The recent rash of labeling-error recalls begs the question of how this fundamental process step can repeatedly cause such costly actions, not to mention the danger to patients. Well-known names are associated with recent recalls: Pfizer/Greenstone's cancer/antidepressant drug mix-up in late March; Upsher-Smith's 3- vs. 10-mg Jantoven warfarin snafu; and Qualitest's phenobarbital/hydrocodone-acetaminophen juxtaposition.
Pfizer says only that incorrect labels were placed on bottles by a contractor. Upsher-Smith cites an "isolated incident" and said in its February recall notice it had already taken corrective measures. Qualitest says that some lots of both the hydrocodone/acetaminophen tablets and the phenobarbital used the same stock inventory of labels.
Upsher-Smith's "isolated incident" likely implies human error, says Trevor Richardson, VP at pharma label printing specialist HP Mile, in a phone interview. "There can be little difference among the labels for different doses of the same product, and there's lots of information on those labels." The numeral specifying dosage might be the only difference on busy-looking labels.
Ways to minimize the likelihood of such errors, he says, include shorter print runs for labels, use of a label-on-demand system, and use of 2D barcodes and a scanner for product verification on the filling line. All involve extra cost, of course, but have clear QC benefits.
A 2D barcode verification system might also have precluded Qualitest's label stock issue, says Richardson. A full-line clearance between labeling jobs might have, too. The full-line clearance yields a higher waste factor, but "it's SOP in our building, based on GMP requirements."