Recommendations for Manufacturers to Prevent Medication Errors Associated with the Label, Labeling and Packaging of Pharmaceutical (Drug) Products and Related Devices

These recommendations primarily apply to pharmaceutical manufacturers.

The Council encourages

  1. ...manufacturers to proactively employ processes such as failure mode and effects analysis (FMEA) and/or other testing processes in its design of label, labeling, and packaging of medications and related devices to minimize the potential for medication errors.
  2. ...manufacturers to print drug names in larger font size than company logos and company names on product labels.
  3. ...manufacturers to include machine-readable bar codes, consistent with FDA regulations, on the labels of all drug products.
  4. ...manufacturers to judiciously use innovative labels, labeling, and/or packaging primarily as a means of aiding practitioners in distinguishing between products with similar names, for example, the use of enhanced lettering, such as VinBLAStine and VinCRIStine.
  5. ...the printing of the drug name (brand and generic) and the strength on both sides of injectables and IV bags, containers, and overwraps. For large volume parenterals and IV piggybacks (minibags), the name of the drug should be readable in both the upright and inverted positions.
  6. ...manufacturers to support the development of continuing education programs focusing on proper preparation and administration of its products.
  7. ...collaboration among the pharmaceutical industry, regulators, standards-setters, health care organizations, health care professionals, and patients to facilitate design of packaging and labeling of drug products to help minimize errors.

Actions/Decisions are those of the Council as a whole and may not reflect the views/positions of individual member organizations.

Adopted: 
May 12, 1997
Revised: 
June 7, 2007