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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:
- ...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.
- ...manufacturers to print drug names in larger font size than company logos and company names on product labels.
- ...manufacturers to include machine-readable bar codes, consistent with FDA regulations, on the labels of all drug products.
- ...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.
- ...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.
- ...manufacturers to support the development of continuing education programs focusing on proper preparation and administration of its products.
- ...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.
Adopted by the National Coordinating Council
for Medication Error Reporting and Prevention
May 12, 1997
Revised June 7, 2007
©
1998–2008 National Coordinating Council for Medication Error Reporting and
Prevention. All Rights Reserved. *Permission is hereby granted to reproduce
information contained herein provided that such reproduction shall not modify
the text and shall include the copyright notice appearing on the pages from
which it was copied.
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