Planned FDA guidance on drug labeling seeks to help reduce medication errors

July 20, 2010

FDA is once again tackling the naming, labeling, and packaging practices connected with drugs and biologics, according to a top official.

FDA is once again tackling the naming, labeling, and packaging practices connected with drugs and biologics, according to a top official.

The agency has made a commitment to publish a draft guidance to reduce medication errors by September 30, the end of fiscal year 2010. To read the FDA notice, log onto www.regulations.gov/ and input the docket number “FDA-2010-N-1068.” The deadline for comment is July 23.

A third of medication errors, including 30% of fatal errors reported to the Institute for Safe Medication Practices, may be attributed to packaging and labeling, FDA noted.

When asked during a 2-day workshop in June how any FDA decisions can be enforced, in light of the fact that discussion on these issues has continued for years, Carol Holquist, RPh, director of FDA’s Division of Medication Error Prevention and Analysis, said, “This is the first step in future development in regulation in that area.”

She told the hearing, “We start with guidance and then we can move to a more stringent requirement, which is regulation. But that can take about 10 to 15 years. So we have to start somewhere, and what we are trying to do is to hear the body of knowledge that is out there and come to a consensus.”

FDA is asking for comments on issues that include challenges to reducing the risk of medication errors connected with the design of container labels, carton labels, and packaging. It’s seeking information about the strengths and limitations of the types of research that study those challenges.

On the issue of proprietary naming, FDA said that frequent sources of errors include look-alike or sound-alike names, modifier omission or oversight, encoded numerals, failure to recognize the active ingredient, dangerous abbreviations and medical abbreviations, and the length of names.

Bona Benjamin, BS Pharm, director of Medication-Use Quality Improvement for the American Society of Health-System Pharmacists, told attendees at the June meeting that the 2007 recommendations ASHP had made to FDA still apply. Among other changes, human factors should be more scientifically applied to labeling and packaging, barcode verification should be promoted, and “FDA should get more muscle” to enforce rules, she asserted.

“If at all possible, dose expression needs to be standardized,” she urged. She also called for infusion concentration to be standardized, a recommendation that came from an ASHP’s 2008 IV Safety Summit.

Benjamin also indicated ASHP is opposed to using color to identify a medication, but not opposed to using it for other purposes.

She noted that almost 20% of hospitals have adopted barcode medication verification, which ASHP advocates, a rate of progress she called remarkable for an innovation.

Robert Feroli, PharmD, medication safety officer for Johns Hopkins Hospital, asserted that in an acute care setting injectables are the drugs most likely to hurt people. He urged that labels express “a clear articulation of what is in there, standard format for that information.”

Panel members at the meeting noted several other nations, particularly the United Kingdom, have a set of standards that addresses many of the issues the United States is now grappling with, including typography, color, testing, text size, and text orientation.

In May the U.S. Pharmacopeial Convention Health Literacy Panel issued recommendations for labels for dispensed prescription packaging, aimed at reducing patient error. That committee called for, among other things, organizing labels in the way that patients seek and understand instructions; using language that is clear, simplified, concise, and standardized; improving readability, including the purpose for use; and using explicit text to describe dosage and interval instructions.

Gerald McEvoy, PharmD, co-chair of the USP panel, told the FDA meeting that many of the same issues apply for health professionals. That committee is now developing a chapter, to be available for public comment this year, to include prescription container label standards.