FDA grapples with curbing IL drug container errors


Last July, an Institute of Medicine (IOM) report estimated that, on average, a hospital patient is subject to at least one medication error per day, although error rates vary by hospital and most do not lead to injury. The report urged the Food & Drug Administration to work with other agencies and healthcare providers to address drug labeling and packaging to minimize errors. In response to this recommendation, the FDA held a one-day public workshop last month to discuss how to improve the labeling of intravenous drug containers.

The meeting included presentations from FDA staff, representatives of the United States Pharmacopeia and the Institute for Safe Medication Practices (ISMP), and pharmaceutical and device manufacturers. Additionally, patient advocacy and education groups, pharmaceutical sponsors, and the general public were able to provide input during the question-and-answer session.

"This was an opportunity to hear from all stakeholders regarding product label placement, style and type of information, the need for standard expression of strength, quantity of information, and use of color on labels," stated Carol Holquist, R.Ph., director, Division of Medication Errors & Technical Support, Center for Drug Evaluation and Research at the FDA.

Different healthcare providers and agencies concentrate on different information on the container label. "Pharmacists and nurses pay more close attention to the drug name and concentration and not as much attention to the lot number and manufacturer. However, the lot number, expiration date, and manufacturer are important to the FDA for purposes of a drug recall," stressed Holquist.

"There is a lot of information on the container labels. We must be consistent about which information is expressed on the label and how that information is stated," said Timothy Lesar, Pharm.D., director of pharmacy at the Albany Medical Center, who spoke on the pharmacist perspective at the workshop. The large amount of information placed on the container label distracts from the most important information, he said.

"There was no consensus on what information could be eliminated from the label," added Holquist. "We have to see which was an FDA requirement, which was an ISMP requirement, and why that information was required to be on the label."

"Over the past years, there's been a lot of improvement, but there is still room for more," said Lesar. "We realize that we have to do it together."

Meeting participants provided suggestions to help distinguish look-alike products and minimize the risk of selecting the wrong product, including label standardization, these of colors, and "tall-man" letters (e.g., VinBLAStine and VinCRIStine). "The use of tall-man lettering may be beneficial. However, it could raise some concerns because it may be overused or used without any reasoning," said Holquist.

"Sometimes color may prevent errors, but it can also lead to errors," added Lesar. "There may be two firms using similar colors. Some-times colors may appear similar depending on the lighting. Also, some people are color blind. This is a time when what is useful in one situation may not be useful in others."

Another suggestion discussed was the standardization of the drug label and how much the label should be standardized. "We may need to standardize the label in an effort to reduce medication errors," said Holquist. "However, a standardized test would be needed to see how the stakeholders feel about the label."

Lesar agreed that a test would be needed. "One question is, Is it better to standardize the label or to have a slightly distinguishable label? The meeting gave us a lot of good ideas, but they're still untested," he said.

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