
authors.initials: SC
authors.lastname: Bailey
authors.affiliation: NoVA Scripts Central Pharmacy, Falls Church, VA, USA.
authors.forename: JoAnn Pearson
authors.initials: JP
authors.lastname: Knox
authors.affiliation: Health Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine at Northwestern University, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL, 60611, USA.
authors.forename: Ashley
authors.initials: A
authors.lastname: Bergeron
authors.affiliation: NoVA Scripts Central Pharmacy, Falls Church, VA, USA.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Abbet
authors.affiliation: CVS/Caremark, Woonsocket, RI, USA.
authors.forename: William H
authors.initials: WH
authors.lastname: Shrank
authors.affiliation: Division of General Medicine, Emory University School of Medicine, Atlanta, GA, USA.
authors.forename: Ruth M
authors.initials: RM
authors.lastname: Parker
authors.affiliation: Department of Pharmacology, Weill Cornell Medical College, New York, NY, USA.
authors.forename: Alastair J J
authors.initials: AJ
authors.lastname: Wood
mesh_terms: D000328:Adult; D004348:Drug Labeling / Q000379:methods / Q000592:standards*; D005260:Female; D005500:Follow-Up Studies; D057220:Health Literacy / Q000379:methods / Q000592:standards*; D006801:Humans; D008297:Male; D055118:Medication Adherence / Q000523:psychology; D008875:Middle Aged; D018802:Patient-Centered Care / Q000379:methods / Q000592:standards*; D055553:Prescription Drugs / Q000592:standards* / Q000627:therapeutic use*
chemical_list: D055553:Prescription Drugs
keywords: adherence; clinical trial; health literacy; label; medication; pharmacy; prescription; understanding