FDA Works Toward Product Naming, Packaging Guidance

[August 15, 2010, AJHP News]

Kate Traynor

COLLEGE PARK, MD 30 July 2010—Pharmacists and other health care professionals in June urged FDA to standardize how medications are named and simplify labeling and packaging to help reduce medication errors.

The two-day public workshop, held in College Park, Maryland, was convened by FDA to gather input from stakeholders as the agency prepares a guidance document for industry on medication labeling, packaging, and naming practices.

"This is the first step in future development in regulation," said Carol Holquist, director of FDA's Division of Medication Error Prevention and Analysis (DMEPA). "What we are trying to do is consider the body of knowledge that's out there and come to a consensus."

She said that although preparing regulations can take "10 to 15 years," FDA hopes to produce a draft guidance document by the end of this fiscal year.

What's in a name? Look-alike and sound-alike drug names are a well-recognized source of medication errors, said Michael Cohen, president of the Institute for Safe Medication Practices (ISMP) and a member of the expert panel FDA convened for the June workshop. ISMP's website lists pairs of drug names that have been linked to medication errors, including problematic names for which the Joint Commission requires accredited health care organizations to take action to improve patient safety.

Robert E. Lee, assistant general patent counsel at Eli Lilly and Company, said the uniqueness of a drug's brand name is important to the product's manufacturer.

"Proprietary names are designed to differentiate products of one manufacturer from another," he said. Thus, a common goal for drug makers is to choose names that neither look nor sound like those of other products, although similarities sometimes occur, he said.

Thomas E. Ruth, director of trademark development for Pfizer, said naming a new drug product typically takes the company 2.5–3 years, during which more than 1000 names are evaluated.

He said the process includes a screening in which potential users of the drug and medication-error experts determine whether the name is "safe enough to take forward."

Too many modifiers. Several panelists said that confusion arises not just from a drug's brand name but also from the modifiers denoting different versions of the drug.

Matthew Grissinger, director of error reporting programs at ISMP, called BTA Pharmaceuticals Inc.'s Cardizem family of diltiazem hydrochloride oral products "an easy one to pick on" for heavy use of modifiers.

Within the Cardizem family, CD and SR denote extended-release capsules with different indications, while LA signifies extended-release tablets—and some formulations have identical strengths that must be indicated on the prescription. Grissinger said situations like this can lead to errors, especially if prescribers neglect to include the modifier in an order.

"The biggest issue is...confusion and lack of standardization," Grissinger said. "Practitioners have to remember all these modifiers."

"How does anybody ever get the right stuff?" wryly commented E. Robert Feroli, medication safety officer for the Johns Hopkins Hospital in Baltimore.

Feroli said modifiers cause safety issues for users of electronic order-entry systems. He said modifiers, especially if they consist of a single letter, may display on a separate line from the rest of the drug's name on a computer screen. He said prescribers may not see the modifier and can easily order the wrong medication.

Timothy Lesar, director of clinical pharmacy services at Albany Medical Center in New York, said confusion also arises when practitioners substitute a brand-name product having a certain modifier with a generic equivalent having a different modifier.

"They aren't synched, as it were," Lesar said of the modifiers. He also said health care providers may not know the differences between extended-release, sustained-release, and coated formulations of a particular product.

Lesar said FDA could help practitioners distinguish among different product formulations by attaching specific definitions to modifiers and requiring manufacturers to use those modifiers consistently.

Holquist noted that manufacturers have asked FDA to approve the use of new modifiers to convey that a new formulation within an existing product line can be taken with or without food.

"From our perspective, the modifiers don't convey anything" in such cases, Holquist said.

She said FDA also has to contend with manufacturers' desire to refresh their brands.

"Companies don't want to have the same modifier for years and years. They want to come up with something new and catchy," she said. If FDA allows such changes, she said, the agency must ensure that clinicians and consumers understand what the new branding conveys.

Labeling and packaging. Kellie Taylor, associate director of FDA's DMEPA, said many deadly medication errors have been attributed to problems with the products' packaging and labeling that lead to the administration of an incorrect product or dosage.

The Institute of Medicine in 2006 recommended that FDA work with a variety of stakeholders to develop, by the end of 2007, safety-related standards for drug packaging and labeling.

Taylor said common error sources include inadequate differentiation of products or product strengths; confusing, missing, or excessive information on the packaging and labeling; and the use of small type.

Several panelists also noted that graphic elements like company logos can consume space that would otherwise be available for conveying information that is essential to product users.

"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," Feroli said. "What I want to do is first identify the vial, and what's in there, [and] how much do I have to pull out of that to match the doctor's order. That's all I want to know. Those are the main elements that a user needs to know not to make an error."

Bona Benjamin, director of medication-use quality improvement for ASHP, told the panelists that many of ASHP's past recommendations for improving labeling practices, particularly for i.v. medications, remain applicable today. These include using bar-code verification to identify medications and making better use of human factors engineering—including the standardization of dosage and intended-use expressions on labels.

Benjamin also urged FDA to forbid the use of the same brand name for products with different active ingredients—a practice FDA refers to as umbrella branding. Benjamin gave as an example Novartis Corporation's Maalox Total Relief, which contains bismuth subsalicylate, in contrast to traditional Maalox antacid products, which contain aluminum hydroxide, magnesium hydroxide, and simethicone.

FDA in February warned that it had received reports of serious adverse events in patients who meant to use an antacid formulation of Maalox but instead purchased the salicylate-containing product.

"I don't understand why this is acceptable. I just don't," Benjamin said of umbrella branding.