title: Applying human factors to develop an improved package design for (Rx) medication drug labels in a pharmacy setting.
abstract: As many as 98,000 people die every year from preventable medical errors. Among pharmacists, the most common error reported is the selection of the wrong drug. Merck met with the U.S. Food and Drug Administration (FDA) to discuss the optimization of the U.S. label for solid oral dosage forms of Merck medications. These discussions led to the development of revised label designs for six products that were then evaluated using failure modes and effects analysis and an expert review by human factors specialists. There were no errors among 425 filled prescriptions in the validation test of the final label. Key changes to the original labels include the use of a non-branded logo, high-contrast color bands for dosage strength, and an enhanced three-dimensional tablet image. The redesigned labels were approved by the US FDA in June 2011.
  
  
  CONCLUSIONS
  The redesigned label should improve the accurate selection of medications from pharmacy shelves.
authors.affiliation: Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.
authors.forename: Julie M
authors.initials: JM
authors.lastname: Gerhart
authors.affiliation: Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.
authors.forename: Holly
authors.initials: H
authors.lastname: Spriggs
authors.affiliation: Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.
authors.forename: Tonja W
authors.initials: TW
authors.lastname: Hampton
authors.affiliation: Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.
authors.forename: Rose Mary B
authors.initials: RM
authors.lastname: Hoy
authors.affiliation: Wiklund Research & Design, Inc. (WR&D, now a UL LLC company), 300 Baker Ave, Concord, MA 01742, USA.
authors.forename: Allison Y
authors.initials: AY
authors.lastname: Strochlic
authors.affiliation: Med-ERRS Inc.,200 Lakeside Dr, Horsham, PA 19044, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Proulx
authors.affiliation: Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: debby.g@comcast.net.
authors.forename: Debra B
authors.initials: DB
authors.lastname: Goetchius
mesh_terms: D000328:Adult; D004348:Drug Labeling / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008508:Medication Errors / Q000517:prevention & control*; D008875:Middle Aged; D010595:Pharmacists; D014481:United States
keywords: Human factors usability test; Label; Medication; Medication error