Descriptive analysis of primary package labels from commercially available prescription solid oral dosage form drugs

To describe formats used by manufacturers to display drug names on primary package labels for prescription solid oral dosage forms.

Cross-sectional study.

Independent community pharmacy in rural Indiana. The images were collected in February 2006.

Not applicable.

High-resolution digital photos were taken of 918 primary package labels (422 brand name and 496 generic) from all solid oral dosage forms stocked in an independent community pharmacy. We coded the images for the presence or absence of specific typographical characteristics used to distinguish the name of the drug. We also coded for the presence or absence of an image of the product on the label.

Frequency of various typographical characteristics used to display the drug name(s) on a primary package label.

Manufacturers use a wide variety of techniques to increase the distinctiveness of drug names on primary package labels, including color, boldface, underlining, italics, capitalization, highlighting, use of abbreviations, and use of parentheses to differentiate the generic name of the drug, as well as use of images of the drug product. The frequency of use of the different techniques varied substantially (e.g., boldface fonts used in nearly 98% of brand-name labels, underlining used in only 0.2% of brand-name labels). The frequency of use of the techniques differed across brand and generic products.

The lack of standardization in the typographical presentation of drug names on primary package labels of solid oral dosage forms in the United States appears to reflect underlying uncertainty about the relative effectiveness of the different techniques. Given the frequency and severity of wrong drug errors caused, at least in part, by the inability of clinicians to distinguish between similar labels, research is urgently needed to determine which technique or combination of techniques will minimize the risk of confusion.