FDA tackles drug packaging and safety, with help from error reports

Improvement processes for safe packaging also involve proper labeling and naming

These labels with the blue stripe. Those ampules with the black text. Sertraline, cetirizine. Celebrex, Cerebyx, Celexa. There’s nothing like look-alike, sound-alike (LASA) medications to set a pharmacist’s teeth gnashing—and with good reason: In its 2006 report, Preventing Medication Errors, the Institute of Medicine noted that 33% of all medication errors and 30% of deaths from medication errors stemmed from issues with medication labeling and packaging.

Since then, FDA’s Center for Drug Evaluation and Research has provided draft guidance to support the pharmaceutical industry’s efforts in developing proprietary names and making packaging and labeling more user-friendly, all with an eye toward improving patient safety and preventing medication errors.

At the heart of FDA’s efforts lies the Division of Medication Error Prevention and Analysis (DMEPA), which oversees premarket review of proposed proprietary medication names, labels and labeling, and packaging. DMEPA also conducts post-marketing surveillance activities to determine if regulatory action is required—and sometimes it is. 

Any discussion of drug packaging and safety should include labeling, said Michael R. Cohen, RPh, MS, ScD(hon), DPS(hon), FASHP, president at the Institute for Safe Medication Practices (ISMP) in Horsham, PA.

“Some companies will have a highly stylized label with their logo more prominent than the name of the drug, with colors, stripes, and all kinds of designs. It sometimes throws people off because they tend to see that more than the name of the drug and the strength,” Cohen said.

To try to counteract that, DMEPA has processes to ensure that the most important information is on the front of the package, printed with enough white space between text to be read easily. DMEPA also makes sure text is not superimposed by images or logos and that product strength stands out on labels, and cautions against nonstandard abbreviations (ie., using “μg”  for microgram, which can be mistaken for “mg”).

Cohen would like to see The Center for Biologics Evaluation and Research (CBER) adopt the same standards. “You can still see ‘u’ and ‘i.u.’ on biological products, and the u looks like a zero. You can end up giving 10 times the appropriate dose. I’d like to see CBER covered by DMEPA.”

Pharmacists have a responsibility to report safety issues involving drug naming, labeling, and packaging, according to Chelsea M. Anderson, PharmD, MBA, BCPS, project manager at the Center for Medication Safety Advancement at Purdue University College of Pharmacy in West Lafayette, IN.

“Although FDA puts out guidance and does their best to make sure you’re able to understand the label, we still need to be vigilant. If you identify issues, don’t expect someone else to report it. Report it to FDA, the manufacturer, and ISMP. That’s one way we can help continue to improve the process.”

Cohen agrees. “There have been hundreds, if not thousands, of changes, thanks to reporting programs used by pharmacists and nurses. We [at ISMP] publicize reports whenever possible. Manufacturers and FDA generally listen. It’s rare that a manufacturer doesn’t get it and isn’t interested in improving their product.”

For the full article, please visit www.pharmacytoday.org for the December 2017 issue of Pharmacy Today.