Washington Letter: FMEA as a Packaging Tool

Failure Modes and Effects Analysis promises to become a more important risk assessment tool for pharmaceutical manufacturing. Could its use be required for labeling and packaging?

By Stephen Barlas, Washington Correspondent

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A July report on medication errors by the Institute of Medicine (IOM) underscored the utility of Failure Modes and Effects Analysis (FMEA) in managing risk. The FDA already endorses FMEA, describing it in a June Quality Risk Management guidance document as “powerful tool.” In fact, the FDA even uses FMEA itself, to help weed out confusing drug names once a new drug application (NDA) has been submitted.

But neither the FDA nor the drug industry use FMEA to assure the development of clear, consistent drug labeling and packaging. According to the IOM’s latest report, failure to use FMEA leads to such problems as:

  • cluttered labeling
  • small font
  • serif typeface
  • lack of background contrast
  • inadequate prominence of reminders and warnings
  • overemphasis on company logos and trade dress

— all of which “continue to have a direct effect on the readability and comprehensibility of product labels, and hence on rates of medication errors.”

The report suggests that the FDA require FMEA analysis for all pharmaceutical labeling and packaging design and assessment, and that drug manufacturers be required to submit those assessments as part of any new drug application (NDA). It also urges the FDA to publish two separate guidance documents, one on naming, the other on labeling and packaging, by the end of 2006, and to encourage industry to expand unit-of-use packaging to new therapeutic areas.

The Pharmaceutical Research and Manufacturers of America has taken no official position on whether FMEA should be required, according to PhRMA associate vice president Alan Goldhammer. In an unsigned response to the IOM report, the FDA alluded to guidance documents on naming, labeling and packaging that it is planning for later this year. So far, the FDA has not weighed in on the IOM report recommendations.

Progress Being Made on Medication Errors

The IOM report asserts that some progress has been made toward reducing medication errors since an earlier advisory committee issued a report on the topic six years ago. However, there is still plenty of room for improvement. “The frequency of medication errors and preventable adverse drug events is cause for serious concern,” said committee co-chair Linda R. Cronenwett, dean and professor, School of Nursing, University of North Carolina, Chapel Hill.

Sen. Charles Grassley (R-Iowa), chairman of the Senate Finance Committee and a key congressional Medicare decision maker, issued a statement after the report’s release highlighting the IOM recommendation that the FDA issue guidance on drug naming, labeling and packaging by the end of 2006.

With regard to the recommendation on wider implementation of unit-of-use packaging, drug companies have been moving in that direction. This is due, in large part, to an FDA requirement that kicked in last April, which states that all drugs going to hospital pharmacies must have a linear bar code containing, at a minimum, the drug’s National Drug Code (NDC) number.

The FDA rule does not require that hospital SKUs (stock keeping units) be packaged in a unit-of-use or unit-dose package. But Reynard Jackson, executive vice president, business development, packaging services at Cardinal Health, says that most of his company’s 200 pharmaceutical packaging clients are beginning to do just that. They’re complying, he says, with the “spirit” of the FDA rule, which is aimed at reducing medication errors. The FDA just approved two Pfizer hospital blister packs for Lipitor (atorvastatin calcium), for example.

“The question is,” asks Opal Johnson, marketing director at Pearson Medical Technologies, “how fast are they [drug manufacturers] moving on this? What are there — 80,000 drugs out there?” Pearson sells its intelliPack2 blister packaging and m:Print bar code labeling equipment to smaller hospitals.



About the Author

Stephen Barlas reports on developments in Washington for newspapers and magazines. A freelance journalist since 1981, he has covered developments at FDA and within the industry for two decades.

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