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MEDICATION SAFETY

Effect of Content and Format of Prescription Drug Labels on Readability, Understanding, and Medication Use: A Systematic Review

Instructor, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, MA

Jerry Avorn, MD

Professor, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School

Cony Rolon, BA

Research Associate, Southern California EPC-RAND, Santa Monica, CA

Paul Shekelle, MD PhD

Director, Southern California EPC-RAND; Chief, Division of General Internal Medicine, Greater Los Angeles Veterans Affairs Healthcare System, Santa Monica

Reprints: Dr. Shrank, 1620 Tremont St., Suite 3030, Boston, MA 02120, fax 617/232-8602, wshrank{at}partners.org

OBJECTIVE: To evaluate the evidence regarding the optimal content and format of prescription labels that might improve readability, understanding, and medication use.

DATA SOURCES: We performed a systematic review of randomized controlled trials, observational studies, and systematic reviews from MEDLINE and the Cochrane Database (1990-June 2005), supplemented by reference mining and reference lists from a technical expert panel.

STUDY SELECTION: We selected studies that focused on the content of physician-patient communication about medications and the content and format of prescription drug labels.

DATA EXTRACTION: Two reviewers extracted and synthesized information about study design, populations, and outcomes.

DATA SYNTHESIS: Of 2009 articles screened, 36 that addressed the content of physician-patient communication about medications and 69 that were related to the content or format of medication labels met review criteria. Findings showed that patients request information about a drug's indication, expected benefits, duration of therapy, and a thorough list of potential adverse effects. The evidence about label format supports the use of larger fonts, lists, headers, and white space, using simple language and logical organization to improve readability and comprehension. Evidence was not sufficient to support the use of pictographic icons. Little evidence linked label design or content to measurable health outcomes, adherence, or safety.

CONCLUSIONS: Evidence suggests that specific content and format of prescription drug labels facilitate communication with and comprehension by patients. Efforts to improve the labels should be guided by such evidence, although additional study assessing the influence of label design on medication-taking behavior and health outcomes is needed. Several policy options exist to require minimal standards to optimize medical therapy, particularly in light of the new Medicare prescription drug benefit.

Key Words: patient information, prescription drug label

Published Online, April 10, 2007. www.theannals.com, DOI 10.1345/aph.1H582

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