Efforts by manufacturers to improve the way they label and package drugs—prompted by new guidelines issued by the FDA just over a year ago—have been largely successful, according to the Institute for Safe Medication Practices (ISMP). The recommendations have made many companies prioritize the information on labels, avoid too similar designs among different products and standardize ways to indicate drug strengths.
“Poor design of container labels and carton labeling can obscure critical safety information,” said Irene Z. Chan, PharmD, BCPS, a safety evaluator in the FDA’s Division of Medication Error Prevention and Analysis, during a Dec. 19 conference hosted online by the ISMP.
Problematic names, labels and packaging contribute to 33% of all medication errors—including a proportionate number of fatalities—out of the annual total of 400,000 errors in the United States, according to a 2006 estimate by the Institute of Medicine.
To address this problem, the FDA issued a series of guidelines to drug manufacturers, beginning in December 2012. They describe ways to properly design drug products, cartons and container labels. The final recommendation, to be released this year, will address naming conventions for proprietary drugs.
Manufacturers’ recent steps to improve labeling safety have a long precedent, according to Michael R. Cohen, RPh, MS, ScD (hon.), FASHP, the president of the ISMP. “We feel pretty proud of the progress that’s been made over the last 20 years,” Dr. Cohen said during the Web conference. He attributed much of this progress to clinicians and patients who have reported problems to the ISMP and the FDA’s MedWatch. “I believe we have the safest drug product labeling and packaging around the world,” he stressed.
What Hospitals Can Do
There are several proactive steps that health systems can take to decrease errors related to drug labels, according to Kelly J. Besco, PharmD, a medication safety coordinator at OhioHealth in Columbus, Ohio, who was not involved with the ISMP conference. Various bar-coding technologies, for example, can “ensure you’re putting the right drug in the right location on an inpatient care unit, or ensure you are giving the correct medication by scanning the drug against a patient’s ID band prior to administration,” she told Pharmacy Practice News.
A cost-benefit analysis of the bar code system at Brigham and Women’s Hospital in Boston found an annual reduction of 517 adverse drug events, saving $2.2 million per year (Arch Intern Med 2007;167:788-794).
Such interventions, however, aren’t always sufficient to overcome poorly constructed containers or imprecise labels, Dr. Chan noted. “What we’ve found is that product design features that predispose end users to errors can often withstand interventions,” she said, including those efforts “focused on product labeling or education of health care providers or patients.”
That’s why the FDA has chosen to focus on the source of the problem—manufacturers with poorly designed labels—rather than on end users. Medication packaging and labels need to reflect the variety of factors that can influence an end user’s behaviors, Dr. Chan said. If manufacturers do not anticipate multiple environments of use, from hospital pharmacies to local drugstores, the lack of foresight can compound poor design problems, she noted.
Effects of Poor Labeling
Such faulty packaging has led to a variety of problems, including people ingesting topical Benadryl sold in drugstores. The container’s shape seemed to indicate it was intended for oral use, Dr. Besco said, and the description “Topical Analgesic” was written in “very, very small” letters on the original labels. “This was the most important piece of information for the consumer to acknowledge prior to taking the medication, and could have prevented the errors from occurring.”
In May 2010, the FDA reported that ingesting Benadryl Extra Strength Itch Stopping Gel caused cases of hallucinations and unconsciousness; in response, Benadryl maker Johnson & Johnson added a sticker with “For Skin Use Only” in large type on the cap.
In a clinical environment, improper type size also can cause harm. Dr. Chan cited the example of a vial of heparin that, with a quick glance at the large bold number on the label, appeared to contain 1,000 units. In actuality, the bold number listed the units per milliliter, and the full 30-mL vial totaled 30,000 units of heparin. “We have run into problems where people see concentration per milliliter and that doesn’t represent the whole content of vial,” Dr. Chan said. “That has led to overdoses.”
Indeed, several high-profile cases of heparin overdoses—some fatal—have occurred in recent years due to such confusion. The FDA responded by recommending that manufacturers follow the guidelines laid out in U.S. Pharmacopeial Convention Chapter <1>. The USP chapter stipulates that small-volume parenteral product labels should state the quantity of a drug per total volume before listing the per milliliter concentration (see photo). Several heparin vial manufacturers have revised their labeling to comply with that directive (Pharmacy Practice News, July 2013; http://bit.ly/1dzevxE).
What’s in a Name?
Labeling-related medication safety issues also can arise when clinicians have difficulty discerning between drug names or packaging. In the event that one drug is mistaken for another, Dr. Besco said, OhioHealth’s medication safety team will partner with pharmacy purchasers to determine if an alternative manufacturer offers the drug in a more distinctive container. Otherwise, the purchasers will try to obtain the drugs in different delivery systems, such as a prefilled syringe.
“There can be so many distractions on a label: corporate logos, different colors, highly stylized graphics,” Dr. Cohen told Pharmacy Practice News. Companies need to be willing to “work with front-line practitioners to test their products prior to marketing,” so pharmacists have a chance to evaluate how well these products are packaged.
No sources reported relevant financial conflicts of interest.