June 5, 2009

Understanding of cold medicine labels lacking: study

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Russell Rothman, M.D., and colleagues are studying how well parents understand the labels on child cough and cold medicine. (photo by Susan Urmy)

Understanding of cold medicine labels lacking: study

Vanderbilt investigators have found that parents often misunderstand the product labels on over-the-counter cough and cold medicines for children.

Russell Rothman, M.D., assistant professor of Internal Medicine and Pediatrics at Vanderbilt Medical Center, is senior author of the study in June’s Pediatrics, entitled “Parental Misinterpretations of Over-the-Counter Pediatric Cough and Cold Medication Labels.” The lead author is Nicole Lokker, Pharm.D., from the University of Wisconsin, who performed the study during her Pharmacist residency at Vanderbilt.

The researchers went to clinics, many of which served at-risk populations, and surveyed 182 caregivers of children one year old or younger. They found most parents read labels incorrectly and said they would use the products shown in a child under the age of 2.

“This study has opened our eyes for how we, as parents, read and understand labels. There are important opportunities to change current labeling and improve parental understanding and child safety,” Rothman said.

The parents and caregivers were shown the labels of four children’s cold and cough products. While each product label specifically advised a doctor be consulted before use in a child younger than 2 two years old, nearly all those surveyed (86 percent), when looking at the front of the product, said it was appropriate for a child younger than 2. After examining the entire package, more than half of the time caregivers said they would give at least one of the products to a 13-month-old child with cold symptoms.

Rothman said a striking finding was that while almost every caregiver surveyed had adequate literacy skills, only 17 percent had “numeracy” skills at a ninth grade level.

Rothman has completed previous studies that show a large portion of the population in the United States has difficulty reading food labels properly because of low numeracy skills. He says this study is particularly important because medications can be harmful when used incorrectly in young children.

“People can understand more when there is plain language right on the front and when dosing tables are clear and placed more prominently on the label. It is also helpful if measuring devices that can be understood by all are included,” Rothman said. “But right now, none of those things are specifically required.”

In the time since the completion of the study in 2007, all four of the products in the study have been voluntarily pulled off the shelves by their manufacturers. The products were pulled after the FDA questioned the safety and efficacy of cold medicines for children and recommended they not be used under the age of 2. An FDA advisory committee has found the products may not even be safe and effective for use in children under age 6, although the FDA has not formally changed its recommendations in that age group. Currently, many manufacturers continue to market products aimed at children 4 years old and above.

Over-the-counter cough and cold medications have been implicated in the deaths of more than 100 infants nationwide over the last 40 years and have been associated with numerous hospital visits.

“A lot of these medications are not proven to be effective so parents should not rush to use them in the first place. Until we have requirements for clearer labeling, if parents are going to use over-the-counter medications they need to make sure the instructions are understood, and they should talk with their doctor or other health care provider before using them,” Rothman said.