reported. When the manufacturer sent the FDA a revised label for approval, it remained at the agency for 6 months without action being taken. Moreover, when the change in labeling was finally approved, the FDA would not discuss it and did not notify patient safety organizations or the public about it. This example illustrates the problems that can occur when human factors issues are not incorporated into labeling and packaging designs, and communications about problems are not transparent.

The FDA has held public meetings to address some of the problems identified above (e.g., naming, need for color coding). Progress is being made incrementally on certain naming issues. For example, the FDA has instituted a requirement that medications have bar codes to facilitate accurate drug dispensing and administration. And at the FDA’s request, the generic drug industry agreed to use a mix of upper- and lowercase letters to highlight the differences between similar generic names, such as vinBLAStine and vinCRIStine (FDA, 2005b). Still, an overall guidance document that formally and comprehensively advises companies on naming, labeling, and packaging for safety has not yet been produced. As a consequence, there is great inconsistency among products and companies as regards follow-through on the detailed aspects of labeling and packaging that can reduce medication errors. In contrast, the National Health Service in the United Kingdom recently released Guidance Note 25: Best Practices for Labeling and Packaging of Medicines, which expanded requirements to increase the clarity and safety of drug labeling on external packaging and blister pacs (MHPRA, 2003). This document addresses several of the issues (e.g., font size, color, design) discussed at FDA public meetings.

The proliferation of manufacturers, medications, formulations, and doses will likely continue, increasing providers’ difficulties in differentiating drug products (Berman, 2004). Thus, a formal action plan to address naming, labeling, and packaging problems is critical to improving the safety of medication use.

The committee believes strongly that industry and the FDA should take several specific actions to address the remaining key problems with drug naming, labeling, and packaging (see Box 6-3). This proposed action plan is founded on two overarching principles:

  • Product naming, labeling, and packaging should be designed for the end user—the provider in the clinical environment and/or the consumer.

  • Safety should always take precedence over commercial interests.

Unit-of-Use Packaging

Chapter 4 examines one possible way of improving consumers’ medication self-management—redesigning pharmacy containers and warning



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement