As FDA Attempts to Tackle Medication Errors, Stakeholder Input is Direly Needed

While medication errors continue to put patients at risk, FDA’s recent meeting on fighting such errors succeeded in revealing interest from several groups, including drug makers and healthcare practitioners, to identify viable solutions. FDA held the meeting June 24-25 to help it draft naming, labeling, and packaging guidance to minimize medication errors. Packaging and labeling issues were discussed on the meeting's first day, with speakers ranging from agency staff to doctors and pharmacists to drug manufacturers and human factors specialists. All acknowledged the significant size and scope of the problem, referencing specific drugs and packaging and labeling troubles. While such anecdotal information certainly provided proof of errors, assimilating such diverse input into one guidance may prove challenging for the agency.

Leading several discussion panels was Kellie Taylor, who serves as associate director for FDA's Division of Medication Error Prevention and Analysis in the Office of Surveillance and Epidemiology. She told the audience that "33 percent of medication error reports to the [Institute of Safe Medication Practices; ISMP] Medication Error Reporting Program may be attributed to packaging and labeling of drug products, including about 30 percent of all fatal errors." FDA currently does not have guidance for industry describing design aspects of carton labeling and container labels, but the agency "is hoping that the input for this meeting will be useful in developing our good naming, labeling, and packaging guidance," Taylor said.

Some of the errors could be attributed to what Taylor described as "small font size and illegible information that makes it difficult to read. . . . When you have these factors inserted into a carton or container label . . . on a shelf in a pharmacy, you can see how having cluttered information, labels that look alike, [and] labels that are poorly differentiated from other drug products can lead to error."

Michael Cohen, ISMP's president, listed several items that should stand out on labels. "The location of the concentration and strength and the volume in comparison to the strength, I think that's critically important," he said. "The use of warnings and reminders, where they're positioned, how easy they are to see, where they are located, how other important information is communicated, typography and the letter case that's used on labels, you touched on the dangerous abbreviation and dose designations, certainly that is critically important."

When branding or company logos are the most prominent items on labeling, other information could be difficult to find or simply fade into the background. "From my vantage point, I do understand how important it is for a pharmaceutical company to have their trademark for sales purposes, but that is the last thing on the mind of the user," said Bob Feroli, medication safety officer, The Johns Hopkins University. "The user wants to quickly, often under duress, [help] the patient [who] is acutely ill; we have to hurry, hurry, hurry, hurry. What I want to do is first identify the vial and what's in there.  What is the medicine in there?  We get into soundalike, lookalikes, problems with that."

There may also be too much "clutter" on labels. "From the user perspective, probably the biggest thing we hear is too much information," said Julie Aker, president and CEO, Concentrics Research LLC "Consumers and patients tell us is there is so much information, it becomes wallpaper.  And when it is wallpaper, now we're glazing over things that we all intended for them to see that are very important. How does a consumer or patient know information that's really, really important?  And how can we help them in that hierarchy of information?"

USP cautioned against using caps and ferrules for more than cautionary statements. "That could make a significant difference, especially for those doing administration, picking up the vial, knowing that the only thing they are going to see on the top of that vial is a cautionary statement," explained Shawn Becker, director, healthcare quality standards, USP.

Raising minimum font sizes may help. "Seven-point font is not sufficient for anybody sitting at this table," said Matthew Grissinger, director, ISMP's Error Reporting Programs. "You don't want a nurse deciding in a code situation how to read concentration of epinephrine.  And so that needs to be addressed as well."

David Lewis, Novartis Pharmaceuticals's global head, pharmacovigilance systems & safety data management, even suggested for vials, "Why put the text horizontally across it, why not put it vertically?"

Color coding has been lauded for its ability to differentiate products on shelves, but also criticized for providing a "crutch" that practitioners could come to rely upon in place of reading text. But color differentiation may emphasize key details. "Colors can be used to differentiate among strength within a product line by being sure to use colors that are sufficiently distinct from one another," said Patricia Manno, labeling compliance manager, labeling services, Merck & Co. "One must use colors of sufficient brightness against the label substrate and be aware that the use of many colors on a small label can hinder legibility and comprehension by increasing the visual complexity of the label."

Electronic technology offers hope, too. "We need to look at how technology can help prevent dispensing errors as well," stated Rich Hollander, vice president, packaging services, Pfizer Inc., and also a member of PMP News's Editorial Advisory Board. "We have to look at ways to close the gap between the regulations that drive manufacturers to put bar codes at most levels of packaging.  And how many dispensaries, either at the bedside or at the pharmacy shelf, are actually leveraging that bar code on there to help prevent dispensing errors, because we can only get so good. The rest we're going to have to rely on technology."

Other speakers agreed, and even called for expanded use of bar coding. James DeVita, director, quality assurance and patient safety, CVS Caremark, said that the bar code "certainly has had a tremendous impact on reducing product selection errors. But not all products have the bar code that we can leverage. For example, some bulk packages have a bar code on the outside of the box but the individual doses on the inside---the products that are dispensed to the patient---don't have a bar code." Added ISMP's Cohen: "It's time to extend the bar code beyond just the requirement for the National Drug Code to be part of it. It needs to have the expiration date and the lot number and perhaps some other information as well."

Perhaps the clearest summary of how packaging and labeling could be designed to reduce errors came from Joanne Kowiatek, pharmacy manager, medication patient safety, University of Pittsburgh Medical Center Presbyterian Shadyside. ""Bar code scanning does help if it is used properly and understood by the nursing staff," she said, adding that what is needed is "just clear information on the label. What is the total amount in this vial. [Is it] a multidose vial. What is the total concentration in here so I don't give the whole vial as the whole dose. Expiration dating . . . half the time you can't read it. It doesn't need to be that large, but you need to be able to see it to get rid of medications that are no longer good. It is difficult, you know, when looking at the vials because there are so many out there. There are so many colors. I think just having clarity on the label, removing all the extraneous, unnecessary information for the provider giving the medication is one of the most helpful things that I think we can do. "

Panelists also discussed the potential use of human factors studies and looking to FDA's Center for Devices and Radiological Health's guidance as an example. But speakers acknowledged that the cost and scope of such studies could be overwhelming. Generic drug makers wondered whether they could do much to change labeling beyond that of the reference-listed drug.
Read FDA's complete transcript for even more input, and be sure to provide your own by July 23.

Given the breadth of drug products that FDA regulates, is one universally applicable guidance even possible, and will it be able to address all medication errors? It is a tall order. Remember that FDA looks at a package and label in the context of a specific product application. Individual products may require individual solutions that can only be arrived at through your careful study and development.

FDA guidance will be helpful, though, especially for those in the industry that await mandates or guidances before making significant process or procedure shifts needed to implement innovative packaging and labeling. I understand industry's prudence. But in some aspects, only you may be able to ascertain product risk and what is needed to mitigate it.

Daphne Allen, Editor

Editor's Note: This article was e-mailed as the July 2010 ePackage e-newsletter. While the date for sending FDA comments on drafting guidance has past, it is never too late to focus reducing medical errors through your own development processes for packaging and labeling. Stay tuned for more news on FDA's guidance and individual companies' attempts to encourage safe product use.