FDA advisory committees recommend not only standardizing language on OTC pediatric cough/cold product labels, but also dosing devices for the products.

The Nonprescription Drugs and Pediatric advisory committees on Oct. 18 and 19 discussed questions on the safety and efficacy of pediatric cough/cold products stated in a citizen petition submitted by pediatric experts in March (¹ Also see "FDA Panel Narrowly Votes Against Cough/Cold Drugs For Children Up To Age 6" - Pink Sheet, 22 October, 2007., p. 3).

NDAC member Ruth M. Parker, a pediatrician and an associate professor at the Emory University School of Medicine, asked the committees to consider standardizing the language on product labels, dosing devices and the units of measurement on the devices.

Parker emphasized standardization in labels and devices will help curb confusion commonly connected to misuse of the products (² Also see "FDA Review Of Children’s Cough/Cold OTCs Has Broader Implications" - Pink Sheet, 5 March, 2007., p. 3).

"We need to take a very serious look at what language should it be, very specifically, and how to communicate that in a standard way," she said.

Parker also said uniform wording better facilitates translating product usage and indication instructions into languages other than English. She added manufacturers should evaluate whether they should provide label instructions for OTC medications in other languages.

The American Pharmaceutical Association backs standardization of labels and devices. During her Oct. 19 presentation to the committees, APhA President Winnie A. Landis said standardization for OTC pediatric cough/cold products should include "Ask your doctor or pharmacist about the directions for this product" and "Do not use in children under two years of age."

"APhA does not support advertising or labeling for any prescription or OTC medication that is false or misleading, or any promotional efforts that encourage indiscriminate use of the medication. Product labeling should only reflect information that is supported by FDA's approval - that such a product is safe and effective for a given patient population and age group," said Landis, a Lafayette, Ind., pharmacist.

Committee members also addressed requiring clear and uniform messages on labels.

"It's got to be said one way - only one way," Parker said, asserting the importance of uniform warning labeling system and suggesting a standard for testing what works with consumers.

"People will not stop at stop signs if there are 20 different stop signs out there - we need one" sign, she said.

However, Richard A. Neill, a physician and an assistant professor of medicine and community health at the University of Pennsylvania School of Medicine, said he questions whether recommendations for a universal warning sign could be applied to the marketplace. Outside the monograph process, FDA's ability to influence label language is limited, added Neill, a temporary voting member for the meeting.

The committee voted unanimously in favor of the standardization of dosing devices across products marketed for the same indications.

"Currently, it varies product by product and by manufacturer and I think when you are asking people to understand subtle differences that are part of labeling that these ... the insistence of the variability is a root cause from misunderstanding this information and mistakes," Parker said.

Michael R. Cohen, a pharmacist and president and founder of the Huntington Valley, Pa.-based Institute for Safe Medication Practices, observed that consumers often confuse tablespoons and teaspoons.

"You can literally take a cup from one item and place it on a totally different drug without the family recognizing that," Cohen said.

Amy. J. Celento-Stamateris, a consumer representative from Nutley, N.J., and a temporary voting member, said more clarity is needed along with a "foolproof" system concerning dosing devices. "All the cups look the same ... it could be different and for a completely different medication," Celento-Stamateris said.

- Katie Stevenson (k.stevenson@elsevier.com)

Standardize Wording, Dosing Devices of Pediatric Cold Products – NDAC

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