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Safer naming, labeling and packaging

The Food and Drug Administration (FDA) is developing guidance on naming, labeling and packaging practices to reduce medication errors: (edocket.access.gpo.gov/2010/2010-8233.htm), and held a public workshop June 24–25, 2010, in Bethesda, MD, to discuss the guidance. Documents and minutes from the meeting can be reviewed at www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2010-N-0168.

The meeting included four different panel discussions:

  • Container label and carton labeling design as they relate to reducing the risk of medication errors.
  • Study design, conduct and interpretation of human factors analysis, Failure Mode and Effects Analysis (FMEA), usability studies, and other studies specifically focused on evaluating the safety of container label and carton labeling designs to reduce the risk of medication errors.
  • Manufacturers’ packaging used for medications as they relate to the safe use of the medicine from a medication errors perspective.
  • Developing proprietary names as they relate to reducing medication errors.

By the end of fiscal year (FY) 2010, the FDA will publish draft guidance on best practices for naming, labeling and packaging drugs and biologics to reduce medication errors. Final guidance will be published by the end of FY 2011. In addition, by the end of FY 2012, the FDA will publish the draft guidance on proprietary name evaluation best practices, with final guidance to follow as soon as feasible.

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