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The variability and quality of medication container labels.

Shrank WH, Agnew-Blais J, Choudhry NK, Wolf MS, Kesselheim AS, Avorn J, Shekelle P

Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, 1620 Tremont St, Ste 3030, Boston, MA 02120, USA. wshrank@partners.org

BACKGROUND: Medication errors occur frequently, and poor medication labeling is cited as a potential cause. We assessed the format, content, and variability of prescription drug container labels dispensed in the community. METHODS: Identically written prescriptions for 4 commonly used medications (atorvastatin calcium [Lipitor], alendronate sodium [Fosamax], trimethoprim-sulfamethoxazole [Bactrim], and ibuprofen) were filled in 6 pharmacies (the 2 largest chains, 2 grocery stores, and 2 independent pharmacies) in 4 cities (Boston, Chicago, Los Angeles, and Austin [Texas]). Characteristics of the format and content of the main container label and auxiliary stickers were evaluated. Labels were coded independently by 2 abstractors, and differences were reconciled by consensus. RESULTS: We evaluated 85 labels after excluding 11 ibuprofen prescriptions that were filled with over-the-counter containers that lacked labels printed at the pharmacy. The pharmacy name or logo was the most prominent item on 71 (84%) of the labels, with a mean font size of 13.6 point. Font sizes were smaller for medication instructions (9.3 point), medication name (8.9 point), and warning and instruction stickers (6.5 point). Color, boldfacing, and highlighting were most often used to identify the pharmacy and items most useful to pharmacists. While the content of the main label was generally consistent, there was substantial variability in the content of instruction and warning stickers from different pharmacies, and independent pharmacies were less likely to use such stickers (P < .001). None of the ibuprofen containers were delivered with Food and Drug Administration-approved medication guides, as required by law. CONCLUSIONS: The format of most container labels emphasizes pharmacy characteristics and items frequently used by pharmacists rather than use instructions or medication warnings. The content of warning and instruction stickers is highly variable depending on the pharmacy selected.

Published 11 September 2007 in Arch Intern Med, 167(16): 1760-5.
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