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J Gen Intern Med. 2016 Dec;31(12):1482-1489. Epub 2016 Aug 19.

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

Author information

1
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.
2
Department of Learning Sciences, School of Education and Social Policy, Northwestern University, Evanston, IL, USA. mswolf@northwestern.edu.
3
Department of Medicine-Pediatrics, Louisiana State University Health Sciences Center - Shreveport, Shreveport, LA, USA.
4
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.
5
Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina - Chapel Hill, Chapel Hill, NC, USA.
6
NoVA Scripts Central Pharmacy, Falls Church, VA, USA.
7
CVS/Caremark, Woonsocket, RI, USA.
8
Division of General Medicine, Emory University School of Medicine, Atlanta, GA, USA.
9
Department of Pharmacology, Weill Cornell Medical College, New York, NY, USA.

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 patient-centered 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 multi-drug regimen; medication adherence measured by self-report 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, 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).

CONCLUSIONS:

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.

KEYWORDS:

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

PMID:
27542666
PMCID:
PMC5130952
DOI:
10.1007/s11606-016-3816-x
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

Dr. Wolf has previously served as a research consultant addressing the design of patient medication information for the following entities: Abbvie, Abbott Labs, Brookings Institution, CVS/Caremark, Deborah Adler, Eli Lilly, Luto UK, Merck, and UnitedHealthcare. Dr. Bailey has also served as a research consultant to Abbvie and Merck. In addition, some authors have received grant funding from Abbvie (Davis, Parker, Wolf), Merck (Parker, Wolf), and UnitedHealthcare (Wolf). All other authors declare that they do not have a conflict of interest. Funding Support for this project was provided by two research grants from the Agency for Healthcare Research and Quality (AHRQ) and the Office of Behavioral and Social Sciences Research (OBSSR) at the National Institutes of Health (NIH); (R01HS17687; R01HS16435). Additional support was provided by a research grant from the California Endowment (20091181) and the American College of Physicians Foundation.

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